Colesevelam Hydrochloride Added to Background Metformin Therapy in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis from 3 Clinical Studies |
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| Institution: | 1. Université Paris-Descartes; Faculté de Médecine; AP-HP; Service de Néphrologie, Hôpital Necker-Enfants Malades, Paris, France;2. University Picardie Jules Verne, Nephrology Dialysis Transplantation Department, CHU Amiens and INSERN UMR 1088, Amiens, France;3. Université Bordeaux Segalen, Service de Néphrologie Transplantation Dialyse, CHU de Bordeaux and INSERM U1026, Bordeaux, France;4. Aix-Marseille Université, Faculté de Médecine, Centre de Néphrologie et de Transplantation Rénale, Hôpital de la Conception, Marseille, France;5. Université Claude Bernard Lyon, Génomique Fonctionnelle de l’Hypertension artérielle, EA 4173, Hôpital Nord-Ouest, Villefranche sur Saône and Department of Nephrology-Hypertension, Hospices Civils de Lyon, Lyon, France;6. Université François-Rabelais, Faculté de Médecine, Service de Néphrologie-Immunologie Clinique, Hôpital Bretonneau, CHU Tours and EA4245, Tours, France;7. Clinical Affairs, Novartis Pharma SAS, Rueil-Malmaison, France;1. Animal Nutrition & Physiology Team, National Institute of Animal science, #1500 Kongjwipatjwi-ro, Wansan-gu, Jeonju-si, Jeollabuk-do, 55365, Republic of Korea;2. Department of Anatomy, Faculty of Medicine, Dr. ALM Postgraduate Institute of Basic Medical Sciences, University of Madras, Taramani Cadia, India;3. Department of food science and technology, Sejong University, 98 Gun-Ja-Dong, Seoul 143-747, Republic of Korea;1. Research Group of Problems in Infectious Diseases (GRIPE), School of Medicine, Universidad de Antioquia UdeA, Medellín, Colombia;2. School of Medicine, Universidad Pontificia Bolivariana, Medellín, Colombia;3. Unit of Infectious Diseases, Hospital Universitario San Vicente Fundación, Medellín, Colombia;1. Amsterdam UMC, Vrije Universiteit, Department of Nutrition and Dietetics, Amsterdam, The Netherlands;2. Amsterdam UMC, Vrije Universiteit, Department of Radiology and Nuclear Medicine, Amsterdam, The Netherlands;3. Zuyderland Medical Center, Department of Gastroenterology, Geriatrics, Intensive Care and Internal Medicine (Co-MIK), Heerlen-Sittard-Geleen, The Netherlands;4. Amsterdam UMC, Vrije Universiteit, Department of Gastroenterology, Amsterdam, The Netherlands;1. Department of Stomatology, The Second Xiangya Hospital, Central South University, Changsha, China;2. Department of Cardiovascular Medicine, The Second Xiangya Hospital, Central South University, Changsha, China;1. Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran;2. Department of Nutrition and Biochemistry, school of Public Health, Tehran University of Medical Sciences, Tehran, Iran;3. Department of Statistics and Epidemiology, school of Public Heath, Tehran University of Medical Sciences, Tehran, Iran |
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| Abstract: | ObjectiveTo evaluate the glucose- and lipid-altering efficacy of colesevelam hydrochloride (HCl) when added to background metformin therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM).MethodsThis post hoc analysis included patients with T2DM from 3 randomized, double-blind, placebo- controlled pivotal studies who received metformin as part of their background antidiabetes therapy. In the pivotal studies, patients with T2DM were randomly assigned to receive colesevelam HCl (3.75 g/d) or placebo added to existing metformin (26 weeks), sulfonylurea (26 weeks), or insulin (16 weeks) monotherapy or combination therapy, wherein the combination therapies may have included metformin.ResultsIn this pooled analysis of 696 patients with T2DM who were receiving metformin monotherapy or metformin combined with other antidiabetes therapies, 355 were randomly assigned to receive colesevelam HCl and 341 to receive placebo. In comparison with placebo, colesevelam HCl significantly reduced hemoglobin A1c (A1C) and fasting plasma glucose (mean treatment difference: -0.50% and -15.7 mg/dL, respectively; P < .001 for both), as well as significantly reduced levels of low-density lipoprotein cholesterol (LDL-C; mean treatment difference: -16.5%), total cholesterol (TC; -5.8%), non-high-density lipoprotein cholesterol (non-HDL-C; -8.2%), and apolipoprotein (apo) B (-7.6%) (P < .0001 for all). Median triglyceride levels were increased with colesevelam HCl (median treatment difference: + 12.8%; P < .0001). In comparison with placebo, colesevelam HCl significantly increased apo A-I (mean treatment difference: + 3.3%; P < .0001), whereas the mean increase in HDL-C with colesevelam HCl was not significant. Colesevelam HCl therapy was generally well tolerated.ConclusionWhen added to metformin-including therapy, colesevelam HCl significantly reduced A1C and fasting glucose, as well as levels of LDL-C, TC, non- HDL-C, and apo B in patients with inadequately controlled T2DM. (Endocr Pract. 2011;17:933-938) |
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