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Semaglutide, reduction in HbA1c and the risk of diabetic retinopathy

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Harvard

Vilsbøll, T, Bain, SC, Leiter, LA, Lingvay, I, Matthews, D, Simó, R, Helmark, IC, Wijayasinghe, N & Larsen, M 2018, 'Semaglutide, reduction in HbA1c and the risk of diabetic retinopathy', Diabetes, Obesity and Metabolism, bind 20, nr. 4, s. 889-897. https://doi.org/10.1111/dom.13172

APA

Vilsbøll, T., Bain, S. C., Leiter, L. A., Lingvay, I., Matthews, D., Simó, R., Helmark, I. C., Wijayasinghe, N., & Larsen, M. (2018). Semaglutide, reduction in HbA1c and the risk of diabetic retinopathy. Diabetes, Obesity and Metabolism, 20(4), 889-897. https://doi.org/10.1111/dom.13172

CBE

Vilsbøll T, Bain SC, Leiter LA, Lingvay I, Matthews D, Simó R, Helmark IC, Wijayasinghe N, Larsen M. 2018. Semaglutide, reduction in HbA1c and the risk of diabetic retinopathy. Diabetes, Obesity and Metabolism. 20(4):889-897. https://doi.org/10.1111/dom.13172

MLA

Vancouver

Author

Vilsbøll, Tina ; Bain, Stephen C ; Leiter, Lawrence A ; Lingvay, Ildiko ; Matthews, David ; Simó, Rafael ; Helmark, Ida Carøe ; Wijayasinghe, Nelun ; Larsen, Michael. / Semaglutide, reduction in HbA1c and the risk of diabetic retinopathy. I: Diabetes, Obesity and Metabolism. 2018 ; Bind 20, Nr. 4. s. 889-897.

Bibtex

@article{4a21d3dbac53430eaa3355c326284e87,
title = "Semaglutide, reduction in HbA1c and the risk of diabetic retinopathy",
abstract = "AIMS: To evaluate diabetic retinopathy data from across the SUSTAIN clinical trial programme.MATERIALS AND METHODS: The SUSTAIN clinical trial programme evaluated the efficacy and safety of semaglutide, a glucagon-like peptide-1 analogue, for the treatment of type 2 diabetes (T2D). In SUSTAIN 6 - a 2-year, preapproval cardiovascular outcomes trial - semaglutide was associated with a significant increase in the risk of diabetic retinopathy complications (DRC) versus placebo. Diabetic retinopathy (DR) data from across the SUSTAIN trials were evaluated and post hoc analyses of the SUSTAIN 6 data were conducted. These included subgroup analyses to identify at-risk patients and a mediation analysis with initial change in HbA1c (percentage-points at Week 16) as a covariate, to examine the role of the magnitude of reduction in HbA1c as an intermediate factor on risk of DRC.RESULTS: There was no imbalance in DR adverse events across the SUSTAIN 1-5 and Japanese trials. The majority of the effect with semaglutide versus placebo in SUSTAIN 6 may be attributed to the magnitude and rapidity of HbA1c reduction during the first 16 weeks of treatment in patients with pre-existing DR, poor glycaemic control at baseline, and treated with insulin.CONCLUSIONS: Early worsening of DR is a known phenomenon associated with the rapidity and magnitude of improvement in glycaemic control with insulin; the DRC findings in SUSTAIN 6 are consistent with this. Guidance regarding the early worsening of DR is recommended with insulin; similar recommendations may be appropriate for semaglutide.",
keywords = "Journal Article",
author = "Tina Vilsb{\o}ll and Bain, {Stephen C} and Leiter, {Lawrence A} and Ildiko Lingvay and David Matthews and Rafael Sim{\'o} and Helmark, {Ida Car{\o}e} and Nelun Wijayasinghe and Michael Larsen",
note = "This article is protected by copyright. All rights reserved.",
year = "2018",
month = apr,
doi = "10.1111/dom.13172",
language = "English",
volume = "20",
pages = "889--897",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "4",

}

RIS

TY - JOUR

T1 - Semaglutide, reduction in HbA1c and the risk of diabetic retinopathy

AU - Vilsbøll, Tina

AU - Bain, Stephen C

AU - Leiter, Lawrence A

AU - Lingvay, Ildiko

AU - Matthews, David

AU - Simó, Rafael

AU - Helmark, Ida Carøe

AU - Wijayasinghe, Nelun

AU - Larsen, Michael

N1 - This article is protected by copyright. All rights reserved.

PY - 2018/4

Y1 - 2018/4

N2 - AIMS: To evaluate diabetic retinopathy data from across the SUSTAIN clinical trial programme.MATERIALS AND METHODS: The SUSTAIN clinical trial programme evaluated the efficacy and safety of semaglutide, a glucagon-like peptide-1 analogue, for the treatment of type 2 diabetes (T2D). In SUSTAIN 6 - a 2-year, preapproval cardiovascular outcomes trial - semaglutide was associated with a significant increase in the risk of diabetic retinopathy complications (DRC) versus placebo. Diabetic retinopathy (DR) data from across the SUSTAIN trials were evaluated and post hoc analyses of the SUSTAIN 6 data were conducted. These included subgroup analyses to identify at-risk patients and a mediation analysis with initial change in HbA1c (percentage-points at Week 16) as a covariate, to examine the role of the magnitude of reduction in HbA1c as an intermediate factor on risk of DRC.RESULTS: There was no imbalance in DR adverse events across the SUSTAIN 1-5 and Japanese trials. The majority of the effect with semaglutide versus placebo in SUSTAIN 6 may be attributed to the magnitude and rapidity of HbA1c reduction during the first 16 weeks of treatment in patients with pre-existing DR, poor glycaemic control at baseline, and treated with insulin.CONCLUSIONS: Early worsening of DR is a known phenomenon associated with the rapidity and magnitude of improvement in glycaemic control with insulin; the DRC findings in SUSTAIN 6 are consistent with this. Guidance regarding the early worsening of DR is recommended with insulin; similar recommendations may be appropriate for semaglutide.

AB - AIMS: To evaluate diabetic retinopathy data from across the SUSTAIN clinical trial programme.MATERIALS AND METHODS: The SUSTAIN clinical trial programme evaluated the efficacy and safety of semaglutide, a glucagon-like peptide-1 analogue, for the treatment of type 2 diabetes (T2D). In SUSTAIN 6 - a 2-year, preapproval cardiovascular outcomes trial - semaglutide was associated with a significant increase in the risk of diabetic retinopathy complications (DRC) versus placebo. Diabetic retinopathy (DR) data from across the SUSTAIN trials were evaluated and post hoc analyses of the SUSTAIN 6 data were conducted. These included subgroup analyses to identify at-risk patients and a mediation analysis with initial change in HbA1c (percentage-points at Week 16) as a covariate, to examine the role of the magnitude of reduction in HbA1c as an intermediate factor on risk of DRC.RESULTS: There was no imbalance in DR adverse events across the SUSTAIN 1-5 and Japanese trials. The majority of the effect with semaglutide versus placebo in SUSTAIN 6 may be attributed to the magnitude and rapidity of HbA1c reduction during the first 16 weeks of treatment in patients with pre-existing DR, poor glycaemic control at baseline, and treated with insulin.CONCLUSIONS: Early worsening of DR is a known phenomenon associated with the rapidity and magnitude of improvement in glycaemic control with insulin; the DRC findings in SUSTAIN 6 are consistent with this. Guidance regarding the early worsening of DR is recommended with insulin; similar recommendations may be appropriate for semaglutide.

KW - Journal Article

U2 - 10.1111/dom.13172

DO - 10.1111/dom.13172

M3 - Journal article

C2 - 29178519

VL - 20

SP - 889

EP - 897

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

IS - 4

ER -

ID: 52073019