Introduction: Several medical journals published viewpoints and counter-viewpoints supporting or opposing a wider utilization of statins for primary prevention. The objective of this article is not to weigh in the benefits versus risks of statin use, but to discuss various aspects of this controversy.
Areas covered: This review discusses the challenges in examining the pleotropic effects/adverse events of statins. It also discusses the pitfalls in assessment of adverse events in randomized controlled trials and observational studies.
Expert opinion: The challenges in solving this controversy include that the pleotropic effect of statins results in an extremely wide spectrum of reported benefits or adverse events, the reported harms/benefits are contradictory, there is basic research ground supporting both sides of the controversy, it is difficult to separate if adverse events are due to statins or due to lower cholesterol, and that there is a lack of standardized definition of statin-associated adverse events and their methods of ascertainment. Both randomized controlled trials and observational studies have pitfalls and caveats in assessment of adverse events. Understanding the points of debate is of paramount significance to enable clinicians to individualize patient care.