Dorsey E Ray, Rabbani Atonu, Gallagher Sarah A, Conti Rena M, Alexander G Caleb
Department of Neurology, University of Rochester Medical Center, New York, USA.
Arch Intern Med. 2010 Jan 11;170(1):96-103. doi: 10.1001/archinternmed.2009.456.
In April 2005, the US Food and Drug Administration (FDA) issued an advisory and subsequent black box warning regarding the risks of atypical anti psychotic use among elderly patients with dementia. The impact of these warnings on atypical drug use is unknown.
We used quasi-experimental, interrupted time-series analyses to examine nationally representative data from IMS Health's National Disease and Therapeutic Index from January 2003 through December 2008. The primary measurement from this audit of office-based physicians was the use of an atypical antipsychotic agent. We quantified the impact of the advisory on atypical antipsychotic use among all individuals and those 65 years or older with dementia.
From January 2003 to March 2005, mentions of total atypical antipsychotic drugs increased at an annual rate of 34%, and among patients with dementia, 16%. In the year prior to the FDA advisory, there were approximately 13.6 million atypical drug mentions, including 0.8 million among those with dementia. In the year following the advisory, atypical drug mentions fell 2% overall and 19% among those with dementia. In 2004, 19% (0.8 of 4.1 million) of drug mentions for dementia were for an atypical agent. By 2008, this proportion decreased to 9% (0.4 of 4.3 million). Atypical drug use slowed for both FDA-approved and off-label indications and declined through 2008 for all populations examined.
The FDA advisory was associated with decreases in the use of atypical antipsychotics, especially among elderly patients with dementia.
2005年4月，美国食品药品监督管理局（FDA）发布了一项咨询意见以及随后的黑框警告，内容涉及老年痴呆患者使用非典型抗精神病药物的风险。这些警告对非典型药物使用的影响尚不清楚。
我们采用准实验性中断时间序列分析，研究了来自艾美仕市场研究公司（IMS Health）的《全国疾病与治疗指数》中2003年1月至2008年12月具有全国代表性的数据。此次对门诊医生的调查的主要衡量指标是使用非典型抗精神病药物的情况。我们量化了该咨询意见对所有个体以及65岁及以上痴呆患者使用非典型抗精神病药物的影响。
2003年1月至2005年3月，非典型抗精神病药物的总体提及量以每年34%的速度增长，而在痴呆患者中，这一增速为16%。在FDA发布咨询意见的前一年，非典型药物提及量约为1360万次，其中痴呆患者中有80万次。在咨询意见发布后的一年里，非典型药物提及量总体下降了2%，在痴呆患者中下降了19%。2004年，痴呆药物提及量中有19%（410万次中的80万次）是关于非典型药物的。到2008年，这一比例降至9%（430万次中的40万次）。对于FDA批准的适应症和未标明的适应症，非典型药物的使用都有所放缓，并且在2008年之前，所有受调查人群的使用量都在下降。
FDA的咨询意见与非典型抗精神病药物使用量的减少有关，尤其是在老年痴呆患者中。
