TY - JOUR
T1 - Exposure to statins is associated to fracture risk reduction in elderly people with cardiovascular disease
T2 - Evidence from the AIFA-I-GrADE observational project
AU - Rea, Federico
AU - Bonassi, Stefano
AU - Vitale, Cristiana
AU - Trifirò, Gianluca
AU - Cascini, Silvia
AU - Roberto, Giuseppe
AU - Chinellato, Alessandro
AU - Lucenteforte, Ersilia
AU - Mugelli, Alessandro
AU - Corrao, Giovanni
PY - 2017/7
Y1 - 2017/7
N2 - Purpose: Conflicting findings were observed from clinical trials and observational studies evaluating the association between the use of statins and the risk of fracture. A case-control study nested into a cohort of elderly patients on treatment with statins for cardiovascular secondary prevention was performed on this issue. Methods: The cohort was formed by 13 875 individuals aged ≥65 years from several Italian health units receiving statins after hospital discharge for cardiovascular outcomes. From this cohort, 964 patients who experienced fracture were identified (i.e., cases). Up to five controls were randomly selected for each case from the underlying cohort. Conditional logistic regression was used to model the risk of fracture associated with adherence to statins, which was measured from the proportion of days covered (PDC) by treatment. A set of sensitivity analyses was performed in order to account for sources of systematic uncertainty. Results: Compared with patients with low adherence (PDC ≤ 40%), those on intermediate (PDC 41-80%) and high (PDC > 80%) adherence exhibited a risk reduction of 21% (95% confidence interval 6% to 23%) and 25% (7% to 40%). Similar effects were observed among patients younger and older than 80 years, as well as among men, while there was no evidence that adherence to statins affected the risk of fracture among women. Sensitivity analyses revealed that the associations were consistent and robust. Conclusions: Use of statins for secondary cardiovascular prevention is associated with fracture risk reduction in elderly people. Further studies are required to better clarify the statin-fracture association in postmenopausal women.
AB - Purpose: Conflicting findings were observed from clinical trials and observational studies evaluating the association between the use of statins and the risk of fracture. A case-control study nested into a cohort of elderly patients on treatment with statins for cardiovascular secondary prevention was performed on this issue. Methods: The cohort was formed by 13 875 individuals aged ≥65 years from several Italian health units receiving statins after hospital discharge for cardiovascular outcomes. From this cohort, 964 patients who experienced fracture were identified (i.e., cases). Up to five controls were randomly selected for each case from the underlying cohort. Conditional logistic regression was used to model the risk of fracture associated with adherence to statins, which was measured from the proportion of days covered (PDC) by treatment. A set of sensitivity analyses was performed in order to account for sources of systematic uncertainty. Results: Compared with patients with low adherence (PDC ≤ 40%), those on intermediate (PDC 41-80%) and high (PDC > 80%) adherence exhibited a risk reduction of 21% (95% confidence interval 6% to 23%) and 25% (7% to 40%). Similar effects were observed among patients younger and older than 80 years, as well as among men, while there was no evidence that adherence to statins affected the risk of fracture among women. Sensitivity analyses revealed that the associations were consistent and robust. Conclusions: Use of statins for secondary cardiovascular prevention is associated with fracture risk reduction in elderly people. Further studies are required to better clarify the statin-fracture association in postmenopausal women.
KW - Databases
KW - Fracture prevention
KW - Nested case-control
KW - Pharmacoepidemiology
KW - Rule-out sensitivity analysis
KW - Statins
KW - Unmeasured confounders
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U2 - 10.1002/pds.4206
DO - 10.1002/pds.4206
M3 - Article
AN - SCOPUS:85017349386
VL - 26
SP - 775
EP - 784
JO - Pharmacoepidemiology and Drug Safety
JF - Pharmacoepidemiology and Drug Safety
SN - 1053-8569
IS - 7
ER -