Monday, April 16, 2012

New anti-cholesterol drug appears safe, effective

CHICAGO—An experimental Merck drug safely boosted good cholesterol to record highs while dropping bad cholesterol to unprecedented lows in a study that stunned researchers and renewed hopes for an entirely new way of lowering heart risks.


We are the most excited we have been in decades” about a novel drug, said the study’s leader, Dr. Christopher Cannon, of Brigham and Women’s Hospital in Boston.


This could really be the next big thing.


The drug, anacetrapib, won’t be on the market anytime soon. It needs more testing to see if its dramatic effects on cholesterol will translate into fewer heart attacks, strokes and deaths. Merck & Co. announced a 30,000-patient study to answer that question and it will take several years.


But the sheer magnitude of its effects so far caused big excitement at an American Heart Association conference in Chicago, where results were presented Wednesday.


The data look spectacular, beyond what anybody would have expected,” said Dr. Robert Eckel, a University of Colorado cardiologist and past president of the heart association.


It’s like a rocket to Jupiter versus one to the moon. I can think of many of my patients who could use the drug right now.


Researchers found no anacetrapib safety issues during the 18-month study, and patients receiving the drug had fewer serious heart problems than those given a placebo. More than 1,600 patients participated in the the Merck-sponsored study.


A top Canadian cholesterol expert said the successful safety hurdle anacetrapib overcame sets it on a clear path to important clinical use.


It appears to have a huge effect on raising HDL, the good cholesterol,” Dr. David Spence, a University of Western Ontario neurologist, told the Star’s Joseph Hall.


This is the beginning of an interesting story that looks very exciting.


The drug also appears to lower a clotting factor known as Lp(a) which is a risk factor for vascular disease, Spence said.


If this class of drugs not only raises HDL, but lowers Lp(a) as well as LDL (bad cholesterol) this should be very promising.


For years, doctors have focused on lowering bad cholesterol to cut heart risks. Statin medicines, sold as Lipitor, Zocor and in generic form, do this. But many statin users still suffer heart attacks, so doctors have been trying to get LDL (bad cholesterol) to very low levels and to boost HDL (good cholesterol).


After six months in the study:


 • LDL scores fell from 81 to 45 in those on anacetrapib, and from 82 to 77 in those given dummy pills.


 • HDL rose from 41 to a whopping 101 in the drug group, and from 40 to 46 in those on dummy pills.


Such large changes have never been seen before, doctors say, and these improvements persisted for at least another year that the study went on.


The study was too small to tell whether anacetrapib lowered deaths, heart attacks or other heart problems, but the trend was in the right direction, with fewer of those cases among patients on the drug. The anacetrapib group also needed significantly fewer procedures to fix clogged arteries.


Importantly, there were no signs of the blood pressure problems that led Pfizer Inc. to walk away from an $800 million investment in torcetrapib, a similar drug it was developing four years ago.


Results of the study also were published online by the New England Journal of Medicine. Some study leaders have consulted for Merck and makers of other heart drugs.

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