Actos Effective in Late-Stage Type 2 Diabetes
16% Lower Combined Risk of Death, Heart Attack, Stroke
Heart Failure a Downside? continued...
"There was two times more heart failure in patients taking Actos," Yki-Järvinen tells WebMD. "Heart failure caused by this drug may not be as bad as heart failure in general. But we don't know how bad this is when the drug causes it."
Since patients treated with Actos were less likely to die from any cause -- and no more likely to die of heart failure than those who took a placebo -- Dormandy says this risk isn't particularly significant for most people with diabetes. And it may be that doctors overdiagnosed heart failure in Actos patients because drug-associated water gain causes swollen ankles - which may also be a symptom of heart failure.
"The crucial fact is that the number of people dying from heart failure in the two groups is identical," he says. "So even if you accept that Actos causes heart failure, it obviously isn't heart failure in any serous sense because it doesn't seem to cause death."
Since only a minority of patients develops heart failure, doctors obviously would like to avoid giving Actos to those most at risk of this apparent side effect.
"But we cannot predict who that will be," Yki-Järvinen says.
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."