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January 12, 2000

Sildenafil and Nonnitrate Antihypertensive Medications—Reply

Author Affiliations

Phil B.FontanarosaMD, Deputy EditorIndividualAuthorMargaret A.WinkerMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Fishbein FellowIndividualAuthor

JAMA. 2000;283(2):201-202. doi:10-1001/pubs.JAMA-ISSN-0098-7484-283-2-jbk0112

In Reply: The FDA's adverse event reporting system is intended to identify safety signals. Pfizer, the FDA, and regulatory authorities in more than 80 countries where sildenafil has been approved closely monitor the postmarketing experience. With more than 10 million prescriptions having been filled by more than 5 million men (representing more than 100 million tablets dispensed), there is a substantial body of evidence that sildenafil is safe when used in accordance with the product label.

The number of reports to the FDA's adverse event reporting system and the quality of information reported depend on a number of factors, including the amount of publicity a product receives. As such, the FDA advises that "it is not possible to calculate a true incidence rate of a particular event for a specified drug" based on data from the adverse event reporting system,1 as neither the true numerator nor the true denominator are known.

Because hypertension is a well-recognized risk factor for erectile dysfunction, it is not surprising that a significant percentage of men taking sildenafil also would be taking concomitant antihypertensive medications. A combined analysis2-4 was conducted of 18 double-blind, placebo-controlled, phase 2 and 3 sildenafil clinical trials, in which 1393 (32.6%) of 4274 patients were taking concomitant antihypertensives including β-blockers, α-blockers, diuretics, angiotensin-converting enzyme inhibitors, and calcium channel blockers, either singly or in combination. In the sildenafil-treated patients, no increase in the overall frequency of adverse events with any class of antihypertensive existed.2-4 The frequency of adverse events related to blood pressure regulation, such as dizziness or hypotension, was comparable for patients who took sildenafil with or without concomitant antihypertensive medication. There were no treatment-related cases of syncope or postural hypotension in patients treated with concomitant antihypertensive medications.2-4

Sildenafil has modest effects on blood pressure and is not, as Dr Cohen suggests, associated with marked hypotension. Single oral doses of 100 mg administered to healthy volunteers produced mean maximum decreases in supine blood pressure of 8.4/5.5 mm Hg. The decrease in blood pressure among patients taking and not taking antihypertensive medications was comparable.5

In the clinical trials (based on >6000 person-years of exposure), myocardial infarctions and deaths occurred with comparable frequency in the sildenafil and placebo treatment groups (A. Hackett, MD, unpublished data, May 1999).2

Food and Drug Administration, Viagra information. Available at: http://www.fda.gov/cder/consumerinfo/viagra/default.htm. Accessed November 12, 1999.
Zusman  RMMorales  AGlasser  DOsterloh  I Overall cardiovascular profile of sildenafil citrate.  Am J Cardiol. 1999;83:35C-44C.Google Scholar
Prisant  MBrown  Mfor the Sildenafil Study Group, Sildenafil citrate: well-tolerated by patients with erectile dysfunction taking concomitant antihypertensive therapy.  Am J Hypertens. 1999;12:10A.Google Scholar
Kloner  RBrown  Mfor the Sildenafil Study Group, Safety of sildenafil citrate in men with erectile dysfunction taking multiple antihypertensive agents.  Am J Hypertens. 1999;12:37A.Google Scholar
Zusman  RMCollins  M Effect of sildenafil on blood pressure in men with erectile dysfunction taking concomitant antihypertensive medication.  J Am Coll Cardiol. 1999;33(suppl):238A.Google Scholar
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Financial Disclosure: Dr Kloner has received research funding from and has served as a consultant to and speaker for Pfizer Inc.