Abstract | INTRODUCTION: DEVELOPMENT: This drug, which binds to a subunit of voltage-dependent calcium channels in neuronal membranes, has a favourable pharmacokinetic profile. Pregabalin administered in two or three divided doses was compared to placebo in three double-blind randomised multicenter clinical trials, including 1,052 patients with focal epilepsy not controlled with other antiepileptic drugs. Results of these studies showed efficacy at doses of 150 mg per day, and a dose-response relationship up to doses of 600 mg per day. At the highest dose, mean seizure reduction for pregabalin was 44.3 to 54%, a significant reduction compared to placebo (p < or =0.0001), and a response rate of 43.5 to 51% (p < or =0.001). In one of these studies 12% of patients treated with pregabalin at 600 mg per day were seizure free for the last month of therapy while another study demonstrated its efficacy when used on a twice daily schedule. Subsequent open studies demonstrated a sustained efficacy of the drug. The most common adverse events were dizziness, somnolence, ataxia, asthenia, and weight gain. Withdrawal from controlled studies due to adverse effects was 15.3% in patients treated with pregabalin, compared with 6.15% in those receiving placebo. CONCLUSION:
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Authors | A Gil-Nagel Rein, J Gómez-Alonso |
Journal | Revista de neurologia
(Rev Neurol)
2005 May 16-31
Vol. 40
Issue 10
Pg. 609-13
ISSN: 0210-0010 [Print] Spain |
Vernacular Title | Experiencia clínica de la pregabalina en el tratamiento de las epilepsias focales. |
PMID | 15926135
(Publication Type: English Abstract, Journal Article, Review)
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Chemical References |
- Anticonvulsants
- Placebos
- Pregabalin
- gamma-Aminobutyric Acid
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Topics |
- Anticonvulsants
(adverse effects, pharmacokinetics, therapeutic use)
- Clinical Trials as Topic
- Dose-Response Relationship, Drug
- Double-Blind Method
- Epilepsies, Partial
(drug therapy)
- Humans
- Multicenter Studies as Topic
- Placebos
- Pregabalin
- Randomized Controlled Trials as Topic
- Treatment Outcome
- gamma-Aminobutyric Acid
(adverse effects, analogs & derivatives, pharmacokinetics, therapeutic use)
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