Statin side effects are 90% nocebo: AHA 2020

The vast majority of symptoms attributed to taking a statin are also reported by people when taking a placebo.

A late-breaking session at the American Heart Association’s Scientific Sessions 2020 was told side effects such as muscle pain were often the reasons patients ceased taking their cholesterol-lowering medications.

Yet in a n-of-1 trial design in 60 patients, symptom intensity when taking statins or placebo were similar and both were significantly higher than when taking no treatment.

Patients in the Self-Assessment Method for Statin Side-effects Or Nocebo (SAMSON) Trial were assigned to treatment, placebo or no treatment in one month blocks in a random sequence over 12 months. Daily symptom intensity was reported via a smartphone application.

The research, also published as Correspondence in the NEJM, found the mean symptom intensity was 8.0 during no-tablet months, 15.4 during placebo months, and 16.3 during statin months.

“In patients who had discontinued statin therapy because of side effects, 90% of the symptom burden elicited by a statin challenge was also elicited by placebo. Half the trial patients were able to successfully restart statins,” the researchers said.

Lead author of the study Dr James Howard, a PhD fellow at Imperial College in London, said in a statement that many patients had difficulty taking statins because of the perceived side effects.

“Patients should be taken seriously when they report side effects, because they are genuinely suffering,” he said.

“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.”

Commenting on the findings for the limbic, cardiologist Associate Professor David Colquhoun said they reinforced what had long been known.

“80 to 90% of people who say they are statin intolerant are not. And they get the same side effects with placebo. So the mind is very powerful.”

“When you just do surveys, up to 25% of people complain of statin side effects, the vast majority of which are aches and pains. But when you do the double-blind crossover study, we know that the people who say they are intolerant to statins … rather than 20-25%, it drops down to 5%.”

Associate Professor Colquhoun, co-president of the Clinical and Preventive Cardiology Council of CSANZ, said one way to help patients was to counter any negative messages patients had heard or seen about statins and instead provide early positive reinforcement.

“What I tell patients is this: more than nine out of 10 patients who take the tablet, have no problem whatsoever. The other thing that is important to emphasise is that this [medication] saves lives.”

Patients should be advised that if they do experience aches and pains, dose reductions, intermittent dosing or a change of medication would most likely solve any problems.

“So it’s not a case of all or none. Nine out of 10 can still tolerate a little tiny dose of statins or ezetimibe.”

He said the other message was that people often get aches and pains which were unrelated to any medication.

“I often recommend a drug holiday and a lot of people are surprised when the aches and pains continue because they have got nothing to do with the statin. So people blame the statin but they might need treatment of their underlying muscle problem.”

He said statin-induced aches and pains do not respond to steroids, NSAIDs or Panadol.

More information on statin-associated muscle symptoms is available from NPS MedicineWise.

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