Statins and side effects: What physicians, and patients, can learn from an eye-opening new study

Severe side effects attributed to statin use may actually not be related to statins at all, according to new findings presented at the American Heart Association’s Scientific Sessions 2020 virtual meeting.

Researchers tracked patients for one year, comparing their self-reported symptoms while taking a statin for four months, a placebo for four months and then neither for four months. Each day during the study, participants were asked to report on the intensity of every symptom they experienced. Patients were told they could stop taking their tablets—which could have been a statin or a placebo—if symptoms became too extreme.

“We know that many patients are not able to take statins because of side effects such as muscle pain, called myalgia,” lead author James Philip Howard, MB, PhD, of Imperial College in London, said in a statement. “Prior placebo-controlled randomized trials have not found evidence of what should be an overwhelmingly obvious difference in side effect symptoms while a person is taking statins rather than taking a placebo. This randomized study allowed us to examine participants' symptoms when they were off all tablets and compare them with symptoms occurring when on statin therapy vs. placebo therapy.”

Sixty patients participated in the study. Overall, 90% of the symptoms reported by participants taking the statin were also reported by participants taking placebo tablets. Patients also had the same likelihood of temporarily stopping the medication whether it was the actual statin or the placebo.

These findings do not suggest, the researchers emphasized, that any patients are making up their symptoms.

“Patients should be taken seriously when they report side effects, because they are genuinely suffering,” Howard added. “We were surprised how severe some of the symptoms experienced during the study were. Twenty-four patients, on 71 occasions, had symptoms so severe they had to stop taking their tablets temporarily. However, this occurred just as frequently when patients took a placebo as when they took a statin.”

One in two patients who participated in the study restarted taking statin medication as recommended, the authors added.

AHA Scientific Sessions 2020 is scheduled for Nov. 13-17, 2020. More information on this virtual event is available here.