Effectiveness of betahistine (48 mg/day) in patients with vestibular vertigo during routine practice: The VIRTUOSO study

Abstract

BackgroundVestibular vertigo is associated with substantially reduced quality of life. Betahistine is effective in improving vertigo-associated symptoms, with longer treatment periods leading to greater improvements; however, it is not known whether these effects persist after treatment cessation.MethodsVIRTUOSO was a prospective, multinational, non-comparative, post-marketing observational programme investigating the effectiveness of betahistine (48 mg/day) and the course of vertigo after the discontinuation of treatment. Patients with vestibular vertigo who were prescribed 48 mg/day betahistine were enrolled in Russia and Ukraine. Treatment duration was up to 2 months, and patients were followed up for 2 months after discontinuation of betahistine. Efficacy endpoints included clinical response (assessed by change in vertigo severity), monthly attack frequency, and physician and patient grading of overall clinical response and improvement of vertigo-associated symptoms.ResultsOverall, 309 patients were enrolled and 305 completed the study. Clinical response was rated as good, very good or excellent in 74.1% of patients at end of treatment, with vertigo severity significantly decreased from baseline (p < 0.001). Monthly vertigo attack frequency decreased significantly during the 2 months of treatment (p < 0.001 from baseline) and further decreased during the 2-month follow-up (p < 0.001 from end of treatment). Overall, clinical response was graded as good or excellent by 94.4% of physicians and 95.4% of patients. Clinical improvement was considered either good or excellent by 82.6–90.5% of physicians and patients for nausea, vomiting and faintness. Only one adverse event was reported, with no serious adverse events.ConclusionOur findings suggest that betahistine (48 mg/day) therapy is effective in treating vertigo in routine clinical settings. The observed effects persisted for 2 months after treatment cessation, suggesting that betahistine may facilitate lasting vestibular compensation.

Betahistine in the Treatment of Peripheral Vestibular Vertigo: Results of a Real-Life Study in Primary Care

“…It is worth noting that although not all patients achieved complete improvement, the average improvement at the end of the follow-up was 89 points on a scale of 0 to 100. These results in addition to supplementing the clinical effectiveness data published in some previously cited studies [12][13][14] are consistent with what was reported in a multicenter observational study published in 2017, conducted in Russia and Ukraine by Parfenov et al, 11 in which 305 patients were included of which 74% achieved a clinical response considered good, very good, or excellent. The findings documented in previous research, as well as those described by us in the present work, can be explained by the mechanism of action of betahistine, which includes among others a histaminergic vasodilator effect of the cerebral and inner ear microcirculation as well as by its action at the level of the central histaminergic system, which improves the process of vestibular compensation and reduces the spontaneous activity of peripheral vestibular receptors.…”

“…For the sample size calculation, the formula proposed by Lemeshow et al was used to estimate a proportion, including the desired precision. 10 Based on the results of the study carried out by Parfenov et al, 11 we assume a 90% expected clinical effect for betahistine, with a level of accuracy of 5% and a type I error of 5%, plus a 10% adjustment for potential losses, we obtained a final sample size of 150 patients.…”

Effectiveness of the Epleys Maneuver for Treatment of Benign Paroxysmal Positional Vertigo

“…In the present study, we found that up to 24 (85.71%) of patients got benefit after the first follow-up visit of one week. In a study from Turkey, they found 86.2% of patients were improved after a single session with Epley maneuver 22 . In a study done by Parfenov week.…”

Vestibular vertigo treatment in a polymorbid patient

“…О Б З О Р Ы Исследование VIRTUOSO продемонстрировало эф-фективность бетагистина в дозе 48 мг/сут для лечения вес-тибулярного головокружения в амбулаторной практике [24]. Примерно в 4% случаев при обследовании пациента не удается установить причину головокружения.…”