Patients taking statins to lower high cholesterol often complain of muscle pain, which can lead them to stop taking the highly effective drug and put them at greater risk of heart attack or stroke.
Some doctors have recommended vitamin D supplements to reduce muscle pain in patients taking statins, but a new study from researchers at Northwestern University, Harvard University and Stanford University shows that the vitamin does not appear to have any significant effect.
The study will be published in November. 23 in JAMA Cardiology.
Although non-randomized studies have reported vitamin D to be an effective treatment for statin-related muscle symptoms, the new study, which is the first randomized clinical trial to look at the effect of vitamin D on statin-related muscle symptoms, was large enough. to exclude important advantages.
In the randomized, double-blind study, 2,083 participants consumed either 2,000 units of vitamin D supplements daily or a placebo. The study found that participants in both groups were equally likely to develop muscle symptoms and discontinue statin therapy.
Over 4.8 years of follow-up, statin-related myalgia was reported by 31% of participants receiving vitamin D and 31% receiving placebo.
“We had high hopes that vitamin D would be effective because in our clinic and across the country, muscle symptoms associated with statins were the main reason so many patients stopped taking statins,” said senior author Dr. Neil Stone, professor of medicine in cardiology and preventive medicine at Northwestern University Feinberg School of Medicine and cardiologist at Northwestern Medicine. “So it was very disappointing that vitamin D failed the rigorous test. Nevertheless, it is important to avoid using ineffective treatments and focus more on research that can provide an answer.”
Statins and vitamin D supplements are two of the most commonly prescribed medications among adults in the United States. About 30 to 35 million Americans are prescribed statins, and about half of the population age 60 and older take vitamin D supplements.
“We used a large, placebo-controlled, randomized trial to test whether vitamin D would reduce statin-related muscle symptoms and help patients stay on their statins,” said lead study author Dr. Mark Hlatky, professor of health policy and cardiovascular medicine at Stanford. “The placebo control in the study was important because if people think vitamin D is supposed to reduce their muscle pain, they may just feel better while taking it, even if vitamin D has no specific effect.”
The study was a sub-study within a larger clinical trial
The 2,083 patients were among a larger group of participants in the Vitamin D and Omega-3 Trial (VITAL), which randomized nearly 26,000 participants to double-blind vitamin D supplementation to determine whether it would prevent cardiovascular disease and cancer. This gave the researchers a unique opportunity to test whether vitamin D reduces muscle symptoms among participants who started statins during the follow-up period of the larger VITAL study. The average age of the study participants was 67 and 51% were women.
“Randomized clinical trials are important because many really good ideas don’t work as well as we’d hoped when they’re tested,” Hlatky said. “Statistical associations do not prove cause and effect. Low levels of vitamin D are associated with many medical problems, but it turns out that giving people vitamin D generally does not fix those problems.”
For patients reporting myalgia associated with statins
Dr. Stone noted that sometimes the secret to understanding patients who struggle with statins is to analyze the other medications they are taking, determine whether or not they have associated metabolic or inflammatory conditions, counsel them about their ability to hydrate adequately, and, importantly, , discuss “the pill”. anxiety.”
“For those struggling with statins, systematic evaluation by a physician experienced in dealing with these issues is still very important,” Stone said.
The idea for this sub-study came from conversations between the co-author of the study, Dr. Pedro Gonzalez, then a resident at Northwestern Memorial Hospital, and Dr. Stone, who runs a large lipid lab at Northwestern.
Additional authors of the study include JoAnn E. Manson and the VITAL Research Group at Brigham and Women’s Hospital, Harvard Medical School, and the Harvard TH Chan School of Public Health.