Endocrine Abstracts

Background: Hypoglycemia is an important side effect in pharmacotherapy of patients with diabetes mellitus. Medical organizations have tried to define hypoglycemia in clinical practice and RCTs with scientific statements and guidelines.

Objective: To explore the method of reporting hypoglycemia conducted on SGLT-2 inhibitor RCTs.

Methods: A systematic review using PubMed to find data on RCTs conducted for SGLT-2 inhibitors, limited to English language.

Results: Of 155 RCTs, 95(61.3) (n(%)) were found to have defined and reported hypoglycemia. The results showed that 8(5.2) RCTs were reported as event/arm, 15(9.7) as event/combined all arms, 69(44.5) as event/patient/arm and 3(1.9) RCTs reported as both event/arm and event/combined all arms. Additionally, 3(1.9) RCTs defined hypoglycemia but did not report it. Hypoglycemia was neither defined nor reported in 57(36.8) of the RCTs. In addition, 41(26.5) RCTs had hypoglycemic episodes that were confirmed, by glucose threshold, whereas only 24(15.5) RCTs had episodes that were reported as symptoms from patients. Hypoglycemic episodes were reported and confirmed in 5(3.2) of the RCTs and 27(17.4) showed that the episodes were reported or confirmed.

Conclusion: This study illustrates that around 40% of RCTs on SGLT-2 inhibitors did not define and report hypoglycemia. The method of reporting hypoglycemia was variable among the RCTs. Almost half the RCTs reported as event/patient/ arm. Additionally, a quarter of RCTs only reported hypoglycemic episodes with confirmation of glucose threshold. Future RCTs should unify the reporting of hypoglycemia for safety assessment of diabetic medication.