Vincent Philippe D, Demers Marie-France, Doyon-Kemp Venessa, Duchesneau Josée, Halme Alex, Masson Violaine
Department of pharmacy, Institut universitaire en santé mentale de Montréal (IUSMM), 7401 Hochelaga, Montreal, Quebec H1N 3M5, Canada; Faculty of pharmacy, Université de Montréal, 2940 Chemin de la Polytechnique, Montreal, Quebec H3T 1J4, Canada; IUSMM research center, 7331 Hochelaga, Montreal, Quebec H1N 3V2, Canada.
Department of pharmacy, Institut universitaire en santé mentale de Québec (IUSMQ), 2601, chemin de la Canardière, Quebec City, Quebec G1J 2G3, Canada; Faculty of pharmacy, Université Laval, 1050 avenue de la Médecine, Quebec City, Quebec G1V 0A6, Canada; IUSMQ Research center, 2601, chemin de la Canardière, Quebec City, Quebec G1J 2G3, Canada.
Schizophr Res. 2017 Jul;185:96-100. doi: 10.1016/j.schres.2017.01.013. Epub 2017 Jan 22.
Superiority of long acting injectable antipsychotics (LAI) over oral antipsychotics remains controversial and dependent on study design and inclusion criteria. Meta-analysis of 21 RCTs demonstrated no difference in their effectiveness, but meta-analysis of 25 mirror-image studies did. None of these included paliperidone palmitate (PP).
We challenged efficiency of PP in a multicentric mirror-image study. Primary outcome was total hospitalization days. Mirror periods were 365days either side of the first injection in model-1, and either side of index admission in model-2. Inclusion criteria were: 18 to 65years, schizophrenia spectrum disorder, ≥3 injections received, and oral antipsychotic prescriptions before PP trial. Exclusion criteria were: prior clozapine or LAI trial. Cost-effectiveness was calculated from a public payer's perspective.
114 patients were recruited (77% males, mean 37years, mean disease duration 10years). Oral antipsychotics adherence was 43%. Mean PP treatment lasted 297days (adherence 81%). Mean annual hospitalization days weren't significantly different in model-1 (45.8days vs 38.5days, p=0.058), but were significantly lower in model-2, (14.4days vs 24.2days, p=0.003). 1.9 admissions per patient-year fell to 0.64 on PP (p<0.0001). PP was approximately cost-neutral: differences were -$326 and $1788 for model-1 and model-2.
PP as a first LAI improved adherence, decreased hospital visits and duration was cost neutral. Drawbacks are the retrospective design and lack of comparator and safety data. Strengths are naturalistic design and adherence calculation. A subset of patients responds well to LAI, leading to meaningful reductions in hospital services requirements.
长效注射用抗精神病药物(LAI)相对于口服抗精神病药物的优越性仍存在争议,且取决于研究设计和纳入标准。对21项随机对照试验的荟萃分析表明它们在有效性方面没有差异,但对25项镜像研究的荟萃分析则显示有差异。这些研究均未纳入棕榈酸帕利哌酮(PP)。
我们在一项多中心镜像研究中对PP的有效性进行了验证。主要结局是总住院天数。在模型1中,镜像期为首次注射前后各365天;在模型2中,镜像期为索引入院前后各365天。纳入标准为:年龄18至65岁,精神分裂症谱系障碍,接受过≥3次注射,以及在PP试验前有口服抗精神病药物处方。排除标准为:既往有氯氮平或LAI试验史。从公共支付者的角度计算成本效益。
共招募了114名患者(77%为男性,平均年龄37岁,平均病程10年)。口服抗精神病药物的依从性为43%。PP治疗的平均持续时间为297天(依从性81%)。在模型1中,平均每年住院天数无显著差异(45.8天对38.5天,p = 0.058),但在模型2中显著更低(14.4天对24.2天,p = 0.003)。每位患者每年的住院次数从1.9次降至PP治疗时的0.64次(p < 0.0001)。PP大致成本中性:模型1和模型2的差异分别为 - 326美元和1788美元。
PP作为第一种LAI可提高依从性,减少住院次数,且持续时间成本中性。缺点是回顾性设计以及缺乏对照和安全性数据。优点是自然主义设计和依从性计算。一部分患者对LAI反应良好,从而显著减少了对医院服务的需求。