Why the study?
Does ticlopidine reduce the incidence of myocardial infarction, stroke and transitory ischaemic attacks in patients with intermittent claudication?
Does ticlopidine reduce the incidence of myocardial infarction, stroke and transitory ischaemic attacks in patients with intermittent claudication?
Long-term treatment with ticlopidine in patients with intermittent claudication significantly reduced mortality, although the reduction in the primary composite cardiovascular endpoint was not statistically significant by intention-to-treat.
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Primary endpoint not met; leaves open a mortality benefit for confirmation in claudication.
The Swedish Ticlopidine Multicentre Study (STIMS) was a double-blind placebo-controlled trial designed to determine whether ticlopidine, a platelet antiaggregatory agent, reduces the incidence of myocardial infarction, stroke and transitory ischaemic attacks in patients with intermittent claudication. A total of 687 patients was monitored for a minimum of 5 years or until an end-point was reached. The number of end points (99 vs. 89), analysed according to the intention-to-treat principle, was 11.4% lower in the ticlopidine group (P = 0.24). The mortality rate was 29.1% lower in the ticlopidine group (64 vs. 89, P = 0.015); this observation could be accounted for by a reduced mortality from ischaemic heart disease. On-treatment analysis showed there to be significantly fewer end points in the ticlopidine group (47 vs. 76, P = 0.017). Diarrhoea was the most common side-effect. Reversible leucopenia or thrombocytopenia was reported in seven patients on ticlopidine. It is concluded that the high morbidity and mortality from cardio- and cerebrovascular disease in patients with intermittent claudication can be reduced by long-term treatment with ticlopidine.
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Janzon et al. (1990) studied this question.
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