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Post by mnkdfann on Sept 16, 2017 16:32:32 GMT -5
In a study published early this year entitled, “Effect of Technosphere Inhaled Insulin on Quality of Life and Treatment Satisfaction” (Mark Peyrot, Richard R. Rubin. Diabetes Technology & Therapeutics. January 2010, 12(1): 49-55. doi:10.1089/dia.2009.0115,) the authors explain that, “research suggests that insulin-naive patients offered an option of taking inhaled insulin are much more likely to initiate insulin therapy than those offered an option of subcutaneous insulin. Thus, availability of the Technosphere insulin system might contribute to reduced delay in the initiation of insulin therapy, a goal suggested by recent clinical guidelines. In addition, research suggests that inhaled insulin is preferred to subcutaneous insulin. Most (85%) patients who received an inhaled insulin during the main phase of a clinical trial chose to continue doing so during the open-label extension phase, and 75% of patients using subcutaneous insulin during the parallel group phase chose to switch to the inhaled insulin.” It was published in 2010, not 'early this year'. Sort of funny you took the forum ID 'itellthefuture777' but you mainly post old time capsule stuff. Is your name meant to be ironic?
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Post by itellthefuture777 on Sept 16, 2017 16:35:04 GMT -5
In a study published early this year entitled, “Effect of Technosphere Inhaled Insulin on Quality of Life and Treatment Satisfaction” (Mark Peyrot, Richard R. Rubin. Diabetes Technology & Therapeutics. January 2010, 12(1): 49-55. doi:10.1089/dia.2009.0115,) the authors explain that, “research suggests that insulin-naive patients offered an option of taking inhaled insulin are much more likely to initiate insulin therapy than those offered an option of subcutaneous insulin. Thus, availability of the Technosphere insulin system might contribute to reduced delay in the initiation of insulin therapy, a goal suggested by recent clinical guidelines. In addition, research suggests that inhaled insulin is preferred to subcutaneous insulin. Most (85%) patients who received an inhaled insulin during the main phase of a clinical trial chose to continue doing so during the open-label extension phase, and 75% of patients using subcutaneous insulin during the parallel group phase chose to switch to the inhaled insulin.” The graph below shows the superior kinetics of Afrezza, practically mimicking a normal person’s insulin response to a meal. This is the key for reducing Hypoglycemia and improving post prandial glucose levels. It helps if you read the paper itself. Lets be clear on what this trial was: - First of all this was a comparison of Afrezza as the active arm, and Technosphere only (no insulin) as the placebo arm. - At no point was subcutaneous insulin used or compared. This was Mannkind products only. - The study used Medtone inhalers which is why it had to be rerun as study 175 in the ADCOM presentation. - The 93% satisfaction number is with the inhaler device (Medtone), not with Afrezza. This score is basically useless since the Medtone device is no longer used hence the need to rerun the trial. Still, it seems people like the Medtone device - Those numbers at the end (85% continue, 75% swap) were from an entirely different trial not involving Mannkind at all, it was for Exubera. The bottom line here? This is a comparison of inhaled insulin vs. Technosphere, at no point was subcutaneous insulin involved. The new inhaler saved 1/3 of the cost of goods, didn't require cleaning, so efficent and saved so much that Mannkind gives it free with the purchases as a two week use and toss item. I believe it also won the global award for inhalers besting Mercks inhaler. If 93% where happy with Medtone..but now getting a smaller sleek inhaler that you don't have to dismantle and clean..thats free..is somehow going to be less satisfying...I seriously doubt it..
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Post by itellthefuture777 on Sept 16, 2017 16:57:03 GMT -5
Not doubting the numbers you posted itell, just curious where you got the "93% satisfaction survey in quality of life". I don't remember reading or catching that before. ltell - got a study for "with some restoritive..also reduces insulin resistance "? I know Al said it many times. "Al Mann - from recent Quarterly call: I have long argued that AFRESA does not require complex meal titration. Certainly there is no need for carb counting and so forth. The basis of my view was derived from the dose escalation study with meal challenges in which better glucose control was achieved with ever greater doses of AFRESA, yet without any hypos. Yet based on decades of battling these challenges of conventional insulin therapy, some physicians have questioned my suggestion. Therefore, I proposed a meal escalation study in which patients would take a fixed dose of AFRESA and then a series of meal challenges. Our clinical team designed a protocol to set a standard meal with 50 g of carbohydrates. That was the 100% challenge. This was followed by challenges at 200%, 50% and zero percent. When I heard of zero I was shocked. Surely there would be severe hypo. The remarkable thing was that with the regular prescribed dose of AFRESA regardless of carbohydrate intake between zero and 100 grams the range of excursion is only plus or minus 30-35 mg [reduction] from baseline for all of the Type II patients in the study. At the ASDA meeting I described to Dr. [Jay Skyler] the finding that in Type II diabetes with a fixed dose of AFRESA and even with no food there is excellent control without hypo risk. I asked him how that was possible. "Obvious," he responded. He was basing his comments on our recently reported 118 trial in which we showed rapid and virtually complete sensation of [hepatic] glucose relief with AFRESA and the common inability of the remaining endogenous insulin to maintain control, as is the case for a healthy person without diabetes. Indeed, I mentioned this result to a number of KOL's who agree with Jay. So I say to you that AFRESA is what no other insulin has ever done for Type II diabetes. AFRESA restores more physiologic hepatic function, takes a load off the pancreas and avoids the hyperinsulinemia resulting from resistance of other insulins. It better mimics the normal pancreas response. So what does all this mean? First let me say that we will need to follow these findings with much larger trials. If the results of the larger trials support the earlier findings then I state to you that AFRESA should be used very early, certainly after failure with Metformin and as a first sign therapy for a significant portion of patients who are not candidates for Metformin or who do not do well with Metformin. It should be used well before fasting glucose is out of control and as we have seen, AFRESA even leads to lower fasting levels by eliminating the excessive gluconeogenesis. Of course, we will have to repeat some of these findings with specific trials but we have already seen the possibilities for AFRESA as we evaluate the timing of hypos in our already completed trials to date. From what we have seen in our extensive clinical program, AFRESA should benefit the entire progression spectrum of Type II diabetes with a very simple therapy and the experts tell us that it could even stop the progression of the disease."http://www.healthline.com/diabetesmine/the-truth-about-afresa-inhalable-insulin-a-chat-with-al-mann
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Post by itellthefuture777 on Sept 16, 2017 16:59:50 GMT -5
I believe Al based his remarks on the meal study 118 and several leading key opinion leaders.
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Post by liane on Sept 16, 2017 19:04:04 GMT -5
FYI itell - a few paragraph breaks would be helpful in your longer posts
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Post by agedhippie on Sept 16, 2017 21:05:52 GMT -5
It helps if you read the paper itself. Lets be clear on what this trial was: - First of all this was a comparison of Afrezza as the active arm, and Technosphere only (no insulin) as the placebo arm. - At no point was subcutaneous insulin used or compared. This was Mannkind products only. - The study used Medtone inhalers which is why it had to be rerun as study 175 in the ADCOM presentation. - The 93% satisfaction number is with the inhaler device (Medtone), not with Afrezza. This score is basically useless since the Medtone device is no longer used hence the need to rerun the trial. Still, it seems people like the Medtone device - Those numbers at the end (85% continue, 75% swap) were from an entirely different trial not involving Mannkind at all, it was for Exubera. The bottom line here? This is a comparison of inhaled insulin vs. Technosphere, at no point was subcutaneous insulin involved. The new inhaler saved 1/3 of the cost of goods, didn't require cleaning, so efficent and saved so much that Mannkind gives it free with the purchases as a two week use and toss item. I believe it also won the global award for inhalers besting Mercks inhaler. If 93% where happy with Medtone..but now getting a smaller sleek inhaler that you don't have to dismantle and clean..thats free..is somehow going to be less satisfying...I seriously doubt it.. I think that the Dreamboat is better than the Medtone inhaler was never in doubt. So all my points still stand and subcutaneous insulin was not used or compared.
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Post by itellthefuture777 on Sept 17, 2017 0:27:00 GMT -5
The new inhaler saved 1/3 of the cost of goods, didn't require cleaning, so efficent and saved so much that Mannkind gives it free with the purchases as a two week use and toss item. I believe it also won the global award for inhalers besting Mercks inhaler. If 93% where happy with Medtone..but now getting a smaller sleek inhaler that you don't have to dismantle and clean..thats free..is somehow going to be less satisfying...I seriously doubt it.. I think that the Dreamboat is better than the Medtone inhaler was never in doubt. So all my points still stand and subcutaneous insulin was not used or compared. The trial participants where previously using other insulin and shots..so mute point
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Post by agedhippie on Sept 17, 2017 9:05:48 GMT -5
I think that the Dreamboat is better than the Medtone inhaler was never in doubt. So all my points still stand and subcutaneous insulin was not used or compared. The trial participants where previously using other insulin and shots..so mute point Now you are making things up. This is from your own post earlier in the thread: Methods: Subjects were 119 insulin-naive subjects with starting hemoglobin A1c >6.5%: 58 in the active inhaled insulin arm and 61 in the inhaled placebo arm (67% male; mean age 55 years; mean duration of diagnosed diabetes 7 years). Insulin-naive - that means they have never used insulin before. Just in case there is any doubt about that here is an excerpt giving the selection criteria from the paper: So the participants had never used insulin before the trial, never used subcutaneous insulin during the trial, and so obviously cannot compare using Afrezza with subcutaneous insulin - the point is definitely not moot.
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Post by itellthefuture777 on Sept 18, 2017 2:29:48 GMT -5
It's a moot point because it is a 93% satisfaction survey quality of life..improvement...as far as having not had insulin prevoiusly or not..is irrelevant
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Post by agedhippie on Sept 18, 2017 7:39:35 GMT -5
It's a moot point because it is a 93% satisfaction survey quality of life..improvement...as far as having not had insulin prevoiusly or not..is irrelevant Not what your last post said but we will let that go for the moment and l lets look at this 93% satisfaction survey quality of life claim. The immediate problem is that the 93% figure comes from Table 5 and is the average of results in that table. Sadly this is not quality of life, but is twelve questions asking about useability of the inhaler and titled satisfaction with the inhaler device. Nothing to do with quality of life, not even anything to do with insulin since both Afrezza and placebo users are included since both used the inhaler. The 93% satisfaction survey quality of life improvement is made up. It's 93% satisfaction with an obsolete inhaler (Medtone).
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Post by itellthefuture777 on Sept 18, 2017 8:45:30 GMT -5
The new inhaler is free..smaller..don't have to clean it..sleek..and you toss it after two weeks...I simply don't understand why you are so upset as it is so much more efficent it saves 1/3 the cost of goods
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Post by cretin11 on Sept 18, 2017 11:33:54 GMT -5
itellthefuture, i think the issue is that you seem to exaggerate or misrepresent things. we all want to be optimistic, but it's more important to be accurate. people will give your posts more credence.
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