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Post by sayhey24 on Jun 21, 2018 5:27:37 GMT -5
Too funny - Spencer says "The results show that it is almost better to have a traditional treatment and be compliant than be on Afrezza and not compliant."
What Spencer clearly demonstrated is he needs to stick to typing historical script numbers into his spreadsheet and pressing the linear regression function.
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Post by sayhey24 on Jun 21, 2018 5:35:56 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.
I think you read it too fast. The hypo numbers are there and are significant - 33% reduction in sever hypos which is huge.
This was not an A1c study but what it shows is the PWD can now reduce fasting BG from 160 to 140 and not see a significant increase in sever hypos. This is the A1c "golden nugget" in Dr. Kendall vein of gold. Remember - prandial insulin is to get the PWD back to baseline asap and afrezza allows that in a very tight range which allows reducing the fasting baseline and thats HUGE. Reducing the fasting baseline is what allows significant A1c reduction.
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Post by hellodolly on Jun 21, 2018 5:52:49 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.
I think you read it too fast. The hypo numbers are there and are significant - 33% reduction in sever hypos which is huge.
This was not an A1c study but what it shows is the PWD can now reduce fasting BG from 160 to 140 and not see a significant increase in sever hypos. This is the A1c "golden nugget" in Dr. Kendall vein of gold. Remember - prandial insulin is to get the PWD back to baseline asap and afrezza allows that in a very tight range which allows reducing the fasting baseline and thats HUGE. Reducing the fasting baseline is what allows significant A1c reduction.
Thanks sayhey. Always enjoy your contributions and education.
Now, with the information in hand and published for others to see, would it be worth the $$ and effort from MNKD do a deeper study on the affect Afrezza has on A1c's and/or hypo's. Or, is this enough along with the literature that has been dug up by Kendall to forgo any further impact studies on A1c's?
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Post by peppy on Jun 21, 2018 5:54:37 GMT -5
STAT will be released on Saturday. Seeking Alpha hasn't seen it. We will all see it Saturday. What study was he referring to? I do not know, I will not click on seeking alpha chit at this point in time. from my point of view, alpha only tells one side of the story. He can talk all he wants about Time In Range, for any published study. THE STAT STUDY COMES OUT Saturday. I image what ever dodo bird was typing for big pharmaceutical on alpha kill for money was talking about, the outcomes for the stat? I am bad at darts. clinicaltrials.gov/ct2/show/NCT03143816Primary Outcome Measures : Improved time in range (70-180 mg/dl) with TI on CGM [ Time Frame: 4 weeks ] Better post-prandial glucose excursion (1-4 hours after meals) with TI [ Time Frame: 4 weeks ] Secondary Outcome Measures : Less glucose variability (GV) (standard deviation and/or coefficient variation) [ Time Frame: 4 weeks ] The area under the curve calculation (AUC) in the PPBG and PPGE, [ Time Frame: 4 weeks ] Change in HbA1c in one-month treatment [ Time Frame: 4 weeks ] above the target time (>180 mg/dl) on CGM [ Time Frame: 4 weeks ] hypoglycemia frequency (below the target <70, <60, <50 mg/dl) on CGM [ Time Frame: 4 week
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Post by akemp3000 on Jun 21, 2018 6:09:12 GMT -5
Mike C said, "doctors will be shocked at the results". Dr. Kendall says RAAs are antiquated and barbaric and that Afrezza should be the standard of care. Because of these type statements, it's my opinion that any attempts to dilute or downplay the STAT study results are not likely based on informed sound analysis. I look forward to hearing Dr. Kendall's most important interpretation and explanation. After all, it's likely the reason he left a global executive position at Lilly to join little Mannkind corporation.
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Post by #NoMoreNeedles on Jun 21, 2018 7:18:25 GMT -5
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Post by akemp3000 on Jun 21, 2018 7:32:27 GMT -5
"We conclude that TI improves PPBG when treat-to-target algorithms are used in patients with T1D on MDI".
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Post by peppy on Jun 21, 2018 7:40:27 GMT -5
"We conclude that TI improves PPBG when treat-to-target algorithms are used in patients with T1D on MDI". The STAT Study. Post-prandial hyperglycemia is difficult to control due to lack of an ideal prandial insulin. TI (Afrezza®) has the most rapid onset of action, lasts for 2 hours. Sixty patients with T1D on multiple daily injections (MDI) were randomized in a multi-center study, stratified by baseline A1c values (<8.5% or ≥ 8.5%) to the control group using aspart (n=34) vs. TI group (n=26). The TI arm was advised to take extra inhalations at 1 and 2 hours after meals based on PPBG. Baseline characteristics were similar (Figure 1a). Forced Expiratory Volume did not differ at all times. We used intent-to-treat analysis, and examined outcomes over a 4-week period using linear regression with repeated measures. Mean CGM glucose, SD, time in range (70-180 mg/dL), % time in hyper- (>180 mg/dL) or hypoglycemia (<70, <60, or <50 mg/dL) were similar in both groups. PPBG at 1 hour was lower in the TI group (mean ± SE PPBG difference -31.7±6.6 mg/dL, p<0.0001). PPBG was numerically lower at 2 hours (mean ± SE PPBG -13.0±7.1 mg/dL, p=0.07) with no difference at 3 and 4 hours (Figure 1b). The TI group increased bolus insulin dose (mean ± SD of 47.8 ± 23.9 U/day) compared to the control group (23.0 ± 9.8 U/day; p<0.0001) in week 1. Bolus insulin dose in the TI group was higher (28.2 U/day; p<0.0001), and did not differ by study week (p=0.25). We conclude that TI improves PPBG when treat-to-target algorithms are used in patients with T1D on MDI.
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ADA
Jun 21, 2018 8:36:27 GMT -5
tomtabb likes this
Post by agedhippie on Jun 21, 2018 8:36:27 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. 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. I see compliance as a huge problem for the two dose model. Over the course of a month, and with CGMs in front of them, nearly half the participants on Afrezza are non-compliant. If you cannot keep almost all of a small group in compliance for a month with medical oversight to hand the question has to be asked if the two dose model is viable over the long run given that compliance tends to deteriorate with time. To be honest I see it as the equivalent of the advice given to RAA patients to test and correct 2 hours after a meal - nobody does it and I would bet money that the RAA group in this study did not making the whole of the RAA group non-compliant. If that was Al's view on how to use basal he was simply wrong. That is not how basal works and he seems to be confusing it with a very long acting prandial. Basal keeps you flat, it does not reduce your levels (used properly). The severe hypos are a red herring, the results published are not statistically significant so the insurers will not act on them. Mannkind themselves admitted that in the PR they had to correct. I think we are glass half empty vs. glass half full (I am a born pessimist You see the STAT results as showing the results that can be achieved with compliant patients, I see an inability to keep even a small group of patients compliant for even a month. I believe the artificial pancreas is around 75% TIR but I would have to check.
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Post by Deleted on Jun 21, 2018 8:40:12 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?
Not sure Warren thought of that specifically but the new guy just hired to run the Berkshire, JPM, Amazon healthcare initiative likely will have. www.wsj.com/articles/amazon-berkshire-and-jpmorgan-pick-ceo-for-new-health-care-company-1529504379DexCom is developing a very small sensor (nickel sized) that will be able to send the data directly to a smartphone. DEX has a relationship with Verily (Google Health Initiative) which will then allow the smartphone to transmit the data to Verily's cloud for analysis. All players in the healthcare space are trying to get their hands on the data for precisely the purpose you indicated, patient compliance and pay for performance. A bit of a conflict based on my comments as AWS will want in this space too so in this situation, they will duke it out with Verily. Notice the uptick in advertising to ask the public if they have pre-diabetes? A1C of 5.7 or higher is the point at which one is pre-diabetic. You don't think providers want this info so at some point they can go to the payors and say we have reduced our pre-diabetic patient population by xxxxxx or yy%. BTW, most endos are happy with a type 1 with an A1C in the 6s as they don't want to be too aggressive with their patients and risk an increase in hypo events. Now only if there was a mealtime insulin that worked well and reduced incidences of hypoglycemia, that would be a game changer. Sarc off. We are finally at the moment of truth. Mannkind lives or dies based on Afrezza sales in the United States. ADA gives the company a lot more firepower. Showtime.
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ADA
Jun 21, 2018 9:03:17 GMT -5
alethea likes this
Post by epc1355 on Jun 21, 2018 9:03:17 GMT -5
The poster is available now, so that is what Spencer is commenting on. Unfortunately I kind of agree with him, the results show some improvement, but are a little underwhelming in my opinion. Bummer. But I'm a dermatologist, not a endocrinologist....so what do I know?! Hopefully its more meaningful to them.
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Post by akemp3000 on Jun 21, 2018 9:15:07 GMT -5
Compliance and whether or not people take their medicines will always be an issue for the general population and studies but it certainly won't be significant enough to keep Afrezza from becoming the recommended standard of care. Facts are supporting this transition, i.e., faster in, faster out, less hypos, lower A1c, no meal-time needles. IMO, the STAT study will be like a giant billboard at the ADA that when seen, discussed and understood by endos and pcp's will finally start leading PWDs to a life they've not seen before. A life described by long-time Afrezza users as a game changer where they can finally live their lives as a non-diabetic...almost. I believe Dr. Kendall said TI is the greatest breakthrough in diabetes in 90 years. The paradigm shift is underway. Now, we need scripts and wall street to catch up.
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Post by peppy on Jun 21, 2018 10:12:23 GMT -5
Too funny - Spencer says "The results show that it is almost better to have a traditional treatment and be compliant than be on Afrezza and not compliant."
What Spencer clearly demonstrated is he needs to stick to typing historical script numbers into his spreadsheet and pressing the linear regression function.
That Spencer guy is an idiot.
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Post by mannmade on Jun 21, 2018 10:20:05 GMT -5
Oddly it is my understanding that to be compliant using traditional RAA’s requires:
1. Taking 20 to 30 mins before you eat, which means no flexibility to change meal time 2. Injections 3. Counting carbs 4. Possible stacking with roller coaster 5. Higher risk of hypo which if occurs does contribute to artificially lower Hba1c 6. Much more complicated to use 7. Stigma for some, especially young adults...See article recently posted
Now let’s look at Afrezza 1. No carb counting or very little 2. No needles 3. No stigma 4. Just a Bolus or two depending on post meal spikes which is still an issue with RAA’s 5. Freedom from pump if desired 6. Possible non diabetic Hba1c with no severe hypos as seen by multiple users
Did I miss anything?
Oh yeah, duh... compliance with any med would likely be better than non compliance... GLTAL’s!!!
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Post by hellodolly on Jun 21, 2018 11:59:03 GMT -5
Oddly it is my understanding that to be compliant using traditional RAA’s requires: 1. Taking 20 to 30 mins before you eat, which means no flexibility to change meal time 2. Injections 3. Counting carbs 4. Possible stacking with roller coaster 5. Higher risk of hypo which if occurs does contribute to artificially lower Hba1c 6. Much more complicated to use 7. Stigma for some, especially young adults...See article recently posted Now let’s look at Afrezza 1. No carb counting or very little 2. No needles 3. No stigma 4. Just a Bolus or two depending on post meal spikes which is still an issue with RAA’s 5. Freedom from pump if desired 6. Possible non diabetic Hba1c with no severe hypos as seen by multiple users Did I miss anything? Oh yeah, duh... compliance with any med would likely be better than non compliance... GLTAL’s!!! And there it is...sitting right in front of us. Maybe, just maybe, this is what is exciting to Mike and David. While there may not be a significant difference with TIR (not a problem but says we are just as good or even slightly better), Afrezza does exactly what all the other medications do with fewer complications, less hassle, better delivery of insulin, ultra-fast, and mimics the pancreas. We have the goods to prove that Afrezza does what all the other meds do, but we can show you how to live a better lifestyle and get better results with the same chit called insulin, head to head! We were looking in the wrong direction, turn around.
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