首页> 美国卫生研究院文献>The Journal of Headache and Pain >Value of postmarketing surveillance studies in achieving a complete picture of antimigraine agents: using almotriptan as an example
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Value of postmarketing surveillance studies in achieving a complete picture of antimigraine agents: using almotriptan as an example

机译:上市后监测研究在了解抗偏头痛药物方面的价值:以阿莫曲坦为例

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摘要

Randomised controlled trials cannot collect all the data relevant for use in everyday clinical practice because drug exposure is limited, endpoints are restricted and some patient populations are excluded. Postmarketing surveillance (PS) studies can add important information for real–world clinical practice. Acute migraine therapy with almotriptan 12.5 mg was evaluated in 4 PS studies, 2 conducted in Spain, 1 in Germany and 1 in France. Almotriptan was associated with a high rate of treatment response and was well tolerated in all 4 studies. In the Spanish and German studies, 2–hour pain–relief, 2–hour pain–free, and sustained painfree rates were enhanced when patients treated mild pain. Patient satisfaction with almotriptan, assessed in the German and French studies, was high and the majority of patients preferred almotriptan to their previous acute migraine therapy. In conclusion, PS studies augment our knowledge of antimigraine therapy, giving a more complete picture of how such agents work in the general population.
机译:随机对照试验无法收集与日常临床实践有关的所有数据,因为药物暴露受到限制,终点受到限制并且某些患者人群被排除在外。上市后监视(PS)研究可以为现实世界的临床实践添加重要信息。在4项PS研究中评估了12.5 mg阿莫曲坦的急性偏头痛治疗,其中2项在西班牙进行,1项在德国进行,1项在法国进行。阿莫曲坦与高治疗反应率相关,并且在所有四项研究中耐受性都很好。在西班牙和德国的研究中,当患者治疗轻度疼痛时,2小时缓解,2小时无痛和持续无痛的发生率增加。在德国和法国的研究中评估出的患者对阿莫曲坦的满意度很高,大多数患者较之前的急性偏头痛治疗更喜欢阿莫曲坦。总之,PS研究增加了我们对偏头痛治疗的了解,从而更全面地了解了这类药物在普通人群中的工作方式。

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