Pitavastatin (Livalo) for Hyperlipidemia And Mixed Dyslipidemia: A Novel Therapeutic Agent, or a ‘Me-Too’ Drug?

Hyperlipidemia is extremely prevalent in both men and women today. Total cholesterol (TC) levels, as well as low-density lipoprotein-cholesterol (LDL-C) levels, usually increase throughout our lives. Nearly half of all Americans older than 20 years of age have TC levels exceeding 200 mg/dL. Only 50% of adults who qualify for lipid-lowering therapy receive it, and only one-third of treated patients are at their cholesterol goals. In addition to a high prevalence, hyperlipidemia has a significant impact on public health, as this condition is a risk factor for many types of cardiovascular disease (CVD), including coronary heart disease (CHD).1 The National Cholesterol Education Program’s Expert Panel on Detection, Evaluation, and Treatment of High Cholesterol in Adults (ATP III) describes the approach to the management of hyperlipidemia. These guidelines recommend that LDL-C be the initial target of lipid-lowering therapy, because it is most often associated with the risk for developing CHD. Other secondary targets of lipid-lowering therapy include serum triglycerides (TGs) and non–high density lipoprotein-cholesterol (non–HDL-C). Although the goal is to decrease most lipid markers, HDL-C levels should be increased, because this lipoprotein may aid in removing cholesterol from atherogenic lesions. The guidelines further describe general goals for optimal lipid levels: TC below 200 mg/dL, LDL-C below 100 mg/dL, HDL-C above 40 mg/dL, and TG below 150 mg/dL. Patient-specific goals are further defined based on CHD risk factors.2 Statins are frequently prescribed for the treatment of hyperlipidemia, largely as a result of their efficacy and side-effect profile.2 Despite their overall safety, a possible link to diabetes has recently been proposed.3 Table 1 compares statins currently on the market in terms of their effect on the lipid panel.4–6 Table 1 Efficacy of Currently Available HMG CoA Reductase Inhibitors (Statins) The newest entry in this class on the U.S. market is pitavastatin (Livalo, Kowa).7 It has been approved in Asia, where it has been used for many years. In this article, we review the available data from clinical trials as well as other information relevant to clinical practice.