Norwegian Nifedipine Multi-Center Trial - Norwegian Nifedipine

Description:

Early nifedipine for limiting infarct size in acute MI.

Hypothesis:

To investigate whether early intervention with nifedipine in acute myocardial infarction might reduce infarct size, as determined by creatine kinase MB isoenzymes.

Study Design

Study Design:

Patients Screened: 885
Patients Enrolled: 227
Mean Follow Up: 6 weeks
Mean Patient Age: 61
Female: 26

Patient Populations:

Severe chest pain for at least 30 min, or ECG changes suggesting MI (ST segment elevation > 0.2 mV in precordial leads or > 0.1 mV in limb leads, or new significant Q wave).
Evaluation within 12 hours of onset.

Exclusions:

Age < 35 or ≥ 75 years
Use of calcium antagonist within previous 48 hr
Other serious disease
Hypotension
Pulmonary edema
Aortic or mitral stenosis
Inability to attend 6 week follow-up

Primary Endpoints:

Accumulated CK-MB release

Secondary Endpoints:

Mortality

Drug/Procedures Used:

Nifedipine 10mg sublingually, then 10mg po qid for 6 weeks, or placebo.

Concomitant Medications:

Beta blockers were used prior to enrollment in 13% of patients assigned nifedipine and 21% of patients assigned placebo.

Principal Findings:

Of the 227 patients who were randomly assigned treatment, 112 received nifedipine and 115 placebo. Treatment was initiated a mean of 5.2 hours after onset of symptoms.

Mortality at 6 weeks was similar, with 10 deaths in each group.

Infarct size index (CK-MB geq/m2) was 25 +/- 16 (n = 71) in the nifedipine group and 23 +/- 13 (n = 77) in the placebo group (NS).

Interpretation:

Early treatment with nifedipine in patients with AMI did not appear to reduce infarct size as determined by enzyme level. Although blood pressure reduction was achieved with nifedipine, there was no observed clinical benefit. In a similar fashion, the Trent nifedipine study observed no mortality benefit from nifedipine after myocardial infarction. The investigators concluded that there was no reason to recommend general treatment with calcium antagonists to reduce infarct size.

References:

1. Circulation 1984;70:638-44. Final results

Keywords: Early Intervention (Education), Myocardial Infarction, Isoenzymes, Chest Pain, Research Personnel, Creatine Kinase, MB Form, Blood Pressure, Electrocardiography, Nifedipine, Calcium Channel Blockers


< Back to Listings