Effects and safety profile of betahistine in patients in the Russian contingent of OSVaLD, an open-label observational study in vestibular vertigo

Abstract

Background

We report here data from the >200 patients recruited in Russia to take part in OSVaLD, a 12-week, open-label, post-marketing surveillance study of the response to betahistine 48 mg/day in vertigo of peripheral vestibular origin carried out in a total of 13 countries.

Methods

The primary efficacy endpoint was change in the Dizziness Handicap Inventory (DHI; 100-point scale). Changes in Hospital Anxiety and Depression Scale (HADS) and Medical Outcomes Study Short-Form 36, version 2 (SF-36v2^®) scores were a priori secondary Outcomes.

Results

Total DHI score improved by 43 points during betahistine treatment. This aggregate improvement was equally distributed across the three domains of the DHI (physical, emotional, and functional; P<0.0001 for main and subscore changes from baseline). Statistically significant improvements versus baseline were also observed in mean HADS scores for anxiety and depression (both P<0.0001), and in the Physical Component Summary and Mental Component Summary scores of the SF-36v2 (both P<0.0001 versus baseline). Only one suspected adverse drug reaction was recorded in the Russian safety population (n=204), indicating that betahistine was well tolerated in those patients.

Conclusion

Betahistine 48 mg/day was associated with clear improvements in well-configured and widely validated measures of health-related quality of life and an encouraging tolerability profile in patients in Russia who took part in OSVaLD.

Keywords:

• betahistine
• vertigo
• dizziness
• anxiety
• depression
• quality of life
• Russia

Acknowledgments

The authors wish to thank the physicians and patients who participated in the OSVaLD survey. A full listing of the investigators from 34 centers in Russia contributing data to this report appears here: Alekseeva N (Moscow), Artemova I (Moscow), Batysheva T (Moscow), Bobyreva S (Moscow), Boyko A (Moscow), Buldakova N (Moscow), Ganzhula P (Moscow), Gaponova O (Moscow), Hanevich T (Moscow), Hozova A (Moscow), Isachenkova O (Moscow), Ismailov A (Moscow), Zhuravleva E (Moscow), Kostenko E (Moscow), Lilenko S (St Petersburg), Lisenker L (Moscow), Makarova G (Moscow), Manevich T (Moscow), Matsnev E (Moscow), Melnikov O (Moscow), Morozova S (Moscow), Nesterova O (Moscow), Nikulina I (Moscow), Otcheskaya O (Moscow), Pivovarova V (Moscow), Rotor L (Moscow), Rylskiy A (Moscow), Shalabanova I (Moscow), Shinkarev S (Moscow), Sorokoumov V (St Petersburg), Vdovichenko T (Moscow), Vinetskiy Y (Moscow), Vostricova I (Moscow), Zadorozhnaya T (Moscow). Preparation of this report was assisted by Hughes associates, Oxford, UK.

Author contributions

All the named authors made substantial contributions to the acquisition of data, and to its analysis and interpretation. They also contributed to drafting the article and/or revising it critically for important intellectual content. All named authors provided final approval of the version to be published and were accountable for ensuring that questions related to the accuracy or integrity of any part of the work were appropriately investigated and resolved.

Disclosure

OSVaLD is supported financially by Abbott Products Operations AG, Allschwil, Switzerland. The authors report no conflicts of interest in this work.