Articles tagged with 'Cardiovascular Diseases' | Bayer

Newsroom Bayer (Cardiovascular Diseases)

2022
September
20,
2022
| 11:45 AM Europe/Amsterdam
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...
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September
02,
2022
| 10:15 AM Europe/Amsterdam
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...
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August
29,
2022
| 09:24 AM Europe/Amsterdam
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 ...
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August
28,
2022
| 09:14 AM Europe/Amsterdam
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...
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August
22,
2022
| 09:00 AM Europe/Amsterdam
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 ...
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July
28,
2022
| 13:05 PM Europe/Amsterdam
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...
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June
30,
2022
| 08:30 AM Europe/Amsterdam
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...
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June
03,
2022
| 09:00 AM Europe/Amsterdam
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...
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May
23,
2022
| 16:39 PM Europe/Amsterdam
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...
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May
23,
2022
| 14:00 PM Europe/Amsterdam
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...
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May
19,
2022
| 10:00 AM Europe/Amsterdam
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...
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May
17,
2022
| 09:00 AM Europe/Amsterdam
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...
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April
04,
2022
| 19:00 PM Europe/Amsterdam
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...
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April
04,
2022
| 10:00 AM Europe/Amsterdam
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...
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April
03,
2022
| 18:15 PM Europe/Amsterdam
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...
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March
29,
2022
| 08:30 AM Europe/Amsterdam
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...
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March
16,
2022
| 08:30 AM Europe/Amsterdam
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 ...
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February
24,
2022
| 08:30 AM Europe/Amsterdam
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 ...
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February
21,
2022
| 08:30 AM Europe/Amsterdam
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...
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2021
December
17,
2021
| 12:45 PM Europe/Amsterdam
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...
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November
15,
2021
| 09:30 AM Europe/Amsterdam
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...
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November
11,
2021
| 12:45 PM Europe/Amsterdam
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...
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November
08,
2021
| 14:30 PM Europe/Amsterdam
Exploratory analysis of the FIGARO-DKD study with finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist, indicated a reduction in renal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), as seen i...
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November
05,
2021
| 09:00 AM Europe/Amsterdam
A secondary analysis of FIGARO-DKD will be presented, further investigating the cardiovascular benefits of finerenone / A subgroup analysis of FIDELITY, a prespecified pooled analysis of more than 13,000 patients from the Phase III studies FIGARO-DKD...
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October
27,
2021
| 14:00 PM Europe/Amsterdam
New analysis from the Phase III FIGARO-DKD study will be presented, which investigated the impact of finerenone on renal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) / A subgroup analysis from FIDELITY, a prespecif...
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September
27,
2021
| 14:30 PM Europe/Amsterdam
Pivotal UNIVERSE Phase 3 study published in the Journal of the American Heart Association found rivaroxaban (Xarelto™) was associated with numerically fewer thrombotic events and similar safety compared to aspirin in 2-8 years old children with conge...
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September
20,
2021
| 14:00 PM Europe/Amsterdam
There are limited treatment options available for chronic kidney disease (CKD), and patients often still progress to kidney failure or premature death / The Phase III study FIND-CKD will investigate the effect of finerenone on kidney and cardiovascul...
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August
24,
2021
| 14:00 PM Europe/Amsterdam
Patients after recent lower-extremity revascularization due to symptomatic PAD now included in the label in the US / Xarelto plus aspirin is the first treatment approach indicated in the US for both coronary artery disease (CAD) and PAD, now includin...
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August
17,
2021
| 10:00 AM Europe/Amsterdam
Detailed results from the FIGARO-DKD study will be presented, which investigated the efficacy and safety of finerenone regarding cardiovascular and kidney outcomes versus placebo in addition to standard of care in patients with chronic kidney disease...
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July
21,
2021
| 12:45 PM Europe/Amsterdam
Approved for adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous therapy / Studied in a population with a high risk of cardiovascular death or heart failure hospitalization / The ...
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