A5062575477- Pharmacogenetics and Drug Metabolism
- Diabetes Treatment and Management
- Pharmaceutical studies and practices
- Alzheimer's disease research and treatments
- Cancer Immunotherapy and Biomarkers
- Metabolism, Diabetes, and Cancer
- Autoimmune and Inflammatory Disorders Research
- Monoclonal and Polyclonal Antibodies Research
- Medical Imaging Techniques and Applications
- S100 Proteins and Annexins
- Asthma and respiratory diseases
- Adolescent and Pediatric Healthcare
- Cancer Research and Treatments
- Dermatology and Skin Diseases
- Dementia and Cognitive Impairment Research
- Computational Drug Discovery Methods
- Acute Lymphoblastic Leukemia research
- Biosimilars and Bioanalytical Methods
- Neuroendocrine Tumor Research Advances
- Neuroinflammation and Neurodegeneration Mechanisms
- Heat shock proteins research
- Inflammatory Bowel Disease
- Vasculitis and related conditions
- Autophagy in Disease and Therapy
- CAR-T cell therapy research
Pfizer (United States)
2012-2024
Aim To investigate the efficacy and safety of ertugliflozin, in a phase II dose‐ranging study, patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled on metformin. Methods A total 328 [mean duration, 6.3 years; mean glycated haemoglobin HbA1c ), 8.1%] were randomized to once‐daily ertugliflozin (1, 5, 10, 25 mg), sitagliptin (100 mg) or placebo, for 12 weeks. The primary endpoint was change from baseline week concentration secondary endpoints changes body weight, fasting...
This study compared the blood pressure-lowering effect of ertugliflozin (1, 5, 25 mg), hydrochlorothiazide (HCTZ; 12.5 mg) and placebo in 194 patients with type 2 diabetes mellitus hypertension for 4 weeks using ambulatory pressure monitoring. Endpoints (change from baseline to week 4) were: 24-h mean systolic (SBP; primary); daytime, night-time, seated predose SBP, 24-h, diastolic pressure, urinary glucose excretion fasting plasma (FPG; secondary). Safety tolerability were monitored....
To evaluate whether amyloid-related imaging abnormalities with edema/effusion (ARIA-E) observed in bapineuzumab clinical trials was associated specific biomarker patterns.Bapineuzumab, an anti-β-amyloid monoclonal antibody, evaluated patients mild to moderate Alzheimer disease. Amyloid PET imaging, CSF biomarkers, or volumetric MRI (vMRI) were assessed.A total of 1,512 participants underwent one more assessments; 154 developed incident ARIA-E. No differences at baseline between ARIA-E and...
Abstract These analyses characterized tofacitinib pharmacokinetics (PKs) in children and adolescents with juvenile idiopathic arthritis (JIA). Data were pooled from phase I (NCT01513902), III (NCT02592434), open‐label, long‐term extension (NCT01500551) studies of tablet/solution (weight‐based doses administered twice daily [b.i.d.]) patients JIA aged 2 to less than 18 years. Population PK modeling used a nonlinear mixed‐effects approach, covariates identified using stepwise forward‐inclusion...
Abrocitinib is an oral small-molecule Janus kinase (JAK)-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis. In vitro studies indicated that abrocitinib a weak time-dependent cytochrome P450 (CYP) 2C19/3A and inducer CYP1A2/2B6/2C19/3A. To assess potential effect on concomitant medications, drug-drug interaction (DDI) were conducted with sensitive probe substrates these CYP enzymes. The impact hormonal contraceptives (ethinyl estradiol levonorgestrel), as CYP3A...
Background: Tofacitinib is an oral JAK inhibitor that being investigated for juvenile idiopathic arthritis (JIA). Objectives: To describe tofacitinib pharmacokinetics (PK) in patients with JIA, identify potential covariates accounting variability exposure, assess the formulation effect of solution vs tablet and propose a simplified dosing regimen. Methods: This was pooled analysis data from 3 clinical studies JIA aged 2−<18 years: Phase 1, open-label (OL), non-randomised study (...