Colesevelam Hydrochloride to Treat Hypercholesterolemia and Improve Glycemia in Prediabetes: A Randomized,Prospective Study |
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| Institution: | 1. Metabolic Institute of America, Tarzana, California;2. University of Miami Miller School of Medicine, Miami, Florida;3. UAB Diabetes Research and Training Center, University of Alabama at Birmingham, Birmingham, Alabama;4. Tulane University Health Sciences Center, New Orleans; Louisiana;5. Dallas Diabetes and Endocrine Center at Medical City, Dallas, Texas;6. Daiichi Sankyo, Inc., Parsippany, New Jersey;7. Daiichi Sankyo Pharma Development, Edison, New Jersey.;1. Diabetes Trials Unit, University of Oxford, Oxford, United Kingdom;2. Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong;3. Department of Medicine, University of Montreal, CRCHUM, Montreal, Canada;4. Zhongshan Hospital, Fudan University, Shanghai, China;5. Department of Medicine and Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada;6. Department of Cardiology, Peking University First Hospital, Beijing, China;7. Bayer Pharmaceuticals China, Beijing, China;8. Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom;9. Cardiology Unit, Karolinska University Hospital Solna, Stockholm, Sweden;10. Bayer AG, Pharma Division, Berlin, Germany;11. Department of Cardiology and Structural Heart Diseases, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland;12. Department of Neurosciences and Preventive Medicine, Danube-University Krems, Krems, Austria;13. Chronic Disease Prevention Unit, National Institute for Health and Welfare, Helsinki, Finland;14. King Abdulaziz University, Jeddah, Saudi Arabia;15. Dasman Diabetes Institute, Dasman, Kuwait;p. China-Japan Friendship Hospital, Beijing, China;q. People''s Hospital of Peking University, Beijing, China;r. Department of Endocrinology, People''s Liberation Army General Hospital, Beijing, China |
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| Abstract: | ObjectiveTo assess the effect of the bile acid sequestrant colesevelam hydrochloride in patients with hypercholesterolemia and prediabetes.MethodsIn this 16-week, randomized, double-blind study, adults with untreated prediabetes (2-hour postoral glucose tolerance test OGTT] glucose ≥ 140 to 199 mg/dL, fasting plasma glucose FPG] ≥ 110 to 125 mg/ dL, or both), low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL, and triglycerides < 500 mg/dL were randomly assigned to receive colesevelam (3.75 g/d) or placebo. The primary end point was percent change in LDL-C from baseline to week 16 with last observation carried forward. Secondary end points included change in FPG, hemoglobin A1c (A1C), and 2-hour post-OGTT glucose level from baseline to week 16 and attainment of LDL-C and FPG targets.ResultsIn total, 216 patients were randomized (colesevelam, 108; placebo, 108). In comparison with placebo, colesevelam significantly reduced LDL-C (mean treatment difference, -15.6%), non-high-density lipoprotein cholesterol (-9.1%), total cholesterol (-7.2%), apolipoprotein B (-8.1%) (P < .001 for all the foregoing), FPG (median, -2.0 mg/dL; P = .02), and A1C (mean, -0.10%; P = .02). Colesevelam did not significantly change 2-hour post-OGTT glucose (-1.9 mg/dL; P = .75) or high-density lipoprotein cholesterol (-0.5%; P = .80). In addition, colesevelam significantly increased triglyceride levels relative to placebo (median, 14.3%; P < .001). The proportion of patients achieving target levels with colesevelam versus placebo, respectively, was as follows: LDL-C < 100 mg/dL (29% versus 11%; P < .001), A1C < 6.0% (37% versus 25%; P = .05), FPG < 110 mg/dL (48% versus 56%; P = .97), and normalization of glucose (FPG < 100 mg/dL 40% versus 23%; P = .06]). Colesevelam had a weight-neutral effect and was well tolerated.ConclusionColesevelam is an option for managing the lipid profile and normalizing glucose levels in patients with hypercholesterolemia and prediabetes. Further study is warranted to determine whether colesevelam slows or prevents progression of prediabetes to type 2 diabetes. (Endocr Pract. 2010;16:617-628) |
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