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Post by uvula on Jun 20, 2018 18:42:52 GMT -5
Also afrezza is always used with a basal insulin. Could some hypos of afrezza patients be due to the basal?
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Post by goyocafe on Jun 20, 2018 18:50:53 GMT -5
Pep, my point is we hear a lot on this board about Afrezza virtually eliminating hypoglycemic events, forgetting about the comparison with any other drug or treatment, I would have thought they number would have been lower. Now, if in this particular trial the foregoing statement of virtually eliminating hypoglycemic events is not applicable, fine. Or if it's due to noncompliance with treatment protocol, fine again. But I thought that if you use Afrezza as directed (or as intended by MannKind), you would get a far smaller percentage of hypoglycemic events. I would be happy for someone to set me straight on this. so this is the old data. Saturday we get to see what the cgm's show, per STAT. Wasn’t the Affinity trial also constrained by FDA dosing restrictions and dose timing? I recall talk of the early dosing being a cause for more hypos with Afrezza than would have been if they had been allowed to dose closer to actual food consumption. But that information could be related to a different study.
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Post by sayhey24 on Jun 20, 2018 19:07:48 GMT -5
HALF (rounding) the number of severe hypoglycemic events per subject.
AFFINITY-1, a treat-to-target study in T1D on multiple daily injection therapy, demonstrated one such ultra-short acting insulin, TI (Afrezza®), was non-inferior to SC aspart in A1C reduction (Bode et al, Diabetes Care 2015). Consistent with its action profile, a lower rate of HG was observed in TI users overall, particularly in the 2-5 h post-meal interval and in those achieving target A1C<7%. Pep, my point is we hear a lot on this board about Afrezza virtually eliminating hypoglycemic events, forgetting about the comparison with any other drug or treatment, I would have thought they number would have been lower. Now, if in this particular trial the foregoing statement of virtually eliminating hypoglycemic events is not applicable, fine. Or if it's due to noncompliance with treatment protocol, fine again. But I thought that if you use Afrezza as directed (or as intended by MannKind), you would get a far smaller percentage of hypoglycemic events. I would be happy for someone to set me straight on this. BBR - What you are saying is true for the PWD not using another medication especially basal insulin or a TZD. The key to afrezza is mimicking first phase release and putting the liver back in sync with the pancreas. The basal some what prevents this.
In many of Al Mann's presentations he made the distinction between the T2 taking it care-free and the T1 who would not have to do the complex titrating but they would still need to use care. In the 175 T2 study the hypos were tracked to PWDs using TZDs in addition to afrezza.
Remember, back in the day few thought afrezza would initially be approved for T1 use. The ADCOM vote shocked most.
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Post by jkendra on Jun 20, 2018 19:26:44 GMT -5
HALF (rounding) the number of severe hypoglycemic events per subject.
AFFINITY-1, a treat-to-target study in T1D on multiple daily injection therapy, demonstrated one such ultra-short acting insulin, TI (Afrezza®), was non-inferior to SC aspart in A1C reduction (Bode et al, Diabetes Care 2015). Consistent with its action profile, a lower rate of HG was observed in TI users overall, particularly in the 2-5 h post-meal interval and in those achieving target A1C<7%. Pep, my point is we hear a lot on this board about Afrezza virtually eliminating hypoglycemic events, forgetting about the comparison with any other drug or treatment, I would have thought they number would have been lower. Now, if in this particular trial the foregoing statement of virtually eliminating hypoglycemic events is not applicable, fine. Or if it's due to noncompliance with treatment protocol, fine again. But I thought that if you use Afrezza as directed (or as intended by MannKind), you would get a far smaller percentage of hypoglycemic events. I would be happy for someone to set me straight on this. Maybe DBC can explain
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Post by sayhey24 on Jun 20, 2018 19:50:50 GMT -5
I would have thought the score would have been more lopsided in our favor. Have I been dreaming too much? You took the words out of my mouth. The first thing which hits me is a 33% decrease in severe hypos. This by itself is HUGE. They had nearly 20 fewer severe hypo events. One event can kill you but from an insurance perspective each fewer event is HUGE ER savings.
The second thing which stood out was the significantly tighter range the compliant TI users had. With these people who can keep the tight range you can increase basal and lower the baseline which at 4hrs based on the graph is about 160mg/dl. Take that down to 140 mg/dl and this groups would still not be going below 70 mg/dl. This would take you from an RAA A1c of about 8.0 to an afrezza 6.7 which is also HUGE.
All said this study obsoletes RAA's as long as the patient is compliant. The best way to keep the PWD compliant is cloud monitoring and pay for performance with insurance incentives. I wonder if Warren Buffet ever thought of that?
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ADA
Jun 20, 2018 20:00:04 GMT -5
Post by agedhippie on Jun 20, 2018 20:00:04 GMT -5
In STAT study, can they divide the standard treatment group into compliant and non-compliant groups and compare head-to-head with TI? There will always be a non-compliant group, either in TI or standard treatment. When the results from the non-compliant group are removed, the effects usually get better. Some might skip planned/required daily injections then time in range (TIR) would be low as in TI non-compliant. If you merge the compliant and non-compliant TI users in STAT it looks to me like there would be no difference between the Afrezza and non-Afrezza users with the exception of the 1hr post-prandial. I would like to have seen the TIR grapg for the non-Afrezza users but I guess we are going to have to wait for the talk for the full data.
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ADA
Jun 20, 2018 20:19:38 GMT -5
Post by johnhindepost on Jun 20, 2018 20:19:38 GMT -5
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ADA
Jun 20, 2018 20:47:46 GMT -5
Post by goyocafe on Jun 20, 2018 20:47:46 GMT -5
In STAT study, can they divide the standard treatment group into compliant and non-compliant groups and compare head-to-head with TI? There will always be a non-compliant group, either in TI or standard treatment. When the results from the non-compliant group are removed, the effects usually get better. Some might skip planned/required daily injections then time in range (TIR) would be low as in TI non-compliant. If you merge the compliant and non-compliant TI users in STAT it looks to me like there would be no difference between the Afrezza and non-Afrezza users with the exception of the 1hr post-prandial. I would like to have seen the TIR grapg for the non-Afrezza users but I guess we are going to have to wait for the talk for the full data. So the STAT data is out?
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Post by mnkdfann on Jun 20, 2018 21:04:18 GMT -5
If you merge the compliant and non-compliant TI users in STAT it looks to me like there would be no difference between the Afrezza and non-Afrezza users with the exception of the 1hr post-prandial. I would like to have seen the TIR grapg for the non-Afrezza users but I guess we are going to have to wait for the talk for the full data. So the STAT data is out? The summary data in the poster presentation, but not the data presumably used in the oral presentation. At least, that's how I read it.
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Post by MnkdWASmyRtrmntPlan on Jun 20, 2018 21:35:54 GMT -5
You took the words out of my mouth. The first thing which hits me is a 33% decrease in severe hypos. This by itself is HUGE. They had nearly 20 fewer severe hypo events. One event can kill you but from an insurance perspective each fewer event is HUGE ER savings.
The second thing which stood out was the significantly tighter range the compliant TI users had. With these people who can keep the tight range you can increase basal and lower the baseline which at 4hrs based on the graph is about 160mg/dl. Take that down to 140 mg/dl and this groups would still not be going below 70 mg/dl. This would take you from an RAA A1c of about 8.0 to an afrezza 6.7 which is also HUGE.
All said this study obsoletes RAA's as long as the patient is compliant. The best way to keep the PWD compliant is cloud monitoring and pay for performance with insurance incentives. I wonder if Warren Buffet ever thought of that?
Thank you for your great insight and contributions, sayhey.
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Post by sayhey24 on Jun 21, 2018 5:01:10 GMT -5
In STAT study, can they divide the standard treatment group into compliant and non-compliant groups and compare head-to-head with TI? There will always be a non-compliant group, either in TI or standard treatment. When the results from the non-compliant group are removed, the effects usually get better. Some might skip planned/required daily injections then time in range (TIR) would be low as in TI non-compliant. If you merge the compliant and non-compliant TI users in STAT it looks to me like there would be no difference between the Afrezza and non-Afrezza users with the exception of the 1hr post-prandial. I would like to have seen the TIR grapg for the non-Afrezza users but I guess we are going to have to wait for the talk for the full data. Aged - this is a great point. The non-compliant group is basically mirroring the 171 study but now we have an AGP window into why afrezza users did not get a better A1c. Al Mann talked during the 171 debriefing that by increasing the basal to reduce the fasting target baseline afrezza would have achieved significantly better A1c but few were listening. The general feeling was this would significantly increase the hypos and Al was out of his mind.
What we can now see through the AGP is Al was right again. By increasing the basal and decreasing the fasting baseline to 140mg/dl the afrezza users will not see an increase in severe hypos and will see significant A1c reductions.
Another point this study raises for future study is what cardiaovascular effects would afrezza have long term by blunting the post meal spike. If insurance companies are looking to reduce diabetes costs and knowing the damage post meal spikes cause its pretty clear now by not using afrezza, the RAAs are costing insurance companies significant money both short term with severe hypos and longer term with complications like heart disease. If the insurance companies can just get the PWDs to age 65 without a heart attack and then on the Medicare thats really big.
All in all this STAT study is much more significant than I was expecting. If properly explained it demonstrates afrezza as the game changer current users are seeing.
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ADA
Jun 21, 2018 5:10:45 GMT -5
Post by #NoMoreNeedles on Jun 21, 2018 5:10:45 GMT -5
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ADA
Jun 21, 2018 5:14:46 GMT -5
Post by hellodolly on Jun 21, 2018 5:14:46 GMT -5
I briefly read it coming into work (confession there), and I didn't see anything about reduced A1c or hypos? Did I peruse to quickly? Seems like it was all about TIR. What I seemed to like about this was the fact that we do have an edge in TIR and we have the added benefits of the drug acting/mimicking the pancreas, reduced A1c's and reduction in hypo events. I hope that's what MNKD sales reps pound into the head of the endo's and GPs.
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Post by peppy on Jun 21, 2018 5:17:54 GMT -5
I briefly read it coming into work (confession there), and I didn't see anything about reduced A1c or hypos? Did I peruse to quickly? Seems like it was all about TIR.
STAT will be released on Saturday. Seeking Alpha hasn't seen it. We will all see it Saturday.
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ADA
Jun 21, 2018 5:19:44 GMT -5
Post by hellodolly on Jun 21, 2018 5:19:44 GMT -5
I briefly read it coming into work (confession there), and I didn't see anything about reduced A1c or hypos? Did I peruse to quickly? Seems like it was all about TIR.
STAT will be released on Saturday. Seeking Alpha hasn't seen it. We will all see it Saturday. What study was he referring to?
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