Efficacy and acceptability of oxcarbazepine vs. carbamazepine with betahistine mesilate tablets in treating vestibular paroxysmia: a retrospective review

Chong, Yap Seng; Xiang, Wenping; Hou, Xue; He, Xin; Li, Xiue; Zhang, Jun; Geng, Shuang

doi:10.1080/00325481.2016.1173515

Cited by 10 publications

(13 citation statements)

References 15 publications

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“…In a randomized controlled clinical trial, OXA treatment reduced the number of days with at least one vertigo attack by one-third, and the average number of attacks almost to half the numbers under placebo. This is consistent with open-label studies and clinical experience with OXA and other sodium channel blockers in VP [ 1 , 14 ]. This is also consistent with the benefit to patients with other neurovascular compression syndromes, i.e., trigeminal neuralgia and hemifacial spasm, from CBZ or OXA.…”

Section: Discussionsupporting

confidence: 89%

“…In terms of treatment, in the initial studies, surgical decompression was recommended [ 12 , 13 ]. Nowadays, the treatment of choice for VP, as with the other cranial nerve NVCC syndromes, is the use of carbamazepine (CBZ) or OXA, also based on two retrospective studies [ 1 , 14 ]. Both showed a good effect of CBZ and oxcarbazepine (OXA) (for review see [ 15 ]).…”

Section: Introductionmentioning

confidence: 99%

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A randomized double-blind, placebo-controlled, cross-over trial (Vestparoxy) of the treatment of vestibular paroxysmia with oxcarbazepine

et al. 2017

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ObjectiveVestibular paroxysmia (VP) is characterized by short, often oligosymptomatic attacks of vertigo which occur spontaneously or are sometimes provoked by turning the head. Despite the description of the disease almost 40 years ago (first termed “disabling positional vertigo”), no controlled treatment trial has been published to date. The Vestparoxy trial was designed as a randomized, placebo-controlled, double-blind cross-over trial to examine the therapeutic effect of oxcarbazepine (OXA) in patients with definite or probable VP.MethodsPatients were recruited from August 2005 to December 2011 in the outpatient Dizziness Unit of the Department of Neurology of the Munich University Hospital, and randomized to receive OXA (first week: 300 mg once per day, second week: 300 mg b.i.d., third week: 300 mg t.i.d. until the end of the third month), followed by placebo or vice versa with a 1-month wash-out period in between. The primary endpoint was the number of days with one or more attacks. Secondary endpoints were the number of attacks during the observed days, and the median (for each day) duration of attacks. All these endpoints were assessed using standardized diaries collected at the end of each treatment phase.ResultsForty-three patients were randomized, 18 patients provided usable data (2525 patient days) for at least one treatment phase and were included in the main (intention-to-treat) analysis. The most common reasons for discontinuation documented were adverse events. The risk of experiencing a day with at least one attack was 0.41 under OXA, and 0.62 under placebo treatment, yielding a relative risk of 0.67 (95% CI 0.47–0.95, p = 0.025). The number of attacks during the observed days ratio was 0.53 (95% CI 0.42–0.68, p < 0.001) under OXA compared to placebo. Median attack duration was 4 s (Q25: 2 s, Q75: 120 s) under OXA, and 3 s (Q25: 2 s, Q75: 60 s) under placebo treatment. When days with no attacks, i.e., duration = 0, were included in the analysis, these figures changed to 0 (Q25: 0, Q75: 3 s), and 2 (Q25: 0, Q75: 6 s). No serious adverse events or new safety findings were identified during the trial.ConclusionsThe Vestparoxy trial showed a significant reduction of VP attacks under OXA compared to placebo treatment, confirming the known and revealing no new side effects.

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Section: Discussionsupporting

confidence: 89%

Section: Introductionmentioning

confidence: 99%

A randomized double-blind, placebo-controlled, cross-over trial (Vestparoxy) of the treatment of vestibular paroxysmia with oxcarbazepine

et al. 2017

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“…Our retrospective review found that the response rates in both the CBZ+BMT group and the OXC+BMT group were higher compared to the CBZ-alone group, which indicated that BMT could provide effective augmentation for CBZ and OXC in treating VP. 13 In our previous study, we also found that CBZ+BMT and OXC+BMT had similar efficacy and acceptability. 13 But this finding needs to be assessed in further research, for the following two reasons: 1) our previous study was not a randomized controlled trial; and 2) the doses of CBZ, OXC, and BMT are different in different patients.…”

Section: Introductionmentioning

confidence: 73%

“… 13 In our previous study, we also found that CBZ+BMT and OXC+BMT had similar efficacy and acceptability. 13 But this finding needs to be assessed in further research, for the following two reasons: 1) our previous study was not a randomized controlled trial; and 2) the doses of CBZ, OXC, and BMT are different in different patients. Therefore, this randomized controlled trial was conducted to evaluate whether CBZ+BMT and OXC+BMT had similar efficacy and acceptability in treating VP, and to investigate whether the synergistic effect could be increased along with the increased dose of BMT.…”

Section: Introductionmentioning

confidence: 73%

Randomized trial of betahistine mesilate tablets as augmentation for oxcarbazepine and carbamazepine in treating vestibular paroxysmia

Xue

Xiang

et al. 2018

DDDT

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BackgroundVestibular paroxysmia (VP) is a rare episodic peripheral vestibular disorder. This study was conducted to compare the efficacy and acceptability of carbamazepine (CBZ) plus betahistine mesilate tablets (BMT) (CBZ+BMT) and oxcarbazepine (OXC) plus BMT (OXC+BMT) in treating VP, and investigated whether the synergistic effect could be increased along with the increased dose of BMT.MethodsVP patients were recruited and randomly assigned to receive CBZ+BMT or OXC+BMT. The doses of CBZ and OXC were set to 200 and 300 mg/time, twice daily, respectively. The doses of BMT were set to 12 and 18 mg/time, twice daily. Half of the patients in each group received BMT 12 mg/time and the other half received BMT 18 mg/time. The treatment was continued for 12 weeks. The vertigo frequency, vertigo score, vertigo duration, response rate, and drug-related side effects were analyzed.ResultsIn total, 92 patients in the CBZ+BMT group and 93 patients in the OXC+BMT group completed this trial. After 12 weeks of treatment, the two groups had similar average vertigo frequency, average vertigo score, average vertigo duration, and response rate. But the incidence of side effects was significantly higher in the CBZ+BMT group than in the OXC+BMT group (p=0.04). Subgroup analysis found that patients receiving BMT (18 mg) had greater reductions in average vertigo frequency, average vertigo duration, and average vertigo score, and higher response rates than patients receiving BMT (12 mg).ConclusionThese results demonstrated that OXC+BMT may be suitable as an alternative method in VP patients with CBZ hypersensitivity, and the synergistic effect could be increased along with the increased dose of BMT.

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“…Yi et al, compared carbamazepine, carbamazepine plus betahistine mesilate and oxcarbazepine plus betahistine mesilate in treating vestibular paroxysmia in a retrospective review. 39 After 12 weeks' treatment, the carbamazepine plus betahistine mesilate group had a greater reduction in the frequency of vertigo, vertigo duration and vertigo score than the other two groups. The oxcarbazepine plus betahistine group also did better than betahistine alone group.…”

Section: Betahistine Mesilatementioning

confidence: 84%

Betahistine dihydrochloride or betahistine mesilate: two sides of the same coin or two different coins

Hazra

Maroo

2017

Int J Basic Clin Pharmacol

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The antivertigo drug betahistine exerts a histamine modulatory action in the vestibular system and the brain. It is marketed both as the dihydrochloride and the mesilate salt in India. We conducted a published literature based systematic review to ascertain differences, in any, between the salt and ester forms of the drug. Search of the Medline database was supplemented by searching through references in full text papers and retrieving summary of product characteristic literature. Although the weight of published evidence is greater for betahistine dihydrochloride, in the absence of head-to-head studies comparing the efficacy of the two formulations in Ménière's disease and other vertigo disorders of vestibular origin, it is not possible to conclude that there are definite differences in this regard. However, potentially relevant differences exist to suggest that the two forms are not interchangeable for the treatment of vestibular dysfunction. Molecular weight comparison indicates that the pill burden would be higher for betahistine mesilate for delivering equivalent doses. There could be ethnically influenced differences in pharmacokinetic behavior. There are concerns of potential long-term DNA toxicity due to mesilate ester contaminants during production of betahistine mesilate, which is not there for the hydrochloride form. Detailed post-marketing surveillance data exists only for the dihydrochloride salt. Otorhinolaryngologists and other physicians seeking to optimize treatment with betahistine should be aware of these differences.

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Efficacy and acceptability of oxcarbazepine vs. carbamazepine with betahistine mesilate tablets in treating vestibular paroxysmia: a retrospective review

Abstract: These results indicated that using BMT as an augmentation for CBZ or OXC might be a good choice in treating VP.

Cited by 10 publications

References 15 publications

A randomized double-blind, placebo-controlled, cross-over trial (Vestparoxy) of the treatment of vestibular paroxysmia with oxcarbazepine

A randomized double-blind, placebo-controlled, cross-over trial (Vestparoxy) of the treatment of vestibular paroxysmia with oxcarbazepine

Randomized trial of betahistine mesilate tablets as augmentation for oxcarbazepine and carbamazepine in treating vestibular paroxysmia

Betahistine dihydrochloride or betahistine mesilate: two sides of the same coin or two different coins

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