Tuesday, January 03, 2006

My take on inhaled insulin

I have seen quite a few posts recently surrounding inhaled insulin. I've posted my ideas about it in a few comments, but now a full fledged post about it will exist in my own blog.

I hate inhalers. I know inhalers. I have asthma. I have three inhalers plus two nebulizer solutions. I need to take them. I don't want to inhale insulin too. I want to pump insulin (I don't pump as of yet).

My concerns:

1. How the heck is it going to be dosed? Dosing insulin is a pain in the butt as it is. I need half units. Dosing asthma inhalers that have been around for years is still far from precise. Everyone I know takes a different dose of Lantus, Humalog, Novalog, etc, but with my one inhaler, Advair, there are three doses, 100/50, 250/50, and 500/50. Granted, you can change the amount of times you take it, but still not much flexibility. As far as another inhaler, albueterol, everyone I know who takes it takes teh same amount, 2 puffs as needed. Asthma inhalers are important, obviously, but there is much more danger in underdosing them than overdosing them. The answer? Asthma inhalers don't need to be precise. You take them, if they don't work, you up the dose, if you have to many side effects, you lower the dose or try a different one. I don't want to call it simple, because it is not, but there is not nearly the need for precision there is with insulin. .5 units of insulin is a big deal for me. I need to know that is how much I am getting, and there needs to be a mechanism to allow the person to control how much they take.

2. Accuracy of technique is another concern of mine. Non-asthmatics may not realize this, but you need to take an inhaler correctly for it to work. I didn't realize this for awhile, but I took my inhaler incorrectly, swallowing much of my dose, for the first few weeks taking it. I kept needing to go back to the doctors office for nebulizer treatments, then buy my own nebulizer. I realized I was swallowing a lot of my dose. No, that does not happen much anymore, but still, it was not fun when it did happen. Also, how much of a dose I get varies a lot on how deep I breath in. Varying doses and insulin = not good.

3. Inhalers aren't small. This is a minor issue, but my purse is full! I have my wallet, keys, meter, pens, check book, insulin, syringe, glucose, granola, and inhaler in there. Believe it or not, a vial of insulin and syringe take up less room than an inhaler, and the insulin inhaler pictures I have seen are bigger than asthma inhalers.

4. Lung damage. Of course this has been mentioned repeatedly, but I already have less than perfect lungs that already have to deal with 3 inhalers, two of them steroid inhalers. I can't imagine my lungs taking one more inhaler. Plus, it doesn't seem like steroids and insulin would mix well.

So in short, insulin inhalers may get a niche later on, but right now, I feel it has too many concerns for me to be even remotely excited by the prospect.

6 comments:

Johnboy said...

Personally, I don't find the needle to be painful and there isn't much of a point for pump users.

Add the reasons you mention, and I won't be in line for this.

Megan said...

Johnboy, same here, same here.

Ellen said...

240 page document prepared by Exubera to the FDA http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_01_01-Pfizer-Exubera.pdf . I have no doubt FDA will approve. Big pharma yields tremendous power in the US.

How small a drop in your airway test would be acceptable to you? Research Probes Efficacy, Safety of Inhaled Insulin -- Simmons 1 (1): 12 -- DOC News ...A "small but clinically insignificant drop" was observed in some of the airways tests, said Anthony Barnett, MD, the lead study investigator for Exubera

Entrez PubMed ....The efficiency of inhaled insulin is lower than that of subcutaneous injection because pulmonary delivery of insulin involves some loss of drug within the inhaler or mouth during inhalation. A concern of many clinicians is the possibility of long-term effects from the intraalveolar deposition of insulin within the lung, since insulin is known to have growth-promoting properties. The long-term safety of these products has not been established.

Entrez PubMed ...In clinical trials of patients with type 1 or 2 diabetes who were treated with Exubera((R)), the only significant clinical adverse effect was cough. This was generally characterized as mild to moderate in severity, decreased over time and was not associated with declines in lung function.

Entrez PubMed ...Completed phase 2 and 3 studies up to 4 years in duration indicate that the differences over time in pulmonary function changes between patients treated with Exubera((R)) and control patients are small, non-progressive, clinically insignificant and reverse after discontinuation of Exubera((R)) therapy

Entrez PubMed ...Among various difficulties of the pulmonary insulin delivery, the finding of an effective promoter, capable of increasing the bioavailability of insulin, is a crucial issue. The cost of such insulin administration might also be a problem. Finally, careful studies concerning the safety of this kind of administration, particularly potential long-term pulmonary toxicity, are mandatory.

Persons with diabetes want to AVOID severe hypoglycemia. This is from an abstract of a recent Skyler article. Entrez PubMed... Inhaled insulin was associated with a lower overall hypoglycemia rate but higher severe hypoglycemia rate. ... Increased insulin antibody serum binding without associated clinical manifestations occurred in the inhaled insulin group. Pulmonary function between the groups was comparable, except for a decline in carbon monoxide-diffusing capacity in the inhaled insulin group without any clinical correlates.


http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_01_01-Pfizer-Exubera.pdf
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_02_00-FDA-TOCTable%20of%20Contents.htm


http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4169S1_00_Slide-Index.htm

Megan said...

Interesting ellen. I think that convinced me even more against it.

skytor said...

I think the long reaserched for inhaled insulin is a big time and money waster, in addition to sidetracking the press (and the public) about the "pains" of diabetes. Why can't they focus on the real pains? Find a cure! Improve the CGMS system. Improve islet transplants. Get a CGMS hooked up to a pump.

Megan said...

I saw an article about the paradigm 715, which will be the guardian hooked up to a pump, but it is not closed loop yet, all the pump does is get the results from the CGMS, not act on them.