Efficacy of Betahistine by Patient-Reported Outcomes and its Tolerability Profile in Indian Patients with Vestibular Vertigo.

ABSTRACT

OBJECTIVE: Patients with vestibular vertigo suffer from disabling symptoms which affect their quality of life. This article presents the efficacy and safety profile of betahistine hydrochloride in Indian patients suffering from vestibular vertigo (OSVaLD study). METHODS: Study included patients suffering from vertigo, who were prescribed betahistine (48 mg/day) according to local label. Safety and efficacy populations of this study included 80 and 75 subjects respectively. The study included three visits an initial baseline visit, and two follow-up visits (one month and three months [final visit] post-commencement of betahistine therapy). Efficacy was assessed by administering three patient-reported outcomes (PROs) namely, Dizziness Handicap Inventory (DHI), Hospital Anxiety and Depression Scale (HADS), and Medical Outcome Study Short Form-36 version2 (SF-36®v2). Safety assessment was made by reports of Suspected Adverse Drug Reactions (SADRs) which began during the study. RESULTS: Mean changes in total DHI score for Indian efficacy population at follow-up and final visits were 31 and 44 points respectively. These changes indicated significant improvements in self-perceived impairment associated with vertigo. Similar improvements in quality of life were observed by HADS subscales (HADS-A and HADS-D) and SF-36®v2 summary scores (PCS [physical component summary] and MCS [mental component summary]). There was only one report of SADR in this study in a female subject receiving betahistine 16 mg t.i.d. This SADR was gastritis of mild severity and was probably not related to betahistine. CONCLUSIONS: A significant number of vestibular vertigo patients reported fair degree of spontaneous recovery. Betahistine treatment improved quality of life, was safe and well-tolerated by Indian patients suffering from vertigo.