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Low Vitamin D as a Risk Factor for the Development of Myalgia in Patients Taking High-Dose Simvastatin: A Retrospective Review

Abstract Background Statins are the treatment of choice for dyslipidemia, primarily lowering elevated LDL-C levels and reducing the occurrence of major cardiovascular events. In June 2011, the Food and Drug Administration issued a warning regarding the use of high-dose simvastatin 80 mg and its risk... Full description

Journal Title: Clinical therapeutics 2014, Vol.36 (5), p.770-777
Main Author: Mergenhagen, Kari, PharmD, BCPS AQ-ID
Other Authors: Ott, Michael, PharmD, BCPS , Heckman, Kerry, PharmD , Rubin, Lisa M., PharmD , Kellick, Kenneth, PharmD, CLS
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: Bridgewater, NJ: Elsevier Inc
ID: ISSN: 0149-2918
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title: Low Vitamin D as a Risk Factor for the Development of Myalgia in Patients Taking High-Dose Simvastatin: A Retrospective Review
format: Article
creator:
  • Mergenhagen, Kari, PharmD, BCPS AQ-ID
  • Ott, Michael, PharmD, BCPS
  • Heckman, Kerry, PharmD
  • Rubin, Lisa M., PharmD
  • Kellick, Kenneth, PharmD, CLS
subjects:
  • Adult
  • Aged
  • Alcoholism
  • Alfacalcidol
  • Antilipemic agents
  • Biological and medical sciences
  • Body mass index
  • Calcifediol
  • Cardiovascular disease
  • Diabetes
  • Diseases of striated muscles. Neuromuscular diseases
  • Dosage and administration
  • Dose-Response Relationship, Drug
  • Drug therapy
  • Drugstores
  • Humans
  • Hypothyroidism
  • Internal Medicine
  • Kidney diseases
  • Laboratories
  • Logistic Models
  • Low density lipoproteins
  • Male
  • Medical Education
  • Medical Records
  • Medical sciences
  • Middle Aged
  • muscle pain
  • Muscular Diseases - chemically induced
  • myalgia
  • Myalgia - blood
  • Myalgia - chemically induced
  • myopathy
  • Neurology
  • Patients
  • Pharmacology. Drug treatments
  • Potassium
  • Retrospective Studies
  • rhabdomyolysis
  • Rhabdomyolysis - chemically induced
  • Risk Factors
  • Simvastatin
  • Simvastatin - administration & dosage
  • Simvastatin - adverse effects
  • Statins
  • Triglycerides
  • Veterans
  • Vitamin B
  • Vitamin D
  • Vitamin D - blood
  • Vitamin D Deficiency - complications
  • Young Adult
ispartof: Clinical therapeutics, 2014, Vol.36 (5), p.770-777
description: Abstract Background Statins are the treatment of choice for dyslipidemia, primarily lowering elevated LDL-C levels and reducing the occurrence of major cardiovascular events. In June 2011, the Food and Drug Administration issued a warning regarding the use of high-dose simvastatin 80 mg and its risk of myopathy. Objective The incidence of myalgia, myopathy, and rhabdomyolysis was analyzed in a veteran population prescribed simvastatin 80 mg. Risk factors for myalgia were examined and compared with the results of recently published studies. Methods This was a retrospective medical record review of 450 patients who were prescribed simvastatin 80 mg at the Veterans Affairs Western New York Healthcare System between August 1, 2006, and July 31, 2011. Records were examined for evidence of myalgia, myopathy (incipient or definite), and rhabdomyolysis. Variables that may have contributed to the development of myalgia were also collected and analyzed. Results Myalgia was reported by 50 patients (11.1%), whereas rhabdomyolysis developed in 1 patient (0.22%). No patient fit the criteria for myopathy (incipient or definite). Myalgia was statistically more likely to occur in younger patients, patients with a history of myalgia, and patients with low vitamin D levels. The mean (SD) vitamin D level in patients experiencing myalgia was 26.2 (12.9) versus 36.3 (11.8) ng/mL. The 25-hydroxyvitamin D level in those who reported myalgia was approximately 10 ng/mL lower compared with those who tolerated simvastatin 80 mg ( P = 0.0003). There was no statistically significant association between length of therapy and development of myalgia. Conclusion A lower incidence of adverse muscle events with high-dose simvastatin 80 mg was found in patients with higher vitamin D levels, suggesting that correction of 25-hydroxyvitamin D levels before statin therapy initiation may mitigate one risk factor in the development of statin-related myalgia. Vitamin D insufficiency appears to be a risk factor for the development of myalgia.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0149-2918
fulltext: fulltext
issn:
  • 0149-2918
  • 1879-114X
url: Link


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titleLow Vitamin D as a Risk Factor for the Development of Myalgia in Patients Taking High-Dose Simvastatin: A Retrospective Review
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creatorMergenhagen, Kari, PharmD, BCPS AQ-ID ; Ott, Michael, PharmD, BCPS ; Heckman, Kerry, PharmD ; Rubin, Lisa M., PharmD ; Kellick, Kenneth, PharmD, CLS
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descriptionAbstract Background Statins are the treatment of choice for dyslipidemia, primarily lowering elevated LDL-C levels and reducing the occurrence of major cardiovascular events. In June 2011, the Food and Drug Administration issued a warning regarding the use of high-dose simvastatin 80 mg and its risk of myopathy. Objective The incidence of myalgia, myopathy, and rhabdomyolysis was analyzed in a veteran population prescribed simvastatin 80 mg. Risk factors for myalgia were examined and compared with the results of recently published studies. Methods This was a retrospective medical record review of 450 patients who were prescribed simvastatin 80 mg at the Veterans Affairs Western New York Healthcare System between August 1, 2006, and July 31, 2011. Records were examined for evidence of myalgia, myopathy (incipient or definite), and rhabdomyolysis. Variables that may have contributed to the development of myalgia were also collected and analyzed. Results Myalgia was reported by 50 patients (11.1%), whereas rhabdomyolysis developed in 1 patient (0.22%). No patient fit the criteria for myopathy (incipient or definite). Myalgia was statistically more likely to occur in younger patients, patients with a history of myalgia, and patients with low vitamin D levels. The mean (SD) vitamin D level in patients experiencing myalgia was 26.2 (12.9) versus 36.3 (11.8) ng/mL. The 25-hydroxyvitamin D level in those who reported myalgia was approximately 10 ng/mL lower compared with those who tolerated simvastatin 80 mg ( P = 0.0003). There was no statistically significant association between length of therapy and development of myalgia. Conclusion A lower incidence of adverse muscle events with high-dose simvastatin 80 mg was found in patients with higher vitamin D levels, suggesting that correction of 25-hydroxyvitamin D levels before statin therapy initiation may mitigate one risk factor in the development of statin-related myalgia. Vitamin D insufficiency appears to be a risk factor for the development of myalgia.
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languageeng
publisherBridgewater, NJ: Elsevier Inc
subjectAdult ; Aged ; Alcoholism ; Alfacalcidol ; Antilipemic agents ; Biological and medical sciences ; Body mass index ; Calcifediol ; Cardiovascular disease ; Diabetes ; Diseases of striated muscles. Neuromuscular diseases ; Dosage and administration ; Dose-Response Relationship, Drug ; Drug therapy ; Drugstores ; Humans ; Hypothyroidism ; Internal Medicine ; Kidney diseases ; Laboratories ; Logistic Models ; Low density lipoproteins ; Male ; Medical Education ; Medical Records ; Medical sciences ; Middle Aged ; muscle pain ; Muscular Diseases - chemically induced ; myalgia ; Myalgia - blood ; Myalgia - chemically induced ; myopathy ; Neurology ; Patients ; Pharmacology. Drug treatments ; Potassium ; Retrospective Studies ; rhabdomyolysis ; Rhabdomyolysis - chemically induced ; Risk Factors ; Simvastatin ; Simvastatin - administration & dosage ; Simvastatin - adverse effects ; Statins ; Triglycerides ; Veterans ; Vitamin B ; Vitamin D ; Vitamin D - blood ; Vitamin D Deficiency - complications ; Young Adult
ispartofClinical therapeutics, 2014, Vol.36 (5), p.770-777
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0Low Vitamin D as a Risk Factor for the Development of Myalgia in Patients Taking High-Dose Simvastatin: A Retrospective Review
1Clinical therapeutics
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descriptionAbstract Background Statins are the treatment of choice for dyslipidemia, primarily lowering elevated LDL-C levels and reducing the occurrence of major cardiovascular events. In June 2011, the Food and Drug Administration issued a warning regarding the use of high-dose simvastatin 80 mg and its risk of myopathy. Objective The incidence of myalgia, myopathy, and rhabdomyolysis was analyzed in a veteran population prescribed simvastatin 80 mg. Risk factors for myalgia were examined and compared with the results of recently published studies. Methods This was a retrospective medical record review of 450 patients who were prescribed simvastatin 80 mg at the Veterans Affairs Western New York Healthcare System between August 1, 2006, and July 31, 2011. Records were examined for evidence of myalgia, myopathy (incipient or definite), and rhabdomyolysis. Variables that may have contributed to the development of myalgia were also collected and analyzed. Results Myalgia was reported by 50 patients (11.1%), whereas rhabdomyolysis developed in 1 patient (0.22%). No patient fit the criteria for myopathy (incipient or definite). Myalgia was statistically more likely to occur in younger patients, patients with a history of myalgia, and patients with low vitamin D levels. The mean (SD) vitamin D level in patients experiencing myalgia was 26.2 (12.9) versus 36.3 (11.8) ng/mL. The 25-hydroxyvitamin D level in those who reported myalgia was approximately 10 ng/mL lower compared with those who tolerated simvastatin 80 mg ( P = 0.0003). There was no statistically significant association between length of therapy and development of myalgia. Conclusion A lower incidence of adverse muscle events with high-dose simvastatin 80 mg was found in patients with higher vitamin D levels, suggesting that correction of 25-hydroxyvitamin D levels before statin therapy initiation may mitigate one risk factor in the development of statin-related myalgia. Vitamin D insufficiency appears to be a risk factor for the development of myalgia.
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8Cardiovascular disease
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10Diseases of striated muscles. Neuromuscular diseases
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12Dose-Response Relationship, Drug
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15Humans
16Hypothyroidism
17Internal Medicine
18Kidney diseases
19Laboratories
20Logistic Models
21Low density lipoproteins
22Male
23Medical Education
24Medical Records
25Medical sciences
26Middle Aged
27muscle pain
28Muscular Diseases - chemically induced
29myalgia
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32myopathy
33Neurology
34Patients
35Pharmacology. Drug treatments
36Potassium
37Retrospective Studies
38rhabdomyolysis
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40Risk Factors
41Simvastatin
42Simvastatin - administration & dosage
43Simvastatin - adverse effects
44Statins
45Triglycerides
46Veterans
47Vitamin B
48Vitamin D
49Vitamin D - blood
50Vitamin D Deficiency - complications
51Young Adult
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titleLow Vitamin D as a Risk Factor for the Development of Myalgia in Patients Taking High-Dose Simvastatin: A Retrospective Review
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2Alcoholism
3Alfacalcidol
4Antilipemic agents
5Biological and medical sciences
6Body mass index
7Calcifediol
8Cardiovascular disease
9Diabetes
10Diseases of striated muscles. Neuromuscular diseases
11Dosage and administration
12Dose-Response Relationship, Drug
13Drug therapy
14Drugstores
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16Hypothyroidism
17Internal Medicine
18Kidney diseases
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21Low density lipoproteins
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abstractAbstract Background Statins are the treatment of choice for dyslipidemia, primarily lowering elevated LDL-C levels and reducing the occurrence of major cardiovascular events. In June 2011, the Food and Drug Administration issued a warning regarding the use of high-dose simvastatin 80 mg and its risk of myopathy. Objective The incidence of myalgia, myopathy, and rhabdomyolysis was analyzed in a veteran population prescribed simvastatin 80 mg. Risk factors for myalgia were examined and compared with the results of recently published studies. Methods This was a retrospective medical record review of 450 patients who were prescribed simvastatin 80 mg at the Veterans Affairs Western New York Healthcare System between August 1, 2006, and July 31, 2011. Records were examined for evidence of myalgia, myopathy (incipient or definite), and rhabdomyolysis. Variables that may have contributed to the development of myalgia were also collected and analyzed. Results Myalgia was reported by 50 patients (11.1%), whereas rhabdomyolysis developed in 1 patient (0.22%). No patient fit the criteria for myopathy (incipient or definite). Myalgia was statistically more likely to occur in younger patients, patients with a history of myalgia, and patients with low vitamin D levels. The mean (SD) vitamin D level in patients experiencing myalgia was 26.2 (12.9) versus 36.3 (11.8) ng/mL. The 25-hydroxyvitamin D level in those who reported myalgia was approximately 10 ng/mL lower compared with those who tolerated simvastatin 80 mg ( P = 0.0003). There was no statistically significant association between length of therapy and development of myalgia. Conclusion A lower incidence of adverse muscle events with high-dose simvastatin 80 mg was found in patients with higher vitamin D levels, suggesting that correction of 25-hydroxyvitamin D levels before statin therapy initiation may mitigate one risk factor in the development of statin-related myalgia. Vitamin D insufficiency appears to be a risk factor for the development of myalgia.
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pmid24742497
doi10.1016/j.clinthera.2014.02.023
orcididhttps://orcid.org/0000-0002-2131-3204