Assistant Professor Chebrolu Hanumaiah Institute of Pharmaceutical Sciences Guntur, Andhra Pradesh, India
Background: Sodium glucose co transporter -2 (SGLT-2) inhibitors, initially used to treat patients with type 2 diabetes mellitus were now found to be efficacious in heart failure. Along with reduction in blood glucose, additional cardio protective and Reno protective benefits have been demonstrated with SGLT-2 Inhibitors in the clinical trials.
Objectives: The present study was aimed to evaluate the efficacy of SGLT2 inhibitors in patients with Heart failure with reduced ejection fraction regardless of the presence or absence of Diabetes Mellitus.
Methods: This is a randomized open labelled study conducted over a period of 2 years from November 2021 to March 2024 in a tertiary care hospital in Southern India. Patients receiving standard of care for Heart failure were compared with interventional arm where SGLT-2 Inhibitors (Dapagliflozin 10mg) were added to standard of care. Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) and Sr. Creatinine were considered to assess the cardiovascular and renal benefits respectively. Baseline and Post-Interventional (6 months) KCCQ and Sr. Creatinine were taken and the difference between both the readings was used to define the efficacy of the intervention. Means with standard deviations and Medians with Inter Quartile Ranges were used for variables with normal and non-normal distribution. T-test was used to measure the above changes at a two sided significance level of 0.05 along with 95% confidence interval (CI’s).
Results: A mean change of 1.35 (95% CI, 0.52-2.20; P=0.002) points was obtained in the Overall KCCQ score in interventional group compared to a non-significant change of -0.06 (95% CI, -1.29-1.17; P=0.92) points in control group, and a mean change of 1.31 (0.55-2.08) points in KCCQ-CS was observed in interventional group compared to a non-significant change of -0.19 (-1.28-0.90) points in control group. A Slight decrease in Sr. Creatinine was also observed in patients taking SGLT-2 Inhibitors (0.018, 95% CI, 0.009 - 0.023, P=0.029) compared to standard of care.
Conclusions: In this study, SGLT-2 inhibitors were associated with increased clinical efficacy in managing heart failure and preserving renal function compared to the control group. This increased efficacy was observed across the population, irrespective of diabetic status.
