Department of Urology, Beijing Shougang Hospital, Affiliated Hospital of Beijing University, Beijing, China.
Clin Drug Investig. 2012 Jan 1;32(1):29-39. doi: 10.2165/11593750-000000000-00000.
Dutasteride is a dual inhibitor of type I and type II 5α-reductases and provides nearly complete suppression of dihydrotestosterone, which plays a key role in the aetiology and development of benign prostatic hyperplasia (BPH). Most knowledge about the efficacy and safety of dutasteride in BPH derives from three pivotal phase III studies conducted primarily in Caucasian populations.
This study aimed to evaluate the efficacy and safety of dutasteride in Chinese adults with symptomatic BPH.
This was a randomized, double-blind, parallel-group, placebo-controlled study conducted over 6 months, followed by an open-label extension of 12 months. A total of 253 BPH subjects with a total prostate volume (TPV) of ≥30 cm3, a maximal urinary flow rate (Q(max)) between 5 and 15 mL/s, and an American Urology Association Symptom Index (AUA-SI) score of ≥12 units were randomized to dutasteride 0.5 mg/day orally or matching placebo treatment in a 1:1 ratio. After 6 months, eligible subjects who volunteered to enter the open-label extension received dutasteride 0.5 mg/day orally. Changes in TPV, Q(max) and AUA-SI as well as drug safety were evaluated.
Dutasteride significantly reduced mean TPV compared with placebo at 3 and 6 months (both p < 0.05). At 6 months, mean TPV decreased by 17.14% versus 3.71% in the dutasteride and placebo groups, respectively. Numerically higher improvements in Q(max) and AUA-SI were observed in the dutasteride group at 3 and 6 months, but there was no statistically significant difference between treatment groups. However, ad hoc analysis indicated that, at 6 months, significantly higher proportions of subjects in the dutasteride group experienced a Q(max) improvement of ≥3 mL/s, or an AUA-SI improvement of ≥1 unit, compared with the placebo group (both p < 0.05). According to these criteria, the Q(max) responder rates were 33.63% and 19.83% in the dutasteride- and placebo-treated groups, respectively, and the AUA-SI responder rates were 87.61% and 76.92%, respectively. During the open-label extension, continuous improvements in TPV, Q(max) and AUA-SI were noted in both groups. Dutasteride was well tolerated with a low incidence of treatment-related adverse events over 18 months.
Dutasteride was effective compared with placebo in the treatment of symptomatic BPH among Chinese patients. The efficacy data from trials involving subjects of different ethnic origins showed some similarities. Dutasteride was generally well tolerated during the study period.
度他雄胺是 I 型和 II 型 5α-还原酶的双重抑制剂，可近乎完全抑制双氢睾酮，后者在良性前列腺增生（BPH）的发病机制和发展中起关键作用。关于度他雄胺在 BPH 中的疗效和安全性的大多数知识来自于主要在白种人群中进行的三项关键性 III 期研究。
本研究旨在评估度他雄胺在中国 BPH 成年患者中的疗效和安全性。
这是一项为期 6 个月的随机、双盲、平行组、安慰剂对照研究，随后进行了 12 个月的开放标签扩展期。共有 253 名 BPH 患者，其总前列腺体积（TPV）≥30cm3、最大尿流率（Qmax）介于 5 至 15mL/s 之间且美国泌尿外科学会症状指数（AUA-SI）评分≥12 分，被随机分配至度他雄胺 0.5mg/天或匹配的安慰剂治疗，比例为 1:1。6 个月后，自愿进入开放标签扩展期的合格患者接受度他雄胺 0.5mg/天治疗。评估 TPV、Qmax 和 AUA-SI 的变化以及药物安全性。
与安慰剂相比，度他雄胺在 3 个月和 6 个月时均显著降低了 TPV（均 p<0.05）。6 个月时，度他雄胺组 TPV 平均下降 17.14%，而安慰剂组仅下降 3.71%。3 个月和 6 个月时，度他雄胺组 Qmax 和 AUA-SI 均有更高的改善，但两组间无统计学差异。然而，特别分析表明，6 个月时，度他雄胺组显著更多的患者 Qmax 改善≥3mL/s，或 AUA-SI 改善≥1 个单位，与安慰剂组相比（均 p<0.05）。根据这些标准，度他雄胺组的 Qmax 应答率分别为 33.63%和 19.83%，而安慰剂组分别为 87.61%和 76.92%。在开放标签扩展期，两组的 TPV、Qmax 和 AUA-SI 均持续改善。度他雄胺在 18 个月的治疗期间耐受性良好，治疗相关不良事件发生率低。
与安慰剂相比，度他雄胺在中国 BPH 患者中治疗有效。来自不同种族人群的试验疗效数据显示出一些相似性。在研究期间，度他雄胺总体上耐受性良好。
