Elsevier

Urology

Volume 65, Issue 2, February 2005, Pages 353-359
Urology

Adult urology
Efficacy, safety, and treatment satisfaction of tadalafil versus placebo in patients with erectile dysfunction evaluated at tertiary-care academic centers

https://doi.org/10.1016/j.urology.2004.09.056Get rights and content

Abstract

Objectives

To determine the efficacy, safety, and treatment satisfaction of tadalafil 20 mg for erectile dysfunction (ED) in patients evaluated at tertiary-care academic centers.

Methods

In this randomized, double-blind, placebo-controlled trial, patients were randomly allocated to receive fixed-dose tadalafil 20 mg (n = 146) or placebo (n = 49) for 12 weeks. Efficacy was assessed by the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Global Assessment Question (GAQ); patient and partner treatment satisfaction by the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and SEP; and safety by adverse events, laboratory values, and vital signs.

Results

Mean baseline IIEF erectile function (EF) domain was 12.98. Fifty-one percent of enrolled patients had severe baseline ED, and 82% had organic ED. Pre-existing, ED-associated comorbid conditions were common. When compared with patients treated with placebo, those receiving tadalafil reported significant improvement from baseline in the IIEF EF domain (P <0.001), successful penetration attempts (SEP question 2; P <0.001), successful intercourse (SEP question 3; P <0.001), and all secondary efficacy outcomes (P <0.001). Patients and their sexual partners were also significantly more satisfied with tadalafil treatment (P <0.001), including overall satisfaction (P <0.001) and length of time the treatment worked (P <0.001). Mild or moderate headache, dyspepsia, and myalgia were the most frequent treatment-emergent adverse events reported.

Conclusions

Tadalafil significantly improved erectile function and patient and partner satisfaction and was well tolerated. These results were observed in a tertiary-care, academic center population with a high incidence of severe, organic ED, and comorbid medical conditions, factors known to compromise erectile function and treatment outcome.

Section snippets

Study design

This multicenter, randomized, double-blind, placebo-controlled, parallel-group study was conducted at 20 tertiary-care, academically affiliated investigative sites in the United States. The first patient was enrolled in April 2001, and the study was completed in November 2001. The ethics committees of participating institutions approved the final protocol, amendments, and informed consent document.

A medical history, physical examination, laboratory safety tests, and an electrocardiogram (ECG)

Patients

Of the 241 patients screened, 195 were randomized (tadalafil 146, placebo 49), and 147 (tadalafil 116, placebo 31) completed treatment. Thirty patients (20.5%) treated with tadalafil and 18 (36.7%) treated with placebo discontinued treatment. The most common reasons for early discontinuation were lack of efficacy (tadalafil 5.5%, placebo 18.4%) and adverse events (tadalafil 5.5%, placebo 2.0%).

The two treatment groups were well matched for demographic characteristics and for baseline

Comment

Patients evaluated at tertiary-care academic centers are expected to have more severe ED and ED-associated comorbidities than patients seen in primary-care settings. In this study, 51% of patients presented with severe ED, and 82% had organic ED. This tertiary-care patient population also had a high incidence of hypertension, hyperlipidemia, and diabetes mellitus. In trials with tadalafil investigating subjects with ED due to diabetes or after nerve-sparing prostatectomy, 47% (data on file) and

Conclusions

In this multicenter, randomized, double-blind, placebo-controlled trial, tadalafil 20 mg significantly improved EF in patients evaluated at tertiary-care academic medical centers. Tadalafil was safe, well tolerated, and significantly improved ED-treatment satisfaction (versus placebo) for patients and partners, even though the population had a higher incidence of severe, organic ED and comorbid medical conditions, and the patients were given simplified dosing instructions with no emphasis on

Acknowledgments

Other investigators in the TREATED-US Study Group (in alphabetical order) included Gregory A. Broderick (Mayo Clinic, Jacksonville, Fla); Arthur R. Burnett (Johns Hopkins Hospital, Baltimore, Md); J. François Eid (Weill Medical College of Cornell University, New York, NY); Robert G. Ferrigni (Mayo Clinic, Scottsdale, Ariz); Pablo Gomery (Urology Associates, Massachusetts General Hospital, Boston, Mass); Fred Govier (Virginia Mason Medical Center, Seattle, Wash); Wayne J. G. Hellstrom (Tulane

Cited by (0)

Funding from Lilly ICOS LLC, Bothell, Washington, and Indianapolis, Indiana, supported this work.

Other TREATED-US Study Group investigators are listed in the Acknowledgments.

1

C. C. Carson is a paid consultant to, and study investigator for, Lilly ICOS. R. Shabsigh is a paid consultant to Lilly ICOS, and is a paid consultant to, and study investigator for, Pfizer. S. Segal is an employee of, and holds stock in, Eli Lilly. A. Murphy and P. Fredlund are employees of, and hold stock in, ICOS.

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