Janicak Philip G, Wu Jasmanda H, Mao Lian
Department of Psychiatry, Rush University Medical Center, Chicago, IL, USA.
Curr Med Res Opin. 2008 Jun;24(6):1807-15. doi: 10.1185/03007990802119368.
To assess differences in the number of days hospitalized among schizophrenic patients receiving paliperidone extended-release (paliperidone ER) during the open-label extension (OLE) phases, compared to a similar time period prior to the screening for entry into the double-blind (DB) trials conducted in the United States.
Mental health-related hospital days during the 52 weeks before entering the DB trials and during the OLE phases were compared. The mean number of hospital days per person per year in the pre- and post-periods was calculated and the statistical significance of pre-post differences was assessed using bootstrap resampling methods. Total person-years were also calculated for the pre- and post-periods to account for different lengths of observation.
Patients' (n=215) mean (+/-SD) age was 41.2 (+/-11.0) years; most were male (73.0%); and black (52.1 vs. 45.1% white). The mean (+/-SD) paliperidone ER treatment duration during the OLE phase was 167.0 (+/-145.0) days and the mean (+/-SD) daily dose was 10.5 (+/-2.0) mg. Overall, paliperidone ER patients spent an average (+/-SD) of 13.2 (+/-1.6) and 3.1 (+/-0.7) hospital days per person-year in the pre-and post-periods, respectively (mean +/-SD change 10.0+/-1.8, 95% CI 6.5, 13.4, p<0.001). Using the 2007 Federal Per Diem Base Rate (i.e., $595.09 per day), this reduction in hospital days would result in an average (+/-SD) cost savings of $5951 (+/-1071) per person per year.
Patients had significantly fewer hospital days in the OLE phase compared to the 1-year period prior to entering the DB trial. Paliperidone ER may play a role in reducing mental health-related hospital days and associated costs. Important study limitations include the lack of a control group, the pre-post design comparing historical data with data collected in the trials which could create a bias due to the mismatch in settings, and patients having more frequent contact with treating physicians and investigators during the trial period, which could favor the outcomes in the OLE phase. Further studies are needed to confirm these findings.
评估在美国进行的双盲（DB）试验筛选前的类似时间段相比，精神分裂症患者在开放标签扩展（OLE）阶段接受帕利哌酮缓释片（paliperidone ER）治疗期间的住院天数差异。
比较进入DB试验前52周和OLE阶段与心理健康相关的住院天数。计算前后时期每人每年的平均住院天数，并使用自助重采样方法评估前后差异的统计学显著性。还计算了前后时期的总人年数，以考虑不同的观察时长。
患者（n = 215）的平均（±标准差）年龄为41.2（±11.0）岁；大多数为男性（73.0%）；且为黑人（52.1%，白人占45.1%）。OLE阶段帕利哌酮ER的平均（±标准差）治疗时长为167.0（±145.0）天，平均（±标准差）日剂量为10.5（±2.0）mg。总体而言，帕利哌酮ER患者在前后时期每人每年的平均（±标准差）住院天数分别为13.2（±1.6）天和3.1（±0.7）天（平均±标准差变化为10.0±1.8，95%置信区间为6.5，13.4，p<0.001）。使用2007年联邦每日费用基准率（即每天595.09美元），住院天数的减少将导致每人每年平均（±标准差）节省费用5951（±1071）美元。
与进入DB试验前的1年时期相比，患者在OLE阶段的住院天数显著减少。帕利哌酮ER可能在减少与心理健康相关的住院天数及相关费用方面发挥作用。重要的研究局限性包括缺乏对照组、前后设计将历史数据与试验中收集的数据进行比较，这可能因环境不匹配而产生偏差，以及患者在试验期间与治疗医生和研究人员的接触更频繁，这可能有利于OLE阶段的结果。需要进一步研究来证实这些发现。
