Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2018 Jul;20(7):1781-1786.
doi: 10.1111/dom.13280. Epub 2018 Mar 30.

Use and effectiveness of dapagliflozin in routine clinical practice: An Italian multicentre retrospective study

Gian Paolo Fadini  1 , Giancarlo Zatti  1 , Ileana Baldi  2 , Daniele Bottigliengo  2 , Agostino Consoli  3 , Andrea Giaccari  4 , Giorgio Sesti  5 , Angelo Avogaro  1 ; DARWIN-T2D network
Affiliations
Multicenter Study

Use and effectiveness of dapagliflozin in routine clinical practice: An Italian multicentre retrospective study

Gian Paolo Fadini et al. Diabetes Obes Metab. 2018 Jul.

Abstract

In randomized controlled trials (RCTs), sodium-glucose co-transporter-2 (SGLT2) inhibitors have been shown to confer glycaemic and extra-glycaemic benefits. The DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes) study was a multicentre retrospective study designed to evaluate the baseline characteristics of patients receiving dapagliflozin vs those receiving selected comparators (dipeptidyl peptidase-4 inhibitors, gliclazide, or glucagon-like peptide-1 receptor agonists), and drug effectiveness in routine clinical practice. From a population of 281 217, the analysis included 17 285 patients initiating dapagliflozin or comparator glucose-lowering medications (GLMs), 6751 of whom had a follow-up examination. At baseline, participants starting dapagliflozin were younger, had a longer disease duration, higher glycated haemoglobin (HbA1c) concentration, and a more complex history of previous GLM use, but the clinical profile of patients receiving dapagliflozin changed during the study period. Dapagliflozin reduced HbA1c by 0.7%, body weight by 2.7 kg, and systolic blood pressure by 3.0 mm Hg. Effects of comparator GLMs were also within the expected range, based on RCTs. This real-world study shows an initial channelling of dapagliflozin to difficult-to-treat patients. Nonetheless, dapagliflozin provided significant benefits with regard to glucose control, body weight and blood pressure that were in line with findings from RCTs.

Keywords: cohort study; dapagliflozin; glycaemic control; observational study; type 2 diabetes; weight control.

PubMed Disclaimer

Conflict of interest statement

G.P.F. has received grant support, lecture or advisory board fees from AstraZeneca, Boehringer‐Ingelheim, Eli Lilly, NovoNordisk, Sanofi, Genzyme, Abbott, Novartis and Merck Sharp & Dohme.

A.C. has received consultancy or speaker fees from Abbott, AstraZeneca, Boehringer‐Ingelheim, Bruno Farmaceutici, Janssen, Eli‐Lilly, Merck Sharp & Dohme, Novartis, NovoNordisk, Roche, Sanofi‐Aventis, Servier and Takeda. He has also received research grants from Eli‐Lilly and NovoNordisk. A.G. has received consultancy or speaker fees from AstraZeneca, Boehringer‐Ingelheim, Eli‐Lilly, Merck Sharp & Dohme, Sanofi‐Aventis and Takeda. He has also received a research grant from AstraZeneca. G.S. has received fees for advisory work or lectures from Servier, Intarcia Therapeutics Inc, NovoNordisk, Janssen, Boehringer‐Ingelheim, Eli Lilly, AstraZeneca, Merck Sharp & Dohme Italy, Lilly, Sanofi, Novartis, Abbott and Takeda. A.A. has received research grants, lecture or advisory board fees from Merck Sharp & Dome, AstraZeneca, Novartis, Boeringher‐Ingelheim, Sanofi, Mediolanum, Janssen, NovoNordisk, Lilly, Servier and Takeda. G.Z., D.B. and I.B. declare no conflict of interest.

Figures

Figure 1
Figure 1
Within‐group analysis of effectiveness. For A, glycated haemoglogin (HbA1c), B, body weight and C, systolic blood pressure, panels show baseline and follow‐up values, along with changes from baseline (right panels). Numbers on top of columns indicate the corresponding values. Numbers between brackets indicates the number of available measures for each outcome. *P < .05 vs baseline. DPP‐4i, dipeptidyl peptidase‐4 inhibitor; Dapa, dapagliflozin; GLP‐1RA, glucagon‐like peptide‐1 receptor agonist; SBP, systolic blood pressure
See this image and copyright information in PMC

References

    1. Abdul‐Ghani MA, Norton L, Defronzo RA. Role of sodium‐glucose cotransporter 2 (SGLT 2) inhibitors in the treatment of type 2 diabetes. Endocr Rev. 2011;32:515‐531. - PubMed
    1. Baker WL, Smyth LR, Riche DM, Bourret EM, Chamberlin KW, White WB. Effects of sodium‐glucose co‐transporter 2 inhibitors on blood pressure: a systematic review and meta‐analysis. J Am Soc Hypertens. 2014;8:262‐275, e269. - PubMed
    1. Monami M, Nardini C, Mannucci E. Efficacy and safety of sodium glucose co‐transport‐2 inhibitors in type 2 diabetes: a meta‐analysis of randomized clinical trials. Diabetes Obes Metab. 2014;16:457‐466. - PubMed
    1. Frieden TR. Evidence for health decision making ‐ beyond randomized, controlled trials. N Engl J Med. 2017;377:465‐475. - PubMed
    1. Patel A, Billot L. Reality and truth. Balancing the hope and the hype of real‐world evidence. Circulation. 2017;136:260‐262. - PubMed

Publication types

MeSH terms