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

Authors

Dr. med. Miroslav Novotny (, Czech Republic)
PhD Irene Bognar-Steinberg (, Germany)
PhD Wolfgang Baumann (, Germany)

Proceedings

ASN - Volume 6 - 2011

Topics

Neurootology
Neurootologic therapy
Neurootology
Neurootology
Neurootologic therapy
Pharmacotherapy

Keywords

Betahistine, Cinnarizine, Dimenhydrinate, Ménière’s disease, Vertigo.

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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.