a Department of Medicine , St Joseph's Hospital and Medical Center , Phoenix , AZ , USA.
b Division of Gastroenterology , University of Michigan Health System , Ann Arbor , MI , USA.
Curr Med Res Opin. 2019 Mar;35(3):461-472. doi: 10.1080/03007995.2018.1533456. Epub 2018 Nov 22.
Severe diarrhea-predominant irritable bowel syndrome (IBS-D) is associated with decreased health-related quality of life (HRQOL) and increased health care costs. Treatment recommendations for IBS-D often start with traditional pharmacotherapy (TP), with escalation to alosetron, rifaximin or eluxadoline if there is no success. There has been no previous head-to-head clinical trial comparing IBS-D treatment outcome for alosetron versus TP. This study, GSK protocol S3B30020, evaluated resource use, work productivity, health-related quality of life and global symptom response in women with IBS-D who were treated with alosetron or TP.
A total of 1956 patients who met criteria for severe IBS-D were randomized to treatment with alosetron 1 mg twice daily (BID) or only TP for up to 24 weeks. Work productivity and resource use were evaluated by standard questionnaires, HRQOL by the IBSQOL instrument and IBS symptoms by the Global Improvement Scale (GIS).
Compared to only TP, alosetron-treated patients reported: (1) fewer clinic/office visits for any health problem (p = .0181) or for IBS-D (p = .0004); (2) reduced use of over-the-counter medications for IBS-D (p < .0001); (3) fewer days of lost work productivity (p < .0001); (4) decreased restriction of social and outdoor activities (p < .0001); and (5) greater global improvement in IBS-D symptoms (p < .0001). Alosetron treatment improved HRQOL scores for all domains (p < .0001). Incidence of adverse events during alosetron use was not remarkable and was similar to that previously reported.
Alosetron 1 mg BID significantly reduced health care utilization and lost productivity, and significantly improved global IBS symptoms, HRQOL, and participation in outdoor and social activities compared with treatment response to TP.
严重腹泻为主型肠易激综合征（IBS-D）与健康相关生活质量（HRQOL）下降和医疗费用增加有关。IBS-D 的治疗建议通常从传统药物治疗（TP）开始，如果没有效果，则升级为阿洛司琼、利福昔明或依鲁替尼。以前没有头对头临床试验比较过阿洛司琼与 TP 治疗 IBS-D 的效果。本研究 GSK 方案 S3B30020 评估了 IBS-D 女性患者接受阿洛司琼或 TP 治疗后的资源利用、工作生产力、健康相关生活质量和整体症状反应。
共有 1956 名符合严重 IBS-D 标准的患者被随机分配接受阿洛司琼 1mg 每日两次（BID）或仅 TP 治疗，最长 24 周。工作生产力和资源利用通过标准问卷评估，健康相关生活质量通过 IBSQOL 工具评估，IBS 症状通过全球改善量表（GIS）评估。
与仅 TP 相比，阿洛司琼治疗组患者报告：（1）因任何健康问题（p=0.0181）或 IBS-D（p=0.0004）就诊的次数更少；（2）用于 IBS-D 的非处方药物使用减少（p<0.0001）；（3）丧失工作生产力的天数更少（p<0.0001）；（4）社会和户外活动受限减少（p<0.0001）；（5）IBS-D 症状整体改善更大（p<0.0001）。阿洛司琼治疗改善了所有领域的 HRQOL 评分（p<0.0001）。阿洛司琼使用期间不良反应的发生率并不显著，与之前报道的相似。
与 TP 治疗反应相比，阿洛司琼 1mg BID 可显著减少医疗保健利用和生产力损失，并显著改善全球 IBS 症状、HRQOL 和参与户外和社交活动。
