Department of Urology, Pusan National University School of Medicine, Buan, Korea.
J Sex Med. 2010 Aug;7(8):2842-50. doi: 10.1111/j.1743-6109.2010.01888.x. Epub 2010 Jul 7.
Mirodenafil is a newly developed selective phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED).
To evaluate the efficacy, safety and tolerability of mirodenafil in the treatment of ED in Korean men with diabetes.
A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted with 112 subjects who were randomized to either placebo or mirodenafil 100 mg on demand for 12 weeks.
Primary efficacy variable was the erectile function (EF) domain scores of the International Index of Erectile Dysfunction (IIEF) questionnaire. Secondary efficacy variables included change in the scores of IIEF question 3 and 4 (IIEF Q3 and Q4) from baseline, change in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ) and the Life Satisfaction Checklist (LSC).
After 12 weeks of treatment, mirodenafil group showed significantly greater change in the IIEF-EF domain score from baseline compared with the placebo group (9.3 vs. 1.4, P < 0.0001). The changes from baseline in the mirodenafil group in IIEF Q3 (1.7 vs. 0.4, P < 0.0001) and Q4 (1.7 vs. 0.3, P < 0.0001) were higher compared with the placebo group. Differences between the mirodenafil and placebo groups were significant in the SEP2 (82.0% vs. 55.2%, P = 0.0003), SEP3 (68.9% vs. 22.3%, P < 0.0001). Difference in GAQ "YES" responses was also significant (76.9% vs. 19.1%, P < 0.0001). Normal EF domain scores (≥ 26) at study end were achieved by 32.7% and 9.4% in the mirodeniafl and placebo groups, respectively (P = 0.0031). As for the LSC scores, the mirodenafil group showed significantly greater improvements in sexual life and partner relationship than the placebo group. Most treatment-associated AEs were mild that resolved spontaneously.
Mirodenafil is an effective and well-tolerated agent for the treatment of diabetic patients with ED in Korea.
米罗地尔是一种新开发的选择性磷酸二酯酶 5（PDE5）抑制剂，用于治疗勃起功能障碍（ED）。
评估米罗地尔治疗韩国糖尿病男性 ED 的疗效、安全性和耐受性。
一项多中心、随机、双盲、安慰剂对照、平行组、固定剂量研究纳入了 112 名受试者，他们被随机分为安慰剂组或按需服用米罗地尔 100mg 组，治疗 12 周。
主要疗效变量是国际勃起功能指数（IIEF）问卷的勃起功能（EF）域评分。次要疗效变量包括从基线开始 IIEF 问题 3 和 4（IIEF Q3 和 Q4）评分的变化、从基线开始 IIEF 所有域评分的变化、性接触概况问题 2 和 3（SEP2 和 SEP3）、总体评估问题（GAQ）和生活满意度检查表（LSC）。
治疗 12 周后，米罗地尔组 IIEF-EF 域评分从基线的变化明显大于安慰剂组（9.3 比 1.4，P < 0.0001）。米罗地尔组 IIEF Q3（1.7 比 0.4，P < 0.0001）和 Q4（1.7 比 0.3，P < 0.0001）从基线的变化高于安慰剂组。SEP2（82.0%比 55.2%，P = 0.0003）和 SEP3（68.9%比 22.3%，P < 0.0001）的差异在米罗地尔和安慰剂组之间具有统计学意义。GAQ“是”回答的差异也具有统计学意义（76.9%比 19.1%，P < 0.0001）。在研究结束时，米罗地尔组有 32.7%的患者达到正常 EF 域评分（≥26），安慰剂组有 9.4%的患者达到正常 EF 域评分（P = 0.0031）。对于 LSC 评分，米罗地尔组在性生活和伴侣关系方面的改善明显优于安慰剂组。大多数与治疗相关的不良事件为轻度，可自行缓解。
米罗地尔是一种有效且耐受良好的治疗韩国糖尿病 ED 患者的药物。
