Clinical Outcomes Before and After Prucalopride Treatment: An Observational Study in Patients With Chronic Idiopathic Constipation in the United States.

IF 3 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Clinical and Translational Gastroenterology Pub Date : 2024-05-01 DOI:10.14309/ctg.0000000000000687

Anthony Lembo, Brooks D Cash, Mei Lu, Emi Terasawa, Brian Terreri, Shawn Du, Rajeev Ayyagari, Paul Feuerstadt, Baharak Moshiree, Ben Westermeyer, Selina Pi, Mena Boules

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引用次数: 0

Abstract

Introduction: This real-world US-based claims study compared constipation-related symptoms and complications 6 months before and after prucalopride initiation in adults with chronic idiopathic constipation (CIC).

Methods: This observational, retrospective cohort analysis used the IBM MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental Database (January 2015-June 2020). Prucalopride-treated patients (≥18 years old) who had ≥1 constipation-related International Classification of Diseases, Tenth Revision, Clinical Modification ( ICD-10-CM ) diagnosis code during the baseline or study period were included. The proportions of patients with constipation-related symptoms (abdominal pain, abdominal distension [gaseous], incomplete defecation, and nausea) and constipation-related complications (anal fissure and fistula, intestinal obstruction, rectal prolapse, hemorrhoids, perianal venous thrombosis, perianal/perirectal abscess, and rectal bleeding) were examined. Constipation-related symptoms and complications were identified using ICD-10-CM , ICD-10 - Procedure Coding System , or Current Procedural Terminology codes. Data were stratified by age (overall, 18-64 years, and ≥65 years).

Results: This study included 690 patients: The mean (SD) patient age was 48.0 (14.7) years, and 87.5% were women. The proportions of patients overall with constipation-related symptoms decreased 6 months after prucalopride initiation (abdominal pain [50.4% vs 33.3%, P < 0.001]; abdominal distension [gaseous] [23.9% vs 13.3%, P < 0.001]; and nausea [22.6% vs 17.7%, P < 0.01]; no improvements observed for incomplete defecation). Similarly, the proportions of patients overall with constipation-related complications decreased 6 months after prucalopride initiation (intestinal obstruction [4.9% vs 2.0%, P < 0.001]; hemorrhoids [10.7% vs 7.0%, P < 0.05]; and rectal bleeding [4.1% vs 1.7%, P < 0.05]).

Discussion: This study suggests that prucalopride may be associated with improved constipation-related symptoms and complications 6 months after treatment initiation.

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普鲁卡必利治疗前后的临床效果：对美国慢性特发性便秘患者的观察研究。

简介：这是一项基于美国实际情况的索赔研究：这项基于美国真实世界的索赔研究比较了慢性特发性便秘（CIC）成人患者开始服用普鲁卡必利前后 6 个月的便秘相关症状和并发症：这项观察性、回顾性队列分析使用了 IBM MarketScan® Commercial Claims and Encounters 和 Medicare Supplemental 数据库（2015 年 1 月至 2020 年 6 月）。纳入的普鲁卡因必利治疗患者（≥18 岁）在基线或研究期间有≥1 个便秘相关的《国际疾病分类，第十版，临床修正》（ICD-10-CM）诊断代码。对便秘相关症状（腹痛、腹胀[气胀]、排便不尽和恶心）和便秘相关并发症（肛裂和肛瘘、肠梗阻、直肠脱垂、痔疮、肛周静脉血栓、肛周/直肠脓肿和直肠出血）患者的比例进行了研究。便秘相关症状和并发症使用 ICD-10-CM、ICD-10-程序编码系统或当前程序术语代码进行识别。数据按年龄分层（总体、18-64 岁、≥65 岁）：本研究共纳入 690 名患者：患者平均年龄（标准差）为 48.0（14.7）岁，87.5% 为女性。服用普鲁卡必利 6 个月后，出现便秘相关症状的患者比例有所下降（腹痛[50.4% vs 33.3%, PDiscussion：本研究表明，普鲁卡必利可在开始治疗 6 个月后改善便秘相关症状和并发症。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical and Translational Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

7.00

自引率

0.00%

发文量

114

审稿时长

16 weeks

期刊介绍： Clinical and Translational Gastroenterology (CTG), published on behalf of the American College of Gastroenterology (ACG), is a peer-reviewed open access online journal dedicated to innovative clinical work in the field of gastroenterology and hepatology. CTG hopes to fulfill an unmet need for clinicians and scientists by welcoming novel cohort studies, early-phase clinical trials, qualitative and quantitative epidemiologic research, hypothesis-generating research, studies of novel mechanisms and methodologies including public health interventions, and integration of approaches across organs and disciplines. CTG also welcomes hypothesis-generating small studies, methods papers, and translational research with clear applications to human physiology or disease. Colon and small bowel Endoscopy and novel diagnostics Esophagus Functional GI disorders Immunology of the GI tract Microbiology of the GI tract Inflammatory bowel disease Pancreas and biliary tract Liver Pathology Pediatrics Preventative medicine Nutrition/obesity Stomach.