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More than 20 million Americans have diabetes and approximately
95 percent of those have type 2, formerly called adult onset
diabetes. Among this group, lack of compliance with their
medication routine is a big issue, making them more vulnerable
to complications such as stroke, heart attack and amputation.
In fact, studies show that 36 percent of the time people with type 2 diabetes
who are prescribed insulin don’t take it. Reasons for noncompliance vary
greatly from person to person, say experts, but they include resistance to
taking insulin injections—something those with type 2 often face after
several years of oral medications.
Now there is an alternative that may make it far easier
for people with type 2 to transition to insulin and for those
who already take insulin to stick to their glucose control
goals. The product, called Exubera, is an inhaled insulin
manufactured by Pfizer and it is the first to get the go-ahead
from the Food and Drug Administration for sale to the consumer.
Doctors hope that inhaled insulin will increase compliance
to over 90 percent, the rate seen in studies of those taking
one oral medication. “Not enough people who need to
take insulin do take it. This will facilitate people going
on insulin earlier and will improve overall A1C levels,” remarks
Jay Skyler, M.D., professor in the division of endocrinology,
diabetes and metabolism at the University of Miami.
Exubera has been in clinical trials nearly for 10 years.
Kelly L. Close, editor of the Diabetes Close Up newsletter
and founder of Close Concerns, Inc., a strategic consultancy
devoted to diabetes and obesity research, has a few insights. “Inhaled
insulins have the potential to reduce overall A1C levels—a
very powerful concept, given that more than two thirds of
patients with diabetes in the United States are not achieving
glycemic targets,” says Close. “What we are seeing
with these new products, such as inhaled insulins and other
types of medications for patients with diabetes, are pharmacological
companies actively addressing two growing diseases in our
country—and around the world—obesity and type
2 diabetes.”
With 10 years of data, researchers and the FDA feel confident
that the product does not cause significant or serious lung
problems—a major concern for developers. But ongoing
studies continue to evaluate the long-term repercussions
and the FDA is asking for ongoing surveillance of those taking
the product. Today the warning for Exubera is as follows:
"Inhaled insulins are not recommended for anyone who has lung
problems such as asthma or for people who smoke."
“The label for Exubera recommends lung function testing
at the start of treatment, at six months, at twelve months,
and annually thereafter,” says Ms. Close. “Pfizer
has committed to significant long-term safety studies, including
a large five-year study, a seven-year epidemiological study
of chronic lung disease, a three-year phase 4 pediatric study,
as well as other mechanistic studies. The more studies the
better, as far as we are concerned; it will be worth it in
the long term.”
Exubera delivers insulin in doses of 1 mg and 3 mg, the equivalent
of about three and eight units of insulin. As for the device
itself, Dr. Skyler says the inhaler is not hard to use (one
only needs to know how to breathe) and while cleaning and changing
the insulin release unit is something that needs to be learned,
it should not be an obstacle to use. Soon, what are known as
second-generation versions will be available. Some of these
will offer more varied dosing options; others, lighter or more
streamlined delivery systems.
Other inhaled insulins under development include:
MannKind
Technosphere
Eli Lilly/Alkermes
AIR insulin
Kos’s inhaled insulin
Novo Nordisk/Aradigm’s
AERx iDMS.
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Each of these has a slightly different delivery mechanism, choice of doses and
degree of ease of use. When Dr. Skyler compared them to Exubera, he found that
the MannKind and Lilly devices are very small; the Kos device looks like an asthma
inhaler and holds 120 doses (compared with the single dose of the other devices);
and Novo’s AERx device, while bigger and heavier than the others, includes
sophisticated functions for tasks such as quantifying dosage. He also says that
except for Technosphere, the effect of the inhaled insulins on glucose levels
is about the same. Technosphere seems to have a more rapid onset of action that
mimics normal insulin secretion patterns by reducing the burden on insulin-secreting
cells in the pancreas and rapidly shutting off the liver’s conversion of
glycogen to glucose.
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