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Question:

From Juno.com:

Has the combination of using Rezulin and Glucophage together been approved yet? On a website I was looking at, someone claimed approval by the FDA has not happened yet.

Answer:

Rezulin (troglitazone) and Glucophage (metformin) are both pills for treating Type 2 diabetes. Both work well in many cases to control high blood sugar, and both have side effects (which are different for the two different pills). Rezulin/troglitazone is approved (by the US FDA) for use with insulin, and for use with sulfonylurea medications, as well as by itself ("monotherapy"). Glucophage/metformin is approved for use as monotherapy and together with sulfonylureas.

These pills are completely different from the older, well-established sulfonylurea diabetes pills, and from the recently approved diabetes pill called Precose (acarbose). There's also another diabetes pill coming soon: Prandin (repaglinide).

Preliminary studies have been done that show that troglitazone and metformin when used together are highly effective in blood sugar control. Larger clinical trials are presently underway to demonstrate to the FDA that these drugs should have FDA approval for use in combination with each other.

Since both drugs are available (in the USA; troglitazone has been withdrawn from the UK and European markets) and since it's completely legal for physicians to use approved drugs for "off-label" indications (that is, for reasons that are not approved by the FDA), many diabetes doctors have started using all four types of diabetes pills in varying combinations, including combinations with insulin, individualizing therapy to the patient's exact needs. This sort of combination therapy works well, and I compare modern-day diabetes therapy to making soup: we can treat the patient's diabetes with bean soup, pea soup, carrot soup, or tomato soup, or create specialized blends of vegetable soup as appropriate for the individual circumstances.

WWQ

Original posting 13 Jan 98

  
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Last Updated: Tuesday April 06, 2010 15:08:56
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