Abstract
Introduction: Dapagliflozin is an inhibitor of the sodium-glucose co-transporter type 2 (SGLT2) indicated for the treatment of type 2 diabetes, and more recently for chronic heart failure with reduced ejection fraction, and chronic renal failure. Approved in Europe since 2012, dapagliflozin was the first SGLT2 inhibitor to be marketed in France since April 6, 2020. A national survey was conducted to monitor its risk profile in France.Material and methods: The analysis included all serious adverse events (SAE) reported by the manufacturer or recorded in the national pharmacovigilance database concerning FORXIGA® (dapagliflozin) or XIGDUO® (dapagliflozin/metformin) since their marketing until May 31, 2022.Results: During the study period, 137 858 patient- years (PY) were exposed to dapagliflozin in France. The analysis included 284 serious cases (2.1/1000 PY [95%CI: 1.8–2.3]) including 13 deaths and 549 SAE (4.0/1000 PY [3.6–4.3]). Patients with a SAE had a mean age of 65.3 years (min-max: 20–89) and the sex ratio M/F was 1.51. The three most represented SOC among SAE were infections (n = 105; 19.1%), investigations (n = 62; 11.3%) and gastrointestinal disorders (n = 28; 5.1%). The analysis of SAE of interest reported 62 cases of genitourinary infection (21.8% of serious cases), 63 cases of renal failure (22.2%), 28 cases of diabetic ketoacidosis (9.9%), 14 cases of necrotizing fasciitis of the perineum (Fournier’s gangrene) (4.9%), 10 SAE related to volume depletion/dehydration (3.5%) and 5 cases of distal amputation in the lower limbs (1.8%). We did not identify any signals regarding medication errors, serious skin reactions, prostate, breast and bladder cancers, bone fractures, liver damage, dyslipidemia, drug interactions, rhythm disorders or pancreatitis. No particularly relevant differences were found between the different indications of dapagliflozin.Discussion/Conclusion: There were no new signals identified in this period, the national survey of dapagliflozin must continue to better specify its risk profile, taking into account its new indications.