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Research Consortium On Rare Diseases Calls For Regulators To Adopt New Surrogate End Point For Pivotal Clinical Trials In Patients With AL Amyloidosis

A new white paper from the Amyloidosis Research Consortium concludes that NT-proBNP, a functional biomarker predictive of survival, is a clinically and analytically validated functional biomarker that should be accepted as a surrogate end point in pivotal clinical trials to accelerate the development of therapeutics for AL amyloidosis. This white paper is part of a multifaceted strategy to accelerate the drug development pathway for patients with amyloidosis, which will be highlighted by a public meeting that will include patients, expert physicians from around the world, and regulators at the US Food and Drug Administration (FDA) on November 16, 2015, in Silver Spring, Maryland.

Can This Simple Test Predict Your Chances of Dying? If You Have Coronary Artery Disease, The Answer Is Yes, Say A Group of Renowned Scientists

Critical Diagnostics recently announced the results of the LURIC study of 1345 patients with stable coronary artery disease, established that, in a univariate analysis, patients with ST2 levels in the highest quartile exhibited a 2-fold increased risk of death. Results remained significant even in a fully adjusted model.

Cardiac Biomarker ST2 Helps Assess Heart Failure Risk And Identify Heart Failure Patients Likely To Benefit From Exercise

Critical Diagnostics recently announced that results of the HF-ACTION study just published in the American Heart Association’s Circulation: Heart Failure demonstrate that levels of the biomarker ST2 are predictive of long-term outcomes for people suffering with heart failure, and identify those patients who may benefit from exercise.

Cardiac Biomarker ST2 Proves Far Superior To Galectin-3 In A Head-to-Head Study

Critical Diagnostics recently announced that the study, “Head-to-head comparison of two myocardial fibrosis biomarkers for long-term heart failure risk stratification: ST2 vs. Galectin-3”, recently published online in JACC (the Journal of the American College of Cardiology) comparing the company’s novel cardiac biomarker ST2 to Galectin-3 (Gal-3), a biomarker from BG Medicine (NASDAQ: BGMD), found ST2 to be superior.

Two Biomarkers Predict Increased Risk for “Silent” Strokes

Two biomarkers widely being investigated as predictors of heart and vascular disease appear to indicate risk for “silent” strokes and other causes of mild brain damage that present no symptoms, report researchers from The Methodist Hospital and several other institutions in an upcoming issue of Stroke (now online).

The researchers found high blood levels of troponin T and NT-proBNP were associated with as much as 3 and 3.5 times the amount of damaged brain tissue, respectively. The findings are part of the large-scale Atherosclerosis Risk in Communities (ARIC) study, funded by the National Heart, Lung, and Blood Institute.

“The concept of prevention is expanding,” said principal investigator Christie Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention at The Methodist Hospital. “It’s not good enough to simply do a few tests and try to assess risk for heart attack. What we need to do is assess the risk for heart attack, stroke, heart failure and also asymptomatic disease so we can start preventive efforts earlier. Waiting to correct problems until after a symptomatic stroke may be too late.”

One possible outcome is that patients determined to be in high-risk groups could be started on anti-stroke medications sooner.

In another ARIC paper published two months ago in Stroke, Ballantyne and coauthors reported a strong association between blood levels of troponin T and NT-proBNP and more severe instances of stroke, called symptomatic stroke. The current study looked at the two biomarkers and “subclinical,” asymptomatic events in the brain that are usually caused by a lack of blood flow.

“Taken together, these two papers show the biomarkers are effective at identifying people who are likely to have mild brain disease and stroke well before damage is done,” said Ballantyne, who also is a Baylor College of Medicine professor. “This hopefully will give doctors more time to help patients take corrective steps to protect their brains.”

For the subclinical brain disease study, researchers gleaned data from about 1,100 patient volunteers who agreed to have blood drawn and two MRI scans eleven years apart to look for silent brain infarcts and also white matter lesions (WMLs) caused by chronic inflammation.

Statistical analysis showed a strong relationship between high NTproBNP and the likelihood of brain infarcts and WMLs. Study participants with the highest levels of NT-proBNP had as much as 3.5 times the number of brain infarcts as participants with low NT-proBNP levels, and more WMLs. Those with the highest levels of troponin T had as much as 3.0 times the number of brain infarcts and more WMLs.

The protein troponin T is part of the troponin complex and its presence is often used to diagnose recent heart attacks. NT-proBNP is an inactive peptide fragment left over from the production of brain natiuretic peptide (BNP), a small neuropeptide hormone that has been shown to have value in diagnosing recent and ongoing congestive heart failure.

“The highly sensitive troponin T test we used is not approved for general clinical use in the US yet, but the NT-proBNP test is just now starting to be used more widely beyond making a diagnosis for heart failure,” Ballantyne said.

The Center for Cardiovascular Disease Prevention is part of the Methodist DeBakey Heart & Vascular Center.

Also contributing to this study were Razvan Dadu, Salim Virani, Vijay Nambi, and Ron Hoogeveen (Baylor College of Medicine and Methodist Center for Cardiovascular Disease Prevention), Myriam Fornage and Eric Boerwinkle (University of Texas Health Sciences Center at Houston), Alvaro Alonso (University of Minnesota School of Public Health), Rebecca Gottesman (Johns Hopkins School of Medicine), and Thomas Mosley (University of Mississippi Medical Center). It was funded with grants from NHLBI and NIH, while Roche Applied Science helped fund the development of diagnostic technology.

Stroke is published by the American Heart Association and American Stroke Association.

Source: Cardiovascular Biomarkers and Subclinical Brain Disease in the Atherosclerosis Risk in Communities Study.

Source: Troponin T, N-terminal pro-B-type natriuretic peptide, and incidence of stroke: the atherosclerosis risk in communities study.

Source: The Methodist Hospital System