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Liraglutide Gets EU Positive Opinion for Diabetics with Renal Disease

GLP-1 agonist found to improved glycemic control, resulted in weight loss in type 2 adults with moderate renal impairment…

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Formal approval normally follows a Committee for Medicinal Products for Human Use (CHMP) recommendation within a couple of months, and if this label extension is endorsed in the European Union, liraglutide will become one of a few glucose-lowering agents officially sanctioned for use in this difficult-to-treat patient population, as Dr. Melanie J Davies (University of Leicester, United Kingdom) explained. Dr. Davies is the principal investigator of LIRA-RENAL, the study that looked at this issue.

“People with diabetes are more likely to have renal problems, whether due to the diabetes or other comorbidities,” she said. “But there is a limited choice of glucose-lowering agents that can be used in these patients.”

The positive opinion for the expanded indication for liraglutide was based on the LIRA-RENAL trial, in which patients with type 2 diabetes and moderate renal impairment (eGFR 30–59 mL/min/1.73m2) received liraglutide injected at a dose of 1.8 mg (n=140) or placebo (n=137) added to current therapies, either oral glucose-lowering agents or insulin, for a period of 26 weeks.

For the LIRA-RENAL study, the patients were, on average, 67 years old, and the mean duration of diabetes was 15 years. The primary end point was change in HbA1C from baseline, and liraglutide showed superior glycemic control relative to placebo: the mean change in HbA1C from baseline to week 26 for liraglutide was -1.05% vs -0.38% for placebo.

Those taking liraglutide also lost weight, a known advantage of GLP-1 agonists, and there was a low risk for hypoglycemia. But gastrointestinal side effects, mostly nausea and vomiting, were higher among those taking liraglutide, 35.7% vs 17.5% with placebo, and there was a higher withdrawal due to adverse events in the liraglutide group (13.6%) compared with placebo (2.9%).

There were no other unexpected safety or tolerability issues, including, importantly, no worsening of renal function in subjects over the 6 months of the study. In addition, the effect of liraglutide on blood glucose was consistent across glomerular-filtration subgroups.

The findings mean another option for diabetic patients with chronic kidney disease is hoped to be sanctioned soon, at least in Europe, providing clinicians who currently have limited options with one more choice.

Practice Pearls:

  • There is a limited choice of glucose-lowering agents that can be used for patients with renal problems.
  • There was no worsening of renal function in subjects over the 6 months of the study.
  • The effect of liraglutide on blood glucose was consistent across glomerular-filtration subgroups.

Davies M, et al. Efficacy and Safety of Liraglutide versus Placebo as Add-on to Existing Diabetes Medication in Subjects with Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL). Poster 0965-P at 74th Scientific Sessions of the American Diabetes Association (ADA), 2014.