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Danish Study Group on Verapamil in MI - DAVIT II
Description:
Verapamil versus placebo after acute MI.
Hypothesis:
To evaluate the effect on total mortality and major cardiac events of verapamil started in the second week after MI.
Study Design
Study Design:
Patients Screened: Not reported
Patients Enrolled: 1975
NYHA Class: At 12 month follow-up: Class I: 75.8%, Class II: 22.7%, Class III-IV: 1.5%
Mean Follow Up: average 16 months
Mean Patient Age: = 65 years: 34%
Female: 20%
Mean Ejection Fraction: Not evaluated
Patient Populations:
<75 years of age enrolled 7–15 days after proven MI
Exclusions:
SBP <90 mm Hg, second- or third-degree heart block at 3 days, heart failure not stabilizing on furosemide ≤160 mg/day, treatment with β-blockers or calcium antagonists due to angina pectoris, arrhythmias, hypertension, postoperative infarction, and significant valvular or congenital heart disease.
Primary Endpoints:
Death and reinfarction
Secondary Endpoints:
Sudden death, cardiac death, and cardiac events (cardiac death or reinfarction)
Drug/Procedures Used:
Verapamil 120 mg three times daily (once or twice daily dosing allowed in cases of adverse drug reactions), or placebo.
Principal Findings:
The verapamil group had a 17% lower incidence of death and reinfarction (18.0% vs. 21. 6%; p = 0.03). There was also a nonsignificant 20% lower mortality (11.1% vs. 13.8%; p = 0.11) with a significant mortality reduction in the verapamil-treated patients without congestive heart failure (7.7% vs. 11.8%; p = 0.02). In patients with CHF, there was a similar incidence of primary events (17.9% vs. 17.5%).
Interpretation:
Verapamil therapy after acute MI was associated with a reduction in death and reinfarction but only patients without heart failure.
References:
Am J Cardiol 1990;66:779–785.
Keywords: Drug-Related Side Effects and Adverse Reactions, Heart Failure, Coronary Disease, Verapamil, Calcium Channel Blockers
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