The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. ME Miller, DE Bonds, HC Gerstein, ER Seaquist, RM Bergenstal, J Calles-Escandon, RD Childress, TE Craven, RM Cuddihy, G Dailey, MN Feinglos, F Ismail-Beigi, JF Largay, PJ O'Connor, T Paul, PJ Savage, UK Schubart, A Sood, S Genuth BMJ 2010 1;340():b5444
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Jan 24, 2010 |
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This is a report of a post-hoc analysis of the ACCORD trial that looked for factors associated with severe hypoglycemia in the study.
Initially they defined severe hypoglycemia as a self reported event that required assistance. After March 2003, additional documentation (either a glucose of < 50 or symptoms that resolved with treatment) was also required.
Overall, about 10% reported a severe hypoglycemic episode over the course of the trial, with the majority occurring in the intensive therapy group. The rate remained at about 1% per year in the standard therapy group while in the intensive group the rates were highest in the first year in the study then declined steadily thereafter.
It is important to keep in mind that the overall annual incidence was low: 3.14% in the intensive group and 1.03% in the standard group.
The analysis found two types of variables: ones that were associated with hypoglycemia in both groups (female gender, age, duration of DM, African-American race compared with non-Hispanic whites, history of peripheral neuropathy, lower BMI, higher MA:Cr and higher levels of serum creatinine) and those that were only associated with hypoglycemia in the intensive therapy group (education, higher LDL, use of any insulin at baseline and baseline A1c).
Importantly, rapid lowering of A1c during the first four months of the study was not associated with a higher risk of severe hypoglycemia. In fact, those whose A1c did not drop quickly in the first four months had an increased risk of hypoglycemia.
The fact that lower levels of LDL in the standard group were associated with more hypoglycemia suggests an association with either underlying chronic disease or statin therapy—we shall need to await the completion of the lipid lowering arm to know the answer to this question. Kittie Wyne, MD, PhD, FACE
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