The Credible EMPA-REG Clinical Trials: Impacts of Empagliflozin on Patients with Type 2 Diabetes Mellitus and at Risk of Adverse Cardiovascular Events

Author

Janai D. Minga

Date of Award

Fall 5-2022

Document Type

Thesis

Degree Name

Ph.D. in Pharmaceutical Science

Department

Pharmacy Practice and Clinical Health Sciences

First Advisor

Dr. Willie Capers

Abstract

Background and Literature Review: There still exists limited evidence regarding the potential of effects of an inhibitor of sodium–glucose cotransporter 2 known as empagliflozin when it is added as part of the standard care when treating type 2 diabetes patients with a high risk of cardiovascular morbidity and mortality. A significant number of studies have investigated the potential impacts of empagliflozin in lowering the risk of death from heart failure related problems. Available literature reviews and meta-analysis are in consensus that the empagliflozin has positive effects when used to lower the glucose level in the blood of patients with type 2 diabetes mellitus.

Aim or Purpose of the Study: This study aims at trying to cover this research gap by investigating the main effects of using empagliflozin as a glucose-lowering agent in patients living with type 2 and who are at a high risk of experiencing adverse cardiovascular events. Method: The selected participants in the study are randomly assigned to either receive a placebo or a 10mg or 25mg of the study drug, empagliflozin on daily basis. As critically examined in the pooled empagliflozin group versus the placebo group during the clinical trials, the primary composite outcome obtained during the study include nonfatal stroke, nonfatal myocardial infarction and death from cardiovascular causes. On the other hand, the primary outcomes combined with the hospitalization of the unstable angina are part of the key secondary compose outcome in the placebo and EMPA-REG OUTCOME clinical trials conducted in the study. Findings: The primary outcome during the clinical trials occurred in about 490 out of the 4687 patients (study participants) involved in the empagliflozin group whereas around 282 out of the 2333 respondents received placebo. There were significantly lower death rates amongst the participants who were involved in empagliflozin group during the clinical trials that aimed at investigating the possible effects of the study drug, empagliflozin, on patients living with type 2 diabetes and who had a higher risk of adverse events associated with the cardiovascular disease. Discussion and Conclusion: a lower rate of primary composite outcome associated with heart failure disease were reported amongst those patients who received either 10mg or 25mg of the study drug, empagliflozin, compared to the patients who received placebo.

Recommended Citation

Minga, Janai D., "The Credible EMPA-REG Clinical Trials: Impacts of Empagliflozin on Patients with Type 2 Diabetes Mellitus and at Risk of Adverse Cardiovascular Events" (2022). Honor’s College Freeman Research Journal. 30.
https://digitalscholarship.tsu.edu/frj/30