Afrezza Review: Diabetics Confirm its Advantages

Afrezza is a new super-rapid inhalable meal-time insulin that has been available since early 2015. So far, the’ experiences of Afrezza users (Type 1 and Type 2 diabetics) have confirmed that Afrezza has many advantages (over rapid-acting analog insulin (RAAs)).  Here are some of these advantages (for discussion of the side effects of Afrezza, please refer to this article: Afrezza: Side Effect):

1.      Better A1Cs

Look at Gustavo Basualdo’s result before and after Afrezza: —from 6.5 to 5.4 in 90 days.

In the Type 1 Afrezza Users “Real Life” Results Group as reported by Sam Finta, Sam made this comment: ““all nine of us have achieved lifetime best A1C with much less effort and a tremendously higher quality of life than we ever have before. And every single one of us have posted our official lab reports from our doctors’ offices to be fully transparent in all our results for whoever may be looking at this–doctor’s, diabetes educators, etc. Funny thing is we are all so different. We live in different parts of the country, we’re different ages, professions, backgrounds, and we all had varying starting A1C’s (from 10.2 to 6.5) before beginning Afrezza. Yet, within 3 months’ time, ALL OF US have achieved a “Lifetime Best” A1C on Afrezza!””

http://afrezzauser.com/week-17-afrezza-produces-non-diabetic-a1c/

For more updated A1Cs of Afrezza users, please refer to this article: A1Cs of Afrezza Users.

2.    More time in the zone

Look at Brian Sharp’s BG level over one week. He was able to stay between 60-150 on his blood sugars for 100% of the time. He had ZERO severe or moderate lows and finished the week with an average blood sugar number of 99.

Here is what Howard says regarding this: “”111 Avg BS this wk.=5.49 A1C. Week after week in the same area. Over last 90 days I am 80% 70-130 and 94% 70-160 from 25000 plus readings.””

https://twitter.com/Afrezzaguy/status/626179019994607617

Here is what Gustavo says regarding this: “Great July BGs. And so far my life is as closest to a non-diabetic as it has ever been in 20+yrs of #t1d. #Afrezza”.

Here is what Amy Tenderich says regarding time in the zone:

““Simply put, Afrezza is helping me spend more time in range. My CGM screen now rarely shows the little dotted line going outside the borders of yellow for too-high and red for too-low. I’ve had whole days that remained in the white zone. And I’ve managed to do both a spin class and aerobics class starting at a “normal” blood sugar (100-ish) and ending there as well!””

http://www.healthline.com/diabetesmine/amazing-afrezza-non-invasive-insulin-works#2

3.    Peak action in 15 minutes (Fast acting in correcting BG highs)

With Afrezza, maximum concentration in blood reached within 12 to 15 minutes.

https://www.afrezzapro.com/afrezza-action-profile

Afrezza PK

This means Afrezza is superfast in correcting high BGs. Here is what Laura Kronen says regarding this: “Afrezza brought down a high blood sugar from 329 to 140 in 45 minutes. That would have taken me 3+ hours on [RAA] insulin.”

https://twitter.com/beyouonlybetter/status/619649688661291008

Think about it, if you are having a high blood sugar of 329, would you prefer it to come down in 45 minutes or 3+ hours?

Similarly, here is what Adam says regarding this: ” “#Afrezza drops my blood sugar 300>129 in an hour! no crash!””

https://twitter.com/AdamLasher/status/626531886873980928

Here is an Afrezza user in Tudiabetes.org commenting on this:  “For me, the biggest benefit is how quickly it works. An example – my pump came off during a very very hot and humid day weeks ago while I was running a baseball tryout for my son. I didn’t realize till the end of tryout and by that time I was already over 300. I inhaled 8u Afrezza cartridge and I was in the low 100’s in 40 minutes. Also, the ability to control spikes is a tremendous benefit for me. I see it going over 130 and I know now I can pretty much stop the spike in a very swift way and be back in range.”

http://www.tudiabetes.org/forum/t/i-started-on-afrezza-last-night/23316/270

4.    Action finished in 90 minutes (No worry about IOB or insulin stacking)

With Afrezza, maximum concentration in blood reached within 12 to 15 minutes and declined to baseline by approximately 180 minutes (see chart above).

https://www.afrezzapro.com/afrezza-action-profile

Because of Afrezza’s distinctive fast-in and fast-out pharmacokinetics, one needs not worry about insulin on board or stacking of insulin. Here is what Gustavo Basualdo says regarding this: ““as with any fast acting insulin, exercise has a big impact. If I have a BG of 150, I’ll take 4 units, wait 15 minutes and do a 100 jumping jacks. My BG will drop like a rock, but Afrezza stops working so fast, by the time it gets around 100 or so it will be done and level out.””

http://afrezzauser.com/afrezza-journey/

““Had a post lunch spike. Is my afternoon bike session ruined due to post correcting insulin pooling? Not with #afrezza.”

https://twitter.com/guasaman/status/598227752383164416

Here is what Brian Sharp says regarding this:  ““I am also an avid scuba diver and underwater photographer. With Afrezza, I don’t have to dive with high BG levels or be in fear of crashing. I don’t need to take Afrezza three hours prior to a dive to assure that it’s all gone from my system before I get in the water. I am an experienced deep water diver, cold water, high-altitude, cave diver, wrecks, and night dives. Getting low on any of those types of dives could be fatal and endanger others, so control is paramount.””

http://www.healthline.com/diabetesmine/how-afrezza-changing-life-type-1-diabetic-pilot#3

5.    Less hypos

Study indicates that Afrezza causes less hypos than RAAs do. In the phase III trial (Trial 171), the Afrezza arm has 30% less hypos and 43% less severe hypos.

http://www.medscape.org/viewarticle/845829?src=sttwit

The experience of early adopters of Afrezza confirms this. Here is what Howard says regarding this: “”Still zero severe hypos which is a huge stress relief. Huge spikes in the 200s are a thing of the past. I will never see a 300 again.””

https://twitter.com/Afrezzaguy/status/616699345899945985

Here are what Ana Ortiz and Bill Kinder say regarding this:

“”ALEX: Have you seen any effects of Afrezza on hypoglycemia?

BILL (T2): I set a good lower limit of 70 mg/dl on my CGM and I’ve never had any hypoglycemic issues. I’m lower than I used to be and that’s a good thing, but it’s a little different because I’m used to having higher blood sugar.

ANA (T1): It’s definitely helped with the hyperglycemia. Sometimes I’ll have low blood sugars with Afrezza, but it’s not as extreme – it’s not in the 50’s [mg/dl] anymore. With Afrezza, the lowest I’ve seen is 68 mg/dl or somewhere in the 70s, and it’s not as frequent.””

http://diatribe.org/inhaled-insulin-afrezza-real-deal#sthash.vkBZ1tmL.dpuf

6.    Precise dosing not required (and no carb counting)

Here is what Amy Tenderich says on this issue:  “”In this 2009 interview I did with Al Mann (http://www.healthline.com/diabetesmine/the-truth-about-afresa-inhalable-insulin-a-chat-with-al-mann#2), Al Mann explained that Afrezza essentially “turns off glucogenesis” so no glucose is secreted from the liver in reaction to food. For that reason, people with type 2 can use a set dose of Afrezza for meals and run essentially zero risk of lows no matter what the meal size, whereas type 1s “will still have the issue (of lows) if they dose and don’t eat anything… and if they eat a large meal, they’ll need a larger dose.”

“The advantage for all patients is that they won’t have to do carb counting or anything, because Afrezza does not have to be so precisely matched to food intake,” he adds.

This, my friends, has proven 100% true for me, and it’s a HUGE life improvement to be relieved of all that math (and S.W.A.G. guessing).””

http://www.healthline.com/diabetesmine/amazing-afrezza-non-invasive-insulin-works#2

Here is what Brian Sharp says regarding this: “”I don’t count carbs…. I don’t fixate much of my day controlling my diabetes.””

http://afrezzauser.com/afrezza-delivers-low-a1c/

Here is what Jackie says this: “”Larger meals, I take an 8u, smaller meals I take a 4u. Its that easy. Every now and then a follow up dose.””

http://afrezzauser.com/afrezza-journey/

7.    Spontaneousness (meaning one can enjoy more varieties of food (and in general, life))

Because of the fast-in and fast-out and less hypo prone features of Afrezza, Afrezza has enable PWDs to eat more spontaneously and enjoy greater varieties of food.

Here is what Gustavo says regarding this: “”First impromptu frozen yogurt ever. EVER.””

Here is what Gustavo says in another tweet regarding this: “”I can eat fruit now! Do you know how wonderful a fresh watermelon tastes after an intense run on a hot day?””

Here is what an Afrezza user on Tudiabetes.org says regarding this: “”Got my first A1C since using afrezza as my primary bolus insulin— 5.3. I’ll take it. …. My previous a1c was 5.2, so essentially no change with afrezza… But I tried about 10% as hard and very much expanded the types of foods I was willing to eat.””

http://www.tudiabetes.org/forum/t/i-started-on-afrezza-last-night/23316/239

He gives more information on his experience in another post: “With afrezza I eat what I want, when I want (within reason) then I take either a “large dose” or a “small dose” 20 minutes later… Just that ability to be spontaneous is a big improvement in quality of life.”

http://www.tudiabetes.org/forum/t/i-started-on-afrezza-last-night/23316/267

8.    Reduce risks for complications

High sugar level can lead to many undesirable complications. Blood sugar control during pregnancy may even affect children later on. Study show that, among offspring of women with type 1 diabetes, there exist a consistent negative association between maternal HbA1c in pregnancy and primary school grades.

http://care.diabetesjournals.org/content/38/7/1238.abstract

Now there’s fresh evidence that unchecked blood sugar can affect the brain as well, which may lead to drops in cognitive functions.  A new study published in the journal Neurology reports that changes in blood vessel activity in the brains of diabetics may lead to drops in cognitive functions and their ability to perform daily activities.

http://time.com/3948705/diabetes-harms-the-brain/

On the other hand, per the DCCT (The Diabetes Control and Complications Trial) study and the EDIC (The Epidemiology of Diabetes Interventions and Complications) study, intensive blood glucose control significantly reduces risk of many complications.

DCCT Study Findings

Intensive blood glucose control reduces risk of

                eye disease 76% reduced risk

                kidney disease 50% reduced risk

                nerve disease 60% reduced risk

EDIC Study Findings

Intensive blood glucose control reduces risk of

                any cardiovascular disease event 42% reduced risk

                nonfatal heart attack, stroke, or death from cardiovascular causes 57% reduced risk

http://diabetes.niddk.nih.gov/dm/pubs/control/

Interestingly, here is what Jackie says regarding this: “”Just got back from my Ophthalmologist who has been treating me for early stages of diabetic retinopathy. I have had several laser surgeries there to repair leaky blood vessels in my retina. Scary. Very scary. Today’s visit was quite different I had the full dye test today and the doctor was amazed at how great my eyes looked. No more laser surgeries for me! I am the first patient he knew taking Afrezza and was so excited to hear of my A1C drop to 6.7 and my very realistic goal to get to the mid-5s by year end.  He was sad however that I wouldn’t need to come and see him anymore. Who knows, maybe we can go out for a beer sometime.””

http://afrezzauser.com/afrezza-delivers-results-week-18/

9.    Improve quality of life

Because of the fast-in and fast-out and less hypo prone features of Afrezza, Afrezza has made management of one’s blood sugar level much easier.

Here is what an Afrezza user on Tudiabetes.org says on this: “”Got my first A1C since using afrezza as my primary bolus insulin— 5.3. I’ll take it. …. My previous a1c was 5.2, so essentially no change with afrezza… But I tried about 10% as hard and very much expanded the types of foods I was willing to eat.””

http://www.tudiabetes.org/forum/t/i-started-on-afrezza-last-night/23316/239

He gives more information on his experience in another post: “For injected bolus insulin to work well you have to take it advance before eating, and you have to get the dose almost exactly right, which is very difficult to do. you also need to be able to anticipate your physical activity level for the next few hours…. It just ends up that a huge amount of your day ends up devoted to or worrying about the insulin you’ve injected— hoping it was enough, hoping not too much, adding a little more insulin or eating a little more in a never ending juggling contest.

With afrezza I eat what I want, when I want (within reason) then I take either a “large dose” or a “small dose” 20 minutes later… Just that ability to be spontaneous is a big improvement in quality of life. I don’t spend the next 3 hours worrying about it either…. Because food digests more slowly than afrezza peaks, the users sugar levels have a tendancy to rise as the afrezza wears off, which is sometimes considered afrezzas shortcoming, but it’s also the reason why it’s safer and much harder to produce a significant hypo. Overall it’s just a lot easier and I am able to devote much less time and energy to the whole thing than with injected insulin alone.”

http://www.tudiabetes.org/forum/t/i-started-on-afrezza-last-night/23316/267

Here is what Amy Tenderich says on this: “”This, my friends, has proven 100% true for me, and it’s a HUGE life improvement to be relieved of all that math (and S.W.A.G. guessing).””

http://www.healthline.com/diabetesmine/amazing-afrezza-non-invasive-insulin-works#2

Here is what Laura Kronen says on this: “”Checking my blood sugar is getting boring now. It’s always perfect on #Afrezza. I feel like I just won a 22 year long race with #diabetes.””

https://twitter.com/beyouonlybetter/status/623262429330440192

10. Reduce burden of family members

Afrezza not only helps relieve the burden of PWDs, but also their family members.

Here is what Gustavo says on this: “”Before, my family had to follow my crazy diabetes agenda. Now we can all just go with the flow.  Thank you #afrezza”.”

https://twitter.com/guasaman/status/596926151714451456

Here is that Sam’s son wrote on this in his appeal to the FDA Advisory Committee:

“”Before Afrezza, diabetes was a frequent issue in our lives. Whether it was worrying about his safety when I am not with him, or making sure he has some source of sugar when we go somewhere in case of emergencies, it was a commonly spoken about topic. My dad used to, what I call, “freak out” sometimes. This is when his blood sugar runs too low and he begins to act unnatural due to his need for sugar. This was very scary for me and it happened a good amount of time when he was not on Afrezza.

During my dad’s time using Afrezza, everything changed. Diabetes was no longer a nuisance, it was not talked about at home, and it was almost as if his case of diabetes had disappeared from my life. I did not worry about him when I was not with him. It was a relief and neither of us felt stressed out any more about his case of diabetes. Not to mention the way you inhale insulin made my dad happier because he did not have to give himself shots every day. We also no longer had to calculate beforehand how long before his insulin would kick in so what he should eat before insulin and after and how much to take. From what I understand, Afrezza acts much quicker than normal insulin and this was very noticeable throughout watching my dad on this trial.

Now that my dad is back to normal insulin, all the previous problems are frequent issues in our lives again. I hope that my dad will be able to take Afrezza again as it makes our lives less stressful and I do not have to worry about him as much.””

http://afrezzauser.com/fda-testimony/

11.  Device the size of a whistle – discreet and easy to carry around

Afrezza (the device) is the size of whistle and very discreet and easy to carry out.

Here is what Sam says on this: “”You will see there are lots of travel advantages with Afrezza–you can use it discretely on an airplane, and not have to fly with high blood sugars and go to the bathroom every 30 minutes. And how about not freaking out the person sitting next to you if you pulled out an injectable? Traveling is a breeze with Afrezza.””

http://afrezzauser.com/afrezza-journey/

Here is what Bill says on this: ““I’’ve found the inhaler to be extremely discreet, small, and well functioning.””

http://diatribe.org/inhaled-insulin-afrezza-real-deal#sthash.rbk98r8p.dpuf

Here is what Howard says on this:  “I eat out at least once a day and not once has anyone ever taken notice of me dosing w #Afrezza and I don’t try to even hide it.”

12.  No needles – inhaled

Afrezza is inhaled insulin and therefore, no needles. Imagine how many shots a PWD can save over a life time by using Afrezza over RAAs.

Here is what an Afrezza user on tudiabetes.org says on this: “”I have been a Type 1 diabetic for 58 years. After 52 years of thousands of injections, I became needle-phobic. The OUCH you think is minor to you is not minor to millions of others. ….Spent 5 1/2 years in a research study trial using AFREZZA inhaled insulin. I have not had to take an insulin injection during those 5 1/2 years. Believe me, I know that is not a cure. But for now it is the best out there for those of us struggling physically and emotionally with injections.””

http://www.tudiabetes.org/forum/t/insulin-independence-revolutionary-phase-3-trial-giving-type-1-diabetics-the-promise-of-a-needle-free-life/46721/15

13.  Help lose weight

Study indicates that Afrezza helps to control weight. In the phase III trial (Trial 171), the Afrezza arm patients have a slight drop of weight whereas the RAA arm patients have a slight weight gain.

http://www.medscape.org/viewarticle/845829?src=sttwit

The experience of early adopters of Afrezza confirms this.

Here is Brian Sharp’s comment on this: ““I lost 10 pounds since I started using #Afrezza I feel great! I’m In great shape! I can eat whatever I want when I want! Afrezza is awesome!”

https://twitter.com/BSharp6669/status/596372209771290625

Here is a comment by an Afrezza user from tudiabetes.org.com on this: “”Been using Afrezza for 90 days, just got my A1C and it was reduced from 7.0 to 6.4. My GP was thrilled and so was I. I also lost 10 lbs during the time I have been taking it. I am a Type 2 and my only medication prior to Afrezza was Metformin. I am happy to report no side effects. I use both the 8 unit and 4 unit cartridges. I am a senior so loosing the 10 lbs plus the ease of use and ability to take it at the table makes this drug a winner for me.

http://www.tudiabetes.org/forum/t/i-started-on-afrezza-last-night/23316/271

Here is a comment by an Afrezza user from diabetesdaily.com on this: “”I have another thread which I need to update regarding my experience with Afrezza but I’m happy to report that my a1c dropped after 7 weeks on Afrezza from 6.5 to 6.2. Now on 6th day in a row where my FBG is under 130. When I get time, I will update the other thread with more details. Oh and I lost 11 lbs.””

http://www.diabetesdaily.com/forum/multiple-daily-injections-mdi/82173-afrezza-20

14.  Pump-fee freedom

Afrezza makes it easier to get a pump free life for PWDs.

Here is what Howard says on this: “Almost 2 months of being pump free?I hve not wished it back once[.] the freedom is awesome+I don’t look like I took a shotgun blast to stomach.”

Here is what Gustavo says on this: ““3rd day pump free! Finally stabilizing. Turns out #afrezza+glargine=easier basal control than pump for me #incredible”.”

https://twitter.com/guasaman/status/598715300503126016

15.  Reduce insulin resistance

Afrezza may enable diabetics to reduce insulin resistance and reduce the need of basal insulin (or in some instances, cut the use of basal insulin entirely).

Here is what Sam says on this: “My built up insulin resistance has been reversed! It took 2 weeks of being on 40 days now! Doc appointment confirmed yesterday.”

Dr. Bruce Bode explains it this way: “Glucose and lipotoxicity occurs regardless of the type of diabetes; glucose does not know if the patient is type 1 or type 2. High Glucose and High FFA and other factors impair insulin action as well as insulin release.

We see this phenomena all the time in new onset type 1 diabetes; They go into a honeymoon upon treatment of insulin due to breaking both glucose and lipo toxicity. This may last months or longer.

Sam’s A1c was above 10% with marked variability with now a mean glucose of 95 mg/dl with a SD <35; Amazing; his C-peptide was < 0.3 checked last month. Afrezza is the real deal for individuals like Sam who failed on MDI and are motivated to improve their control. Afrezza allows him to be aggressive with pre meal insulin with low risk of hypoglycemia.”

http://afrezzauser.com/afrezza-confirmed-by-doctor-as-real-deal/

Here is an Afrezza user on tudiabetes.org says: ““I have been a Type 1 diabetic for 58 years. After 52 years of thousands of injections, I became needle-phobic. The OUCH you think is minor to you is not minor to millions of others. ….Spent 5 1/2 years in a research study trial using AFREZZA inhaled insulin. I have not had to take an insulin injection during those 5 1/2 years. Believe me, I know that is not a cure. But for now it is the best out there for those of us struggling physically and emotionally with injections.””

www.tudiabetes.org/forum/t/insulin-independence-revolutionary-phase-3-trial-giving-type-1-diabetics-the-promise-of-a-needle-free-life/46721/15

She gives more information on her experience in another post: “When I first joined the MannKind trial, I was injecting Lantus in the morning at breakfast and inhaling Exubera with each meal. Before Exubera had been taken off the market, I had stockpiled quite a large supply. It could be stored on a shelf at room temperature, no refrigeration was needed.

In the beginning, I still took my Lantus at breakfast and then began using the Technosphere {Afrezza as it is now called} with each meal. My BG levels began to drop. My doctor kept lowering the Lantus until he suggested I drop the injections completely. It took me a couple of days to work up my courage, but the idea of not taking ANY shots was worth it. It worked for a few weeks, and then my BG levels started to rise. Terribly disappointed, I went back on the morning Lantus shots and inhaling at each meal. Shortly, my BG levels dropped again, and my doctor took me off injections again. From then on, NO SHOTS!!! No one can explain it — it just is!””

mnkd.proboards.com/thread/2135/recent-tudiabetes-diabetics-poll#ixzz3hDZioOee

16.  Flexibility (in change routine with no impact on blood sugar)

Here is what Gustavo says on this subject: “”This might be hard for non #T1Ds to grasp, but being able to change my routine with no extra effort or impact in BGs is huge. HUGE #afrezza”.”

https://twitter.com/guasaman/status/626058169110781952

Conclusion

Peter Thiel, in his book “Zero to One: Notes on Startups, or How to Build the Future”, describes companies that create a monopoly on a market (like Google to search engine and Apple to tablet market).  The book describes some companies win market share via a “Creative Monopoly” (i.e., you create a new product that is at least 10 times better than the existing completing product and therefore creates a dominant market position). For example, it can be argued IPAD is at least 10 times better than the other existing tablets (there were some attempts at that time) and that Google’s search engine and Apple’s iPhone were similarly at least 10 times better than the other existing products.

This is what Peter Thiel called “Creative Monopoly” and “Zero to One” (you create something totally new or vastly better) phenomena.

Looking at Afrezza from that angle and thinking about the advantages of Afrezza that Al Mann has envisioned, and Sam and other earlier adopters of Afrezza have experienced, including, among other things, the following:

  •          Better A1Cs
  •          More time-in-zone
  •          Peak action in 15 minutes (fast acting in        correcting BG highs)
  •          Action finished in 90 minutes (no worry about IOB or insulin stacking)
  •          Less hypos
  •          Precise dosing not required (and no carb counting)
  •          Spontaneousness (meaning one can enjoy more varieties of food (and in general, life))
  •          Reduce Risks for Complications
  •          Improve quality of life
  •          Reduce burden of family members
  •          Device the size of a whistle – discreet and easy to carry around
  •          No needles – inhaled
  •          Help lose weight
  •          Pump-free freedom
  •          Reduce insulin resistance
  •          Flexibility (in change routine with no impact on blood sugar)
  •          Other advantages (no smell, no taste; it’s real human insulin – not an modified analogue; likely lead to better compliance)

A strong argument can be made that Afrezza is at least 10 times better (to other RAAs) and therefore is comparable to iPhone (to other early smart phones) and IPAD (to other early tablets) and therefore a “zero to one” product and that Mannkind is in the early stage of dominating the prandial insulin market through a “creative monopoly”.

Disclaimer: This article is a compilation of comments and observations made by some early adopters of Afrezza as publicized in the social media. It is not intended to provide any medical advice. For any medical advice, please consult your doctor.

 

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