- Researchers say they can predict more severe kidney and cardiovascular disease in people with type 2 diabetes when biomarker values are assessed at baseline, after one year, and at three years.
- The biomarkers were used to measure the effects of the drug canagliflozin on disease severity.
- The researchers said the study results strengthen previous data showing a high incident rate of cardiovascular disease in people with type 2 diabetes
A blood test could help predict the risk of progressive heart and kidney disease in people with type 2 diabetes and kidney disease, according to research published today in the American Heart Association journal Circulation.
In their study, researchers analyzed biomarker data from blood samples of 2,627 people who participated in the Canagliflozin and Renal Events in Diabetes with Established Nephropathic Passage Clinical Evaluation (CREDENCE) trial to assess the effects of the drug canagliflozin on four biomarkers.
The scientists checked the biomarkers at the start of the study, the one-year mark, and the three-year mark.
The scientists also looked at the predictive value of the biomarkers on various levels of kidney problems and the risk of death due to kidney disease or cardiovascular disease.
The researchers looked for biomarker values above those seen in healthy individuals, which would predict cardiovascular and renal events. Based on the levels of the biomarkers, the researchers divided participants into low, medium, and high-risk categories.
The scientists reported that people with the highest risk showed higher rates of progressive kidney failure and cardiovascular complications throughout the three-year follow-up period.
Results of the study included:
- High concentrations of the biomarkers at the beginning of the study predicted the severity of the participants’ heart and kidney issues.
- The biomarkers in those taking canagliflozin were lower after one year and three years as compared to those taking a placebo.
- After one year, all biomarkers in participants who took the canagliflozin rose to 10%, compared to 29% for those who took a placebo.
- The researchers noted that canagliflozin can help reduce risks some risks in most people with the highest chance for complications.
Canagliflozin is sold under the brand name Invokana and is an SGLT2 inhibitor used to treat type 2 diabetes. Side effects of canagliflozin include:
According to Dr. James Januzzi, a study lead author and a professor of medicine at Harvard Medical School as well as a cardiologist at Massachusetts General Hospital and the director of heart failure and biomarker trials at the Baim Institute for Clinical Research in Boston, biomarkers “are regularly used when diagnosing and treating a specific condition.”
“They are an objective measure of what is happening at a given moment. They can help with predicting disease progression,” Januzzi explained to Medical News Today.
“In this study, the biomarkers were used to measure baseline and how canagliflozin affected the biomarkers for up to three years follow up, as well as looking at the association between the biomarker concentrations and their changes from year to year to predict cardiovascular and kidney outcomes,” Januzzi said.
The researchers said the results show that biomarkers could reveal varying risk levels and possibly be used to target treatment for individuals with kidney disease more efficiently. They can also help to check whether SGLT2 inhibitors such as canagliflozin should be used.
The researchers said they could predict cardiorenal risk by looking at four biomarkers individually and collectively. The biomarkers also showed the benefits of the medicine.
“This was an interesting study in that it examined a few different biomarkers in patients taking canagliflozin to assess the effects on kidney failure and cardiovascular events,” said Dr. Cheng-Han Chen, an interventional cardiologist and medical director of the Structural Heart Program at MemorialCare Saddleback Medical Center in California who was not involved in the study.
“We typically have an idea of what a normal value for a biomarker should be, and so abnormal values help us in diagnosing various diseases,” Chen told Medical News Today. “In addition, these values, when tracked over time, help us gauge a patient’s response to treatment. The levels of all four biomarkers seemed to be predictive of a patient’s health outcome. This makes the study applicable to all our patients with diabetes not just the ones we are treating with canagliflozin.”
“Canagliflozin is becoming a common medication we use to help reduce the risk of cardiovascular diseases such as heart attacks, stroke, and heart failure, especially in patients with diabetes. This study gives us tools to help us potentially risk-stratify our diabetic patients, identifying those with elevated biomarkers that might benefit the most from taking canagliflozin,” Chen added.
The authors of the study note that these results further strengthen the accumulating data on the substantial cardiovascular risk in people with type 2 diabetes, the value of using biomarkers for predicting major complications in these individuals, and the consistent benefits of SGLT2 inhibitors in reducing events across patients with a wide range of risks.
The use of biomarkers can also help monitor the effectiveness of treatment.
“The authors in this paper identified several biomarkers that correlate with the risk for adverse outcomes,” said Dr. Adriana Quinones-Camacho, the chief of medicine at NYU Langone Health and associate professor in the Department of Medicine, the Leon H. Charney Division of Cardiology at NYU Grossman School of Medicine who was not involved in the study.
“It showed how changes in these biomarkers seen after treatment with canagliflozin when compared to placebo also translate to a reduction in adverse outcomes,” she told Medical News Today. “It is the change, not just the baseline level, of these biomarkers that can help predict adverse events in this patient population”
The limitations of this study included that not all participants had available samples for biomarker measurement. The participants with biomarker measurements may not represent this study’s entire population. Also, biomarker data was not always completed and some participants had missing values.