Original Article
Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis
N Engl J Med 2000; 343:1520-1528November 23, 2000DOI: 10.1056/NEJM200011233432103
- Abstract
Background
Each year, clinical upper gastrointestinal events occur in 2 to 4 percent of patients who are taking nonselective nonsteroidal antiinflammatory drugs (NSAIDs). We assessed whether rofecoxib, a selective inhibitor of cyclooxygenase-2, would be associated with a lower incidence of clinically important upper gastrointestinal events than is the nonselective NSAID naproxen among patients with rheumatoid arthritis.
Methods
We randomly assigned 8076 patients who were at least 50 years of age (or at least 40 years of age and receiving long-term glucocorticoid therapy) and who had rheumatoid arthritis to receive either 50 mg of rofecoxib daily or 500 mg of naproxen twice daily. The primary end point was confirmed clinical upper gastrointestinal events (gastroduodenal perforation or obstruction, upper gastrointestinal bleeding, and symptomatic gastroduodenal ulcers).
Results
Rofecoxib and naproxen had similar efficacy against rheumatoid arthritis. During a median follow-up of 9.0 months, 2.1 confirmed gastrointestinal events per 100 patient-years occurred with rofecoxib, as compared with 4.5 per 100 patient-years with naproxen (relative risk, 0.5; 95 percent confidence interval, 0.3 to 0.6; P<0.001). The respective rates of complicated confirmed events (perforation, obstruction, and severe upper gastrointestinal bleeding) were 0.6 per 100 patient-years and 1.4 per 100 patient-years (relative risk, 0.4; 95 percent confidence interval, 0.2 to 0.8; P=0.005). The incidence of myocardial infarction was lower among patients in the naproxen group than among those in the rofecoxib group (0.1 percent vs. 0.4 percent; relative risk, 0.2; 95 percent confidence interval, 0.1 to 0.7); the overall mortality rate and the rate of death from cardiovascular causes were similar in the two groups.
Conclusions
In patients with rheumatoid arthritis, treatment with rofecoxib, a selective inhibitor of cyclooxygenase-2, is associated with significantly fewer clinically important upper gastrointestinal events than treatment with naproxen, a nonselective inhibitor.
Media in This Article
Figure 1
Cumulative Incidence of the Primary End Point of a Confirmed Upper Gastrointestinal Event among All Randomized Patients.Table 1
Criteria for Gastrointestinal Events.Article Activity
- Article
Nonsteroidal antiinflammatory drugs (NSAIDs) are among the most commonly used medications in the world.1 A major factor limiting their use is gastrointestinal toxicity. Although endoscopic studies reveal that gastric or duodenal ulcers develop in 15 to 30 percent of patients who regularly take NSAIDs,2 the chief concern is clinically important gastrointestinal problems, such as bleeding. It has been estimated that more than 100,000 patients are hospitalized and 16,500 die each year in the United States as a result of NSAID-associated gastrointestinal events.3,4
Most NSAIDs inhibit both cyclooxygenase-1 and cyclooxygenase-2, isoenzymes involved in the synthesis of prostaglandins.5 Cyclooxygenase-1 is constitutively expressed and generates prostanoids involved in the maintenance of the integrity of gastrointestinal mucosa and platelet aggregation,6 whereas at sites of inflammation, cyclooxygenase-2 is induced to generate prostaglandins that mediate inflammation and pain.7 The antiinflammatory effects of nonselective NSAIDs (those that inhibit both cyclooxygenase-1 and cyclooxygenase-2) therefore appear to be mediated through the inhibition of cyclooxygenase-2,8 whereas their harmful effects in the gastrointestinal tract as well as their antiplatelet effects are believed to occur primarily through the inhibition of cyclooxygenase-1.5
Agents that selectively inhibit cyclooxygenase-2 have antiinflammatory and analgesic effects that are similar to those of nonselective NSAIDs,9-12 but they induced significantly fewer ulcers in endoscopic trials.12-15 Whether such a decrease in the number of ulcers translates into a similar decrease in the number of clinical gastrointestinal events is a matter of controversy. We performed a prospective, randomized, double-blind comparison of rofecoxib and naproxen in more than 8000 patients with rheumatoid arthritis.
Methods
Study Population
Patients with rheumatoid arthritis who were at least 50 years old (or at least 40 years old and receiving long-term glucocorticoid therapy) and who were expected to require NSAIDs for at least one year were eligible. Patients were excluded if they had a history of another type of inflammatory arthritis, upper gastrointestinal surgery, or inflammatory bowel disease; an estimated creatinine clearance of 30 ml or less per minute; a positive test for fecal occult blood (this test was performed at base line in all patients); an unstable medical condition; a history of cancer or alcohol or drug abuse in the five years before the study; a history of cerebrovascular events in the two years before the study; or a history of myocardial infarction or coronary bypass in the year before the study. Patients with morbid obesity and those who required or who had been receiving treatment with aspirin, ticlopidine, anticoagulants, cyclosporine, misoprostol, sucralfate, or proton-pump inhibitors or treatment with histamine H2–receptor antagonists in prescription-strength doses were also excluded from the study. Patients enrolled in the study were not thought to require the use of these agents by their treating physicians.
Study Design
The study was conducted at 301 centers in 22 countries. Three to 14 days after discontinuing NSAIDs, eligible patients were randomly assigned to receive either 50 mg of rofecoxib (Vioxx, Merck, Whitehouse Station, N.J.) once daily or 500 mg of naproxen (Novopharm Biotech, Toronto) twice daily. The groups were stratified according to the presence or absence of a history of gastroduodenal ulcer, upper gastrointestinal bleeding, and gastroduodenal perforation. Blinding was achieved through the use of a matching placebo for each study medication.
Patients were permitted to take acetaminophen, non-NSAID analgesic medications, glucocorticoids, and disease-modifying drugs (e.g., methotrexate) to control their rheumatoid arthritis. Patients were also allowed to take antacids and H2-receptor antagonists in the following maximal doses: ranitidine, 150 mg daily; famotidine, 20 mg daily; cimetidine, 400 mg daily; and nizatidine, 150 mg daily. Nonstudy NSAIDs were not allowed. After randomization, the patients returned to the clinic at six weeks and at four months and every four months thereafter until the end of the study. Patients were contacted by telephone at week 10 and every four months thereafter. Compliance was assessed by pill counts at clinic visits and by questioning of patients during the scheduled telephone calls. Serum was obtained from all patients for Helicobacter pylori testing (HM-CAP, Enteric Products, Stonybrook, N.Y.). Investigators were not informed of the results of these tests during the study.
The institutional review board or ethics review committee at each center approved the protocol, and all patients gave written informed consent. A steering committee oversaw the study design, conduct of the trial, analyses of data, and drafting of this report. This committee was composed of 14 members, 2 of whom were employees of the sponsoring pharmaceutical company. An independent data and safety monitoring board monitored the patients' safety. An independent, external (end-point) committee whose members were unaware of the patients' treatment assignments reviewed the data to determine which patients had reached the study end points. Because highly selective cyclooxygenase-2 inhibitors do not inhibit platelet aggregation, which is mediated by cyclooxygenase-1, there was a possibility that the incidence of thrombotic cardiovascular events would be lower among patients treated with nonselective cyclooxygenase inhibitors than among those treated with cyclooxygenase-2–selective inhibitors. Therefore, cardiovascular events were also assessed for a future meta-analysis by independent committees whose members were unaware of the patients' treatment assignments. A separate analysis of these events, however, was not specified in the study design.
Study End Points
Patients who had potential clinical upper gastrointestinal events were evaluated and treated according to the standard practice of the physicians who were caring for them. Patients who stopped taking the study medication before the study ended were followed until the end of the study to determine whether an upper gastrointestinal event had occurred. Only events that were confirmed by the end-point committee according to prespecified criteria (Table 1Table 1
Criteria for Gastrointestinal Events.) and that occurred during treatment or within 14 days after the discontinuation of treatment were included in the primary analysis.In addition, the protocol called for the analysis of all episodes of gastrointestinal bleeding, including confirmed and unconfirmed episodes of upper gastrointestinal bleeding, and bleeding from a site beyond the duodenum that resulted in hospitalization, discontinuation of treatment, or a decrease in the hemoglobin level of at least 2 g per deciliter.
Assessment of Efficacy
For each patient both the investigator and the patient answered a Global Assessment of Disease Activity question at base line (after the discontinuation of prestudy NSAIDs), 6 weeks, 4 months, and 12 months and at the end of the study or when treatment was discontinued. The score can range from 0 (“very well”) to 4 (“very poor”), and higher scores indicate more disease activity. The Modified Health Assessment questionnaire was administered only to patients enrolled at centers in the United States at base line, at six weeks, and at the end of the study or when treatment was discontinued. This questionnaire evaluates the extent of functional disability in eight types of tasks performed on a daily basis. The level of effort required to perform each task is assessed on a 4-point scale on which a score of 0 indicates no difficulty in performing the task and a score of 3 indicates an inability to perform the task.16 Higher scores indicate more severe disability.
Statistical Analysis
The primary hypothesis was that the risk of confirmed upper gastrointestinal events (gastroduodenal perforation or obstruction, upper gastrointestinal bleeding, and symptomatic gastroduodenal ulcers) would be lower among patients who were taking rofecoxib than among those who were taking naproxen. Secondary hypotheses were that the risk of confirmed complicated events (perforation, obstruction, and severe upper gastrointestinal bleeding) and the risk of both confirmed and unconfirmed upper gastrointestinal events would be lower among patients who were taking rofecoxib.
Cox proportional-hazards analysis was used to compare the effect of treatment; the presence or absence of a history of gastrointestinal events was a stratification factor in the analysis.17,18 The scores for the Global Assessment of Disease Activity question and Modified Health Assessment questionnaire were analyzed in terms of the mean change from base line during the treatment period. The primary population for analysis comprised all randomized patients. Subgroup analyses were conducted with use of Cox regression analysis.17,18 Interactions between treatments and subgroups were assessed to determine whether the effect of rofecoxib as compared with that of naproxen was consistent in the subgroups. We assessed data on general safety by evaluating 95 percent confidence intervals of the differences in the proportions of the treatment groups with each adverse event.19 All statistical tests were two-sided.
Results
Characteristics of the Patients
Between January 1999 and July 1999, we screened 9539 patients and enrolled 8076; 4047 were randomly assigned to receive rofecoxib, and 4029 to receive naproxen. The major reasons for exclusion were a contraindication to prolonged NSAID therapy (in the case of 246 patients), a positive test for fecal occult blood (203 patients), and a failure to meet inclusion criteria (355 patients). The median follow-up was 9.0 months in both treatment groups (range, 0.5 to 13). A total of 5742 patients (71.1 percent) continued to take their assigned medication until the end of the study. Rates of discontinuation were similar in the two groups: 29.3 percent in the rofecoxib group (16.4 percent because of adverse events, 6.3 percent because of a lack of efficacy, and 6.6 percent for other reasons) and 28.5 percent in the naproxen group (16.1 percent because of adverse events, 6.5 percent because of a lack of efficacy, and 5.9 percent for other reasons). Ninety-nine percent of the patients in both groups took their medication on at least 75 percent of the study days. The base-line characteristics were similar in the two groups (Table 2Table 2
Base-Line Characteristics of the Patients.).Efficacy
Rofecoxib and naproxen had similar efficacy against rheumatoid arthritis (Table 3Table 3
Effectiveness of Rofecoxib and Naproxen for Rheumatoid Arthritis.). In addition, the rates of discontinuation of treatment owing to a lack of efficacy were low in both groups (6.3 percent in the rofecoxib group and 6.5 percent in the naproxen group).Adverse Gastrointestinal Events
Confirmed upper gastrointestinal events occurred in 177 patients. In 53 of these patients the event was complicated. An additional 13 patients had events that were reported by investigators but that were judged by the end-point committee to be unconfirmed.
The time to the development of a confirmed upper gastrointestinal event is shown in Figure 1Figure 1
Cumulative Incidence of the Primary End Point of a Confirmed Upper Gastrointestinal Event among All Randomized Patients.. The rates per 100 patient-years and incidences of the prespecified clinical events are shown in Table 4Table 4
Incidence of Gastrointestinal Events in the Treatment Groups. and Table 5Table 5
Incidence of Confirmed Upper Gastrointestinal Events., respectively. The relative risk of confirmed upper gastrointestinal events for patients in the rofecoxib group as compared with those in the naproxen group was 0.5 (95 percent confidence interval, 0.3 to 0.6; P<0.001), whereas the relative risk of complicated confirmed upper gastrointestinal events was 0.4 (95 percent confidence interval, 0.2 to 0.8; P=0.005). The relative risk of complicated upper gastrointestinal bleeding for patients in the rofecoxib group as compared with those in the naproxen group was 0.4 (95 percent confidence interval, 0.2 to 0.7; P= 0.004), whereas the relative risk of bleeding beyond the duodenum was 0.5 (95 percent confidence interval, 0.2 to 0.9; P=0.03).A per-protocol analysis of the 7925 patients without substantial protocol violations demonstrated relative risks of confirmed upper gastrointestinal events and complicated confirmed events of 0.4 (95 percent confidence interval, 0.3 to 0.6; P<0.001) and 0.4 (95 percent confidence interval, 0.2 to 0.7; P= 0.003), respectively. The results of an intention-to-treat analysis of all confirmed upper gastrointestinal events throughout the study, including those that occurred at any time after the discontinuation of treatment, were similar and remained statistically significant (data not shown).
Subgroup analyses showed the following relative risks of clinical gastrointestinal events among the patients in the rofecoxib group as compared with those in the naproxen group: patients with no prior gastrointestinal events (relative risk, 0.5; 95 percent confidence interval, 0.3 to 0.7), patients with prior gastrointestinal events (relative risk, 0.4; 95 percent confidence interval, 0.2 to 0.8), patients with no glucocorticoid therapy at base line (relative risk, 0.7; 95 percent confidence interval, 0.4 to 1.2), and patients with glucocorticoid therapy at base line (relative risk, 0.4; 95 percent confidence interval, 0.2 to 0.6). The relative risks in these subgroups and the other prespecified subgroups (defined according to sex, race or ethnic group, and location of study center) were not significantly different, indicating that there was no significant interaction between the treatments and the subgroups.
Treatment with rofecoxib was associated with a significantly lower incidence of clinical gastrointestinal events regardless of the results of serologic tests for H. pylori. However, the relative risks of clinical events among H. pylori–negative patients and H. pylori–positive patients were significantly different (P=0.04, data not shown). Finally, the relative risk of gastrointestinal events remained significantly lower (0.1; 95 percent confidence interval, 0.02 to 1.0) in the rofecoxib group than in the naproxen group even in a subgroup at very low risk (i.e., patients who were younger than 65 years, who were negative for H. pylori, who had no history of a clinical gastrointestinal event, and who were not taking glucocorticoids at base line).
General Safety
The safety of both rofecoxib and naproxen was similar to that reported in previous studies.20,21 The mortality rate was 0.5 percent in the rofecoxib group and 0.4 percent in the naproxen group. The rate of death from cardiovascular causes was 0.2 percent in both groups. Ischemic cerebrovascular events occurred in 0.2 percent of the patients in each group. Myocardial infarctions were less common in the naproxen group than in the rofecoxib group (0.1 percent vs. 0.4 percent; 95 percent confidence interval for the difference, 0.1 to 0.6 percent; relative risk, 0.2; 95 percent confidence interval, 0.1 to 0.7). Four percent of the study subjects met the criteria of the Food and Drug Administration (FDA) for the use of aspirin for secondary cardiovascular prophylaxis (presence of a history of myocardial infarction, angina, cerebrovascular accident, transient ischemic attack, angioplasty, or coronary bypass)22 but were not taking low-dose aspirin therapy. These patients accounted for 38 percent of the patients in the study who had myocardial infarctions. In the other patients the difference in the rate of myocardial infarction between groups was not significant (0.2 percent in the rofecoxib group and 0.1 percent in the naproxen group). When the data showing a reduction in the rate of myocardial infarction in the naproxen group became available after the completion of this trial, Merck, the manufacturer of rofecoxib, notified all investigators in ongoing studies of a change in the exclusion criteria to allow patients to use low-dose aspirin. There was no association between hypertension and myocardial infarction; only a single patient (in the rofecoxib group) had both hypertension and a myocardial infarction as adverse events.
The most common adverse events leading to discontinuation of treatment, excluding the gastrointestinal end points, were dyspepsia, abdominal pain, epigastric discomfort, nausea, and heartburn. In the rofecoxib group, significantly fewer patients discontinued treatment as a result of any one of these five upper gastrointestinal symptoms than in the naproxen group (3.5 percent vs. 4.9 percent). The rates of discontinuation for any gastrointestinal events, including gastrointestinal end points, were also significantly lower in the rofecoxib group than in the naproxen group (7.8 percent vs. 10.6 percent). The incidence of adverse effects related to renal function was low and was similar in the two groups (1.2 percent in the rofecoxib group and 0.9 percent in the naproxen group); only 0.2 percent of patients in each group discontinued treatment because of these adverse effects.
Discussion
We found that, in patients with rheumatoid arthritis, treatment with rofecoxib at twice the maximal dose approved by the FDA for long-term use resulted in significantly lower rates of clinically important upper gastrointestinal events and complicated upper gastrointestinal events than did treatment with a standard dose (1000 mg per day) of naproxen. We also found that the incidence of complicated upper gastrointestinal bleeding and bleeding from beyond the duodenum was significantly lower among patients who received rofecoxib. Only 41 patients would need to be treated with rofecoxib rather than naproxen to avert one clinical upper gastrointestinal event in a one-year period. Although the optimal dose of rofecoxib for the treatment of rheumatoid arthritis has yet to be determined, data from a prior study indicate that maximal efficacy is achieved at a daily dose of 25 mg.23
A prospective study that compared NSAIDs alone with NSAIDs plus misoprostol reported that 0.95 percent of patients with rheumatoid arthritis who were taking an NSAID alone had upper gastrointestinal complications over a period of six months,24 with a relative reduction in the risk of such complications with combination treatment of 40 percent during this period. These results are similar to our finding of a cumulative incidence of serious upper gastrointestinal events over a six-month period of 0.75 percent in the naproxen group and a relative reduction in risk of 67 percent in the rofecoxib group (data not shown). A 50 percent reduction in the incidence of clinically important upper gastrointestinal events with rofecoxib as compared with a nonselective NSAID was also found in a prespecified combined analysis of eight double-blind studies that included 4921 patients with osteoarthritis, none of whom received glucocorticoids.25 Patients with rheumatoid arthritis have a higher risk of upper gastrointestinal events than do patients with osteoarthritis.4 Thus, the results of our study extend the results of the combined analysis to a group of patients at higher risk of bleeding.
The results of a randomized, double-blind comparison of the cyclooxygenase-2–selective inhibitor celecoxib and the nonselective NSAIDs ibuprofen and diclofenac were recently published.26 In this trial of 7968 patients, 73 percent of whom had osteoarthritis and 27 percent of whom had rheumatoid arthritis, data were reported from the first 6 months of a study period that extended for up to 13 months. Treatment with celecoxib was associated with a nonsignificant (P=0.09) trend toward a decrease in the incidence of the primary end point (complicated ulcers and erosions) and a significant decrease (P=0.02) in the incidence of the secondary end point (complicated and symptomatic ulcers).
The incidence of clinically important gastrointestinal events was lower in the rofecoxib group than in the naproxen group in all subgroups we examined. Concomitant glucocorticoid and NSAID therapy has been reported to be associated with a higher risk of a clinical gastrointestinal event than is NSAID therapy alone.4 Therefore, a larger reduction in the incidence of events might have been expected in the subgroup that received both an NSAID and glucocorticoids. There was a greater reduction in the relative risk of events in the subgroup of patients who were taking glucocorticoids at base line than in the subgroup of patients who were not taking glucocorticoids at base line, but the difference between the groups was not significant.
Whether ulcers identified by endoscopic examination are markers of a clinical gastrointestinal event has been a matter of controversy. The relative reduction in the risk of such ulcers in two identical studies that compared 50 mg of rofecoxib daily with 800 mg of ibuprofen three times a day was 71 percent at six months.13,14 Thus, our findings support the concept that the results of endoscopic studies of ulcers can be extrapolated to clinical gastrointestinal events.
In prior endoscopic studies, the frequency of ulcers was similar in patients taking rofecoxib and those taking placebo.13,14 We could not include a placebo group, and no studies have yet assessed whether a cyclooxygenase-2–selective inhibitor or the combination of nonselective NSAIDs plus gastroprotective drugs (such as misoprostol and proton-pump inhibitors) will achieve similar results.
Gastrointestinal symptoms are extremely common with NSAID therapy, as demonstrated by the fact that, in our study, the five most common adverse events leading to the discontinuation of treatment were upper gastrointestinal symptoms. Although gastrointestinal symptoms are poorly correlated with endoscopic findings of ulcers or clinical gastrointestinal events,27 significantly fewer patients in the rofecoxib group than in the naproxen group discontinued treatment because of gastrointestinal symptoms.
The overall mortality rate was similar in the two groups, as were the rates of death from gastrointestinal events and from cardiovascular causes. The rate of myocardial infarction was significantly lower in the naproxen group than in the rofecoxib group (0.1 percent vs. 0.4 percent). This difference was primarily accounted for by the high rate of myocardial infarction among the 4 percent of the study population with the highest risk of a myocardial infarction, for whom low-dose aspirin is indicated.22 The difference in the rates of myocardial infarction between the rofecoxib and naproxen groups was not significant among the patients without indications for aspirin therapy as secondary prophylaxis.
Naproxen inhibits the production of thromboxane by 95 percent and inhibits platelet aggregation by 88 percent, and this effect is maintained throughout the dosing interval28; therefore, the effects of regular use of naproxen may be similar to those of aspirin. Flurbiprofen, another NSAID that is a potent inhibitor of platelet-derived thromboxane, led to a 70 percent reduction in the rate of reinfarction as compared with placebo among patients in whom acute myocardial infarction was successfully treated with thrombolysis, angioplasty, or both.29
Analyses of 7535 patients in double-blind trials comparing rofecoxib with placebo and other NSAIDs (diclofenac, ibuprofen, and nabumetone) that do not produce sustained, maximal inhibition of platelet aggregation revealed similar rates of myocardial infarction in all groups30 (and unpublished data). Thus, our results are consistent with the theory that naproxen has a coronary protective effect and highlight the fact that rofecoxib does not provide this type of protection owing to its selective inhibition of cyclooxygenase-2 at its therapeutic dose and at higher doses. The finding that naproxen therapy was associated with a lower rate of myocardial infarction needs further confirmation in larger studies.
In summary, the use of the cyclooxygenase-2–selective inhibitor rofecoxib resulted in significantly fewer clinically important upper gastrointestinal events than did treatment with naproxen, a nonselective NSAID. The two drugs had similar rates of clinical effectiveness.
Supported by a grant from Merck.
Dr. Bombardier has received clinical research support from Aventis Pharma, Merck Research Laboratories, and Merck Frosst Canada. She has served as a consultant to Knoll Pharmaceutical, Aventis Canada, Schering Canada, Merck Research Laboratories, and Wyeth–Ayerst.
Dr. Laine has received clinical research support from Merck, Wyeth–Ayerst, and AstraZeneca. He has served as a consultant to Merck, Searle, Johnson & Johnson, AstraZeneca, Wyeth–Ayerst, and Tap Pharmaceuticals.
Dr. Burgos-Vargas has received clinical research support from Merck Sharp & Dohme, Pfizer, and Boehringer Ingelheim. He has served as a consultant to Merck and has been a member of a speakers' bureau sponsored by Merck Sharp & Dohme.
Dr. Davis has served as a consultant to Mirvant, Merck Research Laboratories, Parke-Davis, and SmithKline Beecham.
Dr. Day has received clinical research support from Merck, Searle, Pfizer, Roche, and Amgen. He has served as a consultant to Merck, Searle, and Pfizer. He has been a member of speakers' bureaus sponsored by Merck Sharp & Dohme, Searle, Pfizer, and SmithKline Beecham.
Dr. Ferraz has received clinical research support from Bristol-Myers Squibb, Merck Sharp & Dohme, and Aventis Pharma. He has served as a consultant to Aventis Pharma.
Dr. Hawkey has received clinical research support from AstraZeneca, Asta Medica, Boehringer Ingelheim, Boots Healthcare International, Cell Tech, Eisai, Elan, Merck Research Laboratories, NicOx, and Novartis. He has served as a consultant to AstraZeneca, Abbott, Cell Tech, Eisai, Merck Research Laboratories, NicOx, Novartis, Parke-Davis, and Synthelabo Pharmacie. He has been a member of speakers' bureaus sponsored by AstraZeneca, Boehringer Ingelheim, Boots Healthcare International, Takeda, Wyeth Lederle, and Merck Research Laboratories.
Dr. Hochberg has received clinical research support from Merck and Quintiles (Aventis Pharma). He has served as a consultant to Aventis Pharma, Biomatrix, Merck, Negma Laboratories, Procter & Gamble, Roche, and Wyeth–Ayerst. He owns stock in Johnson & Johnson, Eli Lilly, Merck, Procter & Gamble, and Schering-Plough.
Dr. Kvien has received clinical research support from Merck, Searle, Aventis Pharma, and Schering-Plough. He has served as a consultant to Merck, Searle, Aventis Pharma, and Schering-Plough. He has been a member of a speakers' bureau sponsored by Merck and Aventis Pharma.
Dr. Schnitzer has received clinical research support from Abbott, Boehringer Ingelheim, Johnson & Johnson, McNeil Consumer Products, Merck, Novartis, Ortho-McNeil, Parke-Davis, Searle, and Wyeth–Ayerst. He has served as a consultant to Boehringer Ingelheim, Merck, Novartis, Ortho-McNeil, Searle, and SmithKline Beecham. He has been a member of speakers' bureaus sponsored by Boehringer Ingelheim, Merck, Ortho-McNeil, Wyeth–Ayerst, and Searle.
Dr. Weaver has received clinical research support from Merck, Searle, Immunex, Wyeth–Ayerst, Aventis Pharma, Pharmacia–Upjohn, Eli Lilly, Connetics, Parke-Davis, Procter & Gamble, Pfizer, Hoffmann–LaRoche, Centocor, Amgen, Cyprus Bioscience, Helsinn, Novartis, and Boehringer Ingelheim. He has served as a consultant to Merck, Searle, Immunex, Wyeth–Ayerst, Aventis Pharma, Pharmacia–Upjohn, Eli Lilly, Connetics, Parke-Davis, Procter & Gamble, Pfizer, Hoffmann–LaRoche, Centocor, Amgen, Cyprus Bioscience, Helsinn, Novartis, and Boehringer Ingelheim. He has been a member of speakers' bureaus sponsored by Merck, Searle, Immunex, Wyeth–Ayerst, Aventis Pharma, Pharmacia–Upjohn, Eli Lilly, Connetics, Parke-Davis, Procter & Gamble, Pfizer, Hoffmann–LaRoche, Centocor, Amgen, Cyprus Bioscience, Helsinn, Novartis, and Boehringer Ingelheim. He is on the board of directors of MGI Pharma.
We are indebted to Christopher T. Brett, Dayna Carroll, Russell Cender, Edward Chafart, Laurine Connors, Gary Gartenberg, Nicole Gillies, Richard Holmes, Paige Reagan, Douglas J. Watson, Debora P.L. Weiss, and Qinfen Yu for their substantial contributions.
Source Information
From the Institute for Work and Health, Mount Sinai Hospital, and the University Health Network, Toronto (C.B.); the Gastrointestinal Division, Department of Medicine, University of Southern California School of Medicine, Los Angeles (L.L.); Merck, Rahway, N.J. (A.R., D.S.); the Faculty of Medicine and Research Division, Universidad Nacional Autonoma de Mexico, and Hospital General de Mexico, Mexico City, Mexico (R.B.-V.); University of Texas–Houston School of Public Health, Houston (B.D.); the Department of Clinical Pharmacology, University of New South Wales and St. Vincent's Hospital, Sydney, Australia (R.D.); the Division of Rheumatology, Department of Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil (M.B.F.); the Division of Gastroenterology, School of Medical and Surgical Sciences, University Hospital, Nottingham, United Kingdom (C.J.H.); the Division of Rheumatology and Clinical Immunology, University of Maryland, Baltimore (M.C.H.); Oslo City Department of Rheumatology, and Diakonhjemmet Hospital, Oslo, Norway (T.K.K.); and the Office of Clinical Research and Training, Northwestern University School of Medicine, Chicago (T.J.S.). Arthur Weaver, M.D., Arthritis Center of Nebraska, Lincoln, was another author.
Address reprint requests to Dr. Bombardier at the Institute for Work and Health, 250 Bloor St. E., Suite 702, Toronto, ON M4W 1E6, Canada, or at claire.bombardier@utoronto.ca.
Appendix
The following persons participated in the study: International Steering Committee: C. Bombardier (chair), L. Laine (cochair), A. Reicin, M. Hochberg, R. Day, T. Capizzi, P. Brooks, R. Burgos-Vargas, B. Davis, M. Ferraz, C. Hawkey, T.K. Kvien, T. Schnitzer, A. Weaver; Data Safety Board: M. Weinblatt (chair); D. Bjorkman, J. Neaton, A. Silman, R. Sturrock; End-Point Adjudication Committee: M. Griffin (chair), D. Jensen, M. Langman; Investigators: Argentina: E. DiGiorgio, H. Laborde, O. Messina, A. Strusberg; Australia: J. Bertouch, R. Day, G. McColl, P. Ryan, S. Sharma; Brazil: R. Bonfiglioli, C. Borges, J. Brenol, N. da Silva, M. Ferraz, F. Lima, C. Moreira, G. Novaes, A. Pessoa, F. Petean, S. Radominski, A. Samara, B. Souza; Canada: T. Anastassiades, M. Atkinson, A. Beaulieu, M. Bell, M. Camerlain, J. Canvin, M. Cohen, J. Hanly, J. Karsh, T. McCarthy, W. Olszynski, P. Patel, Y. Pesant, W. Pruzanski, K. Siminovitch, J. Thome, V. Verdejo-Aguilar; Chile: L. Barria, C. Fuentealba, L. Massardo, P. Riedemann, L. Roca, H. Rossi; China (Hong Kong): C. Lau; Colombia: M. Abello, P. Chalem, M. Jannault, J. Molina; Costa Rica: R. Alpizar, H. Garcia-Sancho; Czech Republic: L. Konecna, K. Pavelka, M. Sealackova, J. Vitova, R. Ahora; Ecuador: R. Villacis; Finland: M. Hakala, P. Hannonen, T. Helve, M. Nissila; Germany: R. Alten, M. Gaubitz, E. Gromnica-Ihle, H. Hantzschel, G. Hein, M. Keysser, R. Kurthen, B. Lang, F. Mielke, U. Muller-Ladner, C. Richter, M. Schattenkirchner, M. Schneider, H. Sorenson, E. Waldorf-Bolten, H. Watnatz, S. Wassenberg; Guatemala: E. Julian, R. Palomo; Israel: D. Buskila, A. Nahir, I. Rosner; Malaysia: S. Yeap; Mexico: R. Burgos, I. Garcia de la Torre, F. Irazoque, J. Arozco Alcala; New Zealand: P. Jones, L. McLean, C. Rajapakse; Norway: H. Gulseth, K. Helgetveit, A. Johannessen, C. Kaufmann, O. Knudsrod, T. Kvien, K. Mikkelsen, B. Rossebo, G. Sidenwall; Peru: A. Calvo Quioz, M. Gustavo, A. Hilgado, L. Portocarrero, E. Vera Bejar; Poland: J. Badurski, J. Brzezicki, M. Bykowska, I. Fiedorowicz-Fabrycy, J. Gaweda, P. Gluszki, B. Konieczna, S. Mackiewicz, J. Pazdur, L. Szczepanski, J. Szechinski; South Africa: I. Anderson, D. Gotlieb, A. Jacovides, A. Lubbe, G. Mody, M. Tikly; United States: Alabama: G. Divititorio, S. Fallahi, D. McLaine, W. Shergy, M.S. Touger, G. Williams; Arizona: B. Harris, P. Howard, D. Michel, L. Taber, J. Tesser, M. Maricic; California: E. Boiling, M. Brandon, G. Dolan, R. Dore, M. Greenwald, D. Haselwood, M. Keller, K. Kolba, C. Multz, R. Reid, D. Stanton, C. Weidmann, S. Weiner, J. Higashida; Colorado: S. Kassan, R. Lapidus, D. Scott, J. Thompson, C. Van Kerchov; Connecticut: E. Feinglass, J. Green, R. Schoen; Florida: M. Beilian, C. Chappel, J. Forstot, P. Freeman, N. Gaylis, B. Germain, M. Guttierrez, M. Heier, T. Johnson, M. Kaufman, R. Levin, M. Lowenstein, A. Marcadis, M. Mass, S. Matthews, H. McIlwain, J. Miller, M. Nunez, H. Offenberg, J. Popp, A. Reddy, W. Riskin, A. Rosen, Y. Sherrer, K. Stark, A. Torres; Georgia: J. Lieberman; Iowa: M. Brooks; Idaho: F. Dega, C. Scoville, C. Wiesenhutter; Illinois: F. Dietz, I. Fenton, M. Pick, R. Trapp, J. Zuzga, M. Ellman, G. Liang; Indiana: C. Arsever, R. Khairi, M. Stack, R. Fife; Kansas: N. Becker, P. Ginder, R. Lies; Louisiana: W. Eversmeyer, P. Sedrish, L. Serebro; Maine: L. Anderson, S. Block; Maryland: R. Marcus, D. McGinnis, N. Wei, T. Zizic, M. Hochberg; Massachusetts: C. Birbara, A. Dahdul, S. Helfgott, J. Hosey, S. Miller, R. Rapoport; Michigan: P. Coleman, R. Roschmann, H. Uhl, J. Taborn; Missouri: T. Weiss; Montana: S. English; Nebraska: W. Palmer, A. Weaver; Nevada: S. Miller; New Hampshire: B. Samuels, J. Trice; New Jersey: S. Golombek, H. Hassman, R. Hymowitz, C. Knee, D. Macpeek, R. Marcus, G. Rihacek, J. Rohlf, D. Worth; New Mexico: K. Bordenave; New York: P. Chatpar, M. Farber, A. Kaell, A. Porges, P. Riccardi, C. Ritchlin; North Carolina: G. Arnold, W. Chmelewski, G. Collins, W. Harperm, R. Harrell, T. Littlejohn, G. Schimizzi, R. Senter, A. Kashif; Ohio: T. Isakov, B. Long, D. Mandel, B. Rothschild, D. Schumacher, R. Sievers, S. Wolfe, K. Hackshaw, M. Hooper, R. Rothenberg; Oklahoma: C. Codding, R. Hynd, J. McKay, L. Jacobs; Pennsylvania: R. Kimelheim, A. Kivitz, W. Makarowski, G. McLaughlin, J. McMillen, R. Reese, J. Weisberg; Rhode Island: J. Scott; South Carolina: C. Barfiels, M. Brabham, K. Flint; Tennessee: C. Arkin, R. Gupta, R. Krause, H. Marker, T. Namey, L. Robinson, P. Wheeler, B. Tanner; Texas: A. Brodsky, F. Burch, W. Chase, A. Chubick, D. Halter, J. Rutstein; Utah: J. Booth; Virginia: C. Fisher, A. Goldstein; Washington: W. Eider, R. Ettlinger, R. Levy; Wisconsin: M. Pearson, G. Fiocco.
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C. Sierra Benito. (2005) Hipertensión arterial en las enfermedades autoinmunes y sistémicas. Hipertensión y Riesgo Vascular 22:1, 21-31
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U. Grundmann, J. U. Schreiber. (2004) Selektive Zyklooxygenase-2-Inhibitoren zur postoperativen Schmerztherapie. Der Anaesthesist 53:12, 1211-1218
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Jan C. Becker, Wolfram Domschke, Thorsten Pohle. (2004) Current approaches to prevent NSAID-induced gastropathy - COX selectivity and beyond. British Journal of Clinical Pharmacology 58:6, 587-600
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Jennifer M. Stephens, Chris L. Pashos, Seema Haider, Josephine M. Wong. (2004) Making Progress in the Management of Postoperative Pain: A Review of the Cyclooxygenase 2–Specific Inhibitors. Pharmacotherapy 24:12, 1714-1731
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Xuemei Luo, Ricardo Pietrobon, Lesley H. Curtis, Lloyd A. Hey. (2004) Prescription of Nonsteroidal Anti-inflammatory Drugs and Muscle Relaxants for Back Pain in the United States. Spine 29:23, E531-E537
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D. J. Watson, J. A. Bolognese, C. Yu, D. Krupa, S. Curtis. (2004) Use of gastroprotective agents and discontinuations due to dyspepsia with the selective cyclooxygenase-2 inhibitor etoricoxib compared with non-selective NSAIDs*. Current Medical Research and Opinion 20:12, 1899-1908
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Mary F. Walter, Robert F. Jacob, Charles A. Day, Rachel Dahlborg, Yujia Weng, R. Preston Mason. (2004) Sulfone COX-2 inhibitors increase susceptibility of human LDL and plasma to oxidative modification: comparison to sulfonamide COX-2 inhibitors and NSAIDs. Atherosclerosis 177:2, 235-243
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Stephen Y. Chang, Colin W. Howden. (2004) Is no NSAID a good NSAID? approaches to NSAID-associated upper gastrointestinal disease. Current Gastroenterology Reports 6:6, 447-453
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Steven A. Mazzuca, Kenneth D. Brandt, Barry P. Katz, Linda R. Ragozzino, Patricia M. G??Sell. (2004) Can a Nurse-Directed Intervention Reduce the Exposure of Patients With Knee Osteoarthritis to Nonsteroidal Antiinflammatory Drugs?. JCR: Journal of Clinical Rheumatology 10:6, 315-322
1022
Fischer , Michael A. , Schneeweiss , Sebastian , Avorn , Jerry , Solomon , Daniel H. , . (2004) Medicaid Prior-Authorization Programs and the Use of Cyclooxygenase-2 Inhibitors. New England Journal of Medicine 351:21, 2187-2194
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Francis Berenbaum. (2004) COX-3: Fact or fancy?. Joint Bone Spine 71:6, 451-453
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Rick A. Weideman, Kevin C. Kelly, Salahuddin Kazi, Anh Cung, Kevin W. Roberts, Herbert J. Smith, George A. Sarosi, Bertis B. Little, Byron Cryer. (2004) Risks of clinically significant upper gastrointestinal events with etodolac and naproxen: A historical cohort analysis. Gastroenterology 127:5, 1322-1328
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Dieter Steinbilber, Stefan Laufer. (2004) Vioxx
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A. M. Blaicher, H. T. Landsteiner, J. Zwerina, U. Leitgeb, I. Volf, K. Hoerauf. (2004) Effect of non-selective, non-steroidal anti-inflammatory drugs and cyclo-oxygenase-2 selective inhibitors on the PFA-100 closure time. Anaesthesia 59:11, 1100-1103
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J.B. Tuynman, M.P. Peppelenbosch, D.J. Richel. (2004) COX-2 inhibition as a tool to treat and prevent colorectal cancer. Critical Reviews in Oncology/Hematology 52:2, 81-101
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Susana Sánchez-Fidalgo, Inés Martín-Lacave, Matilde Illanes, Virginia Motilva. (2004) Angiogenesis, cell proliferation and apoptosis in gastric ulcer healing. Effect of a selective cox-2 inhibitor. European Journal of Pharmacology 505:1-3, 187-194
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Philip Schoenfeld. (2004) Evidence Based Medicine (EBM) in Practice: Applying Relative Risk and Relative Risk Reduction. The American Journal of Gastroenterology 99:11, 2084-2085
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E. J. Begg. (2004) Individualizing drug therapy, and 'men behaving badly'. British Journal of Clinical Pharmacology 58:5, 449-451
1031
Anthony N. DeMaria. (2004) The fallout from Vioxx. Journal of the American College of Cardiology 44:10, 2080-2081
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S. Lugardon, M. Lapeyre-Mestre, J. L. Montastruc, . (2004) Upper gastrointestinal adverse drug reactions and cyclo-oxygenase-2 inhibitors (celecoxib and rofecoxib): a case/non-case study from the French Pharmacovigilance Database. European Journal of Clinical Pharmacology 60:9, 673-677
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Hyon K. Choi, John D. Seeger. (2004) Observational research in rheumatic disorders. Rheumatic Disease Clinics of North America 30:4, 685-699
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K. Arnold Chan, Sonia Hernandez-Diaz. (2004) Pharmacoepidemiology and rheumatic disorders. Rheumatic Disease Clinics of North America 30:4, 835-850
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P. Geusens, R. Alten, J. Rovensky, V.S. Sloan, G. Krammer, G. Kralidis, P. Richardson. (2004) Efficacy, safety and tolerability of lumiracoxib in patients with rheumatoid arthritis. International Journal of Clinical Practice 58:11, 1033-1041
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Philippe Bertin. (2004) Should gastroprotective agents be given with COX-2 inhibitors? A question worthy of scrutiny. Joint Bone Spine 71:6, 454-456
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Topol , Eric J. , . (2004) Failing the Public Health — Rofecoxib, Merck, and the FDA. New England Journal of Medicine 351:17, 1707-1709
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Chin Lee, Walter L. Straus, Robert Balshaw, Suna Barlas, Suzanne Vogel, Thomas J. Schnitzer. (2004) A comparison of the efficacy and safety of nonsteroidal antiinflammatory agents versus acetaminophen in the treatment of osteoarthritis: A meta-analysis. Arthritis & Rheumatism 51:5, 746-754
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Anwar Umar, Michel Boisseau, Abdiryim Yusup, Halmurat Upur, Bernard Begaud, Nicholas Moore. (2004) Interactions between aspirin and COX-2 inhibitors or NSAIDs in a rat thrombosis model. Fundamental and Clinical Pharmacology 18:5, 559-563
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Byron Cryer. (2004) COX-2–specific inhibitor or proton pump inhibitor plus traditional NSAID: Is either approach sufficient for patients at highest risk of NSAID-induced ulcers?. Gastroenterology 127:4, 1256-1258
1042
Erbil Dogan, Uğur Saygili, Cemal Posaci, Burcin Tuna, Sezer Caliskan, Sabahattin Altunyurt, Bahadir Saatli. (2004) Regression of endometrial explants in rats treated with the cyclooxygenase-2 inhibitor rofecoxib. Fertility and Sterility 82, 1115-1120
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Karel PAVELKA. (2004) Symptomatic treatment of osteoarthritis: paracetamol or NSAIDs?. International Journal of Clinical Practice 58, 5-12
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Paul J. Desjardins, Peter M. Black, Steven Daniels, Steven R. Bird, Brian J. Fitzgerald, Richard A. Petruschke, Andrew Tershakovec, David J. Chang. (2004) A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain. Current Medical Research and Opinion 20:10, 1523-1537
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George E EHRLICH. (2004) A benefit/risk assessment of existing therapeutic alternatives for the treatment of painful inflammatory conditions. International Journal of Clinical Practice 58, 20-26
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Francis K.L. Chan, Lawrence C.T. Hung, Bing Y. Suen, Vincent W.S. Wong, Aric J. Hui, Justin C.Y. Wu, Wai K. Leung, Yuk T. Lee, Ka F. To, S.C. Sydney Chung, Joseph J.Y. Sung. (2004) Celecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: Results of a randomized double-blind trial. Gastroenterology 127:4, 1038-1043
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B. Witjes. (2004) Risico van selectieve COX-2-remmers. MFM 42:10, 278-279
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Joaquín Quiralte, Julio Delgado, Blanca Sáenz de San Pedro, Esperanza López-Pascual, Maria A. Nieto, Nancy Ortega, Jose Fernando Florido, José Conde. (2004) Safety of the new selective cyclooxygenase type 2 inhibitors rofecoxib and celecoxib in patients with anaphylactoid reactions to nonsteroidal anti-inflammatory drugs. Annals of Allergy, Asthma & Immunology 93:4, 360-364
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Jayne E. Edwards, Henry J. McQuay, R. Andrew Moore. (2004) Efficacy and safety of valdecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. Pain 111:3, 286-296
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T. J. Gan, G. P. Joshi, S. Z. Zhao, D. B. Hanna, R. Y. Cheung, C. Chen. (2004) Presurgical intravenous parecoxib sodium and follow-up oral valdecoxib for pain management after laparoscopic cholecystectomy surgery reduces opioid requirements and opioid-related adverse effects. Acta Anaesthesiologica Scandinavica 48:9, 1194-1207
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Maryam Asgari, Emily White, Mary-Margaret Chren. (2004) Nonsteroidal Anti-inflammatory Drug Use in the Prevention and Treatment of Squamous Cell Carcinoma. Dermatologic Surgery 30:10, 1335-1342
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C. Hartel, J. von Puttkamer, F. Gallner, T. Strunk, C. Schultz. (2004) Dose-dependent Immunomodulatory Effects of Acetylsalicylic Acid and Indomethacin in Human Whole Blood: Potential Role of Cyclooxygenase-2 Inhibition. Scandinavian Journal of Immunology 60:4, 412-420
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Nancy G. B. Agrawal, Catherine Z. Matthews, Ralph S. Mazenko, Eric J. Woolf, Arturo G. Porras, Xun Chen, Jutta L. Miller, Nicole Michiels, Martin Wehling, Armin Schultz, Alice B. Gottlieb, Walter K. Kraft, Howard E. Greenberg, Scott A. Waldman, Sean P. Curtis, Keith M. Gottesdiener. (2004) The Effects of Modifying In Vivo Cytochrome P450 3A (CYP3A) Activity on Etoricoxib Pharmacokinetics and of Etoricoxib Administration on CYP3A Activity. The Journal of Clinical Pharmacology 44:10, 1125-1131
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Helene Francois, Thomas M. Coffman. (2004) Prostanoids and blood pressure: which way is up?. Journal of Clinical Investigation 114:6, 757-759
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Helene Francois, Thomas M. Coffman. (2004) Prostanoids and blood pressure: which way is up?. Journal of Clinical Investigation 114:6, 757-759
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J. L. Goldstein, G. M. Eisen, N. Agrawal, W. F. Stenson, J. D. Kent, K. M. Verburg. (2004) Reduced incidence of upper gastrointestinal ulcer complications with the COX-2 selective inhibitor, valdecoxib. Alimentary Pharmacology and Therapeutics 20:5, 527-538
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Tobias Kurth, Charles H. Hennekens, Julie E. Buring, J. Michael Gaziano. (2004) Aspirin, NSAIDs, and COX-2 inhibitors in cardiovascular disease: Possible interactions and implications for treatment of rheumatoid arthritis. Current Rheumatology Reports 6:5, 351-356
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David A. Peura. (2004) Prevention of nonsteroidal anti-inflammatory drug–associated gastrointestinal symptoms and ulcer complications. The American Journal of Medicine Supplements 117:5, 63-71
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E.Jan Irvine. (2004) Measurement and expression of risk: Optimizing decision strategies. The American Journal of Medicine Supplements 117:5, 2-7
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David A. Greenwald. (2004) Aging, the gastrointestinal tract, and risk of acid-related disease. The American Journal of Medicine Supplements 117:5, 8-13
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Thomas J. Schnitzer, Jannie Beier, Piet Geusens, Paul Hasler, Sanjay K. Patel, Ingo Senftleber, Xavier Gitton, Alan Moore, Victor S. Sloan, Gyula Poór. (2004) Efficacy and safety of four doses of lumiracoxib versus diclofenac in patients with knee or hip primary osteoarthritis: A phase II, four-week, multicenter, randomized, double-blind, placebo-controlled trial. Arthritis & Rheumatism 51:4, 549-557
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James M. Scheiman, A Mark Fendrick. (2004) Informed Choices in Anti-Inflammatory Drug Therapy. JCR: Journal of Clinical Rheumatology 10:4, 157-159
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Eric J Topol, Gary W Falk. (2004) A coxib a day won't keep the doctor away. The Lancet 364:9435, 639-640
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Robert W. Dubois, Gil Y. Melmed, James M. Henning, Myriam Bernal. (2004) Risk of Upper Gastrointestinal Injury and Events in Patients Treated With Cyclooxygenase (COX)-1/COX-2 Nonsteroidal Antiinflammatory Drugs (NSAIDs), COX-2 Selective NSAIDs, and Gastroprotective Cotherapy. JCR: Journal of Clinical Rheumatology 10:4, 178-189
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Mostafa A Shehata, Ahmed Ashour, Nagiba Y Hassan, Ahmad S Fayed, Badr A El-Zeany. (2004) Liquid chromatography and chemometric methods for determination of rofecoxib in presence of its photodegradate and alkaline degradation products. Analytica Chimica Acta 519:1, 23-30
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Thomas J Schnitzer, Gerd R Burmester, Eduardo Mysler, Marc C Hochberg, Michael Doherty, Elena Ehrsam, Xavier Gitton, Gerhard Krammer, Bernhard Mellein, Patrice Matchaba, Alberto Gimona, Christopher J Hawkey. (2004) Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial. The Lancet 364:9435, 665-674
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James F. Fries, Kirsten N. Murtagh, Mihoko Bennett, Ernesto Zatarain, Bharathi Lingala, Bonnie Bruce. (2004) The rise and decline of nonsteroidal antiinflammatory drug-associated gastropathy in rheumatoid arthritis. Arthritis & Rheumatism 50:8, 2433-2440
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A. Lanas. (2004) Economic analysis of strategies in the prevention of non-steroidal anti-inflammatory drug-induced complications in the gastrointestinal tract. Alimentary Pharmacology and Therapeutics 20:3, 321-331
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Michael E Farkouh, Howard Kirshner, Robert A Harrington, Sean Ruland, Freek WA Verheugt, Thomas J Schnitzer, Gerd R Burmester, Eduardo Mysler, Marc C Hochberg, Michael Doherty, Elena Ehrsam, Xavier Gitton, Gerhard Krammer, Bernhard Mellein, Alberto Gimona, Patrice Matchaba, Christopher J Hawkey, James H Chesebro. (2004) Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial. The Lancet 364:9435, 675-684
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Loren Laine, Eric S. Maller, Chang Yu, Hui Quan, Thomas Simon. (2004) Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: A double-blind trial. Gastroenterology 127:2, 395-402
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Jennifer M Stephens, Christopher F Bell, Josephine M Wong, Beatriz M Peña, Seema Haider, Chris L Pashos. (2004) Value of cyclooxygenase-2 specific inhibitors in the management of osteoarthritis. Expert Review of Pharmacoeconomics & Outcomes Research 4:4, 441-455
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P. Vergne-Salle, R.-M. Grilo, P. Bertin, C. Bonnet, D. Coyral, S. Perrot, R. Trèves. (2004) Douleurs en rhumatologie, aspects physiopathologiques, moyens d'évaluation, moyens thérapeutiques. EMC - Rhumatologie-Orthopédie 1:4, 266-294
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James D Clark, Steve Tam. (2004) Potential therapeutic uses of phospholipase A 2 inhibitors. Expert Opinion on Therapeutic Patents 14:7, 937-950
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M. Lazzaroni, G. Bianchi Porro. (2004) Gastrointestinal side-effects of traditional non-steroidal anti-inflammatory drugs and new formulations. Alimentary Pharmacology and Therapeutics 20:s2, 48-58
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Rebecca L. Darling, Jimmy J. Romero, Elizabeth J. Dial, Jacqueline K. Akunda, Robert Langenbach, Lenard M. Lichtenberger. (2004) The effects of aspirin on gastric mucosal integrity, surface hydrophobicity, and prostaglandin metabolism in cyclooxygenase knockout mice. Gastroenterology 127:1, 94-104
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Andreas Otto Reiff. (2004) Developments in the treatment of juvenile arthritis. Expert Opinion on Pharmacotherapy 5:7, 1485-1496
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Gurkirpal Singh, Stephan Lanes, George Triadafilopoulos. (2004) Risk of serious upper gastrointestinal and cardiovascular thromboembolic complications with meloxicam. The American Journal of Medicine 117:2, 100-106
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P.W. Sheeran, J.B. Rose, L.M. Fazi, R. Chiavacci, L. McCormick. (2004) Rofecoxib administration to paediatric patients undergoing adenotonsillectomy. Pediatric Anesthesia 14:7, 579-583
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C. J. Hawkey. (2004) Non-steroidal anti-inflammatory drugs: who should receive prophylaxis?. Alimentary Pharmacology and Therapeutics 20:s2, 59-64
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Robert Petrella, Evan F. Ekman, Reinhard Schuller, John G. Fort. (2004) Efficacy of Celecoxib, a COX-2–Specific Inhibitor, and Naproxen in the Management of Acute Ankle Sprain. Clinical Journal of Sport Medicine 14:4, 225-231
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Robin Matuk, Jonathan Crawford, Maria T. Abreu, Stephan R. Targan, Eric A. Vasiliauskas, Konstantinos A. Papadakis. (2004) The Spectrum of Gastrointestinal Toxicity and Effect on Disease Activity of Selective Cyclooxygenase-2 Inhibitors in Patients with Inflammatory Bowel Disease. Inflammatory Bowel Diseases 10:4, 352-356
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O'Dell , James R. . (2004) Therapeutic Strategies for Rheumatoid Arthritis. New England Journal of Medicine 350:25, 2591-2602
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Kenneth G. Saag, Jason J. Olivieri, Fausto Patino, Ted R. Mikuls, Jeroan J. Allison, Catherine H. MacLean. (2004) Measuring quality in arthritis care: The Arthritis Foundation's quality indicator set for analgesics. Arthritis & Rheumatism 51:3, 337-349
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L.-C. Chen, R. A. Elliott, D. M. Ashcroft. (2004) Systematic review of the analgesic efficacy and tolerability of COX-2 inhibitors in post-operative pain control. Journal of Clinical Pharmacy and Therapeutics 29:3, 215-229
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A. J. Kivitz, S. Nayiager, T. Schimansky, A. Gimona, H. J. Thurston, C. Hawkey. (2004) Reduced incidence of gastroduodenal ulcers associated with lumiracoxib compared with ibuprofen in patients with rheumatoid arthritis. Alimentary Pharmacology and Therapeutics 19:11, 1189-1198
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E. Mysler. (2004) Lumiracoxib (Prexige®): a new selective cox-2 inhibitor. International Journal of Clinical Practice 58:6, 606-611
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Avril Melissa Houston, Stephen J. Teach. (2004) COX-2 Inhibitors. Pediatric Emergency Care 20:6, 396-399
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Joshua J Ofman, Enkhe Badamgarav, James M Henning, Kevin Knight, Loren Laine. (2004) Utilization of nonsteroidal anti-inflammatory drugs and antisecretory agents: a managed care claims analysis. The American Journal of Medicine 116:12, 835-842
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Garret A. FitzGerald. (2004) Prostaglandins. JCR: Journal of Clinical Rheumatology 10:Supplement, S12-S17
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Hassan Monfared, James J Sferra, Nagy Mekhail. (2004) The medical management of chronic pain. Foot and Ankle Clinics 9:2, 373-403
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Nathaniel Katz, Diana B. Rodgers, David Krupa, Alise Reicin. (2004) Onset of pain relief with rofecoxib in chronic low back pain: results of two four-week, randomized, placebo-controlled trials*. Current Medical Research and Opinion 20:5, 651-658
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Keri L. Fakata. (2004) Anti-inflammatory agents for the treatment of musculoskeletal pain and arthritis. Current Pain and Headache Reports 8:3, 173-177
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Muhammad Mamdani, David N Juurlink, Douglas S Lee, Paula A Rochon, Alex Kopp, Gary Naglie, Peter C Austin, Andreas Laupacis, Therese A Stukel. (2004) Cyclo-oxygenase-2 inhibitors versus non-selective non-steroidal anti-inflammatory drugs and congestive heart failure outcomes in elderly patients: a population-based cohort study. The Lancet 363:9423, 1751-1756
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F. K. L. Chan, D. Y. Graham. (2004) Prevention of non-steroidal anti-inflammatory drug gastrointestinal complications - review and recommendations based on risk assessment. Alimentary Pharmacology and Therapeutics 19:10, 1051-1061
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Scott Korn, Theodore C Vassil, Paul N.-A Kotey, James R Fricke. (2004) Comparison of rofecoxib and oxycodone plus acetaminophen in the treatment of acute pain: A randomized, double-blind, placebo-controlled study in patients with moderate to severe postoperative pain in the third molar extraction model. Clinical Therapeutics 26:5, 769-778
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B. Fautrel. (2004) Pharmacoepidemiology: lessons from real life. Joint Bone Spine 71:3, 175-177
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S BOUEE. (2004) Changes in osteoarthritis management by general practitioners in the COX2-inhibitor era?concomitant gastroprotective therapy. Joint Bone Spine 71:3, 214-220
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Hyon K Choi, John D Seeger, Karen M Kuntz. (2004) Effects of rofecoxib and naproxen on life expectancy among patients with rheumatoid arthritis: a decision analysis. The American Journal of Medicine 116:9, 621-629
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Kim L. Isaacs. (2004) DOES STEROID USE INCREASE FRACTURE RISK IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE?. Evidence-Based Gastroenterology 5:2, 56-57
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Alex M. Blaicher, Harald T. Landsteiner, Olga Al-Falaki, Jochen Zwerina, Ivo Volf, Diego Gruber, Michael Zimpfer, Klaus Hoerauf. (2004) Acetylsalicylic Acid, Diclofenac, and Lornoxicam, but Not Rofecoxib, Affect Platelet CD 62 Expression. Anesthesia & Analgesia1082-1085
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Michalis V Karamouzis, Athanasios G Papavassiliou. (2004) COX-2 inhibition in cancer therapeutics: a field of controversy or a magic bullet?. Expert Opinion on Investigational Drugs 13:4, 359-372
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M. R. Hernandez, R. Tonda, M. Pino, M. Serradell, G. Arderiu, G. Escolar. (2004) Evaluation of effects of rofecoxib on platelet function in an in vitro model of thrombosis with circulating human blood. European Journal of Clinical Investigation 34:4, 297-302
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N. D. Yeomans. (2004) Impact of cyclooxygenase-2 inhibitors: are they fulfilling their promises?. Internal Medicine Journal 34:4, 145-147
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L. Biancone, C. Tosti, A. Geremia, D. Fina, C. Petruzziello, S. Emerenziani, F. Pallone. (2004) Rofecoxib and early relapse of inflammatory bowel disease: an open-label trial. Alimentary Pharmacology and Therapeutics 19:7, 755-764
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B. Norgard, L. Pedersen, S. P. Johnsen, R. E. Tarone, J. K. McLaughlin, S. Friis, H. T. Sorensen. (2004) COX-2-selective inhibitors and the risk of upper gastrointestinal bleeding in high-risk patients with previous gastrointestinal diseases: a population-based case-control study. Alimentary Pharmacology and Therapeutics 19:7, 817-825
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Md.Jashim Uddin, P. N. Praveen Rao, Edward E Knaus. (2004) Design of acyclic triaryl olefins: a new class of potent and selective cyclooxygenase-2 (COX-2) inhibitors. Bioorganic & Medicinal Chemistry Letters 14:8, 1953-1956
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James M. Scheiman, Byron Cryer, Michael B. Kimmey, Richard I. Rothstein, Dennis S. Riff, Michael M. Wolfe. (2004) A randomized, controlled comparison of ibuprofen at the maximal over-the-counter dose compared with prescription-dose celecoxib on upper gastrointestinal mucosal injury. Clinical Gastroenterology and Hepatology 2:4, 290-295
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Margaret E. McCann, Donald R., Donghui Zhang, Christine Brideau, W. Cameron Black, Peter D. Hanson, Gerard J. Hickey. (2004) In vitro effects and in vivo efficacy of a novel cyclooxygenase-2 inhibitor in dogs with experimentally induced synovitis. American Journal of Veterinary Research 65:4, 503-512
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F. F. Joshua, S. P. Oakley, G. A. Major. (2004) Impact of selective cyclooxygenase-2 inhibitors on anti-ulcer medication and non-steroidal anti-inflammatory drug use in patients with rheumatic disease. Internal Medicine Journal 34:4, 153-161
1116
D. Kellstein, D. Ott, S. Jayawardene, J. Fricke. (2004) Analgesic efficacy of a single dose of lumiracoxib compared with rofecoxib, celecoxib and placebo in the treatment of post-operative dental pain. International Journal of Clinical Practice 58:3, 244-250
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K. Zelenakas, J. R. Fricke, S. Jayawardene, D. Kellstein. (2004) Analgesic efficacy of single oral doses of lumiracoxib and ibuprofen in patients with postoperative dental pain. International Journal of Clinical Practice 58:3, 251-256
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Peter Honig. (2004) Merck Sharp and Dohme versus Laporte. The Lancet 363:9414, 1079-1080
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Stephen E Kimmel, Jesse A Berlin, Muredach Reilly, Jane Jaskowiak, Lori Kishel, Jesse Chittams, Brian L Strom. (2004) The effects of nonselective non-aspirin non-steroidal anti-inflammatory medications on the risk of nonfatal myocardial infarction and their interaction with aspirin. Journal of the American College of Cardiology 43:6, 985-990
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Brian J. Anderson. (2004) Comparing the efficacy of NSAIDs and paracetamol in children. Pediatric Anesthesia 14:3, 201-217
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Yaron Niv. (2004) Ethics of Sample Collecting in Gastrointestinal Endoscopy-based Research. Journal of Clinical Gastroenterology 38:3, 206-208
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Henry Krum, Danny Liew, Juan Aw, Steven Haas. (2004) Cardiovascular effects of selective cyclooxygenase-2 inhibitors. Expert Review of Cardiovascular Therapy 2:2, 265-270
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Anthony S Dalpiaz, Dave Peterson. (2004) Parecoxib: a shift in pain management?. Expert Review of Neurotherapeutics 4:2, 165-177
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Devashish Kothapalli, Ilia Fuki, Kamilah Ali, Sheryl A. Stewart, Liang Zhao, Ron Yahil, David Kwiatkowski, Elizabeth A. Hawthorne, Garret A. FitzGerald, Michael C. Phillips, Sissel Lund-Katz, Ellen Puré, Daniel J. Rader, Richard K. Assoian. (2004) Antimitogenic effects of HDL and APOE mediated by Cox-2–dependent IP activation. Journal of Clinical Investigation 113:4, 609-618
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Devashish Kothapalli, Ilia Fuki, Kamilah Ali, Sheryl A. Stewart, Liang Zhao, Ron Yahil, David Kwiatkowski, Elizabeth A. Hawthorne, Garret A. FitzGerald, Michael C. Phillips, Sissel Lund-Katz, Ellen Puré, Daniel J. Rader, Richard K. Assoian. (2004) Antimitogenic effects of HDL and APOE mediated by Cox-2–dependent IP activation. Journal of Clinical Investigation 113:4, 609-618
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M. B. Kimmey, A. Lanas. (2004) Appropriate use of proton pump inhibitors with traditional nonsteroidal anti-inflammatory drugs and COX-2 selective inhibitors. Alimentary Pharmacology and Therapeutics 19:s1, 60-65
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David J Exon, S.C Sydney Chung. (2004) Endoscopic therapy for upper gastrointestinal bleeding. Best Practice & Research Clinical Gastroenterology 18:1, 77-98
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João Freitas, Vitor Farricha, Isabel Nascimento, Paula Borralho, António Paramés. (2002) Rofecoxib. Journal of Clinical Gastroenterology 34:4, 451-453
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M. Brian Fennerty. (2002) Barrett's-related esophageal cancer: Has the final hurdle been cleared, now paving the way for human chemoprevention trials?. Gastroenterology 122:4, 1172-1175
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William H Frishman. (2002) Effects of nonsteroidal anti-inflammatory drug therapy on blood pressure and peripheral edema. The American Journal of Cardiology 89:6, 18-25
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Hubert Blain, Christelle Boileau, Françoise Lapicque, Emmanuelle Nédélec, Damien Lœuille, Cécile Guillaume, Alain Gaucher, Claude Jeandel, Patrick Netter, Jean-Yves Jouzeau. (2002) Limitation of the in vitro whole blood assay for predicting the COX selectivity of NSAIDs in clinical use. British Journal of Clinical Pharmacology 53:3, 255-265
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Stephen E. Kimmel, Jesse A. Berlin, Judith L. Kinman, Sean Hennessy, Harold Feldman, Jeffrey L. Carson, Brian L. Strom. (2002) Parenteral ketorolac and risk of myocardial infarction. Pharmacoepidemiology and Drug Safety 11:2, 113-119
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Holger Ulbrich, Gerd Dannhardt. (2002) NSAR: Klassifizierung und Wirkspektrum: Eine heterogene Arzneistoffklasse. Pharmazie in unserer Zeit 31:2, 146-154
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John GF Cleland. (2002) No reduction in cardiovascular risk with NSAIDs—including aspirin?. The Lancet 359:9301, 92-93
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Judith Jacobi, Gilles L. Fraser, Douglas B. Coursin, Richard R. Riker, Dorrie Fontaine, Eric T. Wittbrodt, Donald B. Chalfin, Michael F. Masica, H. Scott Bjerke, William M. Coplin, David W. Crippen, Barry D. Fuchs, Ruth M. Kelleher, Paul E. Marik, Stanley A. Nasraway, Michael J. Murray, William T. Peruzzi, Philip D. Lumb. (2002) Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Critical Care Medicine 30:1, 119-141
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Luis Miguel Ruilope, Antonio Coca. (2002) Inhibidores selectivos de la ciclooxigenasa-2 (Coxibs) y morbilidad cardiovascular. Medicina Clínica 118:6, 219-221
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Ángel Lanas. (2002) Efectos secundarios gastrointestinales y cardiovasculares de los inhibidores selectivos de la ciclooxigenasa-2. Medicina Clínica 118:6, 237-238
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Marc C. Hochberg. (2001) What a difference a year makes: Reflections on the ACR recommendations for the medical management of osteoarthritis. Current Rheumatology Reports 3:6, 473-478
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Radko Komers, Sharon Anderson, Murray Epstein. (2001) Renal and cardiovascular effects of selective cyclooxygenase-2 inhibitors. American Journal of Kidney Diseases 38:6, 1145-1157
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J.I.W. Jones, C.J. Hawkey. (2001) Physiology and organ-related pathology of the elderly: stomach ulcers. Best Practice & Research Clinical Gastroenterology 15:6, 943-961
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Alex Macario, Arthur G. Lipman. (2001) Ketorolac in the Era of Cyclo-Oxygenase-2 Selective Nonsteroidal Anti-Inflammatory Drugs: A Systematic Review of Efficacy, Side Effects, and Regulatory Issues. Pain Medicine 2:4, 336-351
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P. Y. Martin, J. Desmeules. (2001) Risques rénaux des anti-inflammatoires non stéroïdiens COX 2 sélectifs. Douleur et Analgésie 14:3, 163-167
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Joshua M Cox, Marco Pappagallo. (2001) Contemporary and emergent pharmacological therapies for chronic pain: nonopioid analgesia. Expert Review of Neurotherapeutics 1:1, 81-91
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Carlo Patrono, Paola Patrignani, Luis A. García Rodríguez. (2001) Cyclooxygenase-selective inhibition of prostanoid formation: transducing biochemical selectivity into clinical read-outs. Journal of Clinical Investigation 108:1, 7-13
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Robert McMurray. (2001) Cyclooxygenase 2 inhibition and thrombosis: Comment on the article by Crofford et al. Arthritis & Rheumatism 44:4, 984-984
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Thomas J. Schnitzer. (2001) Osteoarthritis management: the role of cyclooxygenase-2-selective inhibitors. Clinical Therapeutics 23:3, 313-326
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Andrew Whelton, John G. Fort, Joseph A. Puma, Diane Normandin, Alfonso E. Bello, Kenneth M. Verburg. (2001) Cyclooxygenase-2???Specific Inhibitors and Cardiorenal Function: A Randomized, Controlled Trial of Celecoxib and Rofecoxib in Older Hypertensive Osteoarthritis Patients. American Journal of Therapeutics 8:2, 85-95
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Serge Steinfeld, Stefaan Poriau. (2001) Patient and Physician Satisfaction with Rofecoxib in Osteoarthritis: Results of the EVA (Experience with VIOXX in Arthritis) Survey *. Current Medical Research and Opinion 17:2, 81-87
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Hideo NAKAMURA. (2001) Cyclooxygenase(COX)-2 selective inhibitors: aspirin, a dual COX-1/COX-2 inhibitor, to COX-2 selective inhibitors.. Folia Pharmacologica Japonica 118:3, 219-230
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