レベチラセタム(イーケプラ)が片頭痛に有効
片頭痛はしばしば慢性化・難治化する疾患である。海外では、重要の片頭痛患者に対し、抗てんかん薬が使用されている。インド・UP Rural Institute of Medical Sciences and ResearchのArchana Verma氏らは、成人の片頭痛予防に対する、抗てんかん薬レベチラセタム(商品名:イーケプラ、本疾患には国内未承認)の有効性および忍容性を評価した。Clinical neuropharmacology誌2013年11-12月号の報告。
片頭痛患者65例を対象とした、前向き無作為化プラセボ対照試験。対象患者は、レベチラセタム(LEV)群32例、プラセボ群33例に無作為に割り付けられた。試験完了症例数は、LEV群25例、プラセボ群27例であり、13例は早期に試験を中止した。LEVは250mg/日から投与を開始し、1週間おきに250mgずつ追加し、最終投与量である1000mg/日まで増量した。観察期間は3ヵ月間。
<結果>
★LEV群ではプラセボ群と比較し、片頭痛の頻度(1ヵ月当たりの回数)が有意に減少し(ベースライン時5.17回[SD:1.19]→最後の4週間2.21回[1.47])、重症度も有意に減少した(2.75[0.44]→1.29[0.75])。
★また、LEV群ではプラセボ群と比較し、症状コントロールのために使用する対症療法薬の投与量も有意に減少した(p<0.0001)。
★頭痛頻度が50%以上減少した患者の割合は、LEV群64%、プラセボ群22%であった。
★成人片頭痛患者へのレベチラセタム投与は、頭痛の頻度や重症度を改善し、対症療法薬の使用も軽減できることが示された。
Levetiracetam in migraine prophylaxis: a randomized placebo-controlled study in a rural medical institute in northern India.
Archana Verma, Dhiraj Srivastava, Alok Kumar, Vineeta Singh
Affiliation
*Departments of Neurology, †SPM, ‡Forensic Medicine and Toxicology, UP Rural Institute of Medical Sciences and Research, Saifai, Etawah, Uttar Pradesh, India; and §Department of Neurology, University of California, San Francisco, San Francisco, CA.
Clinical neuropharmacology. 2013 Nov-Dec;36(6);193-7. doi: 10.1097/WNF.0000000000000005.
PMID:24201237
Abstract
OBJECTIVE :
Migraine is often a chronic and disabling disorder. The objective of our study was to assess the efficacy and tolerability of levetiracetam (LEV) in adult migraine prophylaxis.
METHODS :
We conducted a prospective, randomized, placebo-controlled study. A total of 65 patients were randomized in a 1:1 ratio to receive LEV (n = 32) or placebo (n = 33). Twenty-five patients completed the study in the LEV group and 27 patients in the placebo group. Thirteen subjects discontinued early during the trial. After a 1-month run in period, LEV was started at a dose of 250 mg/d (or the matching placebo) and was increased by 250 mg/wk until the final dosage of 1000 mg/d was reached. The titration phase was followed by maintained phase of 3 months.
RESULTS :
In LEV group, we found a significant reduction in the frequency (attacks per month) of migraine (from 5.17 [SD, 1.19] at baseline to 2.21 [1.47] in the last 4 weeks) and also in severity of migraine from (2.75 [0.44] to1.29 [0.75]) as compared to the placebo group. Patients treated with LEV also reported a statistically significant reduction in the quantity of symptomatic drugs needed for symptom control as compared to the placebo group (P < 0.0001). The percentage of patients on LEV who experienced greater than or equal to 50% reduction in headache frequency was 64% compared with 22% for placebo.
CONCLUSIONS :
Compared with the placebo group, LEV offers improvement in headache frequency and severity as well as it lowers the requirement for other symptomatic drugs in adult migraine patients.