Articles tagged with 'Cardiovascular Diseases' | Bayer

Three new investigator-sponsored collaborative studies are funded by Bayer and will evaluate the efficacy and safety of finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist (MRA), in approximately 9,300 heart failure (HF) pati...

Phase II/III study VALOR will assess efficacy, safety and pharmacokinetics of vericiguat in pediatric patients / VALOR is the pivotal study in pediatric heart failure with vericiguat

The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program enrolling more than 27,000 patients in over 40 countries / Asundexian is being evaluated as a potential improved treatment option in st...

Late-stage development programs with significant potential to drive long-term growth / New R&D strategy and operating model sharpening innovation focus and strengthening early development pipeline in oncology, cardiovascular, neurology & rare disease...

In the prospective observational XARENO study, after a two year follow up period, Xarelto was associated with a reduced risk of adverse kidney outcomes and all-cause mortality in patients with non-valvular atrial fibrillation (NVAF) and advanced chro...

European Commission granted approval for a label update to extend the indication of Kerendia™ to early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and to include findings from the Phase III FIGARO-DKD cardiovascular (...

CHMP opinion is based on the results from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), which included approximately 7,400 patients across a broad range of disease...

FIDELITY: Late-breaking data from pooled, post-hoc analysis will provide new insights into the efficacy and safety of Kerendia in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have sustained an acute change in estimated glo...

New post-hoc analyses from the prespecified pooled analysis FIDELITY will provide insights into the effects of finerenone on kidney and cardiovascular outcomes by use of glucagon-like peptide-1 receptor agonists (GLP-1RA) at baseline, as well as by b...

U.S. Food and Drug Administration (FDA) granted label update for Kerendia™ (finerenone) to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) associated with type 2 diabetes...

Data from FIDELITY, a prespecified pooled analysis of the Phase III FIDELIO-DKD and FIGARO-DKD studies, highlight the potential of Kerendia™ (finerenone) to reduce the incidence of sudden cardiac death / While in the overall FIDELITY population, the ...

The OCEANIC program will start with two Phase III studies investigating the efficacy and safety of asundexian in prevention of stroke events in patients with atrial fibrillation as well as patients with a non-cardioembolic ischemic stroke or high-ris...

Late-breaking data from a new exploratory analysis of FIDELITY investigating causes of mortality in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) treated with Kerendia™ (finerenone) or placebo / New Phase IIb data from PACIFIC ...

Berlin, Germany, July 28, 2022 – Bayer today announced completion of two Phase 2b clinical trials: the RE-THINC ESRD trial and the CONVERT trial. The RE-THINC ESRD trial evaluated the safety of fesomersen, Bayer’s investigational, subcutaneously admi...

Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are progressing to kidney failure and premature death / Kerendia™ (finerenone) is the first non-steroidal, selective mineralocorticoid rece...

New post-hoc analysis from FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD, evaluated the effect of Kerendia™ (finerenone) by baseline HbA1c categories, HbA1c variability, and diabetes duration in patients with chronic kidney d...

Data from the exploratory post hoc analysis of FIDELITY also highlight the potential of Kerendia™ (finerenone) to reduce the incidence of hospitalization for heart failure (HHF), with a more pronounced effect in patients with left ventricular hypertr...

Results from the extension part of the COMPASS study support the long-term use of Xarelto (rivaroxaban) plus aspirin for vascular protection in patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) / The XATOA reg...

Studied in adults with symptomatic chronic heart failure and reduced ejection fraction who are stabilized after a recent decompensation event with IV therapy / Approved in China to reduce the risk of heart failure (HF) hospitalization or the need for...

New subgroup analysis from FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD, will reveal further insights into the efficacy and safety of Kerendia™ (finerenone) in patients with stage 4 chronic kidney disease (CKD) and type 2 di...

Cardiovascular (CV) complications are among the most frequent causes of death for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), with atherosclerotic CV disease (ASCVD) on top of CKD and T2D having the highest risk of all-cause...

In the prospective observational XARENO study, after one year follow up, Xarelto was associated with a greater net clinical benefit and a reduced risk of kidney failure in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kid...

Data from the PACIFIC-AF trial demonstrated lower observed rates of ISTH major and clinically relevant non-major bleeding for asundexian (a FXIa inhibitor) compared with apixaban in patients with atrial fibrillation at risk of stroke / The data, simu...

Pre-specified subgroup analyses from FIDELITY explore the efficacy and safety of finerenone (Kerendia™) in primary and secondary prevention of cardiovascular (CV) and kidney outcomes in patients with a combination of cardiovascular disease, chronic k...

Regulatory submission is based on positive data from the pivotal Phase III FIGARO-DKD study, published in the New England Journal of Medicine, which covers a broad range of disease severities of chronic kidney disease associated with type 2 diabetes ...

There is a high unmet need for new treatments to preserve kidney function and delay kidney disease progression in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) / The Phase II CONFIDENCE study will investigate the effect of the ...

Kerendia is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) / The approv...

Finerenone, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, is recommended by CHMP for marketing authorization for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) / CHMP opinion is based on t...

For children and adolescents with chronic kidney disease (CKD), as for adults, the unmet need is high for new treatments to delay disease progression and preserve kidney function / The Phase III study FIONA will investigate the effect of finerenone i...

New Phase III study VICTOR will assess vericiguat efficacy and safety in patients who have not had a recent worsening heart failure event / VICTOR expands upon the Phase III VICTORIA study, providing further insight into the use of vericiguat in a br...