THE LOW CARB DIABETIC

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THE LOW CARB DIABETIC

Promoting a low carb high fat lifestyle for the safe control of diabetes. Eat whole fresh food, more drugs are not the answer.


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    The Newly Approved Basal Insulin Tresiba's Label Is Disappointing

    Jan1
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    The Newly Approved Basal Insulin Tresiba's Label Is Disappointing Empty The Newly Approved Basal Insulin Tresiba's Label Is Disappointing

    Post by Jan1 Tue Oct 20 2015, 22:59

    Saw this article on the excellent Jenny Ruhl blog. Jenny  was diagnosed with diabetes in 1998. Since then she's kept her A1cs in the 5.0-6.0% range.

    "We have been hearing for quite a while about the benefits of Novo Nordisk's new, longer acting basal insulin, Tresiba, whose approval was delayed for a year while the FDA waited for cardiovascular safety data .

    Well, the FDA finally approved it last week. And lo and behold, none of the main claims that have been made for Tresiba until now appear in the official, FDA-sanctioned Prescribing Information (PI), A.K.A. "label."

    You can read the whole PI/label here:  http://www.novo-pi.com/tresiba.pdf

    The hype was that Tresiba caused fewer hypos than existing basal insulins. If this is so, it is not demonstrated anywhere on the label. There were hefty hypo rates reported in 6 of the 7 studies summarized in the label. The percent of of people in these studies who had hypos where blood sugar dropped below 56 mg/dl via a blood sugar meter test were: 46.5%,  28.5%,  50%,  43.8%,  50.9%,  80.9% and 42.5%.  (Page 9 of the PI)

    There is no way to directly compare these studies with studies of other basal insulins, as it is clear that there is really no way to compare any of these studies of Tresiba with any other study of Tresiba. When you have a range of outcomes from 28.5% to 80.9%, means and medians are worthless. There is just too much variation from study to study. So comparisons with studies of other insulins that would demonstrate superiority would have to be cherry picked. I am certain, of course, that they will be. Drug salespeople are extremely good at coming up with creative ways to promote drugs in ways that are not actually substantiated by existing research.

    (It's worth noting that Toujeo's claims of causing fewer hypos were also removed from its U.S. when it was recently approved.  Toujeo is the latest incarnation of Lantus, which is being pitched as a "new" insulin though it is actually the same insulin molecule as is found in Lantus, just dressed up with a new pen and a new, higher price tag.)"

    Read more of this article here
    http://diabetesupdate.blogspot.co.uk/2015/09/the-newly-approved-basal-insulin.html
    chris c
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    The Newly Approved Basal Insulin Tresiba's Label Is Disappointing Empty Re: The Newly Approved Basal Insulin Tresiba's Label Is Disappointing

    Post by chris c Wed Oct 21 2015, 21:00

    Some of the best controlled Type 1s I know have turned, or returned, to Beef Lente as a basal. Yet most GPs and many Endos refuse to believe it is available.

    In the US it is actually illegal to possess - UNLESS you import it yourself, for personal use only, which you can only do after filling in a load of government paperwork. Such is the hold of Big Pharma over reality.
    graham64
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    The Newly Approved Basal Insulin Tresiba's Label Is Disappointing Empty Re: The Newly Approved Basal Insulin Tresiba's Label Is Disappointing

    Post by graham64 Wed Oct 21 2015, 21:49

    The cost of drugs and insulin for diabetics is spiraling out of control throwing Tresiba into the mix is just another cynical attempt to line the pockets of big pharma.


     Infographic: Diabetes drug costs rising at staggering rate

    http://medcitynews.com/2015/08/infographic-diabetes-drug-costs-rising-at-staggering-rate/?rf=1

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    The Newly Approved Basal Insulin Tresiba's Label Is Disappointing Empty Re: The Newly Approved Basal Insulin Tresiba's Label Is Disappointing

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