A cholesterol drug with a dirty little secret gets one more chance

Somewhere out there, thousands of study subjects are taking a placebo.

They have no idea how lucky they are.

Recently Merck & Co. executives announced that a safety review board gave a green light for the completion of the IMPROVE-IT trial.

IMPROVE-IT is testing Merck’s Vytorin, a cholesterol- lowering drug that combines Zocor (a statin) with Zetia (a drug that blocks cholesterol absorption in the intestines).

And you might recall these two interesting details about Vytorin: 1.) It’s clinically proven to lower LDL cholesterol. And 2.) It’s clinically proven to narrow arteries.

Yeah–insane, but true.

Last year I told you about the ENHANCE STUDY. (You’ve got to love the adorable happy-face names they give these trials.) In that study, subjects with high cholesterol took either Zocor alone or Vytorin. LDL dropped in both groups, and the average thickness of artery walls increased.

And here’s the amazing part: It wasn’t a surprise.

An FDA report about ENHANCE states that, based on a previous study, researchers anticipated that Zocor would increase artery wall thickness.

Incredible, but that’s how it goes in the big time world of major drug trials. Narrowed arteries? No problemo.

It’s hard to say exactly when IMPROVE-IT will be finished, because this study has an unusual design: It will be done when the number of heart attacks, strokes, and other cardiovascular events reaches 5,250.

So far, the halfway point has been reached. That means that for 2,625 subjects, the study is already over. And you can’t help but wonder: How many of them had narrower arteries at the end than they did when the study began?

But look on the bright side: Most likely, their LDL was impressively low!

To Your Good Health,

Jenny Thompson

Source:
“U.S. Safety Panel Says Big Vytorin Study Can Go On” Ransdell Pierson, Reuters Health, 3/12/10, reutershealth.com