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

Abstract

Background and methods: An effcacy population of 2 45 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 4 1 points (on a 100-point scale). Statistically signifcant 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 signifcant 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 profle in these Romanian patients with recurrent peripheral vestibular vertigo.