By Martha Kerr
SAN ANTONIO, Texas (Reuters Health) – After disappointing early results with clinical trials of citicoline and other choline precursors as neuroprotective agents for stroke in evolution, meta-analyses of those trials now show that those agents can exert neuroprotective effects equivalent to those demonstrated in animal studies.
These findings were presented here Thursday at the American Stroke Association's 27th International Stroke Conference.
Dr. Steven Warach and colleagues at the National Institute of Neurological Disorders and Stroke in Bethesda, Maryland, pooled data on two trials of citicoline: one involved 41 patients who received oral citicoline 500 mg daily for 6 weeks, the second involved 62 patients who took oral citicoline 2,000 mg daily for 6 weeks. The trials also included 111 patients who received placebo.
The clinical endpoint was infarct size after 12 weeks, determined by MRI. The investigators found that infarct size had increased by 85% in patients on placebo, by 34% in patients receiving the 500 mg dose of citicoline and by only 2% in patients receiving 2,000 mg citicoline. The results shown on MRI indicate that citicoline does have a neuroprotective effect, Dr. Warach said.
"There was a dose-dependent effect…that replicates animal study results," Dr. Warach announced. "Maybe these drugs are working, but we are not targeting them properly." Patients with smaller infarcts were much more likely to show clinical improvement, he added.
Next, Dr. Jeffrey L. Saver of the UCLA Stroke Center in Los Angeles, California, presented results of a meta-analysis of choline precursors as neuroprotectants to meeting attendees.
His meta-analysis involved 8 clinical trials, consisting of 2,063 patients, 1,171 who received active treatment and 892 who served as controls. Treatment with the choline precursor was initiated within two weeks of symptom onset.
"Individually, these trials gave conflicting results," Dr. Saver remarked. "But with meta-analysis, there seems to be substantial benefit if treatment is started within 14 days…For every 1,000 patients treated, there were 104 patients with a better outcome."
Active treatment reduced morbidity and mortality by 10.4%, an effect that "was obscured by the small sample size of the individual trials and differences in trial design, which we controlled for," Dr. Saver concluded.
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