Yale cardiologist Harlan Krumholz takes on the Abbott Laboratories lipid drugs TriLipix and TriCor in Forbes. Pointing to big growth in sales of the two drugs--28 percent year-over-year, to $372 million for the first quarter--Krumholz notes that they are "particularly good at lowering triglyceride levels." Which is good, right?
Not so fast, Krumholz says. Fibrate drugs such as TriLipix and TriCor do have a good effect on laboratory test results. But do they have any effect on actual outcomes? While a better lab result might transiently bring a smile to your face," Krumholz writes, "ultimately you care more about what happens to you in the long-run--and you are only smiling because you think it is an indicator of your health and future risk."
No stranger to controversy, Krumholz is a major proponent of outcomes research. He's also outspoken about drugs whose results he considers questionable. He recommended against Merck's Vytorin combo pill--which combines the statin drug Zocor with another Merck cholesterol fighter, Zetia--after it failed to outperform Zocor in one study.
There are two major outcomes studies of Abbott's fenofibrate, Krumholz says, and the results haven't been promising. One National Institutes of Health trial found no benefit from adding the drug to a statin. The American Heart Association recently determined that the benefit of lowering triglycerides with drugs "is not known," he says. And despite this, many experts maintain that the fibrate drugs do help patients. Will Krumholz's questions change anyone's mind? An FDA advisory panel meets later this month to talk about the recent fibrate-statin combo study, so we might get an indication then.
- read the Forbes column