* No better than Plavix in medically managed ACS patients
* Blow to Lilly and Daiichi Sankyo's hopes for expanded use
* Study finding is positive news for rival AstraZeneca
By Ben Hirschler
MUNICH, Aug 26 Eli Lilly's new heart
drug Effient failed to beat the older product Plavix in a
head-to-head clinical study, dashing hopes for its expanded use
in treating less critically sick heart patients.
The finding, released at a medical meeting on Sunday, is
good news for rival AstraZeneca, whose competitor
product Brilinta did show an edge over Plavix in a comparable
group of patients in an analysis published last year.
The battle among the different blood-thinning drugs, which
are all designed to prevent dangerous clots in heart patients,
has moved up a gear this year with the expiry of patents on
Sanofi and Bristol-Myers Squibb's Plavix.
That has opened the door to cut-price generic versions of
Plavix, or clopidogrel, on both sides of the Atlantic, upping
the ante on the newer rivals to prove they really offer a
Lilly and its partner Daiichi Sankyo had hoped to
prove that Effient was a better option for patients with acute
coronary syndrome (ACS) who do not get a stent to open blocked
arteries or bypass surgery.
ACS covers a range of serious conditions, including heart
attacks and unstable angina, caused by a sudden reduction of
blood flow to part of the heart.
In fact, the large study funded by the two companies and
involving more than 9,000 patients found there was no difference
between Effient and Plavix in preventing heart attacks, strokes
and deaths. Both drugs were tested alongside aspirin.
There was also no difference in serious bleeding
complications, which is always a risk with blood-thinners.
There was a lower risk of adverse events in patients on
Effient after 12 months of treatment, but this trend was not
conclusive and lead investigator Dr Magnus Ohman of Duke
University Medical Center said further exploration of the
finding was needed.
Most trials evaluating anti-clotting drugs for ACS have
focused on patients undergoing invasive procedures, usually
getting a stent - a tiny wire mesh tube that is left in the
coronary artery to prevent it from closing up again.
But some 40 percent of patients who are not in urgent need
of such invasive intervention are managed solely with drug
therapy, and it had been thought that they should do better on a
newer and more potent medicine like Effient.
Daiichi research head Glenn Gormley said the trial result
was "not the outcome we anticipated" and medical experts at the
European Society of Cardiology annual congress, where the
findings were reported, agreed the result was unexpected.
"The outcome is a bit surprising because we think usually
that more aggressive therapy in the face of acute coronary
syndrome would lead to less adverse outcome - but the data is
what the data is," said Dr William Zoghbi, president of the
American College of Cardiology.
Effient was launched three years ago and the drug has taken
off more slowly than many analysts expected, with worldwide
sales last year of $302.5 million. Analysts, on average, expect
sales to reach $1.1 billion by 2016, according to Thomson
The results of the Effient study were published
simultaneously online by the New England Journal of Medicine.