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 |
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Affiliation: | 1. Department of Endocrinology, Beijing Hospital of the Ministry of Health, Beijing, China;2. Department of Endocrinology, Peking University First Hospital, Beijing, China;3. Department of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China;4. Department of Endocrinology, Beijing Friendship Hospital, Capital Medical University, Beijing, China;5. Department of Endocrinology, Shanghai Pudong New Area People''s Hospital, Shanghai, China;6. Department of Endocrinology, Xin Hua Hospital Affiliate to Shanghai Jiao Tong University School of Medicine, Shanghai, China;7. Department of Endocrinology, The Luhe Teaching Hospital of the Capital Medical University, Beijing, China;8. Department of Biostatistics, PPD Pharmaceutical Development (Beijing) Co, Ltd, Beijing, China;9. Department of Endocrinology and Metabolism, Peking University People''s Hospital, No 11, Xizhimen South Street, Beijing, 100044, China |
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Abstract: | AimTo 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.MethodsWe 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/m2, n = 155) and overweight/obese (BMI ≥ 25 kg/m2, 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).ResultsThe 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).ConclusionsNewly-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. |
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Keywords: | Adverse drug event Chinese Diabetes mellitus type 2 Glucophage Gastrointestinal |
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