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Post by Deleted on Jan 4, 2017 18:29:08 GMT -5
I realize there is confusion regarding pharmacodynamics and pharmacokinetics so I captured the label image that graphs the dynamics of Afrezza and Lispro and posted it on my profile. Kinetics refers to the amount of medication that enters your system; dynamics is the amount of activity as medication enters your system. As one can see, Afrezza's activity peaks approximately 53 minutes and then decreases to baseline at 160 minutes. While Afrezza and Lispro's activity coincide where Afrezza peaks, Lispro continues rising and stays elevated much longer. This is the reason Afrezza has a much smaller likelihood of causing hypoglycemia compared to analogues like Lispro.
Hopefully that helps?
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Post by Deleted on Jan 27, 2017 9:08:24 GMT -5
Just as a reminder, the difference between analogues and Afrezza is due to the dynamics. Please refer to the label for the graph.
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Post by sayhey24 on Jan 27, 2017 20:33:31 GMT -5
Just as a reminder, the difference between analogues and Afrezza is due to the dynamics. Please refer to the label for the graph. You got me a little confused. Pharmacodynamics is the study of how a drug affects an organism, whereas pharmacokinetics is the study of how the organism affects the drug. What the graph (page 15 of the label) on the left is showing is the glucose infusion rate - time curve , which is the PD. The graph on the right is the one Al carried everywhere and it shows the PK. The difference between RAAs and Afrezza is the molecular structure of human insulin to the GMO RAA molecule. What makes afrezza unique from injected human insulin is that the injected human insulin mimics the hexamer structure of how insulin is stored in the beta cells. When released from the pancreas into the blood it is released as a monomer which is the same as when afrezza is absorbed in the lungs. Afrezza is a monomer and the ONLY monomer insulin outside of what the pancreas releases. This allows the NEAR-Natural PK profile afrezza has. The RAAs are GMO molecules where the GMO modification limits the molecules forming a hexamer structure. Suspended in the solution are monomers, dimmers and hexamers, basically a fruit salad. The monomers allow RAA to have the same onset. However the hexamers cause the long tail and the dimmers kind-of mimic phase 2 insulin release. The difference between the RAAs and afrezza is the PK profile which with afrezza mimics a near-normal pancreas. And, can mimic the phase 2 if the PWD doses, if needed about 60 minutes after the first puff. Mimicing Phase 1 and Phase 2 without a CGM is a lot of finger pricks but phase 1 is extremely important to signal the liver to stop dumping sugar into the blood and which is something the RAA don't seem to do. |
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Post by Deleted on Jan 27, 2017 23:15:16 GMT -5
Read my first post then refer to page 6, figure 3 of the label.
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Post by sayhey24 on Jan 28, 2017 8:42:45 GMT -5
Read my first post then refer to page 6, figure 3 of the label. OK - here is the label, we must be referring to two different things accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf I don't see a figure on page 6. I see a discussion on hypoglycemia. But it does not really matter. What matters is afrezza is the only diabetes treatment which can mimic a near-Natural pancreas with phase 1 and phase 2 insulin release because it is monomer human insulin. The exact same that the pancreas secretes. I could even go out on a limb and point to the AspB10 findings at Nova Nordisk and throw out a red herring that RAAs could pose a potential long term cancer risk in women. With these GMO RAAs who knows? |
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Post by agedhippie on Jan 28, 2017 11:01:05 GMT -5
Read my first post then refer to page 6, figure 3 of the label. OK - here is the label, we must be referring to two different things accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf I don't see a figure on page 6. I see a discussion on hypoglycemia. But it does not really matter. What matters is afrezza is the only diabetes treatment which can mimic a near-Natural pancreas with phase 1 and phase 2 insulin release because it is monomer human insulin. The exact same that the pancreas secretes. I could even go out on a limb and point to the AspB10 findings at Nova Nordisk and throw out a red herring that RAAs could pose a potential long term cancer risk in women. With these GMO RAAs who knows? Ooh - alternative facts there! None of the RAA cause cancer. That has been gone over very thoroughly and there is 20 years of data on huge populations to back that up. |
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Post by sayhey24 on Jan 28, 2017 12:52:58 GMT -5
OK - here is the label, we must be referring to two different things accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf I don't see a figure on page 6. I see a discussion on hypoglycemia. But it does not really matter. What matters is afrezza is the only diabetes treatment which can mimic a near-Natural pancreas with phase 1 and phase 2 insulin release because it is monomer human insulin. The exact same that the pancreas secretes. I could even go out on a limb and point to the AspB10 findings at Nova Nordisk and throw out a red herring that RAAs could pose a potential long term cancer risk in women. With these GMO RAAs who knows? Ooh - alternative facts there! None of the RAA cause cancer. That has been gone over very thoroughly and there is 20 years of data on huge populations to back that up. As I said a Red Herring but its hard to argue with the AspB10 results and the lesson learned was when you start modifying molecules things can start getting dangerously unpredictable. Why even have the discussion or take the risk when human insulin can be used which provides near-natural pancreatic function? How long does it take for the average smoker to develop lung cancer 20-30 years? With RAAs who knows? How many other things have we been told are perfectly safe? What we do know is AspB10 almost ended RAA development efforts and now they can be replaced with a near-natural alternative. |
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Post by agedhippie on Jan 28, 2017 13:27:40 GMT -5
Ooh - alternative facts there! None of the RAA cause cancer. That has been gone over very thoroughly and there is 20 years of data on huge populations to back that up. As I said a Red Herring but its hard to argue with the AspB10 results and the lesson learned was when you start modifying molecules things can start getting dangerously unpredictable. Why even have the discussion or take the risk when human insulin can be used which provides near-natural pancreatic function? How long does it take for the average smoker to develop lung cancer 20-30 years? With RAAs who knows? How many other things have we been told are perfectly safe? What we do know is AspB10 almost ended RAA development efforts and now they can be replaced with a near-natural alternative. Lol. This is beginning to get mildly surreal. You can assert whatever you like - that does not make it true. Nor does saying. "With RAA who knows?" to which the answer is millions of diabetics, decades of experience, and the entire academic and medical community. |
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Post by sayhey24 on Jan 28, 2017 14:16:27 GMT -5
As I said a Red Herring but its hard to argue with the AspB10 results and the lesson learned was when you start modifying molecules things can start getting dangerously unpredictable. Why even have the discussion or take the risk when human insulin can be used which provides near-natural pancreatic function? How long does it take for the average smoker to develop lung cancer 20-30 years? With RAAs who knows? How many other things have we been told are perfectly safe? What we do know is AspB10 almost ended RAA development efforts and now they can be replaced with a near-natural alternative. Lol. This is beginning to get mildly surreal. You can assert whatever you like - that does not make it true. Nor does saying. "With RAA who knows?" to which the answer is millions of diabetics, decades of experience, and the entire academic and medical community. Hey - and you trust these guys? I am not asserting anything. I am just pointing to the AspB10 work and ask, are you sure about these GMO RAAs? Why does it seem that all the studies which talk about reversing T2s with early-on intensive insulin therapy get buried? What would happen to BP sales if all these T2s did not progress into the recursive death spiral? Why do you think none of them fight metformin? Maybe because they figure they will get the PWDs sooner or later anyway? How many of these perfectly safe chemical concoctions have turn into a big mess? Orinase is at the top of my list but there are much better examples like Avandia and Actos. Why does it seem all these BPs want afrezza buried? Just the pressure put on the FDA not to approve was amazing and all it was they needed to approve was human insulin as a monomer which mimiced pancreatic PK. Did they really deserve the first CRL let alone the second? Who was Martin S. working for at the time? The entire academic and medical community, right. Is this the same community still believing lower A1c is going cause a greater chance of a heart attack in diabetics and who think a 7.5 is great? The same community which did the ACCORD study? |
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Post by Deleted on Jan 28, 2017 19:16:45 GMT -5
I am unable to paste from the label that has the pharmacodynamics of Afrezza versus Lispro. Perhaps liane or mn can post it?
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Post by mango on Jan 28, 2017 19:52:29 GMT -5
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Post by Deleted on Jan 28, 2017 20:11:53 GMT -5
Thanks for posting the kinetics graph. Can you post the dynamics graph of Afrezza and Lispro?
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Post by mango on Jan 28, 2017 20:32:53 GMT -5
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Post by agedhippie on Jan 28, 2017 20:35:55 GMT -5
Lol. This is beginning to get mildly surreal. You can assert whatever you like - that does not make it true. Nor does saying. "With RAA who knows?" to which the answer is millions of diabetics, decades of experience, and the entire academic and medical community. Hey - and you trust these guys? I am not asserting anything. I am just pointing to the AspB10 work and ask, are you sure about these GMO RAAs? Why does it seem that all the studies which talk about reversing T2s with early-on intensive insulin therapy get buried? What would happen to BP sales if all these T2s did not progress into the recursive death spiral? Why do you think none of them fight metformin? Maybe because they figure they will get the PWDs sooner or later anyway? How many of these perfectly safe chemical concoctions have turn into a big mess? Orinase is at the top of my list but there are much better examples like Avandia and Actos. Why does it seem all these BPs want afrezza buried? Just the pressure put on the FDA not to approve was amazing and all it was they needed to approve was human insulin as a monomer which mimiced pancreatic PK. Did they really deserve the first CRL let alone the second? Who was Martin S. working for at the time? The entire academic and medical community, right. Is this the same community still believing lower A1c is going cause a greater chance of a heart attack in diabetics and who think a 7.5 is great? The same community which did the ACCORD study? Do I trust them? Yes, they have kept me alive and healthy this long. Am I sure about RAA (GMO - Lol) safety? Yes, decades of results assure me of that. The whole fake insulin thing was litigated decades ago. There was a group of people who thought both RAA (engineered insulin) and Regular (GMO produced insulin) were unnatural and wanted to stick with porcine and bovine insulins. How did that end? Look around you... All the stuff about T2, other drugs, etc. Nice pivot!  |
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Post by Deleted on Jan 28, 2017 21:10:42 GMT -5
mango - thank you for posting this graph. From graph A: the areas under each curve one can see that the activity (dynamics) of Afrezza is much smaller than Lispro; this is the reason Afrezza causes fewer hypos than analogues. Hopefully this clears up the confusion?
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