Treatment Of Episodes Research Articles

Initiation and continuation of pharmacological therapies in patients hospitalized for heart failure in Japan.

Currently, the utilization patterns of medications for heart failure (HF) after worsening HF events remain unelucidated in Japan. Here, we conducted a retrospective cohort study evaluating the changes in HF drug utilization patterns in 6 months before and after hospitalizations for HF. The adherence to newly initiated HF medications was evaluated based on the proportion of days covered (PDC) and persistence as continuous treatment episodes among new users. The study included 9091 patients hospitalized for HF between January 2016 and September 2019, including 2735 (30.1%) patients who were newly prescribed at least one HF medication after hospitalization. Despite increases in the use of foundational HF therapy (beta-blockers, angiotensin-converting-enzyme inhibitors/angiotensin receptor blockers, or mineralocorticoid receptor antagonists), 35.6% and 7.6% of patients were treated with the HF foundational monotherapy or diuretics alone after hospitalization, respectively. The mean PDC of newly initiated HF medications ranged from 0.57 for thiazide diuretics to 0.77 for sodium-glucose cotransporter-2 inhibitors. Continuous use of HF medications during the first year after initiation was observed in 30-60% of patients. The mean PDC and one-year continuous HF medication use were consistently lower in patients aged ≥ 75years and in patients with a history of HF hospitalization for all HF medication classes except for tolvaptan and digoxin. Despite the guideline recommendations of HF pharmacotherapy, both treatment and adherence were suboptimal after HF hospitalization, especially in vulnerable populations such as older patients and those with prior HF hospitalizations.

Risk of Cardiovascular Events in Schizophrenic Patients Treated with Paliperidone Palmitate Once-Monthly Injection (PP1M): A Population-Based Retrospective Cohort Study in Taiwan.

Schizophrenia is one of the leading causes of disability. Paliperidone palmitate once-monthly injection (PP1M) was developed to provide consistent drug delivery and improve medication adherence for maintenance treatment. It is well known that patients with schizophrenia have higher cardiovascular risks, however little is known about the cardiovascular risks of patients with schizophrenia treated with PP1M in Asia. This study aimed to estimate the incidence of cardiovascular events after initiating PP1M treatment and evaluate the cardiovascular risk associations compared with oral second-generation antipsychotics (SGAs). Data from Taiwan's National Health Insurance Research Database were used to identify a cohort of adult patients with schizophrenia who received any SGAs from 1 March 2012 to 31 December 2018. Patients who initiated PP1M treatment were enrolled for descriptive analysis of incidence rates. PP1M patients were propensity matched 1:1 to patients initiating a new oral SGA, for comparative analysis based on demographics, clinical characteristics and treatment history at baseline, in three-step matching procedures, following the prevalent new-user design to enhance comparability. Follow-up ended at the end of the treatment episode of index drug, death, last record available, or end of the study (31 December 2019). Study endpoints included serious cardiovascular events (including severe ventricular arrhythmia and sudden death), expanded serious cardiovascular events (which further included acute myocardial infarction and ischemic stroke), and cardiovascular hospitalizations. Risks of study endpoints between matched cohorts were compared using Cox regression. Overall, 11,023 patients initiating PP1M treatment were identified (49.5% were females; mean age of 43.2 [12.2] years). Overall incidences for serious cardiovascular events, expanded serious cardiovascular events, and cardiovascular hospitalizations were 3.92, 7.88 and 51.96 per 1000 person-years, respectively. In matched cohort analysis (N=10,115), the hazard ratios (HRs) between initiating PP1M and a new oral SGA for serious cardiovascular events, expanded serious cardiovascular events, and cardiovascular hospitalizations were 0.86 (95% confidence interval [CI] 0.55-1.36), 0.88 (95% CI 0.63-1.21), and 0.78 (95% CI 0.69-0.89), respectively. This study reported the population-based incidence of cardiovascular events in schizophrenic patients initiating PP1M treatment. PP1M was not associated with increased risks of serious cardiovascular events but was potentially associated with lower risks of cardiovascular hospitalizations compared with oral SGAs.

Spatially resolved immune exhaustion within the alloreactive microenvironment predicts liver transplant rejection.

Allograft rejection is common following clinical organ transplantation, but defining specific immune subsets mediating alloimmunity has been elusive. Calcineurin inhibitor dose escalation, corticosteroids, and/or lymphocyte depleting antibodies have remained the primary options for treatment of clinical rejection episodes. Here, we developed a highly multiplexed imaging mass cytometry panel to study the immune response in archival biopsies from 79 liver transplant (LT) recipients with either no rejection (NR), acute T cell-mediated rejection (TCMR), or chronic rejection (CR). This approach generated a spatially resolved proteomic atlas of 461,816 cells (42 phenotypes) derived from 96 pathologist-selected regions of interest. Our analysis revealed that regulatory (HLADR+ Treg) and PD1+ T cell phenotypes (CD4+ and CD8+ subsets), combined with variations in M2 macrophage polarization, were a unique signature of active TCMR. These data provide insights into the alloimmune microenvironment in clinical LT, including identification of potential targets for focused immunotherapy during rejection episodes and suggestion of a substantial role for immune exhaustion in TCMR.

Costs associated with adverse events during treatment episodes for adult attention-deficit/hyperactivity disorder

Objective Attention-deficit/hyperactivity disorder (ADHD) medication is frequently associated with adverse events (AEs), but limited real-world data exist regarding their costs from a payer’s perspective. Therefore, this study evaluated the healthcare costs associated with common AEs among adult patients treated for ADHD in the US. Methods Eligible adults treated for ADHD were identified from a large US claims database (1 October 2015–30 September 2021). A retrospective cohort study design was used to assess excess healthcare costs and costs directly related to AE-specific claims per-patient-per-month (PPPM) associated with 10 selected AEs during ADHD treatment. To account for all costs associated with the AE, treatment episodes with a given AE were compared to similar treatment episodes without this AE. Entropy balancing was used to create cohorts with similar characteristics. Studied AEs were selected based on their prevalence in clinical trials for common ADHD medications and were identified from ICD-10-CM diagnosis codes recorded in claims. Results Among the 461,464 patients included (mean age: 34.2 years; 45.5% males), 49.4% had ≥1 AE during their treatment episode. Treatment episodes with AEs were associated with statistically significant AE-specific medical costs (erectile dysfunction: $57; fatigue: $82; dry mouth: $90; diarrhea: $162; insomnia: $147; anxiety: $281; nausea: $299; constipation: $356; urinary hesitation: $491; feeling jittery: $723) and excess healthcare costs PPPM (erectile dysfunction: $120, fatigue: $248, insomnia: $265, anxiety: $380, diarrhea: $441, dry mouth: $485, nausea: $709, constipation: $802, urinary hesitation: $1,105, feeling jittery: $1,160; p < .05). Limitations AEs were identified based on recorded diagnosis on medical claims and likely represent more severe AEs. Therefore, costs may not be representative of milder AEs. Conclusions This study found that AEs occurring during ADHD treatment episodes are associated with significant healthcare costs. This highlights the potential of treatments with favorable safety profiles to alleviate the burden experienced by patients and the healthcare system.

Real-world effectiveness of long-acting injectable vs. oral antipsychotics in patients with bipolar I disorder: a 1-year retrospective observational study

Objective Long-acting injectable (LAI) antipsychotics are recommended in the treatment non-adherence. Despite the widespread use of LAI antipsychotics, there is limited data on clinical outcomes in bipolar I disorder (BD-I) patients with real-world data. We aimed to compare BD-I patients treated with LAI and oral antipsychotics (OAP) in terms of treatment effectiveness in a 1-year follow-up period. Methods The study was conducted retrospectively with electronic health records of 116 BDI patients. The primary outcomes were whether patients in the LAI group and the OAP group differed in relapse, rehospitalization, emergency room (ER) visits, and all-cause treatment discontinuation at 1-year follow-up after a mania episode. Cox regression modeling was used to predict the recurrence of any mood episode and all-cause treatment discontinuation during follow-up. The secondary outcomes evaluated were the effects of sociodemographic and clinical parameters and concomitant psychotropic medications on the course of the illness and treatment adherence. Results Of all 116 patients, 33 (28.4%) were under LAI, and 83 (71.6%) were under OAP treatment. LAI users had a history of more hospitalizations and total mood episodes. Patients in the LAI group had more treatment non-adherence before the index hospitalization. At 1-year follow-up, there was no difference between the groups in terms of any mood relapse, rehospitalization, ER visits, and all-cause treatment discontinuation. As a secondary outcome, lithium users were found to have fewer new episodes and discontinuations of treatments. Conclusions In real-world data, there is no evidence that LAI antipsychotics (compared to OAP) are superior in the maintenance treatment of BD. These results are important in terms of reflecting clinical practices for the treatment of BD-I. These results do not devalue the use of LAI therapy in BD; however, more studies are needed to identify positive predictors for LAI treatments in BD.

Estimated Number of Injection-Involved Overdose Deaths in US States From 2000 to 2020: Secondary Analysis of Surveillance Data.

In the United States, both drug overdose mortality and injection-involved drug overdose mortality have increased nationally over the past 25 years. Despite documented geographic differences in overdose mortality and substances implicated in overdose mortality trends, injection-involved overdose mortality has not been summarized at a subnational level. We aimed to estimate the annual number of injection-involved overdose deaths in each US state from 2000 to 2020. We conducted a stratified analysis that used data from drug treatment admissions (Treatment Episodes Data Set-Admissions; TEDS-A) and the National Vital Statistics System (NVSS) to estimate state-specific percentages of reported drug overdose deaths that were injection-involved from 2000 to 2020. TEDS-A collects data on the route of administration and the type of substance used upon treatment admission. We used these data to calculate the percentage of reported injections for each drug type by demographic group (race or ethnicity, sex, and age group), year, and state. Additionally, using NVSS mortality data, the annual number of overdose deaths involving selected drug types was identified by the following specific multiple-cause-of-death codes: heroin or synthetic opioids other than methadone (T40.1, T40.4), natural or semisynthetic opioids and methadone (T40.2, T40.3), cocaine (T40.5), psychostimulants with abuse potential (T43.6), sedatives (T42.3, T42.4), and others (T36-T59.0). We used the probabilities of injection with the annual number of overdose deaths, by year, primary substance, and demographic groups to estimate the number of overdose deaths that were injection-involved. In 2020, there were 91,071 overdose deaths among adults recorded in the United States, and 93.1% (84,753/91,071) occurred in the 46 jurisdictions that reported data to TEDS-A. Slightly less than half (38,253/84,753, 45.1%; 95% CI 41.1%-49.8%) of those overdose deaths were estimated to be injection-involved, translating to 38,253 (95% CI 34,839-42,181) injection-involved overdose deaths in 2020. There was large variation among states in the estimated injection-involved overdose death rate (median 14.72, range 5.45-31.77 per 100,000 people). The national injection-involved overdose death rate increased by 323% (95% CI 255%-391%) from 2010 (3.78, 95% CI 3.33-4.31) to 2020 (15.97, 95% CI 14.55-17.61). States in which the estimated injection-involved overdose death rate increased faster than the national average were disproportionately concentrated in the Northeast region. Although overdose mortality and injection-involved overdose mortality have increased dramatically across the country, these trends have been more pronounced in some regions. A better understanding of state-level trends in injection-involved mortality can inform the prioritization of public health strategies that aim to reduce overdose mortality and prevent downstream consequences of injection drug use.

Prospective validation of a model-informed precision dosing tool for vancomycin treatment in neonates.

We recruited 48 neonates (50 vancomycin treatment episodes) in a prospective study to validate a model-informed precision dosing (MIPD) software. The initial vancomycin dose was based on a population pharmacokinetic model and adjusted every 36-48 h. Compared with a historical control group of 53 neonates (65 episodes), the achievement of a target trough concentration of 10-15 mg/L improved from 37% in the study to 62% in the MIPD group (P = 0.01), with no difference in side effects.

Electroconvulsive Therapy (ECT): A Scotland Wide Naturalistic Study of 4,826 treatment episodes

IntroductionDespite its apparent efficacy in the treatment of a range of psychiatric disorders, electroconvulsive therapy (ECT) is viewed by some as a contentious treatment. Although most clinicians and researchers consider ECT a safe and effective treatment, there are ongoing and significantly publicised concerns about potential side effects.ObjectivesTo explore use of ECT across Scotland in a large naturalistic clinical sample across an 11-year period from 2009 to 2019. To consider the efficacy and side effects of ECT for a range of common psychiatric disorders including, depression, bipolar depression, schizophrenia, and mania.MethodsUsing data from the Scottish Electroconvulsive Therapy (ECT) Accreditation Network (SEAN), information was collected for all adults who had received ECT. Variables included age, sex, Scottish Index of Multiple Deprivation (SIMD) quintile, International Classification of Diseases, Tenth Edition (ICD-10) diagnosis, indication for ECT, Mental Health Act status, consent status, entry and exit Montgomery-Asberg Depression Rating Scores (MADRS), entry and exit Clinical Global Index Severity CGI-S) scores and reported side effects. Side effects were recorded as present if the side effect was reported at any point during the episode of treatment.Results4826 ECT episodes were recorded. The majority of episodes were in women (68.4%, n=3,301). Average age at treatment onset was 58.52 years. Males were slightly younger (m=58.24 years vs f= 58.65 years, p= 0.20). Mean number of treatments/episode was 9.59 (95% CI 9.32 – 9.85). Mean treatment dose delivered was 277.75mC (95%CI 272.88 – 282.63mC).2920 episodes of treatment had CGI-S entry and exit recorded. At entry, mean CGI-S indicated marked illness (5.03 95% CI 4.99-5.07). Recipients with schizophrenia had the highest CGI-S score (5.45 95% CI 5.21-5.60), followed by those with post-partum disorders (5.38, 95% CI 4.61-6.14). At exit, mean CGI scores indicated borderline illness (2.07, 95% CI 2.03-2.11), recipients diagnosed with mixed affective state had the lowest CGI-S score (1.72, 95% CI 0.99-2.47) followed by those with schizoaffective disorder (2.01, 95% CI 1.76-2.42).Anaesthetic complications (n=34) and prolonged seizures (n=38) were rare, occurring in &lt;1% of treatment episodes. Cardiovascular complications were reported in 2.2% (n= 102). Nausea was reported in 7.2% (n= 334) and muscle aches in 12% (n=560). Confusion was reported in 19% (n=879) and cognitive side effects were reported in 26.2% (n=1212). One third of treatment episodes reported confusion or cognitive side effects (33.1%, n=1545).ConclusionsFrom this large naturalistic clinical sample, ECT appears to be effective in improving illness severity as measured by CGI-S score. While some side effects (such as prolonged seizures and cardiovascular complications) were rare, others (such as confusion or cognitive side effects) were relatively common.Disclosure of InterestNone Declared

Comparing nurses attending a specialised mental health programme with and without substance use disorder: a retrospective, observational study in Spain

ObjectivesTo analyse the differences between nurses with and without substance use disorders (SUDs) admitted to a specialised mental health programme.DesignRetrospective, observational study.SettingSpecialised mental health treatment programme for nurses in Catalonia,...

Self-help group (SHG) attendance and treatment outcomes among older adults in the US

BackgroundSubstance dependency is a global problem and significantly affects the geriatric population in the United States. This study aims to determine how self-help group (SHG) attendance affects substance use treatment outcomes among older adults in the US. MethodsThis cross-sectional study used the 2020 discharge treatment episodes data set (TEDS-D)fromthe Substance Abuse and Mental Health Services Administration (SAMHSA). Multivariable logistic regression was used to evaluate the relationship between self-help group attendance and treatment outcomes among older adults. ResultsWe included 3,424 older adults (19.2% female). The primary substance use was alcohol in more than two-thirds of the participants (67.9%), while heroin (17.1%), cocaine (5.8%), and other opiates/synthetics (3.3%) were the other common primary substance of abuse among other participants. In the multivariate logistic regression analysis, SHG attendance at discharge from treatment facility was significantly associated with reduced frequency of use of primary substance -FUPS (p-value = 0.013) and increased odds of treatment completion (p-value <0.001) but no significant association with arrests at discharge from treatment facility (p-value = 0.101). SHG attendance on admission into treatment facility was associated with reduced odds of treatment completion (p-value <0.001). Having a living arrangement at discharge was found to be associated with reduced FUPS (p-value <0.001) but with lower odds of treatment completion (p-value <0.001). ConclusionAssociation of SHG attendance with positive treatment outcomes indicates the need to enhance access to this service in the geriatric population.

Long-term safety, tolerability and efficacy of apomorphine sublingual film in patients with Parkinson’s disease complicated by OFF episodes: a phase 3, open-label study

BackgroundApomorphine sublingual film (SL-APO) is an on-demand treatment for OFF episodes in patients with Parkinson’s disease (PD).ObjectiveTo assess the long-term (≥ 3 years) safety/tolerability and efficacy of SL-APO.MethodsStudy CTH-301 (http://www.clinicaltrials.gov NCT02542696; registered 2015-09-03) was a phase 3, multicentre, open-label study of SL-APO in PD patients with motor fluctuations, comprised of a dose-titration and long-term safety phase. All participants received SL-APO. The primary endpoint was safety/tolerability (treatment-emergent adverse events [TEAEs]) during the long-term safety phase. Efficacy assessments included the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III (motor examination), assessed at weeks 24, 36 and 48 during the first year of the long-term safety phase.Results496 patients were included and 120 (24.2%) completed the long-term safety phase. Mean duration of SL-APO exposure was 294.3 days. TEAEs related to study drug were experienced by 65.3% of patients (most common: nausea [6.0%], stomatitis [1.8%], lip swelling [1.8%], dizziness [1.6%], oral mucosal erythema [1.6%], mouth ulceration [1.6%]). TEAEs leading to study drug withdrawal were experienced by 34.0% of patients (most common: nausea [5.4%], lip swelling [4.5%], mouth ulceration [2.6%], stomatitis [2.3%]). A clinically meaningful reduction in MDS-UPDRS part III score was observed as soon as 15 min following administration of SL-APO, with peak effects observed approximately 30 min post-dose and sustained up to 90 min post-dose; results were consistent over 48 weeks.ConclusionsSL-APO was generally well tolerated and efficacious over the long term as an on-demand treatment for OFF episodes in patients with PD.

Survey of hereditary angioedema episodes and quality of life impairment through a patient-participatory registry

Hereditary angioedema (HAE) adversely affects patients’ social and daily life significantly, and the disease burden is high. We recruited study participants from a patient-participatory registry, Rare and Undiagnosed Diseases Study (RUDY) Japan, to better understand the broader effect of HAE on patients’ lives. Thirteen patients with HAE who registered between January 2019 and March 2021 completed an online questionnaire to record details of episodes and the angioedema quality of life (AE-QoL) questionnaire, in which they described the degree to which QoL was impaired. In all, 58 episodes were recorded, and self-reported data were accumulated from 24 returned AE-QoL questionnaires. The episodes peaked between approximately 06:00 and 07:00 h and between approximately 16:00 and 20:00 h. Of the 58 episodes, 38 (65.5%) were treated; 24 (63.2%) were treated at patients’ homes. The drugs used in treatment were hospital-administered human C1-inhibitor preparations for 14 episodes and home-administered icatibant for 26 episodes. Time between episode onset and treatment initiation and between episode onset and full recovery tended to be shorter with icatibant treatment at home. The total AE-QoL score was 37.1 ± 22.9, indicating great impairment of QoL, with particularly high scores in the fatigue/mood and fears/shame domains. Most previous studies of real-world HAE episodes have been retrospective, based on patients’ memories. Collaboration between patients and researchers revealed the location of episodes, the time of day they appeared, treatments for episodes, and the degree to which patients’ QoL was impaired by HAE in this prospective study.

Evaluation of the Effect of Fluid and Electrolyte Therapy on Electrolytes and Acidosis Resolution Time in Diabetic Ketoacidosis

Objective: Fluid replacement and insulin infusion are the cornerstones of treatment of diabetic ketoacidosis, but the optimal volume, rate of infusion, and electrolyte content of fluid replacement have been controversial. The aim of this study was to investigate the effects of treatment on pH, bicarbonate (HCO3), anion gap, chloride, and potassium levels as well as time to resolution of acidosis in children with diabetic ketoacidosis. Material and Methods: Ninety-six episodes with diabetic ketoacidosis between January 2015-December 2017 were evaluated. Results: The mean resolution time of acidosis was 13.4±7.1 hours. Anion gap was returned to normal in 68 (70.8%) episodes at the 4th hour of treatment with a mean of 11±4.2 mmol/L. Episodes with potassium phosphate (KPO4) replacement resulted in a faster increase in pH and a significantly shorter resolution time of acidosis (p&amp;lt;0.001). Acidosis persisted at the 16th hour of treatment in episodes with lower pH, lower serum bicarbonate (HCO3) and higher white blood cell (WBC) counts on admission (p&amp;lt;0.001, p=0.003 p=0.033, respectively). Hyperchloremia (Cl/Na ratio &amp;gt; 0.79) was observed in 97% of cases after 8 hours of treatment. Conclusion: Although the value of the anion gap in predicting acidosis is controversial, severe DKA episodes and high white blood cell count at admission; potassium replacement with high amounts of chloride and KCl containing fluids given during treatment have been associated with a longer recovery time of acidosis.

Evaluation of adherence to antipsychotics: A real-world data study using four different dosing assumptions.

This study aimed to assess the frequency of dosing inconsistencies in prescription data and the effect of four dosing assumption strategies on adherence estimates for antipsychotic treatment. A retrospective cohort, which linked prescription and dispensing data of adult patients with ≥1 antipsychotic prescription between 2015-2016 and followed up until 2019, in Catalonia (Spain). Four strategies were proposed for selecting the recommended dosing in overlapping prescription periods for the same patient and antipsychotic drug: (i) the minimum dosing prescribed; (ii) the dose corresponding to the latest prescription issued; (iii) the highest dosing prescribed; and (iv) all doses included in the overlapped period. For each strategy, one treatment episode per patient was selected, and the Continuous Medication Availability measure was used to assess adherence. Descriptive statistics were used to describe results by strategy. Of the 277 324 prescriptions included, 76% overlapped with other prescriptions (40% with different recommended dosing instructions). The number and characteristics of patients and treatment episodes (18 292, 18 303, 18 339 and 18 536, respectively per strategy) were similar across strategies. Mean adherence was similar between strategies, ranging from 57 to 60%. However, the proportion of patients with adherence ≥90% was lower when selecting all doses (28%) compared with the other strategies (35%). Despite the high prevalence of overlapping prescriptions, the strategies proposed did not show a major effect on the adherence estimates for antipsychotic treatment. Taking into consideration the particularities of antipsychotic prescription practices, selecting the highest dose in the overlapped period seemed to provide a more accurate adherence estimate.

Associations between alcohol taxes and varied health outcomes among women of reproductive age and infants.

No studies have examined whether alcohol taxes may be relevant for reducing harms related to pregnant people's drinking. We examined how beverage-specific ad valorem, volume-based, and sales taxes are associated with outcomes across three data sets. Drinking outcomes came from women of reproductive age in the 1990-2020 US National Alcohol Surveys (N = 11659 women $\le$ 44years); treatment admissions data came from the 1992-2019 Treatment Episode Data Set: Admissions (N = 1331 state-years; 582436 pregnant women admitted to treatment); and infant and maternal outcomes came from the 2005-19 Merative Marketscan® database (1432979 birthing person-infant dyads). Adjusted analyses for all data sets included year fixed effects, state-year unemployment and poverty, and accounted for clustering by state. Models yield no robust significant associations between taxes and drinking. Increased spirits ad valorem taxes were robustly associated with lower rates of treatment admissions [adjusted IRR = 0.95, 95% CI: 0.91, 0.99]. Increased wine and spirits volume-based taxes were both robustly associated with lower odds of infant morbidities [wine aOR = 0.98, 95% CI: 0.96, 0.99; spirits aOR = 0.99, 95% CI: 0.98, 1.00] and lower odds of severe maternal morbidities [wine aOR = 0.91, 95% CI: 0.86, 0.97; spirits aOR = 0.95, 95% CI: 0.92, 0.97]. Having an off-premise spirits sales tax was also robustly related to lower odds of severe maternal morbidities [aOR = 0.78, 95% CI: 0.64, 0.96]. Results show protective associations between increased wine and spirits volume-based and sales taxes with infant and maternal morbidities. Policies that index tax rates to inflation might yield more public health benefits, including for pregnant people and infants.

Sociodemographic and treatment-related determinants of recent substance use among adults with comorbid substance misuse and psychotic disorders discharged from substance use treatment

IntroductionRates of alcohol and illicit substance use are higher among persons with psychotic disorders relative to the general population. The adverse health and psychological effects of substance use behaviors disproportionately impact persons with psychotic disorders. Prior research has shown that persons with psychotic disorders experience increased difficulty in reducing substance use behaviors, and interventions targeting substance use behavior change among this population have demonstrated limited effectiveness. One reason for this is that little is known about the factors that influence substance use and behavior change among this population. To address these disparities, the present study investigated sociodemographic and treatment-related factors of substance use recurrence among persons with psychotic disorders who received substance use treatment services. MethodsData came from the 2015–2018 Treatment Episode Dataset-Discharges (TEDS-D). TEDS-D collects annual data on adolescent and adult discharges from state-certified substance use treatment centers in the United States. The study conducted all analyses with a subsample of 1956 adult discharges with a psychotic disorder who received services from an outpatient substance use treatment center for at least one month. χ2 tests of independence and multivariable logistic regression analyses were used to examine associations of sociodemographic and treatment-related characteristics with substance use recurrence while in treatment (α < 0.05 analyses). The study presents results from multivariable logistic regression models as adjusted odds ratios (AORs) with 95 % confidence intervals (CI). ResultsThose who were age 50 or older, were referred to treatment by the criminal justice system, and attended substance use self-help groups had lower odds of substance use recurrence while in treatment. Sex, educational attainment, employment status, living situation, type of substance use, and treatment history were not significantly associated with substance use recurrence. ConclusionsIn designing treatment services, providers should consider whether focusing on sociodemographic, including cultural, factors can affect more positive substance use behavior change and other desired treatment outcomes among those with psychotic disorders and comorbid substance misuse. Further study is needed to identify these factors among specific subpopulations of those with psychotic disorders and substance misuse.

An Australian retrospective observational cohort comparison of the use of long-acting injectable buprenorphine products

IntroductionIn early 2019, Australia became the first jurisdiction to have two brands of long-acting injectable buprenorphine (LAI-B) products available. Previously published studies have mostly followed pre-planned dosing schedules and seldom compared use of both products. This study presents a retrospective analysis of the “real-world” dosing requirements of patients on LAI-B. MethodFive clinics provided data for patients commenced on LAI-B between 1 February 2019 and 30 June 2021 for buprenorphine doses and intervals between dosing. The study recorded basic demographic data including age, gender, and previous dose of transmucosal buprenorphine. The Local Institutional Ethics Committee provided approval. ResultsOver 3600 individual doses (59 % Buvidal® & 41 % Sublocade®) were administered to 340 individual patients (median age 40 years, 63 % male), with the longest duration in treatment of 856 days. Median estimated duration of a treatment episode was 16.5 months (95%CI: 14.3–19.1). Approximately 94 % transferred from transmucosal buprenorphine (median daily dose 16 mg, range 2-32 mg). Most common LAI-B doses were Sublocade® 100 mg (22.4 %) and Buvidal® Monthly 128 mg (21.5 %); Buvidal® Weekly 24 mg (0.8 %) was least used. 13 % transitioned between LAI-B products. Weekly dose intervals were a median 7 days and monthly doses were given a median of 28 days apart. Overall, 36 % discontinued LAI-B before the census date. Discussions and conclusionsMost patients who started LAI-B remained in treatment, with similar rates in both products. A small, but appreciable number of people switched brands, suggesting that it remains important to have treatment options available.

Factors associated with receipt of medication for opioid use disorder among pregnant individuals entering treatment programs in the U.S.

BackgroundOpioid use disorder (OUD) among pregnant individuals in the U.S. has been on the rise, and carries significant health risks if left untreated. Despite the effectiveness of medication for opioid use disorder (MOUD), rates of treatment utilization remain low, and access varies by state. This study seeks to expand on what is known about the utilization of MOUD by estimating annual percentages of MOUD use among treatment admissions among pregnant individuals across all 50 states and U.S. regions. The study also examines how pregnant people experiencing OUD are referred to substance use treatment programs to better understand which referral sources are most effective at linking them to MOUD. MethodsThis study estimated MOUD utilization among pregnant admissions over a 9-year period, identifying trends in the use of this treatment, using national and state level data from the Treatment Episode Dataset-Admissions (TEDS-A). The sample were pregnant females who admitted to treatment with opioids as a primary substance use problem, in all 50 states, from 2010 to 2018. The study examined the referral pathways through which pregnant individuals enter treatment, identifying variations in how they are linked with MOUD. A binary logistic regression was conducted to estimate significant sociodemographic characteristics and referral sources associated with MOUD receipt in treatment. ResultsAmong admissions who reported both pregnancy and OUD across nine years (n= 84,492), the average percentage of MOUD use was 50.8%. Average annual MOUD use was highest in the Northeast region (63.42%), and lowest in the South (34.01%). Maine had the highest MOUD use, for an average of 81.99% across all years. Pregnant individuals who were self-referred to treatment comprised the largest percentage of admissions leading to MOUD use (62.1%), and those referred by the criminal justice system or other legal entity resulted in the lowest MOUD use across years (23.6%). Binary logistic regression results found that race, education, employment status, and referral source were significantly associated with MOUD receipt in 2018; specifically, individuals with a higher education, those were unemployed, and those who were referred to treatment by another substance use or healthcare provider or from the criminal or legal system, were significantly less likely to receive MOUD. ConclusionThis study estimated that an average of approximately half of admissions who were pregnant with OUD received MOUD as part of their treatment plans, and identified regional and state trends which can be further investigated to understand factors contributing to these geographical variations in MOUD access. Also notable were findings pertaining to low MOUD receipt among those referred from criminal or legal entities, warranting further investigation. These findings can lead to a better understanding of which referral sources to treatment can act as effective pathways to MOUD, and best practices to link pregnant individuals with evidence-based care.

Tigecycline-associated hypofibrinogenemia: A single center, retrospective, controlled study

BackgroundTigecycline-associated hypofibrinogenemia has been reported as an important adverse effect in recent years, but controlled studies minimizing confounding factors are needed. The objective of our study was to assess changes in fibrinogen levels in patients for hospitalization, comparing two antibiotic episodes (tigecycline and other) within the same patients. MethodsThe retrospective, self-controlled case series study was conducted at our University Hospitals. The study compared the change in fibrinogen levels during the patient's hospitalization for tigecycline (TigePer) and another antibiotic period (OtherPer). In addition, bleeding events, bleeding risk (determined by the IMPROVE bleeding risk score), as well as 15- and 30-day mortality rates between TigePer and OtherPer were compared. ResultsThe study enrolled 50 patients with 100 episodes of antibiotic treatment. The median age (interquartile range) of the patients was 68.5 (21.5) years, and 38 % were female. As compared to OtherPer, TigePer had a statistically significant reduction in fibrinogen levels (p < 0.001), with a hypofibrinogenemia rate of 40 % in TigePer as compared to 2 % in OtherPer (p < 0.001). TigePer demonstrated a significantly higher 15-day mortality rate (p = 0.006). No significant differences were observed between the two periods in terms of bleeding risk, rate of bleeding events, and 30-day mortality rate (p > 0.05). ConclusionHypofibrinogenemia and other coagulopathies, without associated bleeding events, are more frequently observed in patients receiving tigecycline. Therefore, it is crucial for clinicians to monitor fibrinogen levels during tigecycline use.

A Post-Authorization Safety Surveillance Study to Report Clinical Experience with Purified Factor IX Concentrate in Pediatric Patients with Hemophilia B.

Purified factor IX (FIX) concentrate (IMMUNINE®, Takeda Manufacturing Austria AG, Vienna, Austria) is indicated for the treatment and prophylaxis of bleeding episodes in patients with congenital hemophilia B. Data on the use of purified FIX concentrate in patients ≤6 years old with congenital hemophilia B are limited. Document real-world clinical experience with purified FIX concentrate in routine practice for pediatric patients with hemophilia B. This prospective post-authorization safety surveillance study enrolled patients ≤6 years old with moderate or severe hemophilia B (baseline FIX ≤5%) who were prescribed purified FIX concentrate, as determined by the treating physician. The planned observation period for each patient was either 12 months or ≥50 exposure days, whichever occurred first. The primary endpoints were the occurrence of treatment-related adverse events (AEs) and serious AEs (SAEs), and inhibitor development. Thirteen male patients (mean ± standard deviation age, 3.80 ± 1.76 years) enrolled and received ≥1 treatment with purified FIX concentrate. Thirty-two AEs were reported in 6 patients; 4 were SAEs. No AEs were considered related to purified FIX concentrate. No patients developed inhibitory antibodies. Inhibitor testing was not conducted in 2 patients. Eighteen bleeding episodes were treated with purified FIX concentrate in 6 patients. Hemostatic efficacy was rated as either "excellent" or "good" in all patients with an available rating. No treatment-related AEs were reported, and purified FIX concentrate was shown to be effective in treating and preventing bleeding episodes in pediatric patients ≤6 years old with hemophilia B.