McGowan Mary P
New England Heart Institute, 100 McGregor St, Manchester, NH 03102.
Circulation. 2004 Oct 19;110(16):2333-5. doi: 10.1161/01.CIR.0000145118.55201.15. Epub 2004 Oct 11.
For a variety of reasons, many patients abruptly discontinue statin therapy. The present analysis was conducted to determine whether the risk of cardiovascular outcomes increases after withdrawal of statin therapy in a stable cardiac population.
In the Treating to New Target (TNT) study, 2 doses of atorvastatin (10 and 80 mg once daily) are being used in a double-blind parallel-group design. Of the 18,468 patients screened for study participation, 16,619 entered a dietary lead-in/drug-washout period, and of these, 15,432 eligible participants began treatment with atorvastatin 10 mg/d on an open-label basis. Of the subjects who entered the dietary lead-in/drug-washout period, 57% were receiving prior statin therapy. During the 6-week drug-washout period, there were 24 primary events (defined as coronary heart disease death, nonfatal myocardial infarction, resuscitated cardiac arrest, and fatal or nonfatal stroke); throughout the subsequent 8-week open-label period, there were 31 primary events. This equated to monthly Kaplan-Meier event rates of 0.20% during washout and 0.26% in the open-label phase. Event rates were therefore similar during the 2 phases.
The present analysis demonstrates that short-term discontinuation of statin therapy in stable cardiac patients apparently does not lead to a clinically important increased risk of acute coronary syndromes.
由于多种原因,许多患者突然停止他汀类药物治疗。本分析旨在确定在稳定的心脏疾病人群中,停用他汀类药物治疗后心血管事件风险是否增加。
在达标新治疗(TNT)研究中,采用双盲平行组设计使用两种剂量的阿托伐他汀(每日一次,10毫克和80毫克)。在筛选参与研究的18468名患者中,16619名进入饮食导入/药物洗脱期,其中15432名符合条件的参与者开始接受开放标签的阿托伐他汀10毫克/天治疗。进入饮食导入/药物洗脱期的受试者中,57%之前接受过他汀类药物治疗。在6周的药物洗脱期内,有24起主要事件(定义为冠心病死亡、非致命性心肌梗死、心脏骤停复苏以及致命或非致命性中风);在随后8周的开放标签期内,有31起主要事件。这相当于洗脱期的每月Kaplan-Meier事件发生率为0.20%,开放标签期为0.26%。因此,两个阶段的事件发生率相似。
本分析表明,稳定的心脏疾病患者短期停用他汀类药物治疗显然不会导致急性冠状动脉综合征的临床重要风险增加。