Adult urologyEfficacy of tadalafil for the treatment of erectile dysfunction at 24 and 36 hours after dosing: a randomized controlled trial☆
Section snippets
Study design and patient population
This multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was conducted at 36 centers in Europe and the United States from February through April 2001. Ethical review boards approved its protocol and informed consent documents, and all patients and partners provided written informed consent before enrollment. The study consisted of a 4-week treatment-free run-in period (during which patients qualified for randomization in part by attempting sexual intercourse at least
Results
Of 348 men enrolled, 327 (94%) completed treatment. The baseline characteristics were well balanced in the two treatment groups (Table I). The mean age in each group was 57 years, and most patients had ED for more than 1 year. On the basis of previously established Erectile Function domain categories of the International Index of Erectile Function, about 40% of men had mild ED, 35% had severe ED, and 25% had moderate ED.
Tadalafil was effective for 36 hours, with 132 (59%) of 223 intercourse
Comment
Because of their relatively short half-lives, pharmacologic agents for ED have historically been used just before a couple engages in sexual activity, inextricably linking the medication with a man’s sexual performance. For example, with alprostadil injection (Caverject, Pharmacia & Upjohn, Peapack, NJ), erection is expected to occur within 5 to 20 minutes after dosing and to last up to 1 hour, regardless of sexual stimulation.22 With the alprostadil urethral suppository (MUSE, Vivus, Mountain
Conclusions
The advent of a pharmacologic agent such as tadalafil, with a period of responsiveness that begins soon after dosing and lasts up to 36 hours, may allow men and their partners more freedom in the timing of their sexual activity.
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This study was funded by Lilly ICOS LLC.
H. Porst, H. Padma-Nathan, F. Giuliano, and R. Rosen are paid consultants to both the sponsor of this study and competitors, are study investigators funded by the sponsor, and are members of the speaker’s bureau for the sponsor. G. Anglin and L. Varanese are employees of the sponsor and hold stock in the sponsor.