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Post by curiousdoc on Sept 11, 2015 8:11:32 GMT -5
Inhaled insulin: weighing the pros and cons Published online: September 1, 2015 Giuseppe Derosa, Pamela Maffioli The Lancet Diabetes & Endocrinology www.thelancet.com/journals/landia/article/PIIS2213-8587(15)00317-4/abstractEfficacy, safety, and patient acceptability of Technosphere inhaled insulin for people with diabetes: a systematic review and meta-analysis Published online: September 1, 2015 Anastassios G Pittas, Gregory P Westcott, Ethan M Balk The Lancet Diabetes & Endocrinology www.thelancet.com/journals/landia/article/PIIS2213-8587(15)00280-6/abstractConclusion: "Glycaemic efficacy of Technosphere inhaled insulin is lower than that of subcutaneous insulin, but inhaled insulin has a lower risk of severe hypoglycaemia and weight gain. Long-term outcomes and safety with Technosphere insulin should be further investigated. Until further data for safety become available, Technosphere inhaled insulin should be reserved for healthy adults with diabetes who do not have pulmonary disease and who would otherwise delay initiating or intensifying insulin therapy because they are unwilling or unable to use injectable insulin." Meta-analysis are generally regarded at the top of the evidence based pyramid. I realize there are flaws in this, mainly stemming from the inclusion of multiple FDA trials designed for non-inferiority. However, the average physician will not even appreciate the significance of that. Unfortunately, these types of the results, in top diabetic literature, hold significantly more weight with prescribing physicians thanindividual patient success stories. This was passed along by an endocrinologist colleague of mine (delivered to their inbox this morning). Studies like this, combined with lack of coverage, makes me continue to think it will be a slow adoption and expectations should be tempered. |
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Post by peppy on Sept 11, 2015 10:58:38 GMT -5
Inhaled insulin: weighing the pros and cons Published online: September 1, 2015 Giuseppe Derosa, Pamela Maffioli The Lancet Diabetes & Endocrinology www.thelancet.com/journals/landia/article/PIIS2213-8587(15)00317-4/abstractEfficacy, safety, and patient acceptability of Technosphere inhaled insulin for people with diabetes: a systematic review and meta-analysis Published online: September 1, 2015 Anastassios G Pittas, Gregory P Westcott, Ethan M Balk The Lancet Diabetes & Endocrinology www.thelancet.com/journals/landia/article/PIIS2213-8587(15)00280-6/abstractConclusion: "Glycaemic efficacy of Technosphere inhaled insulin is lower than that of subcutaneous insulin, but inhaled insulin has a lower risk of severe hypoglycaemia and weight gain. Long-term outcomes and safety with Technosphere insulin should be further investigated. Until further data for safety become available, Technosphere inhaled insulin should be reserved for healthy adults with diabetes who do not have pulmonary disease and who would otherwise delay initiating or intensifying insulin therapy because they are unwilling or unable to use injectable insulin." Meta-analysis are generally regarded at the top of the evidence based pyramid. I realize there are flaws in this, mainly stemming from the inclusion of multiple FDA trials designed for non-inferiority. However, the average physician will not even appreciate the significance of that. Unfortunately, these types of the results, in top diabetic literature, hold significantly more weight with prescribing physicians thanindividual patient success stories. This was passed along by an endocrinologist colleague of mine (delivered to their inbox this morning). Studies like this, combined with lack of coverage, makes me continue to think it will be a slow adoption and expectations should be tempered. I stared at the results. I was not sure I was reading it correctly. www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm390865.pdf Attachment DeletedAttachment Deleted
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Post by harrys on Sept 11, 2015 11:10:31 GMT -5
Inhaled insulin: weighing the pros and cons Published online: September 1, 2015 Giuseppe Derosa, Pamela Maffioli The Lancet Diabetes & Endocrinology www.thelancet.com/journals/landia/article/PIIS2213-8587(15)00317-4/abstractEfficacy, safety, and patient acceptability of Technosphere inhaled insulin for people with diabetes: a systematic review and meta-analysis Published online: September 1, 2015 Anastassios G Pittas, Gregory P Westcott, Ethan M Balk The Lancet Diabetes & Endocrinology www.thelancet.com/journals/landia/article/PIIS2213-8587(15)00280-6/abstractConclusion: "Glycaemic efficacy of Technosphere inhaled insulin is lower than that of subcutaneous insulin, but inhaled insulin has a lower risk of severe hypoglycaemia and weight gain. Long-term outcomes and safety with Technosphere insulin should be further investigated. Until further data for safety become available, Technosphere inhaled insulin should be reserved for healthy adults with diabetes who do not have pulmonary disease and who would otherwise delay initiating or intensifying insulin therapy because they are unwilling or unable to use injectable insulin." Meta-analysis are generally regarded at the top of the evidence based pyramid. I realize there are flaws in this, mainly stemming from the inclusion of multiple FDA trials designed for non-inferiority. However, the average physician will not even appreciate the significance of that. Unfortunately, these types of the results, in top diabetic literature, hold significantly more weight with prescribing physicians thanindividual patient success stories. This was passed along by an endocrinologist colleague of mine (delivered to their inbox this morning). Studies like this, combined with lack of coverage, makes me continue to think it will be a slow adoption and expectations should be tempered. I wouldn't discount the significance of "less hypos". This is a significant side effect of current insulin preparations on the market with comorbidity. A hypoglycemic visit to the hospital is a serious event for both the patient and the insurance companies bottom line. This is a "good" conclusion despite better glycemic control not being established, can't win all the battles. The mounting evidence hopefully to come should be enough to tip the scale in favor of coverage and adoption by Endos and GPs. |
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Post by curiousdoc on Sept 11, 2015 11:24:42 GMT -5
I'm not discounting them, Harrys. However, with these results there is absolutely no reason to change a patient from SubQ with a less than ideal A1C if they are not already struggling with hypos. I, too believe in the science of this drug, but the "mounting evidence" you speak of does not yet exist in a form that doctors will accept. And it will take an impressive study to one-up a meta-analysis. Your statement has a little too much blind optimism for me. That said, even getting to advertise less hypos would be a plus.
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Post by harrys on Sept 11, 2015 11:36:44 GMT -5
I'm not discounting them, Harrys. However, with these results there is absolutely no reason to change a patient from SubQ with a less than ideal A1C if they are not already struggling with hypos. I, too believe in the science of this drug, but the "mounting evidence" you speak of does not yet exist in a form that doctors will accept. And it will take an impressive study to one-up a meta-analysis. Your statement has a little too much blind optimism for me. That said, even getting to advertise less hypos would be a plus. I agree there are many obstacles still left. The mounting evidence I'm hoping will go from anectodal reports to in the lab research. It's funny that you would mention "too much blind optimism" I posted for the first time in a while on this board today and am now being attacked for my hidden FUD agenda... be careful what you post here. I am VERY cautiously optimistic here but will be the first to admit things are not going the way I would like it. |
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Post by joeypotsandpans on Sept 11, 2015 11:40:10 GMT -5
If I am a physician and have the choice of prescribing an insulin that (significantly IMO) reduces the risk of Dr. Death knocking on my patients door at any given unforeseen time....no brainer, but that's just me fwiw  However, if I'm a patient which I am...I may not give my physician the choice to make and rather make it for him/her if you get my drift. Now if my insurance company is a UHC (which it just so happens it is) and is causing issues getting covered, well we'll get to that at another point in time Btw, Dr. Bode can get published at any time in the Lancet as well....just sayin....enjoy your weekends everyone! Oh yeah HarryS, thanks for posting the PDF it was appreciated in the context you meant. All Liane was saying is that generally try and keep your posts to one thread otherwise it may get construed as a different type of motivation...as far as the "Ole Boys Club" comment, well look out for a thread titled the same by me in the near future |
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Post by jay1ajay1a on Sept 11, 2015 11:45:20 GMT -5
I'm not discounting them, Harrys. However, with these results there is absolutely no reason to change a patient from SubQ with a less than ideal A1C if they are not already struggling with hypos. I, too believe in the science of this drug, but the "mounting evidence" you speak of does not yet exist in a form that doctors will accept. And it will take an impressive study to one-up a meta-analysis. Your statement has a little too much blind optimism for me. That said, even getting to advertise less hypos would be a plus. I agree there are many obstacles still left. The mounting evidence I'm hoping will go from anectodal reports to in the lab research. It's funny that you would mention "too much blind optimism" I posted for the first time in a while on this board today and am now being attacked for my hidden FUD agenda... be careful what you post here. I am VERY cautiously optimistic here but will be the first to admit things are not going the way I would like it. Harrys, don't worry about the FUD stuff. We have a lot of great and smart folks on this board. There is so much miss information out there that some are quick to FUD you. Welcome to the borad. |
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Post by harrys on Sept 11, 2015 12:24:52 GMT -5
Thanks for the welcome guys. I understand that emotions some time get the best of us, I used to be there.
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Post by peppy on Sept 11, 2015 13:19:06 GMT -5
Inhaled insulin: weighing the pros and cons Published online: September 1, 2015 Giuseppe Derosa, Pamela Maffioli The Lancet Diabetes & Endocrinology www.thelancet.com/journals/landia/article/PIIS2213-8587(15)00317-4/abstractEfficacy, safety, and patient acceptability of Technosphere inhaled insulin for people with diabetes: a systematic review and meta-analysis Published online: September 1, 2015 Anastassios G Pittas, Gregory P Westcott, Ethan M Balk The Lancet Diabetes & Endocrinology www.thelancet.com/journals/landia/article/PIIS2213-8587(15)00280-6/abstractConclusion: "Glycaemic efficacy of Technosphere inhaled insulin is lower than that of subcutaneous insulin, but inhaled insulin has a lower risk of severe hypoglycaemia and weight gain. Long-term outcomes and safety with Technosphere insulin should be further investigated. Until further data for safety become available, Technosphere inhaled insulin should be reserved for healthy adults with diabetes who do not have pulmonary disease and who would otherwise delay initiating or intensifying insulin therapy because they are unwilling or unable to use injectable insulin." Meta-analysis are generally regarded at the top of the evidence based pyramid. I realize there are flaws in this, mainly stemming from the inclusion of multiple FDA trials designed for non-inferiority. However, the average physician will not even appreciate the significance of that. Unfortunately, these types of the results, in top diabetic literature, hold significantly more weight with prescribing physicians thanindividual patient success stories. This was passed along by an endocrinologist colleague of mine (delivered to their inbox this morning). Studies like this, combined with lack of coverage, makes me continue to think it will be a slow adoption and expectations should be tempered. I stared at the results. I was not sure I was reading it correctly. www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm390865.pdf
Does medicine have a way to work with; "your results may vary?" Is there/are there established channels for real world observation? Physicians order and receive the lab work. Physicians have the patient contact. Attachment Deleted
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Post by curiousdoc on Sept 11, 2015 13:30:08 GMT -5
I'm not discounting them, Harrys. However, with these results there is absolutely no reason to change a patient from SubQ with a less than ideal A1C if they are not already struggling with hypos. I, too believe in the science of this drug, but the "mounting evidence" you speak of does not yet exist in a form that doctors will accept. And it will take an impressive study to one-up a meta-analysis. Your statement has a little too much blind optimism for me. That said, even getting to advertise less hypos would be a plus. I agree there are many obstacles still left. The mounting evidence I'm hoping will go from anecdotal reports to in the lab research. It's funny that you would mention "too much blind optimism" I posted for the first time in a while on this board today and am now being attacked for my hidden FUD agenda... be careful what you post here. I am VERY cautiously optimistic here but will be the first to admit things are not going the way I would like it. I am also new here, and even had to look up FUD. I was by no means attacking you personally. I am just trying to evaluate things as objectively as I can as I mull adding to my position, which was started very recently compared to many of the posters here. And while not constant, there is quite a bit of "Ra-Ra" floating around without any real backing. I think we are all hoping for that translation to clinical research, doesn't mean its imminent. |
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Post by cjc04 on Sept 11, 2015 14:18:11 GMT -5
Inhaled insulin: weighing the pros and cons Published online: September 1, 2015 Giuseppe Derosa, Pamela Maffioli The Lancet Diabetes & Endocrinology www.thelancet.com/journals/landia/article/PIIS2213-8587(15)00317-4/abstractEfficacy, safety, and patient acceptability of Technosphere inhaled insulin for people with diabetes: a systematic review and meta-analysis Published online: September 1, 2015 Anastassios G Pittas, Gregory P Westcott, Ethan M Balk The Lancet Diabetes & Endocrinology www.thelancet.com/journals/landia/article/PIIS2213-8587(15)00280-6/abstractConclusion: "Glycaemic efficacy of Technosphere inhaled insulin is lower than that of subcutaneous insulin, but inhaled insulin has a lower risk of severe hypoglycaemia and weight gain. Long-term outcomes and safety with Technosphere insulin should be further investigated. Until further data for safety become available, Technosphere inhaled insulin should be reserved for healthy adults with diabetes who do not have pulmonary disease and who would otherwise delay initiating or intensifying insulin therapy because they are unwilling or unable to use injectable insulin." Meta-analysis are generally regarded at the top of the evidence based pyramid. I realize there are flaws in this, mainly stemming from the inclusion of multiple FDA trials designed for non-inferiority. However, the average physician will not even appreciate the significance of that. Unfortunately, these types of the results, in top diabetic literature, hold significantly more weight with prescribing physicians thanindividual patient success stories. This was passed along by an endocrinologist colleague of mine (delivered to their inbox this morning). Studies like this, combined with lack of coverage, makes me continue to think it will be a slow adoption and expectations should be tempered. I wouldn't discount the significance of "less hypos". This is a significant side effect of current insulin preparations on the market with comorbidity. A hypoglycemic visit to the hospital is a serious event for both the patient and the insurance companies bottom line. This is a "good" conclusion despite better glycemic control not being established, can't win all the battles. The mounting evidence hopefully to come should be enough to tip the scale in favor of coverage and adoption by Endos and GPs. Totally agree,,,, "less hypo's" (arguably should be NO hypo's) AND less weight gain are big concerns.... My wife, 38 yrs old, was diagnosed type 1, 10 years ago. She's put on 25 lbs (she was 5' 8" 130 lbs) that she can't get rid of and struggles with hypo's in the middle of the night, a couple time a week..... Solving only those two issues would change her life. Her appt to DEMAND Afrezza is in 3 weeks. |
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Post by peppy on Sept 11, 2015 14:23:36 GMT -5
I wouldn't discount the significance of "less hypos". This is a significant side effect of current insulin preparations on the market with comorbidity. A hypoglycemic visit to the hospital is a serious event for both the patient and the insurance companies bottom line. This is a "good" conclusion despite better glycemic control not being established, can't win all the battles. The mounting evidence hopefully to come should be enough to tip the scale in favor of coverage and adoption by Endos and GPs. Totally agree,,,, "less hypo's" (arguably should be NO hypo's) AND less weight gain are big concerns.... My wife, 38 yrs old, was diagnosed type 1, 10 years ago. She's put on 25 lbs (she was 5' 8" 130 lbs) that she can't get rid of and struggles with hypo's in the middle of the night, a couple time a week..... Solving only those two issues would change her life. Her appt to DEMAND Afrezza is in 3 weeks. I think the patient population has been under estimated. I think they want to be given the opportunity to try Afrezza. A movement. Shhhh. (Like the first to leave Syria two years ago.)
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Post by peppy on Sept 11, 2015 14:45:47 GMT -5
I'm not discounting them, Harrys. However, with these results there is absolutely no reason to change a patient from SubQ with a less than ideal A1C if they are not already struggling with hypos. I, too believe in the science of this drug, but the "mounting evidence" you speak of does not yet exist in a form that doctors will accept. And it will take an impressive study to one-up a meta-analysis. Your statement has a little too much blind optimism for me. That said, even getting to advertise less hypos would be a plus. 1. Struggling with hypo's would be a good reason?
2. Consider: what if the reason is patient demand? Consider a movement.
3. What has changed is we can see. The patient can see. Consider things have changed. Attachment Deleted
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Post by mnholdem on Sept 11, 2015 14:56:41 GMT -5
I'm not discounting them, Harrys. However, with these results there is absolutely no reason to change a patient from SubQ with a less than ideal A1C if they are not already struggling with hypos. I, too believe in the science of this drug, but the "mounting evidence" you speak of does not yet exist in a form that doctors will accept. And it will take an impressive study to one-up a meta-analysis. Your statement has a little too much blind optimism for me. That said, even getting to advertise less hypos would be a plus. I agree there are many obstacles still left. The mounting evidence I'm hoping will go from anectodal reports to in the lab research. It's funny that you would mention "too much blind optimism" I posted for the first time in a while on this board today and am now being attacked for my hidden FUD agenda... be careful what you post here. I am VERY cautiously optimistic here but will be the first to admit things are not going the way I would like it. It's unfortunate that the trial protocols required patients to administer Afrezza BEFORE eating rather than at the beginning of the meal. I think the Glycaemic efficacy numbers would have been considerably better had Afrezza been administered and dosed correctly.
Unfortunately it's water under the bridge at this point and, hopefully, Sanofi is busy gathering real-life data to undo the "damage". Overcoming the "ho-hum, it's the same as the others" effect of the trial reports is crucial to getting physicians and insurers on board. I don't think attracting diabetics will be a problem, but they listen to their doctors and are at the mercy of their healthcare plans.
Sanofi must demonstrate - using empirical evidence - how and why Afrezza is a superior treatment for T2 and T2 diabetes.
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Post by esstan2001 on Sept 11, 2015 15:26:20 GMT -5
cj04- hope it all works out well for your wife. best of luck.
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