Off–label long acting injectable antipsychotics in real–world clinical practice: a cross-sectional analysis of prescriptive patterns from the STAR Network DEPOT study

Introduction: Information on the off–label use of Long–Acting Injectable (LAI) antipsychotics in the real world is lacking. In this study, we aimed to identify the sociodemographic and clinical features of patients treated with on– vs off–label LAIs and predictors of off–label First– or Second–Generation Antipsychotic (FGA vs. SGA) LAI choice in everyday clinical practice. Method: In a naturalistic national cohort of 449 patients who initiated LAI treatment in the STAR Network Depot Study, two groups were identified based on off– or on–label prescriptions. A multivariate logistic regression analysis was used to test several clinically relevant variables and identify those associated with the choice of FGA vs SGA prescription in the off–label group. Results: SGA LAIs were more commonly prescribed in everyday practice, without significant differences in their on– and off–label use. Approximately 1 in 4 patients received an off–label prescription. In the off–label group, the most frequent diagnoses were bipolar disorder (67.5%) or any personality disorder (23.7%). FGA vs SGA LAI choice was significantly associated with BPRS thought disorder (OR = 1.22, CI95% 1.04 to 1.43, p = 0.015) and hostility/suspiciousness (OR = 0.83, CI95% 0.71 to 0.97, p = 0.017) dimensions. The likelihood of receiving an SGA LAI grew steadily with the increase of the BPRS thought disturbance score. Conversely, a preference towards prescribing an FGA was observed with higher scores at the BPRS hostility/suspiciousness subscale. Conclusion: Our study is the first to identify predictors of FGA vs SGA choice in patients treated with off–label LAI antipsychotics. Demographic characteristics, i.e. age, sex, and substance/alcohol use co–morbidities did not appear to influence the choice towards FGAs or SGAs. Despite a lack of evidence, clinicians tend to favour FGA over SGA LAIs in bipolar or personality disorder patients with relevant hostility. Further research is needed to evaluate treatment adherence and clinical effectiveness of these prescriptive patterns

Comparing Long-Acting Antipsychotic Discontinuation Rates Under Ordinary Clinical Circumstances: A Survival Analysis from an Observational, Pragmatic Study

Background: Recent guidelines suggested a wider use of long-acting injectable antipsychotics (LAI) than previously, but naturalistic data on the consequences of LAI use in terms of discontinuation rates and associated factors are still sparse, making it hard for clinicians to be informed on plausible treatment courses. Objective: Our objective was to assess, under real-world clinical circumstances, LAI discontinuation rates over a period of 12 months after a first prescription, reasons for discontinuation, and associated factors. Methods: The STAR Network ‘Depot Study’ was a naturalistic, multicentre, observational prospective study that enrolled subjects initiating a LAI without restrictions on diagnosis, clinical severity or setting. Participants from 32 Italian centres were assessed at baseline and at 6 and 12 months of follow-up. Psychopathology, drug attitude and treatment adherence were measured using the Brief Psychiatric Rating Scale, the Drug Attitude Inventory and the Kemp scale, respectively. Results: The study followed 394 participants for 12 months. The overall discontinuation rate at 12 months was 39.3% (95% confidence interval [CI] 34.4–44.3), with paliperidone LAI being the least discontinued LAI (33.9%; 95% CI 25.3–43.5) and olanzapine LAI the most discontinued (62.5%; 95% CI 35.4–84.8). The most frequent reason for discontinuation was onset of adverse events (32.9%; 95% CI 25.6–40.9) followed by participant refusal of the medication (20.6%; 95% CI 14.6–27.9). Medication adherence at baseline was negatively associated with discontinuation risk (hazard ratio [HR] 0.853; 95% CI 0.742–0.981; p = 0.026), whereas being prescribed olanzapine LAI was associated with increased discontinuation risk compared with being prescribed paliperidone LAI (HR 2.156; 95% CI 1.003–4.634; p = 0.049). Conclusions: Clinicians should be aware that LAI discontinuation is a frequent occurrence. LAI choice should be carefully discussed with the patient, taking into account individual characteristics and possible obstacles related to the practicalities of each formulation

Off-label long acting injectable antipsychotics in real-world clinical practice: a cross-sectional analysis of prescriptive patterns from the STAR Network DEPOT study

Introduction Information on the off-label use of Long-Acting Injectable (LAI) antipsychotics in the real world is lacking. In this study, we aimed to identify the sociodemographic and clinical features of patients treated with on- vs off-label LAIs and predictors of off-label First- or Second-Generation Antipsychotic (FGA vs. SGA) LAI choice in everyday clinical practice. Method In a naturalistic national cohort of 449 patients who initiated LAI treatment in the STAR Network Depot Study, two groups were identified based on off- or on-label prescriptions. A multivariate logistic regression analysis was used to test several clinically relevant variables and identify those associated with the choice of FGA vs SGA prescription in the off-label group. Results SGA LAIs were more commonly prescribed in everyday practice, without significant differences in their on- and off-label use. Approximately 1 in 4 patients received an off-label prescription. In the off-label group, the most frequent diagnoses were bipolar disorder (67.5%) or any personality disorder (23.7%). FGA vs SGA LAI choice was significantly associated with BPRS thought disorder (OR = 1.22, CI95% 1.04 to 1.43, p = 0.015) and hostility/suspiciousness (OR = 0.83, CI95% 0.71 to 0.97, p = 0.017) dimensions. The likelihood of receiving an SGA LAI grew steadily with the increase of the BPRS thought disturbance score. Conversely, a preference towards prescribing an FGA was observed with higher scores at the BPRS hostility/suspiciousness subscale. Conclusion Our study is the first to identify predictors of FGA vs SGA choice in patients treated with off-label LAI antipsychotics. Demographic characteristics, i.e. age, sex, and substance/alcohol use co-morbidities did not appear to influence the choice towards FGAs or SGAs. Despite a lack of evidence, clinicians tend to favour FGA over SGA LAIs in bipolar or personality disorder patients with relevant hostility. Further research is needed to evaluate treatment adherence and clinical effectiveness of these prescriptive patterns

Preliminary analysis of the conversion of a leisure boat into a battery electric vehicle (BEV)

The aim of this paper is the study of the conversion of a traditional internal combustion engine-powered leisure boat into an electric propelled type. The study focused primarily on the implementation of a Battery Energy Storage System (BESS), with the intention of making it modular to simplify installation and maintenance operations. The economic and commercial aspect of the new electric boat was also explored. The boat selected for the study is located in the Porto Romano shipyard in Fiumicino. The hull measures were taken to identify the available space for installing a storage system, respecting the weight limits while keeping in mind the power required from the substitutive electric motor. The most suitable type of battery was chosen and a preliminary design of the modular Battery Energy Storage System (BESS) was produced. Then the commercial aspect of the boat was considered in light of its potential users, as its refueling costs and its market positioning. To maintain the same characteristics of the traditional boat, the previous propulsion system was analyzed and the same type of propeller (3-blade bronze) was chosen. Furthermore, the best arrangement of the Storage System was evaluated to obtain the greatest possible autonomy

Coronary artery calcification in patients with CRF not undergoing dialysis.

BACKGROUND: Coronary artery calcification (CAC) correlates with the extent of coronary atherosclerosis and, consequently, with an increased risk for cardiovascular events. CAC is more frequent in uremic patients than in the general population. Nearly all data about CAC relate to patients on dialysis therapy. This study evaluates the prevalence and extent of CAC in patients with chronic renal failure (CRF) not yet on dialysis therapy. METHODS: Consecutive outpatients with CRF not on dialysis therapy were enrolled and compared with controls (ie, healthy volunteers and patients with essential hypertension with normal renal function). Patients and controls were asymptomatic and had no previous history of myocardial infarction, coronary bypass surgery, or angioplasty. Patients with diabetes were excluded. Clinical characteristics, biochemical test results (included homocysteinemia and C-reactive protein level), and serum concentrations of calcium, phosphorus, and intact parathyroid hormone (iPTH) were evaluated in patients and controls. CACs were searched for and scored by means of spiral computed tomography (CT). To assess the CAC progression rate, spiral CT was repeated in some patients. RESULTS: Eighty-five patients and 55 controls were studied. Patients were aged 52 +/- 13 years and had a CRF duration of 6.3 +/- 5.6 years, glomerular filtration rate of 33.0 +/- 16.0 mL/min (0.55 +/- 0.27 mL/s), serum calcium level of 9.5 +/- 0.5 mg/dL (2.37 +/- 0.12 mmol/L), serum phosphorus level of 4.1 +/- 0.9 mg/dL (1.32 +/- 0.29 mmol/L), and serum iPTH level of 143 +/- 121 pg/mL (ng/L). CAC was found in 40% of patients and 13% of controls; calcification scores were 422 +/- 634 in patients and 43.9 +/- 33 in controls. Only age ( P < 0.001) was a predictor of CAC. In patients with a repeated score performed (after a mean of 7.9 months), calcification scores increased (from 383 +/- 627 to 682 +/- 890) in 8 of 10 patients. CONCLUSION: CAC is already present in the early phase of CRF; the prevalence is greater in patients with CRF than in controls, but less than that reported in dialysis patients. Serum concentrations of calcium, phosphorus, iPTH, and inflammation markers do not predict the appearance or progression of CAC