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Published in: Diabetes Therapy 2/2020

Open Access 01-02-2020 | Dapagliflozin | Original Research

A Multinational Real-World Study on the Clinical Characteristics of Patients with Type 2 Diabetes Initiating Dapagliflozin in Southern Europe

Authors: Gian Paolo Fadini, Nikolaos Tentolouris, Irene Caballero Mateos, Virginia Bellido Castañeda, Cristóbal Morales Portillo

Published in: Diabetes Therapy | Issue 2/2020

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Abstract

Introduction

A real-world study was performed to describe the clinical characteristics of patients who received dapagliflozin to better understand differences when initiating dapagliflozin in various countries and different prescribing settings.

Methods

We assessed pooled data from observational studies carried out in Italy (n = 2484), Spain (n = 564) and Greece (n = 87). The primary objective was to compare the clinical profile of patients initiating dapagliflozin in the three countries. We also evaluated the percentage of patients who received dapagliflozin in clinical practice who satisfied DECLARE-TIMI 58 enrolment criteria.

Results

In Italy and Spain, around 90% of patients were receiving metformin vs. 66% in Greece (p < 0.0001). Patients in Greece had lower levels of estimated glomerular filtration rate and lower prevalence rates of retinopathy, prior stroke, acute myocardial infarction, peripheral arterial disease and atherosclerotic cardiovascular disease. Grouping the cohorts by prescribing setting (primary vs. specialist care), baseline HbA1c was lower in primary care (8.4 ± 1.7 vs. 8.7 ± 1.5, respectively; p < 0.0001). Significantly more patients were receiving other medications for concomitant conditions in specialist care. A total of 1416 patients (48%) did not meet DECLARE inclusion criteria, while 1561 (52%) patients met the criteria (Greece 41.05%, Italy 53.19%, Spain 51.35%).

Conclusions

Significant differences were seen among patients initiating dapagliflozin in southern Europe. Our results suggest that dapagliflozin was being initiated at different stages of the disease according to the country and prescribing settings. Such geographic heterogeneity may have an impact upon effectiveness of dapagliflozin on glucose lowering, as well as cardiovascular and renal outcomes.
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Literature
1.
go back to reference Ogurtsova K, da Rocha Fernandes JD, Huang Y, et al. IDF diabetes atlas: global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Res Clin Pract. 2017;128:40–50.CrossRef Ogurtsova K, da Rocha Fernandes JD, Huang Y, et al. IDF diabetes atlas: global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Res Clin Pract. 2017;128:40–50.CrossRef
2.
go back to reference Ahmad FS, Ning H, Rich JD, et al. Hypertension, obesity, diabetes, and heart failure-free survival: the cardiovascular disease lifetime risk pooling project. JACC Heart Fail. 2016;4(12):911–9.CrossRef Ahmad FS, Ning H, Rich JD, et al. Hypertension, obesity, diabetes, and heart failure-free survival: the cardiovascular disease lifetime risk pooling project. JACC Heart Fail. 2016;4(12):911–9.CrossRef
3.
go back to reference Donahoe SM, Stewart GC, McCabe CH, et al. Diabetes and mortality following acute coronary syndromes. JAMA. 2007;298(7):765–75.CrossRef Donahoe SM, Stewart GC, McCabe CH, et al. Diabetes and mortality following acute coronary syndromes. JAMA. 2007;298(7):765–75.CrossRef
4.
go back to reference Ritz E, Orth SR. Nephropathy in patients with type 2 diabetes mellitus. N Engl J Med. 1999;341(15):1127–33.CrossRef Ritz E, Orth SR. Nephropathy in patients with type 2 diabetes mellitus. N Engl J Med. 1999;341(15):1127–33.CrossRef
5.
go back to reference Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics–2011 update: a report from the American Heart Association. Circulation. 2011;123(4):e18–209.CrossRef Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics–2011 update: a report from the American Heart Association. Circulation. 2011;123(4):e18–209.CrossRef
6.
go back to reference Davies MJ, Dalessio DA, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;41(12):2669–701.CrossRef Davies MJ, Dalessio DA, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;41(12):2669–701.CrossRef
7.
go back to reference Han S, Hagan DL, Taylor JR, et al. Dapagliflozin, a selective SGLT2 inhibitor, improves glucose homeostasis in normal and diabetic rats. Diabetes. 2008;57(6):1723–9.CrossRef Han S, Hagan DL, Taylor JR, et al. Dapagliflozin, a selective SGLT2 inhibitor, improves glucose homeostasis in normal and diabetic rats. Diabetes. 2008;57(6):1723–9.CrossRef
8.
go back to reference Komoroski B, Vachharajani N, Feng Y, et al. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther. 2009;85(5):513–9.CrossRef Komoroski B, Vachharajani N, Feng Y, et al. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther. 2009;85(5):513–9.CrossRef
10.
go back to reference Mahaffey KW, Neal B, Perkovic V, et al. Canagliflozin for primary and secondary prevention of cardiovascular events: results from the CANVAS program (Canagliflozin Cardiovascular Assessment Study). Circulation. 2018;137(4):323–34.CrossRef Mahaffey KW, Neal B, Perkovic V, et al. Canagliflozin for primary and secondary prevention of cardiovascular events: results from the CANVAS program (Canagliflozin Cardiovascular Assessment Study). Circulation. 2018;137(4):323–34.CrossRef
11.
go back to reference Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377(7):644–57.CrossRef Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377(7):644–57.CrossRef
12.
go back to reference Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295–306.CrossRef Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295–306.CrossRef
13.
go back to reference Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2016;374(11):1094.CrossRef Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2016;374(11):1094.CrossRef
14.
go back to reference Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2019;380(4):347–57.CrossRef Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2019;380(4):347–57.CrossRef
15.
go back to reference Hupfeld C, Mudaliar S. Navigating the “MACE” in cardiovascular outcomes trials and decoding the relevance of atherosclerotic cardiovascular disease benefits versus heart failure benefits. Diabetes Obes Metab. 2019;21(8):1780–9. Hupfeld C, Mudaliar S. Navigating the “MACE” in cardiovascular outcomes trials and decoding the relevance of atherosclerotic cardiovascular disease benefits versus heart failure benefits. Diabetes Obes Metab. 2019;21(8):1780–9.
17.
go back to reference Frieden TR. Evidence for health decision making—beyond randomized, controlled trials. N Engl J Med. 2017;377(5):465–75.CrossRef Frieden TR. Evidence for health decision making—beyond randomized, controlled trials. N Engl J Med. 2017;377(5):465–75.CrossRef
18.
go back to reference Kosiborod M, Cavender MA, Fu AZ, et al. Lower risk of heart failure and death in patients initiated on sodium-glucose cotransporter-2 inhibitors versus other glucose-lowering drugs: the CVD-REAL study (comparative effectiveness of cardiovascular outcomes in new users of sodium-glucose cotransporter-2 inhibitors). Circulation. 2017;136(3):249–59.CrossRef Kosiborod M, Cavender MA, Fu AZ, et al. Lower risk of heart failure and death in patients initiated on sodium-glucose cotransporter-2 inhibitors versus other glucose-lowering drugs: the CVD-REAL study (comparative effectiveness of cardiovascular outcomes in new users of sodium-glucose cotransporter-2 inhibitors). Circulation. 2017;136(3):249–59.CrossRef
19.
go back to reference Toulis KA, Willis BH, Marshall T, et al. All-cause mortality in patients with diabetes under treatment with dapagliflozin: a population-based, open-cohort study in the Health Improvement Network database. J Clin Endocrinol Metab. 2017;102(5):1719–25.CrossRef Toulis KA, Willis BH, Marshall T, et al. All-cause mortality in patients with diabetes under treatment with dapagliflozin: a population-based, open-cohort study in the Health Improvement Network database. J Clin Endocrinol Metab. 2017;102(5):1719–25.CrossRef
20.
go back to reference Nystrom T, Bodegard J, Nathanson D, et al. Novel oral glucose-lowering drugs are associated with lower risk of all-cause mortality, cardiovascular events and severe hypoglycaemia compared with insulin in patients with type 2 diabetes. Diabetes Obes Metab. 2017;19(6):831–41.CrossRef Nystrom T, Bodegard J, Nathanson D, et al. Novel oral glucose-lowering drugs are associated with lower risk of all-cause mortality, cardiovascular events and severe hypoglycaemia compared with insulin in patients with type 2 diabetes. Diabetes Obes Metab. 2017;19(6):831–41.CrossRef
21.
go back to reference Norhammar A, Bodegard J, Nystrom T, et al. Dapagliflozin and cardiovascular mortality and disease outcomes in a population with type 2 diabetes similar to that of the DECLARE-TIMI 58 trial: a nationwide observational study. Diabetes Obes Metab. 2019;21(5):1136–45.CrossRef Norhammar A, Bodegard J, Nystrom T, et al. Dapagliflozin and cardiovascular mortality and disease outcomes in a population with type 2 diabetes similar to that of the DECLARE-TIMI 58 trial: a nationwide observational study. Diabetes Obes Metab. 2019;21(5):1136–45.CrossRef
22.
go back to reference Dalan R. Sodium-glucose cotransporter-2 inhibition in type 2 diabetes mellitus: a review of large-scale cardiovascular outcome studies and possible mechanisms of benefit. Cardiol Rev. 2018;26(6):312–20.CrossRef Dalan R. Sodium-glucose cotransporter-2 inhibition in type 2 diabetes mellitus: a review of large-scale cardiovascular outcome studies and possible mechanisms of benefit. Cardiol Rev. 2018;26(6):312–20.CrossRef
23.
go back to reference Fadini GP, Zatti G, Consoli A, et al. Rationale and design of the DARWIN-T2D (dapagliflozin real world evidence in type 2 diabetes): a multicenter retrospective nationwide Italian study and crowdsourcing opportunity. Nutr Metab Cardiovasc Dis. 2017;27(12):1089–97.CrossRef Fadini GP, Zatti G, Consoli A, et al. Rationale and design of the DARWIN-T2D (dapagliflozin real world evidence in type 2 diabetes): a multicenter retrospective nationwide Italian study and crowdsourcing opportunity. Nutr Metab Cardiovasc Dis. 2017;27(12):1089–97.CrossRef
24.
go back to reference Fadini GP, Sciannameo V, Franzetti I, et al. Similar effectiveness of dapagliflozin and GLP-1 receptor agonists concerning combined endpoints in routine clinical practice: a multicentre retrospective study. Diabetes Obes Metab. 2019;21:1886–94.CrossRef Fadini GP, Sciannameo V, Franzetti I, et al. Similar effectiveness of dapagliflozin and GLP-1 receptor agonists concerning combined endpoints in routine clinical practice: a multicentre retrospective study. Diabetes Obes Metab. 2019;21:1886–94.CrossRef
25.
go back to reference Wittbrodt E, Chamberlain D, Arnold SV, et al. Eligibility of patients with type 2 diabetes for sodium-glucose co-transporter-2 inhibitor cardiovascular outcomes trials: an assessment using the diabetes collaborative registry. Diabetes Obes Metab. 2019;21:1985–9.CrossRef Wittbrodt E, Chamberlain D, Arnold SV, et al. Eligibility of patients with type 2 diabetes for sodium-glucose co-transporter-2 inhibitor cardiovascular outcomes trials: an assessment using the diabetes collaborative registry. Diabetes Obes Metab. 2019;21:1985–9.CrossRef
Metadata
Title
A Multinational Real-World Study on the Clinical Characteristics of Patients with Type 2 Diabetes Initiating Dapagliflozin in Southern Europe
Authors
Gian Paolo Fadini
Nikolaos Tentolouris
Irene Caballero Mateos
Virginia Bellido Castañeda
Cristóbal Morales Portillo
Publication date
01-02-2020
Publisher
Springer Healthcare
Published in
Diabetes Therapy / Issue 2/2020
Print ISSN: 1869-6953
Electronic ISSN: 1869-6961
DOI
https://doi.org/10.1007/s13300-019-00744-6

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