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Data from a pooled post hoc analysis of 14 placebo-controlled, dapagliflozin treatment studies in patients with type 2 diabetes with and without anemia at baseline

Stefánsson, Bergur V. (author)
Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
Heerspink, Hiddo J. L. (author)
Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands ; George Institute for Global Health, Sydney, Australia
Wheeler, David C. (author)
George Institute for Global Health, Sydney, Australia ; Department of Renal Medicine, University College London, United Kingdom
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Sjöström, C. David (author)
Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
Greasley, Peter J. (author)
Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
Sartipy, Peter (author)
Högskolan i Skövde,Institutionen för biovetenskap,Forskningsmiljön Systembiologi,Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden,Translationell bioinformatik, Translational Bioinformatics
Cain, Valerie (author)
Bogier Clinical and IT Solutions, Raleigh, North Carolina, United States
Correa-Rotter, Ricardo (author)
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
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 (creator_code:org_t)
Elsevier, 2021
2021
English.
In: Data in Brief. - : Elsevier. - 2352-3409. ; 37, s. 1-11
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • Dapagliflozin is a highly selective sodium-glucose cotransporter 2 inhibitor associated with stabilization of estimated glomerular filtration rate (eGFR); reductions in glycated hemoglobin (HbA1c), systolic blood pressure, body weight, and albuminuria; and a small and consistent increase in hematocrit [1–4]. This data set is based on the associated article [5] analyzing data from 5325 patients with type 2 diabetes from 14 placebo-controlled, phase 3 (one phase 2/3), double-blind dapagliflozin treatment studies of 24–104 weeks’ duration. Data on dapagliflozin's effects (vs. placebo) on hemoglobin (Hb), hematocrit, serum albumin, serum total protein concentrations, urine albumin/creatinine ratio, eGFR, heart rate, blood pressure, body weight, and safety in patients with type 2 diabetes with and without anemia were pooled and analyzed. Patients were divided into two groups according to baseline Hb levels: anemia (Hb <13 g/dL in men and <12 g/dL in women) and no anemia. Some biomarkers associated with erythropoiesis and the presence of anemia, such as iron, transferrin, ferritin, reticulocytes, and hepcidin, were not included in the original studies and therefore data for these biomarkers were not available. Descriptive statistics were used for baseline characteristics and safety data and a longitudinal repeated-measures mixed model for efficacy data. Changes in Hb concentrations were evaluated, and the proportion of patients with baseline anemia who were no longer anemic at week 24 was determined, as was the occurrence of polycythemia (Hb >16.5 g/dL in men and >16.0 g/dL in women). Because anemia commonly occurs in patients with diabetes and chronic kidney disease [6], the data can be of value to further analyze trends in relevant physiological and pathophysiological parameters.

Subject headings

NATURVETENSKAP  -- Biologi -- Bioinformatik och systembiologi (hsv//swe)
NATURAL SCIENCES  -- Biological Sciences -- Bioinformatics and Systems Biology (hsv//eng)

Keyword

Anemia
Chronic kidney disease
Dapagliflozin
eGFR
Hematocrit
Hemoglobin
SGLT2 inhibitor
Type 2 diabetes
Bioinformatik
Bioinformatics

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ref (subject category)
art (subject category)

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