<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">epilepsia</journal-id><journal-title-group><journal-title xml:lang="en">Epilepsy and paroxysmal conditions</journal-title><trans-title-group xml:lang="ru"><trans-title>Эпилепсия и пароксизмальные состояния</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2077-8333</issn><issn pub-type="epub">2311-4088</issn><publisher><publisher-name>IRBIS LLC</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">epilepsia-264</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ORIGINAL ARTICLES</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОРИГИНАЛЬНЫЕ СТАТЬИ</subject></subj-group></article-categories><title-group><article-title>EFFICACY AND TOLERABILITY OF PROLONGED VALPROATE (DEPAKINE® CHRONOSPHEREТМ) FOR FIRST LINE THERAPY IN ADULT PATIENTS WITH EPILEPSY</article-title><trans-title-group xml:lang="ru"><trans-title>ЭФФЕКТИВНОСТЬ И ПЕРЕНОСИМОСТЬ ПРОЛОНГИРОВАННОГО ВАЛЬПРОАТА (ДЕПАКИН® ХРОНОСФЕРАТМ) КАК ПРЕПАРАТА ПЕРВОЙ ОЧЕРЕДИ ВЫБОРА В ЛЕЧЕНИИ ЭПИЛЕПСИИ У ВЗРОСЛЫХ</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белоусова</surname><given-names>Е. Д.</given-names></name><name name-style="western" xml:lang="en"><surname>Belousova</surname><given-names>Ye. D.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Авакян</surname><given-names>Г. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Avakyan</surname><given-names>G. N.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБУ МНИИ педиатрии и детской хирургии Минздравсоцразвития</institution><country>Россия</country></aff><aff xml:lang="en"><institution>FGBU VPO MNII of pediatry and child surgery, Ministry of Health and Social Development of Russia</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ГБОУ ВПО Российский национальный исследовательский медицинский университет им. Н.И. Пирогова Минздравсоцразвития России (Москва)</institution><country>Россия</country></aff><aff xml:lang="en"><institution>GBOU VPO Russian National Investigational Medical University named after N.I. Pirogov, Ministry of Health and Social Development of the Russian Federation (Moscow)</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2012</year></pub-date><pub-date pub-type="epub"><day>04</day><month>09</month><year>2016</year></pub-date><volume>4</volume><issue>2</issue><fpage>48</fpage><lpage>54</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Belousova Y.D., Avakyan G.N., 2016</copyright-statement><copyright-year>2016</copyright-year><copyright-holder xml:lang="ru">Белоусова Е.Д., Авакян Г.Н.</copyright-holder><copyright-holder xml:lang="en">Belousova Y.D., Avakyan G.N.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.epilepsia.su/jour/article/view/264">https://www.epilepsia.su/jour/article/view/264</self-uri><abstract><p>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.</p></abstract><trans-abstract xml:lang="ru"/><kwd-group xml:lang="ru"><kwd>лечение эпилепсии</kwd><kwd>взрослые</kwd><kwd>Депакин Хроносфера</kwd><kwd>эффективность</kwd><kwd>переносимость</kwd></kwd-group><kwd-group xml:lang="en"><kwd>treatment of epilepsy</kwd><kwd>adults</kwd><kwd>Depakine Chronosphere</kwd><kwd>efficacy</kwd><kwd>tolerability</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">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.</mixed-citation><mixed-citation xml:lang="en">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.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Карлов В.А. Антиэпилептические препараты. Эпилепсия у детей и взрослых женщин и мужчин. Руководство для врачей. Москва; Медицина; 2010; стр.577-585</mixed-citation><mixed-citation xml:lang="en">Карлов В.А. Антиэпилептические препараты. Эпилепсия у детей и взрослых женщин и мужчин. Руководство для врачей. Москва; Медицина; 2010; стр.577-585</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">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.</mixed-citation><mixed-citation xml:lang="en">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.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">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.</mixed-citation><mixed-citation xml:lang="en">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.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">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.</mixed-citation><mixed-citation xml:lang="en">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.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">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.</mixed-citation><mixed-citation xml:lang="en">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.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">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</mixed-citation><mixed-citation xml:lang="en">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</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Engel J.R., A Proposed Diagnostic Schema for People with Epileptic Seizures and with Epilepsy. Epilepsia; 2001; V. 42 (6); V. 796-803.</mixed-citation><mixed-citation xml:lang="en">Engel J.R., A Proposed Diagnostic Schema for People with Epileptic Seizures and with Epilepsy. Epilepsia; 2001; V. 42 (6); V. 796-803.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Депакин Хроносфера. Инструкция по применению препарата. Рег. Номер: ЛСР-005197/08 от 03.07.2008.</mixed-citation><mixed-citation xml:lang="en">Депакин Хроносфера. Инструкция по применению препарата. Рег. Номер: ЛСР-005197/08 от 03.07.2008.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">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</mixed-citation><mixed-citation xml:lang="en">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</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">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.</mixed-citation><mixed-citation xml:lang="en">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.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
