ABSTRACT
Objective: To assess the efficacy and safety of paliperidone palmitate (PP) long-acting injectable antipsychotic (LAI) versus oral antipsychotic (OAP) treatment in adult patients diagnosed with schizophrenia (per DSM-IV or DSM-5 criteria) and varying duration of illness (0-3 years and > 3 years).Methods: Patient-level data from the PRIDE, PROSIPAL, and DREaM studies were included in a post hoc analysis. Efficacy and safety outcomes, including relapse assessments, Personal and Social Performance scale scores, Medication Satisfaction Questionnaire total scores, and treatment-emergent adverse events (TEAEs), were measured systematically. Treatment failure (TF) included relapses due to psychiatric hospitalizations, arrest or incarceration, suicidal or homicidal ideation or behavior, discontinuation due to inadequate efficacy and/or safety or tolerability, treatment supplementation due to inadequate efficacy, and significant worsening of symptoms.Results: Fewer TFs were observed with PP versus OAP in both the 0-3 years group (17.7% and 25.3%, respectively) and the > 3 years group (32.3% and 42.4%, respectively). Time to first TF was significantly longer with PP versus OAP treatment in both duration of illness groups. TEAE rates were similar between the PP and OAP groups, with no new safety signals identified.Conclusions: This post hoc analysis suggests that PP provides significant benefit in reducing TF or relapse compared with OAPs regardless of duration of illness and highlights the potential benefit of implementing PP earlier in the course of schizophrenia.Trial Registration: ClinicalTrials.gov identifiers NCT01157351 (PRIDE), NCT01081769 (PROSIPAL), and NCT02431702 (DREaM).
ABSTRACT
With more long-acting injectable (LAI) antipsychotics available for treating schizophrenia, each with variable durations of action (2 weeks to 3 months), it is important to have clear management strategies for patients developing breakthrough psychotic symptoms or experiencing symptomatic worsening on LAIs. However, no treatment guidelines or clinical practice pathways exist; health-care providers must rely on their own clinical judgment to manage these patients. This article provides practical recommendations-based on a framework of clinical, pharmacokinetic, and dosing considerations-to guide clinicians' decisions regarding management of breakthrough psychotic symptoms. Management options include ruling out/addressing medical illness or substance abuse/misuse as a contributing factor, addressing stressors, optimizing nonpharmacologic treatments, treating medical/psychiatric comorbidities, ensuring proper LAI administration technique, addressing missed LAI doses or lack of steady-state attainment, and increasing LAI dose directly or indirectly by shortening the injection interval (off-label). If these strategies do not work sufficiently with frequent monitoring, the LAI could be supplemented with a low dose of the corresponding oral formulation for fast symptom control (off-label). However, caution should be exercised with this strategy, because data on the safety of concomitant use of LAI and oral antipsychotics (OAPs) are limited, especially over extended periods. If symptoms abate, therapy optimization could be continued and slow discontinuation of the OAP could be considered. For persistent/worsening symptoms, the OAP should be increased to optimum effective dose while intensifying the initial steps used before it was added. If this fails, switching the OAP or LAI could be considered. We believe that these strategies will help clinicians manage breakthrough psychotic symptoms during LAI treatment and improve overall outcomes among those who can benefit from LAIs.
ABSTRACT
Background Half of Americans experience mental illness during their lifetime. Significant opportunity exists for community pharmacists to deliver services to these patients; however, personal and practice-related barriers may prevent full engagement. Objective To assess the demographics, practice characteristics, service provision, stigma, attitudes and beliefs of a national sample of community pharmacists towards individuals with mental illness. Setting National random sample of 3008 community pharmacists in the USA. Method 101-item cross-sectional mailed survey questionnaire on: (1) demographics, (2) knowledge and practice characteristics, (3) provision of clinical pharmacy services, and (4) comparative opinions. Main outcome measure Scaled measures of service provision (comfort, confidence, willingness and interest) and comparative opinions (stigma, attitudes and beliefs) of mental illness, four linear regression models to predict service provision. Results A total of 239 responses were received (response rate 7.95%). Across pharmacy services, ratings for willingness/interest were higher than those for comfort/confidence. Pharmacists who reported providing medication therapy management (MTM) services for patients reported higher comfort (18.36 vs. 17.46, p < 0.05), confidence (17.73 vs. 16.01, p < 0.05), willingness (20.0 vs. 18.62, p < 0.05) and interest (19.13 vs. 17.66, p < 0.05). Pharmacists with personal experience with mental illness also resulted in higher scores across all four domains of service provision, lower levels of stigma (18.28 vs. 20.76, p < 0.05) and more positive attitudes (52.24 vs. 50.53, p < 0.01). Regression analyses demonstrated increased frequency of MTM service delivery and more positive attitudes as significantly predictive across all four models for comfort, confidence, willingness and interest. Increased delivery of pharmacy services was significantly associated with both willingness and interest to provide mental illness-specific services. Conclusion Despite willingness/interest to provide services to patients with mental illness, decreased levels of comfort/confidence remain service-related barriers for community pharmacists.
