Short-Term Efficacy and Safety of Adding Ezetimibe to Current Regimen of Lipid-Lowering Drugs in Human Immunodeficiency Virus-Infected Thai Patients Treated with Protease Inhibitors.

Long-term complications of protease inhibitor (PI) treatment includes increased cardiovascular risks due to dyslipidemia in patients infected with human immunodeficiency virus (HIV). Ezetimibe reduces low-density lipoprotein cholesterol (LDL-C) without drug interactions with PIs and statins. Furthermore, the addition of ezetimibe to statins is an optional treatment in HIV-infected patients with uncontrolled dyslipidemia. The objective of this study was to determine the short-term efficacy and safety of adding ezetimibe to the currently administered statin regimen. Thirty-two patients received ezetimibe (10 mg daily) in addition to their ongoing lipid-lowering therapy for 18 weeks. Serum LDL-C, total cholesterol (TC), triglycerides (TGs), TC/high-density lipoprotein cholesterol (HDL-C) ratio, and HDL-C were measured at baseline, and weeks 6, 12, and 18. Safety parameters were assessed by adverse event reports and laboratory assessments throughout the study. The mean percent change from baseline to endpoint in LDL-C, TC, TGs, and TC/HDL-C ratio were -23.3% (p<0.001), -15.0% (p=0.001), -22.1% (p=0.004), and -16.2% (p=0.018), respectively. No adverse event or other abnormal laboratory results occurred. Addition of ezetimibe to currently administered lipid-lowering drugs in HIV-infected patients receiving PIs with uncontrolled dyslipidemia demonstrated significantly improved efficacy in reducing their LDL-C, TC, TGs, and TC/HDL-C ratio levels. Moreover, this therapy was safe and well-tolerated.