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Cinnarizine in refractory migraine prophylaxis: Efficacy and tolerability. A comparison with sodium valproate

Mansoureh, T. and Rahmat Jirde, M. and Nilavari, K. and Ashrafian, H. and Razeghi, S. and Kohan, L. (2008) Cinnarizine in refractory migraine prophylaxis: Efficacy and tolerability. A comparison with sodium valproate. Journal of Headache and Pain, 9 (2). pp. 77-82. ISSN 11292369 (ISSN)

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Abstract

This was a double-blind clinical trial designed to assess the efficacy and safety of the cinnarizine (CIN) in patients with migraine who were refractory to propranolol and tricyclic antidepressants in comparison with sodium valproate (SV) to investigate whether CIN could be at least as effective as SV. A total of 125 patients were treated in a treatment period of 12 weeks. All patients had at least one intake of trial medication and 2-week post baseline efficacy observation which all were included in the ITT analysis. Of the 125 subjects treated, 46 discontinued prematurely: 25 from the CIN and 21 from the SV group. The main reasons for premature discontinuation were: lost to follow up (25/ 46, 63.2%), insufficient response (16/46, 20%), and adverse events (5/ 46, 12.8%). No statistically significant inter-group differences in the number of discontinuation was observed (p > 0.05). In both groups, number of attacks, intensity, and duration of attacks significantly decreased (p < 0.05). No statistically significant inter-group differences were observed regarding the mean number of attacks, duration, and intensity of migraine attacks for any of the time intervals analysed, except for the mean reduction of third and fourth visits intensity from baseline which were significantly different in two groups (p < 0.05), with the CIN group showing more reduction. Analysis of the number of responders showed that in the CIN group 61.2% subjects were responders, and 63.8% in the SV group. No statistically significant differences between the treatment groups were found for any of the secondary parameters. Overall 26 subjects reported one or more adverse events during the study period: 13 subjects in each group. Five subjects discontinued prematurely due to adverse events; two in the CIN group with significant weight gain, and 3 in the SV group with significant weight gain and severe tremor. These results suggest that CIN is an effective and safe prophylactic agent even in severe migraine headache. © Springer-Verlag 2008.

Item Type: Article
Additional Information: Unmapped bibliographic data: LA - English [Field not mapped to EPrints] J2 - J. Headache Pain [Field not mapped to EPrints] C2 - 18286231 [Field not mapped to EPrints] AD - Department of Neurology, Medical Sciences/University of Tehran, Sina Hospital, Imam Khomeini St, 11367-46911 Tehran, Iran [Field not mapped to EPrints] AD - Department of Neurology, Gorgan University of Medical Sciences, Gorgan, Iran [Field not mapped to EPrints] DB - Scopus [Field not mapped to EPrints]
Uncontrolled Keywords: Cinnarizine, Migraine prophylaxis, Sodium valproate, cinnarizine, propranolol, tricyclic antidepressant agent, valproic acid, abdominal pain, adolescent, adult, article, clinical trial, controlled clinical trial, controlled study, disease duration, disease severity, double blind procedure, drug efficacy, drug response, drug safety, drug tolerability, drug treatment failure, drug withdrawal, female, follow up, hair loss, headache, human, major clinical study, male, migraine, nausea, priority journal, randomized controlled trial, side effect, somnolence, statistical significance, treatment duration, tremor, vertigo, vomiting, weight gain, Adolescent, Adult, Calcium Channel Blockers, Cinnarizine, Female, GABA Agents, Humans, Male, Middle Aged, Migraine Disorders, Treatment Outcome, Valproic Acid
Subjects: مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
موارد کلی
Divisions: معاونت تحقیقات و فناوری
Depositing User: GOUMS
Date Deposited: 19 Apr 2015 03:57
Last Modified: 25 Feb 2017 07:40
URI: http://eprints.goums.ac.ir/id/eprint/2342

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