Patients who take statins and have elevated triglyceride (TG) levels experience more severe cardiovascular disease (CVD), higher costs, and increased healthcare use than patients with lower TG levels, according to recent study results in Mayo Clinic Proceedings.
In order to understand the real-world outcomes, costs, and utilization effects for statin users with elevated TG levels (≥150 mg/dL) within a clinical practice context, study investigators conducted a retrospective administrative comparative analysis using the Optum Research Database, a data set containing 160 million health records and that includes insurance claims.
Study researchers identified ~1.6 million patients who had submitted prescription claims for a statin between January 1, 2010 and December 31, 2010. Of those patients, 390,632 met inclusion criteria (≥6 months of qualified baseline data before the date of their first statin claim, ≥45 years old with documented diabetes or atherosclerotic cardiovascular disease [ASCVD], and ≥6 months of follow-up care unless follow-up ceased because of death).
Study researchers then stratified these patients into groups according to TG levels to form an elevated cohort (n=27,471; TG levels ≥150 mg/dL) and a comparative cohort (n=32,506; TG levels <150 mg/dL and high-density lipoprotein cholesterol levels >40 mg/dL). They used propensity score analyses to create matched groups by controlling for confounding relationships, resulting in balanced cohorts with a total of 23,181 patients in each of the 2 groups.
The primary study endpoint was to assess the occurrence of major adverse cardiovascular events (MACE) (associated death, nonfatal myocardial infarction, nonfatal stroke, coronary artery revascularization, unstable angina). Secondary objectives included quantifying the direct healthcare costs and healthcare resource use in this patient population.
Using a multivariate analysis, study researchers found that rate of occurrence of MACE was significantly higher in the elevated TG group than the comparator group at 25.8% (hazard ratio [HR], 1.26; 95% CI, 1.19-1.34; P <.001).
Study investigators found other significant predictors of increased MACE in the model, including being a man (HR, 1.32; 95% CI, 1.24-1.40; P <.001), having diabetes (HR, 1.37; 95% CI, 1.26-1.48; P <.001), having ASCVD (HR, 2.16; 95% CI, 2.01-2.33; P <.001), having experienced a nonfatal myocardial infarction (HR 1.32; 95% CI, 1.20-1.45; P <.001), having had a nonfatal stroke (HR, 1.14; 95% CI, 1.04-1.24; P =.004), and having required coronary revascularization (HR, 1.46; 95% CI, 1.33-1.61; P <.001).
Study investigators used a generalized linear model to determine cost ratios and healthcare costs; they assessed resource utilization on per-patient per-month bases. Healthcare costs and utilization analyses showed that patients with elevated TG levels had significantly higher mean healthcare costs than the comparative group ($1438±$3214 vs $1270±$2516, P <.001); likewise, patients with diabetes and ASCVD had significantly higher cost ratios (1.47; 95% CI, 1.38-1.56; P <.001 and 1.65; 95% CI, 1.57-1.74; P <.001, respectively).
Extrapolation from per-patient per-month average direct healthcare costs showed that patients with elevated TG levels spent $47 million more on health care than the comparative cohort.
Utilization was also significantly higher for patients with elevated TG levels, with a 13.4% higher occurrence of inpatient stays (HR 1.13; 95% CI 1.1-1.17; P <.001) and 55% (12,739) more emergency department visits in the elevated TG group vs 53.7% [12,446] in the comparative group (P =.005).
Study limitations included the observational nature of the study as well as the possibility of claims data including inaccuracies regarding health events and other factors (eg, limits to managed healthcare plans, dispensed medication not always equal to medication used, no tally of outside health plan costs). Additional limitations include potential differences in baseline parameters for which no measures were available in the database.
Study investigators concluded that statin-treated patients with a high risk for CVD and elevated TG levels had worse CV outcomes and greater health economic burden than patients with well-managed TG levels. Study investigators also noted that the “group of patients with elevated TG levels and a history of diabetes and/or ASCVD is relatively large and may be commonly encountered in clinical practice, so it warrants further study.”
Disclosure: This study was supported by Amarin Pharma, Inc. Please refer to the reference for a complete list of authors’ disclosures.
Toth PP, Philip S, Hull M, Granowitz C. Association of elevated triglycerides with increased cardiovascular risk and direct costs in statin-treated patients. Mayo Clin Proc. 2019;94(9):1670-1680.