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In this article we investigate the post-launch retail prescription trends of asenapine (Saphris®, Merck and Co.) and iloperidone (Fanapt®, Vanda Pharmaceuticals Inc./Novartis), two new atypical antipsychotics to launch in the United States market in October 2009 and January 2010, respectively. In the first 12 months following the asenapine launch, and in the nine months since the iloperidone launch, asenapine and iloperidone have secured 0.22 and 0.10 percent of the total prescription market; however, both products nearly double those respective shares when total prescriptions are isolated to new patient prescriptions (0.44% for asenapine and 0.17% for iloperidone). Since launch, asenapine has shown stronger signs of growth, largely attributed to its approval in multiple indications as compared to iloperidone's single indication. [ABSTRACT FROM AUTHOR]

In this article, the authors explore trends in intended usage of atypical antipsychotics to treat dementia following the United States Food and Drug Administration advisory safety warning issued in April 2005. Analysis suggests that physician-reported intended usage of antipsychotics to treat dementia has declined by nearly 50 percent over the past five years. When reviewing the products intended for use in the treatment of patients with dementia, atypical intended usage has declined considerably while the intended usage of anti-Alzheimer's disease treatments has grown to replace those shares. [ABSTRACT FROM AUTHOR]

In this article, we investigate the range of treatments prescribed for bipolar disorder. Our analysis shows that, while a large portion of patients is treated by a single mechanism of action (44%), an equally sizable group of patients receives two or more drug classes (56%) to treat the disorder. From a therapeutic class perspective, 71 percent of patients with bipolar disorder receive an atypical antipsychotic, 53 percent receive a mood stabilizer, and 30 percent receive an antidepressant. While antipsychotics and mood stabilizers represent the vast majority of bipolar disorder monotherapy (90%), antidepressants are more commonly seen as part of a combination treatment. [ABSTRACT FROM AUTHOR]

In this article, we explore the current state of the psychiatry drug development pipeline. Analysis suggests that overall, the psychiatry pipeline is heavily skewed toward a few major indications and tends to have more programs in early development (Phase I and II) than later stages (Phase III). A review of development sponsors shows a fairly even split of programs between Top 50 Pharmaceutical companies and small to mid-sized biopharmaceutical companies. [ABSTRACT FROM AUTHOR]

In this article, we explore the accelerated penetration of generic antidepressants in the United States market following the availability of generic citalopram and sertraline. Analysis suggests that overall, generic penetration into the antidepressant market has grown from approximately 41 percent in January 2004 to over 73 percent in January 2010. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty. [ABSTRACT FROM AUTHOR]

Menopause is a normal part of aging and in the general population is associated with chronic conditions that impact health, mortality, and well-being. Menopause is experienced differently by autistic individuals, although no studies have investigated this topic in a large sample. The purpose of this study was to investigate rates of, and factors associated with symptomatic menopause among autistic individuals and to identify the prevalence of co-occurring conditions in symptomatic individuals. We included autistic females aged 35-70 years enrolled for 10 + months in 2014-2016 Medicare and/or Medicaid (n = 26,904), excluding those with gender dysphoria. Those with symptomatic menopause were compared to a non-symptomatic reference group on demographic, enrollment characteristics, and co-occurring conditions through logistic regression. Approximately 4% of publicly-insured autistic females aged 46-70 years had symptomatic menopause in their medical records. Intellectual disability was associated with a lower likelihood of symptomatic menopause, and being Medicare-enrolled or dual-enrolled was associated with higher likelihood of having symptomatic menopause recorded. In adjusted models, rates of ADHD, anxiety and depressive disorders, headache/migraine, altered sensory experiences, altered sexual function, and sleep disturbance were significantly higher in the symptomatic menopause sample compared to the reference group. More work to better support autistic women in discussing menopausal symptoms and co-occurring conditions with primary care providers is needed, particularly among those for whom self-report of symptoms are more challenging to ascertain. Factors associated with specific types of health care coverage warrant greater investigation to support better identification., (© 2024. The Author(s).)

Background: The autistic population is rapidly increasing; meanwhile, autistic adults face disproportionate risks for adverse COVID-19 outcomes. Limited research indicates that autistic individuals have been accepting of initial vaccination, but research has yet to document this population's perceptions and acceptance of COVID-19 boosters., Objective: This study aims to identify person-level and community characteristics associated with COVID-19 vaccination and booster acceptance among autistic adults, along with self-reported reasons for their stated preferences. Understanding this information is crucial in supporting this vulnerable population given evolving booster guidelines and the ending of the public health emergency for the COVID-19 pandemic., Methods: Data are from a survey conducted in Pennsylvania from April 11 to September 12, 2022. Demographic characteristics, COVID-19 experiences, and COVID-19 vaccine decisions were compared across vaccination status groups. Chi-square analyses and 1-way ANOVA were conducted to test for significant differences. Vaccination reasons were ranked by frequency; co-occurrence was identified using phi coefficient correlation plots., Results: Most autistic adults (193/266, 72.6%) intended to receive or received the vaccine and booster, 15% (40/266) did not receive or intend to receive any vaccine, and 12.4% (33/266) received or intended to receive the initial dose but were hesitant to accept booster doses. Reasons for vaccine acceptance or hesitancy varied by demographic factors and COVID-19 experiences. The most significant were previously contracting COVID-19, desire to access information about COVID-19, and discomfort with others not wearing a mask (all P=.001). County-level factors, including population density (P=.02) and percentage of the county that voted for President Biden (P=.001) were also significantly associated with differing vaccination acceptance levels. Reasons for accepting the initial COVID-19 vaccine differed among those who were or were not hesitant to accept a booster. Those who accepted a booster were more likely to endorse protecting others and trusting the vaccine as the basis for their acceptance, whereas those who were hesitant about the booster indicated that their initial vaccine acceptance came from encouragement from someone they trusted. Among the minority of those hesitant to any vaccination, believing that the vaccine was unsafe and would make them feel unwell were the most often reported reasons., Conclusions: Intention to receive or receiving the COVID-19 vaccination and booster was higher among autistic adults than the population that received vaccines in Pennsylvania. Autistic individuals who accepted vaccines prioritized protecting others, while autistic individuals who were vaccine hesitant had safety concerns about vaccines. These findings inform public health opportunities and strategies to further increase vaccination and booster rates among generally accepting autistic adults, to better support the already strained autism services and support system landscape. Vaccination uptake could be improved by leveraging passive information diffusion to combat vaccination misinformation among those not actively seeking COVID-19 information to better alleviate safety concerns., (©Lindsay Shea, Dylan Cooper, Jonas Ventimiglia, Shelby Frisbie, Conner Carlton, Wei Song, Mark Salzer, Brian Lee, Emily Hotez, David J Vanness. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 28.08.2024.)

Research has demonstrated that autistic individuals have higher rates of police contact, however, research has seldom explored the fundamental reasons for these interactions and how this might vary across international contexts. To remedy this, the Global Autism and Criminal Justice Consortium created and disseminated the Global Criminal Justice Survey. Descriptive statistics of survey respondents with and without police contact were compared to glean differential characteristics. Frequency and type of recent police interactions (within the last 5 years) among autistic individuals were also examined to better contextualize the reasons that autistic individuals encounter police. Study findings indicated that across a global sample (i.e., North America, Scandinavia, Europe, and Oceania) nearly half of all autistic individuals had an interaction with police and that those with a history of police contact were usually older, had higher educational qualifications, and were more likely to have a co-occurring mental health or developmental disorder. Among types of interactions, noncriminal encounters, such as welfare checks, traffic incidents, wandering, and behaviors associated with autism, were most common, followed by autistic individuals alleging a crime was committed against them. These findings offer important directions for future research and for targeted policy responses that can address the unique needs of autistic individuals within the justice system., (© 2024 International Society for Autism Research and Wiley Periodicals LLC.)

Importance: Youth with intellectual and developmental disabilities (I/DD) are more likely to be placed in foster care than other youth. Examining the clinical and sociodemographic characteristics of youth with I/DD in the foster care system is critical for identifying disparities and understanding service needs., Objective: To produce a population-level analysis of youth with I/DD in foster care that examines differences in rates of foster care involvement based on race, ethnicity, age, and sex., Design, Setting, and Participants: This cross-sectional study involved all individuals with I/DD 21 years and younger enrolled in Medicaid through foster care in 2016 via data from Transformed Medicaid Statistical Information System (T-MSIS) Analytic Files (TAF) for all 50 US states and Washington, DC. As a key insurer of I/DD services and foster care, Medicaid claims offer a timely population-level analysis. Youth with I/DD were grouped into diagnostic subgroups: autism spectrum disorder (ASD) only, intellectual disability only, or ASD and ID. The data analysis took place from July 2022 to September 2023., Exposure: TAF data contain Medicaid enrollment information by month with a binary indicator of foster care involvement, and eligibility files identify race, ethnicity, age, and sex., Main Outcomes and Measures: The period prevalence of foster care involvement was determined among I/DD youth by diagnostic subgroups using an intersectional approach across race, ethnicity, age, and sex. Logistic regression examined associations between risk for foster care involvement and race, ethnicity, age, and sex., Results: A total of 39 143 youth with I/DD had foster care involvement in 2016. Black youth (adjusted odds ratio [aOR], 1.37; 95% CI, 1.28-1.47) and females (aOR, 1.18; 95% CI, 1.1-1.27) had increased likelihood for foster care involvement. The likelihood for foster care involvement increased with age in all groups relative to the age group 0 to 5 years old., Conclusions and Relevance: This study found that among youth with I/DD, Black youth and females faced higher risk for foster care involvement, and the likelihood of foster care involvement increased with age. There is an urgent need for research that focuses on addressing system-level factors that drive increased risk. Understanding the specific health needs of Black and female youth with I/DD is critical to ensure the formation, implementation, and monitoring of equitable delivery of health services.

Policy Points Employment is a key social determinant of health and well-being for the estimated 5.4 million autistic adults in the United States-just as it is for citizens without disabilities. Evaluation and monitoring of publicly funded employment services is paramount given the dramatic increases in adults with autism who need job supports. Vocational Rehabilitation agencies appeared to be absorbing short-term employment needs of autistic people, but Medicaid was severely lacking-and losing ground-in serving those who need longer-term employment services. Across both Vocational Rehabilitation and Medicaid, we estimated that only 1.1% of working-age autistic adults who potentially need employment services are actually receiving them-leaving an estimated 1.98 million autistic individuals without the employment services that are associated with achievement of well-being., Context: Employment is a key social determinant of health. As such, high rates of unemployment, underemployment, and poverty across the rapidly growing autistic population are concerning. A web of publicly funded services exists to support the employment, and associated health and well-being, of United States citizens with autism and other intellectual and developmental disabilities, namely through Vocational Rehabilitation (VR) and Medicaid home- and community-based services (HCBS) waivers. Given an absence of overarching surveillance of employment services, this study aimed to characterize the distribution of autistic service users across Medicaid versus VR, understand the types of employment services utilized within these programs and expenditures, and assess overall capacity to provide employment services as needs continue to increase., Methods: This study examined the distribution of employment services among autistic people compared with those with intellectual disability using 2008-2016 data from the Centers for Medicare & Medicaid Services and the Rehabilitation Services Administration. Estimated need for employment services among autistic individuals was compared with capacity derived from VR service counts and a review of HCBS waivers., Findings: The number of autistic people served through VR tripled during the study years, whereas those served through Medicaid only increased slightly. VR spending increased by 384% over the study years, whereas Medicaid costs decreased by 29%. Across VR and Medicaid, we estimated that only 1.1% of working-age autistic adults who needed employment services received them., Conclusions: Although VR appeared to be absorbing short-term employment needs of autistic individuals, Medicaid was severely lacking-and losing ground-in serving those who needed longer-term employment services. VR far outpaced Medicaid in both the number of autistic people served and total expenditures across the study years. However, an estimated 1.98 million autistic adults did not receive employment services that could be critical to improving their health and well-being., (© 2023 Milbank Memorial Fund.)

Substance use, HIV/AIDS, domestic violence and mental health (SAVAME) are syndemic health issues that disproportionately burden Latinos in the U.S. Yet, there are limited evidence-based interventions to address these interrelated syndemic issues and their shared socio-ecological determinants. This study sought to test the feasibility and acceptability of CRiSOL, a peer-based, resilience-focused intervention to reduce the impact of the SAVAME syndemic on Latino immigrants. Fifteen Latino immigrant community leaders were recruited and trained to serve as health promotion agents in their naturally existing social networks. The training was implemented with high fidelity, received with high satisfaction by the peer leaders, and associated with significant improvements in their knowledge, leadership skills, and social capital. During an 8-month outreach phase, nine leaders remained active in the program and documented 825 one-on-one interactions with community members, during which they provided advice/counseling (52.2% of interactions), health information/education (32.5%), referrals to health and social services (38.5%), food aid (39.9%), and service navigation/assistance (10.2%). While future research must be conducted to establish the effectiveness of CRiSOL, findings from this pilot evaluation indicate the feasibility, acceptability, and high level of reach of this intervention and suggest significant potential to reduce the SAVAME syndemic burden in Latino communities., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Martinez-Donate et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Prcis: This retrospective study found a statistically significant reduction in mean intraocular pressure (IOP) and the number of medications after intracameral Bimatoprost sustained release (SR) injection in patients with glaucoma. A history of selective laser trabeculoplasty (SLT) did not impact treatment outcomes., Purpose: To determine outcomes of Bimatoprost SR on IOP and the number of topical IOP-lowering medications in patients with glaucoma. A secondary objective was to determine the outcomes of Bimatoprost SR in patients with a prior history of SLT., Methods: Retrospective case series. One hundred eighteen eyes from 84 patients that received Bimatoprost SR by 6 glaucoma specialists at Wills Eye Hospital from March 2020 to September 2021 were examined. The intervention was a single injection of intracameral Bimatoprost SR. The main outcome measures included IOP and the number of medications., Results: The most recent mean follow-up time for all eyes was 27.8 ± 18.6 weeks. The mean posttreatment IOP at the most recent follow-up of 16.6 ± 5.3 mm Hg was significantly lower than the mean under-therapy pretreatment IOP of 18.5 ± 5.7 mm Hg for all eyes ( P < 0.01). The mean posttreatment number of medications at the most recent follow-up of 1.3 ± 1.3 decreased compared with the number of pretreatment medications of 2.1 ± 1.4 for all eyes ( P < 0.01). Analysis of multilevel models controlling for demographic variables demonstrated a statistically significant reduction in IOP and number of medications posttreatment ( P < 0.01). A prior history of SLT (n = 54) had no impact on treatment for both IOP and the number of medications ( P > 0.1 for both)., Conclusions: Intracameral Bimatoprost SR reduced IOP and decreased the number of medications. Prior history of SLT did not impact Bimatoprost SR treatment outcomes., Competing Interests: Disclosure: R.M.N.: Allergan/Abbvie. M.R.M.: Allergan, Glaukos, Bausch and Lomb, Alcon, Nicox, Santen, Qura. M.J.P.: New World Medical. N.N.K.: Abbvie/Allergan, Guardion Health Services Inc, Equinox, Nicox, Olleyes, Santen, Glaukos, Diopsys, Aerie, Regeneron, Alimera, Genetech. D.L.: Allergan, Glaukos, New World Medical, Ocular Therapeutix, Olleyes, Equinox, Mati, Nicox, Santen. The remaining authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Perceived discrimination is a significant risk factor for worse ageing health outcomes. Yet, the specific individual and relational stress pathways linking discrimination to disease are less understood, especially in the context of cardiometabolic health. We tested family stress and psychophysiological distress (negative affect and high-risk lipid/fat metabolism) as mediators linking perceived discrimination to cardiometabolic morbidity and health appraisal over 20 years for midlife adults. Using data from participants who completed the Biomarker Project (2004-2009) of the Midlife in the U.S. project, and examining data over the study's three waves (1995-1996, 2004-2006, and 2013-2014), we used structural equation modelling to test pathways for participants who reported zero cardiometabolic conditions at baseline (n = 799). Greater Time 1 discrimination was associated with greater Time 2 family strain, which was in turn associated with worse negative affect; worse Time 2 negative affect was associated with worse Time 3 health appraisal; metabolic lipids risk did not serve as an indirect pathway to Time 3 cardiometabolic morbidity (χ 2  = 147.74, p < 0.001; RMSEA = 0.056; CFI = 0.902; SRMR = 0.047). The inclusion of family in interventions to mitigate the impact of discrimination may be indicated for promoting cardiometabolic wellness., (© 2022 John Wiley & Sons Ltd.)

Children with autism situated in lower income families often receive intensive educational interventions as their primary form of treatment, due to financial barriers for community interventions. However, the continuity of care can be disrupted by school transitions. The quality of social relationships during the transition to a new school among parents, school staff and community providers, called the team-around-the-child (TAC), can potentially buffer a child with autism from the adverse effects caused by care disruptions. Qualities of social relationships, including trust and collaborative problem solving, can be measured using social network analysis. This study investigates if two different types of TAC relationships, defined as (1) the level of trust among team members and (2) the degree of collaborative problem solving among team members, are associated with perceived successful transitions for children with autism from lower income families. Findings suggested that TAC trust is significantly associated with the outcome of transition success for children with autism immediately post-transition., Competing Interests: Conflicts of Interest: One author, Deborah E. Linares, declares a conflict of interest. She was employed by HRSA, the funder of the research, when she participated in the writing of the article. All other authors declare no conflict of interest. Other than Linares’ co-authorship, the funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

The health issue addressed is the unmet need to universally screen and treat depression, which is one of the most common mental health disorders among adults in the United States. The US Preventive Services Task Force recommends screening adults for depression in primary care and using evidence-based protocols. This quality improvement project implemented VitalSign6, a measurement-based care program, to improve depression screening and treatment of adults in primary care at an academic medical center. A pre-post design was used to determine effectiveness of changes in screening, outcomes, and satisfaction. Of 1200 unique adult patients, 95.4% received initial screening. Providers diagnosed and administered measurement-based care to 236 patients. After 14 weeks, 27.5% returned for at least 1 follow-up. Results showed a statistically significant decrease in self-reported depression scores from baseline to follow-up. VitalSign6 was effective in improving identification and management of depression in primary care.

Objective: The aim of this study was to assess the efficacy of maintenance pembrolizumab in patients with extensive-stage SCLC after treatment with platinum and etoposide., Methods: Patients with extensive-stage SCLC with a response or stable disease after induction chemotherapy were eligible. Pembrolizumab at a dose of 200 mg administered intravenously every 3 weeks was initiated within 8 weeks of the last cycle of chemotherapy. The primary end point of the study was progression-free survival (PFS) from study registration, with overall survival (OS) as a key secondary end point. Available tumor tissue was assessed for expression of programmed death ligand 1 (PD-L1) both in the tumor cells and in the surrounding stroma. Blood for circulating tumor cells was collected before the first, second, and third cycles of pembrolizumab., Results: Of the 45 patients enrolled, 56% were male and 22% had treated brain metastases. The median PFS was 1.4 months (95% confidence interval [CI]: 1.3-2.8), with a 1-year PFS of 13%. The median OS was 9.6 months (95% CI: 7.0-12), with a 1-year OS of 37%. Of the 30 tumors that could be assessed, three had PD-L1 expression (≥1%) in the tumor cells. A total of 20 tumors could be assessed for PD-L1 expression in the stroma. The median PFS in the eight patients with tumors positive for expression of PD-L1 at the stromal interface was 6.5 months (95% CI: 1.1-12.8) compared with 1.3 months (95% CI: 0.6-2.5) in 12 patients with tumors negative for this marker. No unexpected toxicities were observed., Conclusion: Maintenance pembrolizumab did not appear to improve median PFS compared with the historical data. However, the 1-year PFS rate of 13% and OS rate of 37% suggest that a subset of patients did benefit from pembrolizumab., (Copyright © 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)

Phenylketonuria (PKU) results in an accumulation of phenylalanine (phe) in the blood which can lead to multiple health consequences in affected individuals. Treatment for PKU is available; however adherence to medical management recommendations can be difficult. When recommendations are not followed and the health of a child is at risk, one intervention that may be necessary is a referral for medical neglect to the local child protective services (CPS) agency. This study summarizes the cases that were referred from our metabolic clinic at the Children's Hospital of Michigan to CPS, and the outcomes of that intervention. CPS referrals helped to improve adherence to medical management recommendations in the majority of cases, including a lower blood phe level for the child; however, at times that improvement did not occur until after a second referral and/or the child's temporary removal from the home., (Copyright © 2015 Elsevier Inc. All rights reserved.)

In this article, we explore the current state of the psychiatry drug development pipeline. Analysis suggests that overall, the psychiatry pipeline is heavily skewed toward a few major indications and tends to have more programs in early development (Phase I and II) than later stages (Phase III). A review of development sponsors shows a fairly even split of programs between Top 50 Pharmaceutical companies and small to mid-sized biopharmaceutical companies.

The expression of tenascin, an extracellular matrix glycoprotein, was studied in three human prostatic carcinoma cell lines by Northern and Western blot analyses and in human prostate tissues by immunohistochemistry and Western blot analysis. All three carcinoma cell lines expressed tenascin mRNA and protein, which were found predominantly in secreted form in culture supernatant. By immunohistochemistry, fetal prostatic tissue showed strong and diffuse tenascin immunoreactivity around developing glands. Normal adult prostatic tissue revealed only focal, scant periglandular and stromal immunoreactivity around acini and ducts. Most cases of hyperplasia and intraepithelial neoplasia showed variable periglandular immunostaining. Tenascin periglandular staining with diffuse stromal extension was noted with all grades of adenocarcinoma; however, the intensity was variable and appeared unrelated to the histologic grade. Metastatic prostatic carcinoma showed strong immunoreactivity in lymph nodes and bone marrow samples, with only weak reactivity of the normal connective tissue framework in both tissues. Western blot analysis of prostatic hyperplasia and carcinoma demonstrated the large and small isoforms of tenascin. These findings suggest a prominent role for tenascin in stromal alterations associated with both benign and malignant prostatic epithelial growth processes.

Tenascin expression was evaluated in 21 human glioma cell lines and in normal adult tissue extracts by Western and Northern blotting. The cell lines differed in their relative expression of tenascin in the cell-associated and supernatant compartments. Glioma cell line tenascin production was not uniformly stimulated by changes in fetal bovine serum concentration in the growth media. In most glioma cell lines and normal tissue extracts, reducing Western blots and Northern blots revealed two tenascin species, respectively: a major 340 kDa polypeptide and a 9 kb RNA transcript accompanied by a less intense 250 kDa polypeptide and 7 kDa RNA species. In U-87 MG and in normal adult kidney extracts, however, the 250 kDa band and 7 kb transcript were more prominent. Quantitation of tenascin in the glioma lines revealed variable levels that were significantly higher than those in the tissue extracts.

Cholestyramine, a well-known bile-salt sequestrant, can be used effectively to remove cholate or deoxycholate from a solution of phosphatidylcholine-bile salt mixed micelle. Upon removal of the bile salt, unilamellar phospholipid vesicles form essentially instantaneously. Cholestyramine resin could be pelleted and removed from the vesicle solution after a low speed centrifugation. Based on phosphate analyses, the recovery of vesicles was approximately 60% of the starting material. The average diameter of these vesicles, as estimated by gel exclusion chromatography on sephacryl S-1000 beads and by trapped volume measurement using [3H]sucrose, ranged between 85 to 121 nm. Phosphatidylethanolamine, cholesterol, or n-alkane such as tetradecane can be incorporated into the vesicles without any selective loss; however, selective loss was experienced when negatively charged phospholipid species such as phosphatidylglycerol or phosphatidylserine was included in vesicle formation.