Effects and safety profile of betahistine in patients in the Russian contingent of OSVaLD, an open-label observational study in vestibular vertigo

Figures & data

Table 1 Demographic features of the Russian efficacy/safety populations in the OSVaLD study

Characteristic	Efficacy/safety population (n=204)
Sex, n (%)
Male	55 (27.0)
Female	149 (73.0)
Age (years), (mean ± SD)	50.8±13.3
Age group (years), n (%)
18–29	13 (6.4)
30–39	24 (11.9)
40–49	57 (28.2)
50–59	54 (26.7)
60–69	41 (20.3)
70–79	12 (5.9)
80–89	1 (0.5)
Height (cm), (mean ± SD)	167±8.0
Weight (kg), (mean ± SD)	74.4±14.0
BMI (kg/m^2), (mean ± SD)	26.5±4.3
Qualifying diagnosis, n (%)
PVVUP	139 (68.1)
BPPV	36 (17.6)
Ménière’s disease	7 (3.4)
Multiple diagnoses	13 (6.4)
Other	9 (4.5)

Abbreviations: BMI, body mass index; PVVUP, peripheral vestibular vertigo of unknown pathophysiology; BPPV, benign paroxysmal positional vertigo; SD, standard deviation.

Figure 1 Changes from baseline in components of the DHI and in total DHI score in the Russian efficacy population of the OSVaLD study. Negative change values signify a reduced level of disability. P<0.0001 for all intradomain comparisons.

Abbreviation: DHI, Dizziness Handicap Inventory.

Figure 2 Changes from baseline in the domains of the SF-36v2 instrument in the Russian efficacy population of the OSVaLD study. Data shown are mean ± SD. Higher numbers signify a better level of functioning. P<0.0001 for all intradomain comparisons.

Abbreviations: SF-36v2, Medical Outcomes Study Short-Form 36, version 2; 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; SD, standard deviation.

Table 2 On-study trends in the PCS and MCS subscales of the SF-36v2^® in the Russian efficacy population of the OSVaLD study

SF-36v2 subscale	Baseline	End of study	Change (final – baseline)
PCS	41.8±7.1	50.4±7	8.7±7.4
PVVUP	42±6.5	50.3±6	8.3±6.6
BPPV	40.5±8.2	51.2±8.5	10.7±10.5
Ménière’s disease	44.5±5	53.9±4.4	9.4±3.7
MCS	33.1±11	48.3±8.7	15.2±12.1
PVVUP	32.3±10.4	48.1±8.5	15.8±12
BPPV	33.6±11	48.1±8.7	14.5±13
Ménière’s disease	41±13	52.1±8.7	11.1±9.4

Notes: Data shown are mean ± SD. Higher numbers signify better level of functioning. P<0.0001 for all comparisons of final versus baseline mean values.

Abbreviations: PVVUP, peripheral vestibular vertigo of unknown pathophysiology; BPPV, benign paroxysmal positional vertigo; SF-36v2, Medical Outcomes Study Short-Form 36, version 2; PCS, Physical Component Summary; MCS, Mental Component Summary; SD, standard deviation.

Table 3 Trends in HADS-A and HADS-D scores and distributions in the Russian efficacy population of the OSVaLD study (n=204)

HADS score	Baseline	End of study	Change (final – baseline)
HADS-Anxiety score	9.1±4	4.8±3.6	−4.3±4.3
HADS-Anxiety level (%)
Moderate	30.4	5.4
Severe	8.8	1.0
HADS-Depression score	8±4.3	3.7±3.6	−4.3±4.8
HADS-Depression level (%)
Moderate	20.1	5.9
Severe	8.3	0.5

Notes: Data shown are mean ± SD unless stated otherwise. Negative change values signify reduced level of disability. P<0.0001 for all comparisons of final versus baseline mean values.

Abbreviations: HADS-A, Hospital Anxiety and Depression Scale-Anxiety subscale; HADS-D, Hospital Anxiety and Depression Scale-Depression subscale; SD, standard deviation.

Figure 3 Patients’ impression of betahistine therapy in the Russian efficacy population of OSVaLD.