A 50-week extension study on the safety and efficacy of colesevelam in adults with primary hypercholesterolemia

American Journal of Cardiovascular Drugs

Volumn 10, Issue 5, 2010, Pages 305-314

  Davidson, Michael H ^a   Donovan, Joanne M ^b   Misir, Soamnauth ^c   Jones, Michael R ^c  

^a UNIVERSITY OF CHICAGO   (United States)

^b GENZYME CORPORATION   (United States)

^c DAIICHI SANKYO INC   (United States)

Author keywords

Bile acid binding protein modulators, therapeutic use; Colesevelam, therapeutic use; Hypercholesterolaemia, treatment

Indexed keywords

ATORVASTATIN; COLESEVELAM; FLUINDOSTATIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; NICOTINIC ACID; PRAVASTATIN; SIMVASTATIN; TRIACYLGLYCEROL;

ABDOMINAL PAIN; ACCIDENTAL INJURY; ADULT; AGED; ANEMIA; ANGINA PECTORIS; ARTICLE; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; COHORT ANALYSIS; CONSTIPATION; DEPRESSION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DYSPEPSIA; EDEMA; FEMALE; FLATULENCE; FOLLOW UP; HEART INFARCTION; HUMAN; HYPERCHOLESTEROLEMIA; INFECTION; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NERVOUSNESS; OPEN STUDY; PAIN; PATIENT PARTICIPATION; PRIORITY JOURNAL; SCREENING; SIDE EFFECT; TRIACYLGLYCEROL BLOOD LEVEL; UNITED STATES;

ADULT; AGED; ALANINE TRANSAMINASE; ALLYLAMINE; ANTICHOLESTEREMIC AGENTS; ASPARTATE AMINOTRANSFERASES; CHOLESTEROL, HDL; CHOLESTEROL, LDL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPERCHOLESTEROLEMIA; MALE; MIDDLE AGED;

EID: 77957295590     PISSN: 11753277     EISSN: 1179187X     Source Type: Journal    
DOI: 10.2165/11584310-000000000-00000     Document Type: Article

References (21)

1. NCEP ATP III. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation 2002 Dec. 17;106(25):3143-421
2. Wilson PW, D'Agostino RB, Levy D, et al. Prediction of coronary heart disease using risk factor categories. Circulation 1998 May 12;97(18):1837-47 (Pubitemid 28213628)
3. Kannel WB, Neaton JD, Wentworth D, et al. Overall and coronary heart disease mortality rates in relation to major risk factors in 325, 348 men screened for the MRFIT. Multiple Risk Factor Intervention Trial. Am Heart J 1986 Oct; 112(4):825-36
4. Stamler J, Wentworth D, Neaton JD. Is relationship between serum cholesterol and risk of premature death from coronary heart disease continuous and graded? Findings in 356, 222 primary screenees of the Multiple Risk Factor Intervention Trial (MRFIT). JAMA 1986 Nov. 28;256(20):2823-8 (Pubitemid 17178359)
5. The Lipid Research Clinics Coronary Primary Prevention Trial results: II. The relationship of reduction in incidence of coronary heart disease to cholesterol lowering. JAMA 1984 Jan 20;251(3):365-74 (Pubitemid 14215914)
6. The Lipid Research Clinics Coronary Primary Prevention Trial results: I. Reduction in incidence of coronary heart disease. JAMA 1984 Jan 20;251(3):351-64
7. Pekkanen J, Linn S, Heiss G, et al. Ten-year mortality from cardiovascular disease in relation to cholesterol level among men with and without preexisting cardiovascular disease. N Engl J Med 1990 Jun. 14;322(24):1700-7 (Pubitemid 20231527)
8. Rossouw JE, Lewis B, Rifkind BM. The value of lowering cholesterol after myocardial infarction. N Engl J Med 1990 Oct. 18;323(16):1112-9 (Pubitemid 20370733)
9. Wong ND, Wilson PW, Kannel WB. Serum cholesterol as a prognostic factor after myocardial infarction: the Framingham Study. Ann Intern Med 1991 Nov. 1;115(9):687-93
10. Insull Jr W. Clinical utility of bile acid sequestrants in the treatment of dyslipidemia: a scientific review. South Med J 2006 Mar; 99(3):257-73
11. Shepherd J, Packard CJ, Bicker S, et al. Cholestyramine promotes receptormediated low-density-lipoprotein catabolism. N Engl J Med 1980 May 29;302(22):1219-22 (Pubitemid 10112393)
12. Bays H, Dujovne C. Colesevelam HCl: a non-systemic lipid-altering drug. Expert Opin Pharmacother 2003 May; 4(5):779-90 (Pubitemid 36622207)
13. Braunlin W, Zhorov E, Smisek D, et al. Invitro comparisonof bile acid binding to colesevelam HCl and other bile acid sequestrants. Polymer Reprints 2000;41:708-9
14. Davidson MH, Dillon MA, Gordon B, et al. Colesevelam hydrochloride (cholestagel): a new, potent bile acid sequestrant associated with a low incidence of gastrointestinal side effects. Arch Intern Med 1999 Sep. 13;159(16):1893-900 (Pubitemid 29424709)
15. Davidson MH, Toth P, Weiss S, et al. Low-dose combination therapy with colesevelam hydrochloride and lovastatin effectively decreases low-density lipoprotein cholesterol in patients with primary hypercholesterolemia. Clin Cardiol 2001 Jun; 24(6):467-74 (Pubitemid 32520218)
16. Hunninghake D, Insull Jr W, Toth P, et al. Coadministration of colesevelam hydrochloride with atorvastatin lowers LDL cholesterol additively. Atherosclerosis 2001 Oct; 158(2):407-16 (Pubitemid 32913651)
17. Bays HE, Davidson M, Jones MR, et al. Effects of colesevelam hydrochloride on low-density lipoprotein cholesterol and high-sensitivity C-reactive protein when added to statins in patients with hypercholesterolemia. Am J Cardiol 2006 Apr. 15;97(8):1198-205
18. Moore A, Phan BAP, Challender C, et al. Effects of adding extended-release niacin and colesevelam to statin therapy on lipid levels in subjects with atherosclerotic disease. J Clin Lipidol 2007;1(6):620-5 (Pubitemid 350215509)
19. National Cholesterol Education Program (NCEP) step 1 diet [online]. Available from URL: http://www.americanheart.org/presenter.jhtml?identifier=4764 [Accessed 2010 Aug. 5]
20. Dobs AS, Prasad M, Goldberg A, et al. Changes in serum lipoprotein (a) in hyperlipidemic subjects undergoing long-term treatment with lipid-lowering drugs. Cardiovasc Drugs Ther 1995 Oct; 9(5):677-84
21. Brunzell JD, Davidson M, Furberg CD, et al. Lipoprotein management in patients with cardiometabolic risk: consensus conference report from the American Diabetes Association and the American College of Cardiology Foundation. J Am Coll Cardiol 2008 Apr. 15;51(15):1512-24 (Pubitemid 351470037)