Prevalence of type 2 diabetes is increasing at an alarming pace,
fueled by the rising rates of overweight and obesity in many
populations. A recent study estimated that the number of people
with diabetes increased worldwide from 153 million in 1980 to 347
million in 2008. This study estimated that from 1980 to 2008, the
age standardized prevalence of diabetes in the United States
increased from 6% to 12% in men and from 5% to 9% in women. In the
VA, prevalence of diabetes is higher than in the general population
and increasing over time. Miller et al. reported estimated rates of
diabetes in VA of 17% in fiscal year (FY) 1998, 19% in FY99 and 20%
in FY00. More recently, it was estimated that nearly 25% of
veterans receiving care in the VA have diabetes. Although people
with diabetes have a substantially increased risk of cardiovascular
disease (CVD), three large well designed recent clinical trials
testing intensive versus conventional glucose control strategies
(ACCORD, ADVANCE and VA-DT), have found that intensive glucose
control does not reduce the risk of CVD death or all-cause
mortality although it reduces the risk of microvascular
complications (nephropathy, retinopathy and neuropathy) and
possibly non-fatal myocardial infarction. Intensive glucose control
also increases the risk of hypoglycemic episodes. Several recent
meta-analyses that included these large "intensive versus
conventional control" trials have concluded that intensive control
is associated with a 2-2.5 fold increased risk of severe
hypoglycemia. However, these reviews included only randomized
controlled trials; we are unaware of a comprehensive systematic
review examining incidence of and risk factors for severe
hypoglycemia in adults with type 2 diabetes in both real-world and
clinical trial settings. Despite the increased risk of hypoglycemia
with intensive glycemic control, influential national guidelines
support an aggressive approach for patients with type 2 diabetes,
recommending a target hemoglobin A1c level (HbA1c) of less than 7.
This recommendation implies that the benefits of tight control
outweigh the risks even though the balance between these benefits
and harms is not actually known. In particular, the effects of
hypoglycemia on outcomes besides CVD events and all-cause mortality
have not, to our knowledge, been rigorously evaluated. The VA/DoD
guidelines recommend a more nuanced approach: target HbA1c levels
are based on life expectancy and severity of microvascular
complications. A level of less than 7% is recommended only for
those with no microvascular complications and a life expectancy of
greater than 10 years. We conducted the current review to provide
broader insight into the incidence of, the risk factors for, and
the clinical impact of severe hypoglycemia in adults with type 2
diabetes treated with glucose lowering medications. The key
questions were as follows: In adults with type 2 diabetes treated
with one or more hypoglycemic agents: Key Question #1: What is the
incidence of severe hypoglycemia in adults with type 2 diabetes on
one or more hypoglycemic agents? Key Question #2: What are the risk
factors for severe hypoglycemia in adults with type 2 diabetes on
one or more hypoglycemic agents (e.g., demographics,
co-morbidities, diabetes treatment regimen, other medication use,
goal and achieved HbA1c)? Key Question #3: What is the effect of
severe hypoglycemia on other outcomes in adults with type 2
diabetes on one or more hypoglycemic agents (e.g., quality of life,
mortality, morbidity, utilization)?
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