Bristol's Plavix May Be Used for Years, Not Months, Doctors Say
By Michelle Fay Cortez
Nov. 15 (Bloomberg) -- Heart patients who get drug-coated stents implanted to prop open clogged arteries are being told for the first time they may have to spend years, instead of months, taking Plavix, a blood thinner from Bristol-Myers Squibb Co. and Sanofi-Aventis SA.
Labels on the stents say use of Plavix, the world's second- biggest selling drug in 2005 with $6.3 billion in sales, is needed for three to six months. American Heart Association guidelines suggest the $4-a-day pill be taken for up to 12 months. About 850,000 Americans will get the stents this year.
Several private cardiologists interviewed this week at the association's meeting in Chicago said they're telling patients they may have to take the drug for years, and perhaps a lifetime, after recent data linked stents to deadly blood clots. And officials of the nation's two top heart groups say they're planning a new public campaign that will begin within weeks urging that stent patients stay on Plavix.
``We're up in the indefinite range for some of our patients,'' said David O. Williams, a cardiologist at Rhode Island Hospital in Providence. ``That's not because we know the answer, but because we don't know the answer. I think a little bit out of ignorance, and a bit to get the doctors off the hook, we have to move to indefinite treatment.''
The recommendations from doctors and heart groups may boost Plavix sales for Bristol, which markets the drug in the U.S., as it struggles to recover from a controversial flood of generic copies earlier this year. Worldwide sales of Plavix, which reduces the risk of heart attacks and strokes, plunged 36 percent to $630 million in the third quarter.
Shares of Bristol-Myers fell 4 cents to $24.40 at 2:10 p.m. today in New York Stock Exchange composite trading.
Legal Dispute
Bristol-Myers is embroiled in a legal dispute with closely held Apotex Inc. over a patent that expires in 2011. Apotex argued the Plavix patent is invalid. In August, three weeks after the Canadian company began selling a cheaper version of the blood thinner, a judge ordered Apotex to halt the shipments. A trial is set for January.
``It's almost inevitable that Plavix use is going to go up,'' said Les Funtleyder, an analyst at Miller Tabak in New York, in a telephone interview today. ``If you're moving this out to an indefinite time period, that changes things a lot.''
Still, it's not clear how long patients will follow their doctor's orders, even with the encouragement of major U.S. groups, such as the American Heart Association, he said.
``Getting people to take medications for a long time isn't easy,'' Funtleyder said. ``Recommendations are really important, but getting patients to comply is going to be harder.''
Bristol-Myers
Bristol-Myers said the company currently recommends use of Plavix for as long as one year when it is taken with aspirin, company spokesman Ken Dominski said today in a telephone interview. Dominski would not say how many Plavix prescriptions are being filled by patients with stents.
The market for stents, which prop open clogged heart arteries, is expected to top $6 billion this year, analysts say. About five million people worldwide have received drug-coated stents, often in more than one blood vessel.
Plavix, given after patients get angioplasty and stents to prop open their clogged arteries, reduces the risk of heart attacks and strokes.
The jury is still out on whether the drug-coated stents increase the risk of late blood clots known as thrombosis, said Williams, a professor of medicine at Brown University in Providence. Still, it's better safe than sorry.
`Reasonable to Do'
``I think it's a reasonable thing to do at this point,'' Williams said in an interview this week at the American Heart Association's annual meeting. ``I'd rather err on the side of protecting the patient than having them unprotected.''
Three common reasons patients stop taking Plavix is because it causes easy bruising and bleeding, it's expensive and they just don't understand how important it is, said Sidney Smith, a spokesman and past president of the American Heart Association and director of the Center for Cardiovascular Science and Medicine at the University of North Carolina, Chapel Hill.
``Ignorance and cost ought to be things we can correct,'' Smith said.
Both the American Heart Association and the American College of Cardiology have agreed on a preliminary statement concerning use of Plavix ``that could be forthcoming in the next couple of weeks,'' Smith said in a telephone interview today.
Research that started coming out about 18 months ago show an increased risk of clotting with drug-coated stents -- about one additional case for every 200 patients treated with a drug coated device instead of a bare metal one, said Deepak Bhatt, an interventional cardiologist at the Cleveland Clinic.
Reducing Risk
``I think it would be logical to try to reduce that risk even further, if possible, with Plavix,'' he said in an interview.
Plavix, given with aspirin to high risk heart patients, can increase the risk of bleeding and the need for blood transfusions, Bhatt said. People also have to stop it when they undergo surgery. For those reasons, doctors must be careful of which patients they start on long term Plavix therapy, he said.
Samin Sharma, director of interventional cardiology at Mount Sinai Hospital in New York, extended Plavix treatment to at least three years for all patients getting drug-coated stents the first week in September. He doesn't prescribe the drug indefinitely, he said, because of the bleeding risk.
``Plavix doesn't come without a price,'' he said. ``Rather than give it indefinitely, we give it for three years and then we'll really see'' how patients do, he said in a telephone interview earlier this week.
The U.S. Food and Drug Administration is holding a meeting in December about the safety of the stents. Hopefully, the agency will address the issue of Plavix as well, Bhatt said.
``This issue of the right thing to do with Plavix duration is not going to go away,'' Bhatt said. ``Doctors are definitely looking for guidance on this issue.''
To contact the reporter on this story: Michelle Fay Cortez in Chicago at mcortez@bloomberg.net
Last Updated: November 15, 2006 14:15 EST
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