Rea Federico, Calusi Giulia, Franchi Matteo, Vetrano Davide Liborio, Roberto Giuseppe, Bonassi Stefano, Kirchmayer Ursula, Chinellato Alessandro, Bettiol Alessandra, Sultana Janet, Mugelli Alessandro, Corrao Giovanni
National Centre for Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy.
Dipartimento di Statistica e Metodi Quantitativi, Sezione di Biostatistica, Epidemiologia e Sanità Pubblica, Università degli Studi di Milano-Bicocca, Via Bicocca degli Arcimboldi, 8, Edificio U7, 20126, Milan, Italy.
Drugs Aging. 2018 Dec;35(12):1099-1108. doi: 10.1007/s40266-018-0600-0.
The objective of this study was to investigate the relationship between adherence to statin therapy and the risk of exacerbation among elderly individuals affected by chronic obstructive pulmonary disease and cardiovascular disease.
Using the healthcare utilisation databases of five Italian territorial units accounting for nearly 35% of the Italian population, we recruited a cohort of 6263 elderly persons (i.e. aged 65 years or older) with co-existing chronic obstructive pulmonary disease and cardiovascular disease who initiated statin therapy. Exposure was adherence to statins measured by the proportion of days of follow-up covered. Outcome was the first hospital admission for chronic obstructive pulmonary disease occurring in the period of observation. A proportional hazards model was used to estimate the hazard ratio and 95% confidence intervals for the exposure-outcome association, after adjusting for several covariates. A set of sensitivity analyses was performed to account for sources of systematic uncertainty.
During an average follow-up of about 4 years, 1307 cohort members experienced the outcome. Compared with patients with low adherence (proportion of days of follow-up covered ≤ 40%), those with intermediate (proportion of days of follow-up covered 41-80%) and high (proportion of days of follow-up covered > 80%) adherence exhibited a lower risk of exacerbation of 16% (95% confidence interval 3-27) and 23% (95% confidence interval 10-34).
In a real-world setting, we observed evidence that adherence to statin therapy markedly reduced the risk of chronic obstructive pulmonary disease exacerbations in elderly patients with co-existing chronic obstructive pulmonary disease and cardiovascular disease. Given the limited and controversial evidence from trials, more randomised controlled trials are urgently needed to better examine the potential benefits of statins as adjunct therapy in chronic obstructive pulmonary disease.
本研究旨在调查慢性阻塞性肺疾病和心血管疾病老年患者他汀类药物治疗依从性与病情加重风险之间的关系。
利用覆盖近35%意大利人口的五个意大利地区单位的医疗保健利用数据库，我们招募了一组6263名同时患有慢性阻塞性肺疾病和心血管疾病且开始他汀类药物治疗的老年人（即65岁及以上）。暴露因素为通过随访覆盖天数比例衡量的他汀类药物依从性。结局为观察期内首次因慢性阻塞性肺疾病住院。在调整了几个协变量后，使用比例风险模型估计暴露-结局关联的风险比和95%置信区间。进行了一组敏感性分析以考虑系统不确定性来源。
在平均约4年的随访期间，1307名队列成员出现了该结局。与低依从性患者（随访覆盖天数比例≤40%）相比，中等依从性（随访覆盖天数比例41-80%）和高依从性（随访覆盖天数比例>80%）患者病情加重风险分别降低了16%（95%置信区间3-27）和23%（95%置信区间10-34）。
在现实环境中，我们观察到有证据表明，在同时患有慢性阻塞性肺疾病和心血管疾病的老年患者中，他汀类药物治疗依从性显著降低了慢性阻塞性肺疾病病情加重的风险。鉴于试验证据有限且存在争议，迫切需要更多随机对照试验来更好地研究他汀类药物作为慢性阻塞性肺疾病辅助治疗的潜在益处。
