my personal edition > epilepsy > news


  E-Mail this DGNews to a colleague

DGNews

Lyrica (Pregabalin) Appears to Reduce Frequency of Partial Seizures by More Than Half

NEW YORK, NY -- February 14, 2005 -- Pfizer Inc's Lyrica™ (pregabalin) capsules significantly reduced the frequency of partial seizures by up to 53 percent and was well tolerated as an add-on therapy to other antiepileptic treatments, according to a new study published in the peer- reviewed journal Neurology.

Epilepsy, a chronic neurological condition that is characterized by seizures, affects an estimated 50 million people worldwide, with 2.5 million people affected in the United States alone. Reducing the frequency of seizures remains a significant challenge in treating patients with epilepsy. In fact, more than one-third of epilepsy patients continue to experience seizures while taking one antiepileptic therapy, and more than 30 percent of patients taking two or more antiepileptic drugs have uncontrolled seizures.

In this double-blind controlled study, patients treated with Lyrica three times daily experienced up to 53 percent fewer seizures, and patients treated with Lyrica twice daily experienced up to 44 percent fewer seizures compared to a one percent increase in seizures among patients receiving placebo. Also, patients were classified as responders if they experienced a 50 percent reduction in seizure frequency compared with baseline. Nearly half (49 percent) of patients treated with Lyrica three times daily and 43 percent of patients treated with Lyrica twice daily were responders, compared to 9 percent of placebo patients.

"There is considerable need for an add-on drug like Lyrica, which improves seizure control with a tolerable safety profile," said Dr. Ahmad Beydoun, lead study author and an associate professor of neurology, University of Michigan Health System in Ann Arbor, Michigan. "These results are impressive given that at baseline the average patient was experiencing 21 to 25 seizures per month despite taking at least one antiepileptic treatment."

In the trial, 312 patients who had failed two or more antiepileptic drugs at maximally tolerated doses were randomized to receive treatment with one of two 600 mg per day Lyrica regimens (300 mg twice daily or 200 mg three times daily) or placebo.

"The efficacy rates in this study support those seen in two previously- published trials," said Dr. Beydoun. "In addition, this study suggests that we can achieve comparable efficacy using either the twice-daily or thrice- daily dosing regimen."

Seizures are generally categorized according to symptoms, external signs and duration. Partial seizures are classified as simple, in which the person stays alert, or complex, in which there is a change in consciousness. Generalized seizures may be convulsive or non-convulsive, and include brief lapses of attention or prolonged loss of consciousness. In all the different types of seizures measured, including simple partial-onset, complex partial- onset and secondarily generalized seizures, Lyrica treatment resulted in fewer seizures, compared to placebo.

In this study, the most common side effects reported by patients receiving Lyrica were dizziness, somnolence and ataxia. Most adverse events were mild- to-moderate in intensity and did not differ in type or frequency between the two Lyrica regimens.

The U.S. Food and Drug Administration (FDA) approved Lyrica in December 2004 for the management of the two most common forms of neuropathic (nerve) pain, diabetic peripheral neuropathy and postherpetic neuralgia. Pfizer received an approvable letter from the FDA for the use of Lyrica in the adjunctive treatment of partial seizures in adults. In July 2004, Pfizer received European Commission approval to market Lyrica in European Union member states as adjunctive therapy for partial seizures and for the treatment of peripheral neuropathic pain. Lyrica has been studied in more than 9,000 patients.


SOURCE: Pfizer Inc

E-Mail this DGNews to a colleague

To print, use this version