Dear Dr. Roach: Over the past year, I have taken three different statins, all with disastrous side-effects. I am currently getting a month off before my doctor tries another one. I have talked to everyone I know or meet about these drugs. My decidedly unscientific survey results are that about a third of the people take them without problems, a third cannot take them because of side-effects, and the last third tell their doctors they take them but they actually don鈥檛. Are the reported side-effect statistics somehow being manipulated?
J.T.
Statin drugs, used to reduce the risk of a heart attack and stroke in people at high risk, are generally well-tolerated drugs. The numbers from your unscientific survey do not match the results of placebo-controlled studies. In people who were enrolled in clinical trials, about 13 per cent could not tolerate the statin drug during an average of four years in the trial; however, 14 per cent of people on placebo pills, which contain no active medication, could not tolerate the placebo and had to stop it. This suggests that, compared with placebo, statin drugs are well-tolerated.
However, when people know they are taking a statin, the risk of having a side- effect, especially muscle aches, is much higher than in people who don鈥檛 know what they are taking. In some observational trials, as many as 25 to 30 per cent of people are unable to tolerate statin drugs (which is much closer to what your informal survey showed).
I frequently discuss the placebo effect, where people get benefit from taking a medication or supplement that they think will help them. It is real and powerful at relieving symptoms. The findings from open-label statin drug trials show the opposite, called the 鈥渘ocebo effect.鈥� This is when you expect a medication to cause a side-effect, and it does.
A powerful lesson can be drawn from a trial of a new class of cholesterol-lowering medication, called the PCSK-9 inhibitors. One study took people who, like you, had been unable to tolerate three different statins. The participants in the study went four weeks with no medication. They were then randomized to statin or placebo, and 60 per cent of those who were unable to tolerate any statin were able to do so (even ones they were unable to take previously) 鈥� when they were unaware of what they were taking. This shows that while some people truly develop side-effects due to the statin, much or most of the apparent statin intolerance was due to the nocebo effect.
Deciding what to do for an individual like you is difficult, as one can never know in an individual whether the effects are 鈥渞eal鈥� or nocebo. Statins are the most effective class of drug to reduce heart- disease risk, so on the one hand, you don鈥檛 want to withhold medication that is likely to improve and extend someone鈥檚 life. On the other hand, you don鈥檛 want the risk of 鈥渄isastrous鈥� side effects. Waiting four weeks and trying a different statin (fluvastatin and pravastatin tend to be tolerated best, but rosuvastatin and atorvastatin have been shown to be useful in people who haven鈥檛 tolerated other statins) is one approach; CoQ10 supplementation (itself largely, but not entirely, a placebo) also has helped. Finally, a healthy diet might reduce the dose of statin needed, or even eliminate the need entirely in some people. People with known blockages should be on a statin if possible.
Dr. Roach regrets that he is unable to answer individual letters, but will incorporate them in the column whenever possible. Readers may email questions to [email protected].
