Key result
An as-treated analysis showed diltiazem strengthened beneficial effects on mortality and reinfarction in patients without pulmonary congestion and harmful effects in those with pulmonary congestion.
Why the study?
Does actual compliance with diltiazem therapy affect mortality and reinfarction rates in patients after myocardial infarction compared to intention-to-treat analysis?
RCT
Yes
Does actual compliance with diltiazem therapy affect mortality and reinfarction rates in patients after myocardial infarction compared to intention-to-treat analysis?
Analyzing trial data by actual drug compliance rather than intention-to-treat strengthens the observed beneficial and harmful effects of diltiazem post-myocardial infarction depending on the presence of pulmonary congestion.
Answers are grounded in this paper and cite their sources.
Supports differential diltiazem effects by compliance and congestion post-MI; leaves open prospective validation before clinical consideration.
A clinical trial efficacy analysis based on actual drug usage is described. The influence of diltiazem therapy on mortality and reinfarction in the multicenter diltiazem post-infarction trial (MDPIT) is analyzed using records for drug discontinuation and reinitiation; the results are then compared with the previously published “intention to treat” analysis. As expected, previously reported beneficial effects of diltiazem therapy in patients without pulmonary congestion and previously reported harmful effects in patients with pulmonary congestion are strengthened for patients while on study medication; both effects are weakened for those not on study medication. It is also shown that for patients assigned to placebo, being on or off study medication is a powerful prognostic indicator of subsequent outcome events, especially among patients with pulmonary congestion. Analysis of discontinuation rates suggested that patients assigned to diltiazem therapy were likely to discontinue trial medication earlier than were patients assigned to placebo, especially for those patients with pulmonary congestion.
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Oakes et al. (1993) conducted an RCT in Myocardial Infarction. Diltiazem vs. Placebo was evaluated on Mortality and reinfarction. An as-treated analysis showed diltiazem strengthened beneficial effects on mortality and reinfarction in patients without pulmonary congestion and harmful effects in those with pulmonary congestion.
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