Effects and tolerability of betahistine in patients with vestibular vertigo: results from the Romanian contingent of the OSVaLD study

Abstract

Ovidiu Băjenaru,1 Adina Maria Roceanu,2 Silviu Albu,3 Viorel Zainea,4 Alexandru Pascu,4 Mădălina Gabriela Georgescu,4 Sebastian Cozma,5 Luigi Mărceanu,6 Dafin Fior Mureşanu7 1Department of Neurology, Carol Davila University of Medicine and Pharmacy, 2Department of Neurology, University Hospital, Bucharest, 3IInd Department of Otolaryngology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, 4Institute of Phono-Audiology and ENT Functional Surgery Prof Dr Dorin Hociota, Carol Davila University of Medicine and Pharmacy, Bucharest, 5ENT Department, University of Medicine and Pharmacy Grigore T Popa, Audiology and Vestibulogy Department, Rehabilitation Clinical Hospital, Iasi, 6Transilvania University, Faculty of Medicine, Department: Doctoral Program (PhD), Brasov, 7"RoNeuro" Institute for Neurological Research and Diagnostic Cluj-Napoca, University of Medicine and Pharmacy "Iuliu Haţieganu", Department of Clinical Neurosciences, Cluj-Napoca, Romania Background and 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). Conclusion: 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. Keywords: betahistine, vertigo, dizziness, anxiety, depression, Romania