Source: Rev Assoc Med Bras  |  Posted 6 years ago

By Fran Lowry

WASHINGTON, DC -- December 8, 2005 -- Adjunctive treatment with pregabalin is effective and well tolerated in patients with partial seizures, even when they are highly refractive to other antiepileptic drugs.

J.A. Barrett, MD, Pfizer Global Pharmaceuticals, Pfizer, Inc., New York, United States, presented results of a study of the CNS-active compound pregabalin on December 7[^]th[] at the 59[^]th[] Annual Meeting of the American Epilepsy Society (AES).

"Pregabalin has consistently been found to be effective, safe, and well-tolerated when used as add-on therapy for partial seizures," Dr. Barrett said. "Our analysis was done to characterize the intensity and duration of adverse events that are sometimes associated with its use."

The researchers analyzed the adverse events reported in four clinical trials of adjunctive use of pregabalin for refractory partial seizures. Patients were considered refractory if their epilepsy was inadequately controlled on one to three antiepileptic drugs (AEDs). Each of the four double-blind, randomized, placebo-controlled trials lasted for 12 weeks and a total of 1174 patients were evaluated.

The patients were randomized to treatment with pregabalin at doses that ranged from 150-600 mg/day, or to placebo, and adverse events were noted daily. The majority (89%) of patients were white, 51% were female, and 74% were taking two or more concomitant AEDs. The duration of epilepsy was 25 years, with a median seizure rate of 9.5 seizures per 28 days recorded at baseline, Dr. Barrett noted.

In all four trials, adverse events associated with treatment were mild to moderate. "They were transient, and tended to resolve as treatment continued," Dr. Barrett said. "The most common adverse events were dizziness, somnolence, ataxia, and asthenia. Most patients experienced dizziness on the first week of treatment, but this went away as treatment continued."

Relatively few patients discontinued treatment, he said.

"Pregabalin has a highly predictable, linear pharmacokinetic profile and exhibits no known clinically significant drug-drug interactions," he added.

"Our findings from these four trials suggest that the drug is well tolerated and that the adverse events experienced by some patients receiving pregabalin are mild to moderate, occur at the start of treatment, and tend to be transient in nature," he concluded.

[Presentation title: Multi-Trial Analysis of the Duration and Intensity of Adverse Events Associated with Pregabalin Adjunctive Treatment of Partial Seizures. Abstract 2.233]