INTRODUCTION

The following questions were met:

I. Why is the study needed?

This was answered by stating how B-blockers are commonly used in the treatment of coronary heart
disease, elucidating how although the benefits of B-blockers had been demonstrated in experimental animal models
and a number of clinical trials, there is still a need to address the question of benefit of B-blockade in patients after
myocardial infarction.

II. What is the purpose of the study?

The was answered by stating that the primary objective of the trial was to test in a multicenter
randomized, double-blind, placebo-controlled trial, whether the daily administration of propranolol hydrochloride to
patients who had at least one documented MI would result in a significant reduction in mortality from all causes
during a two-to-four year follow-up period. Secondary objectives were also stated.

III. What has been done before and how does this study differ?

These were answered by stating that a number of clinical trials had been carried out using B-blockers in
the long-term treatment of myocardial infarction; however the results were inconclusive, because of small sample
size and limitations in design and analysis. This study therefore differs in that it is a study of sufficient size.

ARE THE RESULTS OF THE STUDY VALID?

I. Was there randomization?

Yes. There was a coordinating center that randomly assigned either propranolol or placebo to the eligible
patients - men and women, age 30 through 69 years, hospitalized with an acute MI documented by appropriate
symptoms, and ECG and enzymatic changes, excluding those having medical contraindications to propranolol, such
as marked bradycardia; a history of severe congestive heart failure or asthma as an adult; a life-threatening illness
other than CHD; had or were likely to undergo cardiac surgery; or were already taking or were likely to have Bblockers prescribed to them. About 23% or 3,837 patients of the target population were randomized 1,916 to
propranolol and 1,921 to placebo.

II. Was follow-up completed?

Yes. It was stated that after an average follow-up period of 25.1 months, 138 patients in the propranolol
group (7.2%) and 188 in the placebo group (9.8%) had died. Eight additional patients also died on or before the
official end of the trial 5 in the placebo group and 3 in the propranolol group. All subjects who enrolled in the study
was accounted for until the end. A table also shows the percentages of patients who had the study medications
withdrawn for medical reasons at last clinic visit, including patients taking non-study medications at any time during
the trial.

III. Was the study blinded?

Yes. Propanolol or placebo was randomly assigned to the eligible patients in a double-blind manner to
prevent bias.

IV. Were the baseline characteristics of the group similar?

Yes. This is evident in Table 1 of the paper showing baseline comparison in terms of age, sex, mean BP, and
mean cholesterol levels.