Efficacy and Safety of Prucalopride in Chronic Constipation: An Integrated Analysis of Six Randomized, Controlled Clinical Trials.
Efficacy and Safety of Prucalopride in Chronic Constipation: An Integrated Analysis of Six Randomized, Controlled Clinical Trials.
复制标题
DOI：
10.1007/s10620-016-4147-9
复制
发表时间：
2016-08
影响因子：
3.1
通讯作者：
Levine A
中科院分区：
文献类型：
--
作者：
Camilleri M;Piessevaux H;Yiannakou Y;Tack J;Kerstens R;Quigley EMM;Ke M;Da Silva S;Levine A
普卢卡必利是一种选择性、高亲和力的5-羟色胺4受体激动剂，可刺激胃肠和结肠动力，缓解成人慢性便秘（CC）的常见症状。尚未评价按性别划分的相对疗效。使用6项大型、随机、对照临床试验的数据，评价普卢卡必利2 mg每日一次治疗男性和女性CC患者的总体疗效和安全性。数据来自6项III期和IV期、双盲、随机、安慰剂对照、平行组试验。主要疗效终点为12周治疗期间平均每周自发性完全排便（SCBM）≥3次的患者百分比。在所有试验中评估安全性。总体而言，2484例患者（597例男性; 1887例女性;普卢卡必利，1237例;安慰剂，1247例）被纳入综合疗效分析，2552例患者被纳入综合安全性分析。普卢卡必利组（27.8%）在12周治疗期间达到平均SCBM ≥3次/周的患者显著多于安慰剂组[13.2%，OR 2.68（95% CI 2.16，3.33），p < 0.001]。普卢卡必利具有良好的安全性和耐受性特征。男性和女性之间的疗效和安全性结局无显著差异。综合分析证实了普卢卡必利治疗男性和女性CC的有效性和安全性。
Prucalopride, a selective, high-affinity 5-hydroxytryptamine 4 receptor agonist, stimulates gastrointestinal and colonic motility and alleviates common symptoms of chronic constipation (CC) in adults. The relative efficacy by gender has not been evaluated. To evaluate the global efficacy and safety of prucalopride 2 mg daily in men and women with CC using data from six large, randomized, controlled clinical trials. Data were combined from six phase 3 and 4, double-blind, randomized, placebo-controlled, parallel-group trials. The primary efficacy endpoint was the percentage of patients with a mean of ≥3 spontaneous complete bowel movements (SCBMs) per week over 12 weeks of treatment. Safety was assessed throughout all the trials. Overall, 2484 patients (597 men; 1887 women; prucalopride, 1237; placebo, 1247) were included in the integrated efficacy analysis and 2552 patients were included in the integrated safety analysis. Significantly more patients achieved a mean of ≥3 SCBMs/week over the 12 weeks of treatment in the prucalopride group (27.8 %) than in the placebo group [13.2 %, OR 2.68 (95 % CI 2.16, 3.33), p < 0.001]. Prucalopride had a favorable safety and tolerability profile. Efficacy and safety outcomes were not significantly different between men and women. The integrated analysis demonstrates the efficacy and safety of prucalopride in the treatment of CC in men and women.