Doctors hopeful easier blood thinners are nearing

From the Associated Press:
A trio of experimental drugs has doctors hopeful that for the first time in decades, millions of people at risk of lethal blood clots may soon get easier treatment.

The first goal is a pill option for people who now need daily blood-thinning shots for weeks after knee or hip replacement surgery.

But the ultimate goal is an alternative to that old standby warfarin, also called Coumadin, the nation's most troublesome lifesaver because of side effects and restrictions its 2 million users face.

Now in late-stage testing in thousands of Americans are three pills that work to prevent blood clots in ways that promise to be less burdensome. One of the trio, Boehringer Ingelheim's Pradaxa, just began selling in Europe.

The drug research comes as Medicare is considering withholding payment from hospitals when at-risk patients develop clots in their veins, usually the legs — a common preventable cause of hospital deaths. The National Quality Forum has estimated that only about a third of patients who need protective blood thinners while hospitalized get them.

Known medically as a "deep vein thrombosis" or DVT, such a clot can kill quickly if it moves up to the lungs. There aren't good counts, but recent estimates suggest that about 900,000 people a year suffer a vein clot, and nearly 300,000 die. Being immobile for long periods, such as during hospitalizations or even long airplane flights, can trigger a clot. Vice President Cheney suffered one after a long trip last year. NBC correspondent David Bloom died of one in 2003 after spending days in a cramped military vehicle while covering the invasion of Iraq. ...more

New Anti-Clotting Pill Works Well in Trials

From the Washington Post:
A new anti-clotting drug that could be one of the long-sought alternatives to commonly used blood thinners has performed well in hip and knee replacement patients, physicians report.

The drug, rivaroxaban, was more effective at reducing potentially fatal blood clots than heparin, with no increase in side effects, according to studies by three research teams reporting this week in theNew England Journal of MedicineandThe Lancet.

"It was superior to low molecular weight heparin, one of the two most common prophylaxis modalities in the United States," said Dr. William Geerts, a professor of medicine at the University of Toronto, and a member of a team that tested rivaroxaban after hip replacement surgery.
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Prophylaxis in this case means prevention of blood clots. Heparin is commonly used in hospitals because it is easier to manage than Coumadin (warfarin), which requires frequent blood tests for close control. The new drug, rivaroxaban, is an easily swallowed pill that does not require constant monitoring.

In the international trial of 4,541 people who had hip surgery, 1.1 percent of those given rivaroxaban suffered problems such as deep-vein blockage or pulmonary embolism, compared to 3.7 percent of those given enoxaparin, a widely used form of heparin. The incidence of major bleeding was similar in both groups -- six of 2,209 for rivaroxaban, and two of 2,224 for enoxaparin. ...more

J&J, Bayer Pill Caused Fewer Clots Than Sanofi Drug in Study

From Bloomberg:
Bayer AG and Johnson & Johnson's experimental blood thinner led to fewer clots and deaths in patients after hip surgery than a widely used therapy sold by Sanofi-Aventis SA, a study found.

About 1.1 percent of patients had serious blood clots or died on the Bayer and J&J pill, rivaroxaban, compared with 3.7 percent of those taking Sanofi's injected medicine, Lovenox, according to research reported today at the American Society of Hematology meeting in Atlanta. Both drugs had similar rates of bleeding, a side effect of anti-clotting medications.

Rivaroxaban may help J&J and Bayer take market share from the injectable Lovenox, Sanofi's best-seller with $3.5 billion in sales last year. Bayer, Germany's largest drugmaker, asked European regulators to allow sale of the drug under the brand name Xarelto in October, and has projected peak sales of $2.9 billion. J&J, of New Brunswick, New Jersey, has said it will seek U.S. marketing approval in the second half of 2008. ...more

Bayer plans largest-ever study for blood-clot drug

From Reuters:
Bayer is planning a late-stage study for its promising blood-clot drug rivaroxaban for hospitalised patients with internal diseases, the German drugs and chemicals group said on Tuesday.

"It is planned for a total of about 50,000 patients to take part in these studies, making it the largest clinical study programme Bayer has ever undertaken," Chief Executive Werner Wenning told reporters. Wenning said rivaroxaban, which the company wants to market under the trade name Xarelto, is the most promising product in its pipeline.

Rivaroxaban's current indications are prevention of venous thromboembolism, treatment of deep-vein thrombosis, stroke prevention in atrial fibrillation and acute coronary syndrome. ...more

Bayer's blood-clot drug beats Lovenox in key study

From the Scotsman (UK):
Bayer AG's experimental pill rivaroxaban is significantly more effective than standard injections of Lovenox in preventing blood clots after knee surgery, researchers said on Sunday.

The news confirms the German drugmaker's leadership in the multibillion-dollar race to bring a new class of oral anticoagulants to market.

Results of a large Phase III trial showed only 9.6 percent of patients given rivaroxaban experienced venous thromboembolism (VTE), or blood clots, following total knee replacement against 18.9 percent of those on Sanofi-Aventis SA's Lovenox. ...more

New clot drugs beckon as replacements for warfarin

From Reuters:
A new crop of medicines to prevent stroke and blood clots could emerge within several years, easing dangers and hardships for patients and creating blockbuster sales for drugmakers.

The oral drugs could prove better and safer than injectable medicines such as heparin now widely used to cut the risk of dangerous blood clots in the legs and lungs after major surgery.

But makers of the new drugs say their biggest use would be as an alternative to warfarin, a pill used for decades by people with atrial fibrillation -- or irregular heartbeat -- to prevent strokes. An estimated two million Americans have been diagnosed with the heartbeat problem and the number is expected to double in the next 20 years. ...more