Long-term effects of intensive glucose lowering on cardiovascular outcomes
Randomized controlled trial published in The New England journal of medicine (2011)
Abstract
BACKGROUND: Intensive glucose lowering has previously been shown to increase mortality among persons with advanced type 2 diabetes and a high risk of cardiovascular disease. This report describes the 5-year outcomes of a mean of 3.7 years of intensive glucose lowering on mortality and key cardiovascular events. METHODS: We randomly assigned participants with type 2 diabetes and cardiovascular disease or additional cardiovascular risk factors to receive intensive therapy (targeting a glycated hemoglobin level below 6.0%) or standard therapy (targeting a level of 7 to 7.9%). After termination of the intensive therapy, due to higher mortality in the intensive-therapy group, the target glycated hemoglobin level was 7 to 7.9% for all participants, who were followed until the planned end of the trial. RESULTS: Before the intensive therapy was terminated, the intensive-therapy group did not differ significantly from the standard-therapy group in the rate of the primary outcome (a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes) (P=0.13) but had more deaths from any cause (primarily cardiovascular) (hazard ratio, 1.21; 95% confidence interval [CI], 1.02 to 1.44) and fewer nonfatal myocardial infarctions (hazard ratio, 0.79; 95% CI, 0.66 to 0.95). These trends persisted during the entire follow-up period (hazard ratio for death, 1.19; 95% CI, 1.03 to 1.38; and hazard ratio for nonfatal myocardial infarction, 0.82; 95% CI, 0.70 to 0.96). After the intensive intervention was terminated, the median glycated hemoglobin level in the intensive-therapy group rose from 6.4% to 7.2%, and the use of glucose-lowering medications and rates of severe hypoglycemia and other adverse events were similar in the two groups. CONCLUSIONS: As compared with standard therapy, the use of intensive therapy for 3.7 years to target a glycated hemoglobin level below 6% reduced 5-year nonfatal myocardial infarctions but increased 5-year mortality. Such a strategy cannot be recommended for high-risk patients with advanced type 2 diabetes. (Funded by the National Heart, Lung and Blood Institute; ClinicalTrials.gov number, NCT00000620.).
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Intensive glucose lowering has previously been shown to increase mortality among persons with advanced type 2 diabetes and a high risk of cardiovascular disease.
Why This Matters for Hirudotherapy
This randomized controlled trial reported 5-year cardiovascular outcomes from a mean of 3.7 years of intensive glucose lowering (target HbA1c <6.0%) versus standard therapy in high-risk patients with type 2 diabetes, finding that intensive therapy reduced nonfatal myocardial infarctions but increased all-cause mortality (HR 1.19, 95% CI 1.03–1.38). The intensive arm was terminated early due to excess deaths. This study has no relevance to hirudotherapy, leech therapy, or the leech secretome. It addresses pharmacologic glycemic targets in diabetes and cardiovascular risk, with no connection to leech-derived therapeutics or anticoagulation strategies involving leech-based agents.
Citation
Long-term effects of intensive glucose lowering on cardiovascular outcomes
et al. · The New England journal of medicine, 2011
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