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3 results on '"Sue Vallow"'

1. Assessing the Impact of Losmapimod on Proteinuria in Idiopathic Focal Segmental Glomerulosclerosis

Author

Marcella Paglione, Jorge Alfonso Ross Terres, Alan W. McMahon, Robert N. Willette, John R. Sedor, Patrick H. Nachman, M. Claire Holland, J. Charles Jennette, Michelle A. Hladunewich, Sue Vallow, Richard A. Lafayette, Feng Gao, Kevin S. Thorneloe, Debbie S. Gipson, Dennis L. Sprecher, Brad H. Rovin, and Sean J. Barbour

Subjects
medicine.medical_specialty, Population, 030232 urology & nephrology, Urology, Renal function, 030204 cardiovascular system & hematology, urologic and male genital diseases, 03 medical and health sciences, 0302 clinical medicine, Clinical Research, Clinical endpoint, Medicine, education, education.field_of_study, Proteinuria, Losmapimod, business.industry, urogenital system, nephrotic syndrome, Glomerulosclerosis, clinical trial, medicine.disease, Interim analysis, female genital diseases and pregnancy complications, FSGS, Nephrology, medicine.symptom, proteinuria, business, Nephrotic syndrome, glomerulosclerosis
Abstract

Introduction Idiopathic focal segmental glomerulosclerosis (FSGS) is a leading cause of nephrotic syndrome and end-stage renal disease. In preclinical models and biopsies of human FSGS kidneys, p38 mitogen-activated protein kinase (MAPK) has demonstrated enhanced activity; and p38 MAPK inhibition has improved disease markers. This proof-of-concept trial aimed to assess efficacy, safety, tolerability, and pharmacokinetics of losmapimod, an oral p38 MAPK inhibitor, in humans with FSGS. Methods A single-arm, multicenter, open-label, Phase II trial (NCT02000440) was conducted in adults with FSGS; proteinuria ≥2.0 g/d; estimated glomerular filtration rate (eGFR) ≥45 ml/min per 1.73 m2; blood pressure 20% in 3 patients. One patient achieved a proteinuria response (≥50% reduction) at week 2 but subsequently relapsed. Losmapimod pharmacokinetics were consistent with prior studies. No serious adverse events (AEs) were reported. Conclusion p38 MAPK inhibition with losmapimod did not result in ≥50% reduction of proteinuria in patients with FSGS. However, study population heterogeneity may have contributed to our negative findings and therefore this does not eliminate the potential to demonstrate benefit in a population more sensitive to p38 MAPK inhibition if identifiable in the future by precision-medicine methods., Graphical abstract

Published
2020

3. Using the patient global assessment of the method of pain control to assess new analgesic modalities in clinical trials.

Author

Margaret Rothman, Sue Vallow, C. V. Damaraju, and David J. Hewitt

Subjects
*EVALUATION of medical care, *POSTOPERATIVE pain treatment, *ANALGESICS, *CLINICAL trials, *MEDICAL history taking, *DRUG efficacy, *FENTANYL, *MORPHINE
Abstract

ABSTRACTObjective:To assess the validity of the patient global assessment (PGA) of the method of pain control, a single-item patient-reported outcome measure of a method of pain control for patients experiencing postoperative pain.Research design and methods:Content validity of the PGA of the method of pain control was assessed using cognitive debriefing interviews. Construct validity was evaluated using data from six clinical trials that compared the efficacy of the fentanyl HCl iontophoretic transdermal system (fentanyl ITS) with morphine intravenous patient-controlled analgesia or placebo fentanyl ITS for acute postoperative pain management.Main outcome measures:To assess the construct validity of the PGA rating scale, four hypotheses were developed that related positive PGA ratings (‘good’ or ‘excellent’) to (1) lower pain intensity scores, (2) higher satisfaction ratings, (3) a greater propensity to select the assigned pain control method in the future, and (4) favorable ratings of ease of use/convenience on the Patient Ease-of-Care Questionnaire. Descriptive statistics were used to evaluate the association of pain intensity and Overall Ease-of-Care scores with PGA ratings. An exact linear-by-linear association test was conducted to evaluate the association of satisfaction ratings and propensity to select the pain control method in the future with PGA ratings.Results:Results of cognitive debriefing interviews indicated that the PGA incorporates patient perceptions of several aspects of treatment with an analgesic modality, including level of pain, ease of use, and control of administration. PGA ratings were associated in the expected direction with other patient-reported outcomes used in several clinical studies.Conclusions:Findings suggest that both the content and construct validity of the PGA of the method of pain control in clinical trial settings are supported. However, this conclusion is potentially limited by the use of a narrow range of therapeutic interventions and, in some cases, small sample sizes in the clinical trials used to assess construct validity. The PGA of the method of pain control is an informative and useful measure for assessing pain control provided by different drug delivery systems for patients experiencing postoperative pain. [ABSTRACT FROM AUTHOR]

Published
2009
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