Insulin degludec (Tresiba) and insulin degludec/aspart, (Ryzodeg) approved by FDA, with some concerns....
Ok, the no-voting panelist who's most quoted in the article, Erica Brittain, isn't a doctor, but a statistician! Maybe we need to look closely at at that part of the approval process! I sense an opportunity to reduce the federal budget!!
My endos participated in trials with degludec (Tresiba) and were pleased about the outcome. It is really hard to outweigh the risk reduction of having a lower frequency of lows and more stable control with a potential risk of heart disease (so far only statistical indications).
Press Releases about Degludec: "Hypoglycaemia, and particularly night-time hypoglycaemia, is a major concern for people living with diabetes and the principal limiting factor to effective glucose control, thereby increasing their risk of long-term complications. The reduction in rates of nocturnal hypoglycaemia with insulin degludec will hopefully allay some of this concern and encourage patients and physicians to aim for more ambitious glucose targets". However the FDA indicated in some reports that they have doubts about these benefits. I am a bit critical here because the German drug administration even failed to proof the benefits of analog insulins at all. How laughable is that?
Degludec (Tresiba) has a duration of action that lasts up to 40 hours. It is a modified insulin that has one single amino acid deleted in comparison to human insulin, and is conjugated to hexadecanedioic acid via gamma-L-glutamyl spacer at the amino acid lysine at position B29.
Levemir in contrast is an insulin analogue in which a fatty acid (myristic acid) is bound to the lysine amino acid at position B29.
I think we always have to be careful about approving drugs, particularly ones that might be used by millions. Here is what the studies showed about the heart risks:
A meta-analysis of 16 clinical studies found that degludec products could increase the composite risk of cardiovascular death, nonfatal MI, nonfatal stroke, and unstable angina by 10% relative to active comparators, FDA reviewers wrote in briefing documents ahead of Thursday's Endocrinologic and Metabolic Drugs Advisory Committee meeting.
We all remember what happened with Avandia. And we will only have statistical indications of an association between the drug use and heart disease. The real problem is that a controlled study can find a problem far less harmful and more precise than just releasing a drug and looking for any bad outcomes.