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

September 14, 2006

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COPENHAGEN, Denmark, Sept. 14 (Pfizer PR) -- Adult patients with diabetes who took Exubera® (insulin human [rDNA origin]) inhalation powder 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."

Posted by dlife at September 14, 2006 09:52 AM

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