Heart failure & cardiomyopathies
Medication-Attributable Adverse Events in Heart Failure Trials
An erratum to this article was published (JACC Heart Fail, Jun 2023 ↗)
Pooled result · Frequency of AEsResult — go to the resultAbsolute difference +5%Authors' conclusion
In clinical trials of GDMT for HFrEF, AEs are observed frequently. However, rates of AE are similar between active medication and control, suggesting these may reflect the high risk nature of the heart failure disease state rather than be attributive to a specific therapy.
Study context
- Population
- Patients with heart failure with reduced ejection fraction (HFrEF) in landmark CV outcomes trials17 trials
- Comparison
- GDMT vs placebo
- Outcome
- Rates of adverse events (AEs)
Methodological detailsplacebo-controlled trials
- Placebo-controlled trials
Pooled result
Frequency of AEs
Absolute difference
+5%
P < 0.001
As reported in the abstract
Further pooled results
| Outcome | Absolute difference | P value |
|---|---|---|
| Drug discontinuation due to AEIntervention vs Placebo | −1.1% | P = 0.015 |
- Drug discontinuation due to AE: beta-blocker: 11.3% (95% CI 10.3%-12.3%) vs 13.7% (95% CI 12.5%-14.9%)
Drug discontinuation due to AE
- No significant difference in ACEi, MRA, SGLT2 inhibitor or ARNI/ARB trials
Individual types of AE
- Small differences in absolute frequency, largely not statistically significant
Original publication
Medication-Attributable Adverse Events in Heart Failure Trials. JACC Heart Fail. Published 1 February 2023. doi:10.
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