Background: The PARADIGM-HF clinical trial showed a significant reduction in heart failure (HF) hospitalizations and cardiovascular (CV) death in patients with heart failure and reduced ejection fraction (HFrEF) and treated with S/V compared to enalapril. The impact of S/V on real-world outcomes is not well studied.
Objective: To assess the association of hospitalization and therapy with S/V vs. ACEI/ARB in patients with HFrEF in the US.
Methods: Adult patients with ≥1 claim for S/V or ACEI/ARB from 7/7/2015-5/31/2016 were selected from the MarketScan databases. Patients with S/V were assumed to have HFrEF based on its prescribing information. Patients with ACEI/ARB had claims-based evidence of HFrEF. The index date was the 1st claim for S/V (searched first) or ACEI/ARB. All patients had data for ≥24 months pre-index and ≥6 months post-index, unless inpatient death occurred within 6 months post-index. HF, HF-related, and all-cause hospitalizations in the 6 months pre- and post-index were examined. HF hospitalizations had a primary diagnosis or a diagnosis-related group code for HF. HF-related hospitalizations had a non-primary HF diagnosis and a primary diagnosis of CV or chronic kidney disease, diabetes, chronic obstructive pulmonary disease, pneumonia or signs/symptoms related to HF. All-cause hospitalizations had any diagnosis. Multivariable regressions with scaled Poisson distribution tested the association between number of hospitalizations post-index and therapy with S/V vs. ACEI/ARB, controlling for patients’ characteristics, baseline costs and hospitalizations.
Results: A total of 956 patients had ≥1 claim for S/V (median age 64 years, 71% male, mean Charlson Comorbidity Index [CCI] score 3.1); 55,492 patients had ≥1 claim for ACEI/ARB (median age 70 years, 62% male, CCI 3.3). There were significantly fewer hospitalizations in the 6 months post-index than pre-index for all patients, with a greater reduction observed in patients with S/V vs. ACEI/ARB. The pre-post differences for % of patients with HF hospitalizations (S/V vs. ACEI/ARB) were -9.5% vs. -3.2%; HF-related hospitalizations -13.0% vs. -6.3%; and all cause hospitalizations -14.5% vs. -8.0%. Although multivariate analyses demonstrated that HF hospitalizations post-index in S/V patients were not significantly different (rate ratio [95% confidence interval] 0.91 [0.78-1.06], p=0.23), there were significantly fewer HF-related (0.82 [0.71-0.94]) and all-cause hospitalizations (all-cause 0.78 [0.69-0.89]); both p <0.05, compared to ACEI/ARB.
Conclusions: Compared to ACEI/ARB, S/V therapy among patients with HFrEF is related to reduction of costly hospitalizations, which may translate to potential cost saving in HF care. The lack of HF hospitalization significance may represent the disparity in the sample size. Sponsorship: The study was funded by Novartis Pharmaceuticals Corp., East Hanover, NJ.