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

Băjenaru O, Roceanu AM, Albu S, Zainea V, Pascu A, Georgescu MG, Cozma S, Mărceanu L, Mureşanu DF - Int J Gen Med (2014)

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurology, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.

ABSTRACT

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.

No MeSH data available.


Related in: MedlinePlus

Changes from baseline in components of the DHI and in total DHI score in the Romanian efficacy population of the OSVaLD study.Notes: Negative change values signify reduced level of disability. P<0.0001 for all intradomain comparisons.Abbreviations: DHI, Dizziness Handicap Index; OSVaLD, Observational Study in patients suffering from recurrent peripheral vestibular Vertigo to Assess the effect of betahistine 48 mg/day on quality of Life and Dizziness symptoms.
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f1-ijgm-7-531: Changes from baseline in components of the DHI and in total DHI score in the Romanian efficacy population of the OSVaLD study.Notes: Negative change values signify reduced level of disability. P<0.0001 for all intradomain comparisons.Abbreviations: DHI, Dizziness Handicap Index; OSVaLD, Observational Study in patients suffering from recurrent peripheral vestibular Vertigo to Assess the effect of betahistine 48 mg/day on quality of Life and Dizziness symptoms.

Mentions: Net changes in the total DHI score and the three dimensions of that score are illustrated in Figure 1. All those indices changed significantly from baseline (P<0.0001). Changes in all elements of the DHI score were similar among the three major diagnostic categories of PVVP, BPPV, and Ménière’s disease, as shown in Figure 2. DHI responses were similar in both sexes. DHI responses were slightly larger in patients (n=168) prescribed betahistine monotherapy than in those (n=77) prescribed combination therapy, but these differences were small. In both these categories, the reductions in overall and dimension-specific DHI scores from baseline were highly statistically significant (P<0.0001).


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

Băjenaru O, Roceanu AM, Albu S, Zainea V, Pascu A, Georgescu MG, Cozma S, Mărceanu L, Mureşanu DF - Int J Gen Med (2014)

Changes from baseline in components of the DHI and in total DHI score in the Romanian efficacy population of the OSVaLD study.Notes: Negative change values signify reduced level of disability. P<0.0001 for all intradomain comparisons.Abbreviations: DHI, Dizziness Handicap Index; OSVaLD, Observational Study in patients suffering from recurrent peripheral vestibular Vertigo to Assess the effect of betahistine 48 mg/day on quality of Life and Dizziness symptoms.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4260659&req=5

f1-ijgm-7-531: Changes from baseline in components of the DHI and in total DHI score in the Romanian efficacy population of the OSVaLD study.Notes: Negative change values signify reduced level of disability. P<0.0001 for all intradomain comparisons.Abbreviations: DHI, Dizziness Handicap Index; OSVaLD, Observational Study in patients suffering from recurrent peripheral vestibular Vertigo to Assess the effect of betahistine 48 mg/day on quality of Life and Dizziness symptoms.
Mentions: Net changes in the total DHI score and the three dimensions of that score are illustrated in Figure 1. All those indices changed significantly from baseline (P<0.0001). Changes in all elements of the DHI score were similar among the three major diagnostic categories of PVVP, BPPV, and Ménière’s disease, as shown in Figure 2. DHI responses were similar in both sexes. DHI responses were slightly larger in patients (n=168) prescribed betahistine monotherapy than in those (n=77) prescribed combination therapy, but these differences were small. In both these categories, the reductions in overall and dimension-specific DHI scores from baseline were highly statistically significant (P<0.0001).

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurology, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.

ABSTRACT

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.

No MeSH data available.


Related in: MedlinePlus