Novel drugs approved by the EMA, the FDA, and the MHRA in 2023: A year in review.

In 2023, seventy novel drugs received market authorization for the first time in either Europe (by the EMA and the MHRA) or in the United States (by the FDA). Confirming a steady recent trend, more than half of these drugs target rare diseases or intractable forms of cancer. Thirty drugs are categorized as "first-in-class" (FIC), illustrating the quality of research and innovation that drives new chemical entity discovery and development.

The Management of Posttraumatic Stress Disorder and Acute Stress Disorder: Synopsis of the 2023 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline.

Description: The U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD) worked together to revise the 2017 VA/DoD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Disorder.

Relationship between baseline plasma p-tau181 and longitudinal changes in cognition and structural brain measures in a cohort of cognitively unimpaired older adults.

Introduction: Preclinical Alzheimer's disease (AD) affects a significant proportion of cognitively unimpaired (CU) older adults. Currently, blood-based biomarkers detect very early changes in the AD continuum with great accuracy.

Methods: We measured baseline plasma phosphorylated tau (p-tau)181 using electrochemiluminescence (ECL)-based assay (MesoScale Discovery) in 533 CU older adults.

Complementary and integrative interventions for PTSD.

To treat the impact of trauma, most current evidence supports the use of trauma-focused psychotherapy as the first line approach. However, millions of individuals exposed to trauma worldwide seek Complementary and Integrative Health (CIH) therapies in hopes of achieving wellness above and beyond reducing symptoms. But what is the evidence for CIH interventions? What are potential pitfalls? Given the growing popularity of and strong interest in CIH, EJPT is featuring research on these approaches in this special issue.

Development of a Novel Score to Predict Urgent Mechanical Circulatory Support in Chronic Total Occlusion Percutaneous Coronary Intervention.

Estimating the likelihood of urgent mechanical circulatory support (MCS) can facilitate procedural planning and clinical decision-making in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We analyzed 2,784 CTO PCIs performed between 2012 and 2021 at 12 centers. The variable importance was estimated by a bootstrap applying a random forest algorithm to a propensity-matched sample (a ratio of 1:5 matching cases with controls on center).

Feasibility and initial impact of single-session internet-delivered acceptance change skills for emotions for stress- and trauma-related problems: a randomized controlled trial.

Background: Current psychological trauma-focused interventions have left a gap for individuals who may not be ready for trauma-focused treatment and/or who present with other forms of clinically significant distress, such as subthreshold post-traumatic stress disorder (PTSD). Emotion regulation is a possible transdiagnostic mechanism of change that may promote and maintain some of the varied mental health problems related to trauma exposure.

Aims: This study examines the feasibility and initial impact of two brief emotion regulation skill trainings targeting different processes hypothesized to reduce trauma-related problems, compared with an active control.

Guidance for the use and reporting of anaesthetic agents in BJP manuscripts involving work with animals.

Scientists who plan to publish in the British Journal of Pharmacology (BJP) should read this article before undertaking studies utilising anaesthetics in mammalian animals. This editorial identifies certain gaps in the reporting of details on the use of anaesthetics in animal research studies published in the BJP. The editorial also provides guidance, based upon current best practices, for performing in vivo experiments that require anaesthesia.

Use of Mechanical Circulatory Support in Chronic Total Occlusion Percutaneous Coronary Intervention.

The use of mechanical circulatory support (MCS) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We analyzed the clinical and angiographic characteristics, and procedural outcomes of 7,171 CTO PCIs performed between 2012 and 2021 at 35 international centers. Mean age was 64.

Targeting CD38 to Suppress Osteoarthritis Development and Associated Pain After Joint Injury in Mice.

Objective: This study was undertaken to determine the role of CD38, which can function as an enzyme to degrade NAD , in osteoarthritis (OA) development.

Methods: Human knee cartilage from normal donors and OA donors were examined for CD38 expression. "Gain-of-function," through overexpression of CD38 via transient transfection, and "loss-of-function," through pharmacologic inhibition of CD38, approaches were used to assess the effects of CD38 on intracellular NAD :NADH ratio and catabolic activity in chondrocytes.

Dipping Status, Ambulatory Blood Pressure Control, Cardiovascular Disease, and Kidney Disease Progression: A Multicenter Cohort Study of CKD.

Rationale & Objective: Ambulatory blood pressure (BP) monitoring allows concurrent evaluation of BP control and nocturnal BP dipping status, both related to adverse outcomes. However, few studies have assessed the prognostic role of combining information on dipping status and achieved ambulatory BP in patients with chronic kidney disease (CKD).

Study Design: Prospective observational cohort study.

Proton-Pump Inhibitors and Risk of Calcium Pyrophosphate Deposition in a Population-Based Study.

Objective: There are no proven effective medical treatments to prevent calcium pyrophosphate crystal deposition (CPPD). Hypomagnesemia is a known CPPD risk factor. The present study was undertaken to carry out a real-world epidemiologic study on proton-pump inhibitor (PPI) use, which can cause hypomagnesemia, and CPPD risk.

Energy-based devices for the treatment of Acne Scars: 2022 International consensus recommendations.

Background And Objectives: Acne scars are one of the most distressing and long-term consequences of acne vulgaris, with damaging effect on a person's physical, mental, and social well-being. Numerous treatment options are available including surgical and nonsurgical techniques, depending on the clinical presentation. Although considerable advances in the development of new treatment technologies and applications have been made in the last decade, international treatment guidelines and reimbursement schemes have not yet caught up with current knowledge and practice in many centers.

Glycogen metabolism links glucose homeostasis to thermogenesis in adipocytes.

Adipocytes increase energy expenditure in response to prolonged sympathetic activation via persistent expression of uncoupling protein 1 (UCP1). Here we report that the regulation of glycogen metabolism by catecholamines is critical for UCP1 expression. Chronic β-adrenergic activation leads to increased glycogen accumulation in adipocytes expressing UCP1.

It Happened Matters More Than What Happened: Associations Between Intimate Partner Violence Abuse Type, Emotion Regulation, and Post-Traumatic Stress Symptoms.

Intimate partner violence (IPV) has varied consequences including post-traumatic stress (PTS). One proposed risk factor for PTS is escalating types of violence; however, data are mixed. Because emotion dysregulation acts as a causal mechanism across numerous problems co-occurring in survivors of IPV, this study examined its association with PTS severity versus abuse type.

Serum Metabolomics Identifies Dysregulated Pathways and Potential Metabolic Biomarkers for Hyperuricemia and Gout.

Objective: To systematically profile metabolic alterations and dysregulated metabolic pathways in hyperuricemia and gout, and to identify potential metabolite biomarkers to discriminate gout from asymptomatic hyperuricemia.

Methods: Serum samples from 330 participants, including 109 with gout, 102 with asymptomatic hyperuricemia, and 119 normouricemic controls, were analyzed by high-resolution mass spectrometry-based metabolomics. Multivariate principal components analysis and orthogonal partial least squares discriminant analysis were performed to explore differential metabolites and pathways.

Is There a Role for Cartilage Imaging in Athletes?

This article reviews implications for cartilage imaging in athletes in the setting of (1) acute chondral injury diagnosis, (2) evaluation and follow-up of conservative and surgical therapy, and (3) evaluation of cartilage as a surrogate for meniscal function and joint stability. Focal knee cartilage defects are common in athletic populations. Athletes with articular cartilage injury may initially be able to return to sport with conservative therapy; however, a reduction of athletic ability and progression to osteoarthritis is expected in athletes with untreated severe chondral injury.