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Post by mssciguy on Jul 18, 2015 13:23:40 GMT -5
Okay, I just updated the following to indicate Afrezza is "now available" from Afrezza is "soon available" and made a note about it's insurance status being Tier II or preferred depending on insurer.
en.wikipedia.org/wiki/Inhalable_insulin
The link to Afrezza redirects back to above article.
My questions: Is this something Sanofi should be doing? If not I would love to help. My wikipedia user name is mssciguy if anyone else wants to go in and edit, you can see my changes. If you have anything you'd like me to include, I'll try to come back to this thread often. Note that I need a source for any factual content.
Thanks!
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Post by suebeeee1 on Jul 18, 2015 14:36:20 GMT -5
Wow!. I just looked at the "inhalable insulin " link that was posted. Clearly, it needs a total rewrite. The article is very negative about inhaled insulin and is very heavy on the failure of exhubera and the reluctance of doctors and patients to accept a change from injections.
The tiny paragraph on Afrezza isn't very positive either, reflecting all Mannkinds failures with the FDA and all of the restrictions.
If you take on this task, I suggest monumental changes in all of the text. For example, I would not even introduce Exhubera until one gets to reading the history. It is a failed drug that only belongs in the footnotes.
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Post by mssciguy on Jul 18, 2015 15:05:01 GMT -5
Wow!. I just looked at the "inhalable insulin " link that was posted. Clearly, it needs a total rewrite. The article is very negative about inhaled insulin and is very heavy on the failure of exhubera and the reluctance of doctors and patients to accept a change from injections. The tiny paragraph on Afrezza isn't very positive either, reflecting all Mannkinds failures with the FDA and all of the restrictions. If you take on this task, I suggest monumental changes in all of the text. For example, I would not even introduce Exhubera until one gets to reading the history. It is a failed drug that only belongs in the footnotes. Suebeee that's helpful. Maybe, reformat first paragraph to, "Afrezza is the only approved inhaled insulin. It is formulated with recombinant human insulin (identical to the insulin your body produces) for prandial use..." then go on to explain prandial, reference FDA or mannkindcorp website. Yes, it's so dated, maybe a couple years old. New first paragraph (suggestions welcome):
Inhalable insulin is currently in the US, after being approved in 2014[1].Afrezza, a new inhalable insulin product for prandial (mealtime) use was approved for sale in the United States by the FDA in June of 2014, and is now available in the US with Tier II or preferred coverage depending on insurer. Early adopters of Afrezza have been generally enthusiastic about greatly reduced HbA1c levels, as well as better blood glucose control in the short term, as measured by blood glucose monitors, especially after mealtimes. Currently a study is underway to determine whether Afrezza is superior to other short-acting insulins.
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Post by mannmade on Jul 18, 2015 16:58:09 GMT -5
I would also suggest noting that is is further distinguished from both Exhubera and current RAA's which are heximeric and Afrezza is the only monomeric insulin which allows for the fast in/fast out mimicking the function of a normal pancreas/liver which prevents the "stacking" of insulin and resulting in fare fewer severe hypos.
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Post by mssciguy on Jul 18, 2015 17:06:19 GMT -5
I would also suggest noting that is is further distinguished from both Exhubera and current RAA's which are heximeric and Afrezza is the only monomeric insulin which allows for the fast in/fast out mimicking the function of a normal pancreas/liver which prevents the "stacking" of insulin and resulting in fare fewer severe hypos. Excellent, that will be next edit, maybe pull some link from pubmed to cite that one. ty
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Post by mssciguy on Jul 19, 2015 11:54:40 GMT -5
I started a post on Afrezza. It needs some kind of review before publishing. Just copy and paste from Sanofi so far, just a placeholder.
Hope to do the same with Dreamboat.
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Post by mssciguy on Jul 20, 2015 17:21:24 GMT -5
Moving slowly.
Current text
Inhalable insulin is currently in the US, after being approved in 2014.[1]Afrezza, a new inhalable insulin product for prandial (mealtime) use was approved for sale in the United States by the FDA in June 2014, and is now available in the US with Tier II or preferred coverage depending on insurer. Early adopters of Afrezza have been generally enthusiastic about greatly reduced HbA1c levels, as well as better blood glucose control in the short term, as measured by blood glucose monitors, especially after mealtimes. Afrezza has been demonstrated to be non-inferior to other insulins. [2]Currently a study is underway to determine whether Afrezza is superior to other short-acting insulins.
if you have anything else I'll include it. That last bit was posted to ymb
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Post by dreamboatcruise on Jul 20, 2015 17:58:29 GMT -5
I guess I would question a couple of the statements as to whether they are going further than evidence available. It seems we know that many plans are not yet tier II or preferred. Many plans don't yet cover it at all. As for new trials, is there one that has an end point which would prompt a claim of superiority? We previously had trials show that the pk/pd profile is faster than traditional RAA's... but speed alone doesn't seem to be a metric that is considered "superior" unless tied by clinical trial to some other metric such as lower A1c or less hypos.
To some extent I'm surprised the short-long battle hasn't manifested itself in the wikipedia realm yet. I know many topics end up getting edit controls put on them when people get in battles changing the text back and forth.
To answer your earlier question about whether Sanofi should be doing this... it might seem odd, but Wikipedia specifically prohibits companies from creating/contributing to pages about their own products.
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Post by mssciguy on Jul 21, 2015 5:58:58 GMT -5
Dreamboatcruise if there are any specific edits you can think of (anyone else is welcome to join in too), please let me know what they are, whether I've said too little or too much. The new Afrezza article is still not reviewed yet for publication as far as I know--- maybe stick with the inhaled insulin article for now (Afrezza redirects here anyways).
Need references for anything that gets inserted (even if I missed some). Yes I could look them up myself, just not this week, very busy on something else related to paid employment (still a necessary evil until if/when we take off).
Come on Sanofi, you are done launching Toujeo, now how about us?
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Post by peppy on Jul 21, 2015 6:08:42 GMT -5
Dreamboatcruise if there are any specific edits you can think of (anyone else is welcome to join in too), please let me know what they are, whether I've said too little or too much. The new Afrezza article is still not reviewed yet for publication as far as I know--- maybe stick with the inhaled insulin article for now (Afrezza redirects here anyways).
Need references for anything that gets inserted (even if I missed some). Yes I could look them up myself, just not this week, very busy on something else related to paid employment (still a necessary evil until if/when we take off).
Come on Sanofi, you are done launching Toujeo, now how about us? A reference for the hexamer/monomer component that could/may get added.
insulinnation.com/treatment2/inhalable-insulin-a-breathtaking-development/
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Post by liane on Jul 21, 2015 6:18:55 GMT -5
mssciguy (and anyone else)
Could I ask a favor that you not use the colored fonts (blue in particular) on a regular basis. Links in particular come up in blue on this board by default. And in general, it's nice to reserve the colored fonts for occasional added emphasis. Thanks!
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Deleted
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Posts: 0
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Post by Deleted on Jul 21, 2015 9:09:18 GMT -5
Okay, I just updated the following to indicate Afrezza is "now available" from Afrezza is "soon available" and made a note about it's insurance status being Tier II or preferred depending on insurer.
en.wikipedia.org/wiki/Inhalable_insulin
The link to Afrezza redirects back to above article.
My questions: Is this something Sanofi should be doing? If not I would love to help. My wikipedia user name is mssciguy if anyone else wants to go in and edit, you can see my changes. If you have anything you'd like me to include, I'll try to come back to this thread often. Note that I need a source for any factual content.
Thanks! Great work, thanks for your efforts. Note after the first paragraph it says "Once it has been absorbed, it begins working within the body over the next few hours" which does not do justice to Afrezzas quick onset, peak and time to leave body.
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Post by dreamboatcruise on Jul 21, 2015 9:45:31 GMT -5
Dreamboatcruise if there are any specific edits you can think of (anyone else is welcome to join in too), please let me know what they are, whether I've said too little or too much. The new Afrezza article is still not reviewed yet for publication as far as I know--- maybe stick with the inhaled insulin article for now (Afrezza redirects here anyways).
Need references for anything that gets inserted (even if I missed some). Yes I could look them up myself, just not this week, very busy on something else related to paid employment (still a necessary evil until if/when we take off).
Come on Sanofi, you are done launching Toujeo, now how about us? With regard to insurance coverage it might be best to set expectations for patients that they may well have to jump through hoops with regard to authorization, and perhaps provide some details on the assistance Sanofi offers with the paperwork for insurers (though I can't cite the specifics) and suggest that patients should check their plan formulary before seeing their doc. If patients see the wikipedia and go in prepared to get the authorization step going that would cut down time and hassle of getting the prescription. Many docs don't bother finding out what is covered and simply write a script only to have it rejected at the pharmacy counter. Also, due to possibility of being tier 3 or even not covered, it would be worth putting in reference and link to the discount card. It would be nice if most patients encountered non restricted tier 2 or better, but as of yet that is not the case. As for additional trials we know of, I think you might say "Additional trials are being conducted which may be necessary for regulatory approval outside the U.S. Follow on trials required by FDA have not yet begun. Trials to demonstrate superiority of patient outcomes with Afrezza versus traditional RAA's is a stated goal of the company." Would be nice if there was concrete cite for each of those assertions, but I don't have those off hand. I believe the last sentence is true. I know they have stated "label improvement". I think "superiority" would be easier for a lay person to understand vs "label improvement", though technically "label improvement" could simply mean removal of restrictions or warnings.
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Post by mssciguy on Jul 21, 2015 17:39:05 GMT -5
Okay, I just updated the following to indicate Afrezza is "now available" from Afrezza is "soon available" and made a note about it's insurance status being Tier II or preferred depending on insurer.
en.wikipedia.org/wiki/Inhalable_insulin
The link to Afrezza redirects back to above article.
My questions: Is this something Sanofi should be doing? If not I would love to help. My wikipedia user name is mssciguy if anyone else wants to go in and edit, you can see my changes. If you have anything you'd like me to include, I'll try to come back to this thread often. Note that I need a source for any factual content.
Thanks! Great work, thanks for your efforts. Note after the first paragraph it says "Once it has been absorbed, it begins working within the body over the next few hours" which does not do justice to Afrezzas quick onset, peak and time to leave body. Thanks.... I was very careful not be too promotional without reference and today (DING!) I get a message from the Wikipedia self-promotion police to please explain my affiliation. This will take time. I'll stick with the facts, and your point about superior pharmacokinetics is perfect, thanks. Will try to express in ordinary English like you did, without being self promotional...
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Post by dreamboatcruise on Jul 21, 2015 18:28:51 GMT -5
Here is my contribution with regard to lower hypoglycemic events. Hopefully with citation sufficiently backing it up.
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Results from Afrezza ("TI" in citations below) clinical trials (Affinity) show a reduction in hypoglycemia event rate compared to a traditional Rapid Acting Analog (RAA) insulin.
"TI patients had a lower hypoglycemia event rate than aspart patients (9.8 vs. 14.0 events/patient-month, P < 0.0001)." [cite #1]
While the study was not designed to target maximum A1c reduction, the results show that Afrezza should allow more aggressive treatment to target lower A1c levels while maintaining acceptable levels of hypoglycemia risk.
"Both nonsevere and severe hypoglycemia event rates in the TI-Gen2 group were consistently lower regardless of the achieved HbA1c value at week 24 (Fig. 3A and B) and after adjustment for HbA1c change from baseline to week 24 (Fig. 3C). Similarly, the hypoglycemia rate was lower in the TI group after HbA1c was added to the statistical model used in the data analysis (Supplementary Table 7). Furthermore, the timing of the hypoglycemia events with TI paralleled its rapid kinetics; hypoglycemia event rates within 2 h postmeal were comparable between TI and insulin aspart but were two- to threefold higher in the insulin aspart group >2–5 h after meals (Fig. 3D)." [cite #1]
Anecdotal evidence from early patients shows success in achieving lower A1c levels compared to use of traditional RAA's without risk of serious hypoglycemia events [cite #2]. The rapid kinetics allow users to selectively extend the action of meal-time dosing by utilizing a follow on dose of Afrezza after meal consumption only when needed based on the food actually consumed or real time blood glucose readings. This avoids hypos in the 2-5 hour range with RAA's when insulin action can outlive the digestion of food. Additional clinical studies utilizing new dosing protocols are anticipated with the goal of showing superiority of Afrezza in this regard.
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[cite #1] Bode, Bruce W., et al. "Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial." Diabetes Care (2015): dc150075.
[Cite #2] Link to most recent AfrezzaUser results page.
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