Statins don't cause muscle pain



Fears of statin side effects may well have heightened the incidence of heart attacks and strokes, the team believe, and they call for the removal of warnings from the drug's packaging in future.

"If patients now begin to understand that actually this is not something that is specifically due to the chemistry of the drug then it may well be that your muscle aches and pains might get better", said Sever. There are patients refusing to take statins, Global Positioning System not prescribing them, and patients on statins who are stopping taking them.

It is the opposite to the well-known placebo effect, the beneficial response experienced by some trial patients to "dummy" drugs containing no active ingredients.

The authors speculated that they may have underestimated the nocebo effect, since ASCOT-LLA was performed during 1998-2005, "before claims that statin therapy causes high rates of side effects had become as common as they are now".

Other research had found that more than half of patients put on statins abandoned them within a year, most commonly because of side-effects, he said.

By contrast, when the patients and their doctors were aware of whether the patient was taking statins, reports of muscle-related problems were 41% higher among those who were taking statins. After the initial three-year trial ended, people were told if they had been taking statins or not and were allowed to continue taking the drugs if they wanted to.

An investigation into statins has demonstrated aching muscles and other reported symptoms could not be blamed on the drugs.

Over three years, participants were randomly picked to receive a statin or a placebo. Once the trial had concluded, patients continued to be monitored for a further two years as part of a follow up. There was no significant difference in rates of erectile dysfunction or cognitive impairment between the two groups.

During the blinded phase of the study, the rate of muscle-related symptoms was similar whether patients received a statin or placebo (2.03% per year versus 2% respectively).

Professor at Imperial College London and co-author of the study, Peter Sever, said reports of side effects had led to a fall in the number of patients taking statins and a reluctance among some doctors to prescribe them.

"These observations should help assure physicians and patients that most statin-associated adverse events are not causally related to use of the statins", they wrote in the Lancet.

He added: "Th ese warnings should not be on the label". This means hundreds of thousands of people could be missing out on potentially life-saving drugs because of misconceptions about side effects that appear to be largely in the mind.

"It would make life much more simple". "This is not a case of people making up symptoms or that the symptoms are 'all in their heads.' Patients can experience very real pain as a result of the nocebo effect and the expectation that drugs will cause harm". These included myopathy, which results in muscle weakness, and the very rare but serious muscle-wasting condition rhabdomyolysis. "Just as the placebo effect can be very strong, so too can the nocebo effect". "What our study shows is that it is precisely the expectation of harm that is likely to be causing the increase in muscle pain and weakness, rather than the drugs themselves causing them".

The study was funded by drug company Pfizer, which makes statins, but the authors stressed all data collection, analysis and interpretation of the results was carried out independently.

Professor Sever added: "There are increasing numbers of patients and physicians who are anxious about these supposed side effects of statins".

Statins are a class of drugs that are used to lower the levels of cholesterol in the blood which can help in preventing the risk of heart attack and stroke considerably.

The team did not directly explore whether or not a correlation exists between media reporting and individuals' reporting of side effects. "We wanted to explore why this might be the case, and whether someone who doesn't know they are taking statins will still experience the side effects".

"Any new significant information will be carefully reviewed and action taken if required, including updates to product labelling".

Professor Sir Nilesh Samani, medical director at the British Heart Foundation, pointed out that muscle aches, memory loss, sleep disturbance and erectile dysfunction occurred in the general population for a "whole variety of reasons".

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