| Do food and dose timing affect the efficacy of sildenafil? A randomized placebo-controlled study. | |
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MedLine Citation:
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PMID: 17233779 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Norman Zinner |
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Publication Detail:
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Type: Controlled Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The journal of sexual medicine Volume: 4 ISSN: 1743-6095 ISO Abbreviation: - Publication Date: 2007 Jan |
Date Detail:
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Created Date: 2007-01-19 Completed Date: 2007-03-21 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 101230693 Medline TA: J Sex Med Country: United States |
Other Details:
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Languages: eng Pagination: 137-44 Citation Subset: IM |
Affiliation:
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Western Clinical Research Inc, Torrance, CA 90505, USA. wewedoc@aol.com |
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Dose-Response Relationship, Drug Double-Blind Method Erectile Dysfunction / drug therapy* Food-Drug Interactions* Humans Male 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* |
| Chemical | |
Reg. No./Substance:
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0/Phosphodiesterase Inhibitors; 0/Piperazines; 0/Purines; 0/Sulfones; 0/Vasodilator Agents; 139755-83-2/sildenafil |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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