I’ve been researching the pulmonary disease contraindication for Afrezza, and like so much else concerning this drug it’s hard to find anything in depth about it.
I have moderate asthma, and have had a few bronchospasms over the past ten years. When I have an asthma episode it’s easily and well controlled with an albuterol inhaler.
My question is, is the contraindication because Afrezza can induce bronchospasm, or is it because of reduced pulmonary absorption of the drug? My p02 normally runs at 98% or better (except when I have an asthma episode), so I don’t think absorption would be a problem. But acute bronchospasm induction would make Afrezza a non starter for me.
I believe the concern is potential elevated risk of bronchospasm
I’ve never heard any discussion of absorbtion being a primary concern.
You’d really have to talk it over with someone who prescribes it and weigh the pros and cons and potential benefits to determine if it’s an option for you. It’s
Counter indicated for “severe lung disease” I believe… I don’t know if mild asthma meets that criteria, but that’s something you’d have to hash out with the prescriber.
I wouldn’t just go write yourself an rx at Costco for it
I agree with @Sam – this is also what I read: the issue is not with how much absorption you get for the drug, but what it may do to your lungs, I think mostly in terms of the mechanical issues with fine particle inhalation.
My son has a similar concern to you. He used to have asthma, and occasionally has exercise asthma when he is physically stressed (such as being sick with upper respiratory virus). I directly asked his endo about it, who proceeded to tell me right away she would never prescribe it to him until he was much older, then discussed fine particle inhalation consequences as the primary danger.
[EDIT] I would totally be ready for my son to consider it once he is fully grown btw.
Doc, If it were me I would call the company and try and get to one of their clinical people. They still probably won’t know the answer, but might get you info from one of their physician experts. It is a good question, but not sure who would be able to answer at this point. I wouldn’t expect most endo’s to know the answer either.
I am not an expert (obviously) but I couldn’t find any data that shows any proven risks of lung disorders because of using Afrezza. It sounds to me that the FDA was just conservative with the warnings. Below is a compilation I put together for a friend and athlete. You may have read all this, but just in case its useful.
On the 1.5 reduction on pulmonary capacity for Afrezza
Read the fine line: See below -> not clinically meaningful difference
Same thing for the 4 cancer cases in the trials. Ex-smokers 2, and the other 2 badly screened prior to the trials. And non-significant statically anyway.
The key is in how technosphere works. Its passive. More in this thread: http://www.tudiabetes.org/forum/t/wary-of-interested-in-or-using-afrezza-you-should-read-this/23368/35
See the posts from real afrezza users in the link below, all spirometry’s are normal at the 2 year mark for most (link below, including my tweet with screenshots of spirometry’s)
The big issue I think is -> If you don’t know the HUGE benefits of Afrezza for athletes, you can’t really evaluate the ROI. E.g. cyclists could recover exponentially quicker with Afrezza after exercise. Like a non-diabetic. No more wait times to eat the carbs they need. Regardless of the starting BG level. Minimized risks of hypos. No carb counting, just sugar surfing. (e.g. arrived today after an intense 2 hour training + our chat, had 149, puffed 12U, had a big shake with 2 bananas, protein powder, milk and a good spray of honey, one hour later big pasta salad. And it was VERY easy)
References (bold is mine): http://www.afrezzajustbreathe.com/afrezza-pulmonary-safety-studies/
Results: Baseline demographics and pulmonary function were similar between diabetes treatment groups. Lung function declined frombaseline in all groups. TI was non-inferior to usual care for mean change in FEV1from baseline to month 24 [mean (s.e.m.) 0.037 (0.0119) l;95% CI 0.014 to 0.060] using mixed-model repeated-measure with a pre-speci?ed non-inferiority margin of 50 ml/year. After a greater initialdecline at month 3 with TI, rate of change (slope) in FEV1, FVC and DLCO(months 3–24) was not statistically different between treatment groups. TI was well tolerated; no serious safety concerns emerged. The most common respiratory event associated with TI was mild, transient cough, occurring within minutes of inhalation.
Conclusions: Observed changes in lung function with TI were small, occurred early after therapy initiation, remained non-progressive over 2 years and were unlikely to be clinically meaningful.
latest doc forum on Afrezza. About the cancer patients in the trials
Dr. Bode, Reply: "As far as I know, there’s no reported (cases). The ones’ who had lung cancer, there were a total of four, 2 during and 2 afterwards. These people - 2 of them had long standing history of smoking. One person only used it (AFREZZA) a very short time, less than a few weeks. So you know, obviously, so many people think this rate of lung cancer of these 4 cases is so unexpected. They also showed that when they looked at the Chest xRay, 2 out of the 4 had changes on their xRay that was misdiagnosed unfortunately. So there’s no way that inhaled insulin can cause cancer within. You know, 10 weeks, 20 weeks, and this thing (AFREZZA) doesn’t hang out in the lungs. There’s no activity in the lungs.
Also, and key to understand -> TI mechanism is passive and ph based.