MDPIT
Trial question
What is the effect of diltiazem in patients with previous MI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
20.0% female
80.0% male
N = 2466
2466 patients (493 female, 1973 male).
Inclusion criteria: patients aged 25-75 years with previous MI.
Key exclusion criteria: ongoing cardiogenic shock or symptomatic hypotension; pulmonary hypertension with RV failure; hypersensitivity to diltiazem.
Interventions
N=1232 diltiazem (at a dose of 240 mg/day for 12-52 months).
N=1234 placebo (matching placebo for 12-52 months).
Primary outcome
All-cause mortality
13.47%
13.53%
13.5 %
10.1 %
6.8 %
3.4 %
0.0 %
Diltiazem
Placebo
No significant
difference ↔
No significant difference in all-cause mortality (13.47% vs. 13.53%; HR 0.98, 95% CI 0.78 to 1.22).
Secondary outcomes
No significant difference in first recurrent cardiac event (16.4% vs. 18.31%; HR 0.9, 95% CI 0.74 to 1.08).
Borderline significant increase in death from cardiac causes (8.4% vs. 8.9%; ARD 0.5, 95% CI 0 to 1).
No significant difference in nonfatal reinfarction (8% vs. 9.4%; ARD -1.4, 95% CI -5.38 to 2.58).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients aged 25-75 years with previous MI, diltiazem was not superior to placebo with respect to all-cause mortality.
Reference
Multicenter Diltiazem Postinfarction Trial Research Group. The effect of diltiazem on mortality and reinfarction after myocardial infarction. N Engl J Med. 1988 Aug 18;319(7):385-92.
Open reference URL