Federico Rea1,2, Giulia Calusi3,4, Matteo Franchi3,4, Davide Liborio Vetrano5,6, Giuseppe Roberto7, Stefano Bonassi8,9, Ursula Kirchmayer10, Alessandro Chinellato11, Alessandra Bettiol12, Janet Sultana13, Alessandro Mugelli12, Giovanni Corrao3,4. 1. National Centre for Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy. f.rea@campus.unimib.it. 2. 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. f.rea@campus.unimib.it. 3. National Centre for Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy. 4. 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. 5. Department of Neurobiology, Care Sciences and Society, Aging Research Center, Karolinska Institutet, Stockholm University, Stockholm, Sweden. 6. Department of Geriatrics, Catholic University of Rome, Rome, Italy. 7. Epidemiology Unit, Regional Agency for Healthcare Services of Tuscany, Florence, Italy. 8. Department of Human Sciences and Quality of Life Promotion, San Raffaele University, Rome, Italy. 9. Unit of Clinical and Molecular Epidemiology, IRCCS San Raffaele Pisana, Rome, Italy. 10. Department of Epidemiology, Lazio Regional Health Service, Rome, Italy. 11. Treviso Local Health Unit, Treviso, Italy. 12. Department of Neurosciences, Psychology, Drug Research and Children's Health, University of Florence, Florence, Italy. 13. Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.
Abstract
OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
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