Linaclotide 290microgram capsules

IntroductionUnderstanding the safety of pharmacotherapy for irritable bowel syndrome (IBS) enables individuals to make informed treatment decisions. While many studies include the number needed to treat to highlight therapeutic benefits, adding the number needed to harm (NNH), a measure we evaluate herein, could enable more comprehensive risk-benefit assessments.MethodsPubMed, Web of Science, and Cochrane databases were searched through October 2024. Clinical trials investigating IBS pharmacotherapies including discontinuation rates because of adverse events (AEs) were included. Data were pooled using a random-effects model. The primary outcome was NNH for each pharmacotherapy, defined as the reciprocal of the absolute difference in risk of AEs leading to treatment discontinuation between the experimental and placebo groups. Secondary outcomes included the relative risk of withdrawing because of an AE and the most common AEs for each drug.ResultsFifty-four trials met inclusion criteria. For constipation-predominant IBS pharmacotherapies, the NNH for linaclotide, lubiprostone, plecanatide, tegaserod, and tenapanor was 35 ( P DiscussionAmong pharmacotherapies for IBS, tricyclics (especially at elevated doses), tenapanor, and alosetron have the highest absolute risk of discontinuation because of an AE when compared with rifaximin, the safest pharmacotherapy studied.

Abstract licence: CC BY-NC-ND

Background and aimsIntestinal secretagogues and prokinetic agents are commonly used for managing irritable bowel syndrome with constipation (IBS-C). However, no studies have provided direct head-to-head comparisons of these medications. This study aimed to evaluate the dose-stratified relationships and safety profiles of multiple agents to treat IBS-C.MethodsWe searched PubMed, Embase, Cochran Library, and Web of Science for randomized controlled trials (RCTs) from their inception until 21 November 2024. Eligible trials assessed the efficacy and safety of intestinal secretagogues or prokinetic agents in patients with IBS-C. The outcomes were abdominal symptoms, stool characteristics, and the incidence of adverse events.ResultsA total of 1,152 articles were identified, and 16 trials involving five drugs with various dosing regimens were included. Our results suggest that linaclotide (62.5 μg qd, 290 μg qd, 500 μg qd and tenapanor 50mg bid) may be superior to placebo and tenapanor (5 mg bid) in improving abdominal pain. Linaclotide (290 μg qd) was significantly more effective than placebo in alleviating abdominal cramping and increasing bowel movement frequency. Regarding safety, linaclotide (125 μg qd) was associated with a higher incidence of adverse events than both linaclotide (62.5 μg qd) and placebo. Tenapanor (50 mg bid) and linaclotide (125 μg qd) were linked to more adverse events than tenapanor (20 mg bid). Linaclotide (290 μg qd) also had a higher incidence of adverse reactions than placebo.ConclusionsFor patients with IBS-C, higher doses of linaclotide and tenapanor may provide enhanced symptom relief, but caution is warranted regarding their safety profiles.

Abstract licence: CC BY-NC-ND