Doctors are publishing more and more
about overtesting, overtreatment, and just about over everything,
except about reducing medications as patients age and fewer patients
reap the benefits of some medications. This blog is about intensive
treatment that doctors at the
Mayo Clinic think is being overdone.
With a more-is-better mindset common in
society, frequent commercials encouraging checks of glycated
hemoglobin (HbA1C) levels, and ads for new diabetes medications to
lower HbA1C in adults with Type 2 diabetes, Mayo Clinic researchers
were not too surprised to find overtesting occurring.
Beyond overtesting, however, such focus
on HbA1C levels can lead to serious harms for patients, reports the
research team, especially as more diabetes medications are needed to
keep HbA1C within desired targets. This is particularly important
for older patients with other medical conditions, they report in a
new study, published online on June 6 in JAMA Internal Medicine.
What surprises me about what the
doctors are saying is more what they are not saying. Nowhere in the
article is nutrition and management of carbohydrate consumption even
mentioned. Most do not even suggest insulin and remain fixated on oral medications. All they seemed concerned about is piling on more
medications to keep the HbA1C on target.
"At first, we were surprised to
find how much overtesting for HbA1C is occurring among adults of all
ages with Type 2 diabetes who were already well-controlled,"
says Rozalina McCoy, M.D., a Mayo Clinic primary care physician and
endocrinologist, and lead author of the study. "But, then,
we realized that not only were patients being tested frequently, they
were also being treated with more medications than we would expect
considering how low their HbA1C already was. So, this led us to do
this study, to see how frequently patients are treated so intensively
that they may be overtreated and what that does to their risk of
hypoglycemia."
"In this study, we found that,
particularly among older patients and patients with serious chronic
conditions, intensive treatment nearly doubled the risk of severe
hypoglycemia requiring medical attention, including hospitalization,"
says Dr. McCoy.
Hypoglycemia is a serious potential
complication of diabetes treatment. It decreases quality of life and
has been associated with cardiovascular events, dementia, and death.
Most professional societies recommend targeting HbA1C levels less
than 6.5 or 7 percent, with individualized treatment targets based on
patient age, other medical conditions, and risk of hypoglycemia with
therapy.
"Treating patients to very low
HbA1c levels is not likely to improve their health, especially not in
the short term, but can cause serious harms, such as hypoglycemia,"
says Dr. McCoy.
For the purposes of this study,
"intensive treatment" was defined as being treated with
more glucose-lowering medications than clinical guidelines consider
necessary given a patient's HbA1C level. Patients whose HbA1C was
less than 5.6 percent (Diabetes is defined by HbA1C 6.5 percent or
higher.) were considered intensively treated if they were taking any
medications. Patients with HbA1C in the prediabetes range, 5.7-6.4
percent, were considered to be intensively treated if using two or
more medications at the time of the test, or if started on additional
medications after the test, because current guidelines consider
patients with HbA1C less than 6.5 percent to be optimally controlled
already. For patients with HbA1C of 6.5-6.9 percent, the sole
criteria for intensive treatment was treatment intensification with
two or more drugs or insulin.
The researchers examined medical
claims, pharmacy and laboratory data of 31,542 adults with stable and
controlled Type 2 diabetes who were included in the OptumLabs Data
Warehouse between 2001 and 2013. None of the patients were treated
with insulin or had prior episodes of severe hypoglycemia -- both
known risk factors for future hypoglycemic events. None of the
patients had obvious indications for tight glycemic control, such as
pregnancy.
"Our goal was to specifically
assess the degree to which intensive treatment -- not other known
risk factors, such as prior hypoglycemic events or insulin therapy --
caused hypoglycemia," says Dr. McCoy. "We also
wondered if young and healthy patients may be better able to tolerate
intensive treatment than older patients or those with complex medical
problems, so we specifically looked at the impact of intensive
treatment on these two groups separately."
Therefore, the patients were separated
by whether they were considered clinically complex, as defined by the
American Geriatrics Society: 75 years or older; having end-stage
kidney disease or dementia; or having three or more serious chronic
conditions. This distinction has been made to help identify patients,
for whom adding glucose-lowering medications is more likely to lead
to treatment-related adverse events, including hypoglycemia, while
not providing substantial long-term benefit.
Of the 31,542 patients in the study,
18.7 percent of clinically complex patients and 26.5 percent of
non-complex patients were treated intensively. Clinically complex
patients had nearly double the rate of severe hypoglycemia than
non-complex patients, and intensive treatment increased it by an
additional 77 percent, from 1.74 to 3.04 percent over two years.
According to Dr. McCoy, "This
means that 3 out of 100 older or clinically complex patients with
diabetes who never had hypoglycemia before, whose HbA1C is within
recommended targets, and who are not on insulin, will experience a
severe hypoglycemic episode at some point over two years."
"This does not even capture the
more mild episodes of low blood sugar that patients can treat at
home, without having to go to the doctor, emergency department or
hospital," she says.
"These findings are concerning
for many reasons," says Dr. McCoy. "Overtreatment
results in greater patient burden, higher risk of medication side
effects, and more severe hypoglycemia, which can lead to serious
injury and even death. It adds more unnecessary costs for patients
and the health care system. And, at the same time, there is often
little or no benefit from such intensive treatment -- not in the long
term and certainly not in the short term."
"As clinicians, we need to
understand not only what tests and medications are necessary, but
also determine which ones are not, and which ones may cause more harm
than good," she says. "We need to individualize
treatments to the needs and goals of our patients, and be comfortable
saying 'sometimes, doing less is ultimately giving our patients
more.' My hope is that others will be able to apply our findings in
their practices for the benefit of patients everywhere."
The goals of the AACE and ADA seem to
be the only concerns and anyone below 6.5 percent A1C are considered
overtreated. I say this is BS and this does not mean blood sugar. I
feel that keeping A1Cs near normal levels with proper nutrition is a
worthy goal for everyone. Doctors that use the goals of the
professional organizations should be put out to pasture.