Patients vexed by Vytorin study
Consumers confused after learning that the drug, which combines two cholesterol-lowering medications, may be no more effective than one of them alone.
TRENTON, N.J. (AP) -- Heart patients can hardly miss the barrage of "food and family" TV ads claiming the drug Vytorin lowers cholesterol from two sources - what you eat and what your body produces due to your genes.
So many patients were stunned when Vytorin's makers, Merck & Co. and Schering-Plough, on Monday finally released results of a study meant to show how well Vytorin reduced plaque buildup in neck arteries in people whose genes gave them stratospheric cholesterol. Instead, it showed $100-a-month Vytorin, which combines Zocor and Zetia, was no more effective and perhaps a bit worse than Zocor alone, which is sold as a generic for a third as much.
Confused, patients around the country taking Vytorin or Zetia called and e-mailed doctors, wondering if they should switch drugs.
"I was concerned," said Orville Crook, 68, of Chesapeake, Va., who takes Vytorin and before that was on Zocor and Zetia together for years.
A retired chief financial officer for a grocery chain, he was particularly worried because he's had a heart attack and a blocked artery cleared out - and his father died at 65 of a cerebral hemorrhage after surgery to open a blockage in his neck, or carotid, artery.
"I was concerned that the report said [Vytorin] didn't keep the plaque from building up" more than Zocor and perhaps it was building up in my arteries, he said Friday.
He called his doctor, John Brush of Cardiology Consultants in Virginia Beach, Va., who noted Crook's level of bad or LDL cholesterol was down from when he took just Zocor years before.
"He said unless his patients wanted to, he wasn't recommending patients change," Crook said. "I've gone along with him."
Brush also told Crook results of three large tests of whether Vytorin reduces risks of heart attack, stroke and death from heart disease - more crucial measures - will be out in a few years.
Such risk reduction has been proven in Lipitor and to some extent Zocor and other drugs in the widely used class called statins. It's believed they do that by boosting so-called good or HDL cholesterol and reducing artery inflammation and fats called triglycerides, on top of lowering bad cholesterol. Zetia, in a different drug class, is only proven to cut bad cholesterol.
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Those distinctions have led to differences in how heart specialists interpret results of the Vytorin study.
They agree heart patients should not stop taking their medicine without consulting their doctor and that more information is needed.
"I think it's fair to say that no one's going to be starting new patients on Vytorin and Zetia," Brush, whose office is getting 20 calls a day from worried patients, added in an interview.
Whitehouse Station, N.J.-based Merck and Kenilworth, N.J.-based Schering-Plough, which jointly market Vytorin and Zetia, released only limited data from the study, which ended in April 2006. They blamed the delay on the complex analysis, but doctor critics have accused them of first trying to change how the results were analyzed, then foot-dragging because the two drugs bring in several billion dollars a year.
Merck and Schering-Plough took the rare step of releasing partial results in a press release rather than full disclosure in a scientific journal or medical conference - after a congressional committee began probing the delay and what it termed "the use of misleading statements in direct-to-consumer advertisements."
The American College of Cardiology quickly put out a statement saying patients should not panic and that further research is needed to determine the best cholesterol-cutting strategy.
Health insurers reviewed the news release, but said their formularies of preferred drugs already favor Zocor and two other generics with lower co-pays, so they don't expect wholesale shifts of patients off Vytorin or Zetia until further data is available.
But Dr. Harlan Krumholz, a Yale School of Medicine cardiology professor, said if patients are taking Zetia "in place of a drug that we know improves outcomes, then that's a form of harm."
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Dr. Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic Foundation, has a similar view.
"I am advising physicians not to use Vytorin or Zetia as first-line drugs," reserving them for patients who don't respond to or can't tolerate statins, Nissen said.
Krumholz added lowering cholesterol levels doesn't prove that risk is being reduced, noting a promising Pfizer drug that increased good cholesterol turned out to raise risk of heart attack and death; Pfizer (PFE, Fortune 500) abandoned it.
Dr. Michael Davidson of the University of Chicago Pritzker School of Medicine, a longtime consultant and lecturer for both Merck (MRK, Fortune 500) and Schering-Plough (SGP, Fortune 500) who spoke on behalf of them, said the study didn't answer the questions posed because the patients taking Vytorin and Zocor both had little plaque buildup. He said statins should still be the first choice, but that some patients need Vytorin or Zetia to reach their cholesterol goals.
作者:admin@医学,生命科学 2011-04-29 17:14