Pyrah Department of Urology, St. James's University Hospital, Leeds, UK.
J Sex Med. 2010 Jan;7(1 Pt 1):244-55. doi: 10.1111/j.1743-6109.2009.01547.x.
Men with erectile dysfunction (ED) are also likely to have associated underlying conditions.
This retrospective analysis evaluated the efficacy and safety of vardenafil in men with ED and underlying conditions, including those taking concomitant medications.
A total of 13 randomized, double-blind, placebo-controlled clinical studies were included. Vardenafil was administered at a starting dose of 10 mg, adjustable to 5 or 20 mg after 4 weeks. Efficacy analyses were performed on the intent-to-treat (ITT) population, using a last observation carried forward approach. Efficacy was assessed for subgroups of patients with diabetes, hypertension, dyslipidemia, or metabolic syndrome (as defined by International Diabetes Federation criteria). Incidence rates of treatment-emergent adverse events were analyzed overall and by subgroup for patients in the safety population.
Primary efficacy measures were the erectile function domain of the International Index of Erectile Function (IIEF-EF), and Sexual Encounter Profile questions 2 and 3 (SEP2, SEP3).
In total, 4,326 patients were randomized to treatment; the ITT population included 4,143 patients, with 4,266 patients valid for safety. At 12 weeks, vardenafil therapy was associated with statistically significant improvements from baseline in IIEF-EF scores, and SEP2 and SEP3 success rates, including patients with ED and diabetes, hypertension, dyslipidemia, or metabolic syndrome. These improvements were irrespective of level of glycemic control, or use of concomitant medications for the treatment of diabetes, hypertension, or dyslipidemia. Across all subgroups, the number and type of treatment-emergent adverse events were consistent with results from previous studies of phosphodiesterase type 5 inhibitors in men with ED and underlying conditions.
Vardenafil demonstrated favorable efficacy and tolerability in this large pool of patients with ED and underlying conditions. Importantly, the use of concomitant medications was not associated with any noteworthy changes in the efficacy or safety profile of vardenafil.
患有勃起功能障碍（ED）的男性也可能存在潜在的基础疾病。
本回顾性分析评估了伐地那非在 ED 合并基础疾病（包括正在服用合并药物的患者）男性中的疗效和安全性。
共纳入 13 项随机、双盲、安慰剂对照的临床研究。伐地那非起始剂量为 10mg，4 周后可调整至 5mg 或 20mg。采用末次观察值结转（LOCF）的意向治疗（ITT）人群进行疗效分析。根据国际糖尿病联合会（IDF）标准定义的糖尿病、高血压、血脂异常或代谢综合征患者亚组评估疗效。在安全性人群中，分析整体和亚组患者中治疗中出现的不良事件发生率。
主要疗效指标为国际勃起功能指数（IIEF-EF）的勃起功能域，以及性经历问卷 2（SEP2）和性经历问卷 3（SEP3）。
共有 4326 例患者随机分组接受治疗；ITT 人群包括 4143 例患者，4266 例患者可进行安全性评估。12 周时，伐地那非治疗与 IIEF-EF 评分、SEP2 和 SEP3 成功率从基线的统计学显著改善相关，包括 ED 合并糖尿病、高血压、血脂异常或代谢综合征的患者。这些改善与血糖控制水平无关，也与合并治疗糖尿病、高血压或血脂异常的药物无关。在所有亚组中，治疗中出现的不良事件的数量和类型与之前研究中观察到的磷酸二酯酶 5 抑制剂在 ED 合并基础疾病男性中的结果一致。
伐地那非在大量 ED 合并基础疾病患者中显示出良好的疗效和耐受性。重要的是，合并用药不会导致伐地那非的疗效或安全性特征发生任何显著变化。
