Results from the first retrospective observational study of people with type 2 diabetes (T2D) treated with dapagliflozin (Forxiga) in routine UK primary care were presented at the 51st Congress of the European Association for the Study of Diabetes (EASD) in Stockholm, Sweden.
The results show that the reductions in blood glucose and weight that were seen in the clinical trial programme are also observed in real-world practice. This is the first study looking at real-world use of a sodium-glucose co-transporter-2 (SGLT2) inhibitor in UK primary care. Anonymised records from 1,732 people with T2D who had been initiated with dapagliflozin were taken from the Clinical Practice Research Datalink (CPRD) and included in the analysis. Patients measurements were recorded at different time points between two weeks and ≥ six months where changes in HbA1c and weight were recorded. In the overall group, the average reductions seen in HbA1c and weight ranged from -0.89 to 1.16% and -2.6 to 4.6kg, respectively, across the different time periods analysed. These results are in line with data from controlled clinical trials.
Professor John Wilding, Head of the Department of Obesity and Endocrinology at the University of Liverpool, and study lead, commented: “We know that the meticulous care received by patients during clinical trials is difficult to replicate in general clinical practice. It is therefore encouraging to see that both the reductions in HbA1c and body weight seen in patients treated with dapagliflozin in trials were also seen in patients treated in UK primary care. As healthcare professionals, it is important that we can offer a treatment to our type 2 diabetes patients that we are confident will achieve results in the real-world that are consistent with the results of the clinical trial programme.
The study also looked specifically at the most common treatment combinations with dapagliflozin and found similar average reductions in HbA1c and weight, respectively, across subgroups in the different time periods analysed: Dual therapy with metformin (-0.88% to -1.08%; -3.2kg to -6.3kg); triple therapy (-0.95% to -1.18%; -2.8kg to -4.4kg); and add-on to insulin (-0.96% to -1.22%; -1.5kg to -3.2kg). The patients included in the CPRD study had a similar age and duration of T2D to those included in the clinical trials, but appeared to have worse baseline glycaemic control and greater weight.
Dapagliflozin is administered as one 10mg tablet once daily and can be taken at any time of day, with or without food and no requirement for titration. Dapagliflozin is generally well-tolerated. Most common side effects include hypoglycaemia, when used with sulphonylurea or insulin; urinary tract or genital infection and polyuria.