Effects of pioglitazone on erectile dysfunction in sildenafil poor-responders: a randomized, controlled study

Babak Gholamine1, Manijeh Motevallian1, Massoumeh Shafiei1, Massoud Mahmoudian2

1Department of Pharmacology & Razi Institute for Drug Research, School of Medicine, Iran University of Medical Sciences, Hemmat Highway, P.O.Box:14155-6183, Tehran, Iran
2Iran Univ. Med. Sci.



Purpose.To assess the effects of pioglitazone on sildenafil responsiveness in men with erectile dysfunction (ED) and a history of poor response to sildenafil. Methods. In a double -blinded study, 38 men aged 47 ± 1.5 years with moderate-to-severe ED and poor response to sildenafil were randomly assigned to take : pioglitazone 30 mg once daily (n=19) or placebo (n=19) for 9 weeks. Erectile function (EF) scores which were assessed by EF domain of International Index of Erectile Function (IIEF) along with responses to Global Assessment Questions (GAQs) were major outcome measures. Serum levels of total testosterone (T), dehydroepiandrosterone sulfate (DHEAS), glucose, lipid profiles and liver function tests were minor outcome measures. Results. Pioglitazone significantly improved major outcome measures compared with placebo ( p < 0.05). A decrease from baseline of total cholesterol level was more in pioglitazone group than in placebo group (p < 0.05). In 84% of the sildenafil poor responders (n=38), at least one of the associated risk factors of ED was found. There was undiagnosed hypercholesterolemia in 34% of the subjects. Serum levels of T, DHEAS, glucose and other parameters remained unchanged in both groups. Pioglitazone was well tolerated either alone or in co- administration with sildenafil. Conclusions. Pioglitazone safely increased sildenafil response to improve ED of men with prior sildenafil failure. This improvement is regardless of fasting glucose and sex hormones levels. Screening for identifying and treatment of risk factors of ED is beneficial for sildenafil poor responders

Key words:Erectile dysfunction, Pioglitazone, Sildenafil,Testosterone

J Pharm Pharm Sci, 11 (1): 22-31, 2008

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DOI: http://dx.doi.org/10.18433/J3TG6H