Adverse Drug Reactions to SGLT2i Reported by Type 2 Diabetes New Users: An Active Surveillance Study

<b>Background/Objectives</b>: Patients' perspectives on adverse drug reactions (ADRs) may be used to update the safety profile of a drug. We aimed to prospectively follow-up on type 2 diabetes (T2D) patients who were new users of sodium-glucose co-transporter 2 inhibitors (SGLT2i) and to characterize the patient-reported ADRs within routine practice in Romania. <b>Methods</b>: T2D patients from ambulatory settings were interviewed over the phone based on standardized forms, at four time-points across 12 months. We captured the patients' history and auto-medication, as well as any ADR that implied causality to SGLT2i, based on the patient's perspective. <b>Results</b>: In total, 64 patients, with genders being equally represented and with a median age of 59 years (Q1, Q3: 51, 64) were followed-up with. We identified 73 ADRs to SGLT2i that were suspected to be associated with the drug, with an average of 2.35 ADRs per patient (range 0-7 ADRs/patient). The most reported ADR was pollakiuria (7; 9.58%), followed by vulvovaginal candidiasis (6; 8.21%), dysuria (4; 5.47%), and hypoglycemia (4; 5.47%). SGLT2i treatment was interrupted for eight patients. Three (4.10%) ADRs were considered serious as important medical events (hypertensive crisis, angina pectoris, and dyspnea). A positive dechallenge was recorded for 14 ADRs, of which 9 ADRs had a positive rechallenge as well. A probable causality was assessed for 13 of the 73 patient-reported ADRs. <b>Conclusions</b>: Most of the identified ADRs were in line with the known safety profile of SGLT2i. Only three ADRs were serious and unexpected relative to the safety profile, but these had confounding factors that could explain the reactions. Therefore, no new safety concerns related to SGLT2i were determined in this observational study.