Vitamin D does not reduce statin-associated muscle symptoms: VITAL

The rate of muscle symptoms with statins was high in the study, but vitamin D had little impact on alleviating patients’ concerns.

According to an analysis of the VITAL study, taking vitamin D does not significantly affect statin-associated muscle symptoms (SAMS), nor does it prevent patients from discontinuing their medication because of muscle pain.

During 5 years of follow-up, the rate of SAMS was 31% in both patients taking vitamin D and those taking placebo in the US National Heart, Lung and Blood Institute (NHLBI) funded study. The rate of statin discontinuation was 13% in the vitamin D and placebo treatment groups.

“These null results in a large, contemporary randomized clinical trial suggest that vitamin D has little or no association with the occurrence of SAMS,” write Mark A. Hlatky, MD (Stanford University School of Medicine, CA), and colleagues in the paper this week. week published in JAMA Cardiology.

VITAL was a nationwide, randomized, placebo-controlled US study with a 2×2 factorial design of both vitamin D at a dose of 2000 IU per day and marine n-3 fatty acids at a dose of 1 g per day. The study, published in 2018, found that neither vitamin D nor n-3 fatty acids reduced the risk of major cardiovascular events or cancer compared to placebo.

With VITAL, researchers say they had a unique opportunity to evaluate whether vitamin D could reduce the risk of SAMS. As part of the study, new statin users were sent a survey asking about muscle symptoms, including musculoskeletal pain or discomfort that lasted more than a few days while taking the lipid-lowering therapy. They were also asked if they stopped taking the statins because of the discomfort.

Speaking to TCTMD, Hlatky noted that the rationale for testing vitamin D to treat SAMS was based in part on findings showing it has some effects on muscle function. There are also studies showing that patients with SAMS have lower levels of vitamin D, he said.

The analysis included 1,033 participants randomized to vitamin D and 1,050 assigned to placebo. Overall, muscle symptoms were reported by 317 (31%) and 325 (31%) of patients in the treatment and placebo groups, a non-significant difference. The number of statin discontinuations was also no different. In two-thirds of patients with measured 25-hydroxy vitamin D (25-OHD) levels, there was no difference in SAMS between the two treatments. The effect of vitamin D on muscle symptoms was similar across baseline 25-OHD levels.

The researchers note that the rate of SAMS was high in VITAL, but point out that statin therapy was initiated by the participants’ physicians and that SAMS was not prospectively evaluated or treated.

When it comes to treating patients with statin-related muscle pain, Hlatky said there are options other than vitamin D.

“Since vitamin D is not effective for SAMS, I would recommend the approach in the 2018 ACC/AHA Cholesterol Guidelines, which is based on stopping [statin therapy] for a period of time, and then restart with a different drug and/or a lower dose,” he said. “That is often effective.”

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