1. A randomized controlled proceedings recovered that pretreatment with supplemental vitamin D did not trim the hazard of statin-associated musculus symptoms successful big patients.
2. Vitamin D supplementation besides did not trim the hazard of statin discontinuation.
Level of Evidence Rating: 1 (Excellent)
Study Rundown: Statins are amongst the astir communal medications prescribed successful North America for dyslipidemia and bosom protection. Adverse effects see statin-associated musculus symptoms (SAMS), which tin beryllium bothersome and often pb to medicine discontinuation. Recently, low-grade grounds has emerged for vitamin D supplementation arsenic a perchance effectual means of reducing the incidence of SAMS successful patients utilizing statins. This survey represents a secondary investigation of alternate outcomes (rate of SAMS and statin discontinuation) from a randomized controlled proceedings seeking to measure the effect of vitamin D connected crab hazard successful statin users.
In total, 25,871 participants were randomized. At baseline, 8890 (34%) of patients were taking a statin; of those who were not connected statin therapy astatine baseline, 2,835 reported taking a statin during the follow-up period. 31% of patients successful some the vitamin D and placebo groups reported musculus symptoms portion taking a statin medication. The complaint of statin discontinuation was besides the aforesaid successful some groups astatine 13%. Baseline serum measurements of vitamin D levels were besides not antithetic betwixt the 2 groups.
This secondary investigation of the VITAL proceedings demonstrated that vitamin D supplementation does not impact the hazard of experiencing SAMS successful big patients taking statin medications. Strengths of this survey included the randomized proceedings design, which does good to power for confounding and the ample survey size. Drawbacks of this survey see the inability to measure statin compliance arsenic good arsenic chronology (i.e., the timing of SAMS compared to initiation of statin therapy). Future studies should enactment to elucidate different agents which whitethorn beryllium adjuvant successful preventing SAMS successful statin users.
Click present to work this survey successful JAMA Cardiology
Relevant reading: Statin-associated musculus disease: advances successful diagnosis and management
In-Depth [randomized controlled trial]: Data from this survey was derived from the VITAL (vitamin D and omega-3) study, a ample randomized controlled proceedings seeking to measure the interaction of vitamin D supplementation connected crab hazard successful statin-users. Eligible patients were men implicit the property of 50 and women implicit the property of 55 who had nary cardiovascular illness oregon crab history. Participants were randomized to person vitamin D supplements (2000 IU per day), omega-3 supplements oregon a placebo and completed a survey astir the medications they were taking astatine baseline and implicit a bid of follow-up questionnaires. Patient enrolment took spot betwixt November 2011 and March 2014; the mean follow-up clip was 4.8 years.
Overall, 31% of patients successful some the vitamin D and the placebo radical reported SAMS. Therefore, the adjusted likelihood ratio for SAMS successful the vitamin D radical versus placebo was 0.97 (95% assurance interval 0.80-1.18). 13% of patients successful some groups discontinued the statin medication; the adjusted likelihood ratio for discontinuation was 1.04 (0.80-1.35).
Amongst patients who underwent serum vitamin D measurements implicit the survey course, baseline levels were the aforesaid successful some groups, with a mean level of 30.4 ng/mL and a median level of 30.0 ng/mL. The frequence of SAMS amongst patients with serum vitamin D measurements was besides not antithetic betwixt groups: 28% of the vitamin D supplementation patients vs 31% of the placebo patients experienced SAMS. The likelihood ratio for SAMS successful vitamin D users versus placebo participants who had serum vitamin D measurements was 0.86 (95% CI, 0.69-1.09).
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