Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.
State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Division of Gastroenterology and Hepatology, Shanghai Cancer Institute, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
J Dig Dis. 2022 Feb;23(2):99-110. doi: 10.1111/1751-2980.13081.
To conduct a sub-cohort analysis to evaluate the efficacy and safety of linaclotide in Chinese patients with constipation-predominant irritable bowel syndrome (IBS-C) using data from a completed trial (NCT01880424).
In this phase III, double-blind, placebo-controlled trial, IBS-C patients were randomized to receive linaclotide (290 μg/d) or placebo for 12 weeks. Efficacy was assessed with two co-primary responder end-points (12-wk abdominal pain/discomfort: ≥30% reduction in either score with neither deteriorating from baseline for ≥6 wks; 12-wk IBS degree of relief: score ≤2 for ≥ 6 wks), seven secondary endpoints and several additional end-points.
In total, 659 Chinese IBS-C patients received linaclotide (n = 327) or placebo (n = 332). The 12-week abdominal pain/discomfort end-point was met in 62.1% and 53.3% of the linaclotide-treated and placebo-treated patients, respectively (odds ratio [OR] 1.43, 95% confidence interval [CI] 1.05-1.96, P = 0.023); the 12-week IBS degree of relief end-point was achieved in 32.7% and 16.9% of the patients treated with linaclotide and placebo, respectively (OR 2.40, 95% CI 1.66-3.47, P < 0.001). The linaclotide-treated patients had a shorter time to the first spontaneous bowel movement than the placebo-treated patients (23.6 h vs 43.7 h, P < 0.001). Linaclotide produced significantly greater improvement than placebo in all secondary end-points from the first 2 weeks (all P < 0.001). Diarrhea was reported in 8.3% of linaclotide-treated patients and 1.2% of placebo-treated patients.
Linaclotide (290 μg/d) was efficacious and well-tolerated in Chinese IBS-C patients with a rapid onset of effect.
使用已完成的试验（NCT01880424）的数据，进行亚组分析以评估利那洛肽在中国便秘型肠易激综合征（IBS-C）患者中的疗效和安全性。
在这项 III 期、双盲、安慰剂对照试验中，IBS-C 患者被随机分配接受利那洛肽（290μg/d）或安慰剂治疗 12 周。使用两个共同主要应答终点（12 周腹痛/不适：评分至少降低 30%，且无恶化≥6 周；12 周 IBS 缓解程度：评分≤2 且至少持续 6 周）、7 个次要终点和几个其他终点评估疗效。
共有 659 名中国 IBS-C 患者接受利那洛肽（n=327）或安慰剂（n=332）治疗。利那洛肽治疗和安慰剂治疗患者的 12 周腹痛/不适终点分别为 62.1%和 53.3%（比值比[OR] 1.43，95%置信区间[CI] 1.05-1.96，P=0.023）；12 周 IBS 缓解程度终点分别为 32.7%和 16.9%（OR 2.40，95%CI 1.66-3.47，P<0.001）。利那洛肽治疗患者的首次自发性排便时间短于安慰剂治疗患者（23.6 小时比 43.7 小时，P<0.001）。利那洛肽在所有次要终点的治疗 2 周内均显著优于安慰剂（均 P<0.001）。利那洛肽治疗患者的腹泻发生率为 8.3%，安慰剂治疗患者为 1.2%。
利那洛肽（290μg/d）在中国 IBS-C 患者中有效且耐受良好，起效迅速。
