Colivicchi Furio, Gulizia Michele Massimo, Franzini Laura, Imperoli Giuseppe, Castello Lorenzo, Aiello Alessandro, Ripellino Claudio, Cataldo Nazarena
Cardiology Division, S. Filippo Neri Hospital, ASL Roma 1, Rome, Italy.
Cardiology Division, Garibaldi Nesima Hospital, Catania, Italy.
Adv Ther. 2016 Nov;33(11):2049-2058. doi: 10.1007/s12325-016-0412-8. Epub 2016 Sep 26.
Switching from any statin to another non-equipotent lipid lowering treatment (LLT) may cause a low-density lipoprotein cholesterol increase and has been associated with a higher probability of negative cardiovascular outcomes. The aim of the study was to assess the impact of switching from rosuvastatin to any other LLT on clinical outcomes in primary care.
This was a retrospective analysis based on data from IMS Health Longitudinal Patient Database, which is a general practice database including information of more than 1.0 million patients representative of the Italian population by age, and medical conditions. Patients that started on rosuvastatin (10-40 mg/day) between January 2011 and December 2013 were considered. The date of the first prescription was defined as the index date (ID). The observation period lasted from the ID to September 2015 or until LLT discontinuation, or the occurrence of an acute myocardial infarction (AMI), or death.
The primary end point of the study was the occurrence of an AMI during the observation period. The final study population included 10,368 patients. During the observation period, 2452 (23.6%) patients were switched from rosuvastatin to another LLT. The majority of patients (55.6%) were switched to atorvastatin, followed by simvastatin (24.9%), simvastatin/ezetimibe combination (10.0%) and other statins (9.5%). Female gender (HR, hazard ratio, 1.10, 95% CI, confidence interval, 1.02-1.19, p = 0.04) and the presence of chronic kidney disease (HR 1.47, 95% CI 1.16-1.86, p = 0.05) were associated with a higher probability of switch. During the observation period, 113 patients experienced an AMI (incidence of 6.7 AMI/1000 patient-years). Multivariate analysis with Cox proportional hazards method, including switching as a time-dependent covariate, demonstrated that changing from rosuvastatin to another LLT was an independent predictor of AMI (HR 2.2, 95% CI 1.4-3.5, p = 0.001).
We conclude that switching from rosuvastatin to another non-equipotent LLT may impart an increased risk of AMI and should be avoided.
AstraZeneca SpA.
从任何一种他汀类药物换用另一种非等效的降脂治疗（LLT）可能会导致低密度脂蛋白胆固醇升高，并与心血管不良结局的较高概率相关。本研究的目的是评估在初级保健中从瑞舒伐他汀换用任何其他LLT对临床结局的影响。
这是一项基于艾美仕市场研究公司纵向患者数据库数据的回顾性分析，该数据库是一个全科医疗数据库，包含100多万名按年龄和医疗状况具有意大利人群代表性的患者信息。纳入2011年1月至2013年12月开始服用瑞舒伐他汀（10 - 40毫克/天）的患者。首次处方日期定义为索引日期（ID）。观察期从索引日期持续至2015年9月，或直至LLT停药、急性心肌梗死（AMI）发生或死亡。
本研究的主要终点是观察期内发生的AMI。最终研究人群包括10368名患者。在观察期内，2452名（23.6%）患者从瑞舒伐他汀换用了另一种LLT。大多数患者（55.6%）换用了阿托伐他汀，其次是辛伐他汀（24.9%）、辛伐他汀/依折麦布联合用药（10.0%）和其他他汀类药物（9.5%）。女性（风险比[HR]，1.10；95%置信区间[CI]，1.02 - 1.19；p = 0.04）和存在慢性肾病（HR 1.47，95% CI 1.16 - 1.86，p = 0.05）与换用的较高概率相关。在观察期内，113名患者发生了AMI（发生率为6.7例AMI/1000患者年）。采用Cox比例风险法进行多变量分析，将换用作为时间依赖性协变量，结果表明从瑞舒伐他汀换用另一种LLT是AMI的独立预测因素（HR 2.2，95% CI 1.4 - 3.5，p = 0.001）。
我们得出结论，从瑞舒伐他汀换用另一种非等效的LLT可能会增加AMI风险，应避免这种转换。
阿斯利康公司。
