Dataset Information

Effectiveness and safety of an extended-release tablet of sodium valproate for the prophylactic treatment of migraine: Postmarketing surveillance in Japan.

ABSTRACT:

Background

Sodium valproate is a standard drug for first-line prophylactic treatment of migraine. However, little information is available of its use in Japanese patients.

Aim

To evaluate the effectiveness and safety of an extended-release tablet of sodium valproate in the prophylactic treatment for Japanese patients with migraine by postmarketing surveillance.

Methods

This was a prospective, multicenter and non-interventional observation study in routine clinical practice. A total of 1222 patients with migraine of all age groups (aged <10 to ?80 years) and both sexes (17.3% men and 82.7% women) from 169 sites were enrolled.

Results

Migraine frequency during a 4-week period was reduced from 10.2 ± 6.0 days in 1040 patients to 5.0 ± 4.6 days in 944 patients (P < 0.001): 70.8% of patients experienced remission of migraine by ?30%, 59.0% by ?50% and 11.8% by ?100%. Multivariate analysis and stratification sampling showed that this sodium valproate tablet was the most effective in patients with more migraine days, and complete remission was observed in 29% of patients whose migraine days were less than 3 days per 4 weeks at baseline. The extended-release tablet of sodium valproate reduced migraine intensity and duration of migraine attacks. The incidence of adverse drug reactions was 6.3% (67/1070 patients) and well tolerated. However, four pregnancies were discovered in this survey.

Conclusions

This first large observation study in Japan suggests that an extended-release tablet of sodium valproate is effective and safe for the prophylactic treatment of patients with migraine in routine clinical practice.

SUBMITTER: Takeshima T

PROVIDER: S-EPMC5074326 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Publications

Effectiveness and safety of an extended-release tablet of sodium valproate for the prophylactic treatment of migraine: Postmarketing surveillance in Japan.

Takeshima Takao T Suzuki Norihiro N Matsumori Yasuhiko Y Shimmoto Naoki N Kurihara Yuji Y Gunji Ryoji R Sakai Fumihiko F

Neurology and clinical neuroscience 20160426 4

<h4>Background</h4>Sodium valproate is a standard drug for first-line prophylactic treatment of migraine. However, little information is available of its use in Japanese patients.<h4>Aim</h4>To evaluate the effectiveness and safety of an extended-release tablet of sodium valproate in the prophylactic treatment for Japanese patients with migraine by postmarketing surveillance.<h4>Methods</h4>This was a prospective, multicenter and non-interventional observation study in routine clinical practice. ...[more]

PMID: 27818772

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Dataset Information

Effectiveness and safety of an extended-release tablet of sodium valproate for the prophylactic treatment of migraine: Postmarketing surveillance in Japan.

Background

Aim

Methods

Results

Conclusions

Publications

Effectiveness and safety of an extended-release tablet of sodium valproate for the prophylactic treatment of migraine: Postmarketing surveillance in Japan.

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