Empagliflozin: Providing a superior option to T2DM treatment with reducing HF rates (EMPRISE study)
M3 India Newsdesk Oct 18, 2022
This article elucidates the EMPRISE study's findings and highlights the significant effect that SGLT2 inhibitors may have when compared to other glucose-lowering treatments.
Key takeaways
- Current American Diabetes Association (ADA) recommendations advocate metformin as the first pharmacologic agent for the treatment of T2DM, with early introduction of insulin if DM is considerably out of control.
- It is suggested that patients with known atherosclerotic cardiovascular disease, heart failure (HF), or high risk for HF use SGLT2 as an adjunctive treatment.
- Prior to a dramatic paradigm change in the treatment protocol for T2DM, additional long-term data including safety outcomes will be required.
- The positive benefits of empagliflozin and other SGLT2 seem to include weight reduction, anti-fibrotic effects, and enhanced natriuresis in addition to glycemic management.
Diabetes mellitus and CVD
Diabetes mellitus (DM) is a significant cardiovascular disease risk factor (CVD). Patients with concurrent heart failure (HF) and diabetes mellitus (DM) are growing as the population ages and have worse results than those without concurrent DM. However, there is no clear evidence that intensive glucose-lowering treatment with conventional medications lowers the incidence of HF, the rate of cardiovascular events, or mortality.
Moreover, several hypoglycemic medications, although efficiently lowering blood glucose, have been reported to enhance cardiovascular (CV) adverse effects. In 2008, the FDA demanded that all new antidiabetic medications show cardiovascular (CV) safety, with a minimum of two years of follow-up data and independent adjudication of CV outcomes. Due to this, there have been several CV safety studies in patients with known CVD over the last few years, and some of these investigations have accidentally shown a confirmed CV benefit in individuals with DM.
EMPRISE, a 5-year, real-world study comparing the safety and efficacy of empagliflozin to other glucose-lowering agents, suggests empagliflozin was associated with relative risk reductions for heart failure hospitalisation greater than 50 per cent versus DPP 4 inhibitors and greater than 30 per cent versus GLP 1 receptor agonists.
Principal outcomes of EMPRISE
EMPRISE was begun in 2016 to supplement the EMPA-REG OUTCOME study findings by giving information on the comparative efficacy and safety of Jardiance with DPP-4 inhibitors and GLP-1 receptor agonists in ordinary clinical treatment.
The final analyses of EMPRISE U.S. data evaluated the first five years of empagliflozin (Jardiance) use in nearly 500,000 adults with type 2 diabetes, with and without cardiovascular disease, in the United States between 2014 and 2019: the first included more than 230,000 adults who initiated Jardiance or a DPP-4 inhibitor (115,116 adults in each treatment arm); the second included more than 260,000 adults who initiated Jardiance or a GLP-1 receptor agonist (130,408 adults in each treatment arm).
87 per cent of the detected 18,880 empagliflozin initiators were successfully matched with the 201,839 sitagliptin initiators, yielding 16,443 PS-matched patient pairings. There were no significant differences between the PS-matched couples' baseline characteristics. Empagliflozin reduced the risk of HHF-specific by 50 per cent [HR=0.5 (0.28-0.91)] and the risk of HHF-broad by 49 per cent [HR0.51 (0.39-0.68)] throughout a mean follow-up period of 5.3 months.
When filtered further by subgroups with CVD or HF history, only the HHF-broad definition remained statistically significant in all categories. With 100 more factors, high-dimensional propensity score matching for enrichment yielded consistent findings. These findings were stable throughout time and for both the 10 mg and 25 mg dosages of empagliflozin.
Implications for India
Diabetes patients are four times more likely to be hospitalised for heart failure, and frequent hospitalisations lead to poorer results, thus therapy alternatives that enhance clinical outcomes are essential. In India, diabetic patients between the ages of 20 and 79 were >70 million in 2021 (29 million persons with DM in the United States) and are projected to rise to 124.8 million by 2045. It is essential that healthcare providers caring for this group have access to cardiovascular therapies that are effective in normal care.
These five-year EMPRISE findings indicating empagliflozin was related to a lower risk of hospitalisation for heart failure and mortality are positive for persons with type 2 diabetes and their care teams.
Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.
About the author of this article: Dr Monish Raut is a practising super specialist from New Delhi.
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