Abstract 146: Clinical and Economic Consequences of Statin Intolerance in the U.S.: Results from an Integrated Health System

Background: Low-density lipoprotein cholesterol (LDL-C) is a key therapeutic target for reducing risk of cardiovascular (CV) events. While statins are the mainstay of therapy due to efficacy and safety, observational studies indicate patients prescribed statins are unable to tolerate them to varying degrees. The study objective was to examine the clinical and economic consequences of statin intolerance (SI) comparing SI patients to non-SI patients on statin therapy. Methods: This retrospective cohort study used data from an integrated health system’s electronic health record from 2009-2014. Adult patients diagnosed as statin intolerant (identified through a custom diagnosis code), with ≥ 6 months pre- and post-index date eligibility were considered for the study. All patients were hierarchically ordered into 6 mutually exclusive CV risk categories: recent acute coronary syndrome (ACS, < 12 months pre-index); coronary heart disease (CHD); ischemic stroke; peripheral artery disease (PAD); diabetes; or primary prevention. Index dates were defined as the SI diagnosis date for SI patients and a matched encounter date within ±90 days for controls. A total of 5,252 SI patients were matched to 15,756 non-SI statin users (1:3 ratio) using a propensity score that included CV risk, Charlson comorbidity index, and other clinical characteristics as covariates. Time to first myocardial infarction, unstable angina, coronary revascularization, ischemic stroke, and CV death were compared between groups using Kaplan-Meier plots and Cox proportional hazard models. Total medical costs and LDL-C goal attainment were compared using generalized linear models and conditional logistic regression, respectively. Results: The mean age of the study population was 62 years with the majority being females (61%). Three percent were categorized as recent ACS, followed by 22% for CHD, 1% ischemic stroke, 5% PVD, 17% diabetes and 52% primary prevention patients. Before matching, 5% of statin users were deemed statin intolerant by their provider; although, 86% were still able to tolerate at least asymmetric statin dosing. Compared to the matched cohort, SI patients experienced significantly higher risk of unstable angina (hazard ratio (HR)=1.55, 95% CI=1.29-1.86) and revascularization procedures (HR=1.78, 95% CI=1.47-2.17) but lower risk of CV death (HR 0.42, 95% CI=0.33-0.55). Patients with statin intolerance also experienced higher costs (cost ratio=1.21, 95% CI=1.12, 1.29) and a higher risk of not achieving LDL-C goal (odds ratio=1.84, 95% CI=1.58-2.13). All p-values were <0.0001. Conclusion: While the majority of SI patients were on a statin, SI patients demonstrate a higher risk of some cardiovascular events; incur higher healthcare costs; and difficulty reaching LDL-C goals compared to patients without SI. Alternative treatment strategies are needed to better serve this at-risk patient population.