Impact of Metformin on Statin Persistence: a Post Hoc Analysis of a Large Randomized Controlled Trial
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J Gen Intern Med DOI: 10.1007/s11606-020-06344-6 © Society of General Internal Medicine 2020
University of South Florida Institutional Review Board determined this study exempt.
RESULTS INTRODUCTION
Optimal cardiovascular disease (CVD) risk reduction is impaired by statin-associated muscle symptoms (SAMS).1–3 Severe muscle reactions are well accounted for, yet mild-tomoderate myalgia is common and difficult to track. No valid SAMS therapies exist, and management requires trial-anderror with different statins until one is tolerated.1 Metformin may counter-regulate downstream mediators of myalgia through the PI3K/AKT pathway and mitochondrial function.3 Our post hoc analysis in a subset of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial demonstrated metformin’s association with lower odds of myalgia in statin-treated patients.4 This post hoc analysis investigates metformin’s association with statin nonpersistence in ACCORD-Lipid.
METHODS
ACCORD-Lipid compared fenofibrate versus placebo in statin-treated patients with type 2 diabetes.5 ACCORD-Lipid principally used simvastatin. With simvastatin intolerance, patients were allowed other statins (e.g., atorvastatin). The primary outcome of the present analysis was overall rate of statin persistence between patients taking metformin versus not taking metformin at study-exit. All patients were intended to take statins throughout ACCORD-Lipid. Therefore, patients taking any statin at “study-exit,” regardless of symptoms, were considered persistent. Multivariable logistic regression was used to adjust for potential confounders with statin persistence and SAMS susceptibility (Table 1).1,4 Patients with missing data were excluded from multivariable regression. All comparisons are summarized as OR with 95% CI. Data were analyzed using SPSS version 24. The Prior Presentation The analysis related to the manuscript has been presented at the 2020 American College of Clinical Pharmacy Virtual Annual Meeting; October 19–October 30. Received September 22, 2020 Accepted November 5, 2020
Patient mean age was ~ 63 years and ~ 31% were women. Fewer study-exit metformin users had baseline history of CVD events, coronary artery bypass graft, or heart failure. ACCORD-Lipid assigned trial arm varied somewhat between study-exit metformin users and non-users. At study-exit, fewer metformin users were also using a dihydropyridine calcium channel blocker. At baseline, more study-exit metformin users were current cigarette smokers. Statin persistence was significantly higher with metformin (94.4% versus 89.4%) compared to without metformin (n = 4773 [86% of ACCORD-Lipid population], univariate OR: 2.00; 95% CI: 1.60–2.51). The results remained unchanged when restricting univariate analysis to patients without missing data needed for multivariable regression (n = 3883 [70% of ACCORD-Lipid population]; univariate OR: 1.54; 95% CI: 1.17–2.04). The significantly higher odds of statin persistence with metformin remained unchanged in multivariable regression (n = 3883; multiva
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