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Hypoglycemia a Marker of Poor Diabetes Outcomes

Posted: Friday, October 22, 2010

Severe hypoglycemia in Type 2 diabetes appears to be associated with an increased risk of vascular complications three times the risk of death, researchers have found.

Sophia Zoungas, MD, PhD, of the University of Sydney in Australia, and colleagues reported in the New England Journal of Medicine that, Type 2 diabetes patients who experienced these serious drops in blood glucose had nearly three times the risk of death and twice the risk of a major macrovascular event compared with those who didn't experience hypoglycemia.

"Once severe hypoglycemia occurs, it may be considered a marker of future vulnerability to serious conditions," Zoungas said in a statement. "Importantly, [the study] was not able to show that severe hypoglycemia was the direct cause of the illnesses."

Most trials investigating intense glucose control -- including ADVANCE, ACCORD, and the VA Diabetes Trial -- have found that such management doesn't improve diabetes outcomes.

Researchers have speculated that increased hypoglycemia may be to blame.

So to investigate this relationship, the researchers assessed data from the ADVANCE study, totaling 11,140 patients with Type 2 diabetes.

Over a median follow-up of five years, 231 patients (2.1%) had at least one severe hypoglycemic episode -- 150 of them had been assigned to intense glucose control, while 81 were on standard control (2.7% versus 1.5%).

Minor hypoglycemia was also more common in the intense control arm (52% versus 37.3%).

Zoungas and colleagues found that severe hypoglycemia was associated with a significant increase in the risk of poor outcomes (P<0.001 for all):

    * Death from any cause (HR 2.69, 95% CI 1.97 to 3.67)
    * Major macrovascular events (HR 2.88, 95% CI 2.01 to 4.12)
    * Death from a cardiovascular cause (HR 2.68, 95% CI 1.72 to 4.19)
    * Major microvascular events (HR 1.81, 95% CI 1.19 to 2.74)

Similar associations were apparent for a range of nonvascular outcomes, including respiratory, digestive, and skin conditions, as well as cancer, the researchers said (P<0.01).

Among those who had severe hypoglycemia, 16.8% had a major macrovascular event, 11.5% had a major microvascular event, and 19.5% died. The respective rates for those who didn't report severe hypoglycemia were 10.2%, 10.1%, and 9%.

The median times from the onset of severe hypoglycemia to a first major macrovascular or microvascular event and death were 1.56 years, 0.99 years, and 1.05 years, respectively.

After adjusting for a number of potential confounders, the associations between hypoglycemia and major events were markedly attenuated but remained significant, the researchers said.

That, combined with the lack of a temporal relationship, suggests that the poor outcomes associated with severe hypoglycemia likely reflect the effects of coexisting conditions or other confounders.

"The marked attenuation of the risk estimates after adjustment for a number of baseline and time-dependent characteristics of the patients suggests that the effects of confounding were substantial," they wrote. "The presence of coexisting conditions could increase a patient's vulnerability to both severe hypoglycemia and an adverse clinical outcome in the absence of direct causal link between the two."

They did acknowledge that hypoglycemia itself could be linked to sympathoadrenal activation, abnormal cardiac repolarization, increased thrombogenesis, inflammation, and vasoconstriction.

"It is possible that hypoglycemia contributes to adverse outcomes," they concluded, "but these analyses indicate that hypoglycemia is just as likely to be a marker of vulnerability to such events."
Practice Pearls:

    * Explain to interested patients that severe hypoglycemia in Type 2 diabetes appears to be associated with an increased risk of vascular complications and death.

    * Note that the poor outcomes associated with severe hypoglycemia may reflect the effects of coexisting conditions or other confounders.

Source: http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=9927&catid=53&Itemid=8, Zoungas S, et al "Severe hypoglycemia and risks of vascular events and death" N Engl J Med 2010; 363(15): 1410-1418.

 
 
 
 
 
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