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LETTER TO EDITOR
Year : 2015  |  Volume : 7  |  Issue : 7  |  Page : 337-338

Statin intolerance and vitamin D supplementation: Sunny, but a few clouds remain...


1 Department of Pharmacy Practice and Medicine, Kansas University Medical Center and the University of Kansas School of Pharmacy, Kansas, USA
2 Department of Pharmacy Practice, University of Kansas School of Pharmacy, Kansas, USA
3 Department of Medicine, Kansas University Medical Center and the University of Kansas School of Pharmacy, Kansas, USA

Date of Web Publication21-Jul-2015

Correspondence Address:
James M Backes
Department of Pharmacy Practice and Medicine, Kansas University Medical Center and the University of Kansas School of Pharmacy, Kansas
USA
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/1947-2714.161255

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How to cite this article:
Backes JM, Ruisinger JF, Barnes BJ, Moriarty PM. Statin intolerance and vitamin D supplementation: Sunny, but a few clouds remain... North Am J Med Sci 2015;7:337-8

How to cite this URL:
Backes JM, Ruisinger JF, Barnes BJ, Moriarty PM. Statin intolerance and vitamin D supplementation: Sunny, but a few clouds remain... North Am J Med Sci [serial online] 2015 [cited 2019 Nov 18];7:337-8. Available from: http://www.najms.org/text.asp?2015/7/7/337/161255

Dear Editor,

We read with interest the article by Khayznikov et al., regarding the resolution of statin intolerance with vitamin D repletion. [1] We too have tried this strategy among a similarly statin intolerant population (median - three previous statins) and believe vitamin D supplementation plays a role in treating certain individuals. Our results demonstrated that vitamin D repletion to >30 ng/ml, allowed 53% (18/34) of the intolerant patients to utilize some form of alternative or daily statin dosing or a higher dose among those receiving a statin but experiencing tolerable symptoms, for at least four months (mean follow up 8.5 + 4.4 months). Our findings are encouraging but well below the 88-95% statin tolerability rates reported in the present study.

Directly comparing study populations and results is not feasible; however, one potential explanation for response differences may be the vitamin D level achieved. For instance, the vitamin D levels among those tolerating the statin rechallenge in our group was 44 ng/ml compared to 53-55 ng/ml in the current report, suggesting that perhaps our vitamin D repletion was incomplete, despite each group falling within the range suggested by the Endocrine Society. [2]

Another factor that we believe played a prominent role in the resolution of myalgic symptoms in the current study was the predominant utilization of rosuvastatin. The authors recognize that rosuvastatin is less frequently associated with myotoxicity; however, this should not be minimized. In fact, the same research center performed a similar study, and determined that the vast majority of previously statin intolerant subjects reported no adverse effects when rechallenged with rosuvastatin 5-10 mg daily. [3]

Lastly, we agree with the authors that an optimal study evaluating statin intolerance would be blinded and placebo-controlled, given the subjective nature of most myotoxicity. In fact, this design was recently utilized to assess various lipid-altering agents, including the investigational proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, among subjects unable to tolerate two or more different statins because of unexplained muscle-related symptoms. [4] After successful completion of a four-week single-blind placebo run-in period, subjects were randomized in a double-blind manner to a PCSK9 injection Q two weeks + oral placebo daily, ezetimibe 10 mg daily + placebo injection Q two weeks, or atorvastatin 20 mg daily + placebo injection Q two weeks, for 24 weeks. Such a study design provided novel, insightful, and revealing findings with regard to statin intolerance. For example, the trial demonstrated that 6.9% of subjects were excluded from randomization due to muscle-related adverse events during the placebo run-in period. Further, 75% of the previously intolerant patients tolerated the atorvastatin 20 mg daily for the duration of the 24-week study period. Such results strongly highlight the subjectivity of statin intolerance and the major influence of a placebo effect in many patients.

Statin intolerance, especially among patients with previous sensitivity to multiple agents, is a complex and poorly understood issue that remains a clinical challenge. In the present study, vitamin D repletion likely improved muscle function and resolved symptoms in some patients. However, the vitamin D supplementation may have also provided a placebo effect, while the utilization of rosuvastatin further enhanced response.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Khayznikov M, Hemachrandra K, Pandit R, Kumar A, Wang P, Glueck CJ. Statin Intolerance Because of Myalgia, Myositis, Myopathy, or Myonecrosis Can in Most Cases be Safely Resolved by Vitamin D Supplementation. N Am J Med Sci 2015;7:86-93.  Back to cited text no. 1
    
2.
Pludowski P, Holick MF, Pilz S, Wagner CL, Hollis BW, Grant WB, et al. Vitamin D effects on musculoskeletal health, immunity, autoimmunity, cardiovascular disease, cancer, fertility, pregnancy, dementia and mortality - A review of recent evidence. Autoimmun Rev 2013;12:976-89.  Back to cited text no. 2
    
3.
Glueck CJ, Aregawi D, Agloria M, Khalil Q, Winiarska M, Munjal J, et al. Rosuvastatin 5 and 10 mg/d: A pilot study of the effects in hypercholesterolemic adults unable to tolerate other statins and reach LDL cholesterol goals with nonstatin lipid-lowering therapies. Clin Ther 2006;28:933-42.  Back to cited text no. 3
    
4.
Moriarty PM, Thompson PD, Cannon CP, Guyton JR, Bergeron J, Zieve FJ, et al. ODYSSEY ALTERNATIVE: Efficacy and Safety of the Proprotein Convertase Subtilisin/kexin Type 9 Monoclonal Antibody, Alirocumab, versus Ezetimibe, in Patients with Statin Intolerance as Defined by a Placebo Run-in and Statin Rechallenge Arm. American Heart Association Scientific Sessions 2014; 2014 November 17 th , 2014.  Back to cited text no. 4
    



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[Pubmed] | [DOI]



 

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