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Diabetes
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my personal edition > diabetes > news
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Nektar Reports that Pfizer Announced New Analyses Showing that Exubera Is Effective in Diabetes Patients Who Have Respiratory Infections or Who are Exposed to Passive Cigarette Smoke
COPENHAGEN, DENMARK -- September 14, 2006 -- Nektar Therapeutics reported today that Pfizer announced that new ExuberaŽ (insulin human (rDNA origin)) Inhalation Powder data were being presented today at the 42nd European Association for the Study of Diabetes.
Pfizer announced that adult patients with diabetes who took Exubera 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.
Retrospective analyses of 14 Exubera Phase II and III clinical studies showed 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 adult patients who were exposed to a smoky environment.
In addition, Pfizer announced that 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.
Finally, Pfizer announced that 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).
"Today's clinical information is important for the healthcare professionals who treat diabetes," said John Patton, PhD, co-founder and chief scientific officer, Nektar.
Exubera is marketed by Pfizer and is a product of a developmental collaboration between Pfizer and Nektar. Under the agreement between the two companies, Nektar will receive royalties on Exubera as well as revenue for the manufacture of the powder and the Exubera Inhalers.
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 powdered insulin that is inhaled through the mouth prior to eating, using the handheld Exubera 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.
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 comparators showed that Exubera was associated with small, non-progressive 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 healthcare 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.
SOURCE: Nektar Therapeutics
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