Bridging the treatment gap.

The leading cause of death and disability in the United States today is cardiovascular disease (CVD). The main risk factor, hypercholesterolemia, is grossly undertreated, although it is widely appreciated that lowering cholesterol levels is key to reducing the incidence of CVD. Cholesterol-lowering therapy decreases total mortality, cardiovascular events, the need for revascularization procedures, and hospitalization costs. A 25-35% reduction of low-density lipoprotein (LDL) indicates significant benefits with regard to morbidity and mortality. Unfortunately, most patients who are candidates for cholesterol-lowering treatment do not receive it. Wider use of lipid-lowering agents could, in fact, make a significant difference in patient outcomes. There is strong interest on the part of consumers in over-the-counter (OTC) cholesterol-lowering products that may help them reduce their risk of developing heart disease and live healthier lives. Surveys estimate that half of all patients with high cholesterol would like to have an OTC statin product made available. Increased availability of cholesterol-lowering therapies as well as changes in physician prescribing practices could benefit a broad spectrum of the population that is currently untreated or undertreated. Current prescribing practices and guidelines have not resulted in widespread use of these therapies; therefore, outcomes for CVD prevention remains suboptimal. The proposed advantages of making statins available over-the-counter include their known efficacy, dose consistency, and proven safety profile.