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Error in USPSTF Report on Statin Use
JAMA ( IF 63.1 ) Pub Date : 2020-02-18 , DOI: 10.1001/jama.2020.0298
Roger Chou 1
Affiliation  

The 2016 review1 for the US Preventive Services Task Force on statins for prevention of cardiovascular disease in adults had errors in the analysis of statins vs placebo and cardiovascular mortality. For the JUPITER trial, we interpreted “MI, stroke or cardiovascular death” as reported in the main trial publication2 as “myocardial death, stroke death, or cardiovascular death,” when it meant “nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death.” Therefore, the analysis erroneously included nonfatal myocardial infarction and stroke events (83/8901 vs 157/8901 in the rosuvastatin vs placebo groups, respectively) in the analysis of cardiovascular mortality (Figure 3, panel B in the evidence review). The US Food and Drug Administration (FDA) review of atorvastatin reported 29 vs 37 cardiovascular mortality events in the rosuvastatin vs placebo groups, respectively, in JUPITER.3 However, a subsequent publication from 2 of the original JUPITER authors4 reported numbers of confirmed cardiovascular deaths of 35 vs 43 (not including 16 vs 25 cases of sudden death) in the rosuvastatin vs placebo groups. For the ASTRONOMER trial, data for cardiovascular deaths were transposed from another trial (2/103 vs 12/79 for statins vs placebo); the correct data are 2/134 vs 5/135.5



中文翻译:

USPSTF使用他汀类药物的报告中的错误

美国关于他汀类药物预防成年人心血管疾病的美国预防服务工作队的2016年评论1在他汀类药物与安慰剂和心血管疾病死亡率的分析中存在错误。对于JUPITER试验,我们解释为“ MI,中风或心血管死亡”,如主要试验出版物2所述。表示“非致命性心肌梗塞,非致命性中风或心血管死亡”,即“心肌死亡,中风死亡或心血管死亡”。因此,在心血管死亡率的分析中,该分析错误地包括了非致命性心肌梗塞和中风事件(瑞舒伐他汀组与安慰剂组分别为83/8901 vs 157/8901)(图3,证据评审中的B组)。美国食品和药物管理局(FDA)对阿托伐他汀的评价报告说,瑞舒伐他汀组与安慰剂组的心血管死亡事件分别为29例和37例。3但是,JUPITER的原始作者中有2人其后的出版物4据报道,瑞舒伐他汀组与安慰剂组的确诊心血管死亡人数分别为35例与43例(不包括16例与25例猝死)。对于ASTRONOMER试验,心血管死亡数据来自另一项试验(他汀类药物与安慰剂组为2/103 vs 12/79);正确的数据是2/134与5/135。5

更新日期:2020-02-18
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