Do food and dose timing affect the efficacy of sildenafil? A randomized placebo-controlled study

Journal of Sexual Medicine

Volumn 4, Issue 1, 2007, Pages 137-144

  Zinner, Norman ^a  

^a Western Clinical ResearchInc   (United States)

Author keywords

Food Effect on Medication; Impotence; Timing Medication

Indexed keywords

PLACEBO; SILDENAFIL;

ADULT; AGED; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; COITUS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSAGE SCHEDULE COMPARISON; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG EFFICACY; EATING HABIT; ERECTILE DYSFUNCTION; FOOD; FOOD DRUG INTERACTION; FOOD INTAKE; HUMAN; MALE; PATIENT SATISFACTION; PENIS ERECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SEXUAL BEHAVIOR; SEXUAL INTERCOURSE; TREATMENT OUTCOME;

EID: 33845743037     PISSN: 17436095     EISSN: 17436109     Source Type: Journal    
DOI: 10.1111/j.1743-6109.2006.00400.x     Document Type: Article

References (28)

1. Jackson G, Gillies H, Osterloh I. Past, present, and future: A 7-year update of Viagra (sildenafil citrate). Int J Clin Pract 2005; 59: 680-91.
2. Althof SE, O'leary MP, Cappelleri JC, Hvidsten K, Stecher VJ, Glina S, King R, Siegel RL. Sildenafil citrate improves self-esteem, confidence, and relationships in men with erectile dysfunction: Results from an international, multi-center, double-blind, placebo-controlled trial. J Sex Med 2006; 3: 521-9.
3. Cappelleri JC, Bell SS, Althof SE, Siegel RL, Stecher VJ. Comparison between sildenafil-treated subjects with erectile dysfunction and control subjects on the Self-Esteem and Relationship questionnaire. J Sex Med 2006; 3: 274-82.
4. Carson CC, Lue TF. Phosphodiesterase type 5 inhibitors for erectile dysfunction. BJU Int 2005; 96: 257-80.
5. DeBusk RF, Pepine CJ, Glasser DB, Shpilsky A, DeRiesthal H, Sweeney M. Efficacy and safety of sildenafil citrate in men with erectile dysfunction and stable coronary artery disease. Am J Cardiol 2004; 93: 147-53.
6. Giuliano F, Hultling C, El Masry WS, Smith MD, Osterloh IH, Orr M, Maytom M for the Sildenafil Study Group. Randomized trial of sildenafil for the treatment of erectile dysfunction in spinal cord injury. Ann Neurol 1999; 46: 15-21.
7. Pickering TG, Shepherd AMM, Puddey I, Glasser DB, Orazem J, Sherman N, Mancia G. Sildenafil citrate for erectile dysfunction in men receiving multiple antihypertensive agents: A randomized controlled trial. Am J Hypertens 2004; 17: 1135-42.
8. Pfizer Inc. Viagra (sildenafil citrate). United States prescribing information. Pfizer Inc. ; 2005.
9. Nichols DJ, Muirhead GJ, Harness JA. Pharmacokinetics of sildenafil citrate after single oral doses in healthy male subjects: Absolute bioavailability, food effects and dose proportionality. Br J Clin Pharmacol 2002; 53: 5S-12S.
10. Rajagopalan P, Mazzu A, Xia C, Dawkins R, Sundaresan P. Effect of high-fat breakfast and moderate-fat evening meal on the pharmacokinetics of vardenafil, an oral phosphodiesterase-5 inhibitor for the treatment of erectile dysfunction. J Clin Pharmacol 2003; 43: 260-7.
11. He ZJ. Effects of food and alcohol on the pharmacokinetics of vardenafil [in Chinese]. Zhonghua Nan Ke Xue 2005; 11: 477-9.
12. Forgue ST, Patterson BE, Bedding AW, Payne CD, Phillips DL, Wrishko RE, Mitchell MI. Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol 2005; 61: 280-8.
13. Carter AJ, Ballard SA, Naylor AM. Effect of the selective phosphodiesterase type 5 inhibitor sildenafil on erectile dysfunction in the anesthetized dog. J Urol 1998; 160: 242-6.
14. Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA for the Sildenafil Study Group. Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med 1998; 338: 1397-404.
15. Saenz de Tejada I, Angulo J, Cuevas P, Fernandez A, Moncada I, Allona A, Lledo E, Körschen HG, Niewohner U, Haning H, Pages E, Bischoff E. The phosphodiesterase inhibitory selectivity and the in vitro and in vivo potency of the new PDE5 inhibitor vardenafil. Int J Impot Res 2001; 13: 282-90.
16. Schulman CC, Shen W, Stothard DR, Schmitt H. Integrated analysis examining first-dose success, success by dose, and maintenance of success among men taking tadalafil for erectile dysfunction. Urology 2004; 64: 783-8.
17. Curran MP, Keating GM. Tadalafil. Drugs 2003; 63: 2203-12.
18. Moncada I, Jara J, Subira D, Castano I, Hernandez C. Efficacy of sildenafil citrate at 12 hours after dosing: Re-exploring the therapeutic window. Eur Urol 2004; 46: 357-60.
19. Bayer Pharmaceuticals Corporation. Levitra (vardenafil HCI). United States prescribing information. Bayer Pharmaceuticals Corporation ; 2005.
20. Eli Lilly. Cialis (tadalafil). United States prescribing information. Eli Lilly; 2005.
21. Gingell C, Sultana SR, Wulff MB, Gepi-Attee S. Duration of action of sildenafil citrate in men with erectile dysfunction. J Sex Med 2004; 1: 179-84.
22. Padma-Nathan H, Siegel R, Stecher V, DeRiesthal H. The association between minimum time to onset of action of sildenafil and minimum effective plasma sildenafil levels. J Androl 2005; 26 (suppl): 51.
23. Eardley I, Ellis P, Boolell M, Wulff M. Onset and duration of action of sildenafil citrate for the treatment of erectile dysfunction. Br J Clin Pharmacol 2002; 53: 61S-65S.
24. Gepi-Attee S, Sultana SR, Hodgson G, Wulff MB, Gingell C. Duration of action of sildenafil citrate among men with erectile dysfunction of no known organic cause. Int J Impot Res 2001; 13 (suppl 1): S21.
25. Herbette LG, Vecchiarelli M, Sartani A, Leonardi A. Lercanidipine: Short plasma half-life, long duration of action and high cholesterol tolerance. Updated molecular model to rationalize its pharmacokinetic properties. Blood Press Suppl 1998; 2: 10-7.
26. Levine J, Gordon NC, Poole T, Benowitz N. Relationship of duration of analgesia to opioid pharmacokinetic variables. Brain Res 1983; 289: 391-4.
27. Pentikainen PJ, Neuvonen PJ, Penttila A. Assessment of beta-blocking activity of trimepranol in man. Int J Clin Pharmacol Biopharm 1978; 16: 279-84.
28. Rosenkranz B, Winkelmann BR, Parnham MJ. Clinical pharmacokinetics of molsidomine. Clin Pharmacokinet 1996; 30: 372-84.