Epanolol as a Model for Assessing Patient Preference in Anti‐Anginal Drug Therapy

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Abstract
Since drug therapy of angina is likely to produce a similar degree of efficacy for most drugs in common use, treatment choice should additionally focus on other factors, notably adverse events, quality of life, and convenience. Improvements in these factors can also lead to better compliance and can aid the doctor by cutting down the number of patient visits required to optimize therapy. The authors have evaluated the patient's overall assessment of symptomatic relief and adverse experiences in a comparative manner by means of the two‐period crossover design using the patient's declared treatment preference as the primary measurement. This encapsulates several factors in a single assessment that can be understood by both physician and patient The authors carried out two such studies of epanolol (Visacor), a novel anti‐anginal agent with both beta‐1 selective antagonist activity and also beta‐1 selective partial agonist activity. In one study (n = 608) the comparator was metoprolol, and in the other (n = 571) it was nifedipine. This article describes and evaluates the methodology of these studies. To assess preference optimally, each patient had to receive both treatments in short but clinically relevant treatment periods, with no washout Re‐entry into the second period, after withdrawal from the first was permitted. Both studies showed advantages for epanolol, more marked in the case of nifedipine, arising from equivalent efficacy but fewer adverse events. Critical evaluation of the clinical trial design and the results does not cast doubt on these conclusions, so that the methodology has been shown to be of practical value in assisting treatment choice.