Sorry, lots of questions in this post! Thanks for any answers you’re willing to give
I’m hoping to make a few changes at my next Endo appointment on Jan 8. My new insurance covers nearly all types of insulin, and I’m really excited to try out Tresiba. While reading the forum, I realized that lots of people are now using Afrezza. This is also covered under my new insurance for a slightly higher cost.
I’m nervous about trying Afrezza because it’s new and affects a different part of the body than injections. I feel like I read so many conflicting opinions on it’s safety. It’s difficult to determine how much of the concern is only due to how new the drug is and how much is valid. I don’t have asthma now, but I did have it when I was a baby. I “grew” out of it. I’m not sure if that indicates anything about my lung function now, but I will talk to my doctor about it.
It would be so nice to have an ultra-rapid acting insulin to help with post-meal spikes. I’m not trying to spur some big debate on the safety of the drug. I am mostly just asking for you to share your experiences on the following. I’d like to be as prepared as possible for my appointment.
Did your doctor respond positively to your request for Afrezza? If not, what were their concerns? If you still started using Afrezza, how did you convince the doctor that it was a good fit for you?
Have you had any adverse reactions? I prefer to see my endo as little as possible (though she’s a nice enough lady, and I really like how she does prescriptions). If I choose to start using Afrezza, will I need to ask for frequent check-ups to check my lung function?
If you researched Afrezza before starting it, what study convinced you that it would be safe for you?
Given that I’m considering switching/adding two insulins, are there any questions about these insulins that you wish you had asked your doctor before you started using them? Any recommendations on how I should space out the transition if I’m approved for both?
Again, thanks for your insight and any recommendations!
My doctor responded positively to my request to start Afrezza but I first had to take a spirometer test to show Mannkind (the manufacturer) that I had sufficient lung capacity/function. Although I continue to bolus with Humalog from my insulin pump, my endocrinologist can see from my Dexcom records that sometimes I mistime the meal boluses and sometimes have highs that don’t respond well to correction boluses.
I have not had any AEs from taking Afrezza. I capture my heart rate while riding my bike and have not noticed any increased heart rate (suggesting impaired lung function) on days when I’ve had Afrezza before the ride. The only reaction I’ve had is that once I coughed out a good amount of the inhaled powder. It is slightly irritating to your lungs for a few minutes during and after inhalation.
I looked at posts about the clinical studies for Afrezza (e.g., https://camargopharma.com/2014/07/mannkind-breathes-easier-inhaled-insulin-finally-approved/) and know how conservative the FDA is when considering new formulations of drugs. Given the amount of money, time and patient exposure that Mannkind invested in, I’m sure that they did what they had to to show safety. I would suggest Googling “safety of inhaled Afrezza” since a lot of hits come up. Some links are to scientific papers. The blogs at http://afrezzauser.com/blog/ and http://www.afrezzajustbreathe.com/interviews-of-afrezza-users/ are very worthwhile.
I would suggest allowing 3-4 weeks after trying the first before adding on the second but if I was in your position, I’d follow my endocrinologists suggestions. My endo said that I should consider inhaled Afrezza to be half as effective as injected short-acting insulin (i.e, 8U of Afrezza = 4U of Humalog). That’s not what I subsequently found on Medscape (https://reference.medscape.com/drug/afrezza-insulin-inhaled-342711#0):
"Dosage adjustment may be needed when switching from insulin to inhaled insulin
- Up to 4 units SC = 4 units inhaled
- 5-8 units SC = 8 units inhaled
- 9-12 units SC = 12 units inhaled
- 13-16 units SC = 16 units inhaled
- 17-20 units SC = 20 units inhaled
- 21-24 units SC = 24 units inhaled"
Based on my BG response to 8U Afrezza, I’d say that my doctor is closer to having the correct conversion.
When trying any new diabetes meds, I think that it would be imperative to be using a continuous glucose monitor if for no other reason than seeing the time course of Afrezza or Tresiba would require a lot of finger sticks. Good luck and please let us know how they worked for you.
We are not on Afrezza (yet) but have done extensive research on it. My personal conclusion at this time is there appears to be no evidence so far that shows significant safety issues. We have already asked our (pediatric) endo once, to no avail so far.
@mwashburn, very nice post!
I’ve been using afrezza for several years ranging back and forth from using as my sole bolus, to just for corrections, and everywhere in between as my patterns have evolved over time. I have no concerns about it’s safety whatsoever.
A lot of the negativity surrounding it on the internet goes back to the history of it being patented and brought to market by a tiny tiny micro-cap penny-stock company. Hordes of unsophisticated investors piled on with both short and long sales of these shares and then took to the internet to spread both exuberance and terror regarding it.
It is a good medication. It is FDA approved to treat diabetes. It was unanimously recommended for approval by the FDAs expert committee which included some of the top pulmonologists in the world.
The crap you read about it all over the internet is just the result of short sellers planting seeds of fear, uncertainty, and doubt all over the internet about it.
@Sam, @Katers87 had several specific questions in the OP, I think you may have answers for all of them, bioth for Afrezza and Tresiba.
@Katers87, the normal procedure is one basic spirometer test before prescribing, one after 6 months, and one every year afterwards.
Don’t let them prescribe you the very expensive lung function test, the one that is required is cheap and basic.
I’ll respond more when I can get to a real keyboard. The lung function thing is not a real concern… they do it once to make sure you don’t have any major unknown lung disease… the recommendation is that they do it periodically after that but it’s proved to be really a non issue after thousands of patients have been using it for years now and it really hasn’t caused any problems
Thanks for your in-depth answer! It’s good to hear that your doctor responded well. I’m hoping that won’t be a barrier for me. I had no idea that the effectiveness of Afrezza vs Humalog may differ in the way you described. This will definitely be something I’ll have to track when/if I start using it.
I’m glad to hear you had no adverse reactions! Especially considering that you would likely notice since you ride a bike/exercise.
I do use a Dexcom so I have that covered at least! I’ll let you know how things go!
Do you know why would they try to prescribe the expensive test?
It gives them a little more info. To many medical professionals the price does not seem to matter. However, only the basic test (FEV1) is required:
You can actually buy the hardware yourself for about $75 and test it as much as you want:
Just because endocrinologists aren’t in the habit of performing spirometer testing generally so the term they’re familiar with is “lung function test”
It was a dirty politics arm twisting competitor lobbying of the fda that ever led to any such recommendations in the first place. These is no legitimate medical necessity for any of it.
These issues are worth looking at for everyone so they can make the best choice. I think there are legitimate concerns with reduction in pulmonary function. You can look at the clinical studies. I am not saying they are severe, but they have been documented. This is straight from the pharmaceutical company that makes it. I believe it’s in the Afrezza package insert.
(FEV = Forced Expiratory Volume)
Afrezza causes a decline in lung function over time as measured by FEV1. In clinical trials excluding patients with chronic lung disease and lasting up to 2 years, Afrezza treated patients experienced a small but greater FEV1 decline than comparator-treated patients. The FEV1 decline was noted within the first 3 months, and persisted for the entire Afrezza duration of therapy (up to 2 years of observation). In this population, the annual rate of FEV1 decline did not appear to worsen with increased duration of use. The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established. There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1 after discontinuation of Afrezza.
The question of course, is is this data meaningful or significant to the people who actually have the background to understand it meaningfully and in context… I defy you to find a pulmonologist who actually was appropriately tasked with evaluating it instead of just spouted off a random quote which has been pulled completely out of context (which are easy to find) who feels it is problematic or significant… the fda expert committee on pulmonology voted unanimously to approve it. That’s good enough for me.
I think it’s interesting that the expected FEV1 decline over the full 2 years is around .1 (comparator - I think this is the control group), and the FEV1 decline due to Affrezza appears to be about .05 in the first 3 months and then follows in parallel nearly same path as the comparator group. Kinda helps me put the decline in perspective to see it this way. The overall FEV1 decline due to Afrezza is about the decline that you would expect to see in 1 year of your life.
It would’ve been really helpful if they’d measured FEV1 decline in a group that used Afrezza for a year and then discontinued use for a year. I wonder if this group would revert back to comparator levels or if their levels continue to run ~.05 lower. I found some studies back in 2011-2012 that indicated that there is this reversion with Technosphere insulin, but the studies didn’t specify Afrezza specifically. I’m not sure how this insulin differs from Afrezza now.
Thanks for sharing @Sam and @Eric.
I’m not questioning the data, but I would like to know the ages, sexes, and heights of the subjects, since these influence total lung capacity. For instance, after age 35, lung function naturally begins to decline; the decline is nonlinear and can double after about age 70. In the early years of decline, the decline in FEV1 is about 120 mL in a five-year period, not far off the –0.1 L shown in the chart. The question for me as a potential user would be: Is this decline even noticeable, and is the slightly stronger decline seen in the n1 group noticeable? If it is noticeable or affects my activities, then which is the lesser evil: being occasionally short of breath, or radically reducing my incidence of hyperglycemia?
Those are the kind of metrics the actual experts analyzed I’d have to assume when they declared unequivocally that it’s a non issue. I’m not an expert but I can tell you from personal experience that my tendency to get out of breath when exercising has actually appreciably decreased since I started using it—- not that I think that that’s directly related to it, just that I’ve gotten in progressively better shape over the same time frame and it hasn’t been a factor
That’s good news! I’m glad to hear it hasn’t interfered at all in your workout routines/getting in better shape. This is just the kind of information I was hoping to hear
@Gus is an iron-man triathlete and uses the stuff a ton. @DuckFiabetes is an avid long distance bicyclist and does as well.
Sorry I haven’t had chance to respond to your original post more comprehensively but did want to mention the doctors response part. I had been watching afrezza come through development and approval, excitedly, so I approached my doc as soon as it was approved and said I wanted it. He expressed just a slight amount of doubt based on a previous inhaled insulins poor results (exubera) but then wrote the script. I was his first patient on it, he has since prescribed it to many more and seems to think highly of it…
It’s an approved medication for diabetes, you have diabetes… if your doc isn’t familiar with it and you ask for it and they’re not willing to become familiar for your benefit—- they’re not a good doctor. You should have no qualms whatsoever about asking for it, it’s remarkable that people think it’s some kind of sketchy request—— that’s the legacy of all the short selling trolls that swarmed the internet about it…
Top doctors discuss Afrezza for Medscape Here’s a good link I posted a few months ago where you can listen to highly noted endocrinologists discussing it and addressing some of your concerns…
I use Afrezza, too, especially for corrections and extra-carby meals like Thai food. My doctor’s office had samples (all 4-unit cartridges) that were about to expire and I said I’d like to try it. They were happy to have me try them and report back. There’s a bit of a learning curve in terms of getting the hang of how to inhale (without coughing), figuring out how much each dose covers since it doesn’t correspond to the same amount of Humalog, and getting the timing right for your starting BG and carb load. The neat thing is how fast it works and then is out of your system–maybe 1-1.5 hours for me.
Thanks for the link and sharing your experiences. I watched the video, except for the parts about type 2. I particularly enjoyed Dr. Pettus’ excitement and pretty accurate depiction of how a type 1 diabetic might respond to hearing about this drug. I wish they hadn’t glossed over the lung cancer thing, but I think they were trying to focus on the benefits of the drug rather than the lung cancer cases (2 nonsmokers) after the trial that were dismissed as not attributable to Afrezza. It would be nice to know how they came to that conclusion though. I read in another forum that these two individuals may have worked in jobs that were high-risk for lung cancer, but I don’t have an official reference for that. Do you have a resource that you referenced about that?
I’ve decided that I’m not worried about the FEV1 decline based on the experiences of people in the forum, links people provided, and results from studies. Still researching on the cancer thing, but I think that it may just be too new for a study to conclusively state that it doesn’t cause cancer. If I can’t be convinced before my endo appointment, I’ll probably still ask for the lung test/Afrezza prescription anyway. It might be worth the risk even if the risk exists. I’m sure there are lots of cancer risks in my day to day life.