March 31, 2008

More Insight into Who Should Take Statins

You will be seeing a lot of news coverage coming out of this week's cardiology conference about a large study of the statin drug, Crestor, which supposedly found it cut cardiovascular deaths in a group of people with normal LDL better than a placebo.

What most news coverage is leaving out is this: The group of people with "normal" cholesterol who took Crestor in this study weren't just any old group of people. They were people with elevated CRP.

This is an important distinction. CRP stands for C-reactive protein and it is a measure of inflammation. Earlier studies had shown that statins are only helpful in reducing cardiovascular events in people with pre-existing heart disease. Accumulating evidence suggests that they do this by reducing the artery inflammation that is characteristic of heart disease, not by reducing cholesterol. There has never been any truly solid proof that high cholesterol in and of itself causes heart attacks.

So this latest Crestor study may actually have done to finally narrow down who it is who should be taking statin drugs to the subgroup of people, whatever their cholesterol might be, whose CRP is elevated.

Given the way this new story is being reported, I'm not sure we can count on the drug company to give doctors thats message. Instead, the message might be that everyone, no matter what their cholesterol might be, should take this expensive drug.

This might be a mistake. Statins cause serious and sometimes irreversible side effects, some of them affecting mental function. They are particularly dangerous in older people.

If your doctor wants you to take a statin, demand that you first have a CRP test. If your CRP is normal and you have not been diagnosed with heart disease using a definitive diagnosis from something like an artery scan, rather than an inference from something like a high cholesterol test value, you may not need the statin.

I've done this myself, and my CRP was rock solid normal. That is one reason I have been very resistant to the idea of taking statins no matter how high my LDL might be. I saw a statin cause almost instant deterioration in my dad's hitherto stellar mental functioning, and no way am I gambling with mine!

Another piece of Crestor news is that a smaller study, which reanalyzed results of the Asteroid trial, found evidence of some regression in artery plaque in people taking Crestor. This particular trial did not investigate whether the changes observed actually mapped down to fewer heart attacks.

Also, keep in mind that these are reports at a convention, not peer reviewed research studies, and we won't really know how significant the findings were until we see the actual data in a publication. We also won't learn about the side effect profile of Crestor that was observed in these trials.

So, as is usually the case, the devil may well be in the details. For now, it's worth noting that most of the coverage of these reports is in the business press because the bottom line is that $tatin$ are all about profit$.

Here's one of the more informative reports about these studies:

Another Blow for Schering and Merck


Scott S said...

Excellent information. I believe many people have been prescribed statin drugs on the basis of partial information, and the assumption that reducing cholesterol would reduce cardiovascular disease risk by itself. We now have a growing body of evidence that a) that is a mistaken assumption and b) that statin drugs are not benign, and cause muscle damage and even, as you note, mental damage, too.

The bigger question is whether these examples should be used to justify more regulation on drug sales? Presently, the few efforts to limit this on the state level have been overturned by the courts, so its really up to our legislators in Congress to do something about this, just don't expect anything before 2009!

Anonymous said...

I don't think it can be overemphasized that this is not a peer reviewed study. The media loves to jump all over studies from the poster sessions of meetings, yet they do not make it clear that there has been no rigorous review of the results yet.

You may remember Dr. Mike Eades's blog post about the significance (or lack of) poster session studies and the way the media reports on them as if they are reported established scientific fact.

Anonymous said...

I found this exceedingly useful. Statins are NOT completely benign; they often cause more problems than they solve, and the "solid evidence" for prescribing them is limited, to say the least.

I'm sorry to say I have completely lost faith in the US Food and Drug Administration on this one: they're sitting around, waiting for the drug companies to tell them when there are problems.

The drug companies have ever incentive imaginable to minimize reports of problems, and to disguise those that they find IN THEIR OWN testing in a way that the FDA won't necessarily notice.

Like Scott, I don't think anything will change until after Jan 21, 2009.

I was Rx'd Lipitor as a "precaution" despite no obvious cholesterol related problems, except being a diabetic. Not only did it NOT improve my cholesterol levels (which were already acceptable) BUT I developed the "Lipitor-itis" frequently mentioned as a "rare but potentially dangerous side effect."

Rare, maybe. Dangerous? You'd better believe it: I stopped taking the stuff on February 21, and still ache.

Anonymous said...

The question of "to statin or not to statin" has been on my mind for several months. On a hunch, my physician ran a hs-CRP on me last year. Score: 29 (anything over 3 is considered high; a 29 is hideous). Repeated the test twice and the "best" score for me was a 27, indicating some serious level of inflammation is going on. Have ruled out arthritis, asthma, cancer, environmental toxins as causes, leaving cardiovascular "issues" as the likely cause. It's not my diabetes -- I keep an a1c of between 5.1 and 5.3 and rely on carb restriction of about 60 grams per day to keep those numbers. Every other indicator is good, blood pressure, total cholesterol (but HDL is dropping to under 40 the last two tests).

Neither I nor my physician are fans of statins. I, too, watched my very bright father's intellect deteriorate significantly when he was put on statins. He died 10 weeks ago at the age of 90 and spent the last six months of his life horribly confused and weakened. Not a future I want.

The temptation to take the statins is huge--I've developed eye problems that have been diagnosed as inflammation-related (not diabetic), but I'm still not convinced.

The real rub in all this is that there is no longer a reasonable assumption that either the FDA or the medical community is doing their jobs to police the pharmaceutical companies. I'm to the point that I flat out don't trust ANY drug that hasn't been on the market 30+ years!

Unknown said...

If you have inflammation because of arthritis can it make you get a heart attack? Or is it a different kind of inflammation? What else can reduce inflammation besides statins?

Jenny said...


That's a good question and one I don't know the answer to. Heart disease is something I know about only in the context of diabetes.

Anonymous said...

Andrew Weil, M.D. promotes an "inflammation-fighting" diet plan, and I include many of Weil's guidelines for eating foods that are considered non-inflammatory. I also include a good bit of tumeric and ginger in my diet, since these spices are known to be anti-inflammatory. I'm scheduled for retest of both hs-crp and oxidative stress tests mid-April, so I'm hoping for some improvement.

Anne said...

Nonegiven - there are some supplements that can decrease inflammation. Fish oil and cucurmin are two that come to mind.

There was a recent article about the atheroprotective and anti-inflammatory effect of a vegan/gluten free diet in those with rheumatoid arthritis. (pubmed 18348715) I have a feeling that removing gluten(wheat, barley, rye) made the biggest difference.

You can find more information on decreasing inflammation in relation to the heart on Dr. Davis blog

susan allport said...

Thought you'd be interested in this short omega-3 video:


Alcinda (Cindy) Moore said...

"If your doctor wants you to take a statin, demand that you first have a CRP test"
And if it's elevated, try dietary and lifestyle changes before medications. Quit smoking, start exercising, eliminate processed foods and omega6 oils, etc.

I was one that took a statin because it was recommended and I was "high" risk and it almost destroyed me! Muscle and joint pain, depression and cognitive failure almost cost me my job and it made life miserable. Turns out, most of my "risk" is my lipd levels. No family history, no diabetes or heart disease, etc and my "risk" was moderate, not high! (Yea, doc lied to get me on meds!)