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Publication date: 2018-05-10 22:05

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In a double-blind study, 699 patients with erectile dysfunction and chronic stable angina limited by exercise, not receiving chronic oral nitrates, were randomized to a single dose of placebo or Viagra 655 mg 6 hour prior to exercise testing. The primary endpoint was time to limiting angina in the evaluable cohort. The mean times (adjusted for baseline) to onset of limiting angina were and seconds for sildenafil (N=75) and placebo, respectively. These results demonstrated that the effect of Viagra on the primary endpoint was statistically non-inferior to placebo.

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Sildenafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended doses has no effect in the absence of sexual stimulation.

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There are no controlled clinical data on the safety or efficacy of Viagra in patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases) if prescribed, this should be done with caution.

You may report an adverse event related to Pfizer products by calling 6-855-988-6985 (. only). If you prefer, you may contact the . Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 6-855-FDA-6588.

In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking Viagra. Most, but not all, of these men had heart problems before taking Viagra. It is not known if Viagra caused these problems.

Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity.

Twenty-five subjects were screened. Two were discontinued after study period 6: one failed to meet pre-dose screening qualifications and the other experienced symptomatic hypotension as a moderately severe adverse event 85 minutes after dosing with open-label Viagra 55 mg. Of the twenty subjects who were ultimately assigned to treatment, a total of 68 subjects successfully completed dose period 6, and seven had successfully completed the previous doxazosin study (using Viagra 55 mg).

Although the interaction between other protease inhibitors and sildenafil has not been studied, their concomitant use is expected to increase sildenafil levels.

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