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[IPu] American Diabetes Assn and Others :Drs fail to Intensify Needed Therapy in People with Diabetes


Doctors Failing To Intensify Needed Therapy In People With Diabetes

Clinical Inertia Means Hypertension and High Glucose Levels Inadequately

Washington, DC (June 10, 2006) (C Four independent studies showing that
doctors are failing to intensify therapy in people with type 2 diabetes and
high blood glucose levels or high blood pressure were reported here today at
the American Diabetes Association's 66th Annual Scientific Sessions. Their
findings suggest that clinical inertia (C lack of physician action in the face
of abnormal findings (C

may be an important barrier to effective diabetes management.

"Physicians do not appear to be aware of the American Diabetes Association
guidelines or choose not to follow them because, in the population we studied,
the antihypertensive regimen was intensified in only 26 percent of visits in
which the individuals had elevated blood pressure," said Alexander Turchin,
MD, MS, Associate Physician, Division of Endocrinology, Brigham and Women's
Hospital, and Instructor in Medicine, Harvard Medical School, in a recent

"Our study showed that failure to appropriately intensify antihypertensive
treatment is a very common problem in diabetes care, because physicians
intensified antihypertensive treatment in only 12 percent of visits in which
we found sub-optimally controlled blood pressure," said Shari Bolen, MD,
Senior Clinical Fellow in Internal Medicine, The Johns Hopkins University
School of Medicine, in a recent interview.

Other studies identified failure to intensify treatment to maintain blood
glucose levels at the recommended A1C goal of less than 7%. A1C is a blood
test that measures blood glucose levels over a period of two to three months.
A U.S. study found that physicians delayed therapy intensification for those
on oral anti- diabetic drugs on average until A1C was 8.5%. Another study
indicated that up to 75 percent of people with type 2 who were using insulin
alone in the UK and Germany may have levels exceeding 7%.

Some 20.8 million adults and children in the United States have diabetes, a
group of serious diseases characterized by high blood glucose levels that
result from defects in the body's ability to produce and/or use insulin.
Diabetes can lead to severely debilitating or fatal complications, such as
heart disease, blindness, kidney disease, and amputations. It is the fifth
leading cause of death by disease in the U.S. Type 2 diabetes involves insulin
resistance (C the body's inability to properly use its own insulin. It usually
occurs in those who are over 45 and overweight, but it has increasingly been
seen in obese children and teens in recent years.

Clinical Inertia in Hypertension (C Brigham & Women's

The Brigham and Women's Hospital study reviewed nearly 11,000 outpatient
records of 1,244 hypertensive people with diabetes followed by 166 physicians
from 2000 to 2004. They analyzed the blood pressure results and evidence of
antihypertensive therapy intensification and found that the regimens were
intensified in only 26 percent of visits where elevated blood pressure was

"The level of increase in the blood pressure significantly affected the
likelihood that the treatment would be intensified," explained Dr. Turchin,
who was the lead author on the study. For every 10 mm of mercury of systolic
pressure, the probability of an intensification of the antihypertensive
regimen increased 40 percent; for every 10 mm of mercury of diastolic
pressure, the probability increased 20 percent.

"It is not surprising that physicians would react more to systolic than
diastolic pressure because elevated systolic pressure has a very strong
correlation with cardiovascular complications," he explained.

A physician's age also affected the likelihood of treatment of
intensification. The younger the physician, the greater the probability that
medication would be intensified. "It could be that the younger physician,
having just completed a residency, is more aware of the current American
Diabetes Association guidelines," said Dr. Turchin.

If the individual belonged to a minority group, the physician was about 10
percent more likely to intensify the antihypertensive regimen, likely due to
the fact that non-Caucasians have a higher rate of complications arising from

"While some reasons for not intensifying therapy at a given visit are valid (C
such as that the provider was not the individual's regular physician or that
the person has a history of stabilizing pressure by the next visit (C the
majority of people with diabetes with elevated blood pressure do not have
treatment intensified appropriately at a given visit," said Dr. Turchin. "Our
analysis enables us to identify which doctors are not intensifying therapy so
that we can provide professional education and feedback to them, which has
been shown in other studies to decrease clinical inertia and improve

Clinical Inertia in Hypertension (C Johns Hopkins

The Johns Hopkins study looked at 254 people with type 2 diabetes and
hypertension in a managed care program of government employees and their
dependents who were generally adherent and whose physicians were part of an
academically affiliated outpatient center.

"Through a review of medical records and pharmacy and claims data from 1999 to
2001, we identified 1,374 visits with sub- optimally controlled blood
pressure, during which physicians intensified antihypertensive treatment in
only 12 percent of visits," said Dr Bolen, who was lead author on the study.

In this study, elevations in diastolic and systolic blood pressure were about
equally as likely to trigger intensification. For every 10 mm of mercury
increase, the provider was 40 percent more likely to intensify. Also the
reason for the visit was another factor. Physicians were twice as likely to
intensify if it was a routine visit as compared to an urgent visit.
Intensification was almost twice as likely if the person was seen by their
regular doctor as opposed to a covering provider.

"Several factors were associated with a 40 to 50 percent lesser likelihood of
intensification including a higher glucose level or a history of coronary
heart disease, suggesting in both instances that the physician focused on
other clinical concerns to the detriment of attention to the hypertension
problem," said Dr. Bolen. Co-management of the individual with a cardiologist
yielded a similar lesser likelihood of intensification, suggesting that the
physician was perhaps erroneously relying on the cardiologist to manage the
blood pressure.

"Improvements in continuity of care and care coordination are possible targets
to help improve outcomes in hypertension management for people with diabetes,"
said Dr. Bolen.

Clinical Inertia in Oral Anti-Diabetes Agents

A study of clinical inertia in the prescribing of oral anti- diabetic drugs
was based on a retrospective analysis of the pharmacy and lab claims of a
commercial, preferred-provider organization model of a national managed care
organization. Individuals covered by this plan are geographically diverse
across the U.S. The health plan provides fully insured coverage for physician,
pharmacy and hospital services, with 23 million participants dating back to
1994. To "create" a study group, they identified 9,416 people who had received
a first prescription of an oral anti-diabetic drug (C either metformin, a
sulfonylurea, or a thiazolidinedione (C between January 2001 and April 2004.

"At the time they started on these anti-diabetic drugs, the average A1C was
8.4% which included the 33 percent who were at or below the ADA goal of less
than 7%," reported Craig A. Plauschinat, PharmD, MPH, Outcomes Research
Manager, Novartis Pharmaceuticals Corp., who was senior author of the study.
"Unfortunately, this included 67 percent who were well above the goal at A1C
levels of 9.5%."

The average time to therapy intensification (C when the physician added
another oral anti-diabetic drug (C was 240 days. By that time, the average A1C
was 8.5%, but 67 percent of these individuals had A1C levels approaching 10%.

"Disturbingly, 50 percent of those who were intensified did not have an A1C in
their charts prior to the addition of a second drug," said Dr. Plauschinat.
"It is unknown how the physician made the decision to add a second drug in the
absence of A1C testing, although it is possible the decision was based on a
finger stick glucose test in the office or patient reports of home blood
glucose testing." The study only looked at claims, not physician notes.

He observed that infrequent A1C monitoring may have contributed to delayed
therapy intensification. On average, these patients only had one A1C test
annually, in contrast to the twice a year testing recommend by the ADA when
individuals are at the A1C goal and the four times a year recommended for
those not at goal.

"Interventions assisting patients and physicians to recognize and overcome
clinical inertia represent a specific opportunity to improve glycemic control
in type 2 diabetes," said Dr. Plauschinat.

Failure of Insulin Therapy in Type 2 Diabetes

More complex problems were at work in a study of insulin therapy, which
involves one or more insulin injections daily. Those on insulin therapy are
typically expected to self-monitor their blood glucose levels daily with
finger-stick blood testing, enabling them to modify their insulin, diet, and
exercise levels, under their physician's guidance, to achieve recommended
glycemic targets.

To assess the extent to which such targets are actually achieved, researchers
obtained the last recorded A1C levels of adults with type 2 in Germany and the
UK who were prescribed insulin. The data was obtained from Intercontinental
Medical Statistics, a company that collects data for pharmaceutical firms. The
data was sampled from 6 million records from 1,045 physicians in 983 practices
in Germany, and from 3.6 million records from 630 physicians in 200 practices
in the UK.

"Overall, the average A1C for 3,658 individuals was 8.4%," said Stephen Gough,
MD, Professor of Medicine at the Institute of Biomedical Research, the Medical
School, University of Birmingham, and consultant physician at the University
Hospital Birmingham, NHS Foundation Trust, UK. Dr. Gough was the lead author
on the study. However, about one third had A1C levels !] 9% and 18.2% had A1Cs
!] 10%.

Similar proportions of patients were poorly controlled in both countries. The
International Diabetes Federation, which establishes guidelines for physicians
in Europe, like the American Diabetes Association, also recommends that
treatment be instituted to keep blood glucose levels below 7%.

"If this sample is representative, which we believe it is, glycemic control
may be suboptimal for up to three-quarters of the people using insulin alone
to control type 2 diabetes," said Dr. Gough. "Identifying and overcoming
obstacles that prevent optimal insulin therapy, including adequate
intensification when needed, is essential if the gap between recommended
glycemic targets and control is to be closed."

However, Dr. Gough was reluctant to blame the results entirely on clinical
inertia because he believes the problem is more complex in patients on
insulin. He noted that some physicians are fearful of causing hypoglycemia,
especially in the elderly or in those with co-morbidities, where tight control
can be a problem. Further, some patients simply refuse to take multiple
injections every day.

Nonetheless, he acknowledges that further physician education is needed with
regard to achieving optimal glycemic control, such as how to mix different
types of insulin properly and/or how to teach patients to use such insulins
and new devices.

"Many physicians are still locked into once a day insulin injections, and you
often cannot get good diabetes control with that approach," said Dr. Gough.
"Many patients need additional injections (C so the physician has to deal with
complexity and patient education (C to help those with diabetes achieve
appropriate control."

The American Diabetes Association is the nation's leading voluntary health
organization supporting diabetes research, information and advocacy. Founded
in 1940, the Association has offices in every region of the country, providing
services to hundreds of communities. For more information, please call the
American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit
http://www.diabetes.org. Information from both these sources is available in
English and Spanish.

Abstract #12-OR (Turchin), #1140-P (Bolen), #552-P (Plauschinat), #477-P

Embargoed until: Saturday, June 10 10:00 pm EDT

Contact: Diane Tuncer, 703-299-5510 Elizabeth Magsig, 703-549-1500, ext 2146
NEWS ROOM June 9 -13, 2006: East Registration, Washington Convention Center
(202) 249-4017; Fax: (202) 249-4024

2006 American Diabetes Association
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