(10-11-10) Severe hypoglycemia and risks of vascular events and death.

Zoungas S, Patel A, Chalmers J, de Galan BE, Li Q, Billot L, Woodward M,
Ninomiya T, Neal B, MacMahon S, Grobbee DE, Kengne AP, Marre M, Heller S;
ADVANCE Collaborative Group.

George Institute for International Health, University of Sydney, Sydney,
Australia. [email protected]
Abstract
BACKGROUND: Severe hypoglycemia may increase the risk of a poor outcome in
patients with type 2 diabetes assigned to an intensive glucose-lowering
intervention. We analyzed data from a large study of intensive glucose lowering
to explore the relationship between severe hypoglycemia and adverse clinical
outcomes.

METHODS: We examined the associations between severe hypoglycemia and the
risks of macrovascular or microvascular events and death among 11,140 patients
with type 2 diabetes, using Cox proportional-hazards models with adjustment for
covariates measured at baseline and after randomization.

RESULTS: During a median follow-up period of 5 years, 231 patients (2.1%) had
at least one severe hypoglycemic episode; 150 had been assigned to intensive
glucose control (2.7% of the 5571 patients in that group), and 81 had been
assigned to standard glucose control (1.5% of the 5569 patients in that group).
The median times from the onset of severe hypoglycemia to the first major
macrovascular event, the first major microvascular event, and death were 1.56
years (interquartile range, 0.84 to 2.41), 0.99 years (interquartile range,
0.40 to 2.17), and 1.05 years (interquartile range, 0.34 to 2.41),
respectively. During follow-up, severe hypoglycemia was associated with a
significant increase in the adjusted risks of major macrovascular events
(hazard ratio, 2.88; 95% confidence interval [CI], 2.01 to 4.12), major
microvascular events (hazard ratio, 1.81; 95% CI, 1.19 to 2.74), death from a
cardiovascular cause (hazard ratio, 2.68; 95% CI, 1.72 to 4.19), and death from
any cause (hazard ratio, 2.69; 95% CI, 1.97 to 3.67) (P<0.001 for all
comparisons). Similar associations were apparent for a range of nonvascular
outcomes, including respiratory, digestive, and skin conditions (P<0.01 for all
comparisons). No relationship was found between repeated episodes of severe
hypoglycemia and vascular outcomes or death.

CONCLUSIONS: Severe hypoglycemia was strongly associated with increased risks
of a range of adverse clinical outcomes. It is possible that severe
hypoglycemia contributes to adverse outcomes, but these analyses indicate that
hypoglycemia is just as likely to be a marker of vulnerability to such events.
(Funded by Servier and the National Health and Medical Research Council of
Australia; ClinicalTrials.gov number, NCT00145925.).

Source: N Engl J Med. 2010 Oct 7;363(15):1410-8.

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