Center for Health Statistics, University of Illinois at Chicago, Chicago, IL 60612, USA.
Pharmacoepidemiol Drug Saf. 2010 Dec;19(12):1241-7. doi: 10.1002/pds.2036. Epub 2010 Oct 4.
On 16 December 2008, FDA issued a class warning for antiepileptic drugs and suicidal thoughts and behavior. The purpose of this study was to determine if the antiepileptic drug gabapentin increases risk of suicide attempt in patients to which it was prescribed for various indications.
We conducted a pharmacoepidemiologic study in which suicide attempt rates were compared before and after gabapentin was prescribed. We used the PharMetrics medical claims database to study the relationship between gabapentin and suicide attempts in a cohort of 131,178 patients with a 1-year window of information before and after initial prescription. Patients had diagnoses of epilepsy, pain disorders, bipolar illness, major depressive disorder, schizophrenia, and other psychiatric disorders.
Overall, there was no significant difference in suicide attempt rates before (3.48/1000 patient years--PY) versus after (3.45/1000 PY) gabapentin prescription. Pre-prescription suicide attempt rates were five times higher in psychiatric populations compared with non-psychiatric populations leading us to analyze the two groups separately. No drug effect was detected in the non-psychiatric populations. Significant reductions in suicide attempt rates were seen for bipolar disorder (47.85/1000 PY versus 31.46/1000 PY), major depressive disorder (17.30/1000 PY versus 12.66/1000 PY), and other psychiatric disorders (12.84/1000 PY versus 10.14/1000 PY). Person-time analysis revealed an overall significant reduction in suicide attempt rates (2.01/1000 PY on drug versus 2.30/1000 PY off drug).
This study finds that gabapentin does not increase risk of suicide attempts in non-psychiatric populations and is associated with a reduction in suicide attempt risk in patients with psychiatric disorders.
2008 年 12 月 16 日,FDA 发布了抗癫痫药物与自杀意念和行为的一类警告。本研究的目的是确定抗癫痫药物加巴喷丁是否会增加各种适应症患者尝试自杀的风险。
我们进行了一项药物流行病学研究,比较了加巴喷丁处方前后的自杀未遂率。我们使用 PharMetrics 医疗索赔数据库,在一个包含 131178 名患者的队列中研究了加巴喷丁与自杀未遂之间的关系,这些患者在初始处方前和后有 1 年的信息窗口。患者的诊断包括癫痫、疼痛障碍、双相情感障碍、重性抑郁障碍、精神分裂症和其他精神障碍。
总体而言,加巴喷丁处方前后的自杀未遂率没有显著差异(3.48/1000 患者年[PY]比 3.45/1000 PY)。在精神科人群中,自杀未遂的发生率是无精神科人群的五倍,这促使我们对这两组人群分别进行分析。在非精神科人群中未检测到药物效应。双相情感障碍(47.85/1000 PY 比 31.46/1000 PY)、重性抑郁障碍(17.30/1000 PY 比 12.66/1000 PY)和其他精神障碍(12.84/1000 PY 比 10.14/1000 PY)的自杀未遂率显著降低。个体时间分析显示,自杀未遂率总体显著降低(药物治疗时为 2.01/1000 PY,停药时为 2.30/1000 PY)。
本研究发现,加巴喷丁不会增加非精神科人群自杀未遂的风险,并且与精神障碍患者自杀未遂风险的降低有关。