A simple blood test may predict the risk of progressive heart and kidney disease in people with Type 2 diabetes and kidney disease, according to new research published today in the American Heart Association’s flagship journal Circulation.
“High levels of certain biomarkers are indicators of heart and kidney
complications and may help predict future risk of disease progression,” said
lead author James Januzzi, M.D., the Hutter Family Professor of Medicine at
Harvard Medical School, a cardiologist at the Massachusetts General Hospital
and the director of heart failure and biomarker trials at the Baim Institute
for Clinical Research in Boston. “Treatment with canagliflozin, a sodium
glucose co-transporter 2 inhibitor, lowered biomarker levels and reduced the
risk of hospitalization for heart failure and other heart complications in
people at the highest risk.”
Health professionals regularly measure biomarkers to screen, diagnose or
treat specific conditions. Previous research has shown that concentrations of
some biomarkers may predict the onset and progression of chronic kidney disease
as well as cardiovascular events in people with Type 2 diabetes.
The researchers analyzed biomarker data from the blood samples of 2,627
people who participated in the Canagliflozin and Renal Events in Diabetes with
Established Nephropathy Clinical Evaluation (CREDENCE) trial to assess the
effects of canagliflozin on concentrations of the four biomarkers from the
study start, the one-year mark and the three-year mark. They also examined the
prognostic value of each biomarker on various levels of kidney problems, and
risk of death due to kidney disease or cardiovascular disease. Patients were
separated into low, medium and high risk categories. People at highest risk
showed dramatically higher rates of progressive kidney failure and
cardiovascular complications throughout the three-year study period.
The analysis found:
·
High concentrations of each
biomarker at the beginning of the study were strongly predictive of the
severity of the participant’s heart and kidney issues.
·
The concentrations of each of the
four biomarkers in people taking canagliflozin were lower after one year and
three years compared to those taking the placebo.
· After one year, the levels of all biomarkers in participants who took canagliflozin rose 3% to 10%, compared to an increase of 6% to 29% in the those who took the placebo.
“It was reassuring to discover that canagliflozin helped reduce risks the
most in people with the highest chances for complications. Future studies are
needed to better understand how Type 2 diabetes in conjunction with kidney
disease develops and progresses so that we may initiate life-saving therapies
earlier, before symptoms of heart and kidney disease have occurred.” Januzzi
said. “Given that the American Heart Association/American College of Cardiology
and the American Diabetes Association now all recommend measurement of
biomarkers to enhance ability to predict risk in persons with Type 2 diabetes,
these results may considerably extend the reach of biomarker-based testing,
refining accuracy even further.”
The study was limited in that not all study participants in the CREDENCE
trial had available samples for biomarker measurement, and the participants
with biomarker measurement may not be representative of the study’s entire
population. Additionally, biomarker data over time were not complete, and some
study participants had missing values during the study follow-up period. While
prognostic thresholds for predicting the risk of kidney and heart complications
in people with Type 2 diabetes have been identified for two of the biomarkers,
prognostic thresholds remain exploratory for the other two.
Background:
·
The CREDENCE trial (2014-2018)
compared the effectiveness of a placebo to 100 mg of canagliflozin, which is
used to treat Type 2 diabetes. It works in the kidneys to prevent the
absorption of glucose. People enrolled in the phase 3 clinical trial had Type 2
diabetes and chronic kidney disease; the trial concluded canagliflozin was more
effective than placebo in reducing cardiovascular disease and kidney failure in
the participants.
·
The four biomarkers analyzed in the
study were: N-terminal pro-B-type natriuretic peptide; high-sensitivity cardiac
troponin T; growth differentiation factor-15; and insulin-like growth factor
binding protein 7.
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