When should statins be discontinued?

When to Discontinue Statins

Statins should be discontinued when patients experience severe muscle symptoms, develop functional decline or frailty in older adults, or have limited life expectancy where the potential benefits no longer outweigh the risks. 1

Discontinuation Due to Adverse Effects

Muscle-Related Symptoms

• Severe muscle symptoms or fatigue: Promptly discontinue statin therapy and evaluate for rhabdomyolysis by checking CK, creatinine, and urinalysis for myoglobinuria 1
• Mild to moderate muscle symptoms: Temporarily discontinue statin until symptoms can be evaluated, then assess for other conditions that might increase risk (hypothyroidism, reduced renal/hepatic function, rheumatologic disorders, vitamin D deficiency) 1
• After symptom resolution: If no contraindication exists, consider rechallenging with the original or lower dose of the same statin to establish causality between symptoms and therapy 1

Other Adverse Effects

• Discontinue statins if unexplained severe hepatotoxicity develops (though this is rare, with serious hepatotoxicity risk of approximately 0.001%) 2
• The risk of statin-induced serious muscle injury including rhabdomyolysis is <0.1%, but requires immediate discontinuation if suspected 2

Discontinuation in Special Populations

Older Adults

• Consider discontinuation in adults ≥75 years of age when there is:
  • Functional decline (physical or cognitive) 1
  • Multimorbidity or frailty 1
  • Reduced life expectancy that limits potential benefits 1

End-of-Life and Palliative Care

• Discontinue statins in patients with limited life expectancy (1-12 months) as benefits take years to accrue while risks remain immediate 3
• Discontinuation of statins in palliative care settings has been associated with:
  • Improved quality of life 3
  • Reduced medication burden 3
  • Cost savings (approximately $3.37 per day per patient) 3
• Patients with life-limiting illness generally have few concerns about statin discontinuation and may perceive benefits including better quality of life 4

Pregnancy

• Discontinue statins when pregnancy is recognized 5, 6
• Statins may cause fetal harm by decreasing cholesterol synthesis and possibly other biologically active substances derived from cholesterol 5, 6
• Treatment of hyperlipidemia is generally not necessary during pregnancy 5, 6

Common Pitfalls in Statin Discontinuation

• Unnecessary discontinuation: Obtain baseline history of muscle symptoms before starting therapy to avoid attributing pre-existing symptoms to statins 1
• Failure to recognize statin-associated symptoms: In clinical practice, approximately 10% of patients stop taking statins due to subjective complaints (mostly muscle symptoms), while in clinical trials this difference is <1% compared to placebo 2
• Inadequate follow-up after discontinuation: When discontinuing for mild-moderate symptoms, patients should be evaluated for alternative causes and rechallenged if appropriate 1
• Continuing statins until death: Studies show statins are often continued until death even in patients with poor-prognosis cancer or other life-limiting conditions 7, 8

Decision Algorithm for Statin Discontinuation

1. Assess for severe adverse effects:

   • If present → Discontinue immediately 1

2. Evaluate patient age and health status:

   • If ≥75 years with frailty, functional decline, or multimorbidity → Consider discontinuation 1

3. Determine life expectancy:

   • If <1 year → Discontinue, especially for primary prevention 3, 4

4. Check pregnancy status:

   • If pregnant → Discontinue 5, 6

5. For mild-moderate symptoms:

   • Temporarily discontinue → Evaluate → Consider rechallenge at same or lower dose 1

When discontinuing statins, it's important to document the reason clearly and monitor patients for any changes in cardiovascular risk or symptom improvement.