The diabetes medicine has heart and kidney benefits, the researchers find

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The study was funded by the pharmaceutical company Janssen, manufacturer of the drug canagliflozin, which has the Invokana brand.
In March, the company submitted a new drug application to the US Food and Drug Administration for canagliflozin to be used to reduce the risk of end-stage renal disease and renal or cardiovascular death in adults with type 2 diabetes and chronic kidney disease.

The study included 4,401 patients, aged 30 and older, with type 2 diabetes and chronic kidney disease. These patients were randomly assigned to 690 sites in 34 countries to take canagliflozin or a placebo, from March 2014 to May 2017.

They were followed at 3, 13 and 26 weeks, during which the effects of the drug were monitored.

The researchers found that in the canagliflozin group the relative risk of death from renal causes was 34% lower and the relative risk of end-stage renal disease was 32% lower. The group also had a lower risk of cardiovascular death, heart attack, stroke and hospitalization for heart failure.

Based on the study's data, the researchers estimated that treatment with canagliflozin would have prevented 22 hospitalizations for heart failure and 25 composite events of cardiovascular death, heart attack or stroke among 1,000 patients.

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Regarding the harmful results, canagliflozin has been found to increase the risk of having a lower limb amputation as a side effect, but the researchers saw no significant difference in the risk of amputation of the lower limbs between the two groups in the study. Rates of bone fracture, another known side effect of canagliflozin, were also similar in the two groups, according to the study.
The study also showed that the risk of diabetic ketoacidosis, a problem that threatens life when the body begins to break down fat at a fast, unhealthy rate, was low overall but higher in the canagliflozin group.

The study had some limitations, including the fact that it did not include patients with very advanced kidney disease. Nor did it include patients whose kidney disease was thought to be due to conditions other than type 2 diabetes. Further research is needed to determine whether the results of the study could be generalized to other types of kidney disease.

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This study has the potential to influence medical practice, said Dr. Mark Molitch, a professor of endocrinology at the Feinberg School of Medicine at Northwestern University, who was not involved in the new study but often prescribed canagliflozin for his patients.
Canagliflozin, a drug used to treat type 2 diabetes, belongs to a class of drugs called sodium-glucose inhibitors cotransporter-2, or SGLT2, which lower blood sugar causing the kidneys to remove sugar from the body through the 39; urine.

"With this whole class of drugs, we really need to think about how we use it because of the heart benefits and kidney benefits," Molitch said about SGLT2 inhibitors.

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"This class of drugs really has its primary action on the kidney, from the point of view of diabetes, so normally we have a lot of glucose – the main sugar that circulates in the blood – and then the kidney filters glucose. Time has no glucose in the urine because the kidney reabsorbs all the glucose that is filtered by the blood, "he said. "What these drugs do is that they block the reabsorption of glucose into the blood from the urine and then excrete a lot of glucose in the urine."

Molitch, a member of the Endocrine Society, added that the benefits to the heart and kidneys described in the new study "are beyond" the benefits of simply lowering blood sugar.

"We are not yet sure what the mechanisms that cause these benefits to the heart and kidneys are, but they are clearly not just due to the lowering of blood sugar level," he said.

"Cardiac and renal benefits occur in patients with more advanced kidney disease, where the hypoglycemic effects of canagliflozin would be minimal," he said. "So, based on this study, we could use canagliflozin only for kidney benefits and possibly heart benefits while using other drugs to control glucose levels in patients with diabetes and kidney disease."

The effect of the drug "was rather rapid" in the study, Dr. Derek Leroith, professor of medicine and interim chief of Hilda & J. Lester Gabrilove, division of Endocrinology, Diabetes and Bone Diseases at the Icahn School of Medicine of the Mount Sinai in New York said in an e-mail. Leroith is also a chair of guidelines for diabetes for the Endocrine Society.

"This study was designed to include individuals with diabetic kidney disease and, as such, is the first example of reducing the risk of renal failure [as] and improving cardiovascular outcomes," said Leroith, who was not involved in the study . "I believe the document is extremely significant and will have a very educated public with important implications."

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