Four hundred and thirty-eight patients who had suffered a thromboembolic
stroke not less than two weeks or more than four months previously, were entered into a placebo-controlled randomized clinical trial to determine whether
suloctidil (200 mg t.i.d.) would influence the subsequent recurrence of
stroke, the occurrence of
myocardial infarction, or cardiovascular death. The two treatment groups were comparable at baseline with respect to important prognostic variables and there was good adherence to the study protocol during an average follow-up of 20 months. Significantly more patients complained of side-effects in the
suloctidil group and more hepatotoxicity was also reported in the
suloctidil group. Four cases of clinical
hepatitis were suspected to be due to
suloctidil, each of which was reversible on termination of study treatment; relative increases in
SGOT and
SGPT at three months in the
suloctidil group were found to be mild and transient. The primary analysis of efficacy was based on the incidence of the first event of
stroke,
myocardial infarction or cardiovascular death, but excluding events that occurred more than 28 days after complete withdrawal from study medication for whatever reason. Thus, the primary analysis included 38 events in the
suloctidil group and 47 in the placebo group (p = 0.17) representing a risk reduction of 24%. If total mortality is substituted for cardiovascular death, the corresponding figures are 47 in the
suloctidil group and 58 in the placebo group (p = 0.08).(ABSTRACT TRUNCATED AT 250 WORDS)