Elsevier

Urology

Volume 62, Issue 1, July 2003, Pages 121-125
Urology

Adult urology
Efficacy of tadalafil for the treatment of erectile dysfunction at 24 and 36 hours after dosing: a randomized controlled trial☆

https://doi.org/10.1016/S0090-4295(03)00359-5Get rights and content

Abstract

Objectives

To examine the therapeutic effects of tadalafil on erectile dysfunction (ED) at 24 and 36 hours after dosing.

Methods

A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 348 men (mean age 57 years) with ED was conducted in Europe and the United States. Patients were stratified by baseline severity of ED using the Erectile Function domain score of the International Index of Erectile Function and then randomly allocated within the severity group to receive tadalafil 20 mg (n = 175) or placebo (n = 173). Subsequently, participants were randomly assigned to two 4-week treatment intervals, during which they were requested to attempt sexual intercourse approximately 24 or 36 hours after tadalafil or placebo dosing. The primary outcome measure was the proportion of successful sexual intercourse attempts (completed to ejaculation) according to patient self-report using the Sexual Encounter Profile diary.

Results

Of the 348 patients, 327 (94%) completed the trial (163 of 175 in the tadalafil group and 164 of 173 in the placebo group). Thirty-six hours after tadalafil dosing, 59.2% of intercourse attempts were successful versus 28.3% in the placebo group (P <0.001). The proportion of successful intercourse attempts at approximately 24 hours after treatment was also significantly greater with tadalafil (52.9%) than with placebo (29.1%; P <0.001). Tadalafil was well tolerated. The incidences of four treatment-emergent adverse events were significantly greater in the tadalafil group than in the placebo group (all P <0.05): headache, flushing, dyspepsia, and myalgia.

Conclusions

Tadalafil 20 mg is an effective and well-tolerated treatment for ED that has a period of responsiveness of up to 36 hours.

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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    • Cited by (0)

    ☆

    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.

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