Dapagliflozin: Clinical practice compared with pre-registration trial data

Abstract

Background: Dapagliflozin is the first sodium-glucose cotransporter 2 (SGLT2) inhibitor to be approved in Europe and represents a new class of agents developed as oral diabetes medications. Improved glycaemic control and weight loss have been demonstrated in clinical trials but effectiveness outside of the trial environment has not yet been reported. Method: A systematic clinical case note audit of type 2 diabetes patients initiated on dapagliflozin in a diabetes specialist outpatient centre of a London teaching hospital. Results: Of the 96 people included, 42% had a reduction in glycated haemoglobin (HbA1c) of ≥1%, 29% had no reduction; 15% had weight loss ≥5kg, 3% had weight loss ≥10kg and 24% had no weight reduction. Improvements in HbA1c, weight, and blood pressure were consistent with those reported in clinical trials. The rate of discontinuation of dapagliflozin due to side effects (22%) was higher than reported in trials (3-4%), but 52% of people tolerating dapagliflozin were able to stop or reduce one or more other diabetes medications. Conclusions: Dapagliflozin is effective at improving glycaemic control. It also reduces blood pressure, results in weight loss, and reduces the need for concomitant diabetes medications. However, it is not as well tolerated in real-world patients as in participants of clinical trials.