San Antonio Military Medical Center, 3551 Roger Brooke Drive, San Antonio, TX 78234-6200, USA.
Expert Opin Drug Saf. 2013 May;12(3):327-37. doi: 10.1517/14740338.2013.779667. Epub 2013 Mar 14.
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.
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.
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.
一些医学期刊发表了支持或反对更广泛使用他汀类药物进行一级预防的观点和反观点。本文的目的不是权衡他汀类药物使用的益处与风险,而是讨论这一争议的各个方面。
本文讨论了检查他汀类药物的多效性作用/不良事件的挑战。它还讨论了随机对照试验和观察性研究中评估不良事件的陷阱。
解决这一争议的挑战包括他汀类药物的多效性作用导致报告的益处或不良事件极其广泛,报告的危害/益处相互矛盾,有基础研究支持争议的双方,难以区分不良事件是由于他汀类药物还是由于胆固醇降低,以及缺乏他汀类药物相关不良事件及其确定方法的标准化定义。随机对照试验和观察性研究在评估不良事件方面都存在陷阱和注意事项。了解争议点对于使临床医生能够个体化患者治疗至关重要。