Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial.
Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial.
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DOI：
10.1001/jamainternmed.2015.0289
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发表时间：
2015-05
影响因子：
39
通讯作者：
Abernethy AP
中科院分区：
文献类型：
--
作者：
Kutner JS;Blatchford PJ;Taylor DH Jr;Ritchie CS;Bull JH;Fairclough DL;Hanson LC;LeBlanc TW;Samsa GP;Wolf S;Aziz NM;Currow DC;Ferrell B;Wagner-Johnston N;Zafar SY;Cleary JF;Dev S;Goode PS;Kamal AH;Kassner C;Kvale EA;McCallum JG;Ogunseitan AB;Pantilat SZ;Portenoy RK;Prince-Paul M;Sloan JA;Swetz KM;Von Gunten CF;Abernethy AP
对于预后有限的患者，一些药物的风险可能大于益处，特别是当益处需要数年才能积累时；他汀类药物就是一个例子。对于预期寿命有限的患者，关于停止他汀类药物治疗的风险和益处的数据缺乏。评估姑息治疗患者停用他汀类药物的安全性、临床和成本影响。这是一项多中心、平行组、无盲、实用的临床试验。入选条件包括：预期寿命在1个月至1年之间，他汀类药物治疗3个月或更长时间用于心血管疾病的一级或二级预防，近期功能状态恶化，近期无活动性心血管疾病。参与者被随机分配到停止或继续他汀类药物治疗，并每月监测长达1年。研究时间为2011年6月3日至2013年5月2日。所有分析均采用意向治疗法进行。从符合条件的患者中退出他汀类药物治疗，随机分配到停药组。延续组患者继续接受他汀类药物治疗。结果包括60天内死亡（主要结果）、生存、心血管事件、工作状态、生活质量（QOL）、症状、非他汀类药物的数量和成本节约。共有381名患者入组；其中189人随机停止他汀类药物治疗，192人随机继续治疗。平均（SD）年龄为74.1（11.6）岁，22.0%的参与者认知受损，48.8%的参与者患有癌症。停药组和继续治疗组60天内死亡的参与者比例无显著差异（23.8% vs 20.3%; 90% CI, - 3.5% ~ 10.5%; P = 0.36），未达到非劣效性终点。停止他汀类药物治疗组的总生活质量更好（平均McGill生活质量评分，7.11 vs 6.85; P = 0.04）。很少有参与者发生心血管事件（停药组13例，继续组11例）。平均每天节省3.37美元，每位患者节省716美元。这项实用的试验表明，停止他汀类药物治疗是安全的，可能与改善生活质量、使用更少的非他汀类药物以及相应的药物成本降低相关。在这种情况下，考虑到与他汀类药物继续治疗相关的不确定的获益和潜在的生活质量下降，患者与提供者进行了深思熟虑的讨论是必要的。clinicaltrials.gov标识符：NCT01415934
For patients with limited prognosis, some medication risks may outweigh the benefits, particularly when benefits take years to accrue; statins are one example. Data are lacking regarding the risks and benefits of discontinuing statin therapy for patients with limited life expectancy. To evaluate the safety, clinical, and cost impact of discontinuing statin medications for patients in the palliative care setting. This was a multicenter, parallel-group, unblinded, pragmatic clinical trial. Eligibility included adults with an estimated life expectancy of between 1 month and 1 year, statin therapy for 3 months or more for primary or secondary prevention of cardiovascular disease, recent deterioration in functional status, and no recent active cardiovascular disease. Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to 1 year. The study was conducted from June 3, 2011, to May 2, 2013. All analyses were performed using an intent-to-treat approach. Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group. Patients in the continuation group continued to receive statins. Outcomes included death within 60 days (primary outcome), survival, cardiovascular events, performance status, quality of life (QOL), symptoms, number of nonstatin medications, and cost savings. A total of 381 patients were enrolled; 189 of these were randomized to discontinue statins, and 192 were randomized to continue therapy. Mean (SD) age was 74.1 (11.6) years, 22.0% of the participants were cognitively impaired, and 48.8% had cancer. The proportion of participants in the discontinuation vs continuation groups who died within 60 days was not significantly different (23.8% vs 20.3%; 90% CI, −3.5% to 10.5%; P = .36) and did not meet the noninferiority end point. Total QOL was better for the group discontinuing statin therapy (mean McGill QOL score, 7.11 vs 6.85; P = .04). Few participants experienced cardiovascular events (13 in the discontinuation group vs 11 in the continuation group). Mean cost savings were $3.37 per day and $716 per patient. This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL, use of fewer nonstatin medications, and a corresponding reduction in medication costs. Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted. clinicaltrials.gov Identifier: NCT01415934