An open-treatment six-week study of the clinical effectiveness of Paliperidone Palmitate in schizophrenia: data from acute units in Spain (SHADOW study).

OBJECTIVES: To evaluate clinical evolution of patients with schizophrenia admitted in acute units because of a relapse and treated with once-monthly Paliperidone Palmitate (PP1M). METHODS: This multicentre, open-label, prospective observational study followed patients with schizophrenia treated with PP1M in acute psychiatric units for up to 6 weeks. RESULTS: Out of the 280 enrolled patients, 61 received PP1M as antipsychotic monotherapy, and 219 in combination with other antipsychotics. The average Clinical Global Impression-Schizophrenia (CGI-SCH) score decreased from 4.7 at baseline to 3.3 at final visit (p < .0001); the change was clinically and statistically significant both in patients treated with PP1M in monotherapy and in combination with other antipsychotics. Clear improvements in functioning and high patient satisfaction with the treatment were observed. Time from admission to PP1M therapy initiation correlated with the length of hospital stay (p < .0001); earlier start of PP1M treatment was associated with shorter hospital stay. Adverse events were reported in 7.1% of patients (all non-serious). CONCLUSIONS: PP1M was effective and well tolerated in treatment of acute episodes of schizophrenia both in monotherapy and in combination with other antipsychotics in clinical setting. Early start of PP1M therapy in acute schizophrenia episodes might help to shorten hospital stay.

Impact of 3-Monthly Long-Acting Injectable Paliperidone Palmitate in Schizophrenia: A Retrospective, Real-World Analysis of Population-Based Health Records in Spain.

BACKGROUND: Treatment of schizophrenia requires long-term medication to prevent relapse. Treatment nonadherence may increase the risk of relapse, leading to increased hospitalizations and emergency room (ER) visits. Long-acting injectables (LAIs) such as paliperidone palmitate have improved treatment adherence and therefore symptoms. However, real-world studies comparing 3-monthly LAI formulations with other LAIs and oral antipsychotics (OAs) are scarce. OBJECTIVE: The objective of this study was to investigate and evaluate the clinical effectiveness of paliperidone palmitate LAI monthly (PP1M; Xeplion®) and 3-monthly (PP3M; Trevicta®) formulations compared with the monthly LAI aripiprazole (AM; Abilify Maintena®) and OAs in Spain. METHODS: This was a retrospective, observational study including 2275 adult patients with schizophrenia in a Spanish population. Data from hospital, primary care, and pharmacy dispensation electronic medical records were obtained between January 2017 and February 2018. The main outcomes included psychiatric hospitalizations and ER visit rates, days on treatment, and treatment persistence. RESULTS: Patients receiving PP3M had a significantly lower mean hospitalization rate (0.00046 ± standard deviation [SD] 0.00181; p < 0.0001) than other treatment groups. Kaplan-Meier curves revealed that 92.0 and 88.4% of patients receiving PP3M remained hospitalization free by 12 and 18 months, respectively. All treatment groups had at least a twofold significantly higher risk of psychiatric hospitalizations compared with those receiving PP3M or OAs, and the hospitalization risk among the PP3M group was significantly lower (hazard ratio [HR] 0.46; 95% confidence interval [CI] 0.31-0.67). The risk of ER visits was significantly lower with both PP3M and PP1M than with OAs, and lowest with PP3M (HR 0.462 [95% CI 0.29-0.62] and HR 0.833 [95% CI 0.59-0.97], respectively). Time until treatment switch with PP3M was high, with more than 86.5% of patients remaining on treatment at 18 months. CONCLUSIONS: PP3M was more effective than OAs and monthly LAIs in improving clinical outcomes for patients with schizophrenia in a real-world setting in Spain.

Impact on functionality of the paliperidone palmitate three-month formulation in patients with a recent diagnosis of schizophrenia: a real-world observational prospective study.

BACKGROUND: Information on the effect of the paliperidone palmitate three-month (PP3M) formulation on functionality in patients in the early stages of psychosis is lacking. The primary aim of this study was to evaluate the impact of PP3M on functionality in patients recently diagnosed with schizophrenia. RESEARCH DESIGN AND METHODS: This was an observational, multicenter, and prospective study in patients with a recent diagnosis of schizophrenia undergoing treatment with PP3M. Evaluations included the Personal and Social Performance (PSP) scale, the Clinical Global Impression-Schizophrenia (CGI-Sch), the Medication Satisfaction Questionnaire and the Involvement Evaluation Questionnaire. RESULTS: A total of 101/110 evaluable patients (91.8%) completed the study and were included in the efficacy analyses. The total PSP score increased from a mean of 68.5 (15.3) at baseline to a mean of 72.1 (15.4) at month 6 and 74.8 (16.7) at month 12 with a before-and-after difference of 3.6 (95% CI, 1.6 to 5.5, p < 0.001) at month 6 and 6.2 (95% CI, 4.2 to 8.3, p < 0.001) at month 12. CGI-Sch severity significantly decreased from a mean score of 2.8 (1.1) at baseline to a score of 2.2 (1.1) at month 12 with a before-and-after difference of -0.6 (95% CI, 0.8 to -0.4, p < 0.001). CONCLUSIONS: Early introduction of PP3M in the course of schizophrenia is associated with a meaningful benefit in social functioning and at least maintains clinical stability.

Real-world data on paliperidone palmitate for the treatment of schizophrenia and other psychotic disorders: a systematic review of randomized and nonrandomized studies.

The aim of this study was to perform a systematic review of the effects of 1-month paliperidone palmitate (PP1M) for the treatment of schizophrenia and related psychotic disorders in terms of outcomes reported in real-world evidence studies. A systematic review of real-world randomized and nonrandomized studies with PP1M was performed and is reported according to PRISMA guidelines. Comparative effectiveness data with oral antipsychotics indicate that PP1M has a lower likelihood of relapse-related events, including rehospitalization, and these differences are clinically relevant. A randomized, double-blind study showed that PP1M has no advantage over haloperidol decanoate in the time to treatment failure. Although there was a marked variability across studies, PP1M was not superior to other antipsychotics in terms of study completion rates. Pharmacoeconomic data show that, during a follow-up period of 12 months, the mean total healthcare cost was not significantly different in patients treated with PP1M compared with those receiving oral antipsychotics. The mean maximum prolactin levels were significantly higher with PP1M than with haloperidol decanoate; however, neither drug differs in the frequency of prolactin-related adverse events. Results on prolactin-related adverse events were inconsistent in two randomized comparisons with oral antipsychotics and were not reported in a randomized comparison with aripiprazole. There were no significant differences between haloperidol decanoate and PP1M in the severity of abnormal involuntary movements and parkinsonism, or in the incidence of tardive dyskinesia; however, patients treated with haloperidol decanoate showed greater worsening of akathisia and required treatment for parkinsonism and akathisia significantly more frequently than patients who received PP1M. In conclusion, real-world data that originate from both pragmatic randomized clinical trials and observational studies indicate that PP1M is superior to oral antipsychotics in delaying the time to relapse or treatment failure. Furthermore, the pharmacoeconomic data reviewed for this article suggest that the advantages of PP1M compared with oral antipsychotics are not associated with an increased total cost for healthcare providers.

Adherence predicts symptomatic and psychosocial remission in schizophrenia: Naturalistic study of patient integration in the community. / La adherencia predice la remisión sintomática y psicosocial en esquizofrenia: estudio naturalístico de la integración de los pacientes en la comunidad.

INTRODUCTION: Psychosocial functioning in patients with schizophrenia attended in daily practice is an understudied aspect. The aim of this study was to assess the relationship between symptomatic and psychosocial remission and adherence to treatment in schizophrenia. METHODS: This cross-sectional, non-interventional, and multicenter study assessed symptomatic and psychosocial remission and community integration of 1,787 outpatients with schizophrenia attended in Spanish mental health services. Adherence to antipsychotic medication in the previous year was categorized as≥80% vs.<80%. RESULTS: Symptomatic remission was achieved in 28.5% of patients, and psychosocial remission in 26.1%. A total of 60.5% of patients were classified as adherent to antipsychotic treatment and 41% as adherent to non-pharmacological treatment. During the index visit, treatment was changed in 28.4% of patients, in 31.1% of them because of low adherence (8.8% of the total population). Adherent patients showed higher percentages of symptomatic and psychosocial remission than non-adherent patients (30.5 vs. 25.4%, P<.05; and 32 vs. 17%, P<.001, respectively). Only 3.5% of the patients showed an adequate level of community integration, which was also higher among adherent patients (73.0 vs. 60.1%, P<.05). CONCLUSIONS: Adherence to antipsychotic medication was associated with symptomatic and psychosocial remission as well as with community integration.

Professionals' perception on the management of patients with dual disorders.

BACKGROUND: There is a need to evaluate the professionals' perception about the consequences of the lack of therapeutic adherence in the evolution of patients with co-occurring disorders. METHODS: An online survey, released on the Socidrogalcohol [Spanish Scientific Society for Research on Alcohol, Alcoholism and other Drug Addictions] and Sociedad Española de Patología Dual [the Spanish Society of Dual Pathology] web pages, was answered by 250 professionals who work in different types of Spanish health centers where dual diagnosis patients are assisted. RESULTS: Most professionals perceived the existence of noncompliance among dual diagnosis patients. Almost all of these professionals (99%) perceived that noncompliance leads to a worsening of the progression of the patient's disorder, in both the exacerbation of mental disorders and the consumption of addictive substances. Most of the professionals (69.2%) considered therapeutic alliance as the main aspect to take into account to improve the prognosis in this population. The primary purpose of treatment must be the improvement of psychotic-phase positive symptoms, followed by the control of behavior disorders, reduction of craving, improvement of social and personal performances, and reduction of psychotic-phase negative symptoms. CONCLUSION: Most professionals perceived low adherence among dual diagnosis patients. This lack of adherence is associated with a worsening of their disease evolution, which is reflected in exacerbations of the psychopathology and relapse in substance use. Therefore, we propose to identify strategies to improve adherence.