Changes in HbA1c, body weight, and systolic blood pressure in type 2 diabetes patients initiating dapagliflozin therapy: a primary care database study
Authors Scheerer MF, Rist R, Proske O, Meng A, Kostev K
Received 1 July 2016
Accepted for publication 6 September 2016
Published 31 October 2016 Volume 2016:9 Pages 337—345
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Lucy Goodman
Peer reviewer comments 2
Editor who approved publication: Professor Ming-Hui Zou
Markus F Scheerer,1 Roland Rist,1 Orm Proske,1 Annika Meng,2 Karel Kostev2
1Medical Department, AstraZeneca GmbH, Wedel, Germany; 2IMS Health GmbH & Co. OHG, Frankfurt am Main, Germany
Aims: To investigate changes in glycated hemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP) in type 2 diabetes (T2D) primary care patients initiating dapagliflozin treatment.
Methods: T2D patients who started dapagliflozin in 985 general and 32 diabetologist practices (Disease Analyzer, Germany: December 2012–October 2014) were analyzed (3- and 6-month follow-up). Multivariate linear regression analyses were used to identify clinical characteristics and comorbidity associated with changes in HbA1c, BW, and SBP.
Results: The study included 1,169 T2D patients (age: 62.5 years; men: 59.3%; diabetologist care: 23%) with newly initiated dapagliflozin therapy. At the 3-month stage, dapagliflozin significantly reduced HbA1c (−0.8%±1.4%) compared to the baseline (8.5%±1.5%) (P<0.001). Changes were maintained after 6 months (−0.8%±1.5%) (P<0.001). Patients with high baseline HbA1c values (>9%) showed greater reductions in HbA1c than the overall sample (3 months −1.8%, 6 months −1.8%; both P<0.05). BW and SBP also showed statistically significant reductions with dapagliflozin over 3 and 6 months (−2.2 kg, P<0.001; −2.2 mmHg, P=0.003 and −2.5 kg, P<0.001; −2.3 mmHg, P=0.011, respectively). After 3 months, 53% of patients achieved a reduction in both HbA1c and BW; the same holds true for 45% of patients at the 6-month mark. Similar results were observed both in general and diabetologist practices. In multivariate analyses, baseline HbA1c (parameter estimate: −0.6479) and diabetologist care (−0.2553) were independent predictors of HbA1c change (6 months) (all P<0.05).
Conclusion: T2D patients treated with dapagliflozin therapy achieved statistically significant reductions in HbA1c, BW, and SBP in a real-world primary and diabetologist care setting. The changes were comparable to the results of the dapagliflozin clinical trial program.
Keywords: type 2 diabetes, dapagliflozin, HbA1c, body mass index, systolic blood pressure
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