UPDATE: Trial Of Cholesterol Drugs Terminated
08 Juillet 2009 - 11:33PM
Dow Jones News
A clinical trial comparing Abbott Laboratories' (ABT)
cholesterol drug Niaspan with Zetia from Merck & Co. (MRK) and
Schering-Plough Corp. (SGP) was terminated last month.
An independent steering committee stopped the trial based on
results of a "pre-specified, blinded interim analysis," but not
because of safety concerns, according to a notice posted on a U.S.
National Institutes of Health online registry of clinical trials in
mid-June.
It wasn't immediately clear whether the early termination was a
negative sign for one or both of the drugs.
Abbott, of Abbott Park, Ill., and the Walter Reed Army Medical
Center in Washington are listed as the trial's sponsors and
collaborators.
The trial's lead investigator, cardiologist Allen Taylor of
Washington Hospital Center in Washington, declined to elaborate on
why the trial was terminated, beyond the reason posted on the NIH
site. He said more information might be provided at a later date.
Taylor said Abbott indirectly funded the trial but wasn't involved
in its design or conduct.
Spokespeople for Abbott and a Merck/Schering-Plough joint
venture said they had no insight into the reasons for the trial's
termination, other than the statement on the NIH Web site that it
wasn't for safety reasons. A Walter Reed spokesman couldn't
immediately be reached Wednesday afternoon.
Abbott's Niaspan sales rose 19% to $786 million in 2008.
Zetia generated about $2.2 billion in sales last year, down
nearly 9% from the year before because of studies released during
2008 that raised questions about Zetia's efficacy and safety. Zetia
also is a component of the combination cholesterol drug Vytorin,
also marketed by Merck/Schering-Plough.
The trial of 400 people at risk for heart attacks began in
November 2006 and was expected to be completed later this year. In
the trial, patients already taking so-called statin cholesterol
drugs were given either Niaspan or Zetia. Niaspan is commonly used
to raise good cholesterol levels, while Zetia is used primarily to
lower bad cholesterol, though each has additional uses. Each drug
works by a different mechanism and can be used in combination with
a statin.
Researchers tracked the drugs' effects on artery thickening
after 14 months, using an ultrasound technique known as carotid
intima-media thickness, or CIMT. The primary goal was to assess
whether one drug provided a greater benefit.
Some doctors - and defenders of Vytorin and Zetia - have
previously suggested CIMT monitoring isn't very useful in detecting
significant changes in artery thickness in certain patients. It was
a CIMT trial that first raised questions about the efficacy of
Vytorin and Zetia.
Taylor, the lead investigator, worked at Walter Reed when the
trial began but has since moved to Washington Hospital Center.
Walter Reed was one of the trial's locations.
Taylor declined to identify members of the steering committee
that decided to end the trial.
Abbott shares rose 97 cents to $46.31 Wednesday. Merck rose 42
cents to $28.04, while Schering-Plough rose 17 cents to $25.27.
Information about the trial can be found at:
http://www.clinicaltrials.gov/ct2/show/NCT00397657
-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com