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A drug that lowers blood sugar in people with type 2 diabetes also reduces the risk of end-stage renal disease by 30%, a finding that could help save kidney function in many patients and save billions dollars by preserving them from dialysis, reported Monday.
Type 2 diabetes has reached epidemic proportions in Long Island and beyond, which means that the resulting problems are also increasing. Kidney failure has been increasing by 5% per year for more than a decade and almost half of people on dialysis in the United States have type 2 diabetes.
In the context of an international clinical trial considered a flagship study, patients with type 2 diabetes and chronic renal failure who were taking the drug Invokana found that their risk of becoming complete renal failure was been reduced by one third. This means that the drug has helped prevent dialysis and kidney transplants and reduce the risk of death from end-stage renal failure.
In addition to preserving kidney function, the drug also helped reduce cardiovascular problems, research revealed.
"This is the first study showing such an important effect," said Dr. Douglas Lax, chief of nephrology at the Mercy Medical Center in Rockville Center, which was not part of the research. "It was also the first to look at patients whose kidney disease was already advanced."
About 13,000 people have been tested worldwide, about half of them on Invokana and the other half on placebo. The study was stopped along the way as it would have been unethical to continue taking a placebo that was not helping.
The physicians who led the study, called the Credence trial, estimated that for every 1,000 people taking the drug for 2.5 years, there would be 47 fewer cases of kidney failure, dialysis, and transplants. The cases of adverse events observed during the research – amputations of toes, feet and legs – were similar in patients taking Invokana and placebo.
Invokana is a product of Janssen Pharmaceuticals and costs around $ 475 a month. It was approved in 2013 to reduce blood sugar. But the doctors who tested his ability to preserve kidney function said he hoped the US Food and Drug Administration would approve him for the new role. Physicians, on the other hand, are free to use any "off-label" approved drug, which means prescribing it for a new salvage indication.
"Kidney disease can be slowly progressive," said Lax, "but the fact that they can show such important differences between groups is quite amazing to me.
According to Lax, Invokana is the first drug for type 2 diabetics to treat kidney disease for more than 15 years. Although the study just came out in the New England Journal of Medicine and was reported at a medical conference in Australia, Lax said it would look into it for some of his patients. In addition to his role at Mercy, he oversees the dialysis centers in Hempstead, Oceanside, Bellmore, Freeport and Woodmere.
The National Kidney Foundation congratulated the research on Monday and noted the growing number of kidney diseases across the country.
"Chronic Kidney Disease is a largely invisible and growing public health problem with limited treatment options," said the Kidney Foundation in a statement, adding that the "study" is encouraging for diabetic patients with renal failure and is an important step forward nephropathy at the intermediate stage.
"Diabetes is a key risk factor for chronic renal failure and accounts for 44% of all cases of end-stage renal failure. However, less than 40% of diabetics are fully assessed for kidney disease, "said the foundation.
Nearly 750,000 people a year and 2 million people worldwide are developing end-stage renal disease, according to the Kidney Project at the University of California at San Francisco.
End-stage renal disease mainly affects elderly diabetics of all ethnicities, but is also common among African-Americans, Native Americans and Hispanics of all ages. About 7% of Medicare's annual budget is spent on end-stage renal disease.
Dr. Kenneth Mahaffey, professor of medicine at Stanford University and co-principal investigator of research, said that Invokana protects kidney function by increasing glucose excretion by both organs. He said the research paves the way for a new treatment option.
"For the first time in 18 years, we have a therapy for patients with type 2 diabetes and chronic renal failure that reduces kidney failure," Mahaffey said. "Now, diabetic patients have a promising option to guard against one of the most serious risks of their disease."
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