NEW ORLEANS--Last year, Eli Lilly and Boehringer Ingelheim made headlines with their SGLT2 contender Jardiance, which became the first diabetes med to show it could improve cardiovascular outcomes for patients. And now, it has new results in hand suggesting it may improve kidney outcomes, too.
Data from the EMPA-REG outcomes trial show that the med cut the risk for new-onset or worsening kidney disease by 39% compared with placebo, when added to standard-of-care treatment for adults with Type 2 diabetes and established cardiovascular disease, the drugmakers said Tuesday at the American Diabetes Association’s annual meeting.
Those findings--which were also published in the New England Journal of Medicine--are especially important in light of the fact that more than one-third of Type 2 patients go on to develop kidney disease, which can lead to kidney failure and a need for dialysis, the companies said.
“Thirty percent to 40% of patients suffer some sort of renal impairment over the course of the disease,” Thomas Seck, Boehringer’s VP of clinical development and medical affairs in metabolism, told FiercePharma, and “over the last decade we really have not made much progress in that area.”
Breaking down the results, Jardiance posed a 55% reduction in the initiation of renal replacement therapy, such as dialysis. The drug also reduced two measures that are indicators of kidney problems: It delivered a 44% reduction in the doubling of creatinine, a waste product usually filtered by the kidneys, in the blood; and a 38% reduction in progression to macroalbuminuria, or very high levels of the albumin protein in the urine. It also put the brakes on the decline in kidney function over time when pitted against placebo.
So far, Jardiance is the only SGLT2 med to turn up outcomes evidence that it can slow down the progression of kidney disease, which could provide another leg up over competitors Invokana from Johnson & Johnson and Farxiga from AstraZeneca. Both those companies are still hoping for heart-helping results from their cardiovascular outcomes trials, which wrap up in 2017 and 2019, respectively.
And speaking of heart-helping results, Lilly and BI over the weekend presented data showing that Jardiance’s held up among various subpopulations. The med showed it could reduce the risk of CV events regardless of a patient’s age or LDL--also known as “bad” cholesterol.
The new analysis is important for physicians because “they have to manage individual patients with different risk profiles,” Seck said. “Knowing that the benefits we observed overall seem to be consistent across populations will provide even more confidence in these data, we hope.”
- read Lilly and BI's releases here and here
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