Comparative Efficacy of Linaclotide Versus Other Oral Constipation Treatments in Chronic Constipation: a Network Meta-an
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MEDICINE
Comparative Efficacy of Linaclotide Versus Other Oral Constipation Treatments in Chronic Constipation: a Network Meta-analysis Hiroyuki Okumura 1 & Wentao Tang 2 & Kosuke Iwasaki 2 & Shingo Shoji 1 & Takeo Odaka 3 & Atsushi Nakajima 4 Accepted: 18 August 2020 # The Author(s) 2020
Abstract This systematic literature review and network meta-analysis (NMA) indirectly compared the Japanese standard dose of linaclotide 500 μg with other oral chronic constipation (CC) treatments. PubMed, Cochrane-CENTRAL, IchushiWeb, and ClinicalTrials.gov were systematically searched for eligible randomized controlled trials of 43 oral drugs approved globally for CC, including irritable bowel syndrome with constipation (IBS-C) and opioid-induced constipation (OIC). The mean difference (95% credible interval) in change from baseline in weekly number of spontaneous bowel movements (SBM) was compared between linaclotide 500 μg (unapproved in OIC) and other treatments using Bayesian methodology. Fifty-two publications (54 trials) involving 47 treatments (16 drugs, different doses of the same drug treated as different treatments) were included in the NMA. Despite including various drugs/doses, for the mean difference in weekly SBM change, linaclotide 500 μg was statistically significantly more efficacious than other drugs/doses (vs 500 μg linaclotide) including the following: placebo (− 1.907; − 2.568, − 1.237); lubiprostone 16 μg (− 2.090; − 3.226, − 0.968); methylnaltrexone 150 mg (− 1.807; − 3.126, − 0.491), 300 mg (− 1.411; − 2.722, − 0.096), and 450 mg (− 1.405; − 2.708, − 0.097); naloxegol 5 mg (− 2.074; − 4.001, − 0.131) and 12.5 mg (− 1.329; − 2.347, − 0.318); and tegaserod 4 mg (− 1.133; − 2.059, − 0.207) and 12 mg (− 1.024; − 1.822, −0.228), and statistically significantly less effective than linaclotide 600 μg non-approved dose (1.159; 0.123, 2.199) and bisacodyl 10 mg (2.979; 1.723, 4.233). These findings provide relative efficacy data for linaclotide 500 μg vs other constipation drugs/doses regarding improving weekly SBM in CC and IBS-C and may inform clinical decisionmaking for constipation treatments. Keywords Constipation . Linaclotide . Network meta-analysis . Systematic literature review
Introduction This article is part of the Topical Collection on Medicine Hiroyuki Okumura was an employee of Astellas Pharma Inc. at the time of the study Wentao Tang was an employee of Milliman at the time of the study Electronic supplementary material The online version of this article (https://doi.org/10.1007/s42399-020-00467-x) contains supplementary material, which is available to authorized users. * Hiroyuki Okumura [email protected] 1
Medical Affairs, Astellas Pharma, Inc., Tokyo, Japan
2
Milliman, Tokyo, Japan
3
Odaka Medical and Gastrointestinal Clinic, Chiba, Japan
4
Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan
Chronic constipation (CC), including functional constipation and irritable bowel syndrome with constipation (IBS-C), affects
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