Document Detail

Comparison of efficacy, safety, and tolerability of on-demand tadalafil and daily dosed tadalafil for the treatment of erectile dysfunction.
MedLine Citation:
PMID:  16422874     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To assess and compare the efficacy of on-demand tadalafil and daily tadalafil in the treatment of erectile dysfunction. MATERIALS AND METHODS: A total of 145 men with a mean age of 57.3 years (range 19-82 years) and mild to severe erectile dysfunction of various etiologies were randomized to receive on-demand tadalafil (20 mg) or daily tadalafil (10 mg) taken without food or alcohol restrictions in a trial lasting 26 weeks. The three primary outcome measures were changes from baseline in the erectile function domain of the International Index of Erectile Function (IIEF), the proportion of "yes" responses to questions 2 and 3 of the Sexual Encounter Profile (SEP). Additional efficacy instruments included a Global Assessment Question administered at completion of the study. RESULTS: Compared with baseline, on-demand and daily tadalafil enhanced all efficacy outcomes. Patients receiving on-demand tadalafil (20 mg) and daily tadalafil (10 mg) experienced a significant mean improvement of 8.3 and 11.9, respectively, in the erectile function domain of the IIEF from baseline (P < 0.001). The mean change from baseline was significantly higher for daily dosed tadalafil than for on-demand tadalafil (P < 0.05). Sexual intercourse was successfully completed (SEP3) in 69% and 84% of patients taking on-demand tadalafil and daily tadalafil, respectively, compared with 30% at baseline (P < 0.001). Successful completion of sexual intercourse was statistically higher for daily tadalafil than for on-demand tadalafil (P < 0.05). Treatment with on-demand tadalafil or daily tadalafil was well tolerated, and headaches, facial flushing, and dyspepsia were the most frequently observed adverse events. CONCLUSION: Tadalafil was effective and well tolerated in this patient population. Treatment with daily tadalafil was associated with a significantly higher IIEF erectile function domain score and completion of successful intercourse compared with on-demand tadalafil.
Chris McMahon
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  The journal of sexual medicine     Volume:  2     ISSN:  1743-6095     ISO Abbreviation:  -     Publication Date:  2005 May 
Date Detail:
Created Date:  2006-01-20     Completed Date:  2006-03-07     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  101230693     Medline TA:  J Sex Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  415-25; discussion 425-7     Citation Subset:  IM    
Australian Centre for Sexual Health, Sydney, NSW, Australia.
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MeSH Terms
Aged, 80 and over
Carbolines / adverse effects*,  therapeutic use
Cross-Over Studies
Drug Administration Schedule
Drug Tolerance
Erectile Dysfunction / drug therapy*,  physiopathology
Middle Aged
Phosphodiesterase Inhibitors / adverse effects*,  therapeutic use
Reg. No./Substance:
0/Carbolines; 0/Phosphodiesterase Inhibitors; 0/tadalafil

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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