Boehringer Ingelheim and Eli Lilly recently jointly announced that phase 3 empirical preserved trial of SGLT2 inhibitor jardiance (Chinese trade name: otangjing, common name: empagliflozin) in the treatment of patients with heart failure with preserved ejection fraction (HFPEF) has reached the main end point.
According to the results, Jardiance is the first and only therapy that can significantly reduce the risk of hospitalization for cardiovascular death or heart failure in patients with HFpEF. Together with the results of the empirical reduced trial, these findings confirm jardiance's efficacy in all types of heart failure, regardless of ejection fraction. In the empirical preserved trial, jardiance's safety was basically consistent with the known safety of the drug.
The empirical preserved trial compared jardiance with placebo at a dose of 10 mg. The full results are scheduled to be presented at the European Society of Cardiology (ESC) meeting on August 27, 2021. Bringer Ingelheim and Lilly plan to submit jardiance's regulatory application for HFPEF in 2021.
The results of the empirical preserved trial supplement the results of the previous three phases of empirical reduced trial. The results of the latter trial showed that jardiance significantly reduced the combined relative risk of cardiovascular death or hospitalization for heart failure by 25% in adult patients with reduced ejection fraction (hfref) compared with placebo. In summary, these studies demonstrate the benefits of jardiance for patients with the entire spectrum of heart failure diseases, including hfref and HFPEF.
Mohamed Eid, vice president of clinical development and medical affairs of Boehringer Ingelheim, said: "at present, there is no approved treatment in clinic that can improve the prognosis of patients with HFPEF, so that the medical needs of patients with heart failure, which is already widespread and more and more common, can not be met. The data from the empirical preserved trial mark a new chapter in heart failure and support jardiance's potential as the first SGLT2 inhibitor to treat heart failure in adults with preserved or reduced ejection fraction. "
Milepost Jeff Emmick, vice president of product development, said: "Jardiance is the first SGLT2 inhibitor to reduce cardiovascular mortality in patients with type 2 diabetes mellitus with cardiovascular disease. We have reached another important milestone, this time is heart failure. The results of the empirical preserved trial provide potential for the treatment of a type of heart failure (HFPEF), whose effective treatment has been very challenging until now. The emperor heart failure study is part of our empower clinical trial to explore the effects of jardiance on a range of cardiovascular and renal metabolic diseases in order to significantly improve the prognosis of these highly prevalent diseases that affect many people's lives. "
In June, Jardiance approved a new indication in the European Union: adult patients with symptomatic chronic heart failure (HFrEF, systolic heart failure) who are treated with reduced ejection fraction, regardless of type 2 diabetes. At present, a supplementary new drug application (sNDA) of Jardiance is also being examined by the US FDA: as a potential new therapy for HFrEF adult patients, including patients with and without type 2 diabetes, it reduces the risk of cardiovascular death and hospitalization for heart failure and delays the decline of renal function.
In October 2020, China's NMPA announced the registration of Jardiance for HFrEF adults without diabetes. This is the second indication for jardiance to apply in China. The application for registration of this indication has been submitted simultaneously with that of the United States and the European Union, only six days later than that of the United States, which is also at the forefront of the industry. Jardiance was approved in September 2017 to be listed in China for the treatment of type 2 diabetes. With diet control and exercise, monotherapy, metformin combined with metformin and sulfonylurea therapy can improve glycemic control in type 2 diabetes.
Jardiance approved new indications for hfref based on the results of phase 3 empirical reduced trial (nct03057977). The trial was conducted in HFrEF adults (or without diabetes). Data showed that the study reached the main end point: when combined standard care, compared with placebo, Jardiance 10mg significantly reduced the risk of recurrent cardiovascular death or heart failure in hospitalization by 25%. The primary end point was consistent in subgroups with and without type 2 diabetes mellitus (T2D). The key secondary endpoint analysis showed that jardiance reduced the relative analysis of first and second hospital admissions for heart failure by 30% compared with placebo, and significantly slowed down the decline in renal function. In this trial, jardiance's safety was similar to the known safety of the drug.
Heart failure (HF) affects more than 60 million people worldwide, and there is still a significant unmet medical need for treatment, because about half of the diagnosed patients are expected to die within five years. HF is the leading cause of hospitalization in the elderly over 65 years old. HF is the most common and serious complication after heart attack. It occurs when the heart cannot pump enough blood to other parts of the body. HF patients often have dyspnea and fatigue, which will seriously affect the quality of life.
HF patients usually have impaired renal function, which may have a significant negative impact on the prognosis. The risk of death in HF patients increases with each admission. Heart failure with reduced ejection fraction (hfref) occurs when the heart muscle fails to contract effectively, pumping less blood from the heart into the body than a functioning heart. Heart failure with preserved ejection fraction (HFPEF) occurs when the heart muscle contracts normally but there is not enough blood in the ventricle. Compared with the normal heart, less blood enters the heart.
Empower clinical project is the most extensive and comprehensive one among all SGLT2 inhibitors. It is exploring the impact of jardiance on the life of patients with cardiorenal metabolic diseases.
Jardiance is an oral, once daily, highly selective sglt-2 inhibitor. New sglt-2 inhibitors have been proved to block the reabsorption of glucose in the kidney and excrete excessive glucose to the body, so as to achieve the effect of reducing blood glucose level, and the hypoglycemic effect does not depend on the concentration of glucose β Cell function and insulin resistance. In addition to the clear hypoglycemic effect, the drug can also bring additional benefits of weight loss, blood pressure reduction and uric acid reduction. Jardiance is safe and can reduce the risk of cardiovascular events in diabetics. It is the first type 2 diabetes drug in the world that has been proven to reduce the risk of cardiovascular death.
Jardiance was approved for sale in August 2014 for patients with type 2 diabetes. At the end of 2016, Jardiance was approved to reduce the risk of cardiovascular death in type 2 diabetic patients with concurrent cardiovascular disease. In recent years, the Lilly blinger Ingelheim alliance has been working to develop this drug for the treatment of heart failure and chronic kidney disease.
