Exubera Effective in Diabetes Patients who Have Respiratory Infections or are Exposed to Passive Cigarette Smoke, New Analyses Show

Copenhagen, Denmark (ots/PRNewswire) -

- Twice as Many People With Uncontrolled Type 2 Diabetes Would Accept
Insulin if Offered Exubera, Even in Countries Where Pens are Commonly
Used, Additional Study Shows
- Patients With Diabetes Gained Less Weight With Exubera Than With
Injectable Insulin, According to Five Clinical Studies
- Investigator: 'Patients Taking Exubera are No More Likely to Develop a
Respiratory Infection Than Patients Using Injectable Insulin.'

Adult patients with diabetes who took Exubera(R) (insulin human
[rDNA origin]) were able to safely maintain good blood sugar control
even if they developed a respiratory infection or were exposed to
passive (second-hand) cigarette smoke. These analyses were presented
today at the 42nd European Association for the Study of Diabetes.

In addition, according to a retrospective analyses of 14 Exubera
phase 2 and 3 clinical studies, Exubera was well tolerated and
efficacious, even during respiratory illness in adults with type 1 or
type 2 diabetes.

Another new study found that while passive smoke exposure could
result in decreased absorption, Exubera could be used by patients who
were exposed to a smoky environment.

"This information is important for healthcare providers who have
prescribed or are considering prescribing Exubera to their patients,"
said Professor Philippe Camus, lead investigator from the University
Medical Center, Dijon, France. "It shows that the efficacy and
tolerability of Exubera remain unchanged even if patients develop a
cold or the flu. Also, studies showed patients taking Exubera are no
more likely to develop a respiratory infection than patients using
injectable insulin."

Exubera should not be used by people who smoke or have smoked in
the past six months, or by people who have underlying lung diseases
such as asthma or chronic obstructive pulmonary disease.

An analysis of a previously reported study showed that Exubera has
the potential to encourage twice as many people with uncontrolled
Type 2 diabetes to try insulin (44 percent choosing insulin with
Exubera availability versus 17 percent choosing insulin without
Exubera availability). This held true even in countries where insulin
pens are commonly used to administer insulin. Past studies have shown
that people avoid or delay starting insulin therapy, for example due
to the fear and pain of injection, even when suffering from
devastating complications brought about by uncontrolled blood sugar
levels.

"This finding contradicts the perception that insulin pens can
overcome peoples' resistance to using insulin. If Exubera can get
more people to accept insulin at all and to accept it earlier than
they ordinarily might, we would expect that more people could get
their blood sugars under control," said Professor Nick Freemantle,
professor of clinical epidemiology and biostatistics from the
University of Birmingham, U.K. "This is incredibly important in
helping people to reduce their chances of suffering from the serious
complications of uncontrolled diabetes such as blindness and
amputations as well as for healthcare systems responsible for
reducing diabetes related morbidity and mortality."

In addition, an analysis of five clinical trials showed that
people with either Type 1 or Type 2 diabetes who used Exubera gained
less weight than those using injectable insulin. Type 2 patients
gained less than half with Exubera (0.7 kg vs. 1.6 kg), while the
difference was even greater for Type 1 patients (0.2 kg with Exubera
vs. 1.1 kg with injected insulin).

"Many of my patients worry about weight gain with insulin," said
Dr. Priscilla Hollander, lead investigator from Baylor University
Medical Center, Dallas, U.S. "This analysis reassures me that people
who need insulin will not gain as much weight if they use Exubera.
This may be another reason for physicians and their patients to
consider Exubera to control blood sugar levels."

About Exubera

Exubera is the first inhaled form of insulin and the first insulin
option in the European Union, U.S., Brazil, and Mexico in more than
80 years that does not need to be administered by injection. Exubera
is currently available in the U.S., United Kingdom, Ireland, and
Germany.

It is a fast-acting powered insulin that is inhaled through the
mouth prior to eating, using the handheld Exubera(R) Inhaler. The
unique Exubera Inhaler produces a visible standing cloud of insulin
powder, which is designed to pass rapidly into the bloodstream to
regulate the body's blood sugar levels.

In the European Union, Exubera is approved for the treatment of
adult patients with type 2 diabetes who require insulin therapy and
are not adequately controlled with diabetes pills. In patients with
type 1 diabetes, Exubera should be used in combination with long or
intermediate acting insulin, for whom the potential benefits of
adding inhaled insulin outweigh the potential safety concerns.

In the U.S., Exubera is approved for the treatment of adults with
type 1 or type 2 diabetes for the control of high blood sugar levels.
In patients with type 2 diabetes, Exubera can be used alone or in
combination with diabetes pills or longer-acting insulin. In patients
with type 1 diabetes, Exubera should be used in combination with a
longer-acting insulin.

Exubera is marketed by Pfizer and is a product of a developmental
collaboration between Pfizer and Nektar Therapeutics.

Important Safety Information about Exubera

Patients should not take Exubera if they have poorly controlled or
unstable lung disease, or 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.

In clinical trials, mean treatment group differences between
Exubera and comparator showed that Exubera was associated with small,
nonprogressive declines in lung function relative to comparator
treatments.

Before starting treatment with Exubera, a healthcare professional
will carry out a simple test to check lung function. This will help
to find out if Exubera is the right treatment for individual
patients. Once a patient starts treatment, it is recommended that a
health care provider check lung function again at six months and
yearly thereafter.

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 tended to occur within seconds to minutes after Exubera
inhalation. Coughing occurred less frequently as patients continued
to use Exubera.

For more information about Exubera visit http://www.Exubera.com.

Web site: http://www.pfizer.com
http://www.Exubera.com

ots Originaltext: Pfizer Inc.
Im Internet recherchierbar: http://www.presseportal.de

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