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  4. Liraglutide and Renal Outcomes in Type 2 Diabetes
 
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Liraglutide and Renal Outcomes in Type 2 Diabetes
File(s)
nejmoa1616011.pdf (439.75 KB)
Published version
Author(s)
Mann, JFE
Orsted, DD
Brown-Frandsen, K
Marso, SP
Poulter, NR
more
Type
Journal Article
Abstract
BACKGROUND
In a randomized, controlled trial that compared liraglutide, a glucagon-like pep
-
tide 1 analogue, with placebo in patients with type 2 diabetes and high cardio
-
vascular 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 un
-
known.
METHODS
We report the prespecified secondary renal outcomes of that randomized, con
-
trolled trial in which patients were assigned to receive liraglutide or placebo. The
secondary renal outcome was a composite of new-onset persistent macroalbumin
-
uria, 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, lira
-
glutide resulted in lower rates of the development and progression of diabetic
kidney disease than placebo.
Date Issued
2017-08-31
Date Acceptance
2017-08-01
Citation
NEW ENGLAND JOURNAL OF MEDICINE, 2017, 377 (9), pp.839-848
URI
http://hdl.handle.net/10044/1/54155
DOI
https://www.dx.doi.org/10.1056/NEJMoa1616011
ISSN
0028-4793
Publisher
Massachusetts Medical Society
Start Page
839
End Page
848
Journal / Book Title
NEW ENGLAND JOURNAL OF MEDICINE
Volume
377
Issue
9
Copyright Statement
© 2017 Massachusetts Medical Society
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000408626400007&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
INTENSIVE GLUCOSE CONTROL
GLOMERULAR-FILTRATION-RATE
CARDIOVASCULAR OUTCOMES
KIDNEY-FUNCTION
ALBUMINURIA
DISEASE
MORTALITY
TRIAL
RISK
INDIVIDUALS
Acute Kidney Injury
Aged
Albuminuria
Creatinine
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Double-Blind Method
Female
Follow-Up Studies
Glomerular Filtration Rate
Glucagon-Like Peptide 1
Humans
Hypoglycemic Agents
Intention to Treat Analysis
Kidney Failure, Chronic
Liraglutide
Male
Middle Aged
LEADER Steering Committee and Investigators
11 Medical And Health Sciences
Publication Status
Published
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