Let's start with the headline, drum roll please 🥁... Dapagliflozin in HFmrEF and HFpEF DELIVER Trial results
1. Background💔
HFpEF pts represent approx 50% of all people with HF
Currently limited Tx options in this group
Uncertainty remains re:
- People in highest part of EF range, ?attenuation of Tx effect
- People initiated on Tx during/soon after hospitalisation
- EF improved to >40%
2. Trial design, Endpoints and Flow
Note: either ambulatory or hospitalised patients
6236 patients. 3131 received dapagliflozin. Across 20 countries 🗺️
Follow up - 2.3 years
Equal drop out and incomplete follow up in Tx and in placebo arms
3. Baseline Characteristics
- Including medication 💊 (highest % of pts on MRAs of any trial in HF with mildly reduced and preserved EF at 43%) (77% on loop diuretics)
- 44% of patients with T2DM
Very little difference between full population and population with LVEF < 60%
Worsening HF reduced⬇️by 21%
CV death reduced ⬇️by 12% (non-significant)
Overall reduced primary endpoint by 18%
5. Further endpoint results
- no evidence of attenuation in higher EF group
- similar benefit seen in pts enrolled during or within 30 days of HF hospitalisation compared
Very consistent across subgroups/characteristics
6. Adverse Events
- 2 incidents of DKA
- 6 major hypoglycaemic events (NB: less than placebo)
- 19 amputations (NB: less than placebo)
7. Safe to say I think that DELIVER has DELIVERED. 🚚📮
But what about Empagliflozin in EMPEROR-Preserved I hear you cry...
8. Comparable primary endpoints, principle effects and similar populations used
New information from DELIVER:
- Efficacy in those with improved/recovered LVEF
- Benefit across LVEF categories
EMPEROR-Preserved suggested some attenuation of effects of empa at higher EF
10. How this may change our day to day practice...
Is it time to move away from EF? HF is not a single pathological diagnosis, or a single disease, it is hundreds of diseases, it is a syndrome. How do we move to a more personalised Tx approach?