Statin-associated muscle symptoms (SAMS)

Accessible web versions of NPS MedicineWise Statins clinical tools, SAMS Assessment Guide and SAMS Management Algorithm

Use a systematic approach to assess suspected statin intolerance

Figure A: Tolerability of statin treatment1
  • Statin intolerance is rarely life-threatening and may have a lower incidence than is commonly reported.2-4
  • Statins have been associated with a nocebo effect, whereby patients experience adverse effects based on the expectation of harm from a treatment.5
  • For muscle-related adverse effects:
    - Incidence of statin-associated myalgia is lower in blinded RCTs (1% to 5%)6 compared to observational studies (7% to 29%).4
    - Myopathy incidence is ~ 1 in 10,000 per year.4
    - Rhabdomyolysis incidence is ~ 1 in 100,000 per year.4
  • Involve the patient in assessing and managing adverse effects.
  • Advise patients to contact you if they experience muscle symptoms, and not to stop taking their statin.6
 

SAMS Assessment Guide

SAMS Assessment Guide, created by NPS MedicineWise 2017
See accessible text version of this table below



SAMS less likely SAMS more likely
Unilateral
Non-specific distribution
Tingling, twitching, shooting pain, nocturnal cramps or joint pain		 Nature of symptoms4,6,7 Bilateral
Large muscle groups (eg, thighs, buttocks, calves, shoulder girdle)
Muscle ache, weakness, soreness, stiffness, cramping tenderness or general fatigue
Onset before statin initiation
Onset > 12 weeks after statin initiation		Timing of symptoms4 Onset 4-6 weeks after statin initiation
Onset after statin dosage increase
Non-statin causes of muscle symptoms including:
  • conditions eg, hypothyroidism, polymyalgia rheumatica
  • vitamin D deficiency
  • unaccustomed/heavy physical activity
  • medicines eg, glucocorticoids, antipsychotics, immunosuppressant or antiviral agents
Other considerations4,7
Risk factors for SAMS including:
  • medicine or food interactions
  • high-dose statin therapy
  • history of myopathy with other lipid-modifying medicines
  • regular vigorous physical activity
  • impaired hepatic or renal function
  • substance abuse (eg, alcohol, opioids, cocaine)
  • female
  • low BMI

CK levels4
Elevated (> ULN, but may also be normal)
Elevated CK levels decrease after statin ceased.
 

SAMS Management Algorithm

SAMS Management Algorithm created by NPS MedicineWise 2017.

Read an accessible text version of this flowchart

 

References

  1. Mancini GBJ, Baker S, Bergeron J, et al. Diagnosis, Prevention, and Management of Statin Adverse Effects and Intolerance: Canadian Consensus Working Group Update (2016). Canadian Journal of Cardiology 2016;32:S35-S65. [PubMed].
  2. Collins R, Reith C, Emberson J, et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet 2016;388:2532-61. [PubMed].
  3. Parker BA, Capizzi JA, Grimaldi AS, et al. Effect of statins on skeletal muscle function. Circulation 2013;127:96-103. [PubMed].
  4. Stroes ES, Thompson PD, Corsini A, et al. Statin-associated muscle symptoms: impact on statin therapy—European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management. Eur Heart J 2015. [PubMed].
  5. Gupta A, Thompson D, Whitehouse A, et al. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase. Lancet 2017. [PubMed].
  6. Rosenson RS, Baker SK, Jacobson TA, et al. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol 2014;8:S58-71. [PubMed].
  7. American College of Cardiology. Statin Intolerance App. 2016. [Online] (accessed 1 March 2017).