A Fixed Combination of Cinnarizine/Dimenhydrinate for the Treatment of Patients with Acute Vertigo Due to Vestibular Disorders

Hahn, Aleš; Sejna, I; Stefflova, Bohdana; Schwarz, Mario; Baumann, Wolfgang

doi:10.2165/00044011-200828020-00003

Cited by 29 publications

(15 citation statements)

References 15 publications

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“…The findings of the present study are largely in line with results from previously conducted randomized, double-blind controlled clinical trials, where the fixed-combination preparation has been shown to be significantly more effective than betahistine (dimesylate) in patients with otogenic vertigo [21], vertigo due to vertebrobasilar insufficiency [23], acute vestibular disorders [24], or vestibular neuritis [26], and non-inferior in patients with Menière’s disease [27, 28], respectively.…”

Section: Discussionsupporting

confidence: 88%

Efficacy and Safety of a Fixed Combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg vs Betahistine Dihydrochloride 16 mg in Patients with Peripheral Vestibular Vertigo: A Prospective, Multinational, Multicenter, Double-Blind, Randomized, Non-inferiority Clinical Trial

Scholtz

Hahn

Stefflova³

et al. 2019

Clin Drug Investig

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Background and ObjectiveVertigo derived from peripheral vestibular disorders is quite frequently encountered in daily clinical practice and can be a severely disabling symptom associated with substantial impairment of health-related quality of life for the affected patients. Betahistine, a structural analogue of histamine and presumably the most widely prescribed anti-vertigo drug worldwide, has previously been shown to be an effective and safe treatment for these patients. The objective of the present study was to evaluate whether the fixed combination of cinnarizine and dimenhydrinate (Arlevert®) is non-inferior and thus a potentially useful alternative to betahistine dihydrochloride in the treatment of patients suffering from peripheral vestibular vertigo.MethodsIn this prospective, multicenter, double-blind, randomized, non-inferiority clinical trial, outpatients from 8 ENT clinics in Austria, Bulgaria, the Czech Republic and Russia were randomly assigned to receive three times daily one tablet of either the fixed combination cinnarizine 20 mg/dimenhydrinate 40 mg or betahistine dihydrochloride 16 mg for 4 weeks. Primary endpoint was the reduction of the mean vertigo score (MVS), a validated 12-item composite score defined as the mean of 6 vertigo symptoms (dystasia and walking unsteadiness, staggering, rotary sensation, tendency to fall, lift sensation, blackout) and 6 trigger factors for vertigo (change of position, bowing, getting up, driving by car/train, head movements, eye movement), after 4 weeks of therapy, as judged by the patient on a 5-point visual analogue scale (VAS). The non-inferiority margin was set to 0.3. Secondary outcomes included the patient’s and investigator’s judgment of global efficacy, the patient’s rating of impairment of daily activities, and safety/tolerability of the treatments.ResultsThree hundred and six patients (mean age 53.5 years, approximately 60% female) were enrolled and randomized to the fixed combination cinnarizine/dimenhydrinate (n = 152) or betahistine (n = 154) groups; 297 patients completed the study and 294 (146 and 148, respectively) were valid for the per-protocol analysis, which was used for the non-inferiority analysis. Treatment with cinnarizine/dimenhydrinate led to a stronger reduction of the MVS [least squares mean (LSM)] after 4-week therapy (primary endpoint) in comparison to betahistine (0.395 vs 0.488; difference: − 0.093, 95% CI − 0.180; − 0.007, p = 0.035); since the upper limit of the two-sided 95% confidence interval was not only below the non-inferiority margin of 0.3, but also entirely below 0, superiority of the fixed combination could be demonstrated. The combination preparation was also more effective after 1 week of therapy and received more favorable patient’s ratings on overall efficacy and impairment of daily activities. Both treatments were very well tolerated. Only 12 patients (3.92%) reported 13 non-serious adverse events; 2 cinnarizine/dimenhydrinate-treated patients discontinued the study prematurely due to adverse events as compared ...

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Section: Discussionsupporting

confidence: 88%

Efficacy and Safety of a Fixed Combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg vs Betahistine Dihydrochloride 16 mg in Patients with Peripheral Vestibular Vertigo: A Prospective, Multinational, Multicenter, Double-Blind, Randomized, Non-inferiority Clinical Trial

Scholtz

Hahn

Stefflova³

et al. 2019

Clin Drug Investig

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“…There is insufficient evidence demonstrating the relative efficacy of any given class over another. 205-207…”

Section: Guideline Key Action Statementsmentioning

confidence: 99%

Clinical Practice Guideline: Ménière’s Disease

Basura

Adams

Monfared

et al. 2020

Otolaryngol.--head neck surg.

215

207

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Objective Ménière’s disease (MD) is a clinical condition defined by spontaneous vertigo attacks (each lasting 20 minutes to 12 hours) with documented low- to midfrequency sensorineural hearing loss in the affected ear before, during, or after one of the episodes of vertigo. It also presents with fluctuating aural symptoms (hearing loss, tinnitus, or ear fullness) in the affected ear. The underlying etiology of MD is not completely clear, yet it has been associated with inner ear fluid (endolymph) volume increases, culminating in episodic ear symptoms (vertigo, fluctuating hearing loss, tinnitus, and aural fullness). Physical examination findings are often unremarkable, and audiometric testing may or may not show low- to midfrequency sensorineural hearing loss. Conventional imaging, if performed, is also typically normal. The goals of MD treatment are to prevent or reduce vertigo severity and frequency; relieve or prevent hearing loss, tinnitus, and aural fullness; and improve quality of life. Treatment approaches to MD are many and typically include modifications of lifestyle factors (eg, diet) and medical, surgical, or a combination of therapies. Purpose The primary purpose of this clinical practice guideline is to improve the quality of the diagnostic workup and treatment outcomes of MD. To achieve this purpose, the goals of this guideline are to use the best available published scientific and/or clinical evidence to enhance diagnostic accuracy and appropriate therapeutic interventions (medical and surgical) while reducing unindicated diagnostic testing and/or imaging.

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“…For instance, there is a study in which one Group of patients was given low-dose betahistine (12 mg) and the other Group was given a combination of cinnarizine (20 mg) and dimenhydrinate (40 mg) three times a day. The patients were assessed clinically [25,26] and the combination of dimenhydrinate and cinnarizine, compared to betahistine, provided better control of acute vertigo treatment and vegetative symptoms. Dimenhydrinate and cinnarizine, which is a vestibulosuppressant combination, had better control of episodes of vertigo in this study.…”

Section: Groupmentioning

confidence: 99%

The Effects of Betahistine and Dimenhydrinate on Caloric Test Parameters; Slow-Phase Velocity of Nystagmus

Kıroğlu¹,

Dagkiran²,

Özdemir³

et al. 2014

Int Adv Otol

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OBJECTIVE:The aim of this study is to determine the effects of betahistine and dimenhydrinate on the slow phase velocity. MATERIALS and METHODS:Forty patients with complaints of vertigo and dizziness volunteered to be included in the study. All patients who were included the study were treated at the other medical centers. The patients were divided into two Groups. Patients in the first Group were given betahistine 24 mg three times per day. During this treatment, caloric testing was performed, and the dose was increased to 48 mg three times a day due to ongoing complaints. The test was then repeated four weeks after using this higher dosage. Patients in the second Group had caloric testing while using and four weeks after stopping dimenhydrinate. RESULTS:The study Group was comprised of 40 patients; 20 patients (13 female, 7 male, 18-68 years, median age 46) in the betahistine Group and 20 patients (14 female, 6 male, 24-74 years, median age 44.5) in the dimenhydrinate Group. The average slow phase maximum velocity in the first Group of patients was 18 -/+ 8.2 and 21.1 -/+ 10.8 deg/s at 24 mg betahistine three times a day and 48 mg three times a day, respectively. In the second Group of patients, the average slow phase velocity was 13.4 -/+ 5.1 and 18.2 -/+ 7.5 deg/s during and after stopping the treatment of dimenhydrinate, respectively. The caloric test-induced slow-phase velocity was decreased with dimenhydrinate and increased with the higher dosage of betahistine. CONCLUSION:To our knowledge, this is the first study to demonstrate that betahistine increases caloric-induced slow-phase velocity in humans. Dimenhydrinate and betahistine should not be used together because of their opposite effects on the vestibular system. Dimenhydrinate can be used to treat acute episodes of vertigo, whereas betahistine should not be used during the episode but may be used in the period between the attacks to stimulate the vestibular system.

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A Fixed Combination of Cinnarizine/Dimenhydrinate for the Treatment of Patients with Acute Vertigo Due to Vestibular Disorders

Cited by 29 publications

References 15 publications

Efficacy and Safety of a Fixed Combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg vs Betahistine Dihydrochloride 16 mg in Patients with Peripheral Vestibular Vertigo: A Prospective, Multinational, Multicenter, Double-Blind, Randomized, Non-inferiority Clinical Trial

Efficacy and Safety of a Fixed Combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg vs Betahistine Dihydrochloride 16 mg in Patients with Peripheral Vestibular Vertigo: A Prospective, Multinational, Multicenter, Double-Blind, Randomized, Non-inferiority Clinical Trial

Clinical Practice Guideline: Ménière’s Disease

The Effects of Betahistine and Dimenhydrinate on Caloric Test Parameters; Slow-Phase Velocity of Nystagmus

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