WESTPORT, CT (Reuters Health) – Aptiganel hydrochloride, a glutamate receptor blocker, is not an effective treatment for acute ischemic strokes, and it may actually be harmful, according to a report published in the December 5th issue of The Journal of the American Medical Association.
Currently, tissue plasminogen activator for thrombolysis is the only therapy approved in the US for the treatment of acute ischemic stroke. There has been increasing interest in agents such as aptiganel which do not dissolve the thrombus but inhibit many of the secondary detrimental effects.
Dr. Gregory W. Albers, of Stanford University Medical Center in Palo Alto, California, and colleagues assessed the outcomes of 628 ischemic stroke patients who were randomized to receive one of two doses of aptiganel or placebo within 6 hours of stroke onset. The high-dose aptiganel regimen consisted of a 5-mg bolus followed by 0.75 mg/h for 12 hours, while the low-dose regimen began with a 3-mg bolus and then 0.5 mg/h for 12 hours.
The trial was stopped early due to safety and efficacy concerns, the authors note. At 3-month evaluation, neither aptiganel regimen was linked to an improvement in patient outcomes compared with placebo. In fact, at 7 days after treatment, placebo-treated patients demonstrated significantly greater neurologic improvement than high-dose aptiganel-treated patients (p = 0.04).
The mortality rate at 120 days was higher in the aptiganel groups than in the placebo group, but the differences were not statistically significant, the investigators report.
Dr. Albers and colleagues advise that these results should be carefully considered before studies of other glutamate antagonists are undertaken.
In a related editorial, Dr. Kyra J. Becker and Dr. David L. Tirschwell, from Harborview Medical Center in Seattle, comment that "as the practice of conducting clinical trials involving patients with acute stroke evolves, so do the complexities of conducting and monitoring such trials."
Dr. Becker and Dr. Tirschwell add that "regardless of complexity, the safety of the participating patients, who more often enter clinical trials for the benefit of society rather than for personal gain, must be protected, regardless of effort or cost."
JAMA 2001;286:2673-2682, 2718-2719.
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