(U) Statin-Related Adverse Drug Reactions in UK Primary Care Consultations: A Retrospective Cohort Study to Evaluate the Risk of Cardiovascular Events and All-Cause Mortality

Publication Number: 645

Background: Statin-related adverse drug reactions (ADRs) may negatively affect patients’ treatment outcomes due to impaired medication adherence, prolonged discontinuation, and limited treatment options. There is limited evidence on the impact of statin-related ADRs on patients’ outcomes and treatment pattern changes following these ADRs in a real-world clinical setting.

Objectives: To investigate the risk of subsequent cardiovascular disease (CVD) events and all-cause mortality in patients with statin-related ADRs consultation in primary care and examine whether different treatments following the ADRs affect subsequent outcomes.

Methods: This was a retrospective cohort study of statin users between 2004-2019 using IQVIA Medical Research Data. Patients with statin-related ADRs consultation were matched (1:1) using propensity scores to statin users without ADRs consultation. Cox proportional hazard regression was used to compare the risk of CVD events and all-cause mortality, stratified by history of CVD. In additional analysis, treatment pattern changes within 1-year period following the ADRs were examined and the subsequent outcomes were compared between different treatment groups.

Results:
Among 1,564,687 statin users, 19,035 (1.22%) had a statin-related ADR consultation in primary care. The mean (SD) follow-up time was 6.32 (3.74) and 5.31 (3.83) years for CVD primary and secondary prevention cohort, respectively. Statin-related ADR was associated with subsequent CVD event in both cohorts (adjusted hazard ratio (aHR) of 1.39 (95%CI 1.23,1.57) and 1.34 (95%CI 1.25,1.42), respectively). Within those with statin-related ADR, 38.86% continued receiving any statin prescription or combination of any statin with additional lipid lowering treatment (LLT), 19.64% received other LLT only, and 41.50% discontinued all LLT altogether within a year following the ADR consultation. We found that i) Continued any statin prescription or combination of any statin with additional lipid-lowering treatment (LLT), and ii.) other LLT only, were associated with lower risks of CVD event (aHR 0.71 (95%CI 0.64, 0.78) and 0.75 (95%CI 0.62, 0.92), respectively) and all-cause mortality (aHR 0.46 (95%CI 0.42, 0.50) and 0.52 (95%CI 0.43, 0.64), respectively), compared to discontinuation of all LLT.

Conclusions: Patients with statin-related ADRs had an increased risk of CVD event, indicating that these patients should be monitored more closely. Continued lipid-lowering medication is of importance to protect against CVD event and mortality.