As a recovering ex-pharmaceuticals reporter, I pay more attention than is probably healthy to all sorts of drug studies.
So I was all over the results from a big clinical trial that looked at an experimental medicine to boost "good cholesterol." Unveiled this morning at cardiology meeting in Chicago, the study shows that a daily pill from Merck raised the good stuff, also called HDL cholesterol, by 138 percent in people who got the medicine compared with those who didn't. The medicine also cut their "bad cholesterol," or LDL, by 38 percent.
The 1,600 people in study, which lasted a year and half, already had some form or heart disease or were at a pretty high risk for getting it. And 99 percent of them were also taking one of the conventional cholesterol-fighers called statins, such as Lipitor and Crestor.
In a statement, Harvard cardiologist Christopher Cannon, who led the study group, called the drug exerted a "knock-your-socks-off" increase in HDL and a "jaw-dropping" decline in LDL. The results were published online by the New England Journal of Medicine.
Why all the fuss? Well, having too little good cholesterol raises people's risk for heart disease, even if their LDL is in check. And there aren't many weapons to raise HDL significantly. A prescription-strength version of the B vitamin niacin is one of the current options.
Cannon explained, "The bad cholesterol goes down to the level you are born with and good cholesterol gets up to twice what you are born with," according to Bloomberg.
Now, the study, conducted to give a preliminary read on the safety and effectiveness of the medicine, wasn't big enough to definitely prove the drug is OK. Merck will bankroll a 30,000-patient study to do that.
The elephant in the room is a failed Pfizer drug called torcetrapib, a good-cholesterol raiser in the same family as the Merck drug, called anacetrapib.
In the hunt for a successor to blockbuster Lipitor, Pfizer bet huge on torcetrapib only to find in a late-stage clinical test that patients taking the drug were more likely to die than those who weren't getting it. The company pulled the plug on the medicine. And the failure raised the question: Is there a fundamental problem with this class of drugs or a particular flaw with torcetrapib?
A postmortem suggested that torcetrapib had unique problems, mainly raising blood pressure, something to avoid in patients with heart disease..
Today, the Cleveland Clinic's Steven Nissen, who led one of the torcetrapib trials, commented on the Merck results to Bloomberg, "There is a very good chance that this drug will make it."
The Merck drug didn't lead to significant increases in blood pressure or hurt liver function.
Still there were four deaths from cardiovascular causes among the 800 patients taking Merck's drug compared with just one among the same number in the the just-released trial results. So don't count Merck's drug approved just yet.