Characteristics of Dapagliflozin Responders: A Longitudinal, Prospective, Nationwide Dapagliflozin Surveillance Study in Korea

Eugene Han, Ari Kim, Sung Jae Lee, Je Yon Kim, Jae Hyeon Kim, Woo Je Lee, Byung Wan Lee

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Introduction: Sodium glucose co-transporter 2 (SGLT2) inhibitors, such as dapagliflozin, have demonstrated favorable effects in patients with type 2 diabetes (T2D). However, there are limited reports in the literature regarding the glucose-lowering effects of SGLT2 inhibitors in actual clinical settings. Methods: The post-marketing surveillance data from a longitudinal prospective study of 2007 patients with T2D who were prescribed dapagliflozin (10 mg/day) were analyzed (ClinicalTrials.gov, NCT02252224). Results: After 12 weeks of dapagliflozin treatment, glycated hemoglobin (HbA1c) and body mass index were significantly decreased (P < 0.001) from 8.1 ± 1.3% to 7.5 ± 1.2% and from 28.1 ± 4.4 to 27.6 ± 4.2 kg/m2, respectively. Both body weight and HbA1c were reduced in 67.7% of patients, and HbA1c was lowered in 75.1%. Younger age, male sex, shorter diabetes duration, higher baseline HbA1c and estimated glomerular filtration rate (eGFR), and having dapagliflozin as add-on therapy were associated with stronger HbA1c reductions after dapagliflozin use (all P < 0.05). Moreover, subgroup analysis of eGFR of subjects with renal hyperfiltration (eGFR ≥ 120 ml/min/1.73 m2) showed the largest reduction in glucose level (% change, − 9.5; 95% CI − 6.8 to − 12.3 for HbA1c; P < 0.001). Multivariable logistic regression analysis showed that recent T2D diagnosis and higher HbA1c at baseline in patients who received an add-on regimen of dapagliflozin were statistically significantly associated with a dapagliflozin response (all P < 0.05). Conclusions: Dapagliflozin provides benefits for glycemic control and body weight. Patients in a relatively early stage of the course of diabetes with renal hyperfiltration might be more suitable for and gain maximal benefit from dapagliflozin treatment. Trial Registration: ClinicalTrials.gov identifier, NCT02252224. Funding: AstraZeneca.

Original languageEnglish
Pages (from-to)1689-1701
Number of pages13
JournalDiabetes Therapy
Volume9
Issue number4
DOIs
Publication statusPublished - 2018 Aug 1

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Korea
Sodium-Glucose Transporter 2
Glomerular Filtration Rate
Type 2 Diabetes Mellitus
Symporters
Body Weight
Kidney
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Glucose
Glycosylated Hemoglobin A
Marketing
Longitudinal Studies
Body Mass Index
Therapeutics
Logistic Models
Regression Analysis
Prospective Studies

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Han, Eugene ; Kim, Ari ; Lee, Sung Jae ; Kim, Je Yon ; Kim, Jae Hyeon ; Lee, Woo Je ; Lee, Byung Wan. / Characteristics of Dapagliflozin Responders : A Longitudinal, Prospective, Nationwide Dapagliflozin Surveillance Study in Korea. In: Diabetes Therapy. 2018 ; Vol. 9, No. 4. pp. 1689-1701.
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title = "Characteristics of Dapagliflozin Responders: A Longitudinal, Prospective, Nationwide Dapagliflozin Surveillance Study in Korea",
abstract = "Introduction: Sodium glucose co-transporter 2 (SGLT2) inhibitors, such as dapagliflozin, have demonstrated favorable effects in patients with type 2 diabetes (T2D). However, there are limited reports in the literature regarding the glucose-lowering effects of SGLT2 inhibitors in actual clinical settings. Methods: The post-marketing surveillance data from a longitudinal prospective study of 2007 patients with T2D who were prescribed dapagliflozin (10 mg/day) were analyzed (ClinicalTrials.gov, NCT02252224). Results: After 12 weeks of dapagliflozin treatment, glycated hemoglobin (HbA1c) and body mass index were significantly decreased (P < 0.001) from 8.1 ± 1.3{\%} to 7.5 ± 1.2{\%} and from 28.1 ± 4.4 to 27.6 ± 4.2 kg/m2, respectively. Both body weight and HbA1c were reduced in 67.7{\%} of patients, and HbA1c was lowered in 75.1{\%}. Younger age, male sex, shorter diabetes duration, higher baseline HbA1c and estimated glomerular filtration rate (eGFR), and having dapagliflozin as add-on therapy were associated with stronger HbA1c reductions after dapagliflozin use (all P < 0.05). Moreover, subgroup analysis of eGFR of subjects with renal hyperfiltration (eGFR ≥ 120 ml/min/1.73 m2) showed the largest reduction in glucose level ({\%} change, − 9.5; 95{\%} CI − 6.8 to − 12.3 for HbA1c; P < 0.001). Multivariable logistic regression analysis showed that recent T2D diagnosis and higher HbA1c at baseline in patients who received an add-on regimen of dapagliflozin were statistically significantly associated with a dapagliflozin response (all P < 0.05). Conclusions: Dapagliflozin provides benefits for glycemic control and body weight. Patients in a relatively early stage of the course of diabetes with renal hyperfiltration might be more suitable for and gain maximal benefit from dapagliflozin treatment. Trial Registration: ClinicalTrials.gov identifier, NCT02252224. Funding: AstraZeneca.",
author = "Eugene Han and Ari Kim and Lee, {Sung Jae} and Kim, {Je Yon} and Kim, {Jae Hyeon} and Lee, {Woo Je} and Lee, {Byung Wan}",
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Characteristics of Dapagliflozin Responders : A Longitudinal, Prospective, Nationwide Dapagliflozin Surveillance Study in Korea. / Han, Eugene; Kim, Ari; Lee, Sung Jae; Kim, Je Yon; Kim, Jae Hyeon; Lee, Woo Je; Lee, Byung Wan.

In: Diabetes Therapy, Vol. 9, No. 4, 01.08.2018, p. 1689-1701.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Characteristics of Dapagliflozin Responders

T2 - A Longitudinal, Prospective, Nationwide Dapagliflozin Surveillance Study in Korea

AU - Han, Eugene

AU - Kim, Ari

AU - Lee, Sung Jae

AU - Kim, Je Yon

AU - Kim, Jae Hyeon

AU - Lee, Woo Je

AU - Lee, Byung Wan

PY - 2018/8/1

Y1 - 2018/8/1

N2 - Introduction: Sodium glucose co-transporter 2 (SGLT2) inhibitors, such as dapagliflozin, have demonstrated favorable effects in patients with type 2 diabetes (T2D). However, there are limited reports in the literature regarding the glucose-lowering effects of SGLT2 inhibitors in actual clinical settings. Methods: The post-marketing surveillance data from a longitudinal prospective study of 2007 patients with T2D who were prescribed dapagliflozin (10 mg/day) were analyzed (ClinicalTrials.gov, NCT02252224). Results: After 12 weeks of dapagliflozin treatment, glycated hemoglobin (HbA1c) and body mass index were significantly decreased (P < 0.001) from 8.1 ± 1.3% to 7.5 ± 1.2% and from 28.1 ± 4.4 to 27.6 ± 4.2 kg/m2, respectively. Both body weight and HbA1c were reduced in 67.7% of patients, and HbA1c was lowered in 75.1%. Younger age, male sex, shorter diabetes duration, higher baseline HbA1c and estimated glomerular filtration rate (eGFR), and having dapagliflozin as add-on therapy were associated with stronger HbA1c reductions after dapagliflozin use (all P < 0.05). Moreover, subgroup analysis of eGFR of subjects with renal hyperfiltration (eGFR ≥ 120 ml/min/1.73 m2) showed the largest reduction in glucose level (% change, − 9.5; 95% CI − 6.8 to − 12.3 for HbA1c; P < 0.001). Multivariable logistic regression analysis showed that recent T2D diagnosis and higher HbA1c at baseline in patients who received an add-on regimen of dapagliflozin were statistically significantly associated with a dapagliflozin response (all P < 0.05). Conclusions: Dapagliflozin provides benefits for glycemic control and body weight. Patients in a relatively early stage of the course of diabetes with renal hyperfiltration might be more suitable for and gain maximal benefit from dapagliflozin treatment. Trial Registration: ClinicalTrials.gov identifier, NCT02252224. Funding: AstraZeneca.

AB - Introduction: Sodium glucose co-transporter 2 (SGLT2) inhibitors, such as dapagliflozin, have demonstrated favorable effects in patients with type 2 diabetes (T2D). However, there are limited reports in the literature regarding the glucose-lowering effects of SGLT2 inhibitors in actual clinical settings. Methods: The post-marketing surveillance data from a longitudinal prospective study of 2007 patients with T2D who were prescribed dapagliflozin (10 mg/day) were analyzed (ClinicalTrials.gov, NCT02252224). Results: After 12 weeks of dapagliflozin treatment, glycated hemoglobin (HbA1c) and body mass index were significantly decreased (P < 0.001) from 8.1 ± 1.3% to 7.5 ± 1.2% and from 28.1 ± 4.4 to 27.6 ± 4.2 kg/m2, respectively. Both body weight and HbA1c were reduced in 67.7% of patients, and HbA1c was lowered in 75.1%. Younger age, male sex, shorter diabetes duration, higher baseline HbA1c and estimated glomerular filtration rate (eGFR), and having dapagliflozin as add-on therapy were associated with stronger HbA1c reductions after dapagliflozin use (all P < 0.05). Moreover, subgroup analysis of eGFR of subjects with renal hyperfiltration (eGFR ≥ 120 ml/min/1.73 m2) showed the largest reduction in glucose level (% change, − 9.5; 95% CI − 6.8 to − 12.3 for HbA1c; P < 0.001). Multivariable logistic regression analysis showed that recent T2D diagnosis and higher HbA1c at baseline in patients who received an add-on regimen of dapagliflozin were statistically significantly associated with a dapagliflozin response (all P < 0.05). Conclusions: Dapagliflozin provides benefits for glycemic control and body weight. Patients in a relatively early stage of the course of diabetes with renal hyperfiltration might be more suitable for and gain maximal benefit from dapagliflozin treatment. Trial Registration: ClinicalTrials.gov identifier, NCT02252224. Funding: AstraZeneca.

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