Efficacy of Dapagliflozin in Southern Europe Across the Spectrum of Characteristics of Type 2 Diabetes: An International Real-World Analysis

Abstract

Purpose

To extend a prior real-world analysis (DARWIN-T2D) of patients with type 2 diabetes initiating dapagliflozin in Italy, Greece, and Spain by evaluating changes in glycemic and extra-glycemic endpoints after initiation of dapagliflozin.

Patients and Methods

The association among demographic/clinical characteristics and the change in glycemic and extraglycemic effectiveness endpoints during the observation period was assayed using a mixed effects model.

Results

A total of 1438 (860 males; 59.8%) patients were evaluated; patients were followed for a mean of 5.6 months. At baseline, 93.4% and 61.9% of patients were on concomitant metformin and insulin, respectively. A significant mean decrease in HbA1c from 8.7% to 7.5% was observed. The mixed model used also revealed several associations between different glycemic and laboratory parameters and patient characteristics at baseline; insulin use was significantly associated with lower HbA1c. Patients with BMI ≥30 kg/m² experienced greater weight loss than those with BMI <30 kg/m². A consistent glucose-lowering effect of dapagliflozin was seen in all subgroups of patients, including those with stage 2 renal impairment and cardiovascular disease.

Conclusion

The present analysis confirms the efficacy of dapagliflozin in diversified real-world settings with broadly similar effects on HbA1c across countries and baseline characteristics.

Keywords:

• type 2 diabetes
• dapagliflozin
• real-life
• glycemic control

Data Sharing Statement

The data from this study are available from the corresponding author upon reasonable request.

Acknowledgments

Writing assistance and statistical analysis of the data were provided by Edra Spa and unconditionally funded by AstraZeneca.

Disclosure

Gian Paolo Fadini, received grants, honoraria or lecture fees from: Abbott, Astra Zeneca, Boehringer, Lilly, Merck-Sharp-Dome, Novartis, Novo Nordisk, Mundipharma, Sanofi, Servier, Takeda; Cristobal Morales, Irene Caballero, and Beatriz González, declare no conflict of interest; Nikolaos Tentolouris has participated in advisory panels for Merck Sharp Dohme (MSD), AstraZeneca, Sanofi, Novo Nordisk, ELPEN, Eli Lilly, Boehringer Ingelheim and Novartis, and has received research support from MSD, Eli Lilly, Novo Nordisk, Sanofi, Pfizer, AstraZeneca, Janssen, Cilag, GlaxoSmithKline and Novartis. Agostino Consoli, has received speaker honoraria from Bristol Myers Squibb, Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp & Dohme, Novartis, Novo Nordisk, Sanofi-Aventis, Sigma-Tau, Takeda, Advisory board fees from Astra Zeneca, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen Farmaceutici, Merck Sharp & Dhome, Novo-Nordisk, has been consultant for Astra Zeneca, Novo-Nordisk, and has received research grant from Eli Lilly and Novo-Nordisk.

Additional information

Funding

DARWIN-T2D Sponsored by “Italian Diabetes Society” and partially supported by a grant from AstraZeneca, DAPA-RWE sponsored by Fundación para la investigación Publica Andaluza (FISEVI) and partially supported by a grant from AstraZeneca, DETECT sponsored by AstraZeneca, HEDGE sponsored by AstraZeneca.