FDA: Aricept Television Ads Include Misleading Claims

April Hollis

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FDA: Aricept Television Ads Include Misleading Claims

机译：FDA：Aricept电视广告包含误导性声明

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Eisai has received an untitled letter for two television advertisements for its Alzheimer's drug Aricept showing dramatic behavior changes that are not representative of clinical trial results.rnThe ads imply that patients' cognitive and daily functioning - specifically attention, focus, orientation, communication, social interaction and engagement - will return to normal as a result of Aricept (donepezil HCl) treatment, the Feb. 5 untitled letter says. But the results from efficacy trials in patients with mild-to-moderate and severe Alzheimer's disease do not support such a drastic improvement.

机译：卫材已经收到两封电视广告的一封无标题的信件，内容是阿尔茨海默氏症药物Aricept的戏剧性行为变化，并不代表临床试验结果.rn这些广告暗示着患者的认知和日常功能-特别是注意力，焦点，方向，沟通，社交互动2月5日的无标题信函说，由于接受了Aricept（盐酸多奈哌齐）治疗，患者的接触和参与度将恢复正常。但是，对轻度至中度和重度阿尔茨海默氏病患者进行的功效试验结果并不支持这种大幅度改善。

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《Washington Drug Letter》 |2010年第9期|7|共1页
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April Hollis;
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FDA: Aricept Television Ads Include Misleading Claims

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