title: Effects and tolerability of betahistine in patients with vestibular vertigo: results from the Romanian contingent of the OSVaLD study.
abstract: METHODS
  An efficacy population of 245 patients with vertigo of peripheral vestibular origin was recruited in Romania as part of a 3-month multinational, post-marketing surveillance study of open-label betahistine 48 mg/day (OSVaLD). Endpoints were changes in the Dizziness Handicap Index (primary endpoint), Medical Outcome Study Short-Form 36 (SF-36v2(®)), and the Hospital Anxiety and Depression Scale.
  
  
  RESULTS
  During treatment, the total Dizziness Handicap Index score improved by 41 points (on a 100-point scale). Statistically significant improvements of 12-14 points were recorded in all three domains of the Dizziness Handicap Index scale (P<0.0001). Betahistine therapy was also accompanied by progressive improvements in mean Hospital Anxiety and Depression anxiety and depression scores (P<0.0001) and significant improvements in both the physical and mental component summary of the SF-36v2 (P<0.0001). Betahistine was well tolerated, with only one suspected adverse drug reaction recorded in the Romanian safety population (n=259).
  
  
  CONCLUSIONS
  Betahistine 48 mg/day was associated with improvements in multiple measures of health-related quality of life and had a good tolerability profile in these Romanian patients with recurrent peripheral vestibular vertigo.
authors.affiliation: Department of Neurology, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
authors.forename: Ovidiu
authors.initials: O
authors.lastname: Băjenaru
authors.affiliation: Department of Neurology, University Hospital, Bucharest, Romania.
authors.forename: Adina Maria
authors.initials: AM
authors.lastname: Roceanu
authors.affiliation: IInd Department of Otolaryngology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
authors.forename: Silviu
authors.initials: S
authors.lastname: Albu
authors.affiliation: Institute of Phono-Audiology and ENT Functional Surgery Prof Dr Dorin Hociota, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
authors.forename: Viorel
authors.initials: V
authors.lastname: Zainea
authors.affiliation: Institute of Phono-Audiology and ENT Functional Surgery Prof Dr Dorin Hociota, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
authors.forename: Alexandru
authors.initials: A
authors.lastname: Pascu
authors.affiliation: Institute of Phono-Audiology and ENT Functional Surgery Prof Dr Dorin Hociota, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
authors.forename: Mădălina Gabriela
authors.initials: MG
authors.lastname: Georgescu
authors.affiliation: ENT Department, University of Medicine and Pharmacy Grigore T Popa, Audiology and Vestibulogy Department, Rehabilitation Clinical Hospital, Iasi, Romania.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Cozma
authors.affiliation: Transilvania University, Faculty of Medicine, Department: Doctoral Program (PhD), Brasov, Romania.
authors.forename: Luigi
authors.initials: L
authors.lastname: Mărceanu
authors.affiliation: "RoNeuro" Institute for Neurological Research and Diagnostic Cluj-Napoca, University of Medicine and Pharmacy "Iuliu Haţieganu", Department of Clinical Neurosciences, Cluj-Napoca, Romania.
authors.forename: Dafin Fior
authors.initials: DF
authors.lastname: Mureşanu
keywords: Romania; anxiety; betahistine; depression; dizziness; vertigo