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Pregabalin Shows Long-term Efficacy, Safety for Partial Seizures: Presented at AES

By Bonnie Darves

BOSTON, MA -- December 18, 2003 -- Patients who take the new-generation antiepileptic drug pregabalin as adjunctive therapy for partial seizure control may experience sustained efficacy without some of the troubling side effects of longstanding antiepileptics, according to new research reported here December 9^th at the American Epilepsy Society Annual Meeting.

Pregabalin is a relatively new central-nervous-system agent that does not act on gamma-aminobutyric acid (GABA) receptors as do some antiepileptics. Pregabalin was well tolerated and effective for as long as 4 years, noted the study's lead author Ahmad Beydoun, MD, University of Michigan Hospital, Ann Arbor, United States.

In the meta-analysis of 4 double blind trials involving 1,480 patients, participants took doses ranging from 75 mg to 600 mg daily (two thirds took 450 mg or more daily) administered either twice daily or three times daily. The mean age of participants was 38.2 years at baseline, and the mean seizure rate per 28 days was 18.2. The longest pregabalin exposure was 4.8 years, and nearly 60% of patients remained on the drug for more than 1 year.

At end point, the overall responder rate was 35%. The 220 patients who remained in the trials for 2 years had an overall responder rate of 52%, and the median seizure reduction rate -- ranging from 49% to 58% -- was maintained over time, Dr. Beydoun noted.

Over the open-label phase, 14% of patients reported a 75% improvement -- and at final observation, 8% of enrolled patients had been seizure-free for 6 months or longer.

Although 79.5% of participants experienced treatment-related adverse events; most were mild to moderate in severity, and only 13% withdrew from the study because of adverse events. The most common were dizziness (33%) and somnolence (27%).


[Study Title: Safety and Sustained Long-term Efficacy of Pregabalin for Partial-Onset Seizures. Abstract 2240]

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