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SYNTEX TICLID (TICLOPIDINE) REDUCED STROKE RISK 21% v. ASPIRIN

Executive Summary

SYNTEX TICLID (TICLOPIDINE) REDUCED STROKE RISK 21% v. ASPIRIN in high-risk patients, researchers of the Ticlopidine American Stroke Study reported in a study published in the Aug. 24 New England Journal of Medicine. Researchers William Hass, MD, New York University Medical Center, et al., also reported that patients taking the platelet antiaggregant had higher incidence of side effects, including raised cholesterol and severe neutropenia, than those taking aspirin. "We conclude that ticlopidine was somewhat more effective than aspirin in preventing strokes in this population, although the risks of side effects were greater," the authors said. The researchers pointed out that "the differences between the effects of the two drugs, although statistically significant, were small." The double-blind, multi-center study followed 3,069 patients with recent transient or mild persistent focal cerebral or retinal ischemia for two to six years. Half were randomly assigned to take 500 mg of ticlopidine daily; the other half took 1,300 mg of aspirin daily. Of those taking ticlopidine, 10% had fatal or non-fatal strokes after three years, compared to 13% for those on aspirin, "a 21% risk reduction." The overall rate of non-fatal stroke or death from any cause was 17% for patients on ticlopidine and 19% for those on aspirin, "a 12% risk reduction." Women seemed to gain slightly more stroke protection from ticlopidine than men. The stroke risk reduction with ticlopidine was 19% for men and 27% for women, while the reduction of the risk of non-fatal stroke or death was 10% for men and 17% for women. The authors note that this may be another important advantage of ticlopidine over aspirin because "previous studies have questioned the efficacy of aspirin for stroke prophylaxis in women." Discussing side effects, the authors note that 62% of patients taking ticlopidine suffered from some adverse experience, compared to 53% of those taking aspirin. More than twice as many ticlopidine patients than aspirin patients (20.4% v. 9.8%) had diarrhea. About 12% of those on ticlopidine had rashes, v. 5% on aspirin. Thirteen, or 0.9% of ticlopidine-treated patients experienced severe neutropenia, while none on aspirin did. Increases in total cholesterol levels were also associated with ticlopidine. The mean increase of cholesterol levels in the ticlopidine patients was 9%, compared to 2% in those treated with aspirin. However, the researchers noted that the cholesterol increase was "not associated with an imbalance in the cholesterol lipoprotein fraction, liver dysfunction, or an increase in vascular ischemic events." Increases were observed in all lipoprotein fractions -- the beneficial high-density lipoprotein (HDL), as well as low-density lipoprotein (LDL) and very-low-density lipoprotein (VLDL). Hemorrhagic events occurred with similar frequency in both ticlopidine and aspirin groups, 9% versus 10%. However, "half these events were thought to be unrelated to the study medication," the authors observed. Noting that "a recent report has suggested that intracranial hemorrhage is a potential complication of the long-term administration of aspirin," the authors maintained that "in this study, hemorrhagic infarction and intracerebral hemorrhage were not frequent events in the patients taking aspirin or ticlopidine." These results, the authors asserted, "suggest that intracranial hemorrhage may not be a complication of the long-term use of the antiplatelet agents ticlopidine and aspirin." Syntex received expedited review status from FDA on July 25 for Ticlid for prevention of threatened and recurrent strokes ("The Pink Sheet" July 31, T&G-7), after filing its NDA June 26. Syntex licenses ticlopidine from the French company Sanofi and retains marketing rights for the U.S., Canada, Mexico, Australia and New Zealand. The Canadian American Ticlopidine Study, published in the June 3 Lancet, concluded that ticlopidine reduced the risk of stroke, myocardial infarction or vascular death by 30% over placebo. As in the NEJM study, however, adverse events, including neutropenia, diarrhea and rash, occurred in more patients on ticlopidine (54%) than in those on placebo (34%).
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