Parfenov V A, Zamergrad M V, Kazei D V, Nauta J
Sechenov First Moscow State Medical University, Moscow, Russia.
Russian Medical Academy of Continuous Professional Education, Moscow, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2020;120(12):42-48. doi: 10.17116/jnevro202012012142.
To evaluate the efficacy and safety of modified-release (MR) betahistine (48 mg once daily) versus betaserc (24 mg twice daily) in patients with Meniere's disease or vestibular vertigo.
A multicentre, double-blind, randomized clinical study in patients with an established diagnosis of Meniere's disease (35%) or vestibular vertigo (65%) was carried out. A total of 264 patients were randomized (132 in each group).The inclusion criteria were a Dizziness Handicap Inventory (DHI) total score of more than 30 points and at least 2 vertigo attacks within the previous 4 weeks. The primary efficacy variable was the change in the DHI total score from baseline to after 12 weeks of treatment. The predefined non-inferiority margin was set at 9 points for the DHI total score.
After 12 weeks of treatment, the DHI total score was significantly (<0.001) decreased compared with baseline, by 32.0±20.7 in the betahistine MR group and by 31.8±19.8 in the betaserc group. The adjusted difference in the change in the DHI total score with a one-sided 97.5% CI was 0.9 (--; 5.3) points, the upper confidence limit (+5.3) fell below the predefined margin of non-inferiority of 9 points, and the non-inferiority of betahistine MR to betaserc was established. The treatment groups were comparable in terms of reduced scores for the functional, emotional and physical subdomains of DHI; reduced frequency, intensity and duration of vertigo attacks; decreased proportion of patients with prolonged attacks and severe symptoms during attacks; and scores on the Clinical Global Impression - Improvement scale. The safety profile of betahistine MR was comparable to that of betaserc, the most frequently reported adverse event was headache in both treatment groups.
Betahistine MR (48 mg once daily) is non-inferior to betaserc (24 mg twice daily) in patients with Meniere's disease or vestibular vertigo and has a comparable safety profile.
评估缓释型倍他司汀（每日一次，48毫克）与甲磺酸倍他司汀（每日两次，24毫克）治疗梅尼埃病或前庭性眩晕患者的疗效和安全性。
对确诊为梅尼埃病（35%）或前庭性眩晕（65%）的患者进行了一项多中心、双盲、随机临床研究。总共264例患者被随机分组（每组132例）。纳入标准为头晕残障量表（DHI）总分超过30分且在过去4周内至少有2次眩晕发作。主要疗效变量是从基线到治疗12周后DHI总分的变化。DHI总分的预定义非劣效界值设定为9分。
治疗12周后，与基线相比，DHI总分显著降低（<0.001），倍他司汀缓释组降低了32.0±20.7，甲磺酸倍他司汀组降低了31.8±19.8。DHI总分变化的调整后差异，单侧97.5%置信区间为0.9（- -；5.3）分，置信上限（+5.3）低于预定义的9分非劣效界值，从而确立了倍他司汀缓释剂相对于甲磺酸倍他司汀的非劣效性。在DHI的功能、情感和身体子领域得分降低；眩晕发作的频率、强度和持续时间降低；发作期间延长发作和出现严重症状的患者比例降低；以及临床总体印象-改善量表得分方面，各治疗组具有可比性。倍他司汀缓释剂的安全性与甲磺酸倍他司汀相当，两个治疗组最常报告的不良事件均为头痛。
对于梅尼埃病或前庭性眩晕患者，倍他司汀缓释剂（每日一次，48毫克）不劣于甲磺酸倍他司汀（每日两次，24毫克），且安全性相当。
