Thankfully, I'm no longer short any Puts for NKTR.
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Exubera Demonstrated Pulmonary Safety with Blood Sugar Control in Three-Year Interim Analyses
CHICAGO (Business Wire) -- Results from three-year interim analyses of two ongoing long-term
clinical trials showed that small mean declines in lung function in
diabetes patients who took Exubera(R) (insulin human (rDNA origin))
Inhalation Powder reversed when Exubera was discontinued. Upon
re-initiation of Exubera, lung function changes similar to first time
users of Exubera were observed. The studies also showed that patients
on an Exubera regimen maintained blood sugar control and generally
gained less weight over the three-year period than those on an
injected insulin regimen. These data were presented today at the 67th
Annual Scientific Sessions of the American Diabetes Association.
In the first two years of these studies, Exubera patients had
small and non-progressive mean declines in lung function that reversed
one month after discontinuing treatment. Upon re-initiation of
Exubera, small changes in lung function re-appeared and were
consistent with those shown in previous Exubera studies. These studies
are part of the largest database of pulmonary function in patients
with diabetes.
"These data further our understanding of the pulmonary profile of
Exubera. This highly effective treatment option will help patients
control their blood sugar levels, which is critical given the
progressive nature of diabetes and the challenges related to treating
and managing the disease over time," said Dr. William Cefalu, lead
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 rates of diabetes are high and growing in almost all areas of
the globe. By 2030, the World Health Organization predicts that 366
million people worldwide will have diabetes.
The ADA recognizes insulin as the most effective medication to
control blood sugar, and despite this, studies have shown that people
- even those poorly controlled - delay the initiation of insulin for 5
years or longer. Injection fear and anxiety are often cited as some of
the key reasons to delay.
"Patients have stated that Exubera has had a positive impact on
their diabetes and some of these patients have been taking Exubera for
up to eight years," said Rochelle Chaiken, M.D., vice president
cardiovascular medical group leader at Pfizer. "We are committed to
educating physicians and patients about the critical role that earlier
insulin initiation may play in managing this disease."
Cefalu et al Study: Type 2 Diabetes
-- The primary endpoint was to evaluate pulmonary safety in patients
without underlying lung disease upon discontinuation and
re-initiation of Exubera.
-- 627 adults with type 2 diabetes who had stable injected insulin
therapy (basal insulin, plus two or three injections of
short-acting insulin) at baseline were randomized to receive either
Exubera or continued injected insulin therapy for two years,
followed by a six month wash-our period during which all patients
received injected insulin, and subsequent re-administration of
their original randomized therapy for six-months.
-- Exubera was well-tolerated and this study confirmed that mean
decreases in lung function as measured by FEV1 and DLco relative to
comparator treatments were small, occurred early, did not progress
and showed resolution one month after discontinuation of therapy.
-- The study also showed the following:
-- Baseline blood sugar levels (A1C) were 7.7 percent in both
groups. After three years, patients in both groups had similar
improvement or maintained their blood sugar levels (A1C levels
of approximately 7.4 percent after 3 years).
-- Patients using Exubera achieved lower fasting blood sugar
levels throughout the study versus comparator.
-- Patients using Exubera gained less weight (3.5 kg, 7.7 pounds)
than those using injected insulin (4.1 kg, 9.1 pounds) over
the three-year study period despite comparable blood sugar
control.
-- Adverse events were similar in both groups with the exception of
cough and shortness of breath (dyspnea), which were more frequent
in the Exubera group. The cough was predominantly mild, occurring
shortly after dosing, decreasing over time and rarely resulted in
discontinuation of treatment.
-- In addition, the overall hypoglycemic and severe hypoglycemic event
rates in the two studies were similar between treatment groups.
Hollander et al Study: Type 1 Diabetes
-- This study, with 580 adults with type 1 diabetes, had the same
endpoints and methodology as the type 2 diabetes study.
-- Exubera was well-tolerated, with comparable lung function changes,
and this study confirmed that mean decreases in lung function
relative to comparator treatments were small, occurred early, did
not progress and showed resolution one month after discontinuation
of therapy.
-- The study also showed the following:
-- Baseline blood sugar levels (A1C) were 7.4 percent (Exubera)
and 7.5 percent (injected insulin). Over three years, blood
sugar control was generally well maintained (A1C levels of
7.6 percent on Exubera and 7.2 percent on injected insulin).
-- Patients using Exubera gained less weight (1.6 kg, 3.5 pounds)
than those using injected insulin (2.9 kg, 6.4 pounds) over
the three-year study period.
-- Adverse events were similar in both groups with the exception of
cough, which was more frequent in the Exubera group. The cough was
predominantly mild, occurring shortly after dosing and rarely
resulted in discontinued treatment. In addition, the overall
hypoglycemic and severe hypoglycemic event rates in the two studies
were similar between treatment groups.
About Exubera
...
Important Safety Information about Exubera
Exubera may lower your lung function, so you will need to take a
breathing test before you start treatment and, from time to time, as
you keep taking Exubera.
You should not take Exubera if you have an unstable or poorly
controlled lung disease (such as unstable or poorly controlled asthma,
chronic obstructive pulmonary disease) or if you smoke, start smoking,
or quit smoking less than 6 months ago.
You should not take Exubera if you are under 18 years of age or if
you are allergic to insulin or any of the inactive ingredients in
Exubera.
Tell your health care provider about all your health and medical
conditions, including if you have any lung disease or breathing
problems, if you are pregnant, or plan to become pregnant.
As with all forms of insulin, a possible side effect of Exubera is
low blood sugar (hypoglycemia), which can be mild to severe. It is
important to check your blood sugar as your health care provider has
advised you. Other common side effects are cough, dry mouth and chest
discomfort. |
