Kales Helen C, Zivin Kara, Kim Hyungjin Myra, Valenstein Marcia, Chiang Claire, Ignacio Rosalinda V, Ganoczy Dara, Cunningham Francesca, Schneider Lon S, Blow Frederic C
Veterans Affairs Health Services Researchand Development Center for Clinical Management Research, Serious Mental Illness Treatment, Resource, and Evaluation Center, Ann Arbor, Michigan, USA.
Arch Gen Psychiatry. 2011 Feb;68(2):190-7. doi: 10.1001/archgenpsychiatry.2010.200.
Use of atypical antipsychotics for neuropsychiatric symptoms of dementia increased markedly in the 1990s. Concerns about their use began to emerge in 2002, and in 2005, the US Food and Drug Administration warned that use of atypical antipsychotics in dementia was associated with increased mortality.
To examine changes in atypical and conventional antipsychotic use in outpatients with dementia from 1999 through 2007.
Time-series analyses estimated the effect of the various warnings on atypical and conventional antipsychotic usage using national Veterans Affairs data across 3 periods: no warning (1999-2003), early warning (2003-2005), and black box warning (2005-2007).
Patients aged 65 years or older with dementia (n = 254 564).
Outpatient antipsychotic use (percentage of patients, percentage of quarterly change, and difference between consecutive study periods).
In 1999, 17.7% (95% confidence interval [CI], 17.2-18.1) of patients with dementia were using atypical or conventional antipsychotics. Overall use began to decline during the no-warning period (rate per quarter, -0.12%; 95% CI, -0.16 to -0.07; P < .001). Following the black box warning, the decline continued (rate, -0.26%; 95% CI, -0.34 to -0.18; P < .001), with a significant difference between the early and black box warning periods (P = .006). Use of atypical antipsychotics as a group increased during the no-warning period (rate, 0.23; 95% CI, 0.17-0.30; P < .001), started to decline during the early-warning period (rate, -0.012; 95% CI, -0.14 to 0.11; P = .85), and more sharply declined during the black box warning period (rate, -0.27; 95% CI, -0.36 to -0.18; P < .001). Olanzapine and risperidone showed declining rates and quetiapine showed an increase during the early-warning period, but rates of use for all 3 antipsychotics declined during the black box warning period. In the black box warning period, there was a small but significant increase in anticonvulsant prescriptions (rate, 0.117; 95% CI, 0.08-0.16; P < .001).
Use of atypical antipsychotics began to decline significantly in 2003, and the Food and Drug Administration advisory was temporally associated with a significant acceleration in the decline.
20世纪90年代,非典型抗精神病药物用于治疗痴呆症神经精神症状的情况显著增加。2002年开始出现对其使用的担忧,2005年,美国食品药品监督管理局警告称,在痴呆症患者中使用非典型抗精神病药物会增加死亡率。
研究1999年至2007年痴呆症门诊患者使用非典型和传统抗精神病药物的变化情况。
时间序列分析使用美国退伍军人事务部的全国数据,在三个时间段估计各种警告对非典型和传统抗精神病药物使用的影响:无警告期(1999 - 2003年)、早期警告期(2003 - 2005年)和黑框警告期(2005 - 2007年)。
65岁及以上的痴呆症患者(n = 254564)。
门诊抗精神病药物使用情况(患者百分比、季度变化百分比以及连续研究期间的差异)。
1999年,17.7%(95%置信区间[CI],17.2 - 18.1)的痴呆症患者使用非典型或传统抗精神病药物。总体使用情况在无警告期开始下降(每季度下降率,-0.12%;95% CI,-0.16至-0.07;P <.001)。黑框警告发布后,下降趋势持续(下降率,-0.26%;95% CI,-0.34至-0.18;P <.001),早期警告期和黑框警告期之间存在显著差异(P =.006)。在无警告期,非典型抗精神病药物的总体使用量增加(增加率,0.23;95% CI,0.17 - 0.30;P <.001),在早期警告期开始下降(下降率,-0.012;95% CI,-0.14至0.11;P =.85),在黑框警告期下降更为明显(下降率,-0.27;95% CI,-0.36至-0.18;P <.001)。奥氮平和利培酮的使用率在早期警告期下降,喹硫平在早期警告期使用率上升,但在黑框警告期这三种抗精神病药物的使用率均下降。在黑框警告期,抗惊厥药物处方量有小幅但显著的增加(增加率,0.117;95% CI,0.08 - 0.16;P <.001)。
2003年非典型抗精神病药物的使用开始显著下降,食品药品监督管理局的警示在时间上与下降的显著加速相关。