Reclassification of simvastatin to over-the-counter status in the United Kingdom: a primary prevention strategy.

Simvastatin (10-mg tablet) has been reclassified for sale as a pharmacy-only over-the-counter medicine in the United Kingdom. It is designed to be a primary prevention agent targeting that segment of the population having a moderate risk of coronary artery disease (CAD). The anticipated effect is a reduction of risk of a first major coronary event (nonfatal myocardial infarction or CAD death). Simvastatin is a component of the Heart Health Programme, which also addresses other modifiable risk factors such as diet, exercise, and smoking. Men >/=55 years of age, men aged 45 to 54 years with >/=1 risk factor, and women aged >/=55 years with >/=1 risk factor have a moderate (10% to 15%) 10-year risk of developing CAD. Risk factors include having a first-degree relative with a history of early family CAD, smoking, being overweight, and South Asian ethnicity. Simvastatin 10 mg lowers low-density lipoprotein cholesterol levels by approximately 30%, with a resultant 33% reduction in risk of a major CAD event after 3 years. After the patient completes a check-box questionnaire regarding his or her medical history and other specific risk factors, the pharmacist performs a few simple physical measurements and makes a decision as to CAD risk and simvastatin eligibility. After 1 month of simvastatin therapy, cholesterol testing is highly recommended to patients, and a kit is made available that permits home blood collection and analysis at a central laboratory.