|
E-mail this page to a friend!
Senior Diabetics Say Goodbye to Injections as FDA
Welcomes Exubera
About 10 million senior citizens have diabetes half
of all U.S. cases
Jan. 28, 2006 The golden years just got a lot
brighter for about 10 million senior citizens who suffer with diabetes.
Exubera, the first inhaled form of insulin and the first option for
diabetics that does not involve an injection, has been approved by the
U.S. Food and Drug Administration. Pfizer Inc. says it expects to have
the drug available by "mid-year."
| |
Related Stories |
|
| |
Study Indicates Inhaler May Replace Needle for
Diabetes Patients?
Nov. 21, 2005 - There is clear evidence from
clinical trials that a new inhaled formulation of insulin, Exubera, is
as effective as traditional subcutaneous injections in controlling blood
glucose in patients with type 1 or type 2 diabetes. The new formulation,
which is likely to be the first non-injectable insulin on the market,
was preferred by a majority of patients due to ease of use and is sure
to be welcomed news for the nearly one in five of seniors over age 60
who suffer with diabetes.
Read more...
Diabetes Month 2005 Finds Disease Continues to
Increase
Centers for Disease Control issues Diabetes Fact
Sheet
Nov. 2, 2005- Diabetes now affects nearly 21
million Americans or 7 percent of the U.S. population and more than
6 million of those people do not know they have diabetes, according to
the latest prevalence data released by the Centers for Disease Control
and Prevention (CDC). The 2005 National Diabetes Fact Sheet has been
issued to coincide with National Diabetes Month in November.
Read more...
Campaign Begins Empowering Older Adults to Manage
Their Diabetes
Oct. 20 A new campaign kicked off today the newly
updated The Power to Control Diabetes Is in Your Hands awareness
campaign for older adults with diabetes. The goal of the campaign is to
help the 18.3 percent of adults age 60 and older senior citizens with
diabetes manage their disease. The highlights include a community action
kit and a brochure designed to reach older adults with diabetes and
their loved ones.
Read
more...
More news on Senior Health and
Medicine - click here |
|
Pfizer also said Exubera (insulin human [rDNA
origin]) Inhalation Powder has been approved for the treatment of adults
with type 1 and type 2 diabetes.
Exubera was found in clinical trials to be as
effective as short-acting insulin injections, and to significantly
improve blood sugar control when added to diabetes pills.
Exubera is the first inhaled form of insulin and
the first insulin option that does not need to be administered by
injection in the United States.
"Exubera is a major, first-of-its-kind, medical
breakthrough that marks another critical step forward in the treatment
of diabetes, a disease that has taken an enormous human and economic
toll worldwide," said Hank McKinnell, chairman and chief executive
officer of Pfizer.
"The global incidence of diabetes is currently at
epidemic levels. Millions of patients are not achieving or maintaining
acceptable blood sugar levels, despite the availability of current
therapies. Exubera meets a critical medical need by offering a highly
effective and needle-free alternative to diabetes pills and insulin
injections to manage this complicated, debilitating disease."
Exubera is a rapid-acting, dry powder human insulin
that is inhaled through the mouth into the lungs prior to eating, using
the handheld Exubera Inhaler. The Exubera inhaler weighs four ounces
and, when closed, is about the size of an eyeglass case. The unique
Exubera Inhaler produces in its chamber a cloud of insulin powder, which
is designed to pass rapidly into the bloodstream to regulate the body's
blood sugar levels.
Exubera Meets Medical Need
"Many people who could benefit from insulin are
fearful of injections, so they delay treatment five years or ten years,
placing them at risk for serious complications. Now, for the first time
patients can improve blood sugar control with fewer or no painful
injections," said Dr. William Cefalu, Exubera investigator and chief of
the division of nutrition and chronic diseases at the Pennington
Biomedical Research Center, a campus of the Louisiana State University
System, in Baton Rouge.
The efficacy and safety profile of Exubera was
studied in more than 2,500 adults with type 1 or type 2 diabetes for an
average duration of 20 months. In clinical trials, many patients using
Exubera reported greater treatment satisfaction than patients taking
insulin by injection. Significantly more patients who had used both
Exubera and insulin injections or diabetes pills reported an overall
preference for Exubera.
"With Exubera, I've been able to control my blood
sugar levels and not constantly worry about how I manage my diabetes,"
said Jamie Villastrigo, a type 2 diabetes patient and Exubera clinical
trial participant.
In patients with type 2 diabetes, Exubera can be
used alone as an alternative to rapid-acting insulin injections or
diabetes pills, or in combination with diabetes pills or longer-acting
insulin. In patients with type 1 diabetes, Exubera will be used in
combination with longer-acting insulin.
The Burden of Diabetes in the United States
Complications commonly associated with uncontrolled
or poorly controlled blood sugar levels include heart disease,
amputation, blindness and kidney failure. Diabetes and its complications
are estimated to account for $132 billion in direct and indirect health
care costs annually.
Nearly 21 million Americans have diabetes and
approximately 95 percent of these people have type 2 diabetes.
Approximately half of all diabetes occurs in people age 60 or older.
In type 2 diabetes, the body does not make or use
insulin well enough to manage blood sugar levels. Type 2 diabetes
progresses over time, and eventually most patients will need to
administer insulin to achieve blood sugar control. In type 1 diabetes,
the body does not make insulin at all. These patients must take insulin
to survive.
All people with type 1 diabetes and a large
percentage of people with type 2 diabetes need treatment with insulin.
While insulin has been proven to be effective to reduce blood sugar
levels and the risk of complications, health care providers and patients
often have been unwilling to start treatment. Factors include patients'
fear of injections and social embarrassment associated with needles.
Exubera is the result of one of the most rigorous
and innovative diabetes development programs. Pfizer has invested in two
state-of-the-art manufacturing facilities -- the world's largest insulin
plants in Frankfurt, Germany, and a highly automated, high-tech
production facility in Terre Haute, Indiana.
Exubera is a product of a collaboration between
Pfizer and Nektar Therapeutics. Pfizer recently reached an agreement to
acquire the sanofi- aventis worldwide rights to Exubera. The two
companies were previously in a worldwide alliance to co-develop,
co-promote and co-manufacture Exubera.
Important Safety Information about Exubera
Patients should not take Exubera if they smoke or
have stopped smoking less than six months prior to starting Exubera
treatment. If a patient starts smoking or resumes smoking, he or she
must stop using Exubera and see a health care provider about a different
treatment.
Exubera may affect lung function so patients need
to have their lungs tested before starting Exubera, and periodically
thereafter, as directed by a healthcare provider. The test involves
exhaling into a measuring device. Exubera is not recommended for people
that have chronic lung disease (such as asthma, chronic obstructive
pulmonary disease or emphysema). Also, Exubera should not be used at all
by people with unstable or poorly controlled lung disease.
Like all medicines, Exubera can cause side effects.
As with all forms of insulin, a possible side effect of Exubera is low
blood sugar levels. Some patients have reported a mild cough while
taking Exubera, which occurred within seconds to minutes after Exubera
inhalation. Coughing occurred less frequently as patients continued to
use Exubera.
Patients and health care providers can call
1-800-EXUBERA and register to receive more information about Exubera
when it is available. The hotline can be accessed in English.
Source: Pfizer Inc - Web site:
http://www.pfizer.com/
Click here to Search SeniorJournal.com for more on
this subject
Click to More Senior News on the
Front Page
Copyright: SeniorJournal.com |
