Heart disease patients with high LDL levels stopped the
progression of coronary plaque buildup by using the
cholesterol-lowering statin drug Lipitor, according to a study
that made headlines and was featured on recent national
television news broadcasts. Another group of patients in the
study took the statin drug Pravachol; in these subjects, plaque buildup continued to progress.
This research was widely reported for two reasons: 1) Lipitor
outperformed its rival Pravachol in lowering LDL, and 2) Lipitor was shown to stop the progression of coronary plaque aggregation.
Sounds like a pretty clear win for Lipitor, doesn’t it? Well
if you’re not looking too closely it does. Because between the perception and the reality of this study there’s a train wreck of misconceptions. And what’s worse, one of the most sweeping comments about the study provides some medical advice that could border on being downright dangerous.
Nothing up my sleeve
The Associated Press and several other major news outlets
portrayed this study as the first time two different statin
drugs have been tested against each other, “head-to-head.”
The Cleveland Clinic directed the research of more than 500
coronary heart disease (CHD) patients over a period of 18
months. Results of the study were announced at a meeting of the American Heart Association, and a full report has been submitted for publication. So for now we can only rely on media reports which, when read carefully, supply these two important pieces of information:
- Pfizer, the maker of Lipitor, provided sponsorship of thestudy (according to the New York Times).
- Patients in the Lipitor group received 80 mg of the drug.
- Patients in the Pravachol group received 40 mg of that drug.
If you tried stacking the deck like that in Vegas they’d run you
out of town on a rail.
Holes you could drive a truck through
Here’s the lead sentence of the Pfizer press release about the study: “Patients taking Pfizer Inc’s cholesterol-lowering
medicine Lipitor (atorvastatin calcium) experienced a
significant reduction in the progression of atherosclerosis, or
hardening of the arteries, compared to patients who received Pravachol (pravastatin) “
Many print and television reporters simply picked up their
information from that press release and faithfully reported the
“results.” But kudos to the Health Day News reporter who did
some digging and interviewing and discovered that the study was specifically designed to produce two different outcomes so that the changing LDL levels of each group could be compared to changes (or lack of change) in arterial plaque. So the trial was not a “head-to-head” statin showdown at all. Any third-grader can tell you that 80-on-40 is not a level playing field.
Furthermore, the fact that Lipitor reduced plaque by 0.4 percentover a year and a half may not actually have any significance at all in terms of preventing deaths from CHD. Until long-term studies on mortality can be mounted, this slight plaque reduction is little more than a moot point.
Statins have also been shown to produce unhealthy side effects, such as liver and kidney dysfunction (according to Pfizer’s Lipitor web site). So when the study is eventually published, I hope we’ll see a genuinely comprehensive comparison of the side effects from taking high doses of Lipitor against low doses of Pravachol.
But don’t hold your breath.
Sinking to a new low
The lead author of the study, Dr. Steven Nissen (a cardiologist at the Cleveland Clinic) added a comment that reopens the debate over the proper level of LDL, the supposedly “bad” cholesterol.
Dr. Nissen told the Associated Press that the data seem to show that “There is no such thing as too low an LDL.” MSNBC picked upon that comment and ran this sub-head on the MSNBC web site:
“New research indicates the lower the level of LDL the better.”
But prior research doesn’t support that claim. And that’s
putting it mildly. Because when LDL is too low, the risk of
death may actually increase.
I asked HSI Panelist Allan Spreen, M.D., to comment on this idea that “the lower the LDL the better” and he pointed out this revealing result of the watershed Framingham Heart Study: “The largest, longest, and most prestigious heart disease study (Framingham) showed that total cholesterol levels (‘total,’ now, mind you, they didn’t talk a whole lot about LDL) that went below 160 caused heart disease problems to go back up! So it’s a curve that bottoms out at 160 instead of a line that gets better and better as you get lower and lower.”
Dr. Spreen’s statement is confirmed by an article in Red Flags Weekly by Malcolm Kendrick, M.D., which offers this quote about the Framingham results as published in the Journal of the American Medical Association: “There is a direct association between falling cholesterol levels over the first 14 years and mortality over the following 18 years.”
And from the National Heart, Lung and Blood Institute’s Honolulu Heart Program (an ongoing study that began in 1965 with more than 8,000 men), Dr. Kendrick presents this quote as it appeared in the Lancet medical journal: “Our data accord with previous findings of increased mortality in elderly people with low serum cholesterol, and show that long-term persistence of low cholesterol concentration actually increases the risk of death.”
No such thing as too low?
The lower the better?
It’s a shame that many heart patients will read about this study and take the lazy reporting of the mainstream news outlets at face value.
To Your Good Health,
Health Sciences Institute
“Pfizer’s Lipitor Shown to Stop Progression of Plaque Build-Up in Arteries, New Study Shows” Pfizer News Release, 11/12/03, pfizer.com
“How Low Should Bad Cholesterol Go? New research indicates the lower the level of LDL the better” Associated Press, 11/12/03, msnbc.com
“Study Finds Differences in 2 Cholesterol-Lowering Drugs” Gina Kolata, The New York Times, 11/12/03, nytimes.com
“Doctors Divided Over Cholesterol Drugs Study” Health Day News, 11/13/03, ajc.com
“The Cholesterol-Lowering Drugs Olympics” Nicholas Regush, Red Flags Daily, 11/15/03, redflagsdaily.com
“Why the Cholesterol-Heart Disease Theory is Wrong” Malcolm Kendrick, M.D., Red Flags Weekly, 12/12/02, redflagsweekly.com
“Lipitor Prescribing Information” lipitor.com