Dataset Information

HbA1c trajectory and cardiovascular outcomes: an analysis of data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study.

ABSTRACT:

Background

We investigated the associations between glycated hemoglobin (HbA1c) trajectories and cardiovascular outcomes using data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study.

Methods

We used HbA1c values within the first 2 years of treatment for modeling with a latent class growth model. Groups of HbA1c trajectories were modeled separately in the standard (group 1-group 4) and intensive (group 5-group 8) treatment arms. The primary outcome in the ACCORD study was a composite of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes. Effects of HbA1c trajectories on cardiovascular outcomes were analyzed using a Cox-proportional hazard model.

Results

Baseline HbA1c levels for the eight trajectories (group 1-group 8) were 7.8 ± 0.8, 8.2 ± 0.9, 9.3 ± 1.1, 9.6 ± 1.2, 7.8 ± 0.7, 10.1 ± 0.8, 8.3 ± 0.7, and 9.5 ± 1.1%, respectively. The respective values after 2 years of treatment were 7.0 ± 0.6, 7.7 ± 0.7, 8.5 ± 0.9, 10.3 ± 1.3, 6.2 ± 0.4, 6.5 ± 0.6, 7.2 ± 0.6, and 8.5 ± 1.1%. After a median follow-up of 4.8 years, group 5 and group 6 had similar outcomes compared with group 1 (reference group). In contrast, group 3, group 4, and group 8 had higher risks of the primary composite outcome compared with group 1.

Conclusion

HbA1c trajectory was associated with cardiovascular outcomes in type 2 diabetes patients with high cardiovascular risk.

SUBMITTER: Wang JS

PROVIDER: S-EPMC8239983 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The Action to Control Cardiovascular Risk in Diabetes (ACCORD) clinical trial was a randomized, multicenter, double 2 x 2 factorial design study involving 10,251 middle-aged and older participants with type-2 diabetes who are at high risk for CVD events because of existing CVD or additional risk factors. The purpose of ACCORD was to determine if intensive glycemic control, intensive lipid management and intensive blood pressure control could prevent major cardiovascular events (myocardial infarction, stroke or cardiovascular death) in adults with type 2 diabetes mellitus. Secondary hypotheses included treatment differences in other cardiovascular outcomes, total mortality, microvascular outcomes, health-related quality of life and cost-effectiveness. The ACCORD trial failed to show a beneficial effect of intensive blood pressure or lipid therapy on the primary outcome, and intensive glycemia management actually increased mortality. The hypothesis underlying this ancillary study is that the failure of ACCORD to achieve its goal of reducing cardiovascular risk in diabetic patients through intensive management of hyperglycemia, dyslipidemia, and hypertension may be the result of variation in drug response due to genetic variation between individual participants. Benefits of intensive therapy may accrue to subsets of subjects with specific genetic variants predisposing to efficacious responses to particular therapeutic regimens, and harms may accrue to those with other variants predisposing to poor efficacy or adverse events. Identifying these variants could lead to a precision medicine approach to treating diabetes where each patient's genetic profile could identify the most efficacious treatment regimen with the lowest likelihood of adverse events. To test this hypothesis, a genome-wide genetic analysis was undertaken, incorporating both common variants distributed across the genome and rare variants targeted to exonic regions. Associations of genetic variants with short term responses to individual medicines as well as long term outcomes were investigated. The dataset is composed of genetic data from the ~6100 participants who agreed to participate in the ACCORD optional genetic studies and who allowed broad investigator access to their samples and the data derived from those samples, and from whom a DNA sample of sufficient quality was obtained. While a total of 8514 participants consented to the optional genetics studies, not all consented to broad investigator access, and those who did not are not included in this dataset, although they were also genotyped. Access to these additional genotypes can only be obtained by direct collaboration with the investigators of this study. Phenotype data used in the association analyses are derived from the ACCORD public release clinical data set, which has been made available through <a href="https://biolincc.nhlbi.nih.gov/studies/accord/">BioLINCC</a>.