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CARDIOLOGY

Effects of Atorvastatin on Lp(a) and Lipoprotein Profiles in Hemodialysis Patients

Associate Professor, Division of Nephrology and Hypertension, School of Medicine; Pharmacotherapy and Experimental Therapeutics, School of Pharmacy, University of North Carolina Kidney Center, University of North Carolina, Chapel Hill, NC

Kimberly A Dornbrook-Lavender, PharmD BCPS

at the time of the study, Cardio-Renal Fellow, University of North Carolina; now, Medical Science Liaison, Shire Pharmaceuticals, Durham, NC

Hyunsook Chin, MPH

Statistician, Division of Nephrology and Hypertension, School of Medicine, University of North Carolina Kidney Center, University of North Carolina

Susan L Hogan, PhD

Assistant Professor, Division of Nephrology and Hypertension, School of Medicine, University of North Carolina Kidney Center, University of North Carolina

Cynthia Denu-Ciocca, MD

Assistant Professor, Division of Nephrology and Hypertension, School of Medicine, University of North Carolina Kidney Center

Reprints: Dr. Joy, School of Medicine, Division of Nephrology and Hypertension, School of Pharmacy, Pharmacotherapy and Experimental Therapeutics, North Carolina Kidney Center, University of North Carolina, CB 7155, 7005 Burnett Womack Building, Chapel Hill, NC 27599, fax 919/966-4251, Melanie_Joy{at}med.unc.edu

BACKGROUND: Dialysis patients have many underlying traditional and nontraditional risk factors that may predispose them to a high prevalence of cardiovascular disease. The effects of statins (eg, atorvastatin) on altering nontraditional lipoprotein measures in dialysis patients have not been extensively investigated.

OBJECTIVE: To evaluate the efficacy of atorvastatin compared with a control group in inducing changes in lipoprotein(a) [Lp(a)], apolipoprotein (Apo) A-1, Apo-B, and fibrinogen levels, as well as the conventional lipoprotein profile, in hemodialysis patients over 36 weeks; secondary objectives were to assess changes in C-reactive protein, albumin, and safety measures.

METHODS: Forty-five hemodialysis patients with low-density lipoprotein cholesterol (LDL-C) levels greater than 100 mg/dL were randomized to parallel groups: atorvastatin (n = 19) or no treatment (n = 26). The atorvastatin dose was titrated from 10 mg to achieve an LDL-C goal of 100 mg/dL or less and therapy was continued for 36 weeks. Biochemical and lipoprotein laboratory tests for efficacy outcomes were obtained at baseline, 12 weeks, and 36 weeks.

RESULTS: The atorvastatin group exhibited clinically significant reductions (mean ± SD) compared with controls in total cholesterol (-21.7 ± 41.7 vs -3.2 ± 40.0 mg/dL, respectively; p = 0.017) and LDL-C (-13.1 ± 32.0 vs -1.1 ± 38.4 mg/dL, respectively; p = 0.058) levels, as well as Lp(a) (-10.6 ± 27 vs 3.5 ± 17.8 mg/dL, respectively; p = 0.046). Statistical analyses included analysis of variance on ranked measures for multivariable modeling and paired t-test to determine changes in efficacy measures between baseline and 36 weeks within groups.

CONCLUSIONS: Atorvastatin was safe and effective in reducing Lp(a), total cholesterol, and LDL-C levels. Given the prevalence of atherosclerosis in hemodialysis patients, therapy aimed at reducing traditional and nontraditional risk factors may be beneficial.

Key Words: atorvastatin, hemodialysis, hypercholesterolemia, lipoprotein(a), Lp(a)

Published Online, November 13, 2007. www.theannals.com, DOI 10.1345/aph.1K407