* Low-dose Xarelto cuts death risk more than 30 pct
* Trial tested drug in acute coronary syndrome
* Rival pill from Bristol/Pfizer fails separate study
* Merck's vorapaxar misses main goal, raises bleeding risk
By Bill Berkrot and Lewis Krauskopf
ORLANDO, Fla., Nov 13 Data showing the life-
saving benefits of a very low dose of a new blood clot
preventer could alter future treatment of patients who suffer
from acute coronary syndrome and provide a boost for the drug's
makers Bayer AG and Johnson & Johnson .
Results of a large, late-stage clinical trial presented on
Sunday showed the new pill, Xarelto, reduced the risk of death
by more than 30 percent in patients who have had an ACS
episode, typically a heart attack caused by a blocked coronary
artery. Xarelto was added on top of blood thinners that are now
the standard of care.
The Atlas study signals a new option for the estimated 1.2
million Americans treated for ACS each year and could open up a
market worth up to $3 billion for the drug's manufacturers. The
companies plan to seek approval for the use by year's end.
"We have seen with this trial a new standard of
anti-thrombotic therapy emerge," said Dr. Paul Armstrong,
professor of medicine at the University of Alberta, Edmonton,
who provided commentary on the Xarelto trial at the American
Heart Association scientific meeting in Orlando, where the
study's details were unveiled.
Xarelto won the battle of new blood thinners at least on
Sunday, as apixaban from Bristol-Myers Squibb and
Pfizer , and Merck's vorapaxar each failed to
meet the main goal of separate, unrelated studies presented at
the meeting attended by thousands of doctors and researchers.
In the Atlas study of 15,526 patients, those who received
2.5 milligrams of Xarelto twice a day on top of current
standard therapy had the risk of cardiovascular death cut by 34
percent and all causes of death by 32 percent compared to
patients on Plavix and aspirin, or just aspirin.
"Until now we have only used anti-platelet therapy and now
we have another class of drug that appears to provide additive
benefit, so I think that is a landmark event," Dr. Raymond
Gibbons of the Mayo Clinic said in an interview at the
Xarelto patients did have a significantly higher incidence
of major bleeding, including intracranial bleeding, but no
increase in fatal bleeds. Researchers said the lower death rate
trumped the bleeding risk.
"You only have to treat 56 patients to save a life. It's
hard not to be excited by the mortality benefit," said Dr.
Michael Gibson, the study's lead investigator, who presented
the results at the meeting.
"If it is approved (for this use) I think it will be widely
adopted," Gibson said.
Xarelto, which inhibits a protein called Factor Xa involved
in the blood clotting process, is vying for position with other
new medicines in the multibillion-dollar anti-clot market,
including apixaban and Pradaxa, which is sold by privately held
German drugmaker Boehringer Ingelheim.
Earlier this month, Xarelto won U.S. approval for
preventing strokes in patients with a dangerously irregular
heartbeat called atrial fibrillation, considered to be by far
the largest and most lucrative use for the new generation of
blood thinners at an estimated $10 billion. Pradaxa is also
approved in those patients.
Based on data from earlier studies in atrial fibrillation
patients, apixaban has been widely viewed as the best of the
new clot preventers. The Xarelto results in ACS patients could
help to level the playing field somewhat as apixaban failed to
help those patients in a prior study.
In data presented in Orlando, apixaban tackled seriously
ill hospitalized patients at high risk of developing dangerous
blood clots in the limbs and lungs. Xarelto suffered a setback
in April when surprisingly high bleeding rates deemed the drug
unacceptable for such patients.
Apixaban, which was compared to an older injected drug,
enoxaparin, showed a trend toward improvement but came up short
of achieving a statistically significant result.
Merck's vorapaxar was also tested in ACS patients, but
proved to be no better in reducing a host of cardiovascular
problems when added on top of aspirin and Plavix. It also
increased the risk of bleeding, including tripling the risk of
Researchers did find vorapaxar cut heart attacks, which
they said warranted further study.
The drug's prospects already were dimmed after being deemed
inappropriate for stroke patients in January, but Merck said it
would wait until it has results from another large study early
next year before deciding the medicine's fate.
Vorapaxar had been touted as the most important drug in
Schering-Plough's experimental drug pipeline when Merck
acquired its rival for $41 billion in late 2009.