Should we encourage over-the-counter statins? A population perspective for coronary heart disease prevention.

Background: Prescribed statin therapy has contributed to a dramatic reduction in primary and secondary coronary heart disease (CHD). In the UK, simvastatin is currently available without prescription; however, the US FDA rejected an application for nonprescription lovastatin in 2005.

Objective And Methods: We used population impact measures for three hypothetical levels of CHD risk to estimate the number of CHD events that would be prevented in the US over 5 years under three scenarios: (i) prescription-only regulations; (ii) approval of over-the-counter (OTC) statins; and (iii) implementation of lifestyle interventions.

Results: For people at very low risk of CHD, 429,299 CHD events could be prevented by the availability of OTC statins and 560,243 CHD events could be prevented among this group by implementing lifestyle interventions. For those at moderate risk of CHD, 244,388 CHD events could be prevented by OTC statins compared with 318 866 by lifestyle interventions. For people at high risk of CHD, prescription statins could prevent 374,897 CHD events over the next 5 years.

Conclusions: Provision of OTC statins to US adults at low or moderate risk of CHD would have a greater impact on CHD prevention than providing prescription statins for those at high risk of CHD. Provision of OTC statins alongside lifestyle interventions among those at low or moderate risk of CHD could substantially reduce the number of CHD events in the population.