The Effects of Carvedilol on Morbidity and Mortality in Patients with Chronic Heart failure - CARVEDILOL

Jul 10, 2003
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Date Published:
01/01/1996
Date Updated:
07/10/2003
Original Posted Date:
07/10/2003
References

Description:

Safety and tolerability of carvedilol for congestive heart failure.

Hypothesis:

Carvedilol is safe and efficacious in treating congestive heart failure patients when added to standard triple therapeutics.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 1,094
NYHA Class: I=(53%), III=(44%), IV=(3%)
Mean Follow Up: 6.5 months (1 day - 15 months)
Mean Patient Age: 58
Female: 24
Mean Ejection Fraction: 23%

Patient Populations:

Symptoms of CHF at least 3 months
Left ventricular ejection fraction < 0.35%
Baseline treatment with digoxin, diuretics, and ACE inhibitor encouraged

Exclusions:

Heart rate < 68
Systolic blood pressure > 160 mmHg or < 85 mmHg
Diastolic blood pressure > 100 mmHg
Calcium channel blockers, alpha or beta blockers, amiodarone
Recent cardiovascular event or procedure (3 months)
Uncorrected, primary valvular disease
Myocarditis
Sustained ventricular tachycardia or heart block not treated or controlled with antiarrhythmic therapy or pacemaker.
Other co-morbid condition limiting survival

Primary Endpoints:

Tolerability of carvedilol
Total mortality

Secondary Endpoints:

Hospitalization for heart failure or other cardiovascular causes
Exercise times in individual trials

Drug/Procedures Used:

Carvedilol 6.25 to 50mg BID (average 45)

Concomitant Medications:

Digitalis (91%)
Diuretics (95%)
ACE inhibitors (95%)
Direct acting vasodilator (32%)

Principal Findings:

Mortality in placebo group was 7.8% versus 3.2% in carvedilol group. (65% risk reduction; p <0.001).

Carvedilol associated with a 27% reduction in risk of hospitalization for cardiovascular causes (19.6% versus 14.1%; p = 0.036).

Carvedilol also reduced combined risk of hospitalization or death (p < 0.001).

Interpretation:

"Carvedilol reduces the risk of death as well as the risk of hospitalization for cardiovascular causes in patients with heart failure who are receiving treatment with digoxin, diuretics, and an angiotensin-converting enzyme inhibitor." (From Abstract)

This was a pooled analysis project. The individual trials were not powered to assess mortality effects a priori.

References:

1. N Engl J of Med 1996;334:1349-55. Pooled analysis results

Keywords: Carbazoles, Digoxin, Risk Reduction Behavior, Diuretics, Heart Failure, Coronary Disease, Stroke Volume, Propanolamines, Hospitalization


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