Correspondence

Risks of Salmeterol?

N Engl J Med 1994; 331:1314November 10, 1994

Article

To the Editor:

I have a large geriatric-internal medicine practice. I have enthusiastically adopted the use of the salmeterol inhaler (twice a day) for my patients as a way to improve compliance. In the past three months, two elderly patients with moderately severe asthma have had fatal respiratory arrests at home. Both were found holding their inhalers. Both had been told that they should expect a delay of a half-hour to an hour in the onset of the action of salmeterol and that they could use their previous inhaler (albuterol) for emergencies, but they did not do so.

I believe that although the occurrence of these two cases may be a coincidence, the use of salmeterol may pose an increased risk among the elderly. I suggest caution in the use of this drug until the Food and Drug Administration investigates this matter.

Frank N. Finkelstein, M.D.
110 Long Pond Rd., Plymouth, MA 02360

Author/Editor Response

Glaxo, the manufacturer of salmeterol, replies:

To the Editor: It is difficult to comment on Dr. Finkelstein's cases as presented, because he provides few details. Since salmeterol first became available, in 1990, however, over 11 million patient-months of experience have been accumulated worldwide. Salmeterol was shown to be well tolerated and effective in 177 elderly patients with asthma (mean age, >70 years) under controlled conditions in a total of nine Glaxo-sponsored clinical trials.1-3 In addition, a large, double-blind, randomized surveillance study conducted in the United Kingdom involved over 25,000 patients, approximately 4000 of whom were over 65 years of age.4 No evidence of a drug-related increase in the risk of morbidity or mortality in any age group, including the elderly, was noted.

The importance of education for patients with asthma cannot be overemphasized.5 Education is particularly important for elderly patients, a group with a greater potential for problems in compliance and a higher risk of death from asthma, as compared with younger patients. According to 1991 data from the National Center for Health Statistics, the asthma-related death rate per 100,000 patients is 80 percent higher among people who are 65 to 74 years old than among those who are 55 to 64 years old and three times the rate among those 45 to 54 years old.

With the addition of salmeterol to a therapeutic regimen, patients should be instructed to use their short-acting, inhaled β₂-adrenergic-receptor agonist for the relief of acute bronchospasm. Salmeterol is indicated for long-term maintenance treatment and prevention of bronchospasm in patients with asthma who are 12 years of age or older and require regular treatment with inhaled, short-acting β₂-agonists. It is not indicated for the relief of the acute symptoms of asthma, as explicitly stated in both the product information and the instructions for use by patients. When used as recommended, salmeterol offers patients several unique benefits, and ongoing worldwide monitoring of its safety does not indicate an increased risk among elderly patients.

James B.D. Palmer, M.D.
Kathleen A. Rickard, M.D.
J. Richard Thompson, Pharm.D.
Glaxo, Research Triangle Park, NC 27709

5 References

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   Jenkins MM, Price K, Pounsford JC, et al. Safety and efficacy of salmeterol in elderly patients with asthma. Am Rev Respir Dis 1992;145:Suppl:A65-A65 abstract.
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2. 2

   Dawe CN, Cheesman MG, Poundsford JC. Salmeterol is an effective bronchodilator in elderly patients. Eur Respir J 1992;5:Suppl 15:204S-205S abstract.
   

3. 3

   Stark ID, Luce P. Inhaled salmeterol in elderly patients with reversible airways obstruction. Eur Respir J 1991;4:Suppl 14:332S-332S abstract.
   

4. 4

   Castle W, Fuller R, Hall J, Palmer J. Serevent nationwide surveillance study: comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment. BMJ 1993;306:1034-1037
   CrossRef | Web of Science | Medline

5. 5

   National Asthma Education Program. Expert Panel report -- guidelines for the diagnosis and management of asthma. Bethesda, Md.: National Institutes of Health, August 1991. (NIH publication no. 91-3042.)
   

Citing Articles (7)

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   John J. Oppenheimer, Stephen P. Peters. (2010) Is the maintenance and reliever approach the answer?. Annals of Allergy, Asthma & Immunology 104:2, 112-117
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   John Oppenheimer, Harold S Nelson. (2008) Safety of long-acting ??-agonists in asthma: a review. Current Opinion in Pulmonary Medicine 14:1, 64-69
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   Teresa D. Holimon, Carol C. Chafin, Timothy H. Self. (2001) Nocturnal Asthma Uncontrolled by Inhaled Corticosteroids. Drugs 61:3, 391-418
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4. 4

   Dawn E Drotar, E Elizabeth Davis, Donald W Cockcroft. (1998) Tolerance to the Bronchoprotective Effect of Salmeterol 12 Hours After Starting Twice Daily Treatment. Annals of Allergy, Asthma & Immunology 80:1, 31-34
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5. 5

   Soong Tan, Ian P Hall, Jane Dewar, Eleanor Dow, Brian Lipworth. (1997) Association between β2-adrenoceptor polymorphism and susceptibility to bronchodilator desensitisation in moderately severe stable asthmatics. The Lancet 350:9083, 995-999
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6. 6

   Allan Gibofsky. (1996) Legal issues in allergy and clinical immunology. Journal of Allergy and Clinical Immunology 98:6, S334-S338
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   D. Robin Taylor, Malcolm R. Sears, Donald W. Cockcroft. (1996) THE BETA-AGONIST CONTROVERSY. Medical Clinics of North America 80:4, 719-748
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