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News — November/December 2009
AACE Releases Algorithm for Treatment of Type 2 Diabetes Patients
A new, first-of-its-kind diabetes algorithm created to
help achieve glycemic control in type 2 patients was published
in Endocrine Practice.
This diabetes algorithm, released as a consensus statement
from the American Association of Clinical Endocrinologists
(AACE) and the American College of Endocrinology
(ACE), is a simple 1-page resource designed to
assist primary care physicians, endocrinologists, and others
in the management of type 2 diabetes.
“Depending on a patient’s current A1C level, a physician
will use the algorithm to determine whether mono-, dual-,
or triple-combination therapy should be considered,” said
Helena Rodbard, MD, former AACE President and Co-
Chair of the Algorithm Task Force. “To minimize the risk of
diabetic complications, the algorithm will help achieve
a[n] A1C value <6.5% when appropriate.”
According to a news release from AACE, until now,
there has never been a treatment algorithm that considers
currently approved classes of medications emphasizing
safety and efficacy while also considering secondary factors
such as the overall cost of care—not just the cost of
medications. These drug classes include biguanides, dipeptidyl
peptidase—4 inhibitors, incretin mimetics, thiazolidinediones,
alpha-glucosidase inhibitors, sulfonylureas,
meglitinides, bile-acid sequestrants, amylin analogs, and
insulin therapy.
“We felt that an authoritative, practical algorithm for
managing type 2 diabetes was essential,” former AACE
President and Co-Chair of the Algorithm Task Force, Paul
S. Jellinger, MD, said. “We believe that this algorithm represents
the treatment preferences of most clinical endocrinologists.
This is a point-of-care tool that helps clinicians
make appropriate and safe treatment decisions.”
The algorithm also prioritizes medication choices
according to risk of hypoglycemia, safety, efficacy, simplicity,
and anticipated degree of patient adherence. It was created
by a consensus group of leading endocrinologists
combining very extensive clinical experience, clinical
researchers, practitioners and academicians, and is based
on the AACE/ACE Diabetes Guidelines and recent medical
literature.
With nearly 80 million people suffering from diabetes
and prediabetes in the United States, there is a shortage of
endocrinologists to care for all patients. Many patients are
treated by primary care physicians. The algorithm represents
an important tool to assist and educate clinicians.
Smoking Bans Reduce Risk of Secondhand Smoke-Related MI
Smoking bans are effective at reducing the risk of
myocardial infarction (MI) and coronary heart disease
(CHD) associated with exposure to secondhand smoke,
according to a new report from the US Institute of
Medicine (IOM). The report also confirms there is sufficient
evidence that breathing secondhand smoke boosts
nonsmokers’ risk for heart problems, adding that indirect
evidence indicating that even relatively brief exposures
could lead to a[n] MI is compelling.
“It’s clear that smoking bans work,” said Lynn Goldman,
professor of environmental health sciences, Johns Hopkins
Bloomberg School of Public Health, and chair of the committee
of experts that wrote the report. “Bans reduce the
risks of [MI] in nonsmokers as well as smokers. Further
research could explain in greater detail how great the
effect is for each of these groups and how secondhand
smoke produces its toxic effects. There is no question,
however, that smoking bans have a positive health effect.”
About 43% of nonsmoking children and 37% of nonsmoking
adults are exposed to secondhand smoke in the
United States, according to public health data. Despite
significant reductions in the percentages of Americans
breathing environmental tobacco smoke over the past
several years, roughly 126 million nonsmokers were still
being exposed in 2000, according to a news release from
the National Academies of Sciences.
A 2006 report from the US Surgeon General’s office concluded
that exposure to secondhand smoke causes heart
disease and indicated that smoke-free policies are the most
economical and effective way to reduce exposure. The
effectiveness of smoking bans in reducing heart problems
has continued to be a source of debate, however.
The IOM committee conducted a comprehensive
review of published and unpublished data and testimony
on the relationship between secondhand smoke and
short-term and long-term heart problems. Eleven key
studies that evaluated the effects of smoking bans on MI
rates informed the committee’s conclusions about the
positive effects of smoke-free policies. The studies calculated
that reductions in the incidence of MI range from
6% to 47%. Given the variations in how the studies were
conducted and what they measured, the committee
could not determine more precisely how great the effect
is. Only two of the studies distinguished between reductions
in MIs suffered by smokers versus nonsmokers. The
repeated finding of decreased MI rates overall after bans
were implemented conclusively demonstrates that
smoke-free policies help protect people from the cardiovascular
effects of tobacco smoke, the committee said.
The report also provides a detailed discussion of the
evidence from animal research and epidemiological studies
showing a cause-and-effect relationship between secondhand
smoke exposure and heart problems.
FDA Investigates CV Risk Associated With Sibutramine
The US Food and Drug Administration (FDA) is reviewing
preliminary data from a recent study suggesting
that patients using sibutramine (Meridia, Abbott) have a
higher number of cardiovascular events than patients
using a placebo.
The analysis of these data is ongoing and the FDA is
making no conclusions about the preliminary findings at
this time, according to a news release. The findings highlight
the importance of avoiding the use of sibutramine in
patients with a history of coronary artery disease, congestive
heart failure (CHF), arrhythmias, or stroke, as recommended
in the current sibutramine labeling.
The SCOUT (Sibutramine Cardiovascular Morbidity/
Mortality Outcomes in Overweight or Obese Subjects
at Risk of a Cardiovascular Event) study began in 2002.
The analysis of the study results is ongoing by the manufacturer.
The FDA was made aware of the preliminary
results for the study primary endpoint—a combination of
MI, stroke, resuscitated cardiac arrest, or death—in mid-
November 2009. Part of a post-approval commitment
between the European Medicines Agency and the manufacturer,
the study was designed to show that weight loss
with sibutramine and standard care was more effective in
reducing the number of cardiovascular events compared with weight loss from a placebo and standard care.
The FDA stated that patients included in the study
were aged ≥55 years, overweight or obese, and had a history
of heart disease or type 2 diabetes plus one additional
cardiovascular risk factor. Patients who recently had an
MI or stroke, or had poorly controlled CHF, were not
included in the study. Approximately 10,000 patients
enrolled in the study.
The preliminary analysis of the primary endpoint suggests
that patients using sibutramine experienced a higher
number of cardiovascular events compared with those
using a placebo. The preliminary data shows that cardiovascular
events were reported in 11.4% of patients using
sibutramine compared with 10% of patients using a placebo.
This difference is higher than expected, suggesting
that sibutramine is associated with an increased cardiovascular
risk in the study population.
According to the FDA, health care professionals should
continue to evaluate the benefits and risks of sibutramine,
taking into account individual patient medical histories.
Both health care professionals and consumers are encouraged
to report side effects from the use of sibutramine to
FDA's MedWatch Adverse Event Reporting program.
New Data Show CKD Rates Rising Due to Diabetes
New data confirms that the rate of chronic kidney disease
(CKD) is inching upward, keeping pace with the rising
rates of diabetes. In late September, the US Renal Data
System published its 2009 Annual Data report, which
showed the incidence of CKD in the United States.
Medicare population is now 9.8%, up from 8.7% reported
in last year’s data analysis.
According to a news release from the TMF Health
Quality Institute, diabetes, the leading cause of kidney disease,
moved closer to affecting one in four Medicare beneficiaries
nationally: The newest data show 24.8% have the
disease, up from the 23.6% one year earlier. The Texas
Department of State Health Services estimates more than
1.8 million Texans have diabetes.
Dallas-based nephrologist Roberto Collazo-Maldonado,
MD, is not surprised by the data. “Because Texas has a big
problem with diabetes,” Dr. Collazo said, “more people
will get kidney disease. If we find it early, we can effectively
treat [CKD] to prevent and avoid dialysis. That is, if we
find it early.”
The American Diabetes Association recommends people
with diabetes have an annual microalbumin test.Fewer than 40% of Texas Medicare beneficiaries with diabetes
received this screening in 2007, according to claims
data from the Centers for Medicare & Medicaid Services.
“I regularly see patients who discover they have [CKD]
when they come to the hospital for emergency treatment
because their kidneys have failed,” Dr. Collazo continued.
“This is too late. People with diabetes must check their
kidney health every year.
Up to 40% of people with diabetes will experience kidney
problems in their lifetime, according to the news
release from. Minorities with diabetes are also disproportionately
affected: blacks are four times more likely than
whites to experience kidney failure, and Mexican Americans
with diabetes are twice as likely as non-Hispanic
whites to have diabetes.
Accounting for 44% of new cases, diabetes is the leading
cause of CKD, the US Renal Data System reported in
2007. The second leading cause is high blood pressure.
Other risk factors are age, obesity and a family history of
kidney problems. TMF Health Quality Institute is an
Austin, Texas-based nonprofit consulting company
focused on promoting quality health.
Healthy Neighborhoods May Lower Diabetes Risk
Individuals living in neighborhoods conducive to physical
activity and providing access to healthy foods may
have a lower risk of developing type 2 diabetes in a 5-year
period, according to a report in Archives of Internal
Medicine.
“The worldwide epidemic of type 2 diabetes is largely
driven by the combined rise in obesity, intake of energydense
or nutrient-poor foods, and physical inactivity,” the
authors wrote as background information in the article.
Interventions to reduce risk on the individual level—
including surgery, medication, and behavior change—
have had mixed results. Large-scale behavior change may
be necessary to reverse the diabetes epidemic, but such a
change is difficult to achieve and may be unsustainable if
the surrounding environment is not supportive, according
to a news release from the journal’s publisher.
Amy H. Auchincloss, PhD, MPH, of Drexel University
School of Public Health, Philadelphia, and colleagues studied
2,285 adults age 45 to 84 who were initially examined
between 2000 and 2002. Study participants were from
three of the sites in the MESA (Multi-Ethnic Study of
Atherosclerosis) for which neighborhood level data were
obtained: Baltimore; Forsyth County, NC; and New York City/Bronx. Blood glucose levels were obtained from
study participants at baseline and at three follow-up
examinations, during which other individual characteristics
also were assessed (including diet, body mass index
[BMI], and physical activity levels).
Measures of neighborhood resources were obtained
from a separate assessment in which other residents of
the same neighborhoods rated the suitability of their
environment for physical activity and access to healthy
foods. For instance, they were asked if it was pleasant or
easy to walk in their neighborhood, and whether a large,
high-quality selection of fruits, vegetables and other lowfat
foods was available. Scores for physical activity and
healthy foods were calculated for each neighborhood on
scales of one to five.
Over a median of 5 years of follow-up, 233 of the 2,285
participants (10.2%) developed diabetes. Average neighborhood
scores were 3.68 for physical activity and 3.36 for
healthy foods.
“Better neighborhood resources, determined by a combined
score for physical activity and healthy foods, were
associated with a 38% lower incidence of type 2 diabetes,”
the authors wrote. This was similar to the reduction in
risk observed among individuals whose BMI was five
points lower. “The association remained statistically significant
after further adjustment for individual dietary factors,
physical activity level and BMI.”
The increasing prevalence of type 2 diabetes in the past
30 years makes it urgent to identify environmental features
that may mitigate risk, the authors concluded.
Diabetes Education Decreased Health Care Costs
A new study of an extensive database of Medicare and
commercial (employee and dependent) member claims
revealed that people with diabetes who received diabetes
education had lower average health care costs than
patients who did not participate in diabetes education.
The study was published in The Diabetes Educator and
conducted by Solucia Consulting of Farmington, Conn.,
and underwritten by a grant from the American
Association of Diabetes Educators.
Diabetes education is the ongoing process of facilitating
the knowledge, skill, and ability necessary for diabetes selfcare.
Diabetes education aims to achieve optimal health
status, better quality of life and reduce the need for costly
health care. It is most often provided by diabetes educators,
who are health care professionals that have speciaized training in diabetes care, traditionally drawn from
nursing and dietetics and more recently involving pharmacists.
The authors studied 3 years of claims data that reflected
care of 634,645 individuals with diabetes. The
researchers compared claims from those who received
diabetes education with those who did not. According to
the analysis, commercially insured patients who received
diabetes education cost, on average, 5.7% less than those
who did not receive diabetes education. Medicare
patients who participated in diabetes education cost the
health care system 14% less than Medicare patients who
did not participate. Moreover, those who belonged to
physician practices that more frequently referred patients
for diabetes education had better overall quality care for
their diabetes.
AACE Issues Guidelines for Ethical Use of Growth Hormone
AACE has released new medical guidelines for the accurate
diagnosis and effective ethical treatment of growth
hormone deficiency in affected patients.
According to a news release, growth hormone replacement
therapy has proven useful for children and adults
with scientifically proven growth hormone deficiency. In
recent years, however, human growth hormone (HGH)
use for anti-aging and athletic enhancement has increased
to the point that this use currently accounts for approximately
30% of growth hormone prescriptions in the
United States. A number of professional athletes have
now admitted or have been alleged to have used HGH to
speed recovery from injury or to enhance performance.
Anti-aging centers tout benefits of HGH to slow the aging
process.
“Although there is not a wealth of medical data published
concerning HGH as a recovery tool for injured athletes,
it’s certainly not an approved indication for use,”
David Cook, MD, Interim Division Chief of Endocrinology
at the Oregon Health & Science University, and coauthor
of the new medical guidelines said.
In addition to addressing the increasing misuse of
growth hormone in anti-aging and sports, the AACE
guidelines more importantly address the accurate diagnosis
and effective therapy for growth hormone-deficient
patients, as well as new cut points or benchmarks for
growth hormone testing.
“These guidelines are the result of recent advancements
in our understanding of the benefits of growth hormone replacement for patients,” Dr. Cook said. “Controlled trials,
using strict dosing regimes and measuring clinical end
points, such as body composition and insulin sensitivity,
have shown us that growth hormone dosing should be
individualized, with close attention to avoiding side
effects,” he said.
According to the news release, the AACE guidelines also
outline new cut points for stimulation testing of growth
hormone deficiency. Stimulation testing measures normal
secretion or low growth hormone secretion, making them
an accurate barometer to gauge growth hormone deficiency.
Despite a growing body of evidence on the benefits of
growth hormone therapy, there is still considerable inconsistency
in the United States in the clinical practice of
growth hormone replacement for adults.
“There are multiple factors accounting for this,” Dr.
Cook said. “Such as the high cost of growth hormone
therapy, the need for daily injections, the lack of awareness
regarding its indications, diagnosis, long-term surveillance,
and concerns about whether there are long-term
risks involved.”
Consequences of untreated growth hormone deficiency
include cardiovascular complications, metabolic complications,
osteopenia/osteoporosis, and diminished quality
of life.
Encouraging Data for Treatment of Low IGF-1
Ipsen announced preliminary results from a phase 2
open-label clinical trial that is evaluating the coadministration
of recombinant human growth hormone (rhGH)
and recombinant human insulin-like growth factor-1
(rhIGF-1) in two separate daily injections as a potential
treatment for children with otherwise unexplained short
stature associated with low IGF-1 levels.
Ipsen also announced results from a long-term study of
rhIGF-1 in patients with severe primary insulin-like growth
factor deficiency (sPIGFD) that demonstrated that longterm
twice-daily therapy with rhIGF-1 improved the adult
and near-adult heights of extremely short patients with
sPIGFD. The data from these two studies were presented
along with posters on rhIGF-1 (Increlex, mecasermin
[rDNA origin] injection) at the 8th Joint Meeting of the
Lawson Wilkins Pediatric Endocrine Society/European
Society for Pediatric Endocrinology in New York, NY.
These studies were performed under investigational
new drug application protocols, and the coadministration of rhGH and rhIGF-1 is not an approved administration
regimen for Increlex. Increlex is currently marketed in the
United States and other countries for the treatment of
growth failure in children with severe primary IGFD using
twice-daily injections.
“The data supporting the efficacy and safety of rhIGF-I
continue to grow, and these results demonstrate that children
with severe primary IGF-I deficiency can improve
their adult/near-adult height with long-term IGF-I therapy,”
said Philippe F. Backeljauw, MD, Professor of
Pediatrics, Cincinnati Children’s Hospital Medical Center.
“These results provide increased confidence to treat
patients with severe primary IGFD with rhIGF-I.”
Women With Breast Cancer Have Low Vitamin D Levels
Women with breast cancer should be given high doses
of vitamin D as a majority of them are likely to have low
levels, which could contribute to decreased bone mass
and greater risk of fractures, according to scientists at the
University of Rochester Medical Center.
In a study of 166 women undergoing treatment for
breast cancer, nearly 70% had low levels of serum vitamin
D, according to a study presented at the American
Society of Clinical Oncology’s Breast Cancer Symposium
in San Francisco. The analysis showed women with latestage
disease and non-Caucasian women had even
lower levels, according to a University of Rochester
Medical Center news release.
“Vitamin D is essential to maintaining bone health, and
women with breast cancer have accelerated bone loss due
to the nature of hormone therapy and chemotherapy. It’s
important for women and their doctors to work together
to boost their vitamin D intake,” said Luke Peppone, PhD,
research assistant professor of Radiation Oncology, at
Rochester’s James P. Wilmot Cancer Center. He is a member
of the National Cancer Institute’s (NCI) Community
Clinical Oncology Program research base in Rochester.
Scientists funded by the NCI analyzed vitamin D levels
in each woman, and the average level was 27 ng/mL; more
than two-thirds of the women had vitamin deficiency.
Weekly supplementation with high doses of vitamin D&MDASH;
&GE;50,000 IU or more—improved the levels, according to
Dr. Peppone’s study.
The IOM suggests that blood levels nearing 32 ng/mL
are adequate. This problem is not unexpected, Dr.
Peppone said, because previous studies have shown that
nearly half of all men and women are deficient in the nutrient, with vitamin D levels <32 ng/mL. Vitamin D,
obtained from milk, fortified cereals and exposure to sunlight,
is well known to play an essential role in cell growth,
in boosting the body’s immune system and in strengthening
bones. Symptoms of vitamin D deficiency include
muscle pain, weak bones/fractures, low energy and
fatigue, lowered immunity, symptoms of depression and
mood swings, and sleep irregularities, many of which are
common for women undergoing breast cancer treatment.
Link Found Between
Osteoporosis and Celiac Disease
People with celiac disease may develop osteoporosis
because their immune system attacks their bone tissue, a
new study has shown. It is the first time an autoimmune
responsehas been shown to cause damage to bones
directly.
Researchers from the University of Edinburgh studied a
protein called osteoprotegerin (OPG) in people with celiac
disease—a digestive condition that affects 1 in 100
people. In healthy people, OPG plays a crucial role in
maintaining bone health by controlling the rate at which
bone tissue is removed. This research is reported in the
New England Journal of Medicine.
According to a news release from University of
Edinburgh, the latest research shows that 20% of celiac
patients produce antibodies that attack the OPG protein
and stop it from working properly. This results in rapid
bone destruction and severe osteoporosis. It was previously
thought that osteoporosis—a known complication
of celiac disease—develops in celiac patients because they
cannot properly absorb calcium and vitamin D from their
diet. Both nutrients are essential for healthy bone development.
The team found that although this new form of
osteoporosis did not respond to calcium and vitamin D
supplements, it can be easily treated with drugs that prevent
bone loss.
Prof. Stuart Ralston, of the Institute of Genetics and
Molecular Medicine at the University of Edinburgh, who
led the team, said: “This is a very exciting step forward.
Not only have we discovered a new reason to explain why
osteoporosis occurs in celiac disease, but we have also
found that it responds very well to drugs that prevent
bone tissue removal. Testing for these antibodies could
make a real and important difference to the lives of people
with celiac disease by alerting us to the risk of osteoporosis
and helping us find the correct treatment for
them.”
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