Stroke, Vol 16, 416-424, Copyright © 1985 by American Heart Association
M Gent, JA Blakely, V Hachinski, RS Roberts, HJ Barnett, NH Bayer, SG Carruthers, SM Collins, MG Gawel and M Giroux-Klimek
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)
ARTICLES
A secondary prevention, randomized trial of suloctidil in patients with a recent history of thromboembolic stroke
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