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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

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], [2], [3], [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.

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.
© 2021 Published by Elsevier Inc. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/ ) Table   Subject Endocrinology, Diabetes and Metabolism Specific subject area Type 2 diabetes, Anemia Type of data Tables  How data were  acquired Data from the 14 studies were originally acquired by patient and investigator report and laboratory tests Data format Raw Analyzed Parameters for data collection Demographic and baseline characteristics, hematocrit, Hb, serum albumin and serum total protein concentrations, urine albumin/creatinine ratio, eGFR, systolic and diastolic blood pressure, heart rate, body weight, and adverse events in patients with type 2 diabetes with baseline anemia (Hb < 13 g/dL in men and < 12 g/dL in women) and no anemia. Description of data collection

Value of the Data
• Our data report on a variety of safety and efficacy parameters in patients with type 2 diabetes ( N = 5325) with and without anemia from 14 placebo-controlled, phase 3 (one phase 2/3), double-blind studies of dapagliflozin treatment over 24-104 weeks. The data contribute to understand the effects of dapagliflozin treatment in patients with type 2 diabetes with and without anemia. • These data may be useful to diabetologists, endocrinologists, nephrologists, hematologists, cardiologists, and patients. • The dapagliflozin treatment data included here expand upon those reported in the associated research article and could be used to interrogate Hb, blood pressure, body weight, and other physiological trends over time. The data could be used to inform the design or interpretation of other studies or analyses of sodium-glucose cotransporter 2 inhibitors. • A strength of this data set is that it contains pooled data from multiple placebo-controlled, double-blind studies, providing an overview of a large patient population, including in patients with eGFR < 60 mL/min/1.73 m 2 . • The data provide a detailed longitudinal picture of adverse events in patients with type 2 diabetes with and without anemia undergoing dapagliflozin treatment.

Data Description
• Efficacy data include Hb, HbA1c, hematocrit, total body weight, sitting systolic and diastolic blood pressure, sitting heart rate, eGFR, urine albumin/creatinine ratio, and the proportion of patients with changes in anemia status from baseline to week 24. Safety data include overall summary of adverse events and adverse events in select system organ classes.

Experimental Design, Materials and Methods
Pooled data were from 14 phase 3 (one phase 2/3), double-blind, placebo-controlled studies of 24-104 weeks' duration that included dapagliflozin 10 mg/day monotherapy in patients with type 2 diabetes ( N = 5325). None of the studies were primarily designed to examine the effect of dapagliflozin on anemia.
The population was divided according to baseline Hb concentrations into anemia (Hb < 13 g/dL in men and < 12 g/dL in women) and no-anemia groups based on criteria defined by the World Health Organization. The studies' protocols did not include specific restrictions or recommendations regarding supplemental iron or diet. Data on race were available and are reported but data on patient ethnicity were not recorded across all trial sites and are thus not reported.
The change in Hb concentrations over 24 weeks in patients receiving dapagliflozin or placebo in the anemia and no-anemia groups was evaluated. As part of the standard clinical trial safety assessment during the individual studies, blood samples were collected and analyzed at central laboratories. Hb concentrations were measured at baseline and at weeks 4, 8, 12, 16, 20, and 24. Changes in Hb concentrations in patients with or without baseline anemia were evaluated, and the proportion of patients with baseline anemia who were no longer anemic at week 24 was determined.
Changes from baseline to week 24 in eGFR (calculated using the Modification of Diet in Renal Disease Study equation), serum albumin, blood pressure, and body weight were also evaluated. Safety outcomes included the occurrence of adverse events and serious adverse events, including those of special interest (renal impairment, urinary tract infection, and volume depletion). Occurrence of polycythemia (Hb > 16.5 g/dL in men and > 16.0 g/dL in women) was also evaluated.
Descriptive statistics were used for presenting baseline characteristics and safety data. For efficacy parameters, we derived the mean changes from baseline values and 95% confidence intervals using a longitudinal repeated-measures mixed model with fixed terms for study, treatment, group, treatment-by-group interaction, week, week-by-group interaction, week-by-treatment interaction, and treatment-by-week-by-group interaction, along with the fixed covariates of baseline, baseline-by-week interaction, and baseline-by-study interaction. Degrees of freedom in the mixed model were approximated by the Kenward-Roger method. If the model(s) did not converge, the models were either re-run using the Kenward-Roger method with the baseline-byweek and baseline-by-study terms removed or the Satterthwaite approximation was used. SAS ® version 9.4 (SAS Institute Inc.) was used for statistical analyses.

Ethics Statement
All protocols from the studies were approved by the relevant institutional review board/ethics committee. Written informed consent was provided by all enrolled patients. The studies were conducted in accordance with the principles of the Declaration of Helsinki.

Acknowledgments
Medical writing support, in accordance with GPP guidelines, was provided by Steven Tresker of Cactus Life Sciences (part of Cactus Communications), and was funded by AstraZeneca.