A pharmacovigilance study of sodium-glucose co-transporter 2 inhibitors: adverse events in type 2 diabetic patients having heart failure with reduced ejection fraction
Abstract
Abstract Introduction: Sodium-glucose co-transporter-2 (SGLT2) inhibitors are reported to reduce the risk of heart failure, provide cardiovascular benefit and preserve kidney function in type 2 diabetes mellitus (T2DM) patients. Pharmacovigilance for SGLT2 inhibitors involves monitoring, assessing, and understanding the safety profiles of these agents. Aim of the study To identify adverse drug reactions (ADR) (Type, Severity, and Causality) related to SGLT2 inhibitor use and to compare the identifiable ADRs between type 2 diabetic patients without heart failure and diabetic patients having heart failure with reduced ejection fraction Patients and methods This study included 65 T2DM patients with prior echocardiographic evidence of left-ventricular systolic dysfunction (LVSD) in addition to 65 control diabetic patients with normal left ventricular function were included. After obtaining full personal ,medical, past and drug history of included patients, a causality assessment using WHO-UMC system was applied as part of pharmacovigilance study to assess SGLT2 inhibitor ADRs in two different visits. Results Laboratory investigations in included patients revealed significantly higher serum potassium in cases group compared to control group. Comparison of laboratory investigations between first and second samples in each group individually revealed significant increase in hematocrit value in both groups. Assessment of causality of recorded ADE in both groups revealed statistical…
Read the paper
Related studies
- Strategy for Mitigating DKA Risk in Patients with Type 1 Diabetes on Adjunctive Treatment with SGLT Inhibitors: A STICH Protocol
- Glucoraphanin: a broccoli sprout extract that ameliorates obesity-induced inflammation and insulin resistance
- SGLT2 Inhibitors in Heart Failure: Targeted Metabolomics and Energetic Metabolism
- Mechanisms of blood pressure reduction with sodium-glucose co-transporter 2 (SGLT2) inhibitors
- Sodium-glucose cotransporter inhibitors: beyond glycaemic control
- Decoding the effects of SGLT2 inhibitors on cardiac arrhythmias in heart failure
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.