1. A randomized controlled trial found that pretreatment with vitamin D supplementation did not reduce the risk of statin-associated muscle symptoms in adult patients.
2. Vitamin D supplementation also did not reduce the risk of statin discontinuation.
Assessment of the level of proof: 1 (Excellent)
Summary of the study: Statins are among the most commonly prescribed drugs in North America for dyslipidemia and cardiac protection. Adverse effects include statin-associated muscle symptoms (SAMS), which can be bothersome and frequently lead to discontinuation of treatment. Recently, low-quality evidence has emerged supporting vitamin D supplementation as a potentially effective means of reducing the incidence of SAMS in patients using statins. This study represents a secondary analysis of alternative outcomes (SAMS and statin discontinuation rates) of a randomized controlled trial to assess the effect of vitamin D on cancer risk in statin users.
A total of 25,871 participants were randomized. At baseline, 8890 (34%) patients were taking a statin; of those not on statin therapy at baseline, 2,835 reported taking a statin during the follow-up period. 31% of patients in the vitamin D and placebo groups reported muscle symptoms while taking a statin drug. The statin discontinuation rate was also the same in both groups at 13%. Baseline serum measurements of vitamin D levels were also not different between the two groups.
This secondary analysis of the VITAL trial demonstrated that vitamin D supplementation does not affect the risk of SAMS in adult patients taking statins. Strengths of this study included the randomized trial design, which controls well for confounders and the large study size. The drawbacks of this study include the inability to assess statin compliance as well as timing (i.e. timing of SAMS relative to statin therapy initiation). Future studies should strive to elucidate other agents that may be useful in preventing SAMS in statin users.
Click here to read this study in JAMA Cardiology
Relevant reading: Statin-Associated Muscle Disease: Advances in Diagnosis and Management
In depth [randomized controlled trial]: The data for this study come from the VITAL (vitamin D and omega-3) study, a large randomized controlled trial to assess the impact of vitamin D supplementation on cancer risk in statin users. Eligible patients were men over 50 and women over 55 who had no cardiovascular disease or history of cancer. Participants were randomized to receive vitamin D supplements (2000 IU daily), omega-3 supplements or a placebo and completed a survey of medications they were taking at baseline and a series of questionnaires feedback. Patient recruitment took place between November 2011 and March 2014; the mean duration of follow-up was 4.8 years.
Overall, 31% of patients in the vitamin D group and the placebo group reported SAMS. Therefore, the adjusted odds ratio for SAMS in the vitamin D group versus placebo was 0.97 (95% confidence interval 0.80-1.18). 13% of patients in both groups discontinued statin treatment; the odds ratio adjusted for discontinuation was 1.04 (0.80-1.35).
Among patients who underwent serum vitamin D measurements during the study, baseline levels were the same in both groups, with a mean level of 30.4 ng/mL and a median level of 30.0 ng/mL. The frequency of SAMS among patients with serum vitamin D assays was also not different between groups: 28% of patients receiving vitamin D supplementation versus 31% of patients on placebo experienced SAMS. The odds ratio for SAMS in vitamin D users compared to placebo participants who had serum vitamin D measurements was 0.86 (95% CI, 0.69-1.09).
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