Liraglutide and renal outcomes in type 2 diabetes

Johannes F. E. Mann, David D. Ørsted, Kirstine Brown-Frandsen, Steven P. Marso, Neil R. Poulter, Søren Rasmussen, Karen Tornoe, Bernard Zinman, John B. Buse, Richard Bergenstal, John Buse, Gilbert Daniels, Johannes Mann, Steven P. Marso, Allan Charles Moses, Michael Nauck, Steven Nissen, Stuart Pocock, Neil Poulter, William SteinbergBernard Zinman, Kirstine Brown Frandsen, Mette Stockner, Peter Kristensen, Lasse Steen Ravn, Marcin Zychma, Allan Flyvbjerg, Ian Ford, Richard T. Kloos, Mark J. Schactman, Peter Sleight, Karl Swedberg, Scott M. Tenner, Sema Akalin, Rosario Arechavaleta, Steve Bain, Miguel Camafort Babkowski, Marian Benroubi, Lori Berard, Abdurrahman Comlekci, Leszek Czupryniak, Björn Eliasson, Mats Eriksson, Vivian Fonseca, Edward Franek, Jorge Gross, Khadija Hafidh, Martin Haluzik, Frances Hayes, Sue-Lynn Lau, et al.

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND In a randomized, controlled trial that compared liraglutide, a glucagon-like peptide 1 analogue, with placebo in patients with type 2 diabetes and high cardiovascular risk who were receiving usual care, we found that liraglutide resulted in lower risks of the primary end point (nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes) and death. However, the long-term effects of liraglutide on renal outcomes in patients with type 2 diabetes are unknown. METHODS We report the prespecified secondary renal outcomes of that randomized, controlled trial in which patients were assigned to receive liraglutide or placebo. The secondary renal outcome was a composite of new-onset persistent macroalbuminuria, persistent doubling of the serum creatinine level, end-stage renal disease, or death due to renal disease. The risk of renal outcomes was determined with the use of time-to-event analyses with an intention-to-treat approach. Changes in the estimated glomerular filtration rate and albuminuria were also analyzed. RESULTS A total of 9340 patients underwent randomization, and the median follow-up of the patients was 3.84 years. The renal outcome occurred in fewer participants in the liraglutide group than in the placebo group (268 of 4668 patients vs. 337 of 4672; hazard ratio, 0.78; 95% confidence interval [CI], 0.67 to 0.92; P=0.003). This result was driven primarily by the new onset of persistent macroalbuminuria, which occurred in fewer participants in the liraglutide group than in the placebo group (161 vs. 215 patients; hazard ratio, 0.74; 95% CI, 0.60 to 0.91; P=0.004). The rates of renal adverse events were similar in the liraglutide group and the placebo group (15.1 events and 16.5 events per 1000 patient-years), including the rate of acute kidney injury (7.1 and 6.2 events per 1000 patient-years, respectively). CONCLUSIONS This prespecified secondary analysis shows that, when added to usual care, liraglutide resulted in lower rates of the development and progression of diabetic kidney disease than placebo. (Funded by Novo Nordisk and the National Institutes of Health; LEADER ClinicalTrials.gov number, NCT01179048.)
Original languageEnglish
Pages (from-to)839-848
Number of pages10
JournalNew England Journal of Medicine
Volume377
Issue number9
DOIs
Publication statusPublished - 2017

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