92 Eligibility and reimbursement of SGLT2 inhibitors in a heart failure outpatient cohort
Abstract
In patients affected by heart failure with reduced (HFrEF) and preserved (HFpEF) ejection fraction, sodium–glucose cotransporter type 2 inhibitor drugs (SGLT2i) have shown unexpected and extraordinary results, regardless of the co-presence of diabetes mellitus (DM). The results of the clinical trials have recently allowed the national drug agency (AIFA) to summarize and simplify SGLT2i indications for treatment; however, the reimbursement of these drugs is currently only ensured to diabetic patients, who represent a small subgroup of heart failure (HF) population. The study aims to determine eligibility for SGLT2i in HF outpatients, according to the inclusion criteria of the main clinical trials, comparing the drug label proposed by EMA/AIFA with the current reimbursement criteria.
In this retrospective, observational study, 206 HF outpatients were enrolled from September 2018 to September 2019. The percentages of eligible patients according to the DECLARE-TIMI 58, EMPA-REG OUTCOME, DAPA-HF, EMPEROR REDUCED, and EMPEROR PRESERVED inclusion criteria were analysed, comparing the indications proposed by the EMA/AIFA label and the current reimbursement criteria. Among the 206 patients enrolled, the mean age was 71 ± 12 years, 24% were diabetic, the mean MDRD eGFR was 61 ± 22 ml/min/1.73m2, the mean ejection fraction (LVEF) was 38 ± 11% (LVEF 60 ml/min/1.73 m2; in our study only 8% of patients met these criteria. Assuming soon to extend the EMA/AIFA indication to HFpEF patients,…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 206 participants or records.
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