ARE STATINS SAFE FOR THESE PATIENTS?
When considering statin therapy, there are some patient populations that warrant particular concern:
Women of childbearing age. Statins are contraindicated in women who are pregnant or breastfeeding1 and should not be initiated in women who are trying to conceive.
Children and adolescents (ages 8-18 years). Statins have been shown to be safe and effective for children and adolescents with familial hyperlipidemia. No effect on growth or maturation has been seen.51 As with adults, however, higher statin doses and the use of concomitant interacting drugs increase the risk for AEs.
Asians. The new ACC/AHA guideline suggests taking Asian ancestry into consideration when prescribing statins because Asians may be more sensitive to medications metabolized by the CYP450 system.1 However, there are no reports of an increased risk for AEs in Asian patients on statins.52
Patient factors that increase risk
Risk factors for statin-induced AEs include1
• Multiple and/or serious comorbidities (eg, hypothyroidism, impaired renal or hepatic function, rheumatic disorders)
• Unexplained ALT elevation more than 3x the upper limit of normal
• History of prior statin intolerance or concomitant use of drugs that affect statin metabolism
• Age older than 75
• Preexisting muscle disorders
• Low vitamin D levels.
If a patient who would clearly benefit from statin therapy develops an AE requiring discontinuation, a retrial—with the same drug or a different statin—is generally recommended once the symptoms resolve.1
CASE
The risk for elevated serum transaminases, insulin resistance, cognitive impairment, and neuropathy associated with statin use is minimal, and further evaluation revealed that Mr L.’s recent symptoms had other causes. The elevated transaminases were due to fatty liver disease, the cognitive impairment was secondary to sleep apnea (both linked to his obesity), and the tingling in his hands was the result of carpal tunnel syndrome caused by his exercise regimen.
When he returns in six months, Mr L. reports that he has been working with both a nutritionist and an athletic trainer. He has sustained a 15-lb weight loss. He is still taking atorvastatin 10 mg; after he began taking CoQ10, his muscle pain resolved. The patient’s cholesterol and transaminase levels are normal, and the cognitive impairment and peripheral neuropathy he reported at his last visit have improved significantly.
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