Kutner Jean S, Blatchford Patrick J, Taylor Donald H, Ritchie Christine S, Bull Janet H, Fairclough Diane L, Hanson Laura C, LeBlanc Thomas W, Samsa Greg P, Wolf Steven, Aziz Noreen M, Currow David C, Ferrell Betty, Wagner-Johnston Nina, Zafar S Yousuf, Cleary James F, Dev Sandesh, Goode Patricia S, Kamal Arif H, Kassner Cordt, Kvale Elizabeth A, McCallum Janelle G, Ogunseitan Adeboye B, Pantilat Steven Z, Portenoy Russell K, Prince-Paul Maryjo, Sloan Jeff A, Swetz Keith M, Von Gunten Charles F, Abernethy Amy P
Department of Medicine, University of Colorado School of Medicine, Aurora.
Department of Biostatistics and Informatics, Colorado School of Public Health, Denver.
JAMA Intern Med. 2015 May;175(5):691-700. doi: 10.1001/jamainternmed.2015.0289.
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.
DESIGN, SETTING, AND PARTICIPANTS: 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Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group.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.
对于预后有限的患者，一些药物治疗风险可能超过益处，尤其是当益处需要数年才能显现时；他汀类药物就是一个例子。关于预期寿命有限的患者停用他汀类药物治疗的风险和益处的数据尚缺乏。
评估在姑息治疗环境中停用他汀类药物对患者的安全性、临床及成本影响。
设计、设置和参与者：这是一项多中心、平行组、非盲、实用的临床试验。纳入标准包括预期寿命在1个月至1年之间的成年人、因心血管疾病一级或二级预防接受他汀类药物治疗3个月或更长时间、功能状态近期恶化且近期无活动性心血管疾病。参与者被随机分为停用或继续他汀类药物治疗两组，并每月监测长达1年。该研究于2011年6月3日至2013年5月2日进行。所有分析均采用意向性分析方法。
随机分配到停药组的符合条件患者停用他汀类药物治疗。继续治疗组的患者继续接受他汀类药物治疗。
结局包括60天内死亡（主要结局）、生存率、心血管事件、功能状态、生活质量（QOL）、症状、非他汀类药物数量以及成本节约情况。
共招募了381名患者；其中189名被随机分配停用他汀类药物，192名被随机分配继续治疗。平均（标准差）年龄为74.1（11.6）岁，22.0%的参与者存在认知障碍，48.8%患有癌症。停药组与继续治疗组在60天内死亡的参与者比例无显著差异（23.8%对20.3%；90%CI，-3.5%至10.5%；P = 0.36），未达到非劣效性终点。停用他汀类药物治疗组的总体生活质量更好（平均麦吉尔生活质量评分，7.11对6.85；P = 0.04）。很少有参与者发生心血管事件（停药组13例，继续治疗组11例）。平均每天节约成本3.37美元，每位患者节约成本71
