Tuesday, November 18, 2008

More on Statins, "Jupiter" and Absolute v. Relative Risk Reductions. . . .

I think the New York Times (overnight, in a health-science piece, by Tara Parker-Pope -- do go read it all!) has it just about right, here -- or at least, the Times comes out about where I do (or, more precisely, where I did, last week) -- on all of this:

. . . .Although many doctors hailed the study as a major breakthrough, a closer look at the research suggests that statins (like Crestor, from AstraZeneca, and Lipitor, from Pfizer) are far from magic pills. While they clearly save lives in people with a previous heart attack or other serious heart problems, for an otherwise healthy person the potential benefit remains small.

Many doctors who believe in using statins for heart disease say they needn’t be given to healthy patients. Instead, they say, the focus should remain on encouraging healthful behavior and screening for traditional risk factors like high blood pressure and cholesterol.

“Statins have many biological effects that appear to be quite meaningful,” said Dr. Valentin Fuster, director of the heart program at Mount Sinai Medical Center in Manhattan and past president of the American Heart Association. “But I don’t think the answer is a magic drug to prevent disease. The answer is to change behavior”. . . .

The researchers sought out men 50 and older and women 60 and older who had elevated CRP but not high cholesterol. The goal was to determine whether statins could improve their health. [Editor's Side Note: Consider this slide from the AHA last week:]

But of nearly 90,000 people who were screened, only 17,802 were selected. That means 80 percent of the recruits were excluded for a variety of reasons — another inflammatory condition like arthritis, medication use, high blood pressure, a history of cancer and so on.

“If you extrapolate that, it means there are not all that many people exactly like those who were studied,” said Dr. Nieca Goldberg, director of the women’s heart program at New York University Langone Medical Center. . . .

Only 1.8 percent of the subjects who took a placebo had a major cardiovascular problem during the study period. Among statin users, 0.9 percent did. In other words, the absolute risk of a serious cardiovascular problem (as opposed to the relative risk) was reduced by less than one percentage point.

Absolute differences in risk are more clinically important than relative reductions in risk in deciding whether to recommend drug therapy,” The New England Journal of Medicine noted in an editorial accompanying a report on the study. . . .

[Emphasis supplied.]

Indeed -- I think there is a vast market for Crestor -- and statins, generally, especially generics, in this market environment -- I just don't see putting very healthy 50 year-olds on it. The perhaps smallish elevated-diabetes-risk alone would be enough for me to shy away from it.

This is simply a note of caution -- not any form of a diatribe.


1 comment:

Anonymous said...

Thoughts About those Darn HMG Co-A Reductase Inhibitors

With statins as a class of medications:

A.E.s are thought to occur more often than they are reported- with high dose statins in particular, yet with the type of statin administered possibly having a correlation with A.E.s as well.
Statins used with macrolide antibiotics can cause accelerated myopathy, it is believed.
Additionally, there is no reduction in mortality or increase in the lifespan of one on statin therapy, according to many. So caution should perhaps be considered if one chooses to prescribe such a drug for a patient. In other words, the health care provider should be assured that statin therapy for their patients is reasonable and necessary.
Several risk factors should determine if one is placed on statin therapy, and not just one. High cholesterol is the apex of such therapy, yet other risk factors of the patient should be examined and evaluated as well.
Statins do decrease CV events and CV risks significantly. This may be due to the fact that statins increase endothelial function, stabilize coronary plaque build- up, and decrease thrombus formation. Maximum reduction in LDL can be determined after about a month of statin therapy.
There is evidence to suggest that statins have other benefits besides lowering LDL, such as reducing inflammation (CRP) with patients on statin therapy, those with dementia or Parkinson's disease, and some forms of Cancer and cataracts.
It appears those statins that are produced specifically by fermentation, such as Zocor and Pravachol, have less incidences of myopathy than the other synthetic statins that exist. This may possibly due to fermented statins are believed to be much more hydrophyllic.
Yet overall, the existing cholesterol lowering recommendations should be re-evaluated, as they may be over-exaggerated, if one chooses to compare these guidelines with others in the past.
Finally, a focus on children and their lifestyles should be amplified so their arteries do not become those of one who is middle-aged, and prevent them from being candidates for statin therapy,

Dan Abshear