Stargardt Tom, Weinbrenner Susanne, Busse Reinhard, Juckel Georg, Gericke Christian A
Berlin University of Technology, Department of Health Care Management, Strasse des 17. Juni 135 EB2, 10623 Berlin, Germany.
J Ment Health Policy Econ. 2008 Jun;11(2):89-97.
In two recent randomised clinical trials, a meta-analysis and in an effectiveness study analysing routine data from the U.S. Veterans Administration the superiority of the newer atypical drugs over typical antipsychotic drugs, concerning both their efficacy and their side-effect profile, has been questioned.
To analyse the effectiveness and cost of atypical versus typical antipsychotic treatment for schizophrenia in routine care.
Cohort study using routine care data from a statutory sickness fund with 5.4 million insured in Germany. To be included, patients had to be discharged with a diagnosis of schizophrenia in 2003 and fulfil membership criteria. Main outcome measures were rehospitalisation rates, mean hospital bed days, mean length of stay, cost of inpatient and pharmaceutical care to the sickness fund during follow-up and medication used to treat side-effects.
3121 patients were included into the study. There were no statistically significant differences in the effectiveness of atypical and typical antipsychotics on rehospitalisation during follow-up (rehospitalisation rate ratio 1.07, 95% confidence interval 0.86 to 1.33). However, there were consistent observations of atypical antipsychotics being more effective for severe cases of schizophrenia (14.6% of study population; >61 prior bed days per year in 2000-2002) in the follow-up period, whereas for the other severity strata typical antipsychotics seemed more effective in reducing various rehospitalisation outcomes. Patients treated with atypical antipsychotics received significantly less prescriptions for anticholinergics or tiaprid (relative risk 0.26, 95% confidence interval 0.18 to 0.38).
The effectiveness of atypical antipsychotics for schizophrenia on rehospitalisation measures appeared similar to that of typical antipsychotics. With the exception of severe cases, the higher costs for atypical antipsychotics were not offset by savings from reduced inpatient care. Major limitations include the lack of statistical power for subgroup analyses, the lack of clinical severity scale data and of life-course medical history data which both increase the risk of residual confounding by disease severity.
This study provides evidence that the effectiveness of atypical and typical antipsychotics measured in terms of hospital readmissions appears to be similar in routine care.
From a clinical perspective, this study provides evidence that the effectiveness of atypical and typical antipsychotics measured in terms of hospital readmissions appears to be similar in routine care.
Routine data studies can yield valuable information for policy decision-makers on the costs and the effectiveness of pharmaceuticals in routine care, complementing efficacy data from randomised clinical trials currently used for licensing and reimbursement decisions.
The non-significant differences in the effectiveness of atypical compared to typical antipsychotics according to severity of disease should be investigated in a prospective observational study or in a randomised clinical trial.
在最近的两项随机临床试验、一项荟萃分析以及一项分析美国退伍军人管理局常规数据的有效性研究中,新型非典型药物相对于典型抗精神病药物在疗效和副作用方面的优越性受到了质疑。
分析在常规护理中,非典型与典型抗精神病药物治疗精神分裂症的有效性和成本。
采用队列研究,数据来自德国一家拥有540万参保人的法定疾病基金的常规护理数据。纳入研究的患者须在2003年被诊断为精神分裂症并符合参保标准。主要观察指标为再住院率、平均住院床日数、平均住院时间、随访期间疾病基金的住院和药物治疗费用以及用于治疗副作用的药物。
3121名患者纳入研究。在随访期间,非典型和典型抗精神病药物在预防再住院方面的有效性无统计学显著差异(再住院率比值为1.07,95%置信区间为0.86至1.33)。然而,有一致的观察结果表明,在随访期间,非典型抗精神病药物对严重精神分裂症患者(占研究人群的14.6%;2000 - 2002年每年住院床日数>61天)更有效,而对于其他严重程度分层,典型抗精神病药物在降低各种再住院结局方面似乎更有效。接受非典型抗精神病药物治疗的患者接受抗胆碱能药物或硫必利的处方明显更少(相对风险0.26,95%置信区间0.18至0.38)。
非典型抗精神病药物对精神分裂症患者再住院措施的有效性似乎与典型抗精神病药物相似。除严重病例外,非典型抗精神病药物较高的成本并未因住院护理减少而节省的费用得到抵消。主要局限性包括亚组分析缺乏统计学效力、缺乏临床严重程度量表数据和生命历程病史数据,这两者都增加了疾病严重程度导致残留混杂的风险。
本研究提供了证据表明,在常规护理中,以再次入院衡量的非典型和典型抗精神病药物的有效性似乎相似。
从临床角度来看,本研究提供了证据表明,在常规护理中,以再次入院衡量的非典型和典型抗精神病药物的有效性似乎相似。
常规数据研究可为政策制定者提供有关常规护理中药物成本和有效性的宝贵信息,补充目前用于许可和报销决策的随机临床试验的疗效数据。
应在前瞻性观察研究或随机临床试验中研究根据疾病严重程度非典型与典型抗精神病药物有效性的非显著差异。