Correspondence
Additional Follow-up from the ABCD Trial in Patients with Type 2 Diabetes and Hypertension
N Engl J Med 2000; 343:1969December 28, 2000
- Article
To the Editor:
In 1998 we presented data from the Appropriate Blood Pressure Control in Diabetes (ABCD) trial on the effect of nisoldipine as compared with enalapril on cardiovascular outcomes after five years of follow-up in 470 patients with hypertension and type 2 diabetes.1 The nisoldipine therapy was terminated in the cohort with hypertension on July 14, 1997, as recommended by the study's data and safety monitoring committee. At that time, there had been 25 myocardial infarctions in the nisoldipine group, as compared with 5 myocardial infarctions in the enalapril group, resulting in an unadjusted risk ratio of 5.5 (95 percent confidence interval, 2.1 to 14.6) and an adjusted risk ratio of 7.0 (95 percent confidence interval, 2.3 to 21.4). During the remaining year of the study, a private detective identified six additional documented nonfatal myocardial infarctions, which were confirmed by the blinded end-point committee. Thus, since the publication of the article, the number of patients in the nisoldipine group with fatal or nonfatal myocardial infarctions has increased from 25 to 27, and the number in the enalapril group has increased from 5 to 9. Hence, the unadjusted risk ratio is now 3.3 (95 percent confidence interval, 1.5 to 7.1; P=0.029) rather than 5.5, and the adjusted risk ratio is now 4.2 (95 percent confidence interval, 1.8 to 10.1; P=0.001) rather than 7.0.
In addition, we discovered more occurrences of congestive heart failure (increasing the number of affected patients from 5 to 10 in the enalapril group and from 6 to 8 in the nisoldipine group) and more deaths from cardiovascular causes (increasing the numbers from 5 to 6 in the enalapril group and from 10 to 11 in the nisoldipine group). However, as was the case at the time the article was written, the differences between the enalapril and nisoldipine groups in terms of occurrences of congestive heart failure and deaths from cardiovascular causes were not statistically significant.
Although the number of events has changed with more intensive follow-up, the conclusion of the study remains the same. Our findings are consistent with those of other recent studies in patients with hypertension and type 2 diabetes,2-4 which have also found a decreased risk of myocardial infarction with the use of angiotensin-converting–enzyme inhibitors.
4 ReferencesRobert W. Schrier, M.D.
Raymond O. Estacio, M.D.
University of Colorado Health Sciences Center, Denver, CO 802621
Estacio RO ,Jeffers BW ,Hiatt WR ,Biggerstaff SL ,Gifford N ,Schrier RW . The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension. N Engl J Med 1998;338:645-652
Full Text | Web of Science | Medline2
Hansson L ,Lindholm LH ,Niskanen L , et al. Effect of angiotensin-converting-enzyme inhibition compared with conventional therapy on cardiovascular morbidity and mortality in hypertension: the Captopril Prevention Project (CAPPP) randomised trial. Lancet 1999;353:611-616
CrossRef | Web of Science | Medline3
Tatti P ,Pahor M ,Byington RP , et al. Outcome results of the Fosinopril versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care 1998;21:597-603
CrossRef | Web of Science | Medline4
Heart Outcomes Prevention Evaluation Study Investigators
CrossRef | Web of Science | Medline
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