Sixty-three percent, 74%, and 82% of the patients on 25 mg, 50 mg and 100 mg of Viagra, respectively, reported an improvement in their erections, compared to 24% on placebo. In these studies, involving about 1600 patients, analyses of patient diaries showed no effect of Viagra on rates of attempted intercourse (about 2 per week), but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1. Viagra was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and antihypertensives/diuretics. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of Viagra. Figure 3 shows that regardless of the baseline levels of function, subsequent function in patients treated with Viagra was better than that seen in patients treated with placebo. An evaluation of visual function at doses up to twice the maximum recommended dose revealed no effects of Viagra on visual acuity, intraocular pressure, or pupillometry. Viagra was administered to more than 3,000 patients aged 19 to 87 years, with ED of various etiologies (organic, psychogenic, mixed) with a mean duration of 5 years. As in the other titration studies, patients were started on 50 mg and allowed to adjust the dose up to 100 mg or down to 25 mg of Viagra; all patients, however, were receiving 50 mg or 100 mg at the end of the study. Therefore, treatments for erectile dysfunction, including Viagra, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. Diary data indicated that on Viagra, 59% of attempts at sexual intercourse were successful compared to 13% on placebo. At the end of the long-term study, 88% of patients reported that Viagra improved their erections. Most studies assessed the efficacy of Viagra approximately 60 minutes post dose. If Viagra is prescribed to patients taking ritonavir, caution should be used. While this normally would be expected to be of little consequence in most patients, prior to prescribing Viagra, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity. 4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on Viagra vs about 20% on placebo. Viagra (sildenafil citrate) is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. On a global improvement question, 57% of Viagra patients reported improved erections versus 10% on placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for Viagra and 29% for placebo. Viagra demonstrated statistically significant improvement compared to placebo in all 21 studies. Similar effects on blood pressure were noted with 25 mg, 50 mg and 100 mg of Viagra, therefore the effects are not related to dose or plasma levels within this dosage range. PDE5 inhibitors, including Viagra, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects. On a global improvement question, 83% of patients reported improved erections on Viagra versus 12% on placebo. Diary data indicated that on Viagra, 48% of intercourse attempts were successful versus 12% on placebo. Viagra improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction. In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and Viagra, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted (see Drug Interactions). Viagra was evaluated primarily at doses of 25 mg, 50 mg and 100 mg in 21 randomized, double-blind, placebo-controlled trials of up to 6 months in duration, using a variety of study designs (fixed dose, titration, parallel, crossover). When Viagra is taken with a high fat meal, the rate of absorption is reduced, with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29%. These results demonstrated that the effect of Viagra on the primary endpoint was statistically non-inferior to placebo. The combination of heparin and Viagra had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.
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