CHARM-Added
Trial question
What is the role of candesartan in patients with chronic HF and reduced left-ventricular systolic function taking ACEis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 2548
2548 patients (542 female, 2006 male).
Inclusion criteria: patients with chronic HF and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors.
Key exclusion criteria: life-threatening adverse event; known bilateral renal artery stenosis; current symptomatic hypotension; persistent systolic or diastolic hypertension; stroke, acute MI, or open heart surgery within the last 4 weeks; or previous heart transplant or heart transplant expected to be performed within the next 6 months.
Interventions
N=1276 candesartan (target dose 32 mg once daily).
N=1272 placebo (matching placebo).
Primary outcome
CV death or hospital admission for CHF
38%
42%
42.0 %
31.5 %
21.0 %
10.5 %
0.0 %
Candesartan
Placebo
Significant
decrease ▼
NNT = 25
Significant decrease in CV death or hospital admission for CHF (38% vs. 42%; HR 0.85, 95% CI 0.75 to 0.96).
Secondary outcomes
Significant decrease in CV death, hospital admission for CHF, and MI (38.8% vs. 43.2%; HR 0.85, 95% CI 0.76 to 0.96).
Safety outcomes
Significant differences in drug discontinuation due to adverse event or abnormal laboratory value (24% vs. 18%, p = 0.0003).
Conclusion
In patients with chronic HF and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors, candesartan was superior to placebo with respect to CV death or hospital admission for CHF.
Reference
McMurray JJ, Ostergren J, Swedberg K et al. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors: the CHARM-Added trial. Lancet. 2003 Sep 6;362(9386):767-71.
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