Halperin's study, called Sportif V, followed 3, 922 patients who were randomly given either warfarin or Exanta.
Additionally, while warfarin can take weeks to have an effect, Exanta starts working within an hour.
The anti-coagulants warfarin and heparin can be easily reversed if a patient develops major bleeding.
The first of these warfarin replacements, from Boehringer Ingelheim, goes before an FDA advisory committee on Monday.
Rather than testing Xarelto against warfarin, the current standard in oral anti-coagulants, Xarelto was studied against placebo.
Xarelto, made by Johnson and Bayer, was better than warfarin in one analysis, about equivalent in another.
It might be useful in patients who are poorly controlled on warfarin or refuse to take it.
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No clinically relevant pharmacokinetic interactions were reported between KYNAMRO and warfarin, or between KYNAMRO and simvastatin or ezetimibe.
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Superiority language in labeling might induce physicians to switch patients who are doing well on warfarin to rivaroxaban.
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Giving patients warfarin involves a whole industry of testing, and it represents a big cost to the medical system.
Experts say the two new options are welcome as warfarin can be problematic.
This could force Boehringer to market Pradaxa as equivalent to warfarin, not better.
Nevertheless, doctors wrote 21 million prescriptions for the anti-coagulant Coumadin (generically known as warfarin), a drug growing 5% a year.
In fact, warfarin is so difficult to manage that it is probably less than effective in many people who take it.
The mean TTR for warfarin in ROCKET was 55%, compared to 63%-73% in other recent warfarin-controlled studies, according to the reviewers.
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"That really has created kind of a cottage industry to regulate warfarin therapy, " says Jonathan Halperin, a cardiologist at Mount Sinai Medical Center.
Different people require different doses of warfarin, and the same person can require a change in dose if his or her diet changes.
It prevented strokes at least as well as warfarin, the 60-year-old drug derived from rat poison, and, if anything, caused less serious bleeding.
The market for drugs to replace warfarin, originally derived from rat poison, is one of the biggest opportunities currently available to the drug industry.
The only way to reduce this risk is with warfarin, a cheap generic that is difficult to given and can cause too much bleeding.
All told, 1.6% of those taking Exanta, or 51 patients, had strokes or other events, compared with 1.4% of those taking warfarin, or 37 patients.
Patients who receive too much warfarin can suffer from severe bleeding.
The reviewers note that the time in the therapeutic range (TTR) for warfarin-treated patients was lower in ROCKET than in similar trials with other drugs.
FORBES: FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)
The government's watchdog NICE says patients with atrial fibrillation (AF), an erratic and sometimes fast heartbeat, can now have rivaroxiban instead of the existing drug warfarin.
Years ago, serving as an FDA advisor, he led an effort on another FDA advisory panel that kept another potential warfarin replacement, Exanta, off the market.
Moreover, Halperin notes, the additional attention patients get in clinical trials caused their warfarin doses to be better adjusted than they would be in the real world.
Now, AstraZeneca (nyse: AZN - news - people ) is in late-stage testing for an experimental pill called Exanta that could eventually replace warfarin.
Since Xarelto is an anti-coagulant with effects similar to warfarin, and warfarin has been shown to be of little use in ACS, why test it at all?
This will intensify because while all the new drugs will be better than warfarin, it may not be clear how much better they are than one another.
While effective, warfarin is incredibly tricky for doctors to use because there is only a tiny margin between giving too little and giving too much, risking uncontrolled bleeding.
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