By Ann Saul
FLORENCE, Italy -- September 22, 2009 -- Pregabalin as a first add-on therapy for patients with partial seizures with or without secondary generalisation was shown to be effective and continued to demonstrate an increase in responder rate after 6 months, according to a study presented at the 13th Congress of the European Federation of Neurological Societies (EFNS).
An open-label, prospective, postmarketing multicentre study of pregabalin add-on therapy was presented here on September 13 by Vladimir Donáth, MD, PhD, Neurologic Clinic, F.D. Roosevelt University Hospital, Banská Bystrica, Slovakia. The study was conducted to assess efficacy of treatment with pregabalin in outpatient subjects who had experienced therapeutic failure in previous monotherapy treatment with another antiepileptic drug.
The trial included 320 patients (average age 42 years). Concomitant therapy included carbamazepine (25.4%), lamotrigine (16.8%), valproate (14.8%), topiramate (11.3%), oxcarbazepine (2.7%), and levetiracetam (2.3%).
At the initial dose of pregabalin, patients received 75 mg twice daily for 7 days. After that, patients received 150 mg twice daily after 1 week and 300 mg twice daily after the following week in case of failure. After the baseline visit, patients were seen at 1 month, 3 months, and 6 months.
The number of seizures decreased 37.5% after month 1; 43.8% after month 3; and 61.3% after month 6, which was significant (P < .05) between months 1 and 3 and between months 1 and 6.
The most commonly reported adverse events included dizziness, tiredness, weight gain, memory impairment, and nausea.
With the add-on therapy of pregabalin, patients also experienced improvements in sleep, anxiety, and depression. At the baseline visit, only 54.7% of patients were in the mild anxiety group (a measure of lesser anxiety), as measured by the Hamilton Anxiety Scale. After 3 months, the number moving from higher levels of anxiety to the mild group had increased to 73.8%, and after 6 months, 91.0% of patients were in the mild anxiety group. Patient depression also improved as measured by the Hamilton Psychiatric Rating Scale for Depression. At the end of 6 months, patients evaluated their quality of life (Quality of Life in Epilepsy-10 questionnaire) over the previous 4 weeks as "quite good."
According to physicians, the efficacy of treatment was considered to be "very good" in 57.0% of patients, and tolerance of treatment was "very good" in 65.2% of patients. Compliance was considered to be "very good" in 63.7% of patients. Nearly half of the patients (48.0%) evaluated the efficacy of treatment as "good." More than half (54.7%) considered the tolerance of treatment as "very good." A small number of patients (7.8%) did not continue the treatment because of lack of effectiveness.
As the first add-on therapy, pregabalin was found to be an effective antiepileptic drug with an increase in responder rate after 6 months. It also provided beneficial effects on anxiety, depression, and sleep disturbance.
Funding for this study was provided by Pfizer Inc.
[Presentation title: Pregabalin as a First Add-On Therapy in Partial Epileptic Seizures and its Influence on Associated Symptoms. Poster 1300]
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