Gholamine Babak, Shafiei Massoumeh, Motevallian Manijeh, Mahmoudian Massoud
Department of Pharmacology & Razi Institute for Drug Research, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
J Pharm Pharm Sci. 2008;11(1):22-31. doi: 10.18433/j3tg6h.
The effects of pioglitazone on sildenafil responsiveness in men with erectile dysfunction(ED) and a history of poor response to sildenafil were assessed.
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 a premedication of pioglitazone 30 mg (n=19) or placebo (n=19) once daily for 9 weeks along with on-demand use of sildenafil during the last month of pioglitazone treatment.Erectile function (EF) scores, 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 profile and liver function test were minor outcome measures.
Pioglitazone significantly improved major outcome measures compared with placebo. The decrease from baseline of total cholesterol level was more in pioglitazone than in placebo-treated groups. In 84% (32 out of 38) of the sildenafil poor-responders, 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. The intervention was well tolerated.
Pioglitazone increased sildenafil response to improve ED of men with prior sildenafil failure and seems to be safe based on the present preliminary study. This improvement is likely regardless of fasting glucose and sex hormones levels.
评估吡格列酮对患有勃起功能障碍（ED）且对西地那非反应不佳的男性患者西地那非反应性的影响。
在一项双盲研究中，38名年龄为47±1.5岁、患有中度至重度ED且对西地那非反应不佳的男性被随机分配，每天服用一次30毫克吡格列酮（n = 19）或安慰剂（n = 19），持续9周，并在吡格列酮治疗的最后一个月按需使用西地那非。主要结局指标包括通过国际勃起功能指数（IIEF）的勃起功能（EF）领域评估的勃起功能评分以及对总体评估问题（GAQ）的回答。次要结局指标包括血清总睾酮（T）、硫酸脱氢表雄酮（DHEAS）、血糖、血脂谱和肝功能检查。
与安慰剂相比，吡格列酮显著改善了主要结局指标。吡格列酮组总胆固醇水平从基线的下降幅度大于安慰剂治疗组。在38名西地那非反应不佳者中，84%（32名）至少存在一种ED相关危险因素。34%的受试者存在未诊断出的高胆固醇血症。两组的血清T、DHEAS、血糖和其他参数均保持不变。该干预耐受性良好。
基于目前的初步研究，吡格列酮可提高西地那非的反应性，改善既往西地那非治疗失败男性的ED，且似乎是安全的。这种改善可能与空腹血糖和性激素水平无关。
