The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials

Autor:	Anthony Lembo, Bernard J. Lavins, S J Shiff, M Currie, Jeffrey M. Johnston, Jennifer G. Chickering, Xinming Hao, X. D. Jia, Caroline B. Kurtz, Lin Chang
Jazyk:	angličtina
Rok vydání:	2014
Předmět:	Adult Male medicine.medical_specialty Abdominal pain Constipation Placebo Severity of Illness Index law.invention chemistry.chemical_compound Quality of life Randomized controlled trial Double-Blind Method law Internal medicine Severity of illness medicine Humans Pharmacology (medical) Linaclotide Hepatology business.industry Gastroenterology Linaclotide for Constipation Surgery Abdominal Pain Clinical trial Treatment Outcome chemistry Patient Satisfaction Chronic Disease Quality of Life Female medicine.symptom Symptom Assessment business Peptides
Zdroj:	Alimentary Pharmacology & Therapeutics
ISSN:	1365-2036 0269-2813
Popis:	Background Few clinical trials in chronic idiopathic constipation (CIC) patients have evaluated abdominal symptom severity and whether CIC patients with abdominal symptoms respond similarly to patients with limited abdominal symptoms. Aims To examine abdominal symptom severity and relationships between symptoms and global measures at baseline; compare linaclotide's effect on symptoms in subpopulations with more or less abdominal pain; and assess relationships between symptom improvement and global measures in these two subpopulations. Methods In two phase 3 trials, patients meeting modified Rome II CIC criteria were assigned to linaclotide 145 μg, 290 μg, or placebo once daily. Patients rated abdominal and bowel symptoms daily during 2-week pre-treatment and 12-week treatment periods. Linaclotide's effect on symptoms and global measures [constipation severity, health-related quality of life (HRQOL), treatment satisfaction] and their inter-relationships were assessed in post hoc analyses of abdominal pain subpopulations. Results Of 1271 CIC patients, 23%, 32%, and 43% reported moderate-to-severe abdominal pain, discomfort, and bloating, respectively, during baseline. In more-severe abdominal pain patients, abdominal symptoms were more strongly correlated than bowel symptoms with global measures, but in less-severe abdominal pain patients, abdominal and bowel symptoms were similarly correlated with global measures, at baseline and post-treatment. Linaclotide significantly improved all symptoms and global measures in both subpopulations. Conclusions When abdominal pain is present in CIC, abdominal and not bowel symptoms may drive patient assessments of constipation severity, HRQOL, and treatment satisfaction. Linaclotide (145 μg and 290 μg) is an effective treatment for both abdominal and bowel symptoms, even in CIC patients with more severe abdominal pain at baseline. (Clinicaltrials.gov: NCT00765882, NCT00730015).
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2242a299b8e7c129a977b2e00743280a http://europepmc.org/articles/PMC4278547 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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