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Oxcarbazepine versus carbamazepine monotherapy for partial onset seizures

  • Review
  • Intervention

Authors


Abstract

Background

Partial onset seizures are often treated with the standard antiepileptic drug carbamazepine. Oxcarbazepine is a newer antiepileptic drug related to carbamazepine that is claimed to be better tolerated.

Objectives

To compare efficacy and tolerability of carbamazepine and oxcarbazepine monotherapy for partial onset seizures.

Search methods

We searched the Cochrane Epilepsy Group Specialised Register (4 August 2009), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library issue 3, 2009), MEDLINE (January 1966 to May 2008), reference lists of relevant articles and conference proceedings. We also contacted manufacturers and researchers in the field for published or unpublished data.

Selection criteria

Blinded and unblinded randomised controlled trials of carbamazepine versus oxcarbazepine monotherapy for partial onset seizures.

Data collection and analysis

Both authors independently assessed trial quality, according to the guidelines in the Cochrane Reviewer's Handbook, and extracted information about study population, type of intervention, outcome measures and study design. All analyses in this review are by intention-to-treat. We tested for statistical heterogeneity among the identified studies using the chi-squared test.

Main results

Three trials (723 participants) were included. Only one trial used adequate outcome measures of efficacy; therefore, the results pertaining to efficacy are based on a single trial, whereas the results pertaining to adverse events are based on all three included trials. There was no overall difference in time to treatment withdrawal between the two drugs (hazard ratio (HR) of oxcarbazepine (OXC) versus carbamazepine (CBZ): 1.04, 95% confidence interval (CI) 0.78 to 1.39). Further analyses showed no significant difference in treatment withdrawal for unacceptable side effects (HR of OXC versus CBZ: 0.85, 95% CI 0.59 to 1.24) and in treatment withdrawal for inadequate seizure control (HR of OXC versus CBZ: 1.33, 95% CI 0.82 to 2.15). Oxcarbazepine and carbamazepine appeared to be similarly effective and well tolerated although the confidence intervals around estimates were wide and do not rule out the possibility of important differences existing. Significantly fewer patients on carbamazepine treatment developed nausea or vomiting, or both (odds ratio of OXC versus CBZ: 3.15, 95% CI 1.39 to 7.14).

Authors' conclusions

Oxcarbazepine and carbamazepine appear to be similarly effective and well tolerated. However, the possibility of important differences existing between these drugs cannot be ruled out.

摘要

背景

oxcarbazepine及carbamazepine治療局部癲癇之比較

局部癲癇(partial onset seizures)通常以標準抗癲癇藥物carbamazepine治療。Oxcarbazepine則是與carbamazepine有關的新型抗癲癇藥物,並聲稱耐受性較佳。

目標

oxcarbazepine及carbamazepine治療局部癲癇之功效及耐受性。

搜尋策略

我們搜尋了Cochrane Epilepsy Group Specialised Register (2009年8月4日)、Cochrane Central Register of Controlled Trials (CENTRAL, Cochrane Library issue 3, 2009)、MEDLINE(1966年1月至2008年5月)、相關文章參考文獻清單、以及研討會論文集。我們也和本領域藥廠及研究人員聯繫,以取得公開或未公開之資料。

選擇標準

採用carbamazepine v.s oxcarbazepine治療局部癲癇的遮盲及未遮盲隨機對照試驗。

資料收集與分析

由2名作者根據Cochrane Reviewer's Handbook準則獨立評估試驗品質,並摘錄有關研究群體、介入方式種類、結果評估方式及研究設計等資訊。本回顧中之所有分析皆採治療意向分析;並使用chisquared test檢定研究異質性。

主要結論

共收錄3項試驗(723名參與者),僅有1項試驗使用合適的結果測量方式,因此有關功效之結果來自一項試驗;有關不良副作用的結果則是以全部收錄的3個試驗為基礎。整體來說,2藥物在退出治療的時間上沒有差異(oxcarbazepine (OXC) v.s carbamazepine (CBZ)hazard ratio: 1.04, 95% confidence interval(CI) 0.78 – 1.39)。 進一步分析因無法忍受副作用而退出治療的時間點亦沒有顯著差異 (OXC vs CBZHR: 0.85, 95% CI 0.59 – 1.24);而因為無法有效控制癲癇發作而退出的時間也沒有差異 (OXC vs CBZHR: 1.33, 95% CI 0.82 to 2.15)。儘管信賴區間過大,因此無法排除可能存在重要的差異,不過Oxcarbazepine和similarly的療效相似,同時耐受度也很好。 使用carbamazepine的患者顯著較少發生 噁心和嘔吐或是兩者都發生的情形(odds ratio of OXC versus CBZ: 3.15, 95% CI 1.39 to 7.14)。

作者結論

Oxcarbazepine及carbamazepine似乎效果相似,並且有良好耐受性。但是,其無法排除此等藥物之間存在重大差異之可能性。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

oxcarbazepine及carbamazepine治療局部癲癇之比較: Carbamazepine是最常用於治療局部癲癇的藥物。Oxcarbazepine是一種較新的藥物,該藥物研發目標即是希望它與carbamazepine一樣有效,但副作用較少。 在此系統性文獻回顧,我們總結3個比較oxcarbazepine與carbamazepine治療的研究。我們發現,兩種藥物效果相似,發生副作用的頻率也差不多,其中carbamazepine患者顯著較少在治療中發生噁心或嘔吐。

Plain language summary

Oxcarbazepine versus carbamazepine monotherapy for partial onset seizures

Carbamazepine is the most commonly used drug to treat partial epileptic seizures. Oxcarbazepine is a newer drug that was developed with the intention to be as effective as carbamazepine but to cause fewer side effects. In this systematic review, we summarise three studies in which oxcarbazepine and carbamazepine treatment were compared directly. We found that both drugs appear to be equally effective and to cause side effects equally often. Significantly fewer patients on carbamazepine developed nausea or vomiting during treatment.

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