Objectives: To determine the effect of the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, pravastatin, on markers of cardiovascular risk and lipodystrophy in HIV-infected, protease inhibitor (PI)-treated men with hypercholesterolaemia.
Methods: A randomized, placebo-controlled, 16-week study was carried out on 33 HIV-infected, hypercholesterolaemic men (fasting total cholesterol > 6.5mmol/L) on PI-containing therapy. Patients commenced dietary assessment and advice at week 0 and were randomized to 12 weeks pravastatin (40 mg each night) or placebo from week 4. The primary endpoint was the time-weighted change (TWAUC) in total cholesterol from week 0. Secondary endpoints included TWAUC cholesterol from week 4 (start of pravastatin), total and regional body fat, fasting lipids, glucose, insulin, and markers of cardiovascular risk.
Results: Of 33 men randomized (pravastatin n = 16, mean age 48 years), 31 completed the study. Groups were matched for baseline cholesterol and body composition. Although there was no significant between-group difference in TWAUC cholesterol from week 0 (pravastatin −0.6 ± 1.0 versus placebo −0.4 ± 1.0 mmol/L/week; P = 0.8), TWAUC cholesterol from week 4 decreased more in the pravastatin group (−0.8 ± 1.0 versus −0.3 ± 0.9 mmol/L/week; P = 0.04). Neither triglycerides nor dietary intake changed. Subcutaneous fat increased significantly with pravastatin (+0.72 ± 1.55 versus +0.19 ± 0.48 kg change in limb fat, P < 0.04; +5.2 ± 8.7 versus −1.3 ± 13.7 cm2 change in abdominal subcutaneous fat, P = 0.02). Apart from homocystine, which decreased in the pravastatin group, there were no significant differences in other cardiovascular, lipid or glucose parameters.
Conclusions: Despite limited effects on cholesterol, 12 weeks use of pravastatin 40 mg each night in HIV-infected men with hypercholesterolaemia resulted in significant increases in subcutaneous fat.
From the aNational Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia
bHIV, Immunology and Infectious Diseases Clinical Services Unit, St Vincent's Hospital, Sydney, Australia
cDepartment of Cardiology, St Vincent's Hospital, Sydney, Australia
dGarvan Institute of Medical Research, Sydney, Australia.
Received 9 November, 2005
Revised 4 January, 2006
Accepted 24 January, 2006
Correspondence to P.W.G. Mallon, National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, 376 Victoria Street, Darlinghurst, NSW 2010, Australia. Tel: +61 2 9385 0900; fax: +61 2 9385 0920; e-mail: email@example.com