The study endpoint is to be a combined endpoint consisting of either definite fatal coronary heart disease or nonfatal MI (i.e., a new nonfatal MI distinct from previous events). Suppose it is projected that the incidence of combined events among controls is 7 per year. Suppose the treatment benefit is projected to be a reduction in the 5year event rate by 30%.

Cardiovascular Disease A secondary prevention trial of lipid lowering is planned in patients with previous myocardial infarction (MI). Patients are to be randomized to either a treatment group receiving diet therapy and cholesterol-lowering drugs or a control group receiving diet therapy and placebo pills. The study endpoint is to be a combined endpoint consisting of either definite fatal coronary heart disease (CHD) or nonfatal MI (i.e., a new nonfatal MI distinct from previous events). Suppose it is projected that the incidence of combined events among controls is 7% per year. What will be the expected rates in Problems 10.42 and 10.43 if this level of lack of compliance is realized? *10.42 What proportion of controls will have events over 5 years? Hint. Assume no deaths due to non-CHD causes. Suppose the treatment benefit is projected to be a reduction in the 5-year event rate by 30%. *10.43 What is the expected event rate in the treated group