title: 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.
  
  
  CONCLUSIONS
  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.
authors: Department of Ear, Nose, and Throat, State Budgetary Educational Institution of Higher Professional Training, IM Sechenov First Moscow State Medical University of the Ministry of Healthcare and Social Development of the Russian Federation, Moscow, Russian Federation.
authors: Svetlana Vyacheslavovna
authors: SV
authors: Morozova
authors: Federal State Budgetary Institution, Scientific Neurology Center of the Russian Academy of Medical Sciences, Moscow, Russian Federation.
authors: Natalia Stepanovna
authors: NS
authors: Alekseeva
authors: St Petersburg Research Institute of Ear, Throat, Nose and Speech, St Petersburg, Russian Federation.
authors: Sergey Vasilyevich
authors: SV
authors: Lilenko
authors: Department of Physiology and Pathology of Auditory and Vestibular Systems, Federal Scientific Center (FSC), Institute for Biomedical Problems, Russian Academy of Sciences (RAS), Moscow, Russian Federation.
authors: Eduard Ivanovich
authors: EI
authors: Matsnev
authors: ANO Guta Clinic, Moscow, Russian Federation.
authors: Oleg Anatol'evich
authors: OA
authors: Melnikov
keywords: Russia; anxiety; betahistine; depression; dizziness; quality of life; vertigo
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