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Topical Alprostadil versus Placebo.






Harms. According to data reported from one trial (study a), 306 in patients with mild to moderate ED, any adverse events were more frequent in those allocated to alprostadil given at 50μ g (66.7 percent), 100μ g (66.7 percent) or 200μ g (77.5 percent) versus placebo (52.5 percent) the corresponding proportions in the second trial with patients with severe ED (study b) for alprostadil given at 100μ g, 200μ g, 300μ g versus placebo were 30, 60, and 51 versus 11 percent respectively. The incidence of adverse events and withdrawals due to adverse events in both patient populations conformed a dose-response trend and that urogenital pain and hypotension occurred numerically more frequently with alprostadil than with placebo.

Efficacy. The success rate of vaginal penetration was assessed in two trials of mild to moderate (study a) and severe patients (study b).306 Within men with severe ED (study b), compared with those allocated to placebo, who reported a 15.6 percent success rate of vaginal penetration at study end, success rates for men allocated to alprostadil were 32.3 percent for 100μ g, 36.2 percent for 200μ g, and 38.6 percent for 300μ g, with none of the between group differences reaching statistical significance. In men with mild to moderate ED (study a), men allocated to placebo reported a 55.3 percent success rate, while the success rates in alprostadi groups were 69.4 percent for 50μ g (p > 0.05 versus placebo), 69.1 percent for 100μ g (p> 0.05 versus placebo), and 82.9 percent for 200μ g (p = 0.01 versus placebo).

Topical Nitroglycerine versus Placebo. Two trials compared the efficacy and harms of nitroglycerine to placebo.313, 315

Harms. In the first trial, men allocated to nitroglycerine ointment compared with placebo reported more adverse events (frequent burning at the application site: 12.6 versus 0 percent; hypotension: 10.3 versus 0 percent).313 In the second trial, men allocated to nitroglycerine plaster had more frequent headache (35.4 versus 1.1 percent) and smarting pain (23.2 versus 1.1 percent) compared with placebo.315 In addition, 6 percent of men allocated to nitroglycerine withdrew from therapy due to adverse events (severe pain) versus 0 percent of placebo subjects.

Efficacy. In one trial of men with physiologic ED (n=132 randomized), 20.7 percent of those allocated to 2.5 g nitroglycerine ointment twice daily over 2 months reported improved erections versus 1.7 percent of those allocated to placebo. 313 In a second trial, men with predominately psychogenic ED and at least partial in-clinic erectile response to intracavernosal papaverine (n=19) were allocated to 10 mg nitroglycerine plaster administered at least one hour prior to anticipated sexual activity for up to 6 doses not more often than once daily versus placebo plaster. Among those in the nitroglycerine plaster group, 16.7 percent reported improved erections versus 11.1 percent of those in the placebo plaster group.315

Topical Nitroglycerine versus Minoxidil. One trial (n=132 participants) compared the efficacy and harms of nitroglycerine ointment to minoxidil.313

Harms. Men assigned to received nitroglycerine ointment group reported more frequent side effects than did men in the minoxidilgroup, including more frequent burning at the application site (12.6 versus 6 percent) and hypotension (10.3 versus 0 percent).313

Efficacy. Among men in the nitroglycerine ointment group, 20.7 percent reported improved erections versus 44.0 percent of those in the minoxidil group.

Topica Aminophylline plus Isosorbide dinitrate plus Co-dergocrine versus Placebo. Two crossover trials compared the efficacy and harms of Aminophylline plus Isosorbide dinitrate plus Co-dergocrine versus placebo.312, 314 In the first trial (n=36), men with predominately physiologic ED were assigned to receive 2 gm of 3 percent aminophylline plus 0.25 percent isosorbide dinitrateplus 0.05 percent co-dergocrine mesylate taken once during a 7 day period versus placebo.314 In the second trial (n=14), men with predominately psychogenic ED who previously responded to IC injections were allocated to 2 ml doses of 3 percent aminophylline plus 0.25 percent isosorbide dinitrate plus 0.05 percent co-dergocrine mesylate or placebo.312

Harms. None of the patients had prolonged erection or priapism, clinically significant cardiovascular adverse events (such as postural dizziness), headache, or pain at site of application.314 The other trial did not report any data on harms.312

Efficacy. In the first trial, among men assigned to active treatment, 58.3 percent reported erection sufficient for successful intercourse versus 8.3 percent of those allocated to placebo.314 In the second trial, men assigned to the active treatment reported that they experienced erections adequate for intercourse after 3.9 percent of treatment applications versus after 5.3 percent of placebo applications. All successful applications for both the active treatment and placebo groups occurred in a single participant.312

Minoxidil versus Placebo. One crossover trial (n=132) compared the efficacy and harms of minoxidil to placebo.313

Harms. Compared with placebo, men allocated to minoxidil reported more frequent burning at the application site (6 versus 0 percent). No hypotension was reported by either the minoxidil or placebo-treated participants.

Efficacy. Among men allocated to minoxidil, 44.0 percent reported improved erections versus 1.7 percent of those allocated to placebo.

Topical Sildenafil versus Oral Sildenafil. One trial (n=80) compared the efficacy and harms of topical sildenafil to oral sildenafil.144

Harms. In men assigned to receive topical sildenafil, four (10 percent) reported mild headache. In those assigned to receive oral sildenafil, two participants (5 percent) developed severe headache, one participant (3 percent) reported disturbed visual function, and one participant (3 percent) experienced severe dyspepsia.

Efficacy. Among men assigned to the topical sildenafil plus oral placebo group, 12.5 percent reported improved erections versus 70.0 percent for men assigned to the oral sildenafil plus topical placebo group.


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