Specialty: Cardiology, CHF
Problem: CCF (EF < 45%)
Population: 6800
Inclusion criteria:
Patients were eligible for the main trial if they had heart failure and a left ventricular ejection fraction of 0.45 or less (6800 patients) and were in normal sinus rhythm. Patients with heart failure and a left ventricular ejection fraction of more than 0.45 (988 patients) were enrolled in an ancillary trial conducted parallel to the main study.
The diagnosis of heart failure was based on current or past clinical symptoms (limitation of activity, fatigue, and dyspnea or orthopnea), signs (edema, elevated jugular venous pressure, rales, or S3 gallop), or radiologic evidence of pulmonary congestion.
Patients were eligible for the study whether or not they were already being treated with digoxin.
Doctors were strongly encouraged to co-prescribe ACEi in both digoxin & control groups.
Exclusion criteria:
Age < 21 years
Baseline left ventricular EF not available
Myocardial infarction, cardiac surgery, or percutaneous transluminal coronary angio-plasty (PTCA) within 4 weeks
Unstable or refractory angina < 1 month
2nd or 3rd AV block without a pacemaker
Atrial fibrillation (with or without pacemaker) or atrial flutter
Cor pulmonale
Constrictive pericarditis (such patients are eligible after surgery)
Acute myocarditis
Hypertrophic cardiomyopathy
Amyloid cardiomyopathy
Complex congenital heart disease
Pre-excitation syndromes
Current treatment with intravenous inotropic agents
Potassium below 3.2 mmoI/L or above 5.5 mmol/L
Need for cardiac surgery (e.g., severe valvular disease, planned coronary artery bypass graft surgery) or PTCA in the near future. (Such patients are eligible after surgery or PTCA.)
Patients on heart transplant list are not eligible
Sick sinus syndrome without pacemaker
Recognizable noncardiac causes of CHF
Significant renal insufficiency (creatinine > 3.0 mg/dL) or severe liver disease.
Any noncardiac disease that shortens life expectance to less than 3 years (e.g. most cancers)
Patient is unlikely to comply with the protocol requirements for follow-up and drug adherence (e.g. chronic alcoholism, no fixed address)
Intervention: Digoxin
Control: Placebo
Follow-up: Mean 37 months
Primary endpoint:
Mortality from any cause
Secondary endpoint(s):
Hospitalization for heart failure
Details:
Patients with heart failure and a left ventricular ejection fraction of more than 0.45 (988 patients) were enrolled in an ancillary trial conducted parallel to the main study.
Results:
- No difference in the mortality between digoxin and placebo arms.
- Reduced hospitalization in the digoxin group ( p < 0.001) with 6% fewer all cause hospitalization.
Ancilliary Trial:
- People with EF > 45% were enrolled in DIG - Preserved trial
Results of which showed again no mortality benefit in digoxin group versus placebo.
Here also there was trend towards reduced hospitalization.
Original Paper
The effect of digoxin on mortality and morbidity in patients with heart failure. The Digitalis Investigation Group.
20 Feb 1997 N Engl J Med. 1997 Feb 20;336(8):525-33.: Digoxin (+-ACE/diuretic) vs. placebo (+-ACE/diuretic)-No difference in mortality (RR 0.99; p=0.8)
-Reduced hospitalisation for HF (RR 0.72; p<0.001)
-6% fewer all-cause hospitalisation (p=0.01)
Ancillary trial (EF > 45% - "diastolic HF")
-No difference in mortality
-Similar trend towards reduce hospitalisation
NO DIFFERENCE IN MORTALITY WITH DIGOXIN:
LESS HOSPITALIZATION WITH DIGOXIN:
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