TABLE 9-12

Recommendations for Use of 3-Hydroxy-3-Methylglutaryl-Coenzyme A Reductase Inhibitors (Statins) in Children and Adolescents

Patient selection
  1. Use algorithm (Fig 9-1) and risk-factor categories (Tables 9-6 and 9-7) to select statin therapy for patients.

  2. Include preferences of patient and family in decision-making.

  3. In general, do not start treatment with statins before the age of 10 y (patients with high-risk family history, high-risk conditions, or multiple risk factors [Tables 9-6 and 9-7] might be considered for medication initiation at age ≤10 y).

  4. Precaution/contraindication with potentially interactive medications (cyclosporine, niacin, fibric acid derivatives, erythromycin, azole antifungal agents, nefazodone, many HIV protease inhibitors); check for potential interaction with all current medications at baseline.

  5. Conduct baseline hepatic panel and CK before initiating treatment.

Initiation and titration
  1. Choice of particular statin is a matter of preference. Clinicians are encouraged to develop familiarity and experience with one of the statins, including dosage regimen and potential drug-drug interactions.

  2. Start with the lowest dose once daily, usually at bedtime. Atorvastatin and rosuvastatin can be taken in the morning or evening because of their long half-lives.

  3. Measure baseline CK, ALT, and AST.

  4. Instruct the patient to report all potential adverse effects, especially muscle cramps, weakness, asthenia, and more diffuse symptoms suggestive of myopathy.

  5. Advise female patients about concerns with pregnancy and the need for appropriate contraception.

  6. Advise about potential future medication interactions, especially cyclosporine, niacin, fibric acid derivatives, erythromycin, azole antifungal agents, nefazodone, and HIV protease inhibitors.

    Check for potential interaction whenever any new medication is initiated.
  1. Whenever potential myopathy symptoms are present, stop medication and assess CK; determine relation to recent physical activity. The threshold for worrisome level of CK is 10 times above the upper limit of reported normal, considering the impact of physical activity. Monitor the patient for resolution of myopathy symptoms and any associated increase in CK level. Consideration can be given to restarting the medication once symptoms and laboratory abnormalities have resolved.

  2. After 4 wk, measure FLP, ALT, and AST and compare with laboratory-specific reported normal values.

    • The threshold for worrisome levels of ALT or AST is ≥3 times the upper limit of reported normal.

    • Target levels for LDL cholesterol: minimal, <130 mg/dL; ideal, <110 mg/dL.

  3. If target LDL cholesterol levels are achieved and there are no potential myopathy symptoms or laboratory abnormalities, continue therapy and recheck FLP, ALT, and AST in 8 wk and then in 3 mo.

  4. If laboratory abnormalities are noted or symptoms are reported, temporarily withhold the medication and repeat the blood work in 2 wk. When abnormalities resolve, the medication may be restarted with close monitoring.

  5. If target LDL cholesterol levels are not achieved, increase the dose by 1 increment (usually 10 mg) and repeat the blood work in 4 wk. If target LDL cholesterol levels are still not achieved, dose may be further increased by 1 increment, or another agent (bile acid sequestrant or cholesterol absorption inhibitor) may be added under the direction of a lipid specialist.

Maintenance monitoring
  1. Monitor growth (height, weight, and BMI relative to normal growth charts), sexual maturation, and development.

  2. Whenever potential myopathy symptoms present, stop medication and assess CK.

  3. Monitor FLP, ALT, and AST every 3–4 mo in the first year, every 6 mo in the second year and beyond, and whenever clinically indicated.

  4. Monitor and encourage compliance with lipid-lowering dietary and medication therapy. Serially assess and counsel for other risk factors such as weight gain, smoking, and inactivity.

  5. Counsel adolescent girls about statin contraindications in pregnancy and the need for abstinence or use of appropriate contraceptive measures. Use of oral contraceptives is not contraindicated if medically appropriate. Seek referral to an adolescent medicine or gynecologic specialist as appropriate.

  • CK indicates creatine kinase; ALT, alanine aminotransferase; AST, aspartate aminotransferase.