Document Detail

Do food and dose timing affect the efficacy of sildenafil? A randomized placebo-controlled study.
MedLine Citation:
PMID:  17233779     Owner:  NLM     Status:  MEDLINE    
INTRODUCTION: Sildenafil citrate has been used worldwide by men with erectile dysfunction. The prescribing information for sildenafil suggests ingestion 1 hour before sexual activity and also notes reduced maximum plasma concentration and delayed time to maximum concentration following ingestion with a high-fat meal. The clinical impact of coingestion of food and these factors has never been evaluated. AIM: To determine, using a naturalistic study design, whether sildenafil taken 1 hour before or during a meal compared with usual ingestion 30-60 minutes before sexual activity affects efficacy or patient satisfaction. METHODS: After a 1-2-week washout, 48 men (29-79 years old), currently satisfied with sildenafil, followed each of four regimens: (A) sildenafil 1 hour before a meal and placebo 30-60 minutes before planned coitus vs. (B) placebo 1 hour before a meal and sildenafil 30-60 minutes before coitus; and (C) sildenafil during a meal and placebo 30-60 minutes before coitus vs. (D) placebo during a meal and sildenafil 30-60 minutes before coitus. Subjects were not instructed to change their regular dietary habits during the course of the study. MAIN OUTCOME MEASURES: Change from baseline in the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score, responses to Sexual Encounter Profile (SEP) questions 2 (erection sufficient for penetration) and 3 (erection sufficient to complete intercourse), and measures of patient preference and satisfaction. RESULTS: Mean changes in IIEF-EF domain scores were 11.4 for regimens A and B and 11.2 for C and D. Positive SEP2 responses were recorded for 93.9% and 91.8% of intercourse attempts in A and B and 91.4% and 92.6% in C and D. Corresponding results for SEP3 were 84.7% and 85.9%, and 83.4% and 87.5%, respectively. There were no significant differences between pairs of treatments on satisfaction. The time between sildenafil ingestion and intercourse attempt (0-0.5 to >10 hours) had no significant effect on responses to SEP2, but decreased responses to SEP3 from a maximum of 92.8% at 1.5-2 hours to 81.6% at more than 10 hours (P = 0.003). CONCLUSIONS: No significant loss of efficacy occurs when sildenafil is taken shortly before or with a meal. The duration of action for sildenafil may exceed 10 hours.
Norman Zinner
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Publication Detail:
Type:  Controlled Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The journal of sexual medicine     Volume:  4     ISSN:  1743-6095     ISO Abbreviation:  -     Publication Date:  2007 Jan 
Date Detail:
Created Date:  2007-01-19     Completed Date:  2007-03-21     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:  137-44     Citation Subset:  IM    
Western Clinical Research Inc, Torrance, CA 90505, USA.
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MeSH Terms
Dose-Response Relationship, Drug
Double-Blind Method
Erectile Dysfunction / drug therapy*
Food-Drug Interactions*
Middle Aged
Patient Satisfaction
Penile Erection / drug effects
Phosphodiesterase Inhibitors / administration & dosage*
Piperazines / administration & dosage*
Purines / administration & dosage
Sulfones / administration & dosage*
Treatment Outcome
Vasodilator Agents / administration & dosage*
Reg. No./Substance:
0/Phosphodiesterase Inhibitors; 0/Piperazines; 0/Purines; 0/Sulfones; 0/Vasodilator Agents; 139755-83-2/sildenafil

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