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Pravastatin for 12 Weeks Boosts Limb Fat in HIV+ Men
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Exclusive report for NATAP
Dublin, November 17, 2005
The first randomized, placebo-controlled trial of pravastatin in people with HIV charted modest drops in cholesterol but surprisingly big gains in arm and leg fat.
Reporting results at the Lipodystrophy Workshop in Dublin, Patrick Mallon from the University of New South Wales in Sydney said the subcutaneous fat surge with pravastatin approximately doubled gains seen in studies of people replacing stavudine (d4T) or zidovudine (AZT) with abacavir or tenofovir.
Although pravastatin is not the most potent drug in this cholesterol-lowering class, it often gets prescribed to people with HIV because it has no dangerous interactions with antiretrovirals. Because no one had tested pravastatin in a placebo-controlled study, Mallon and colleagues mounted such a trial involving 33 men who had a fasting cholesterol level about 6.5 mmol/L and a viral load below 400 copies/mL for at least 3 months while taking a protease inhibitor.
For the first 4 study weeks everyone got dietary advice, then Mallon randomized them to 40 mg of pravastatin daily or placebo. The placebo group was significantly younger, with a median age of 43 years compared with 52 years in the pravastatin group. Men assigned to pravastatin had higher insulin readings and lower triglycerides than men who got placebo. Otherwise the groups matched well.
After 12 weeks of treatment, men taking pravastatin had moderately but significantly lower total cholesterol (-0.82 time-weighted area under the curve, P = 0.04) and non-high-density lipoprotein (HDL) cholesterol (-1.02 time-weighted area under the curve, P = 0.01) than the placebo group. The groups did not differ after 12 weeks in HDL cholesterol or triglyceride changes.
Compared with the placebo group, men taking pravastatin gained significantly more fat by three measures:
- Limb fat: +0.72 kg versus +0.19 kg, P = 0.035
- Total fat: +1.03 kg versus -0.09 kg, P = 0.01
- Subcutaneous adipose tissue: +0.52 mm2 versus -1.3 mm2, P = 0.02
No one changed antiretrovirals during the study, and 3-day dietary records during weeks 0, 4, and 16 indicated no major changes. Viral loads, CD4 counts, and heart disease markers changed little during the trial, and no one took other drugs that might affect cholesterol or body fat. Mallon and colleagues did not randomize study participants on the basis of previous exposure to nucleoside analogs, but he plans to look into that question further.
The study shed no light on why pravastatin may bolster fat in men with HIV.
P.W.G. Mallon, J. Miller, J. Kovacic, et al. Changes in body composition and cardiovascular measures in hypercholesterolaemic HIV-infected men treated with pravastatin: a randomized placebo-controlled trial. 7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV. November 13-16, 2005. Dublin. Abstract 23.
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