Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial
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Key result
Empagliflozin did not significantly improve heart rate variability parameters such as SDANN (adjusted difference 2.5 ms) compared to placebo at 24 weeks in patients with AMI and type 2 diabetes.
Why the study?
Protecting against lethal ventricular arrhythmias causing sudden cardiac death is a major challenge after acute myocardial infarction, and whether SGLT2 inhibitors improve cardiac nerve activity was unknown.
Population
105 patients with AMI and T2DM in Japan
Comparison
Once-daily 10-mg empagliflozin vs placebo
Design
Prospective, multicenter, randomized, double-blind, placebo-controlled trial
Follow-up
24 weeks
Authors
Discussion
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Implication
No HRV benefit with empagliflozin post-AMI in T2D; challenges autonomic modulation hypothesis and redirects mechanistic research.
Key Points
- To determine whether the SGLT2 inhibitor empagliflozin improves cardiac sympathetic and parasympathetic nerve activity in patients with acute myocardial infarction and type 2 diabetes mellitus.
- Prospective, multicenter, randomized, double-blind, placebo-controlled trial in Japan enrolling 105 patients with acute myocardial infarction and type 2 diabetes randomized (1:1) to once-daily 10-mg empagliflozin or placebo for 24 weeks (UMIN000030158).
- Evaluated primary endpoints of 24-week changes in heart rate variability measures (SDANN and LF/HF ratio) and secondary endpoints including heart rate turbulence (HRT) and safety markers.
- In the 96 analyzed patients (46 empagliflozin, 50 placebo), SDANN changed by +11.6 ms (P=0.02) with empagliflozin and +9.1 ms (P=0.06) with placebo, while LF/HF ratio changed by -0.57 (P=0.01) and -0.17 (P=0.43), respectively, without significant intergroup differences.
- Significant within-group HRT improvement occurred only in the empagliflozin group (P=0.01), along with significant reductions in body weight, systolic blood pressure, and uric acid compared with placebo, and no reported adverse events.
Study Design
Type
RCT (n=105)
Blinding
Double-blind
Randomization
1:1
Multicenter
Yes
Structured PICO
P
Population
105 patients with acute myocardial infarction and type 2 diabetes mellitus in Japan, randomized 2 weeks after AMI onset and followed for 24 weeks.
I
Intervention
Empagliflozin 10 mg oral once daily added to conventional therapy for 24 weeks.
C
Comparator
Matching placebo once daily added to conventional therapy (both groups received beta-blockers, antiplatelet therapy, statins, and renin-angiotensin system inhibitors in accordance with local guidelines).
O
Outcome
Changes in heart rate variability (HRV), specifically the standard deviation of all 5-min mean normal RR intervals (SDANN) and the low-frequency-to-high-frequency (LF/HF) ratio from baseline to 24 weeks.
Main Result
Mean Difference: 2.5 (95% CI -9.5–14.5)
Absolute Event Rate: 11.6% vs 9.1%
p-value: p=0.68
Limitations
- Short trial period of 24 weeks
- Conducted only in the Japanese population
- Baseline values of HRV and HRT were somewhat different between the two groups
- Limited group with earlier introduction of SGLT2 inhibitor 2 weeks after AMI onset
Cite This Study
Shimizu et al. (2020) conducted an RCT in Acute myocardial infarction and type 2 diabetes mellitus (n=105). Empagliflozin vs. Placebo was evaluated on Change in SDANN from baseline to 24 weeks (MD 2.5, 95% CI -9.5 to 14.5, p=0.68). Empagliflozin did not significantly improve heart rate variability parameters such as SDANN (adjusted difference 2.5 ms) compared to placebo at 24 weeks in patients with AMI and type 2 diabetes.
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