Carter C S, Mulsant B H, Sweet R A, Maxwell R A, Coley K, Ganguli R, Branch R
Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, PA 15213, USA.
Psychopharmacol Bull. 1995;31(4):719-25.
Risperidone, a new antipsychotic drug, was recently approved by the Food and Drug Administration (FDA) on the basis of its having comparable efficacy and less toxicity than haloperidol. In a preliminary study to evaluate the therapeutic efficiency of this drug, we conducted a survey of resperidone utilization, cost, and safety during its first year of availability at an academic psychiatric hospital. Data were obtained from a computerized, centralized medical record system, from an adverse drug reaction monitoring system, and from pharmacy purchasing records. In its first year of availability, risperidone became the second most widely used antipsychotic agent at our institution. Most of this use extended beyond the adult schizophrenia population, for whom pre-marketing safety and efficacy data are available. The direct institutional cost of risperidone treatment exceeded the entire budget for antipsychotic drugs during the year before its release. Results from the adverse drug reaction reporting system did not indicate a strong advantage of risperidone over more established antipsychotic agents with respect to extrapyramidal side effects. Furthermore, the mean dose of risperidone associated with extrapyramidal symptoms was 3.5 mg/day, considerably lower than that suggested by pre-marketing studies in a more select patient group. These results confirm that new pharmacological agents are generally used in much broader patient populations than those for which efficacy and safety have been established prior to FDA approval. This study also raises questions about the therapeutic efficiency of risperidone compared with other antipsychotic drugs. We conclude that systematic studies of outcome, safety, and cost of new pharmaceuticals in naturalistic settings are needed to provide the data necessary to establish local standards of cost-effective care.
利培酮是一种新型抗精神病药物，最近因其疗效与氟哌啶醇相当且毒性较小而被美国食品药品监督管理局（FDA）批准。在一项评估该药物治疗效果的初步研究中，我们对一家学术性精神病医院在利培酮上市第一年的使用情况、成本及安全性进行了调查。数据来自计算机化的集中病历系统、药物不良反应监测系统以及药房采购记录。在上市的第一年，利培酮成为我们机构使用第二广泛的抗精神病药物。这种使用大多超出了有上市前安全性和疗效数据的成年精神分裂症患者群体。利培酮治疗的直接机构成本超过了其上市前一年抗精神病药物的全部预算。药物不良反应报告系统的结果并未表明利培酮在锥体外系副作用方面比更成熟的抗精神病药物有明显优势。此外，与锥体外系症状相关的利培酮平均剂量为3.5毫克/天，远低于在更特定患者群体中进行的上市前研究所建议的剂量。这些结果证实，新的药理药物通常在比FDA批准前已确定疗效和安全性的人群更广泛的患者群体中使用。这项研究也引发了关于利培酮与其他抗精神病药物相比治疗效果的问题。我们得出结论，需要在自然环境中对新药物的疗效、安全性和成本进行系统研究，以提供建立具有成本效益的护理地方标准所需的数据。
