“Our results confirm that, in the majority of cases, statin therapy is not likely to be the cause of muscle pain in a person taking statin therapy,” said the study, led by authors from ‘Oxford Population Health and the Medical Research Council Population Health. Research Unit at the University of Oxford. “This finding is especially true if the treatment was well tolerated for a year or more before developing symptoms.”
The authors conducted a meta-analysis of 19 randomized, double-blind trials of statin regimens versus placebos. All trials had over 1000 participants and at least two years of follow-up. They also looked at four double-blind trials of more and less intense statin regimens.
Study author Colin Baigent, a professor of epidemiology at Oxford University, said there have been many non-randomized studies that don’t involve any type of placebo or random assignment to a statin that produced “really pretty extreme” estimates of how much muscle pain statins cause.
“It’s deterred patients from starting statins or causing them to stop when they develop muscle pain because they just look in the log and they see statins cause lots and lots of muscle pain and they stop. so,” Baigent told Science Media. Center briefing. “We were really trying to sort that out.”
The new study states that “even during the first year of a moderate-intensity statin regimen, it is likely to be the cause in only about 1 in 15 patients who report muscle symptoms, rising to about one in 10 in those on a more intensive diet.
“In other words, the statin is not the cause of muscle symptoms in more than 90% of people who report such symptoms.”
The authors found that during the first year, statin treatment produced a 7% relative increase in pain or muscle weakness, but there was no significant increase thereafter. The increased risk was already present in the first three months after treatment was assigned.
There were reports of at least one episode of muscle pain or weakness in 27.1% of patients assigned a statin versus 26.6% of those assigned a placebo during a median follow-up 4.3 years old.
In the trials reviewed by the authors, they say that statin treatment, during the first year of use, caused about 11 additional reports of muscle pain per 1,000 patients.
“What we conclude is that there are two things we need to do as a profession, as a society,” Baigent said during the briefing. “The first thing is that we need to better manage patients who report muscle pain when taking a statin, because patients tend to stop the statin and it has a detrimental effect on their long-term health. And the second thing what we need to do is we need to look at the information made available to patients in the package inserts.”
He noted that if people were better informed about the real risks of muscle pain, they might continue on statin therapy longer.
The study has some limitations, including considerable heterogeneity in the methods used for muscle symptoms, some adverse event data not being available, and most studies not excluding participants who can now be classified as intolerant to statins.
In a commentary published alongside the study, Dr. Maciej Banach, a cardiologist at the Medical University of Lodz and the Research Institute of Polish Mother’s Memorial Hospital in Poland, wrote that the possible side effects of statins should not be considered when starting treatment.
“It should be strongly emphasized that the low risk of muscle symptoms is insignificant when compared to the highly proven cardiovascular benefits of statins,” he writes.
Last week, the US Task Force on Preventive Services announced its latest guidelines on using statins to prevent a first heart attack or stroke.
The guidelines are more conservative than those published by other groups, such as the American College of Cardiology. They recommend statins for adults ages 40 to 75 who have at least one risk factor for cardiovascular disease and a 10% or high risk of heart attack in the next 10 years.