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

Figures & data

Table 1 Demographic features of the Romanian efficacy and safety subpopulations of the OSVaLD study

	Efficacy population (n=245)	Safety population (n=259)
Sex, n (%)
Male	87 (35)	93 (36)
Female	158 (65)	166 (64)
Age (years) (mean ± SD)	54.6±14.9	54.4±15.1
Age class (years), n (%)
18–29	11 (4.7)	13 (5.2)
30–39	30 (12.8)	33 (13.3)
40–49	42 (17.9)	44 (17.7)
50–59	66 (28.2)	68 (27.4)
60–69	46 (19.7)	49 (19.8)
70–79	28 (12)	30 (12.1)
80–89	9 (3.8)	9 (3.6)
≥90	2 (0.9)	2 (0.8)
Height (cm) (mean ± SD)	166±8	167±8
Weight (kg) (mean ± SD)	72.1±12.4	72±12.6
BMI (kg/m^2) (mean ± SD)	26±4.2	25.9±4.2

Abbreviations: BMI, body mass index; SD, standard deviation; 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.

Figure 1 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.

Figure 2 Mean changes in elements of the DHI score in patients with diagnoses of Ménière’s disease, BPPV and PVVP. Total change (improvement) in DHI score is shown at the bottom of each column.

Abbreviations: BPPV, benign paroxysmal positional vertigo; DHI, Dizziness Handicap Index; PVVP, peripheral vestibular vertigo of unknown pathophysiology.

Table 2 Trends in HADS-anxiety and HADS-depression scores and distributions in the Romanian efficacy population of the OSVaLD study

	Baseline	Final visit	Change (final – baseline)
HADS-anxiety score	11±4.4	6.2±3.4	−3.9±4.8
HADS-anxiety level (%)
Moderate	28.6	8.3
Severe	25.3	0.9
HADS-depression score	8±4.6	4.2±3.3	−3.5±4.9
HADS-depression level (%)
Moderate	16.7	4.3
Severe	9.8	0

Notes: Unless indicated otherwise data are shown as the mean ± SD. Negatively change values signify a reduced level of disability.

Abbreviations: SD, standard deviation; HADS, Hospital Anxiety and Depression Scale; 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.

Figure 3 Changes from baseline in the domains of the SF-36v2 instrument in the Romanian efficacy population of the OSVaLD study (n=245).

Notes: Data are shown as the mean ± SD. Higher numbers signify a better level of functioning. P<0.0001 for all intradomain comparisons.
Abbreviations: PF, physical functioning; RP, role limitation physical; BP, bodily pain; GH, general health perception; VT, vitality; SF, social functioning; RE, role limitation emotional; MH, mental health; 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; SD, standard deviation; SF-36v2, Medical Outcome Study Short-Form 36.

Table 3 On-study trends in the PCS and MCS subscales of the SF-36v2 in the Romanian efficacy population of the OSVaLD study

	Baseline	Final visit	Change (final – baseline)
PCS	40.2±7.9	49.4±7.4	9±7.4
PVVP	39.8±7.8	49±8.4	8.3±8.1
BPPV	41.5±6.8	49.6±6.3	7.9±6.2
Ménière’s disease	42±8.3	51.3±6.3	9.5±7.2
MCS	35±11	47.6±8	12.6±10.5
PVVP	34.8±11.4	48.7±6.9	13.1±10.3
BPPV	33.6±10.8	47.7±7.6	13.4±12
Ménière’s disease	36±11.1	48.1±9.1	12.8±10.6

Notes: Data are shown as the mean ± SD. Higher numbers signify a better level of functioning.

Abbreviations: PCS, Physical Component Summary; PVVP, peripheral vestibular vertigo of unknown pathophysiology; BPPV, benign paroxysmal positional vertigo; MCS, Mental Component Summary; SF-36v2, Medical Outcome Study Short-Form 36; OSVaLD, a three-month 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; SD, standard deviation.

Figure 4 Patients’ impression of betahistine therapy in the Romanian efficacy population of OSVaLD (n=245).

Abbreviations: 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.