Fonseca V, Seftel A, Denne J, Fredlund P
Section of Endocrinology and Metabolism, Tulane University Health Sciences Centre, 1430 Tulane Avenue-SL 53, New Orleans, LA 70112, USA.
Diabetologia. 2004 Nov;47(11):1914-23. doi: 10.1007/s00125-004-1549-6. Epub 2004 Nov 25.
AIMS/HYPOTHESIS: A retrospective analysis of pooled data from twelve placebo-controlled trials was conducted to characterise the efficacy and safety of tadalafil for the treatment of erectile dysfunction in men with diabetes compared with that in men without diabetes.
Patients were randomly allocated to tadalafil 10 mg, 20 mg, or placebo, taken as needed for 12 weeks. The study population comprised 637 men with diabetes (mean age 57 years) and 1681 men without diabetes (mean age 56 years).
At baseline, patients with diabetes had more severe erectile dysfunction than patients without diabetes, with mean International Index of Erectile Function (IIEF) erectile function domain scores of 12.6 and 15.0 respectively (p<0.001). Compared with placebo, tadalafil 10 mg and 20 mg improved all primary efficacy outcomes in both patient groups (p<0.001). Men with diabetes receiving tadalafil 20 mg experienced a mean improvement of 7.4 in their IIEF erectile function domain score against baseline versus 0.9 for placebo (p<0.001). This group reported on average that 53% of their attempts at intercourse were successful, compared with 22% for placebo (p<0.001 for the change from baseline). Baseline IIEF erectile function domain scores correlated inversely with baseline HbA(1)c levels. The responses to tadalafil were similar regardless of levels of baseline glycaemic control, diabetic therapy received, or previous use of sildenafil.
CONCLUSIONS/INTERPRETATION: Despite more severe baseline erectile dysfunction in men with diabetes, tadalafil was efficacious and well tolerated in this population. As reported for other phosphodiesterase 5 inhibitors, the response to tadalafil was slightly lower in men with diabetes than in men without diabetes.
目的/假设：对12项安慰剂对照试验的汇总数据进行回顾性分析，以比较他达拉非治疗糖尿病男性勃起功能障碍的疗效和安全性与非糖尿病男性的差异。
患者被随机分配至他达拉非10毫克、20毫克组或安慰剂组，按需服用12周。研究人群包括637名糖尿病男性（平均年龄57岁）和1681名非糖尿病男性（平均年龄56岁）。
基线时，糖尿病患者的勃起功能障碍比非糖尿病患者更严重，国际勃起功能指数（IIEF）勃起功能领域平均得分分别为12.6和15.0（p<0.001）。与安慰剂相比，他达拉非10毫克和20毫克改善了两组患者的所有主要疗效指标（p<0.001）。接受他达拉非20毫克治疗的糖尿病男性IIEF勃起功能领域得分相对于基线平均改善7.4，而安慰剂组为0.9（p<0.001）。该组报告平均53%的性交尝试成功，而安慰剂组为22%（从基线变化p<0.001）。基线IIEF勃起功能领域得分与基线糖化血红蛋白（HbA1c）水平呈负相关。无论基线血糖控制水平、接受的糖尿病治疗或以前是否使用过西地那非，对他达拉非的反应相似。
结论/解读：尽管糖尿病男性基线勃起功能障碍更严重，但他达拉非在该人群中有效且耐受性良好。正如其他5型磷酸二酯酶抑制剂的报道，糖尿病男性对他达拉非的反应略低于非糖尿病男性。
