Effect of selected clinical trial publication on adjunctive nonstatin medication prescribing in the Veterans Health Administration system.

PURPOSE The question of whether publication of selected clinical trials is temporally followed by changes in prescribing of adjunctive lipid-lowering medications was evaluated. METHODS In this retrospective preanalysis and postanalysis, Veterans Health Administration (VHA) patients 18 years or older who received a new or renewed order for any lipid-lowering medication between April 2, 2004, and September 2, 2014, were included. This period was chosen based on the publication dates of three trials investigating the efficacy of nonstatin medications: Simvastatin with or without Ezetimibe in Familial Hypercholesterolemia (ENHANCE, April 3, 2008), Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus (ACCORD Lipid, March 14, 2010), and Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy (AIM-HIGH, December 15, 2011). Annual prescribing rates for ezetimibe, fibrates, and niacin were analyzed for 4 years before and after the ENHANCE, ACCORD, and AIM-HIGH trial publication dates, respectively (3 years for niacin in AIM-HIGH) and reported as percent of patients in the cohort. RESULTS Among patients receiving lipid-lowering medications, relatively low overall prescribing rates were observed for all three target medications. Prescribing rates for each medication decreased after its respective trial publication, with ezetimibe having the greatest change. CONCLUSION Prescribing of fibrates, niacin, and ezetimibe in the VHA system decreased after the publication of landmark trials assessing their addition to a statin, consistent with the recommendations in the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guideline, which did not encourage routine use of adjunctive therapies to lower the risk of cardiovascular disease.

目的 评估了选定的临床试验发表之后，辅助降脂药物的处方是否随之发生变化这一问题。 方法 在这项回顾性的分析前和分析后研究中，纳入了退伍军人健康管理局（VHA）18岁及以上在2004年4月2日至2014年9月2日期间收到新的或续签的任何降脂药物医嘱的患者。选择这一时间段是基于三项研究非他汀类药物疗效的试验的发表日期：家族性高胆固醇血症中使用或不使用依折麦布的辛伐他汀试验（ENHANCE，2008年4月3日）、2型糖尿病中联合降脂治疗的效果试验（ACCORD Lipid，2010年3月14日）以及接受强化他汀治疗的低高密度脂蛋白胆固醇水平患者使用烟酸试验（AIM - HIGH，2011年12月15日）。分别分析了ENHANCE、ACCORD和AIM - HIGH试验发表日期前后4年（AIM - HIGH中烟酸为3年）依折麦布、贝特类药物和烟酸的年度处方率，并以队列中患者的百分比报告。 结果 在接受降脂药物的患者中，观察到所有三种目标药物的总体处方率相对较低。每种药物在其相应试验发表后的处方率均下降，其中依折麦布的变化最大。 结论 在退伍军人健康管理局系统中，贝特类药物、烟酸和依折麦布的处方在评估其添加到他汀类药物中的标志性试验发表后减少，这与2013年美国心脏病学会/美国心脏协会（ACC/AHA）指南中的建议一致，该指南不鼓励常规使用辅助疗法来降低心血管疾病的风险。