Circulation. 2004;110:3512-3517
Published online before print November 10, 2004, doi: 10.1161/01.CIR.0000148955.19792.8D
Published online before print November 10, 2004, doi: 10.1161/01.CIR.0000148955.19792.8D
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(Circulation. 2004;110:3512-3517.)
© 2004 American Heart Association, Inc.
Late-Breaking Clinical Trials |
Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER) 2
A Double-Blind, Placebo-Controlled Study of Extended-Release Niacin on Atherosclerosis Progression in Secondary Prevention Patients Treated With Statins
From the Cardiology Service, Walter Reed Army Medical Center, Washington, DC.
Correspondence to Allen J. Taylor, MD, LTC, MC, USA, Director, Cardiovascular Research, Cardiology Service, Walter Reed Army Medical Center, 6900 Georgia Ave, NW, Bldg 2, Room 3L28, Washington, DC 20307-5001. E-mail allen.taylor{at}na.amedd.army.mil
Received October 1, 2004; accepted October 6, 2004.
Abstract
Background— Niacin reduces coronary heart disease morbidity and mortality when taken either alone or in combination with statins; however, the incremental impact of adding niacin to background statin therapy is unknown.
Methods and Results— This was a double-blind randomized placebo-controlled study of once-daily extended-release niacin (1000 mg) added to background statin therapy in 167 patients (mean age 67 years) with known coronary heart disease and low levels of high-density lipoprotein cholesterol (HDL-C; <45 mg/dL). The primary end point was the change in common carotid intima-media thickness (CIMT) after 1 year. Baseline CIMT (0.884±0.234 mm), low-density lipoprotein cholesterol (89±20 mg/dL), and HDL-C (40±7 mg/dL) were comparable in the placebo and niacin groups. Adherence to niacin exceeded 90%, and 149 patients (89.2%) completed the study. HDL-C increased 21% (39 to 47 mg/dL) in the niacin group. After 12 months, mean CIMT increased significantly in the placebo group (0.044±0.100 mm; P<0.001) and was unchanged in the niacin group (0.014±0.104 mm; P=0.23). Although the overall difference in IMT progression between the niacin and placebo groups was not statistically significant (P=0.08), niacin significantly reduced the rate of IMT progression in subjects without insulin resistance (P=0.026). Clinical cardiovascular events occurred in 3 patients treated with niacin (3.8%) and 7 patients treated with placebo (9.6%; P=0.20).
Conclusions— The addition of extended-release niacin to statin therapy slowed the progression of atherosclerosis among individuals with known coronary heart disease and moderately low HDL-C.
Key Words: atherosclerosis • risk factors • lipids
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P. Raggi, A. Taylor, Z. Fayad, D. O'Leary, S. Nissen, D. Rader, and L. J. Shaw Atherosclerotic Plaque Imaging: Contemporary Role in Preventive Cardiology Arch Intern Med, November 14, 2005; 165(20): 2345 - 2353. [Abstract] [Full Text] [PDF]
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L. F Van Gaal, F. Peiffer, and D. Ballaux Reducing cardiovascular risk in patients with type 2 diabetes: the potential contribution of nicotinic acid The British Journal of Diabetes & Vascular Disease, November 1, 2005; 5(6): 344 - 350. [Abstract] [PDF]
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P. Raggi, A. Bellasi, and C. Ratti Ischemia Imaging and Plaque Imaging in Diabetes: Complementary tools to improve cardiovascular risk management Diabetes Care, November 1, 2005; 28(11): 2787 - 2794. [Abstract] [Full Text] [PDF]
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2nd International Symposium on Triglycerides and HDL: Lipid abnormalities and their treatment Diabetes Care, November 1, 2005; 28(11): 2795 - 2802. [Full Text] [PDF]
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F. Espinosa-Larranaga, M. Vejar-Jalaf, and R. Medina-Santillan The importance of low serum levels of high-density lipoprotein cholesterol (HDL-C) as a cardiovascular risk factor Diabetes and Vascular Disease Research, October 1, 2005; 2(1_suppl): S1 - S8. [Abstract] [PDF]
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M. D. Ashen and R. S. Blumenthal Low HDL Cholesterol Levels N. Engl. J. Med., September 22, 2005; 353(12): 1252 - 1260. [Full Text] [PDF]
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J. J.P. Kastelein The realities of dyslipidaemia: what do the studies tell us? Eur. Heart J. Suppl., July 1, 2005; 7(suppl_F): F27 - F33. [Abstract] [Full Text] [PDF]
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B. G. Brown Maximizing coronary disease risk reduction using nicotinic acid combined with LDL-lowering therapy Eur. Heart J. Suppl., July 1, 2005; 7(suppl_F): F34 - F40. [Abstract] [Full Text] [PDF]
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S. J. Nicholls and S. E. Nissen Strategies to promote HDL-C: an emerging therapeutic target Eur. Heart J., May 1, 2005; 26(9): 853 - 855. [Full Text] [PDF]
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E. D. Beishuizen, M. A. van de Ree, J. W. Jukema, J. T. Tamsma, and M. V. Huisman Two-Year Statin Therapy Does Not Alter the Progression of Intima-Media Thickness in Patients With Type 2 Diabetes Without Manifest Cardio-vascular Disease: Response to Cicero et al. Diabetes Care, May 1, 2005; 28(5): 1263 - 1264. [Full Text] [PDF]
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J. M. Lee and R. P Choudhury ARBITER 2: targeting HDL to retard atherosclerosis progression: Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER) 2 The British Journal of Diabetes & Vascular Disease, March 1, 2005; 5(2): 78 - 80. [PDF]
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P. Barter Role of nicotinic acid in raising high-density lipoprotein cholesterol (HDL-C) to reduce cardiovascular risk: an Asian/Pacific consensus: The Pan-Asian Consensus Panel On Hdl-C The British Journal of Diabetes & Vascular Disease, March 1, 2005; 5(2_suppl): S1 - S15. [Abstract] [PDF]
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H. Drexel Modern intervention strategies for managing dyslipidaemia: the case for combination therapy The British Journal of Diabetes & Vascular Disease, January 1, 2005; 5(1_suppl): S17 - S23. [Abstract] [PDF]
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S. M. Grundy Atherosclerosis Imaging and the Future of Lipid Management Circulation, December 7, 2004; 110(23): 3509 - 3511. [Full Text] [PDF]
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