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Breakthrough results for empagliflozin confirm EMPEROR-Preserved as first and only successful trial for heart failure with preserved ejection fraction

Retrieved on:

Tuesday, July 6, 2021

When added to the EMPEROR-Reduced trial results, these findings demonstrate empagliflozins efficacy in all forms of heart failure regardless of ejection fraction.

Key Points:

When added to the EMPEROR-Reduced trial results, these findings demonstrate empagliflozins efficacy in all forms of heart failure regardless of ejection fraction.
HFpEF has long been the most challenging form of heart failure to treat, said Professor Stefan Anker, Heart Failure Cardiologist at Charit Berlin, Germany, and EMPEROR-Preserved Principal Investigator.
Building on previous results from the EMPA-REG-OUTCOME trial, and the EMPEROR-Reduced trial in heart failure with reduced ejection fraction, the EMPEROR-Preserved findings demonstrate that empagliflozin reduces cardiovascular death or hospitalization for heart failure and has the potential to transform the care of people living with heart failure.
With the earlier EMPEROR-Reduced trial results, we are confident in the potential of empagliflozin to positively impact the lives of adults across the full spectrum of heart failure.

Empagliflozin reduced the risk of cardiovascular events and hospitalization for heart failure compared to DPP-4 inhibitors in people with type 2 diabetes

Retrieved on:

Monday, June 28, 2021

Empagliflozin was not associated with a risk of acute kidney injury - analyses showed a 51 percent RRR in acute kidney injury requiring dialysis.

Key Points:

Empagliflozin was not associated with a risk of acute kidney injury - analyses showed a 51 percent RRR in acute kidney injury requiring dialysis.
There was a similar risk of lower limb amputation and bone fractures as with DPP-4 inhibitors.
In addition, there was an increased risk of diabetic ketoacidosis, which is consistent with empagliflozins known safety information.1
The risk of hospitalization for heart failure is up to five times higher if you have type 2 diabetes.
9 It is a widespread condition affecting over 60 million people worldwide and expected to increase as the population ages.

Dapagliflozin is Well Tolerated in Hospitalized COVID-19 Patients

Retrieved on:

Sunday, June 27, 2021

Anti-diabetic drugs, Drugs, Glucosides, SGLT2 inhibitors, Chloroarenes, Health care, Health sciences, Combination drugs, Dapagliflozin, Placebo

Patients received dapagliflozin or placebo for 30 days in addition to the standard of care for COVID-19 in the participating hospital.

Key Points:

Patients received dapagliflozin or placebo for 30 days in addition to the standard of care for COVID-19 in the participating hospital.
Numerically fewer patients treated with dapagliflozin experienced organ failure or death (11.2% versus 13.8% with placebo, respectively), although this difference was not statistically significant.
Dapagliflozin was well tolerated, with numerically fewer serious adverse events than placebo, and these findings were also consistent in patients with and without type 2 diabetes.
The authors state that future trials are needed to further evaluate possible effects of dapagliflozin on the risk of organ failure or death in patients hospitalized with COVID-19.

Jardiance® (empagliflozin) approved in Europe for the treatment of heart failure with reduced ejection fraction

Retrieved on:

Monday, June 21, 2021

Health, Diabetes, Other Health, Clinical trials, Pharmaceutical, Cardiology, Biotechnology, Anti-diabetic drugs, Medical specialties, Heart diseases, Glucosides, SGLT2 inhibitors, Anatomy, Organs anatomy), Boehringer Ingelheim, Empagliflozin, Ejection fraction, Heart failure with preserved ejection fraction, Heart failure

We are delighted to now be able to offer Jardiance to people with heart failure with reduced ejection fraction, regardless of diabetes status.

Key Points:

We are delighted to now be able to offer Jardiance to people with heart failure with reduced ejection fraction, regardless of diabetes status.
This trial will explore empagliflozin in heart failure with preserved ejection fraction, in adults with or without diabetes, continued Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly.
There are two forms of the condition; heart failure with reduced ejection fraction means the heart cannot contract normally, while preserved ejection fraction means the heart cannot properly fill with blood.
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) heart failure studies are two Phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with heart failure with preserved or reduced ejection fraction, with or without diabetes, who are receiving current standard of care:

Metacrine Achieves Full Enrollment for MET409 Phase 2a Combination Trial in Patients With Type 2 Diabetes and NASH

Retrieved on:

Wednesday, June 2, 2021

Anti-diabetic drugs, Glucosides, SGLT2 inhibitors, Boehringer Ingelheim, Empagliflozin, Ethers

NASH is closely linked to several co-morbidities including type 2 diabetes and treating patients holistically will likely require combination therapies, said Hubert C. Chen, M.D., chief medical officer, Metacrine.

Key Points:

NASH is closely linked to several co-morbidities including type 2 diabetes and treating patients holistically will likely require combination therapies, said Hubert C. Chen, M.D., chief medical officer, Metacrine.
We are encouraged by the enthusiasm of investigators, and most importantly patients, in recognizing the potential benefits of our differentiated combinatorial approach.
MET409 has completed a 12-week monotherapy trial in patients with NASH and is being evaluated in a 12-week combination trial with empagliflozin in patients with both NASH and type 2 diabetes.
MET642 has completed a 14-day Phase 1 trial in healthy volunteers and is being evaluated in a 16-week monotherapy trial in patients with NASH.

CHMP issues positive opinion for Jardiance® (empagliflozin) for the treatment of adults with heart failure with reduced ejection fraction

Retrieved on:

Friday, May 21, 2021

b'This press release features multimedia.

Key Points:

b'This press release features multimedia.
Key secondary endpoint analyses from the trial demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent and significantly slowed kidney function decline.4\n\xe2\x80\x9cWe are delighted with the CHMP\xe2\x80\x99s decision to recommend empagliflozin as a treatment for people living with symptomatic chronic heart failure with reduced ejection fraction,\xe2\x80\x9d said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.
\xe2\x80\x9cToday\xe2\x80\x99s decision marks our entrance into a new chapter of heart failure management, enabling us to help address the challenges heart failure patients are facing in the EU and beyond.\xe2\x80\x9d\n\xe2\x80\x9cLater this year, we expect trial results from our study in people with heart failure with preserved ejection fraction, another serious form of the condition.
People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.7,8\nThe EMPEROR-Reduced trial is part of the EMPOWER clinical program, the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.\nThe EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) heart failure studies are two Phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with heart failure with preserved or reduced ejection fraction, both with and without diabetes, who are receiving current standard of care:\n'

SGLT2 Inhibitors Poised to Potentially Reshape Chronic Kidney Disease (CKD) and Diabetic Kidney Disease (DKD) Patient Care After AstraZeneca's Farxiga Approval

Retrieved on:

Wednesday, May 12, 2021

Anti-diabetic drugs, Medical specialties, Glucosides, SGLT2 inhibitors, Kidney diseases, Drugs, Clinical medicine, Canagliflozin, Thiophenes, Nephrology, Dapagliflozin, Diabetic nephropathy

b'EXTON, Pa., May 12, 2021 /PRNewswire/ -- Nephrologists have long considered chronic kidney disease (CKD) progression and diabetic kidney disease (DKD) as areas in dire need of new and better therapeutic options for treatment.

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b'EXTON, Pa., May 12, 2021 /PRNewswire/ -- Nephrologists have long considered chronic kidney disease (CKD) progression and diabetic kidney disease (DKD) as areas in dire need of new and better therapeutic options for treatment.
While Invokana remains nephrologists\' preferred SGLT2 inhibitor, the gap has narrowed in recent quarters with Farxiga making substantial gains in the market as physicians grow more familiar with the agent.
"\nOther nephrologists note that they do not feel comfortable or want to manage a patient\'s diabetes and are concerned about hypoglycemia.
We specialize in select immunology, nephrology, and neurology markets.\nAll company, brand or product names in this document are trademarks of their respective holders.\n'

FARXIGA Approved in the US for the Treatment of Chronic Kidney Disease in Patients at Risk of Progression With and Without Type 2 Diabetes

Retrieved on:

Friday, April 30, 2021

Oncology, Health, FDA, Clinical trials, Pharmaceutical, Cardiology, Biotechnology, Anti-diabetic drugs, SGLT2 inhibitors, Medical specialties, Clinical medicine, Glucosides, Organ systems, Diabetes, Solute carrier family, Dapagliflozin, Sodium-glucose transport proteins, Sodium/glucose cotransporter 2, TIMI

FARXIGA is not expected to be effective in these populations.\nKetoacidosis in Diabetes Mellitus has been reported in patients with type 1 and type 2 diabetes receiving FARXIGA.

Key Points:

FARXIGA is not expected to be effective in these populations.\nKetoacidosis in Diabetes Mellitus has been reported in patients with type 1 and type 2 diabetes receiving FARXIGA.
In placebo-controlled trials of patients with type 1 diabetes, the risk of ketoacidosis was increased in patients who received SGLT2 inhibitors compared to patients who received placebo.
Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors, including FARXIGA.
Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE\xe2\x80\x93TIMI 58 Randomised Trial.

FDA Approves Treatment for Chronic Kidney Disease

Retrieved on:

Friday, April 30, 2021

Medical specialties, Anatomy, Medicine, Kidney diseases, Organ failure, Nephrology, Glucosides, SGLT2 inhibitors, Kidney failure, Dapagliflozin, Chronic kidney disease, Kidney disease

"Today\'s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.

Key Points:

"Today\'s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.
"\nChronic kidney disease occurs when the kidneys are damaged and cannot filter blood normally.
Chronic kidney disease sometimes can progress to kidney failure.
Patients also are at high risk of cardiovascular disease, including heart disease and stroke.\nThe efficacy of Farxiga to improve kidney outcomes and reduce cardiovascular death in patients with chronic kidney disease was evaluated in a multicenter, double-blind study.

KidneyIntelX Demonstrates Performance and Informs Treatment Decisions in Multinational CANagliflozin CardioVAScular Assessment Study (CANVAS)

Retrieved on:

Tuesday, April 20, 2021

Medical specialties, Anatomy, Organ systems, Anti-diabetic drugs, Kidney diseases, Glucosides, SGLT2 inhibitors, Canagliflozin, Thiophenes, Diabetic nephropathy, Chronic kidney disease, Diabetes

b'NEW YORK, April 20, 2021 (GLOBE NEWSWIRE) -- Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) announces the findings of a new study in which the commercially available KidneyIntelX test accurately predicted progression of diabetic kidney disease (DKD) in a multinational cohort from the CANagliflozin CardioVAScular Assessment Study (CANVAS)1 with early-stage DKD (stages 1-3).

Key Points:

b'NEW YORK, April 20, 2021 (GLOBE NEWSWIRE) -- Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) announces the findings of a new study in which the commercially available KidneyIntelX test accurately predicted progression of diabetic kidney disease (DKD) in a multinational cohort from the CANagliflozin CardioVAScular Assessment Study (CANVAS)1 with early-stage DKD (stages 1-3).
\xe2\x80\x9cThe new data from CANVAS supports primary care physicians using the KidneyIntelX score to risk stratify and make informed care decisions with their patients.
Canagliflozin is FDA approved to reduce the risk for end-stage renal disease, worsening of kidney function, cardiovascular death, and hospitalization for heart failure among adults with type 2 diabetes and DKD.
The Centers for Disease Control and Prevention (CDC) estimates that 15% of US adults, or 37 million people, currently have chronic kidney disease (CKD).