Effect of statin use for the primary prevention of cardiovascular disease among older adults: a cautionary tale concerning target trials emulation

Mésidor, Miceline ORCID: https://orcid.org/0000-0001-5788-4984; Sirois, Caroline; Guertin, Jason Robert; Schnitzer, Mireille E; Candas, Bernard; Blais, Claudia; Cossette, Benoit; Poirier, Paul; Brophy, James M; Lix, Lisa; Tadrous, Mina; Diop, Awa; Hamel, Denis et Talbot, Denis (2024). Effect of statin use for the primary prevention of cardiovascular disease among older adults: a cautionary tale concerning target trials emulation Journal of Clinical Epidemiology , vol. 168 , nº 111284. pp. 1-10. DOI: 10.1016/j.jclinepi.2024.111284.

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Résumé

Objectives: Evidence concerning the effect of statins in primary prevention of cardiovascular disease (CVD) among older adults is lacking. Using Quebec population-wide administrative data, we emulated a hypothetical randomized trial including older adults O65 years on April 1, 2013, with no CVD history and no statin use in the previous year.

Study Design and Setting: We included individuals who initiated statins and classified them as exposed if they were using statin at least 3 months after initiation and nonexposed otherwise. We followed them until March 31, 2018. The primary outcome was the composite endpoint of coronary events (myocardial infarction, coronary bypass, and percutaneous coronary intervention), stroke, and all-cause mortality. The intention-to-treat (ITT) effect was estimated with adjusted Cox models and per-protocol effect with inverse probability of censoring weighting.

Results: A total of 65,096 individuals were included (mean age = 71.0 6 5.5, female = 55.0%) and 93.7% were exposed. Whereas we observed a reduction in the composite outcome (ITT-hazard ratio (HR) = 0.75; 95% CI: 0.68-0.83) and mortality (ITT-HR = 0.69; 95% CI: 0.61-0.77) among exposed, coronary events increased (ITT-HR = 1.46; 95% CI: 1.09-1.94). All multibias E-values were low indicating that the results were not robust to unmeasured confounding, selection, and misclassification biases simultaneously.

Conclusion: We cannot conclude on the effectiveness of statins in primary prevention of CVD among older adults. We caution that an in-depth reflection on sources of biases and careful interpretation of results are always required in observational studies.

Type de document:	Article
Mots-clés libres:	Statin use; Primary prevention; Older adults; Cardiovascular disease; All-cause mortality; Quebec; Hypothetical randomized trial
Centre:	Centre INRS-Institut Armand Frappier
Date de dépôt:	21 mai 2024 06:04
Dernière modification:	21 mai 2024 06:04
URI:	https://espace.inrs.ca/id/eprint/15671

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