Board index » diabetes » Insulin puffers story

2003-07-28 07:09:06 PM
Thought the following might be of interest ...
Insulin puffers as effective as injections
Trials with experimental insulin inhalers show they are as effective
as injections - and that diabetics much prefer them, an analysis of
existing studies has found.
www.abc.net.au/science/news/stories/s909977.htm
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Nico Kadel-Garcia wrote:
can meter the dosage as accurately as a syringe, but the respiratory
tract is too variable and unpredictable a site.
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Nico,
IMHO, the reason we don't see inhaled insulin on the market today is not
dosage, but the two related concerns.
First, one patient (out of thousands tested) developed pulmonary fibrosis.
People can develop pulmonary fibrosis spontaneously, and this could be
coincindence. But this prompted a call for additional testing.
Second, there is the issue of antibodies. The titer of insulin antibodies in
the blood is higher in inhaled insulin vs injected insulin.
At the last ADA meetings in New Orleans, there was a symposium about these
issues. The take home message was a) nobody else has had fibrosis and b)
the antibodies don't appear to be a manifestation of any harm.
Once the additional testing is complete, if there are no additional cases of
fibrosis and if there are no new adverse effects noted, then the FDA should
approve this.
As far as the dosing issue, it's actually not as bad as you describe. In
fact, inhaled insulin has some of the best times to peak of any delivery
method, allowing the dose to be given during or just after a meal. It is
also cleared rapidly, reducing the hypo risk pre-meal.
Assuming no new adverse effects on the clinical testing underway, I predict
that 5 years from now the majority of type 2's converting to insulin will
use a basal insulin like glargine or detimir plus inhaled insulin.
Cheers,
William C Biggs MD
"Nico Kadel-Garcia" <nkadel@verizon.net>wrote in message

health diabetes

Dr. Biggs,
What about those of us that are T1's. You said about 5yrs we'll see
T2's using it.
Is it as beneficial as pumping?
What about long term damage?
How would dosing be adjusted? Like a squirt per unit?
RK
"William C Biggs, MD" <SCXQZNQKAJRC@spammotel.com>wrote in message
: Nico,
:
: IMHO, the reason we don't see inhaled insulin on the market today is not
: dosage, but the two related concerns.
:
: First, one patient (out of thousands tested) developed pulmonary fibrosis.
: People can develop pulmonary fibrosis spontaneously, and this could be
: coincindence. But this prompted a call for additional testing.
:
: Second, there is the issue of antibodies. The titer of insulin antibodies
in
: the blood is higher in inhaled insulin vs injected insulin.
:
: At the last ADA meetings in New Orleans, there was a symposium about these
: issues. The take home message was a) nobody else has had fibrosis and b)
: the antibodies don't appear to be a manifestation of any harm.
:
: Once the additional testing is complete, if there are no additional cases
of
: fibrosis and if there are no new adverse effects noted, then the FDA
should
: approve this.
:
: As far as the dosing issue, it's actually not as bad as you describe. In
: fact, inhaled insulin has some of the best times to peak of any delivery
: method, allowing the dose to be given during or just after a meal. It is
: also cleared rapidly, reducing the hypo risk pre-meal.
:
: Assuming no new adverse effects on the clinical testing underway, I
predict
: that 5 years from now the majority of type 2's converting to insulin will
: use a basal insulin like glargine or detimir plus inhaled insulin.
:
: Cheers,
: William C Biggs MD
:
:
: "Nico Kadel-Garcia" <nkadel@verizon.net>wrote in message
: news:2a9Va.10332$AO6.536@nwrdny02.gnilink.net...
:>RK wrote:
:>>"Wilson da Silva" <wfdas@yahoo.com>wrote in message
:>>news:7fc2943a.0307280309.b8c1e88@posting.google.com...
:>>: Thought the following might be of interest ...
:>>:
:>>: Insulin puffers as effective as injections
:>>:
:>>: Trials with experimental insulin inhalers show they are as effective
:>>: as injections - and that diabetics much prefer them, an analysis of
:>>: existing studies has found.
:>>:
:>>: www.abc.net.au/science/news/stories/s909977.htm
:>>
:>>all I gotta say... "what a crock of crap!"
:>>
:>>I found several incorrect statements in that article.
:>>
:>>RK
:>
:>They've never been FDA approved, despite many years of research. The
:>problem seems to be dosage.
:>
:
:
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Since I am long past needle phobia I will not
participate in these changes in my time that is left.
I have had several incidents in my life with new meds
and methods that had very negative effects.
My doc says that it is best to wait a while on
any new item and see what works out.
Lantus was my last early entry because of the acute
insulin program I was on. So far no problems there.
Had to do some sorting of fact from fiction.
Seems to me some drugs are approached with tunnel vision
and sometimes have ignored side effects.
One of the problems with private money drugs that if a problem
is found it is a major loss to drop it, (unless the failure is gross).
Guy.
On Mon, 28 Jul 2003 15:08:20 GMT, "RK" <xxx@xxx.net>wrote:

On Mon, 28 Jul 2003 13:16:45 GMT, mike gray <omspam@worldnut.net>wrote:
of the large majority of people to syringe shots
the site's positive spin on inhaled insulin
is a good example of big pharma
marketing money at work. :(
is it any wonder that Aventis and Novo
have spent millions on new 1x background
insulins (glargine/Lantus in the case of Aventis)
that they can get new patents on
bill t1 since '57
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willbill wrote:
possibility. The developers do keep publishing very promising articles
and papers about it.
They just don't seem able to get enough control over dosage in vivo to
actually use the stuff.
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William C Biggs, MD wrote:
additonal testing. I wonder what else they were sniffing, or if there
were other complicating factors?
most of us Type 1's.
papers myself on dosage, especially for overnight use for people like me.
insulin at meal time. But overnight is a bit tricky, as is the time
between lunch and my rather late supper. If it clears more quickly, then
I'm screwed at about 5pm. And taking *another* dose at that time of a
really fast-acting insulin seems a bit awkward.
played paintball with about 5 years ago (at my bachelor party!) was
working on it and claiming they'd have FDA approval within six months.
It took me a while to stop laughing: maybe he said something that silly
just to ruin my aim, but I still shot him.....
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RK
to head comparison vs a pump. I'm sure that eventually it will be tested
against a pump, but obviously it wouldn't be a double blind type of study.
patients ever develop fibrosis, and if there is any relevance to an
increased insulin antibody titer. Studies are still underway, but appear to
look good so far.
Inhale) and from Aradigm.
Nektar's device is about 1 -2 years ahead of Aradigm in development.
Nektar is working with Aventis and Pfizer to market the device. Nektar has
done the research, the insulin is manufactured by Aventis, and Pfizer &
Aventis will market it.
The Nektar system is dry powder. When I saw it about 3 - 4 years ago they
had little foil packages of insulin that were the equivalent of 3 or 6 units
of insulin. I am not sure how they will be dosing the packages for final
release. I would think the best would be a binary like assortment....1 , 2,
4, 8, and 16 unit packages, or simply have all different doses available
prepackaged. The device spins the insulin into an air chamber, and you then
suck in a deep breath from the air chamber.
Aradigm is working with Novo. The Aradigm system uses wet insulin packaged
in tiny little blisters on a paper strip. A hammer like device strikes the
paper, rupturing the blisters which then are ejected into the air. The
hammer won't trigger off unless you are sucking enough air to get a good mix
and a good inhalation into your lungs. The device even has a little green
light telling you the best time to trigger the dose. I haven't seen the
dosing details on this one.
BTW, one of the curious things presented at the ADA meeting was the effect
of cigarette smoking on inhaled insulin.
Rather than reducing the effect, cigarettes actually made the insulin absorb
more completely and more quickly. They documented some problems with former
smokers on inhaled insulin, relapsing into smoking, and triggering hypos as
a result.
Best wishes,
William C Biggs, MD
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In article <7fc2943a.0307280309.b8c1e88@posting.google.com>, Wilson da
Silva <wfdas@yahoo.com>wrote:
Senkise Vagyok nemo@umb.u-strasbg.fr
To get to real sender replace nemo with me
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On Mon, 28 Jul 2003 23:43:36 GMT, mike gray <omspam@worldnut.net>wrote:
but what'll you buy?
the puffer company(s)?
or Lilly or Novo?
i mean, if Lilly or Novo (or another of the big
synthetic insulin makers) supplies the base insulin
and/or base insulin technology to the "puffer" companies
(i.e. if they get a "cut" based on insulin sales volume),
then maybe Lilly and/or Novo would be the better buy?
i mean, their insulin volume may soon quintuple since
it's my understanding that puffed insulin delivery is
*extremely* wasteful. so given our wacky 3rd party
pay system in the USA, synthetic insulin sales could
easily soon be at 5x current levels
and one more good reason why we'd all be better
off, if everyone in the USA paid out of pocket for
health care and meds, coz that's the only way
we're ever gonna get any real restraint in our
bloody health care system
one other though is that since T2s presently use
about 90% of all insulin sold, we'll soon have T2s
using 98+% of all insulin sold. iow, one more good
reason for T1s with brains to start sweating on the
subject of remaining available insulin suitable for
use by T1s
bill t1 since '57, ex 8-yr pumper, beef-L 1x, simple MDI/DAFNE
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On Tue, 29 Jul 2003 00:11:34 GMT, Nico Kadel-Garcia <nkadel@verizon.net>wrote:
do everything they can to downplay any negative
stuff that comes up during the trail
once this "puffed" insulin stuff is put on the open market
(note: i'm assuming it'll be a script item and NOT OTC)
it'll be open to a *lot* more variability
bill t1 since '57
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willbill wrote:
determining what factors and what are insignificant are very, very
difficult, especially when there's no chance of doing a double blind
(such as in this case, unless we give them nose sprays *and* injections,
which could be quite hazardous if they lose and need to replace a bottle
or a nose spray).
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Bill,
The puffers are relatively big.
Here is a link to the Nektar/Aventis/Pfizer inhaler.
www.nektar.com/content/inhalers
The top one labeled "Nektar Pulmonary Inhaler" is the one for insulin. It is
shown in its *collapsed* state. When expanded it is about 80% longer.
The pens are definitely smaller.
Here is a link to the Aradigm/Novo device.
www.aradigm.com/tech/delivery.html
and it's strips
www.aradigm.com/tech/packet.html
Cheers,
William C Biggs, MD
"Bill Beeman" <bbeeman@beemangroup.com>wrote in message

Senkise,
I think you misread the posting.
There were six STUDIES.
Three STUDIES with type 1 patients, and three STUDIES with type 2 patients.
Not three patients.
Actually, the Cochrane paper stated "Six randomised controlled trials were
found and the overall number of participants was 1191.".
"Six trials have been done on giving short-acting insulin by inhalation
instead of injection. Much of the evidence has not yet been published in
full. The results so far suggest that inhaled insulin gives similar levels
of glycated haemoglobin; overall the incidence of hypoglycaemia also appears
similar, but patients prefer inhaled to injected. The quality of evidence is
not great - only two studies appeared to use the same basal insulin in the
inhaled and injected groups. We need longer studies to see if there are any
side-effects in the lung. More insulin has to be given by inhaled than by
injection to achieve the same effect, and the cost-effectiveness remains to
be assessed."
From: www.cochraneconsumer.com
Cheers,
William C Biggs, MD
"Senkise Vagyok" <nemo@umb.u-strasbg.fr>wrote in message
-

Any news story that refers to Type II diabetes as "a milder form" deserves
to be immediately sent to the trash can. "Mild" diabetes is like "mild"
pregnancy. If a journalist can't get that right, then how can you trust
any of the rest of the piece?
"Wilson da Silva" <wfdas@yahoo.com>wrote in message

Griff Griffith wrote:
difference between nearsighted and flat-out blind. Us Type 1's don't
have *any* insulin to work with, at least after the honeymoon phase.
-

In article <8FWXa.1225$Qs2.734@nwrdny03.gnilink.net>,
Nico Kadel-Garcia <nkadel@verizon.net>wrote:
require far more to handle it than plain Type 1's need. At
this time, we do not know that much about insulin resistance.
It is even possible to be both.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
-

Insurance Companies sure see a difference between Type 1 and 2.
They specifically ask the question "Do you have Type 1 - Insulin Dependent
Diabetes" on all applications for life insurance.
There are no questions such as this regarding "Type 2".
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"Nico Kadel-Garcia" <nkadel@verizon.net>wrote in message

On Tue, 05 Aug 2003 22:59:16 GMT, Nico Kadel-Garcia <nkadel@verizon.net>wrote:
nico? i hate to tell you this, but griff is right
and you are wrong
and there's a sizeable subset of the T1s who
have small amounts of endogenous insulin.
biggs is my main source on this, not to mention
that i e-mailed t1 charly coughran on this issue
about 5 years ago and his response was that
he's never seen anything on it one way or the other
bill t1 since '57
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On Tue, 05 Aug 2003 22:59:16 GMT, Nico Kadel-Garcia
<nkadel@verizon.net>wrote:
All types not just type 1 and type 2, are equally bad, as equally
difficult to manage and will all equally kill or cripple the person
living with it.
Mack
Type 1 since 1975
www.alt-support-diabetes.org
www.insulin-pumpers.org
In tribute to the United States of America and the State
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terrorism.
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