Viagra (Sildenafil), VI-AQUA Trials

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[h=4]Trials combining men with ED of varying etiologies[/h]

In 1996, it was reported that in 12 patients with ED, sildenafil (Viagra) enhanced the erectile response (duration and rigidity of erection) to visual sexual stimulation.[SUP]56[/SUP] This first small controlled crossover trial of sildenafil in 12 men with ED showed that sildenafil increased the duration of rigidity, and the total number of erections.[SUP]56[/SUP]These initial observations were followed by major studies of 861 men with a clinical diagnosis of ED of 6 months duration or longer.[SUP]57[/SUP] Most of the men studied (70%) had organic ED, but 11% had psychogenic ED and 18% had mixed ED.[SUP]57[/SUP]Men taking nitrates were excluded from these studies.[SUP]57[/SUP] In the first study, 532 men received either placebo, or 25, 50 or 100 mg sildenafil approximately 1 h before planned sexual activity.[SUP]57[/SUP] Outcomes were questions three (frequency of penetration) and four (maintenance of erections after penetration) of the International Index of Erectile Function, completed at 0, 12 and 24 weeks.[SUP]57[/SUP] After 24 weeks, improved erections were reported by 56, 77 and 84% of men taking 25, 50 and 100 mg of sildenafil, respectively.[SUP]57[/SUP]In the other part of the study, the flexible dose-escalation study, 329 men received either placebo or 50 mg of sildenafil, 1 h before sexual activity for 12 weeks, and during following visits during this time, they doubled or reduced the dose on the basis of the therapeutic response.[SUP]57[/SUP] At the end of the 12 weeks, most men (74%) were taking 100 mg of sildenafil, and the scores for frequency and maintenance were higher for the last 4 weeks than earlier.[SUP]57[/SUP] After 12 weeks, 74% of men reported improved erections, compared to 19% in the control group.[SUP]57[/SUP] The most common side effects were transient headache, flushing, dyspepsia and rhinitis.[SUP]56[/SUP] Transient visual disturbances (i.e. changes in the perception of colour hue or brightness) were reported by some men.[SUP]57[/SUP] This initial flexible dose-escalation study was performed in the US, but similar studies with similar outcomes have been performed elsewhere (e.g. Malaysian, Singaporean and Filipino,[SUP]58[/SUP] European,[SUP]59[/SUP] Korean[SUP]60[/SUP]) (Table 1).​

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