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Question:

From England, United Kingdom:

I have been thinking of asking my eight year old daughter's clinic about using Lantus insulin. However, I have been to a Lantus website, have just read the product information, and I am a bit concerned at the bit that says:

The findings in female mice were not conclusive due to excessive mortality in all dose groups during the study. Histiocytomas were found at injection sites in male rats (statistically significant) and male mice (not statistically significant) in acid vehicle containing groups. These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. The relevance of these findings to humans is unknown.

I find it a bit alarming that it says that "findings were not conclusive due to excessive mortality in all dose groups" it doesn't sound very good to me! Can you explain why I should or should not be concerned about this? How long are tests done for?

The other thing is the bit about the male rats and histiocytomas and this being statistically significant. Can you tell me if these factors have come up it there are any worries about using this insulin. Can I be sure that years down the line that this insulin won't be found to have some unexpected nasty side effects?

Answer:

Lantus (insulin glargine) is a relatively new insulin, available in the German and US markets for the past few years [and in the UK for a few months, as of November 2002]. It has a great benefit of being more predictable and smoother functioning than NPH, Lente or Ultralente insulin. It also has a benefit of having a relative flat action curve and so decrease the risks of nocturnal hypoglycemia while providing basal insulin functions.

There have been no known tumor risks in humans to date so you should discuss the animal research with your diabetes team and then decide if the potential benefit of this type of insulin outweighs potential risks -- as with any other medication. If you have some concerns, then, of course, there are alternative basal insulins available including Lente, NPH and insulin pumps to provide basal insulin functions.

SB

DTQ-20021029171611
Original posting 12 Nov 2002
Posted to Insulin Analogs

  
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Last Updated: Tuesday April 06, 2010 15:09:38
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