Effects of body mass index or dosage on gastrointestinal disorders associated with extended-release metformin in type 2 diabetes: Sub-analysis of a Phase IV open-label trial in Chinese patients. Issue 3 (July 2016)

• Record Type: Journal Article
• Authors: Guo, Lixin; Guo, Xiaohui; Li, Yan; Hong, Xu; Jiang, Xiaozhen; Su, Qing; Zhao, Dong; Wu, Xiaojing; Ji, Linong
• Is Part Of: Diabetes & metabolic syndrome. Volume 10:Issue 3(2016)
• Page Start: 137
• Page End: 142
• Publication Date: 2016-07
• Subjects: Adverse drug event -- Chinese -- Diabetes mellitus -- type 2 -- Glucophage -- Gastrointestinal; Diabetes -- Periodicals; Metabolism -- Disorders -- Periodicals; Diabetes Mellitus -- Periodicals; Metabolic Diseases -- Periodicals; Diabète -- Périodiques; Métabolisme, Troubles du -- Périodiques; Endocrinologie -- Périodiques; Diabète -- Physiopathologie -- Périodiques; Diabetes; Metabolism -- Disorders; Electronic journals; Periodicals; 616.462
• DOI: 10.1016/j.dsx.2016.01.004
• Languages: English
• ISSNs: 1871-4021

Abstract

Abstract: Aim: To determine whether gastrointestinal (GI) tolerability of metformin monotherapy varies according to baseline BMI or at doses >1500 mg/day in patients newly diagnosed with type 2 diabetes. Methods: We performed a sub-analysis of the safety population from a prospective, multicenter, Phase IV open-label study in which 371 Chinese patients with type 2 diabetes received extended-release metformin monotherapy for 16 weeks. The incidence, severity and duration of GI adverse events (AEs) were compared between normal-weight (BMI < 25 kg/m 2, n = 155) and overweight/obese (BMI ≥ 25 kg/m 2, n = 216) patients. The primary objective was to determine whether baseline BMI affect the incidence, severity and duration of GI AEs, using Fisher's exact test and Student's t -test. Secondary objectives were to compare these factors according to final metformin dose (≤1500 mg/day versus 2000 mg/day). Results: The proportion of patients who reported ≥1 GI AE did not differ significantly between BMI groups (25.2% of the normal-weight group versus 21.3% of the overweight/obese group; p = 0.3840). Patients who reported GI AEs in the two BMI groups experienced similar GI AE severity ( p = 0.5410), mean duration ( p = 0.3572) and duration distribution ( p = 0.1347). There was no significant difference in GI AE severity and duration between metformin dosage groups (≤1500 mg/day versus 2000 mg/day). Conclusions: Newly-diagnosed Chinese type 2 diabetes patients of normal weight are no more likely than overweight/obese patients to suffer from increased incidence rates, severity or duration of GI AEs when treated with first-line extended-release metformin monotherapy. Doses of 2000 mg/day did not increase the severity or duration of GI AEs.