Dale: Five letters were published in NEJM requesting additional information and submitting case histories relevant to the May 14, 1998 article summarizing the major sildenafil clinical studies by Dr. Irwin Goldstein et al.
Here is "the authors response" to the letters also published in this week's NEJM.
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The authors reply:
To the Editor:
In response to the first two letters, it is known that sexual intercourse increases cardiac workload (1) and that the risk of myocardial infarction increases by a factor of 2.5 in the two hours after sexual activity. (2) It seems likely that the risk of cardiac arrhythmia is also increased. The men Dr. Shah describes had severely depressed left ventricular function, a major risk factor for ventricular arrhythmia and sudden death. In clinical trials, the rate of myocardial infarction was similar in men receiving sildenafil and those receiving placebo. (3) We agree with Dr. Shah that physicians should closely follow the recommendations provided. The suggestion by Drs. Schwartz and McCarthy relates only to men with erectile dysfunction who have ischemic heart disease and are not prescribed nitrates in any form. In this group, additional testing before sildenafil treatment may be justified to evaluate the possibility of acute ischemia brought about by sexual activity. These cases emphasize the need for physicians to consider the cardiovascular status of men with erectile dysfunction before any treatment is prescribed.
In response to Saldana et al.: we are unaware of other reports of alveolar hemorrhage in men taking sildenafil. The administration of sildenafil does not increase the antiplatelet action of aspirin.
Little et al. draw attention to the important role of the partner, and we agree that every effort should be made to involve the man's partner early in the treatment of erectile dysfunction. This involvement should include determining the preferences of the partner as well as the man, and informing both about the nature of the sexual dysfunction, the results of diagnostic studies, and the treatment options and their potential consequences. (4)
In response to Drs. Meikle and Arver: serum testosterone and prolactin were measured in all men screened for the sildenafil studies, and men with low values for testosterone or elevated values for prolactin were not eligible for enrollment. We agree that these tests should be performed in all men with erectile dysfunction, because they identify readily reversible causes of the condition. (4)
As Dr. Marshall states, we cited combined prevalence rates for mild, moderate, and complete erectile dysfunction; these rates should reflect the expected rates in clinical practice. Our results thus represent the mean therapeutic responses of all men randomly assigned to treatment. However, Steers et al. have recently published data on the efficacy of sildenafil in men with severe erectile dysfunction. (5) On the basis of end-of-treatment scores, men with severe erectile dysfunction receiving sildenafil had complete response rates of 46 percent, as compared with a rate of 8 percent for those receiving placebo (P<0.001).
In answer to Dr. Budenholzer's question: 101 of 136 men (74 percent) reported improved erections with sildenafil, as compared with 23 of 118 men (19 percent) taking placebo (P<0.001).
Irwin Goldstein, M.D.
Boston Medical Center
Boston, MA 02118
Raymond C. Rosen, Ph.D.
University of Medicine and Dentistry of New Jersey-
Robert Wood Johnson Medical School
Piscataway, NJ 08854
William D. Steers, M.D.
University of Virginia
Charlottesville, VA 22908
for the Sildenafil Study Group
References
1. Hellerstein HK, Friedman EH. Sexual activity and the postcoronary patient. Arch Intern Med 1970;125:987-99.
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2. Muller JE, Mittleman A, Maclure M, Sherwood JB, Tofler GH. Triggering myocardial infarction by sexual activity: low absolute risk and prevention by regular physical exertion. JAMA 1996;275:1405-9.
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3. Morales A, Gingell C, Collins M, Wicker PA, Osterloh IH. Clinical safety of oral sildenafil citrate (Viagra) in the treatment of erectile dysfunction. Int J Impotence Res 1998;10:69-74.
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4. Rosen R, Padma-Nathan H, Goldstein I. Process of care model for the management of erectile dysfunction in the primary care setting. In: Carson C, Kirby R, Goldstein I, eds. Male erectile dysfunction. Oxford, England: Isis Medical Media (in press).
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5. Steers WD, Sildenafil Study Group. Meta-analysis of the efficacy of sildenafil (Viagra) in the treatment of severe erectile dysfunction. J Urol 1998;159:Suppl:238. abstract.
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