Statins don’t work for people w/o heart disease
Posted by medconsumers on October 7, 2010
Attention all people who take cholesterol-lowering statin drugs! Pay particular attention if you’re taking the drug because your cholesterol level is high, but you don’t have heart disease. If this description fits (and it does most statin-takers), then you may know that taking a statin every day for five years provides about a 1% reduction in your chance of having a heart attack or dying of a heart attack.
This benefit established long ago was confirmed in a new meta-analysis of 12 statin vs. placebo trials that also reported serious adverse events and deaths from all causes. How else can researchers tell whether the drug itself is killing some people? How else would you, the statin-taker, know whether the chance of suffering a severe side effect is greater than the chance of avoiding a heart attack?
Apparently, statins don’t cut your chance of dying from anything. “There’s no lifesaving benefit to statins for people without heart disease when you look at deaths from all causes in the less biased trials,” said Jim M. Wright, MD, PhD. University of British Columbia, Vancouver, the lead author of the new analysis. “The number of people who died in the placebo group was the same as the number of people who died in the statin group.”
Yes, the drugs are terrific at lowering cholesterol, as anyone on a statin will readily tell you, but pitiful where it concerns the ultimate goal of avoiding a heart attack.
Ever since statins were marketed for healthy people with high cholesterol, the prevailing message from drug companies and doctors has been “these drugs are extremely safe.” Over the years, muscle pain has been acknowledged as more common than previously thought. The Mayo Clinic website typifies the current thinking:
“The most common statin side effect is muscle pain. You may feel this pain as a soreness, tiredness or weakness in your muscles. The pain can be a mild discomfort, or it can be severe enough to make your daily activities difficult. For example, you might find climbing stairs or walking to be uncomfortable or tiring.
Very rarely, statins can cause life-threatening muscle damage called rhabdomyolysis (about one case for every 15 million prescriptions).”
Dr. Wright and colleagues looked beyond muscle damage for the full range of serious adverse events (SAEs) experienced by the participants in the 12 trials included in their analysis. The SAEs include such disparate events as pneumonia, hospitalizations, and having to undergo a coronary-artery-opening procedure. The chance of having a SAE (about 30%) is exactly the same whether you take a statin or placebo,” said Dr. Wright. “This suggests that statins must be increasing some SAEs that counterbalance the reduction in heart attacks.”
Why, I wonder, do we hear that muscle problems are the only SAEs of statins? “All but one of these statin trials were funded by companies that make statin drugs,” answered Dr. Wright. “In the safety data it appears the authors were only looking for muscle damage. When they didn’t find much, they concluded the drugs are really safe.”
I once cured a case of Alzheimer’s disease simply by telling a friend that her 85-year-old mother could be suffering adverse effects from the statin she was on for years. With much difficulty, my friend finally got her mother’s doctor to stop the statin. The mother’s cognitive impairment disappeared, so did the Alzheimer’s diagnosis. Anecdotal, I know, but nonetheless interesting. Problems with memory, thinking and concentration are among the common adverse effects reported by statin users to an ongoing survey at the University of California, San Diego (click here).
At the risk of making your eyes glaze over, here’s something you should know about the clinical trials supporting statin use in healthy people. Even when the reviews are limited to the 12 best trials, there remains the potential for serious bias in favor of statins. Here’s just one example provided by Dr. Wright. In an ideal trial, both study participants and their doctors should not know who is taking the real drug and who is on placebo. However, statins can dramatically reduce cholesterol levels. The dramatic drop in cholesterol in people randomly assigned to take statins serves to tip off doctors as to who is on the active drug as opposed to the placebo.
When the doctors know who is on the statin drug, explained Dr. Wright, it can affect their decisions about who will be referred for a coronary artery-opening procedure, known as revascularization. “A doctor might be inclined to refer a patient for revascularization, but decide against it once he or she sees that the patient’s cholesterol level is very good.” The number of revascularizations is one “outcome” that most statin trials use as a measure of the drug’s effectiveness.
Maryann Napoli, Center for Medical Consumers©
Dr. Wright reports no conflicts of interest regarding cholesterol-lowering drugs. This analysis was published in the Therapeutics Initiative Letter, an online newsletter of the University of British Columbia (click here). Dr. Wright is the editor-in-chief of this publication, a practising physician specialist in clinical pharmacology and internal medicine, and a professor in the Department of Anesthesia, Pharmacology, & Therapeutics, UBC.
Check out this new website for weighing the harms and benefits of statins for primary prevention. Added December 7, 2010.