Merck cholesterol drug
cuts heart risk only 9 percent, future unclear
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[August 29, 2017] By
(Reuters) - A large study of a new type of
cholesterol medicine from Merck & Co Inc found it cut the risk of heart
attack and death by a modest 9 percent, while causing a build up of the
drug in fat tissue, leaving its commercial future uncertain.
Researchers, who presented the findings to a medical congress in
Barcelona on Tuesday, concluded anacetrapib's efficacy could be due
to its affect on bad LDL cholesterol, rather than any more novel
Merck said it had not decided whether to seek regulatory approval
for the treatment - part of a class known as CETP inhibitors
designed to raise HDL, the so-called good cholesterol.
The company announced in June that the study met its main goal, but
details have only now been disclosed. It had also previously said
that prolonged use of the drug caused accumulation in fat, which may
or may not be a problem.
Bernstein analyst Tim Anderson believes it is now unlikely Merck
will decide to file anacetrapib for approval, while Berenberg's
Alistair Campbell described the results as lacklustre.
"It is difficult to see overwhelming physician enthusiasm for
anacetrapib," Campbell said.
A little over a decade ago, CETP inhibitors were hailed as the next
big heart drug but companies including Pfizer Inc, Eli Lilly and
Roche eventually scrapped development programs amid lack of efficacy
or safety issues.
Since then, drugmakers have gone on to develop and commercialize
another class of cholesterol drugs called PCSK9s.
Merck presented results from its 4-year trial of about 30,000
high-risk heart patients already on statin drugs at the European
Society of Cardiology Congress. Statin drugs lower levels of LDL
The study, also published in the New England Journal of Medicine,
found that adding anacetrapib to a statin reduced the combined risk
of heart attack, heart-related death and need for repeat
artery-clearing procedures to 10.8 percent, compared with 11.8
percent for patients on a placebo and a statin.
The trial, led by the University of Oxford and funded by Merck, did
not find a significant difference in the risk of ischemic stroke.
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The researchers noted that anacetrapib raised blood levels of good
cholesterol by a mean of 43 mg per deciliter compared to the
placebo. The drug also lowered levels of non-HDL cholesterol by 17
mg per deciliter - a level associated with a 10 percent reduction in
the risk of coronary death or heart attack.
"This result reduces the likelihood that other actions of
anacetrapib played a major role in modifying the risk of coronary
events," researchers concluded.
Martin Landray from Oxford, one of the principal investigators,
added: "The large increase in HDL cholesterol levels produced by
anacetrapib did not appear to have much impact on risk."
Merck said safety data was generally consistent with earlier trials
- anacetrapib patients had slightly higher blood pressure levels
than the placebo group - but an analysis showed that the
experimental drug accumulates in adipose tissue.
It found that the amount of anacetrapib in fat tissue fell only a
small amount a year after treatment ended. Although animal studies
have not indicated harm from this, Merck plans a two-year follow up
of patients to study long term effects.
(Additional reporting by Ben Hirschler; Editing by Mark Potter)
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