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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
"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
