March 1, 2009
In a poster presentation at CROI 2009 in Montreal, Canada, the AIDS Clinical Trials Group A5209 study evaluated the drug ezetimibe, when used with a common statin inhibitor (pravastatin, atorvastatin, or fluvastatin), for its ability to lower LDL cholesterol levels in people on stable HIV therapy. LDL is low density lipoprotein cholesterol, commonly referred to as bad cholesterol. Too much bad cholesterol can increase the risk of clogged arteries, heart attack and stroke. Optimally, LDL levels below 100mg/dL are desired.
In the study, everyone had LDL levels above 130 despite being on a cholesterol-lowering statin inhibitor. Average age of the study volunteers was 49 years while about 3 in 4 were men and 57% were people of color. Average CD4 count was 547 and nearly all had undetectable viral loads.
The study included 44 people who took 12 weeks of therapy with 10mg of ezetimibe or placebo in addition to a stable statin inhibitor therapy. After 12 weeks, ezetimibe and placebo were stopped for 4 weeks. After the fourth week of this "washout" phase, those who had taken placebo were given the 10mg ezetimibe therapy, and those who had been on ezetimibe were given 12 weeks of placebo. The therapy proved both safe and effective in lowering LDL cholesterol.
The study showed that adding ezetimibe with a statin inhibitor resulted in significant decreases in lipid levels, including LDL cholesterol, TC, ApoB and non-HDL cholesterol. More than 60% of participants experienced some degree of side effects, the most common being aches, pains and discomfort. Less common side effects were fever, nausea and vomiting, decreases in neutrophil counts, and increases in bilirubin.