ISSN 1612-3352

Editors in Chief

Prof. Dr. Claus F. Claussen, Neurootological Research Institute of the Research Society for Smell, Taste, Hearing and Equilibrium Disorders at Bad Kissingen (4-G-F). Bad Kissingen, Germany.
Dr. med. Julia M. Bergmann,
Dr. med. Guillermo O. Bertora,
Otoneuroophthalmological Neurophysiology,
Buenos Aires, Argentina.

Production Managers

Dr. med. Julia M. Bergmann,
Dr. med. Guillermo O. Bertora,
Otoneuroophthalmological Neurophysiology,
Buenos Aires, Argentina.


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FIXED COMBINATION OF CINNARIZINE AND DIMENHYDRINATE VERSUS BETAHISTINE DIMESYLATE IN MÉNIÈRE’s DISEASE

Abstract

ABSTRACT
Background: Ménière’s disease (MD) is characterized by recurrent, sudden episodes of disabling vertigo. A previous randomized, controlled study demonstrated a high efficacy of a fixed combination of cinnarizine 20mg and dimenhydrinate 40mg (Arlevert®, tid.) in MD, with no statistically significant difference to betahistine (dimesylate salt, 12mg, tid).
Objective: This post hoc analysis was performed to demonstrate non-inferiority of cinnarizine/dimenhydrinate compared to betahistine following current regulatory guidelines.
Methods: Data of 40 patients per group (per-protocol population) were compared using ANCOVA with respect to the primary outcome, the mean vertigo symptom (SM, composed of 12 scores for unprovoked and provoked vertigo, assessed on a 5-point VAS) at Week 12.
Results: SM decreased by >80% during 12-week treatment with either the fixed cinnarizine/ dimenhydrinate combination or betahistine. The decreases in SM in the groups differed by -0.084 points (baseline-adjusted means). The 95% CI for the between-group difference ( 0.247; 0.079) was entirely above the predefined non-inferiority margin of -0.5 (12.5% of VAS range).
Conclusions: The results confirm non-inferiority of a 12-week treatment with the fixed combination compared to betahistine in MD. The fixed cinnarizine/dimenhydrinate combination represents a highly efficient (and safe) treatment option for both the management of acute episodes and long-term treatment of MD.

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