Related Editorial: Intention to Treat...

Related Editorial: Intention to Treat - Initiating Insulin and the 4-T Study

There are 2 comments on the New England Journal of Medicine story from Sep 24, 2007, titled Related Editorial: Intention to Treat - Initiating Insulin and the 4-T Study. In it, New England Journal of Medicine reports that:

Published at www.nejm.org September 21, 2007 Intention to Treat - Initiating Insulin and the 4-T Study Graham T. McMahon, M.D., M.M.Sc., and Robert G. Dluhy, M.D. The normalization of glucose levels plays an ... via New England Journal of Medicine

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Tom Hunter

Somerville, MA

#1 Sep 27, 2007
Nice editorial - clarifies the role quite nicely
Googler

Renens, Switzerland

#2 Oct 2, 2007
Although certainly addressing a question of greatest interest, most of the study results and part of the editorial's conclusion seem at least questionable. In addition, the study design itsself does not necessarily include current "best practice".

First, comparability of the incidence of (self-reported) hypoglycemias is severely limited as therapies with basal or mixed insulin preparations mostly exhibit hypoglycemias during the early night and hypoglycemias at that time are naturally mostly not reported by the patients.

Second, sulfonylureas are normally stopped when therapy with prandial insulin thrice daily or with mixed insulin twice daily is started but is commonly continued when only basal insulin is added. Again, the study practice to continue sulfonylureas may have considerably negatively affected incidence of hypoglycemia in the two groups containing short-acting insulin.

Third, patients with diabetes differ in their insulin requirements. Some(or most)are more prone to postprandial glucose excursions whereas others more to glucose excursions due to hepatic gluconeogenesis during the night (especially those not on metformin). And some may start very well with one short-acting injection in the morning together with a sulfonylurea which may be sufficient to cover the rest of the day. Therefore, a forth group where therapy is adapted according to the actual insulin requirement and not to a giving scheme would probably show the best A1c with the lowest incidence of hypoglycemia.

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