October 11, 2007

More Spinning Statistics to Promote Statins by Drug Cos?

Study: Statin Helps Prevent Heart Attack

Today's health news features a report about a long-term Scottish study that supposedly proves that taking statins for five years lowers the risk of heart attack by 25%. Sounds like everyone on the planet should be taking a statin, right?


Once again, the devil is in the details.

To find out the details, I had to hunt around for reports that gave me the actual numbers involved, since the AP report omits how many people were in the study. Fortunately, a reort in The Scotsman provided critical information left out of the PR release turned AP news story.

Here are the facts:

The study enrolled 6,500 middle aged men [no women] who had extremely high LDL. How high? 192 or over. This is far, far higher than the level at which American doctors tell people they should be taking a statin, high enough that it is clearly abnormal.

Half were put on statins for five years, half on sugar pills. The study stopped in 1995. Over the next ten years 39 percent of the original statin patients were still taking the statins, and 35 percent of the placebo takers were using statins, which of course pollutes the study to the point where it is impossible to draw any conclusions about what happens when you stop the drug.

What was the actual finding?

"Over the 15-year period, 619 of the original statin takers and 674 of the placebo takers died." OF ALL CAUSES.

SO let's do the math. 19% of the ex-statin takers, 40% of whom were still taking the drugs died. 20.7% of the non-statin takers, 35 percent of whom were taking the drugs died. Of all causes.

So in fact, we have a 1.7% difference in total overarall death rate in the two groups. One and a half people per 100. None of the reporting gives the statistics on heart attacks, so it is impossible to know what the real difference in heart attack incidence was in the two groups, but you can be sure that when actual incidence of death is looked at, rather than the factitious "risk of death" measurement which greatly inflates the percentage, it is not going to be high, since obviously many of the deaths were from cancer, accidents, suicide, etc.

More importantly, the study did not look at what the incidence was of dementia in the group of patients taking statins as opposed to those who never took them, a serious concern now that there is some evidence linking dementia with statin use. Nor is there any measurement of "quality of life" issues linked with exhaustion and muscle pain associated with statins.

Finally, it's worth mentioning that without seeing the full data it is hard to know how it might have been massaged to produce the desired result (The study was funded by statin makers and the authors admitted accepting fees from them.) Were the two groups really equal in terms of their cholesterol levels and general overall health?
Often in drug-company funded studies I note that the statistic being used as the prime measurment in a study starts out slightly higher in one group than the other, rather like giving competitors a couple extra feet at the starting gate of a race.

And it is worth noting that this is the only study to date that appears to show that any group of men who had not had heart attacks and took statins had any better survival than those who did not.

My conclusion from this study is this: If you are MALE and your LDL cholesterol is over 192, a statin might be worth taking, but after 5 years, you can probably stop, since the study apparently showed that the very small benefit in terms of life extension--persisted after the drugs were stopped. Though if you are in late middle age, you might want to read up a bit more about the effects of statins on cognitive function before starting them.

Not at all the conclusion that the Press Release turned news report is giving!


Jeffrey Dach MD said...

The truth is that NO woman should ever be given Lipitor or any other statin drug for elevated cholesterol.

There are no statin trials with even the slightest hint of a mortality benefit in women and women should be told so.

In other words, statin drugs don’t work for women.

To read more: Just Say No to Statins

Jeffrey Dach MD

my web site