TURALIO Risk Evaluation and Mitigation Strategy Program (tREMS): 3-year retrospective hepatic safety assessment.

Hepatic safety data assessment from the TURALIO (pexidartinib) Risk Evaluation and Mitigation Strategy (tREMS) Program. Retrospective 3-year assessment (August 2019 to June 2022) of hepatic events from the TURALIO® (pexidartinib) Risk Evaluation and Mitigation Strategy Program. A total of 451 patients, 369 prescribers, 2 wholesalers/distributors and 2 pharmacies were enrolled and certified.

Real-world drug utilization and treatment patterns in patients with tenosynovial giant cell tumors in the USA.

Real-world treatment patterns in tenosynovial giant cell tumor (TGCT) patients remain unknown. Pexidartinib is the only US FDA-approved treatment for TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery. To characterize drug utilization and treatment patterns in TGCT patients.

Real-world treatment patterns, healthcare resource utilization and costs among patients with peripheral T-cell lymphoma.

To evaluate treatment patterns, healthcare resource utilization (HRU) and costs among peripheral T-cell lymphoma (PTCL) patients in the USA. A retrospective cohort study, using the IQVIA PharMetrics Plus claims database from 1 April 2011 to 30 November 2021, identified PTCL patients receiving systemic treatments. Three mutually exclusive subcohorts were created based on line of therapy (LOT): 1LOT, 2LOT and ≥3LOT.

Evaluation of Quantitative Computed Tomography Cortical Hip Quadrant in a Clinical Trial With Rosiglitazone: A Potential New Study Endpoint.

Unlabelled: Quantitative computed tomography (QCT) measurements have been used extensively to ascertain information about bone quality and density due to the 3-dimensional information provided and the ability to segment out trabecular and cortical bones. QCT imaging helps to improve our understanding of the role that each bone compartment plays in the pathogenesis and prognosis of fracture. This study was conducted to explore longitudinal changes in femoral neck (FN) cortical bone structure using both volumetric bone mineral density (vBMD) and cortical shell thickness assessments via QCT in a double-blind, randomized, multicenter clinical trial in postmenopausal women with type 2 diabetes mellitus.

Anaphylaxis Triggers and Treatments by Grade Level and Staff Training: Findings from the EPIPEN4SCHOOLS Pilot Survey.

This pilot survey was designed to evaluate the characteristics of anaphylactic events and epinephrine autoinjector (EAI) use in children in U.S. schools.

EpiPen4Schools pilot survey: Occurrence of anaphylaxis, triggers, and epinephrine administration in a U.S. school setting.

Background: Although epinephrine is the treatment of choice for anaphylaxis, it remains underused.

Objective: This study was designed to describe anaphylactic events and epinephrine autoinjector (EAI) use in U.S.

Potential antidepressant overtreatment associated with office use of brief depression symptom measures.

Background: Use of brief depression symptom measures for identifying or screening cases may help to address depression undertreatment, but whether it also leads to diagnosis and treatment of patients with few or no symptoms-a group unlikely to have major depression or benefit from antidepressants-is unknown. We examined the associations of use of a brief depression symptom measure with depression diagnosis and antidepressant recommendation and prescription among patients with few or no depression symptoms.

Methods: We conducted exploratory observational analyses of data from a randomized trial of depression engagement interventions conducted in primary care offices in California.

Bone mineral density changes following discontinuation of ronacaleret treatment: off-treatment extension of a randomized, dose-finding phase II trial.

Context: Parathyroidectomy in patients with hyperparathyroidism can produce subsequent increases in bone mineral density (BMD). Ronacaleret, a selective calcium-sensing receptor antagonist that stimulates endogenous parathyroid hormone release, induced mild hyperparathyroidism.

Objective: The aim of this study is to evaluate whether BMD changes after cessation of ronacaleret treatment.

Randomized trial of the anti-FGF23 antibody KRN23 in X-linked hypophosphatemia.

Background: X-linked hypophosphatemia (XLH) is the most common heritable form of rickets and osteomalacia. XLH-associated mutations in phosphate-regulating endopeptidase (PHEX) result in elevated serum FGF23, decreased renal phosphate reabsorption, and low serum concentrations of phosphate (inorganic phosphorus, Pi) and 1,25-dihydroxyvitamin D [1,25(OH)2D]. KRN23 is a human anti-FGF23 antibody developed as a potential treatment for XLH.

Mechanism of action study to evaluate the effect of rosiglitazone on bone in postmenopausal women with type 2 diabetes mellitus: rationale, study design and baseline characteristics.

Objectives: Post-hoc analyses have shown an increase incidence of fractures among type 2 diabetes (T2DM) patients treated with thiazolidinediones (TZDs). The mechanisms by which TZDs may be associated with increased fracture risk is not well understood. This article describes the study design and baseline characteristics for a prospective, randomized, double-blind, active-controlled trial to evaluate the effects of rosiglitazone on changes in measures of skeletal structure, surrogates of bone strength and metabolism.

Reductions in biomarkers of cardiovascular risk in type 2 diabetes with rosiglitazone added to metformin compared with dose escalation of metformin: an EMPIRE trial sub-study.

Objective: To compare the effects of rosiglitazone added to metformin with dose escalation of metformin on cardiovascular risk biomarkers in type 2 diabetes mellitus.

Research Design And Methods: Cardiovascular biomarkers were assessed in a sub-population of 122 subjects with type 2 diabetes mellitus (mean age 54.6 and 56.

Effects of rosiglitazone added to submaximal doses of metformin compared with dose escalation of metformin in type 2 diabetes: the EMPIRE Study.

Objective: This study was designed to compare the efficacy, safety and tolerability of rosiglitazone (RSG) added to submaximal doses of metformin (MET) with dose escalation to the maximal effective dose of MET monotherapy in type 2 diabetes mellitus.

Research Design And Methods: In this multi-center, double-blind, randomized, parallel-group study, 766 subjects with a baseline MET dose of 1000 mg/day were randomized to receive either RSG 4 mg/day (4 mg/1000 mg) or MET 500 mg/day (1500 mg/day total dose) for 8 weeks. Only the RSG dose was increased in the combination group - to 8 mg/day (8 mg/1000 mg) - and only the MET dose was increased in the MET monotherapy group - to 2000 mg/day for the remaining 16 weeks.

Immuno-gold localization of prion filaments in scrapie-infected hamster brains.

The brains of scrapie-infected hamsters have been examined for the presence of structures antigenically related to the prion protein (PrP 27-30). Glutaraldehyde-perfused hamster brains, 72 days postinfection, were immunostained using rabbit monospecific antisera raised against synthetic peptides corresponding to the N-terminal 13 or 15 amino acids of PrP 27-30, and using rabbit antisera raised against infectious prions or PrP 27-30 purified from scrapie-infected hamster brains. Antisera to the synthetic peptides stained extracellular filaments in agreement with previous immunoperoxidase studies which used affinity-purified PrP 27-30 antibodies; in addition to subependymal and subpial localization, we show ventricular and perivascular staining.

Site-specific antibodies define a cleavage site conserved among arenavirus GP-C glycoproteins.

Arenaviruses share a common strategy for glycoprotein synthesis and processing in which a mannose-rich precursor glycoprotein, termed GP-C in lymphocytic choriomeningitis virus (LCMV), is posttranslationally processed by oligosaccharide trimming and proteolytic cleavage to yield two structural glycoproteins, GP-1 and GP-2. Mapping the orientation and proteolytic cleavage site(s) in such polyproteins has traditionally required direct protein sequencing of one or more of the cleaved products. This technique requires rigorous purification of the products for sequencing and may be complicated by amino-terminal modifications which interfere with sequence analysis.

Host genetic control of mouse hepatitis virus type-4 (JHM strain) replication. II. The gene locus for susceptibility is linked to the Svp-2 locus on mouse chromosome 7.

Peritoneal macrophages were used to analyze host genetic control of MHV-4 infection in the 14 recombinant-inbred strains between susceptible SWR/J and resistant SJL/J progenitor strains. 4 strains were resistant to MHV-4 infection, while the remaining 10 strains were productively infected. Based upon the strain distribution pattern of susceptibility the gene locus for MHV-4 susceptibility is linked to the Svp-2 locus on the proximal end of mouse chromosome 7.