Department of Health Care Policy, Harvard Medical School, Boston, MA, USA.
Pharmacoepidemiol Drug Saf. 2012 Dec;21(12):1251-60. doi: 10.1002/pds.3272. Epub 2012 May 3.
A 2003 Food and Drug Administration advisory warned of increased hyperlipidemia and diabetes risk for patients taking second-generation antipsychotics (SGAs). After the advisory, a professional society consensus statement provided treatment recommendations and stratified SGAs into high, intermediate, and low metabolic risk. We examine subsequent changes in incident and prevalent SGA use among individuals with severe mental illness.
We created a retrospective cohort using Florida Medicaid's claims from 2001 to 2006. We included non-Medicare eligible adults with bipolar disorder or schizophrenia who filled an SGA prescription. We assessed changes in overall and agent-specific use, discontinuations, interruptions, and therapeutic alternative use among prevalent users and agent-specific use among incident users. Pre-advisory utilization was compared with utilization initially after the advisory and two subsequent periods.
Among prevalent users, overall SGA use decreased slightly, and no increases in treatment interruptions or discontinuations were observed after the advisory and consensus statement publication. Compared with the pre-advisory period, in the months immediately after the advisory, the use of the highest metabolic-risk agent, olanzapine, decreased by 34% among prevalent users with bipolar disorder (adjusted risk ratio [aRR] = 0.66, 95%CI = 0.59-0.74) and 26% among prevalent users with schizophrenia (aRR = 0.74, 95%CI = 0.72-0.76). A greater decrease was estimated among incident users with bipolar disorder (aRR = 0.37, 95%CI = 0.29-0.47) and schizophrenia (aRR = 0.42, 95%CI = 0.35-0.51) during this period. During each subsequent post-advisory period, olanzapine use continued to decrease whereas quetiapine, ziprasidone, and aripiprazole use increased.
The metabolic risk advisory and the published consensus statement were associated with a selective reduction in olanzapine use without evidence of treatment disruptions among this population.
2003 年，美国食品药品监督管理局发布了一项警告，称第二代抗精神病药物（SGAs）会增加患者发生高血脂和糖尿病的风险。该警告发布后，一个专业学会发布了共识声明，为患者提供了治疗建议，并将 SGAs 分为高、中、低代谢风险药物。我们研究了此后严重精神疾病患者使用 SGA 的情况，包括新发病例和现患病例。
我们使用佛罗里达州医疗补助计划 2001 年至 2006 年的理赔数据，创建了一个回顾性队列。队列纳入了未参加医疗保险、患有双相情感障碍或精神分裂症、服用 SGA 处方药物的成年人。我们评估了现患病例中总体和具体药物使用、停药、中断治疗以及治疗替代药物的变化情况，也评估了新发病例中具体药物使用的变化情况。我们将使用 SGA 的情况与发布警告和共识声明之前以及之后两个时期的使用情况进行了比较。
在现患病例中，总体 SGA 使用量略有下降，在发布警告和共识声明后并未观察到治疗中断或停药增加的情况。与发布警告之前相比，在发布警告后的第一个月，双相情感障碍现患病例中，使用最高代谢风险药物奥氮平的比例下降了 34%（调整后的风险比[aRR]为 0.66，95%CI 为 0.59-0.74），精神分裂症现患病例中，该比例下降了 26%（aRR 为 0.74，95%CI 为 0.72-0.76）。在此期间，新发病例中双相情感障碍（aRR 为 0.37，95%CI 为 0.29-0.47）和精神分裂症（aRR 为 0.42，95%CI 为 0.35-0.51）的下降幅度更大。在之后的每个发布警告后时期，奥氮平的使用继续减少，而喹硫平、齐拉西酮和阿立哌唑的使用增加。
代谢风险警告和发布的共识声明与奥氮平的使用选择性减少有关，在该人群中并未观察到治疗中断的情况。
