At the 56th annual European Association for the Study of Diabetes (EASD) 2020 meeting, new results have been presented from the EMPEROR-Reduced trial, which demonstrated the efficacy of empagliflozin in reducing the risk of cardiovascular (CV) death and hospitalization for heart failure (HF) by 25%, and reducing renal decline, in patients with or without diabetes. With this additional evidence of the cardioprotective and nephroprotective properties of Jardiance, GlobalData predicts that Jardiance is likely to achieve a dominant market share in the HF market, directly competing with AstraZeneca’s Farxiga (dapagliflozin), and increase its share in the type 2 diabetes (T2D) market as many patients present with increasingly complex cardio-renal comorbidities.
Jardiance is a leading sodium-glucose co-transporter-2 inhibitor (SGLT-2I) developed by Boehringer Ingelheim (BI) and Eli Lilly and is prescribed for the treatment of T2D. The drug received a label update in June 2019 from the European Commission for the treatment of T2D and HF and a fast track designation from the FDA for chronic HF. Previously, Jardiance had been shown to be cardioprotective and was prescribed to patients with T2D and CV risk factors in the US market. This study demonstrates the additional capabilities of empagliflozin in treating HF and renal failure, significantly preventing the decline of estimated glomerular filtration rate (eGFR) in comparison to placebo. For patients who have diabetes, there is a two to five times higher risk of developing HF, while for patients who have diabetes and HF, there is 60–80% greater probability of CV death and all-cause mortality.
The study was a Phase III double-blind trial with 3,770 patients with class II, III, or IV HF and an ejection fraction of 40% or less randomly assigned to receive empagliflozin 10mg once daily, or placebo, in addition to any ongoing recommended therapy. The primary endpoint was a composite of CV death or HF hospitalization, with a first secondary endpoint of total (first and recurrent) HF hospitalizations and a second secondary outcome of the slope of decline in glomerular filtration rate over time. Over a median period of 16 months, a primary outcome event occurred in 361 of 1,863 patients (19.4%) in the empagliflozin group and in 462 of 1,867 patients (24.7%) in the placebo group. This produced a hazard ratio (HR) for CV death or hospitalization for HF of 0.75 (25% risk reduction in these events; 95% confidence interval [CI], 0.65 to 0.86; P < 0.001). Regardless of the presence or absence of diabetes in patients, the effect of empagliflozin on the primary outcome was consistent. For the first secondary outcome, it was demonstrated that the total number of hospitalizations for HF was lower in the empagliflozin group than in the placebo group (HR, 0.70; 95% CI, 0.58 to 0.85; P < 0.001) and for the second secondary outcome, the annual rate of decline of the eGFR was slower in the empagliflozin group than the placebo group. The results for the second secondary outcome were -0.55 versus -2.28 ml per minute per 1.732 of body-surface area per year (P < 0.001) for the empagliflozin and placebo groups, respectively. There is a clearly significant risk reduction in CV death or hospitalization from HF and a significant risk reduction in serious renal outcome for patients on empagliflozin compared with those taking placebo, regardless of the presence or absence of T2D.
These trial results from the EMPEROR-Reduced Phase III trial demonstrate that empagliflozin is a highly efficacious drug for the treatment of HF, with or without T2D, and strengthen BI and Lilly’s portfolio in both the HF and T2D markets. Key opinion leaders (KOLs) interviewed by GlobalData have expressed a need for T2D therapies that address complex cardiorenal comorbidities and for novel HF therapies that show a marked risk reduction in hospitalization and death from the disease. Jardiance, as shown by the presented data, is able to address the unmet needs of both these disease markets and is likely, therefore, to increase its market share in T2D and HF and become a market-leading drug in the SGLT-2I class.