NEW DRUGS/FORMULARY INFO
Inhaled
Insulin
Two new studies suggest that
in the near future, inhaled insulin formulations will supplant or supplement
injectable insulin therapy. The first study presented the long-term follow-up
results for a phase II study of Exubera,
an inhaled insulin formulation being developed by Pfizer and Aventis.
There was some limited
evidence from earlier studies that the drug might produce a slight
deterioration in pulmonary function, but this was not seen in this study. The
full answer to this safety question will not come until later this year when the
much larger phase III trial is completed.
If Exubera continues to perform well in clinical trials, the drug
could appear on the market in 2005 or 2006. It uses a special inhaled, powdered
form of insulin created by Nektar Therapeutics, which allows the user to inhale
the insulin.
In the second study, Dr.
Wayman W. Cheatham described an inhaled insulin formulation called Technosphere/Insulin, from MannKind
Biopharmaceuticals. It could reduce postprandial stress on beta cells by
mimicking the first phase of insulin response.
This therapy involves the
inhalation of tiny particles that are loaded with regular insulin, after the
start of meals. The reduced postprandial stress achieved with the therapy could
lead to improvements in beta cell function and, as a result, better endogenous
glucose hemostasis. www.medscape.com/viewarticle/480493?src=mp
DRUG INDICATIONS / WARNINGS
ADA Advice to Doctors
Every year, the American
Diabetes Association (ADA) issues Clinical Practice Recommendations, a series
of updated recommendations, to help health care providers treat people with
diabetes using the most current research available. The updated Guidelines
include new recommendations for several key areas of care, including lowering
blood pressure and blood glucose levels, treating high cholesterol, use of
aspirin, and more aggressive physician interventions to help people who smoke
find methods to help them quit.
The updated Guidelines
reflect the results of several scientific studies, including the Heart
Protection Study, the largest-ever cholesterol and diabetes study using a
statin. As reported elsewhere, this study found that people with diabetes could
reduce their risk of having a heart attack or stroke with treatment of a statin
(Lipitor is Omnicare’s preferred statin), even if their cholesterol
levels are normal. As a result, the ADA Guidelines now recommend that statins
be considered for people with diabetes over the age of 40 who have a total cholesterol
level that is greater than or equal to 135.
The Guidelines also
recommend a blood pressure goal of less than 130/80 mm Hg for people with
diabetes and make suggestions regarding which drug classes might be used. They
call for lowering blood glucose levels, as measured by the A1C test,
to less than 7% for most people with diabetes and less than 6% for individual
patients as appropriate. Aspirin is recommended for those with diabetes unless
contraindicated. http://www.diabetes.org/diabetesnewsarticle.jsp?storyId=5861487&filename=20040624/newsrx20040624engnewsrxengnewsrx1434565783953163620156790EDIT.xml
PATIENT CARE INFORMATION
Diabetes
Causes Significant Morbidity/Mortality
Ø
Diabetes was the sixth leading cause of death in the US in 2000
Ø
The risk for death among people with diabetes is two times that of
people without diabetes
Ø
About 65% of diabetes-related deaths are due to heart disease and stroke
Ø
Diabetes is the leading cause of new cases of blindness among adults
aged 20-74 years
Ø
Diabetes is the leading cause of end-stage renal disease, accounting for
44% of new cases
Ø
97% of adults with type 2 diabetes have one or more lipid abnormalities
Ø
Diabetes accounts for 60% of nontraumatic lower limb amputations in the
US
Ø
Total direct medical costs of diabetes in the US in 2002 were $92
billion and indirect costs (disability, work loss, premature mortality) were
$40 billion
National Diabetes Information Clearing House available
at: http://diabetes.niddk.nih.gov/dm/pubs/statistics/index.htm Accessed
03/17/04. Diabetes Care
2003;26:917-932. The National Diabetes
Education Program, available at: http://www.diabetes.org/main/uedocuments/Factsheetthelink2.pdf
Accessed 03/17/04
Benefits from Dietary and
Nonpharmacologic Therapies
Studies that evaluated
dietary education in the clinical management of older adults with diabetes
found that it can significantly improve weight, blood pressure, lipid values,
and glycemic control.
Exercise training can
significantly reduce the decline in maximal aerobic capacity (VO2)
that occurs with age, improve risk factors for atherosclerosis, slow
the decline in age-related lean body mass, decrease central
adiposity, and improve insulin sensitivity; all of which is
beneficial for the older adult with diabetes.
Almost 12% of persons with
diabetes aged over 65 smoke. Of people with diabetes, smokers have a higher
risk than nonsmokers of morbidity and premature death. Within 2-3 years of cessation the former
smoker’s risk of congestive heart disease is reduced to levels comparable with
that of persons who never smoked.
Evidence from middle-aged
and older adult studies suggests that multidisciplinary interventions that
provide education of medication use, monitoring, and recognizing hypo- and
hyperglycemia can significantly improve glycemic control.
Diabetes
Care
2004;27:S36. J Am Geriatr Soc
2003;51:S265-80. J Gen Intern Med
1995;10:59-66.
Benefits from
Pharmacologic Therapy
A study reinforced the
importance of good glycemic control among older type 2 diabetic patients. In a
12-week, placebo-controlled trial of glipizide (Glucotrol, Glucotrol XL) in
type 2 diabetic patients aged 30–85 years, improved glycemic control (A1C
9.3% vs. 7.5%) was associated with enhanced quality of life scores and better
general perceived health, cognitive functioning, sleep, depression, and
vitality. Subjects with better glycemic control also experienced fewer bed-days
and fewer restricted-activity days.
Several studies and reviews
have shown an association between aspirin use and reduction in acute myocardial
infarction and other cardiovascular events and cardiovascular mortality for
older adults with diabetes. The dose of aspirin in the studies ranged from 75
mg to 325 mg. The American Diabetes Association recommends 75 – 162
mg/day of aspirin (one baby aspirin/day).
The Appropriate Blood
Pressure Control in Diabetes (ABCD) Study found that intensive blood pressure
control in older patients with type 2 diabetes slows the progression of
diabetic nephropathy and retinopathy. Blood pressure medications (including
angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor
blockers (ARB)) have been shown to have cardiovascular and renal benefits for
older persons with diabetes.
Several studies and
meta-analyses have shown that a reduction in LDL cholesterol reduces the risk
of cardiovascular events in older adults.
Beneficial effects of lowering LDL have been demonstrated with statins.
A recent finding from the Heart
Protection Study emphasizes that statin therapy should be considered routinely
for all diabetics with cardiovascular risk factors regardless of initial
cholesterol concentration.
JAMA 1998;280:1490-96. Diabetes Care 2004;27:S72-3. ALLHAT in
JAMA 2002;288:2981-97 N Engl J Med 2001;345:861-9. Kidney Int 2002;61:1086-97.
Diabetes Medications: Administration Times by
Bill Fournier, R.Ph., Consultant Pharmacist
Questions often arise
regarding the appropriate times to administer diabetes medications during
medication passes. The following information summarizes the dosing
recommendation of many of the available agents.
Actos
(pioglitazone) Without
regard to meals
Amaryl
(glimepiride) With
breakfast or first main meal of the day
Avandamet
(rosiglitazone/metformin) With meals
Avandia
(rosiglitazone) Without
regard to meals
Diabinese
(chlorpropamide) With
breakfast – may cause GI upset
Glipizide Take ½ hour before meals
Glucophage
(metformin) With
meals
Glucotrol XL
(glipizide) With
breakfast
Glucovance
(glyburide/metformin) With
meals
Glyburide (Diabeta, Micronase) With
breakfast or first main meal of the day
Glynase
(glyburide) With
breakfast of first main meal of the day
Metaglip
(glipizide/metformin) With
meals
Orinase
(tolbutamide) Single
or divided doses – to improve GI tolerance
Prandin
(repaglinide) 0-30
minutes prior to meal
Precose
(acarbose) With
first bite of each main meal
Starlix
(nateglinide) 1-30
minutes prior to meals
Tolinase
(tolazamide) With
breakfast or first main meal of the day
Facts and Comparisons, 2004;
Individual Product Labeling, Omnicare Geriatric Pharmaceutical Care Guidelines,
2004
Type 1 and type 2 diabetes
differ. Over 90% of diabetic patients
have type 2 diabetes. The natural
progression of type 2 diabetes leads to exhaustion of the pancreas and decreased
insulin production. Persistent
hyperglycemia leads to tissue damage in both large and small blood vessels,
which can result in blindness, renal failure, heart disease and amputation.
EDITOR’S CORNER
Omnicare’s Commitment to
Residents with Diabetes
During July and August,
Omnicare consultant pharmacists are focusing on enhancement of their skills and
knowledge in diabetes management. Omnicare serves approximately 300,000
residents with diabetes. Our goals are to decrease adverse drug events by eliminating
unnecessary medications, assure that blood pressure goals are maintained,
achieve lipid control, and maintain plasma blood glucose and A1C
values in the desired range. Consultant Pharmacists will collaborate with
prescribers on changes in drug therapy and monitoring to guide optimal use of insulin, oral antidiabetic drugs,
ACEI/ARB therapy, aspirin and statin medications in residents with diabetes.
Omnicare supports the recommendations of the American Medical Directors
Association, the American Diabetes Association and the American Geriatric
Society for optimal management of elderly persons with diabetes.
|
Diabetes Indicator
|
ADA &
AMDA Targets
|
AGS Targets
|
|
A1C
|
< 7%
|
< 8%
|
|
Fasting Plasma Glucose
|
80 – 120 mg/dl
|
80 – 120 mg/dl
|
|
Blood Pressure
|
< 130/80 mm Hg
|
<140/80 mm Hg
|
|
LDL cholesterol
|
< 100 mg/dl
|
< 100 mg/dl
|
|
Triglycerides
|
< 150 mg/dl
|
150 mg/dl
|
Authored by:
Fred R. Armeni, RPh.,
Pharm.D.
The vast majority of these abstracts
and news items were researched via the Internet, so reprints of original
articles are not possible from the compiler.
