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Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy.

ABSTRACT: AIMS:To evaluate diabetic retinopathy (DR) 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, pre-approval cardiovascular outcomes trial, semaglutide was associated with a significant increase in the risk of DR complications (DRC) vs placebo. 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 glycated haemoglobin (HbA1c; percentage-points at week 16) as a covariate, to examine the role of the magnitude of reduction in HbA1c as an intermediate factor affecting risk of DRC. RESULTS:There was no imbalance in DR adverse events across the SUSTAIN 1 to 5 and Japanese trials. The majority of the effect with semaglutide vs placebo in SUSTAIN 6 may be attributed to the magnitude and rapidity of HbA1c reduction during the first 16?weeks of treatment in patients who had pre-existing DR and poor glycaemic control at baseline, and who were 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.

SUBMITTER: Vilsboll T

PROVIDER: S-EPMC5888154 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy.

Vilsbøll Tina T Bain Stephen C SC Leiter Lawrence A LA Lingvay Ildiko I Matthews David D Simó Rafael R Helmark Ida Carøe IC Wijayasinghe Nelun N Larsen Michael M

Diabetes, obesity & metabolism 20180108 4

<h4>Aims</h4>To evaluate diabetic retinopathy (DR) data from across the SUSTAIN clinical trial programme.<h4>Materials and methods</h4>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, pre-approval cardiovascular outcomes trial, semaglutide was associated with a significant increase in the risk of DR complications (DRC) vs placebo. DR data from across the S ...[more]

PMID: 29178519

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Project description:ObjectiveTo examine the relationship between glycated haemoglobin A1c (HbA1c) levels and the risk of cardiovascular outcomes and all-cause mortality based on data from observational studies and to determine the optimal levels of HbA1c for preventing cardiovascular events and/or mortality in diabetic and non-diabetic populations.Review methodsWe systematically searched Medline, Embase, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews and Web of Science databases, from inception to July 2016, for observational studies addressing the association of HbA1c levels with mortality and cardiovascular outcomes. Random effects models were used to compute pooled estimates of HR and respective 95% CI for all-cause mortality, cardiovascular mortality and risk of cardiovascular events, separately for people with and without diabetes.ResultsSeventy-four published studies were included in the systematic review, but only 46 studies could be incorporated in the meta-analysis. In both diabetic and non-diabetic populations, there was an increase in the risk of all-cause mortality when HbA1c levels were over 8.0% and 6.0%, respectively. The highest all-cause mortality in people with diabetes was HbA1c above 9.0% (HR=1.69; 95% CI 1.09 to 2.66) and in those without diabetes was HbA1c above 6.0% (HR=1.74; 95% CI 1.38 to 2.20). However, both diabetic and non-diabetic populations with lower HbA1c levels (below 6.0% HR=1.57; 95% CI 1.14 to 2.17 and below 5.0% HR=1.19; 95% CI 1.04 to 1.36, respectively) had higher all-cause mortality. Similar pooled estimates were found when cardiovascular mortality was the outcome variable.ConclusionHbA1c is a reliable risk factor of all-cause and cardiovascular mortality in both diabetics and non-diabetics. Our findings establish optimal HbA1c levels, for the lowest all-cause and cardiovascular mortality, ranging from 6.0% to 8.0% in people with diabetes and from 5.0% to 6.0% in those without diabetes.

Dataset Information

Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy.

Publications

Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy.

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