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EFFICACY AND TOLERABILITY OF PROLONGED VALPROATE (DEPAKINE® CHRONOSPHEREТМ) FOR FIRST LINE THERAPY IN ADULT PATIENTS WITH EPILEPSY

Abstract

use of Depakine Chronosphere in Russian clinical practice for first line monotherapy for treatment of adult patients with epilepsy Study objective: to get additional Russian data on Depakine Chronosphere efficacy as a first line monotherapy for treatment of adult patients with epilepsy. Methods: the study was short-term open-label, observational, prospective by its design and was conducted very close to the real clinical practice. Duration of the observation was 2 months. 494 patients older than 18 years (mean 30,2±14,1 years) with different forms of epilepsy were enrolled into the study. Symptomatic focal epilepsy forms were diagnosed in 52% of cases, presumably symptomatic – in 16,8% cases, idiopathic generalized epilepsy – in 29,8%, unspecified – in 1,4%. Patients received Depakine Chronosphere in mean day dosage of 18,58 ± 5,53 mg/kg. Drug efficacy was assessed on the basis of changes in number of seizures. Besides of this, subjective assessment of treatment efficacy was performed by physician and patient. Safety was assessed on the basis of adverse events reports by patients during the observation period. Results: more than 90% of all patients had positive effect on treatment with Depakine Chronosphere (epileptic seizures were stopped and their number reduced). Epileptic seizures were completely stopped in 64,4% of patients. The drug was effective in different forms of epilepsy (in partial and as well as in generalized). Depakine Chronosphere showed good tolerability. Adverse events were observed in 15,7% of patients, but only 0,8% of them led to therapy discontinuation . Physicians and patients assessed treatment efficacy as very good and good in more, than 90% of cases. Good efficacy and tolerability of therapy were confirmed by scale of common clinical assessment – 61,1% of patients had significant improvement and absence of the side effects, 17% of patients had significant improvement and nonsignificant side effects. Conclusion: the study demonstrates efficacy and tolerability of Depakine Chronosphere as monotherapy of epilepsy in adults and it can be considered as a first line therapy.

About the Authors

Ye. D. Belousova
FGBU VPO MNII of pediatry and child surgery, Ministry of Health and Social Development of Russia
Russian Federation


G. N. Avakyan
GBOU VPO Russian National Investigational Medical University named after N.I. Pirogov, Ministry of Health and Social Development of the Russian Federation (Moscow)
Russian Federation


References

1. Landmark CJ, Fossmark H, Larsson PG, Rytter E, Johannessen SI. Prescription patterns of antiepileptic drugs in patients with epilepsy in a nation-wide population. EpilepsyRes.; 2011; V.95(1-2); P.51-9.

2. Карлов В.А. Антиэпилептические препараты. Эпилепсия у детей и взрослых женщин и мужчин. Руководство для врачей. Москва; Медицина; 2010; стр.577-585

3. Marson AG, Al-Kharusi AM, Alwaidh M et al. The SANAD study of effectiveness of valproate, lamotrigine or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial. Lancet; 2007; V.369; P.1016–1026.

4. Jedrzejzak J., Kunchikova M. and Margureanu S. An observational study of first-line valproate monotherapy in focal epilepsy. EuropeanJournalofNeurology; 2008; V.15; P. 66-72.

5. Белоусова Е.Д. Российское наблюдательное исследование эффективности и переносимости Депакина Хроно в качестве первой монотерапии парциальной эпилепсии. Неврология, нейропсихиатрия, психосоматика; 2010; том 3; стр. 47-52.

6. Dulac O. and Alvarez J.-C. Bioequivalence of a New Sustained-Release Formulation of Sodium Valproate, Valproate ModifiedRelease Granules, Compared with Existing Sustained-Release Formulations After Onceor Twice-Daily Administration. Pharmacotherapy; 2005; V.25; N1; P.35 – 41.

7. Белоусова Е.Д., Ермаков А.Ю. Применение Депакина Хроносфера в качестве первой монотерапии для лечения эпилепсии у детей. Неврология, нейропсихиатрия, психосоматика, 2010, N3; стр. 52-57

8. Engel J.R., A Proposed Diagnostic Schema for People with Epileptic Seizures and with Epilepsy. Epilepsia; 2001; V. 42 (6); V. 796-803.

9. Депакин Хроносфера. Инструкция по применению препарата. Рег. Номер: ЛСР-005197/08 от 03.07.2008.

10. Kwan P., Arzimanoglou A. Berg A. Definition of drug resistant epilepsy: Consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies Epilepsia; 2010; V.51(6); P.1069–1077

11. Akiyama T., Kobayashi K., Ogino T. et al.A population-based survey of childhood epilepsy in Okayama Prefecture, Japan: reclassification by a newly proposed diagnostic scheme of epilepsies in 2001. Epilepsy Res.; 2006; V.70; Suppl 1; P.34-40.


Review

For citations:


Belousova Ye.D., Avakyan G.N. EFFICACY AND TOLERABILITY OF PROLONGED VALPROATE (DEPAKINE® CHRONOSPHEREТМ) FOR FIRST LINE THERAPY IN ADULT PATIENTS WITH EPILEPSY. Epilepsy and paroxysmal conditions. 2012;4(2):48-54. (In Russ.)

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ISSN 2077-8333 (Print)
ISSN 2311-4088 (Online)