Adult urologyEfficacy, safety, and treatment satisfaction of tadalafil versus placebo in patients with erectile dysfunction evaluated at tertiary-care academic centers
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
References (19)
- et al.
Impotence and its medical and psychosocial correlatesresults of the Massachusetts Male Aging Study
J Urol
(1994) - et al.
Efficacy and safety of tadalafil for the treatment of erectile dysfunctionresults of integrated analyses
J Urol
(2002) - et al.
Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function
Urology
(1999) - et al.
EDITSdevelopment of questionnaires for evaluating satisfaction with treatments for erectile dysfunction
Urology
(1999) - et al.
Efficacy and tolerability of vardenafil in men with erectile dysfunction following radical prostatectomy
Eur Urol Suppl
(2002) - et al.
Tadalafil in the treatment of erectile dysfunction following bilateral nerve-sparing radical retropubic prostatectomyA randomized, double-blind, placebo-controlled trial
J Urol
(2004) - et al.
Hypertension is associated with severe erectile dysfunction
J Urol
(2000) - et al.
Health outcomes variables important to patients in the treatment of erectile dysfunction
J Urol
(1998) - et al.
The efficacy and safety of tadalafil in U.S. and Puerto Rican men with erectile dysfunction
J Urol
(2004)
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.
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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.