1Department of Psychiatry, Los Andes University Medical School, Mérida, Venezuela.
Aust N Z J Psychiatry. 2014 Feb;48(2):183-92. doi: 10.1177/0004867413502089. Epub 2013 Sep 3.
The antipsychotic drug (APD) clozapine (CLZ) is under-prescribed because of concerns about its safety. We evaluated in separate protocols the frequency of cardiomyopathy and hyponatraemia, which are adverse drug effects, where few comparative studies are available.
Cross-sectional studies in subjects treated for at least 3 consecutive months with the same drug were conducted. Cardiomyopathy: Patients undergoing treatment either with CLZ (n = 125) or with other typical or atypical APDs (n = 59) were examined by a cardiologist who also recorded echocardiograms and electrocardiograms in order to diagnose cardiomyopathy. Hyponatraemia: Fasting sodium levels were assessed in patients receiving any of the following treatments: CLZ (n = 88), other atypical APDs (n = 61), typical APDs (n = 23), typical + atypical APDs (n = 11), and other drugs/drug-free (n = 36).
Cardiomyopathy: No case of cardiomyopathy was detected. The frequency of abnormal ventricular ejection fraction (< 55%) was similar in both treatment groups (p = 1). Hyponatraemia: The frequency of hyponatraemia (percentage; 95% CI) was: CLZ (3.4%; -0.7, 7.1); other atypical APDs (4.9%; -0.5, 10.3); typical APDs (26.1%; 8.2, 44.0); typical + atypical APDs (9.1%; -7.8, 26.0); other drugs/drug-free (0%). None of the CLZ hyponatraemia subjects were on monotherapy.
Our results are at odds with previous studies of CLZ-associated cardiomyopathy. However, they must be compared to further cross-sectional or prospective studies because most published data come from either case reports or pharmacovigilance systems. The frequency of hyponatraemia during CLZ administration was similar to that observed with other atypical APDs, and it was significantly lower than that recorded with typical agents. These results, along with numerous case reports on the effects of CLZ in patients with polydipsia and water intoxication, point to a safe or even positive profile of CLZ on electrolytic regulation.
由于对其安全性的担忧，抗精神病药物（APD）氯氮平（CLZ）的处方不足。我们在单独的方案中评估了心肌病和低钠血症的频率，这些都是药物不良反应，很少有比较研究。
对至少连续接受 3 个月同种药物治疗的患者进行了横断面研究。心肌病：接受 CLZ（n = 125）或其他典型或非典型 APD 治疗的患者（n = 59）由心脏病专家进行检查，心脏病专家还记录了心电图和心电图以诊断心肌病。低钠血症：评估接受以下任何治疗的患者的空腹钠水平：CLZ（n = 88）、其他非典型 APD（n = 61）、典型 APD（n = 23）、典型+非典型 APD（n = 11）和其他药物/无药物（n = 36）。
心肌病：未发现心肌病病例。两组心室射血分数异常（<55%）的频率相似（p = 1）。低钠血症：低钠血症（百分比；95%CI）的频率为：CLZ（3.4%；-0.7，7.1）；其他非典型 APD（4.9%；-0.5，10.3）；典型 APD（26.1%；8.2，44.0）；典型+非典型 APD（9.1%；-7.8，26.0）；其他药物/无药物（0%）。没有 CLZ 低钠血症患者接受单药治疗。
我们的结果与以前关于 CLZ 相关心肌病的研究结果不一致。然而，它们必须与进一步的横断面或前瞻性研究进行比较，因为大多数已发表的数据来自病例报告或药物警戒系统。CLZ 给药期间低钠血症的频率与其他非典型 APD 观察到的频率相似，明显低于典型药物记录的频率。这些结果以及许多关于 CLZ 在多尿和水中毒患者中作用的病例报告表明 CLZ 在电解质调节方面具有安全甚至积极的特征。
