RESUMEN
BACKGROUND: Long-acting antipsychotics (e.g. 1-monthly (PP1M) / 3-monthly (PP3M) injection forms of paliperidone palmitate) have been developed to improve treatment continuation in schizophrenia patients. We aim to assess risk factors of treatment discontinuation of patients on paliperidone palmitate and risperidone microsphere. Additionally, treatment discontinuation between patients with PP1M and PP3M was compared. METHODS: The IQVIA Longitudinal Prescription databases were used. Risk factors of treatment discontinuation were identified by a multilevel survival regression using Cox proportional hazards model. Kaplan Meier analyses were performed by identified significant risk factors. RESULTS: Twenty-five thousand three hundred sixty-one patients (France: 9,720; Germany: 14,461; Belgium: 1,180) were included. Over a one-year follow-up period, a significant lower treatment discontinuation was observed for patients newly initiated on paliperidone palmitate (53.8%) than those on risperidone microspheres (85.4%). Additionally, a significantly lower treatment discontinuation was found for 'stable' PP3M patients (19.2%) than 'stable' PP1M patients (37.1%). Patients were more likely to discontinue when drugs were prescribed by GP only (HR = 1.68, p < 0.001 vs. psychiatrist only) or if they were female (HR = 1.07, p < 0.001), whereas discontinuation decreased with age (31-50 years: HR = 0.95, p = 0.006 and > 50 years: HR = 0.91, p < 0.001 vs. 18-30 years). CONCLUSIONS: This study demonstrates that patients stay significantly longer on treatment when initiated on paliperidone palmitate as compared to risperidone microspheres. It also indicated a higher treatment continuation of PP3M over PP1M. Treatment continuation is likely to be improved by empowering GPs with mental health knowledge and managing patients by a collaborative primary care-mental health model. Further research is needed to understand why females and younger patients have more treatment discontinuation.
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Antipsicóticos , Palmitato de Paliperidona , Adulto , Antipsicóticos/uso terapéutico , Bélgica , Preparaciones de Acción Retardada/uso terapéutico , Femenino , Humanos , Masculino , Microesferas , Persona de Mediana Edad , Factores de Riesgo , Risperidona/uso terapéuticoRESUMEN
RATIONALE: Reducing the frequency of long-acting injectable antipsychotic medication may reduce carer burden. OBJECTIVES: To evaluate the impact of reduced frequency of long-acting injectable antipsychotic medication on carer burden in stable patients with schizophrenia. METHODS: Carer burden was assessed using the Involvement Evaluation Questionnaire (IEQ) within a 52-week, prospective, single-arm, non-randomised, open-label, international, multicentre study evaluating the impact of transitioning stable patients with schizophrenia to paliperidone palmitate 3-monthly (PP3M) from paliperidone palmitate 1-monthly (PP1M). RESULTS: 159 carers completed the IEQ (mean [standard deviation, SD] age: 54.8 [12.8] years); 52.2% were the patients' parent and > 50% had >32 h/week of patient contact. At baseline, mean [SD] IEQ total score was in the lower range (23.8 [12.6]), reflecting patient stabilisation. At last observation carried forward (LOCF) endpoint, the IEQ total score decreased by a mean (95% CI) of -4.0 (-5.9, -2.1), indicating a significant overall reduction in carer burden (P < 0.0001). The six IEQ items with the highest carer burden at baseline were within the urging and worrying domains, in which burden was significantly improved at LOCF endpoint (P < 0.0001). Exploratory analyses found that higher carer burden was associated with lower functional remission (Personal and Social Performance score >70) at baseline and LOCF endpoint, and with the patient being part of the carer's household. Shorter disease duration correlated with better general health of carers at LOCF endpoint. CONCLUSION: Reducing the frequency of antipsychotic medication administration in stable patients with schizophrenia by switching from PP1M to PP3M may reduce carer burden.
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Antipsicóticos , Esquizofrenia , Antipsicóticos/uso terapéutico , Cuidadores , Humanos , Persona de Mediana Edad , Palmitato de Paliperidona/uso terapéutico , Estudios Prospectivos , Esquizofrenia/tratamiento farmacológicoRESUMEN
PURPOSE: To illuminate user experiences of schizophrenia, reasons for receiving antipsychotic medication, and encounters with mental health services. DESIGN AND METHODS: 24 semistructured qualitative research interviews with schizophrenia patients treated with 3-monthly paliperidone palmitate across Scandinavia were synthesized in qualitative content analysis. FINDINGS: Participants describe considerable challenges in everyday functioning. Simultaneously, they rate their current mental and physical well-being high and seem satisfied with their lives. These pathways indicate personal recovery. PRACTICE IMPLICATIONS: The participants emphasize the importance of trustful relations with healthcare professionals, therapeutic conversations, antipsychotic medication in a 3-monthly formulation, and support from relatives.
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Antipsicóticos/administración & dosificación , Palmitato de Paliperidona/administración & dosificación , Esquizofrenia/tratamiento farmacológico , Psicología del Esquizofrénico , Adulto , Anciano , Antipsicóticos/efectos adversos , Femenino , Humanos , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Palmitato de Paliperidona/efectos adversos , Investigación Cualitativa , Calidad de Vida , Países Escandinavos y NórdicosRESUMEN
INTRODUCTION: A three-month injection of paliperidone palmitate (PP3M) has been gradually introduced in the market since 2015. Recently, and due to different reasons, there is an increase in the LAIAs prescription rates, including patients in early phases of psychotic disorders. Areas covered: The following article provides an overview of the antipsychotic market before providing the reader with an overview of the efficacy and tolerability data of the 3-month paliperidone palmitate formulation for the treatment of schizophrenia. The authors take into account the current state of knowledge, as well as the needs not covered by other therapeutic tools at our disposal at this time. Expert opinion: PP3M offers a substantially longer dosing interval than other options, which may be a potential advancement to reduce nonadherence in some patients. Future research, both from randomized controlled trials and large pragmatic studies in real-world settings, will identify which subpopulation and disease stages may obtain greater benefit from this new formulation.
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Antipsicóticos/uso terapéutico , Palmitato de Paliperidona/uso terapéutico , Esquizofrenia/tratamiento farmacológico , Antipsicóticos/efectos adversos , Antipsicóticos/farmacocinética , Análisis Costo-Beneficio , Preparaciones de Acción Retardada , Esquema de Medicación , Semivida , Humanos , Palmitato de Paliperidona/efectos adversos , Palmitato de Paliperidona/farmacocinética , Esquizofrenia/patologíaRESUMEN
AIMS: Paliperidone palmitate 3-month (PP3M) represents a new long-acting injectable antipsychotic therapeutic option. This review aims: 1) to summarize available data relating to efficacy, safety, tolerability and costs of PP3M; 2) to describe hospitalization rate, occupational status, treatment preference, satisfaction, adherence and caregiver burden of patients with schizophrenia who participate in PP3M clinical trials; 3) to examine ethical implications, pros and cons of PP3M use and 4) to propose study designs to further assess PP3M. METHODS: On August 21, 2017, a search on PubMed about PPM3, without any filter restriction, was conducted and all available records were analyzed. Records written in a language other than English were excluded. RESULTS: Twenty-two records were included in this review: 6 reviews, 1 report, 4 pharmacokinetic studies, 2 cost-effectiveness analyses, 1 open-label clinical trial, 2 randomized controlled trials (RCTs), 5 studies based on these 2 RCTs and 1 observational study. DISCUSSION: According to these last 9 studies, when compared with placebo, PP3M showed a longer time to relapse and good safety and tolerability profiles. Furthermore, when compared with paliperidone palmitate 1 month (PP1M), PP3M treatment showed: 1) non-inferiority in terms of efficacy, safety, tolerability, rate of hospitalization, symptomatic and functional remission, treatment preference and variations of the occupational status; 2) a longer time to relapse after treatment discontinuation and 3) a similar reduction of the caregiver burden. CONCLUSION: PP3M is the only 3-monthly long-acting injectable antipsychotic available on the market. This makes it a unique option of treatment, which could be chosen both in early and advanced phases of illness. Nonetheless, longer naturalistic follow-up studies, two-arm head-to-head superiority trials and mirror studies, based on real-world samples of patients, are needed to further assess long-term safety and advantages of this new option of treatment and to define patients' sub-populations that would most beneficiate from it.
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This multicenter, randomized, open-label, parallel-group, phase-1 study assessed the pharmacokinetics (PK), safety, and tolerability of the investigational intramuscular paliperidone palmitate 3-month (PP3M) formulation in patients with schizophrenia or schizoaffective disorder. A total of 328 patients (men or women, aged 18-65 years) were enrolled in 1 of 4 separately conducted panels (A to D). Each panel had 2 single-dose treatment periods (period 1, 1 mg intramuscular paliperidone immediate release [IR]; period 2, intramuscular PP3M 75-525 mg eq) separated by a washout of 7-21 days. Overall, 245 of 308 (79.5%) PP3M-dosed patients completed the study. Because the PK studies of panels A and C were compromised by incomplete injection in some patients, PK data from only panels B and D are presented. Safety data from all panels are presented. Peak paliperidone plasma concentration was achieved between 23 and 34 days, and apparent half-life was â¼2-4 months. Mean plasma AUC∞ and Cmax of paliperidone appeared to be dose-proportional. Relative bioavailability in comparison with paliperidone was â¼100% independent of the dose and injection site. Headache and nasopharyngitis were the most common (>7%) treatment-emergent adverse events. Overall, safety and tolerability were similar to those of the 1-month formulation. Results support a once-every-3-months dosing interval in patients with schizophrenia or schizoaffective disorder.