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Actos Effective in Late-Stage Type 2 Diabetes

16% Lower Combined Risk of Death, Heart Attack, Stroke

Good for Late Diabetes, Good for Early Diabetes?

If Actos helps people with advanced diabetes, might it be more useful earlier in the course of the disease?

The current study does not answer this question. It does, however, provoke speculation.

"The trial was carried out in end-stage diabetics: those who already had evidence of heart disease or minor strokes or whatever," Dormandy says. "If it works for them, it would be extraordinary if it didn't work in type 2 diabetes patients who were earlier in the course of the disease. But that remains speculation. We didn't prove it in this study."

Dormandy notes that during the three-year study, patients who took Actos were only half as likely to start taking insulin as those receiving placebo. That's good news for patients who want to avoid the daily shots.

Yki-Järvinen, however, says patients really should not fear insulin. It's a natural product, she says, and works much better than diabetes drugs.

"The evidence for insulin reducing heart attacks is much better than for this drug," Yki-Järvinen says. "If you use modern, long-lasting insulin, you get good results. And insulin is a natural drug. Of course if you use this pill, it is going to postpone the start of insulin therapy. But insulin itself is not something you have to avoid. One shot a day is no big deal. But this pill is an alternative."

Do Actos Findings Apply to Avandia?

Actos is a member of a family of drugs sometimes called glitazones and sometimes called thiazolidinediones or TZDs. Avandia is another member of this family, and is also currently used to treat high blood sugar in diabetes.

But all these drugs don't work exactly the same. Another glitazone, Rezulin, had to be taken off the market because of severe liver toxicity. Actos and Avandia aren't nearly as hard on the liver -- and Actos actually helps rid the liver of excess fat.

"Although Actos and Avandia are in the same class, there are very significant differences," Dormandy says. "So I think to say that other TZDs necessarily have the same benefit as Actos would be very rash. But they are testing it, and I hope it works."

It's not an academic question. More than one in five Americans with diabetes takes a glitazone drug. Many combine it with insulin -- yet no clinical trial has yet shown whether this actually works.

"This is in a way scary, because there is no study of this," Yki-Järvinen says. "Everyone would like to know if you can use Actos safely when combined with insulin. Unfortunately, this study did not address that question."

The Dormandy study was funded by Takeda Pharmaceuticals and Eli Lilly Co., which jointly market Actos. Eli Lilly is a WebMD sponsor.

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