Bonnet Fabrice, Bénard Antoine, Poulizac Pierre, Afonso Mélanie, Maillard Aline, Salvo Francesco, Berdaï Driss, Salles Nathalie, Rousselot Nicolas, Marchi Sébastien, Hayes Nathalie, Joseph Jean-Philippe
CHU de Bordeaux, Service de Médecine Interne et Maladies Infectieuses, Saint-André Hospital, 1 rue Jean Burguet, F-33000, Bordeaux, France.
ISPED, INSERM U1219, Bordeaux Population Health Research Center, University of Bordeaux, F-33000, Bordeaux, France.
Trials. 2020 Apr 19;21(1):342. doi: 10.1186/s13063-020-04259-5.
The risk/benefit ratio of using statins for primary prevention of cardiovascular (CV) events in elderly people has not been established. The main objectives of the present study are to assess the cost-effectiveness of statin cessation and to examine the non-inferiority of statin cessation in terms of mortality in patients aged 75 years and over, treated with statins for primary prevention of CV events.
The "Statins in the elderly" (SITE) study is an ongoing 3-year follow-up, open-label comparative multi-centre, randomized clinical trial that is being conducted in two parallel groups in outpatient primary care offices. Participants meeting the following criteria are included: people aged 75 years and older being treated with statins as primary prevention for CV events, who provide informed consent. After randomization, patients in the statin-cessation strategy are instructed to withdraw their treatment. In the comparison strategy, patients continue their statin treatment at the usual dosage. The cost-effectiveness of the statin-cessation strategy compared to continuing statins will be estimated through the incremental cost per quality-adjusted life years (QALYs) gained at 36 months, from the perspective of the French healthcare system. Overall mortality will be the primary clinical endpoint. We assumed that the mortality rate at 3 years will be 15%. The sample size was computed to achieve 90% power in showing the non-inferiority of statin cessation, assuming a non-inferiority margin of 5% of the between-group difference in overall mortality. In total, the SITE study will include 2430 individuals.
There is some debate on the value of statins in people over 75 years old, especially for primary prevention of CV events, due to a lack of evidence of their efficacy in this population, potential compliance-related events, drug-drug interactions and side effects that could impair quality of life. Data from clinical trials guide the initiation of medication therapy for primary or secondary prevention of CV disease but do not define the timing, safety, or risks of discontinuing the agents. The SITE study is one of the first to examine whether treatment cessation is a cost-effective and a safe strategy in people of 75 years and over, formerly treated with statins.
ClinicalTrials.gov: NCT02547883. Registered on 11 September 2015.
在老年人中使用他汀类药物进行心血管（CV）事件一级预防的风险/效益比尚未确定。本研究的主要目的是评估停用他汀类药物的成本效益，并在年龄≥75岁、接受他汀类药物进行CV事件一级预防的患者中，检验停用他汀类药物在死亡率方面的非劣效性。
“老年人他汀类药物”（SITE）研究是一项正在进行的为期3年的随访、开放标签、多中心比较随机临床试验，在门诊初级保健机构中分为两个平行组进行。纳入符合以下标准的参与者：年龄≥75岁、接受他汀类药物进行CV事件一级预防且提供知情同意的患者。随机分组后，停用他汀类药物策略组的患者被指导停止治疗。在比较策略组中，患者继续按常规剂量服用他汀类药物。从法国医疗保健系统的角度，通过36个月时每获得一个质量调整生命年（QALY）的增量成本，估计停用他汀类药物策略与继续使用他汀类药物相比的成本效益。全因死亡率将作为主要临床终点。我们假设3年时的死亡率为15%。计算样本量以在显示停用他汀类药物的非劣效性方面达到90%的检验效能，假设组间全因死亡率差异的非劣效性边际为5%。SITE研究总共将纳入2430名个体。
由于缺乏他汀类药物在该人群中的疗效证据、潜在的依从性相关事件、药物相互作用以及可能损害生活质量的副作用，对于75岁以上人群使用他汀类药物的价值，尤其是用于CV事件的一级预防，存在一些争议。来自临床试验的数据指导了CV疾病一级或二级预防的药物治疗起始，但未明确停药的时机、安全性或风险。SITE研究是最早研究停药对于曾接受他汀类药物治疗的75岁及以上人群是否是一种具有成本效益且安全的策略的研究之一。
ClinicalTrials.gov：NCT02547883。于2015年9月11日注册。
