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Post by cjc04 on Sept 11, 2015 16:32:13 GMT -5
cj04- hope it all works out well for your wife. best of luck. Thank you, me too.... It's taken some convincing of her, but I think she's had enough and ready to try. |
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Post by peppy on Sept 11, 2015 16:42:27 GMT -5
With this information; Both T1DM and T2DM subjects on TI experienced lower incidence and event rates of
hypoglycemia compared with subjects on an insulin comparator. This hypoglycemia
advantage for TI-treated subjects was maintained throughout the treatment period and
remained when hypoglycemia rates were adjusted for attained HbA1c levels. www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm390865.pdf
3.Q3. What are the Glycemic Treatment Goals of DM?
3.Q3.1. Outpatient Glucose Targets for
Nonpregnant Adults
• R11. Glucose targets should be individualized
and take into account life expectancy, disease
duration, presence or absence of micro- and
macrovascular complications, CVD risk factors,
comorbid conditions, and risk for hypoglycemia,
as well as the patient’s psychological status
(Grade A; BEL 1). In general, the goal of
therapy should be an A1C level ≤6.5% for most
nonpregnant adults, if it can be achieved safely
(Table 7) (Grade D; BEL 4). To achieve this target
A1C level, FPG may need to be <110 mg/dL,
and the 2-hour PPG may need to be <140 mg/dL
www.aace.com/files/dm-guidelines-ccp.pdf
*Any Type 1 on basal and prandial insulin should be able to make a request of Afrezza from their physician.
These patients have learned to fill syringes and take blood glucose. These have learned about pumps and continuous glucose monitors. The medical profession has told these patients they need to strive for better control. They have learned the new insulin syringes and they now get a lab called an HbA1c that has important numerical values in their lives. And this new insulin, which they can see on a continuous glucose monitor does not allow their blood glucoses to go so high. Sam, Eric, Matt, Laura, these people are smart. Additionally, PWD they are not blind, they can see. 
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Post by ezrasfund on Sept 11, 2015 20:46:14 GMT -5
cj04- hope it all works out well for your wife. best of luck. Thank you, me too.... It's taken some convincing of her, but I think she's had enough and ready to try. cj04, I would suggest that you and your wife start to research the way to "dial in" the use of Afrezza, as her doctor probably will not be much help with this. Unless you have been following this story at least since Afrezza hit the market there is a lot to learn about this "easy to use" mealtime insulin. IMO the best resources are afrezzauser's blog and Matt Bendall's blog, and I think both are eager to help with advice if you reach out to them. The afrezzajustbreathe blog, started by our own compound26 will link you to them and other valuable resources. Also, of course, Sanofi's "concierge service", but they are a bit late to the party LOL. As Matt Bendall and others have said it is best to forget about the protocols of her old mealtime insulin, because Afrezza dosing is totally different. Also the way Afrezza works with her basal insulin will be different and may require adjusting those doses. As you probably know Afrezza is much more than a replacement for Humalog that is inhaled. |
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Post by suebeeee1 on Sept 12, 2015 6:06:07 GMT -5
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. Good luck with your appt. My husband had to have three appts and fire one doc in order to even get a climbing A1C addressed and a prescription for Afrezza written, without insurance coverage. However, he has found it has dropped his daily blood glucose readings (he doesn't have a continuous meter) dramatically. It took some playing with in the beginning to get the mealtime levels under control and we are looking forward to his first A1C blood test, post Afrezza, in a few weeks. I hope you have better luck with the docs than he did! But keep at it and you'll get it! |
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Post by Chris-C on Sept 12, 2015 9:39:12 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. This is an early meta-analysis that included some studies that were poorly designed to adequately measure the glycemic control offered by Afrezza. There are other studies being conducted that will hopefully provide a more compelling picture of the drug's efficacy. So, there will be additional studies and additional meta-analyses. Thus, I disagree with someone's statement that meta-analyses are the gold standard. When properly done, they can be useful, but they are second hand aggregations at best, and the range of rigor in these articles is known to be substantial. We must take this at face value for now. But the Lancet has had it's share of retractions, and has been in the limelight for controversial articles and editorials far too often for my taste. I'm still incredulous that an ill considered Lancet article helped fuel the controversy about a potential relationship between Autism and vaccines. Regards to all Chris C |
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Post by avogadro on Sept 12, 2015 10:06:48 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/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 That may be why sales are so poor, its hard to find healthy diabetics. |
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Post by peppy on Sept 12, 2015 10:36:11 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/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 That may be why sales are so poor, its hard to find healthy diabetics. hypoglycemic risk, dying from the medication that you have to take to live will over ride that. just sayin. (having to eat meats, full of fat to avoid carbs .... heart attack) Attachment Deleted
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Post by spiro on Sept 12, 2015 10:52:59 GMT -5
Actually Avogadro, Spiro believes that it's much harder to find Endo's with enough brains to figure out that Afrezza can control diabetes.
Spiro here, Let's face it, most Endo's are either slow learners or they actually don't care enough about most of their patients glucose control.
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Post by mssciguy on Sept 12, 2015 11:46:00 GMT -5
Actually Avogadro, Spiro believes that it's much harder to find Endo's with enough brains to figure out that Afrezza can control diabetes. Spiro here, Let's face it, most Endo's are either slow learners or they actually don't care enough about most of their patients glucose control. Supposedly there are a lot of Sanofi reps being trained at MGM Grand in Vegas this week (seen on another board cafepharma.com/boards/threads/afrezza-sales-training-meeting-classes.573308/ --scroll down, not fact checked but the poster says elsewhere that he lives there and called the hotel himself). Also, many upcoming reviews of Afrezza including potential superiority, convenience, Endo's are very busy too, many patients reporting 3 months or longer to get Afrezza. This has been discussed elsewhere. |
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Post by peppy on Sept 12, 2015 12:35:40 GMT -5
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.
the trial protocols required patients to administer Afrezza BEFORE eating rather than at the beginning of the meal. I have been searching for the instructions given to the trial participants regarding when to dose the initial meal time Affrezza. I found the additional dose criteria. TI-treated subjects were instructed to
administer a supplemental dose of TI if the 90-minute postprandial BG level was
≥180 mg/dL (10.0 mmol/L). For subjects in the insulin aspart group, correction doses were
allowed by protocol. www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm390865.pdf
***Anyone have the link to the trial dosing instructions?
Attachment Deleted ( In all 3 trials in insulin-using diabetics, both T1DM and T2DM, TI was associated with a
clinically meaningful reduction in severe hypoglycemia event rates from that of
comparators (20% [Trial 009], 43% [Trial 171] and 65% [Trial 102] reductions)
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Post by peppy on Sept 12, 2015 13:46:50 GMT -5
Post-Meal Sugar Peak
Two types of carbs -- sugars and starches -- are responsible for increasing your blood sugar. After you eat these carbs, digestive enzymes break them down into simple sugars, which are absorbed into your bloodstream. The pancreas responds to the influx of sugar by releasing insulin, which returns sugar levels back to normal. Blood sugar begins to rise about 20 minutes after you eat. It can peak at that time if you consumed quickly digested carbs, such as hard candy or juice. After a balanced meal containing protein, fat and fiber, blood sugar peaks about one to two hours after eating. Your blood sugar should drop back down to its lowest level two to four hours after a meal.
www.livestrong.com/article/448193-how-long-after-eating-does-blood-sugar-peak/
THE RUB, Matt told us, Afrezza keeps your blood sugar from rising in the first place. Timing is everything. How Afrezza Works: Insulin to carb ratios www.youtube.com/watch?v=oyqNBxaOGsY
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Post by peppy on Sept 12, 2015 15:02:46 GMT -5
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Post by mnholdem on Sept 12, 2015 15:27:03 GMT -5
Looks like I'm misinformed. I could swear that I read that data revealed many trial patients inhaled Afrezza too soon. It appears that wasn't the case. Good detective work.
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Post by peppy on Sept 12, 2015 15:28:59 GMT -5
Looks like I'm misinformed. I could swear that I read that data revealed many trial patients inhaled Afrezza too soon. It appears that wasn't the case. Good detective work. I read it as well. I had to look. I am glad we have it in print now. We know.
Additionally, Mannkind submitted Afrezza with the black box warning. Did I say that correctly.
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Post by savzak on Sept 12, 2015 17:51:10 GMT -5
Actually Avogadro, Spiro believes that it's much harder to find Endo's with enough brains to figure out that Afrezza can control diabetes. Spiro here, Let's face it, most Endo's are either slow learners or they actually don't care enough about most of their patients glucose control. I hope you're wrong. I hope the biggest problem we face is insurance coverage. Dealing with insurers who understand their business would be much easier for SNY than dealing with doctors who are stupid. I hope endos are smart and will prescribe Afrezza once their patients can afford it. |
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