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Kathy,

Even if the EMEA says that Levemir was tested against NPH, that doesn't mean they're similar. They're clearly not. Or am I missing something -- NPH clearly does not have a 24-hour duration or a flat peak.

They may have the same suspension, or be in the same line, but that's not the way we've been using "Similar to" in our other insulins.

What I thought "similar to" meant was that you could substitute one for another, and get a similar peak, duration, and onset. (i.e. Lantus) If you stretch it to say that they're made of similar materials, or shared some test trials, you have to list every single insulin in the list!

Can you please remove NPH and isophane from the list, or revert to my clarified version, in the box?

Thanks, Steve

Similar /Efficacy Edit

We hope 00:10, 13 Dec 2005 (UTC)

Steve,

Could it be that in the cases of the analog insulins, since there are truly none which are similar to another, we could use the term efficacy for them, meaning Humalog has the same efficacy as both Novolog and Apidra. They are each rapid-acting insulins but are altered in differing ways to produce roughly the same result. Some people are able to use one over the other more successfully, due to the alteration differences.

Effectiveness or non-inferiority is what needs to be proven to any approval body. Aventis chose to test Lantus against ultralente "for the record", Novo chose to test against NPH. I'd read Novo as being the more realistic of the two, as Aventis still will not admit that one shot a day of Lantus does not fit all. Those who need it twice daily use it off label. Novo's literature refers to the need for one or two shots per day with Levemir. When used as a basal, NPH is normally two shots a day. The majority of the pre-approval tests for type 1 conducted were with the use of both NPH and Levemir 2X per day. Only of the "one shot" trials was for type 1 diabetes; the others 2 were for type 2.

Maybe we need to classify the analog insulins differently--and just present them as either rapid-acting, intermediate acting or long-acting--what do you think?

Kathy

You're right, they're not really similar in structure to anything else. Similar in efficacy might be useful for the FDA's purposes but not really for pet owners. As far as I can think, the main points of similarity that matter to our readers are onset, peak, and duration. I'd consider two insulins similar if this chart said so. We already have a long- short- intermediate classification in the box, so why not use the "Similar to" as a way to find alternate insulins that might meet our needs if our main one is unavailable for some reason?
For example, Humalog and Novolog both work by making self-bonding into hexamers difficult by altering position B28. One swaps an amino acid with its neighbor, the other substitutes it. So molecularly they're not similar, but in effect and speed of delivery, they are. And if I ran out of one, I'd likely look for the other. That's useful information, no? Another insulin in the same classification, but that had a somewhat different action profile, would maybe not be so "similar" and I wouldn't want it listed that way.

Levemir/Lantus.... Edit

We hope 01:19, 14 Dec 2005 (UTC)

You're right in the respect that both are long-acting and ALL are completely unique. I believe it will be a case with Levemir as with Lantus, meaning some will do well with 1 shot and others will need 2. Therefore, for some it will be intermediate-acting and others long. Novo was perhaps the smarter of the two; they covered themselves by testing it against NPH and went head to head with the #1 basal insulin. (More people use it than Lantus.) UL in both people and dogs was not popular, due to its unpredictability in both. Therefore, it wasn't difficult for Aventis to beat UL with Lantus.

Those who have given NPH and/or Lantus a try are likely going to head for Levemir if they're not happy. Here they will need to wait until March, says the grapevine.

Kathy

Adding PZI To Similarities Edit

We hope 19:19, 14 Dec 2005 (UTC)

Steve, just thought--duration-wise, PZI would be similar. What do you think about adding it here and also to Lantus information?

Kathy

I wouldn't, but if you want to, I won't complain. It seems somehow wrong to me, but I don't think I could argue it successfully :)

More than one pharmacodynamic action?Edit

I read through the EU submission and couldn't find any reference to more than one pharmodynamic action except this negative one:

Whereas other insulin analogues do not have secondary pharmacodynamic effects, insulin detemir is chemically modified through the covalent binding of myristic acid to the ε-amino group of the Cterminal lysine in the B-chain (B29). To investigate whether this chemical modification could lead to unexpected effects, a battery of screening tests comprising 64 different receptors and subtypes has been performed. Insulin detemir had no functional activity in any of these tests.
In safety pharmacology tests, insulin detemir caused slight CNS depression, slight increases or decreases in blood pressure and a transitory decrease in urine specific gravity that likely were the result of treatment-induced hypoglycaemia.

So unless you're referring to a bit I missed elsewhere, maybe that wording should be changed. Detemir was not shown to have a secondary pharmacodymic action that I can see. --Steve and Jock 18:59, 15 Dec 2005 (UTC)

Changing activity info Edit

We hope 17:29, 17 Dec 2005 (UTC) Sorry about this, was reading the pdf on a postage-stamp size monitor (rapidly approaching blindness). Now that I can read it properly, I certainly do agree and will be editing this.

Kathy

Cool -- I noticed you found the interesting bit about different concentrations -- I extended your note to how the efficacy varied among other species, since of course we're dealing with a couple of them ourselves. --Steve and Jock 19:35, 17 Dec 2005 (UTC)

"I solemnly swear that I am a healthcare professional" Edit

The Novo Nordisk attempt to hide any useful information from non-healthcare professionals, especially if they're from the US, must say something about the legal liabilities in the US. I wonder if it's necessary to avoid being sued somehow?