|
Post by bill on Dec 16, 2015 9:32:43 GMT -5
I've begun to wonder whether trying to get a superiority designation for Afrezza may be expensive, time-consuming, and perhaps unnecessary. After all, Afrezza is just insulin like many other prandial products. The FDA trials didn't show superiority, thus the non-inferior designation.
In some ways, that's correct. Afrezza by itself isn't superior.
It's different, but different in many important aspects. Let's put aside the inhaled versus injectable differences, but instead focus on the fact that when used optimally, one can avoid blood glucose spikes and run less risk of hypoglycemia--as evidenced by flat-line CGM readings and no hypos. If you dose optimally, you'll probably find that your HbA1c values also decrease. You can even take supplementary doses after meals to suppress blood glucose levels after a large, long-lasting meal without inducing hypoglycemia because Afrezza acts quickly and dissipates quickly. That's another difference.
My thought is that it's all about the optimal dosing and timing that makes Afrezza different, and a great product. My marketing tag line would be something like:
"Afrezza, it's a different way to treat your Diabetes."
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Dec 16, 2015 9:59:25 GMT -5
its all about timing - dosing and onset of action and peaking ..and afrezza is the most closest to way insulin should work. So you started on a wrong base. Go back and do your DD again and come back
|
|
|
Post by bill on Dec 16, 2015 10:03:44 GMT -5
its all about timing - dosing and onset of action and peaking ..and afrezza is the most closest to way insulin should work. So you started on a wrong base. Go back and do your DD again and come back It seems like the first part of your post agreed with me exactly. Therefore, I don't agree I started on some wrong base and need to do my DD again. What point are you making? My point was pretty clear, that in some sense Afrezza is only superior because you can use it in ways that make it more effective. You can also use it in ways that make it less effective.
|
|
|
Post by harryx1 on Dec 16, 2015 10:18:03 GMT -5
I like the tag line however I don't agree on the superiority part. IMO, I don't believe Al spent the last 15+ years and almost a billion dollars because he thought that Afrezza was essentially equal to inject-able RAAs. I think he believes that it's superior to anything currently available on the market today and if you watch the diatribe video honoring him, he specifically states (as he holds up the graph) that "you can't even see a pencil mark between the kinetics of Afrezza and a normal pancreas" - anecdotally of course due to the (unnecessary) FDA restrictions.
|
|
|
Post by esstan2001 on Dec 16, 2015 10:35:46 GMT -5
its all about timing - dosing and onset of action and peaking ..and afrezza is the most closest to way insulin should work. So you started on a wrong base. Go back and do your DD again and come back It seems like the first part of your post agreed with me exactly. Therefore, I don't agree I started on some wrong base and need to do my DD again. What point are you making? My point was pretty clear, that in some sense Afrezza is only superior because you can use it in ways that make it more effective. You can also use it in ways that make it less effective. You can also use it in ways that make it less effective >>>>>>> this argument also applies to injectable insulin. In fact, misuse of injectable is more likely to result in death than the same dose / time to dose misuse of Afrezza. So on balance, IMO one can not claim that they are equally inferior here... safer would lead to superiority IMO... Afrezza's action in the body appears superior too ( again IMO)- it distributes over a much larger area to gain entry to the blood faster, and it dissociates immediately releasing monomeric insulin. The end result best mimics endogenous healthy insulin secretion, so here I believe it is superior to the most rapid injectable too. Today, you get a lot of my opinion. ;-)
|
|
|
Post by bill on Dec 16, 2015 10:38:21 GMT -5
I like the tag line however I don't agree on the superiority part. IMO, I don't believe Al spent the last 15+ years and almost a billion dollars because he thought that Afrezza was essentially equal to inject-able RAAs. I think he believes that it's superior to anything currently available on the market today and if you watch the diatribe video honoring him, he specifically states (as he holds up the graph) that "you can't even see a pencil mark between the kinetics of Afrezza and a normal pancreas" - anecdotally of course due to the (unnecessary) FDA restrictions. Interesting points of view. I certainly don't have a problem with the superior label if/when we can get it. OTOH, I can see where a skeptic could take the view that Afrezza's insulin is not necessarily superior and justify it by saying that the trials didn't show superiority when Afrezza was being compared to insulin aspart. I believe we all agree that you CAN get superior results if you use Afrezza optimally. I suspect we can also agree that you may not get superior results if you don't. What's different (and superior) about Afrezza is that you have the ability to get superior results, i.e., Afrezza by itself isn't superior, it's the fact you can use it in ways that get you superior results. The counterintuitive aspect of Afrezza is that the optimal dosing is something you wouldn't do with injectables, i.e., first dose a few minutes into the meal (versus quite a bit ahead of the meal) and supplementary doses after lengthy heavy meals (versus trying to avoid stacking). Afrezza's optimal dosing profile, if used with injectables would run a high risk of inducing hypoglycemia. That's got to be scary until you try it and see that it really does work. Imagine if Afrezza had been developed before injectable insulin. Would anyone even remotely consider using an injectable insulin that required dosing way before meals while also needing to worry about insulin induced hypoglycemia because of it's lengthy persistence? No one would switch from something you inhale after you start your meal while minimizing hypoglycemia because the insulin closes matches the meal-induced rises in blood sugar. The injectable insulin would never get to market and might not even get approved because it would be perceived as too dangerous.
|
|
|
Post by tommix321 on Dec 16, 2015 10:40:35 GMT -5
I've begun to wonder whether trying to get a superiority designation for Afrezza may be expensive, time-consuming, and perhaps unnecessary. After all, Afrezza is just insulin like many other prandial products. The FDA trials didn't show superiority, thus the non-inferior designation. In some ways, that's correct. Afrezza by itself isn't superior. It's different, but different in many important aspects. Let's put aside the inhaled versus injectable differences, but instead focus on the fact that when used optimally, one can avoid blood glucose spikes and run less risk of hypoglycemia--as evidenced by flat-line CGM readings and no hypos. If you dose optimally, you'll probably find that your HbA1c values also decrease. You can even take supplementary doses after meals to suppress blood glucose levels after a large, long-lasting meal without inducing hypoglycemia because Afrezza acts quickly and dissipates quickly. That's another difference. My thought is that it's all about the optimal dosing and timing that makes Afrezza different, and a great product. My marketing tag line would be something like: "Afrezza, it's a different way to treat your Diabetes." The problem is third party payor reimbursement. Unless you're willing to live with getting reimbursed at lispro levels, you need some sort of trial to demonstrate the drug is worth a higher price.
|
|
|
Post by bill on Dec 16, 2015 10:49:12 GMT -5
I've begun to wonder whether trying to get a superiority designation for Afrezza may be expensive, time-consuming, and perhaps unnecessary. After all, Afrezza is just insulin like many other prandial products. The FDA trials didn't show superiority, thus the non-inferior designation. In some ways, that's correct. Afrezza by itself isn't superior. It's different, but different in many important aspects. Let's put aside the inhaled versus injectable differences, but instead focus on the fact that when used optimally, one can avoid blood glucose spikes and run less risk of hypoglycemia--as evidenced by flat-line CGM readings and no hypos. If you dose optimally, you'll probably find that your HbA1c values also decrease. You can even take supplementary doses after meals to suppress blood glucose levels after a large, long-lasting meal without inducing hypoglycemia because Afrezza acts quickly and dissipates quickly. That's another difference. My thought is that it's all about the optimal dosing and timing that makes Afrezza different, and a great product. My marketing tag line would be something like: "Afrezza, it's a different way to treat your Diabetes." The problem is third party payor reimbursement. Unless you're willing to live with getting reimbursed at lispro levels, you need some sort of trial to demonstrate the drug is worth a higher price. Ahh, exactly right. So based on my reasoning it isn't about Afrezza being superior as much as its going to be something like... What percentage of patients using Afrezza achieve statistically lower HbA1c levels? Of the patients achieving those levels, how many episodes of hypoglycemia did they experience and how severe were they compared to those using insulin lispro? Finally, in the longer term how much did the Afrezza users save in health care expenses associated with PWDs versus the insulin lispro users? If 80% of Afrezza users are able to achieve those lower HbA1c levels without any increase (and possibly a decrease) in hypoglycemia then you have a winner. If only 5% obtain those great results, it's not that much of a winner.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Dec 16, 2015 10:52:51 GMT -5
its all about timing - dosing and onset of action and peaking ..and afrezza is the most closest to way insulin should work. So you started on a wrong base. Go back and do your DD again and come back It seems like the first part of your post agreed with me exactly. Therefore, I don't agree I started on some wrong base and need to do my DD again. What point are you making? My point was pretty clear, that in some sense Afrezza is only superior because you can use it in ways that make it more effective. You can also use it in ways that make it less effective. you can use it in ways that make it more effective. You can also use it in ways that make it less effective.? i dont understand the above statement.. You have to use something in ways its effective. Do you use your headache tablet after you dont have headache and says its not effective? i dont get your point
|
|
|
Post by bill on Dec 16, 2015 11:04:46 GMT -5
It seems like the first part of your post agreed with me exactly. Therefore, I don't agree I started on some wrong base and need to do my DD again. What point are you making? My point was pretty clear, that in some sense Afrezza is only superior because you can use it in ways that make it more effective. You can also use it in ways that make it less effective. you can use it in ways that make it more effective. You can also use it in ways that make it less effective.? i dont understand the above statement.. You have to use something in ways its effective. Do you use your headache tablet after you dont have headache and says its not effective? i dont get your point Just like with the FDA studies, if you take Afrezza before the meal like you do with injectable insulin you're likely to see a greater rise in blood glucose during / after the meal than with injectable insulin because Afrezza will be out of your system too soon. Therefore Afrezza won't work as well as it could. If you have a heavy meal that lasts a long time you'll see a larger rise in blood glucose using Afrezza than injectable insulin unless you take a supplementary dose. If you avoid the supplementary dose because you're afraid of stacking and inducing hypoglycemia then you'll have worse results with Afrezza. If users tend don't grasp how DIFFERENT Afrezza is and try to use it like they did their injectable insulin they won't get superior results, they might even get worse results. Habits of a lifetime are hard to break.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Dec 16, 2015 11:10:06 GMT -5
you can use it in ways that make it more effective. You can also use it in ways that make it less effective.? i dont understand the above statement.. You have to use something in ways its effective. Do you use your headache tablet after you dont have headache and says its not effective? i dont get your point Just like with the FDA studies, if you take Afrezza before the meal like you do with injectable insulin you're likely to see a greater rise in blood glucose during / after the meal than with injectable insulin because Afrezza will be out of your system too soon. Therefore Afrezza won't work as well as it could. If you have a heavy meal that lasts a long time you'll see a larger rise in blood glucose using Afrezza than injectable insulin unless you take a supplementary dose. If you avoid the supplementary dose because you're afraid of stacking and inducing hypoglycemia then you'll have worse results with Afrezza. If users tend don't grasp how DIFFERENT Afrezza is and try to use it like they did their injectable insulin they won't get superior results, they might even get worse results. Habits of a lifetime are hard to break. and your point? you are beating a dead horse...and has been discussed over and over and over and over again why dont you write the other way? use injectable insulin the same way you can use afrezza and stacking and starting at the time of meal or into 10 minutes into the meal
|
|
|
Post by bill on Dec 16, 2015 11:16:35 GMT -5
Just like with the FDA studies, if you take Afrezza before the meal like you do with injectable insulin you're likely to see a greater rise in blood glucose during / after the meal than with injectable insulin because Afrezza will be out of your system too soon. Therefore Afrezza won't work as well as it could. If you have a heavy meal that lasts a long time you'll see a larger rise in blood glucose using Afrezza than injectable insulin unless you take a supplementary dose. If you avoid the supplementary dose because you're afraid of stacking and inducing hypoglycemia then you'll have worse results with Afrezza. If users tend don't grasp how DIFFERENT Afrezza is and try to use it like they did their injectable insulin they won't get superior results, they might even get worse results. Habits of a lifetime are hard to break. and your point? you are beating a dead horse...and has been discussed over and over and over and over again why dont you write the other way? use injectable insulin the same way you can use afrezza and stacking and starting at the time of meal or into 10 minutes into the meal If PWDs used injectable insulin the way you describe many would incur hypoglycemia and a few would probably die. I think our dead horse has been beaten enough... I stand by my post; Afrezza's differences are significant enough that they can be used create a successful marketing campaign even without a superiority label.
|
|
|
Post by mssciguy on Dec 16, 2015 11:20:27 GMT -5
Superior to all fast acting insulins. The only ultra fast acting insulin. Few or no hypos.
I'd call it different AND superior.
Of course, not superior to a healthy pancreas but... in many cases your pancreas health increases with Afrezza use (in early diabetes).
I'd call it different AND superior.
|
|
|
Post by harryx1 on Dec 16, 2015 11:22:03 GMT -5
Here's my take: Afrezza IS different and IS superior to anything out there when used the correct way it was meant to be used. Lower A1c's, lower FBG, better overall labs, person feels better overall, potential to drop other meds being used, etc. We've seen all of these things happen more than once. JMHO.
|
|
|
Post by dudley on Dec 16, 2015 13:06:30 GMT -5
Simply absurd. By any standard you can mention Afrezza is superior. Ease of use - superior vs. injectable. Time to peak - superior to injectable. Time out of system - superior to injectable. Hypo incidence avoidance - superior to injectable. HbA1c reduction - superior to injectable. ALL THESE are being demonstrated every day in the real world experiences of users who previously NEVER experienced this sort of performance with the existing RAA regimens. This is a very focused and diligent base of users who tried the best they could with the older regimen and simply got by, with all the misery that goes with that. Afrezza has freed them in so many ways, massive quality of life improvements across the board. To say it is not superior is just refusal to see what is really happening.
|
|