1990 Volume 21 Issue 4 Pages 703-712
It this paper, we evaluated the clinical efficacy and safety of dobutamine hydrochloride (Dobutrex), based on the data collected as a part of postmarketing surveilance of the drug. Taking into account the results of the evaluation, we explored profiles of the adapted patients to this drug, constructed by combining categories of patients' background and treatment factors. Namely, at first, we focused on the improvement ratings as a measure to evaluate clinical efficacy, and evaluated relationships between the improvement ratings and patient factors and those between improvement ratings and treatment factors by applying regression tree method with improvement ratings as response and patient and treatment factors as explanatory variables. The background factors that contributed to clinical efficacy judged by improvement ratings were severity, and presence or absence of underlying diseases and complicasions, and seven “patients profiles”were exposed based on these factors. The treatment factors that contributed to clinical efficacy were the dose used for the longest period duration administration and presence or absence of concomitant drugs, and seven“treatment profiles”were exposed on these treatment factors as well. Joint evaluation of“patients profiles”and“treatment profiles”suggests that high ratings in efficacy are expected for patients with myocardial infarction or other diseases of mild to moderate severity when their morbid states can be controlled by dose less than 10μg within 24 hr.
Then, we evaluated safety in the same manner as we did efficacy, using incidence of side effects as a measure to evaluate safety. As a result, it was seen that the percentage of side effects became relatively high when a high dose was given in a short time to the patients with severe disease. On the whole, the risk of side effects was related more closely to treatment factors than to background factors. Thus, it is necessary to take maximal notice that side effects are liable to occur in patients who are given high doses of the drug in a short time.
