Publication
Title
Long-term safety and tolerability of thdalafil in the treatment of erectile dysfunction
Author
Abstract
Objective: To assess the long-term safety and tolerability of tadalafil for patients with erectile dysfunction (ED). Patients and Methods: This was a multicentre, open-label, 24-month extension trial involving 1173 men with ED. The mean age was 57 (range 23-83) years and 74.8% of patients were taking concomitant medications for comorbid conditions, including diabetes mellitus in 30.5% of men and hypertension in 29.5%. These patients had participated in 1 of 5 previous 8-week or 12-week randomised, double-blind, placebo-controlled tadalafil studies. In the present trial, the starting 10 mg dose of tadalafil could be increased to 20 mg if the patient could not achieve satisfactory intercourse or reduced to 5 mg for an adverse event that was persistent, intolerable and judged by the investigator to be related to tadalafil. Results: Four hundred ninety-three (42.0%) men completed 24 months of treatment. In addition, a further 234 (19.9%) completed 18 months of treatment due to a sponsor decision to reduce the study duration. The total tadalafil exposure was 1676.0 patient-years. Tadalafil was safe and well tolerated. Headache (15.8%), dyspepsia (11.8%), nasopharyngitis (11.4%), and back pain (8.2%) were the most common treatment-emergent adverse events. The rate of discontinuations due to adverse events for this 18-24-month study was 6.3% and the rate for any individual event was <1%. Serious adverse events occurred in 8.6% of patients. No consistent pattern of serious adverse events assessed as causally associated with tadalafil administration was observed. None of the four deaths that occurred during the study was assessed as tadalafil related. There were no clinically significant laboratory or electrocardiographic findings or changes in vital signs in mean baseline-to-endpoint analysis attributable to tadalafil. Tadalafil administration was not causally associated with drug-induced hepatotoxicity, neutropenia, thrombocytopenia, or renal dysfunction. Conclusion: Tadalafil at doses of 5, 10, or 20 mg taken as needed up to once daily for 18 to 24 months was safe and well tolerated. These findings support the long-term use of tadalafil in the clinical management of erectile dysfunction. (C) 2003 Elsevier B.V. All rights reserved.
Language
English
Source (journal)
European urology / European Association of Urology. - Basel
Publication
Basel : 2004
ISSN
0302-2838
Volume/pages
45:3(2004), p. 339-345
ISI
000189226400013
Full text (Publishers DOI)
Full text (publishers version - intranet only)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
Affiliation
Publications with a UAntwerp address
External links
Web of Science
Record
Identification
Creation 03.01.2013
Last edited 26.04.2017
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