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  16th CROI
Conference on Retroviruses and Opportunistic Infections Montreal, Canada
February 8-11, 2009
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First Double-Blind HIV+ Trial of Ezetimibe
Plus Statin Finds Falling LDL Cholesterol

  16th Conference on Retroviruses and Opportunistic Infections,
February 8-11, 2009, Montreal
Mark Mascolini
Adding ezetimibe to a statin significantly lowered low-density lipoprotein (LDL) cholesterol, non-high-density lipoprotein (HDL) cholesterol, total cholesterol, and apolipoprotein B (Apo B, the primary apolipoprotein component of LDL) after 12 weeks in a double-blind, placebo-controlled crossover trial [1]. Side effects were no more frequent or severe with ezetimibe than with placebo.
AIDS Clinical Trials Group (ACTG) investigators compared ezetimibe, which inhibits intestinal absorption of dietary and biliary cholesterol, and placebo in 44 people taking pravastatin, atorvastatin, or fluvastatin with a stable antiretroviral regimen. The investigators excluded anyone with diabetes or a history of coronary heart disease or congestive heart failure, or anyone who used anabolic steroids. Forty-four study participants were randomized to take 10 mg of ezetimibe daily or placebo for 12 weeks, then to take no drugs for 4 weeks, then to switch over to the alternative study assignment.
Median age stood at 49 years, 31 enrollees (70%) were men, 19 (43%) white, 18 (41%) black, 5 (11%) Hispanic, and 2 (5%) of another race or ethnicity. Forty people (91%) never injected illegal drugs. Median CD4 count measured 547 (interquartile range [IQR] 434 to 781), and 42 people (95%) had a viral load below 50 copies. Median LDL cholesterol measured 159.5 mg/dL (IQR 134 to 181), non-HDL cholesterol 197 mg/dL (IQR 170 to 222), total cholesterol 244 mg/dL (IQR 218 to 272), triglycerides 158 mg/dL (IQR 116 to 201), and Apo B 118 mg/dL (IQR 108 to 130).
Thirty-seven people (84%) completed the study, 33 (75%) with all scheduled evaluations. Median differences in four lipid values in 21 people taking ezetimibe versus 20 taking placebo significantly favored ezetimibe:
• LDL cholesterol: -14.11%, P < 0.0001
• Non-HDL cholesterol: -23.18%, P < 0.0001
• Total cholesterol: -18.60%, P < 0.0001
• Apo B: -8.73%, P = 0.02
HDL cholesterol, triglycerides, and high-sensitivity C-reactive protein did not change significantly with ezetimibe.
No one dropped out of the study because of protocol-defined toxicities, and adverse event rates were no higher with ezetimibe than with placebo. Five of 44 study participants (11%) had grade 3 toxicities, including 1 fever, 1 decreased absolute neutrophil count, 2 increased total bilirubins, and 1 case of nausea and vomiting. The most common toxicities were ache, pain, or discomfort reported by 8 people, and nausea, diarrhea, or abdominal distention reported by 5. The ACTG team concluded that adding ezetimibe to a statin "offers a reasonable treatment option in the management of HIV-infected patients with elevated LDL cholesterol."
1. Chow D, Chen H, Glesby M, et al. Ezetimibe is safe and effective in combination with statin therapy for the treatment of elevated low-density lipoprotein cholesterol in HIV-infected subjects: results of ACTG protocol A5209. 16th Conference on Retroviruses and Opportunistic Infections. February 8-11, 2009. Montreal. Abstract 712. (This poster is online at http://www.retroconference.org/2009/PDFs/712.pdf.)