Sam Engel, MD: Ertugliflozin Two-Year Impact on Renal Function


Investigators presented results of a study that analyzed renal function and markers of kidney damage in more than 1,000 patients in two randomized trials examining ertugliflozin.

A recent real world study has found that use of ertugliflozin among type 2 diabetes (t2d) patients could result in the preservation of renal function and improvement in markers of kidney damage.

After analyzing the results of 2 randomized controlled trials evaluating ertugliflozin in t2d patients, investigators found that ertugliflozin use was associated with increased estimated glomerular filtration rate (eGFR) and reduced urine albumin-to-creatinine ratio (UACR) compared to those in non-ertugliflozin groups.

Investigators presented the results of the 2-year study at the American Diabetes Association 2019 Scientific Sessions in San Francisco, CA.

The 2 RCTs examined included 652 participants receiving ertugliflozin 5 mg and 640 received ertugliflozin 15 mg, while 644 were in a group investigators identified as non-ertugliflozin — this group received either glimepiride or placebo.

At baseline, mean eGFR was 88.2 ml/min/1.73 m2 and geometric baseline UACR was 11.6mg/g. At week 6, investigators noted changes in eGFR were -2/3, -2/7, and -.07 ml/min/1.73m2, for the 5mg, 15 mg, and non-ertugliflozin groups, respectively. The UACR at week 104 in the ertugliflozin groups was -29% for ertugliflozin 5mg and -32.7% for ertugliflozin 15mg when compared to the non ertugliflozin group.

Sam Engel, MD, associate vice president of clinical research in diabetes and endocrinology at Merck, sat down with MD Magazine® at ADA 2019 to discuss the results of the study and their clinical impact.

MD Mag: What were the results of your 2-year study into the renal effects of ertugliflozin?

Engel: So, another poster that we've presented here looks at the 2-year effects of ertugliflozin, a SGLT2 inhibitor, on renal function. You know, there are 2 studies in the clinical development program that had a 2-year duration, which gave us the ability to look at the longer term effects. One of them was a study that compared ertugliflozin to a sulfonylurea. The other, was a study that, for the first 26 weeks, looked at ertugliflozin versus placebo but then all placebo patients were switched to a sulfonylurea.

So, we had 104-week data pooled from these 2 studies and what we saw, as has been seen with the class, is there is an early decline in glomerular filtration rate seen with ertugliflozin compared to the comparator, but after that early decline there is a gradual increase in glomerular filtration rate. So, at the end of the 104-week period the glomerular filtration rate in the treatment group was similar to baseline, but in the comparator group, as we expect, there was a decline in GFR.

So, long-term there was a preservation of renal function. We also looked at the impact on albuminuria and, in particular in those patients who had albuminuria at baseline, there was about a 30% reduction in albuminuria in the ertugliflozin groups compared to the comparator groups. So, these data are certainly consistent with what's emerging for the class, which is the potential for both renal protection and potentially for some improvement in markers of kidney damage.

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