Heart study finds faulty link between biomarkers and clinical outcomes

July 14, 2017 by Colum O'connor
Heart study finds faulty link between biomarkers and clinical outcomes
Credit: stock.adobe.com

Surrogate endpoints (biomarkers), which are routinely used in clinical research to test new drugs, should not be trusted as the ultimate measure to approve new health interventions in cardiovascular medicine, according to a recent study by Yale School of Medicine researchers in JAMA.

Biomarkers generally refer to diseases, symptoms, and signs during clinical trials that are associated with other, more complicated diseases and symptoms (clinical outcomes).

In the Yale study, lead author and internal medicine resident at Yale School of Medicine Dr. Behnood Bikdeli and his colleagues examined the potential disconnect between biomarkers and clinical outcomes by screening prior publications in the field of . They found that although the surrogate endpoint trials published in the highest-impact journals frequently demonstrated high effectiveness of the tested drug, less than one third of them had a clinical outcomes trial of the drug for the same purpose published.

Additionally, when there was a subsequent trial, approximately half failed to validate the positive impact of the drug on the . Bikdeli notes that while the new findings only apply to the field of cardiovascular medicine, doctors and researchers in other fields, such as oncology, hold similar reservations about using biomarkers to approve .

Explore further: Yale researchers see decline in hospitalizations for serious heart infection

More information: Behnood Bikdeli et al. Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011, Journal of the American Heart Association (2017). DOI: 10.1161/JAHA.116.005285

Related Stories

Yale researchers see decline in hospitalizations for serious heart infection

September 16, 2013
Hospitalizations for endocarditis, a deadly heart infection that disproportionately affects older heart patients, have declined in recent years despite recommendations for limited use of antibiotics to prevent the illness. ...

All water pills not equally effective against heart failure

April 1, 2013
Loop diuretics, more commonly known as water pills, are the most widely prescribed heart failure medications, but few studies had extensively compared their effectiveness until Yale School of Medicine researchers examined ...

Study finds patterns of biomarkers predict how well people age, risks of age-related disease

January 6, 2017
Levels of specific biomarkers, or chemicals found in the blood, can be combined to produce patterns that signify how well a person is aging and his or risk for future aging-related diseases, according to a new study by researchers ...

Heart risks of glucose-lowering drugs being overlooked in clinical trials

March 12, 2014
Why is heart failure not more rigorously assessed in clinical trials of antidiabetes drugs? In a Personal View, published in The Lancet Diabetes & Endocrinology journal, Professor John McMurray of The University of Glasgow ...

Personalized medicine leads to better outcomes for patients with cancer

June 6, 2016
In a meta-analysis of hundreds of clinical trials involving thousands of patients, researchers at University of California San Diego School of Medicine report that therapeutic approaches using precision medicine, which emphasizes ...

Biological markers increase clinical trial success rate of new breast cancer drugs

October 1, 2012
Using biological markers—genetic characteristics that are associated with some patients with breast cancer—can increase the success rate of clinical trials for breast cancer drugs by almost 50 per cent, says new research ...

Recommended for you

Low-salt and heart-healthy dash diet as effective as drugs for some adults with high blood pressure

November 22, 2017
A study of more than 400 adults with prehypertension, or stage 1 high blood pressure, found that combining a low-salt diet with the heart-healthy DASH diet substantially lowers systolic blood pressure—the top number in ...

Stroke patients may have more time to get treatment, study finds

November 22, 2017
Patients and doctors long have relied on a simple rule of thumb for seeking care after an ischemic stroke: "Time is brain."

Cases of heart failure continue to rise; poorest people worst affected

November 22, 2017
The number of people being diagnosed with heart failure in the UK continues to rise as a result of demographic changes common to many developed countries, new research by The George Institute for Global Health at the University ...

Some cancer therapies may provide a new way to treat high blood pressure

November 20, 2017
Drugs designed to halt cancer growth may offer a new way to control high blood pressure (hypertension), say Georgetown University Medical Center investigators. The finding could offer a real advance in hypertension treatment ...

Could this protein protect people against coronary artery disease?

November 17, 2017
The buildup of plaque in the heart's arteries is an unfortunate part of aging. But by studying the genetic makeup of people who maintain clear arteries into old age, researchers led by UNC's Jonathan Schisler, PhD, have identified ...

Raising 'good' cholesterol fails to protect against heart disease

November 16, 2017
Raising so-called 'good' cholesterol by blocking a key protein involved in its metabolism does not protect against heart disease or stroke, according to a large genetic study of 150,000 Chinese adults published in the journal ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.