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

Diabetes Obes Metab. 2018 Jul;20(7):1781-1786. doi: 10.1111/dom.13280. Epub 2018 Mar 30.

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.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Benzhydryl Compounds / therapeutic use*
  • Blood Glucose / metabolism
  • Blood Pressure
  • Body Weight
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / metabolism
  • Dipeptidyl-Peptidase IV Inhibitors / therapeutic use
  • Female
  • Gliclazide / therapeutic use
  • Glucagon-Like Peptide-1 Receptor / agonists
  • Glucosides / therapeutic use*
  • Glycated Hemoglobin / metabolism
  • Humans
  • Hypoglycemic Agents / therapeutic use*
  • Incretins / therapeutic use*
  • Italy
  • Male
  • Middle Aged
  • Retrospective Studies
  • Sodium-Glucose Transporter 2 Inhibitors / therapeutic use*
  • Treatment Outcome

Substances

  • Benzhydryl Compounds
  • Blood Glucose
  • Dipeptidyl-Peptidase IV Inhibitors
  • Glucagon-Like Peptide-1 Receptor
  • Glucosides
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Incretins
  • Sodium-Glucose Transporter 2 Inhibitors
  • hemoglobin A1c protein, human
  • dapagliflozin
  • Gliclazide