Secondary Prevention Reinfarction Israeli Nifedipine Trial II - SPRINT II

Description:

Nifedipine for mortality in acute myocardial infarction.

Hypothesis:

The early administration of high dose nifedipine improves outcome in high-risk patient post myocardial infarction.

Study Design

Study Design:

Patients Screened: 2,050
Patients Enrolled: 1,358 were initially randomized
NYHA Class: I = (65%), II = (24%), III= (8%), IV=(2%)
Mean Follow Up: 6 months
Mean Patient Age: 64
Female: 26
Mean Ejection Fraction: not given

Patient Populations:

Candidates for this study were patients presenting with definite or suspected acute myocardial infarction in the age range of 50 to 79 years. Criteria for myocardial infarction was chest pain, ECG changes and enzymes. The high-risk indicators to enter the long-term phase of the study were:
1) evidence of prior myocardial infarction,
2) preinfarct angina,
3) history of hypertension,
4) NYHA Class II or higher symptoms during the month before infarction; and,
5) anterior myocardial infarction.

Exclusions:

Need for calcium channel blocker immediately as determined by treating physician
systolic blood pressure < 90 mm Hg
intolerance to Nifedipine
heart disease other than coronary artery disease
prior heart surgery
left bundle branch block or WPW syndrome
other major systemic diseases

Primary Endpoints:

Overall mortality and secondary recurrent myocardial infarction.

Secondary Endpoints:

Recurrent myocardial infarction

Drug/Procedures Used:

Nifedipine (6 mg/day with peak dose reached within a 6 day titration period).

Concomitant Medications:

not given

Principal Findings:

In the 1,006 patients ultimately randomized, mortality was higher (18.7%) in those on nifedipine compared to placebo (15.6%). This difference reflected an increased early mortality within the first 6 days in the nifedipine group compared to placebo (7.8% vs. 5.5%). Non fatal myocardial infarction occurred in 5.1% of nifedipine group and 4.2% of placebo group.

Interpretation:

Nifedipine is not effective therapy in the post myocardial infarction patient, particularly those with concomitant heart failure, and it may be detrimental when administered routinely early post myocardial infarction.

References:

1. Arch Intern Med 1993;153:345-53. Final results

Clinical Topics: Heart Failure and Cardiomyopathies, Prevention, Acute Heart Failure, Hypertension

Keywords: Myocardial Infarction, Chest Pain, Heart Failure, Electrocardiography, Nifedipine, Hypertension, Calcium Channel Blockers


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