Tolerability of Carvedilol and ACE-Inhibition in Mild Heart Failure. Results of CARMEN (Carvedilol ACE-Inhibitor Remodelling Mild CHF EvaluatioN)
Why the study?
Does carvedilol alone or in combination with enalapril have similar safety and tolerability compared to enalapril alone in patients with mild heart failure?
Population
572 patients with mild heart failure (mild CHF). 65% had prestudy use of ACE inhibitors.
Comparison
Carvedilol alone or in combination with… vs Enalapril alone for 18 months.
Design
RCT, Blindly up-titrated
Follow-up
18 months
Authors
Discussion
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Implication
Supports carvedilol or combination use in mild HF; confirms comparable tolerability to enalapril and challenges beta-blocker up-titration concerns.
Structured PICO
Does carvedilol alone or in combination with enalapril have similar safety and tolerability compared to enalapril alone in patients with mild heart failure?
P
Population
572 patients with mild heart failure (mild CHF). 65% had prestudy use of ACE inhibitors.
I
Intervention
Carvedilol (target 25 mg twice daily) alone or in combination with enalapril (target 10 mg twice daily) for 18 months. In the combination arm, carvedilol was up-titrated before enalapril.
C
Comparator
Enalapril alone (target 10 mg twice daily) for 18 months.
O
Outcome
Safety and tolerability (adverse events during up-titration, withdrawal rates, and serious adverse events)safety
Carvedilol is as well tolerated as enalapril during up-titration and long-term treatment in patients with mild heart failure, challenging the perception that beta-blockers are difficult to up-titrate.
Limitations
- High prestudy use of ACE-I (65%) might have introduced a bias by selecting ACE-I tolerant patients
Cite This Study
Komajda et al. (2004) studied this question.