Liraglutide and renal outcomes in type 2 diabetes

Detalhes bibliográficos
Autor(a) principal: Mann, Johannes F. E.
Data de Publicação: 2017
Outros Autores: Ørsted, David D., Frandsen, Kirstine Brown, Marso, Steven P., Poulter, Neil R., Rasmussen, Søren, Tornøe, Karen, Zinman, Bernard, Buse, John B., Gerchman, Fernando, Gross, Jorge Luiz
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFRGS
Texto Completo: http://hdl.handle.net/10183/206553
Resumo: 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.)
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spelling Mann, Johannes F. E.Ørsted, David D.Frandsen, Kirstine BrownMarso, Steven P.Poulter, Neil R.Rasmussen, SørenTornøe, KarenZinman, BernardBuse, John B.Gerchman, FernandoGross, Jorge Luiz2020-03-07T04:17:43Z20170028-4793http://hdl.handle.net/10183/206553001110498BACKGROUND 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.)application/pdfengThe New England journal of medicine. Vol. 377, no. 9 (2017), p. 839-848Diabetes mellitus tipo 2LiraglutidaHipoglicemiantesEnsaio clínico controlado aleatórioLiraglutide and renal outcomes in type 2 diabetesEstrangeiroinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSTEXT001110498.pdf.txt001110498.pdf.txtExtracted Texttext/plain43203http://www.lume.ufrgs.br/bitstream/10183/206553/3/001110498.pdf.txtef624cd49018d9a4eba8c207b846fee5MD53001110498-02.pdf.txt001110498-02.pdf.txtExtracted Texttext/plain185571http://www.lume.ufrgs.br/bitstream/10183/206553/4/001110498-02.pdf.txtba50da50f93af0d689d34ef858f60bb9MD54ORIGINAL001110498.pdfTexto completo (inglês)application/pdf450134http://www.lume.ufrgs.br/bitstream/10183/206553/1/001110498.pdfa494128b1038115fd4a70b14a214d32cMD51001110498-02.pdfTexto completoapplication/pdf525372http://www.lume.ufrgs.br/bitstream/10183/206553/2/001110498-02.pdfa45eb6c1f67058df3e6510c7d7924051MD5210183/2065532021-03-09 04:50:21.045962oai:www.lume.ufrgs.br:10183/206553Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2021-03-09T07:50:21Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false
dc.title.pt_BR.fl_str_mv Liraglutide and renal outcomes in type 2 diabetes
title Liraglutide and renal outcomes in type 2 diabetes
spellingShingle Liraglutide and renal outcomes in type 2 diabetes
Mann, Johannes F. E.
Diabetes mellitus tipo 2
Liraglutida
Hipoglicemiantes
Ensaio clínico controlado aleatório
title_short Liraglutide and renal outcomes in type 2 diabetes
title_full Liraglutide and renal outcomes in type 2 diabetes
title_fullStr Liraglutide and renal outcomes in type 2 diabetes
title_full_unstemmed Liraglutide and renal outcomes in type 2 diabetes
title_sort Liraglutide and renal outcomes in type 2 diabetes
author Mann, Johannes F. E.
author_facet Mann, Johannes F. E.
Ørsted, David D.
Frandsen, Kirstine Brown
Marso, Steven P.
Poulter, Neil R.
Rasmussen, Søren
Tornøe, Karen
Zinman, Bernard
Buse, John B.
Gerchman, Fernando
Gross, Jorge Luiz
author_role author
author2 Ørsted, David D.
Frandsen, Kirstine Brown
Marso, Steven P.
Poulter, Neil R.
Rasmussen, Søren
Tornøe, Karen
Zinman, Bernard
Buse, John B.
Gerchman, Fernando
Gross, Jorge Luiz
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Mann, Johannes F. E.
Ørsted, David D.
Frandsen, Kirstine Brown
Marso, Steven P.
Poulter, Neil R.
Rasmussen, Søren
Tornøe, Karen
Zinman, Bernard
Buse, John B.
Gerchman, Fernando
Gross, Jorge Luiz
dc.subject.por.fl_str_mv Diabetes mellitus tipo 2
Liraglutida
Hipoglicemiantes
Ensaio clínico controlado aleatório
topic Diabetes mellitus tipo 2
Liraglutida
Hipoglicemiantes
Ensaio clínico controlado aleatório
description 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.)
publishDate 2017
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dc.relation.ispartof.pt_BR.fl_str_mv The New England journal of medicine. Vol. 377, no. 9 (2017), p. 839-848
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