1.2. Pediatrics

HMG-CoA reductase inhibitors are FDA-approved for use as a dietary adjunct to reduce total cholesterol, LDL-C, TG, and Apo B in adolescent boys, and girls who are at least one-year post-menarche, (for pravastatin, children and adolescents 8-18 years of age regardless of menarchal status) with elevated LDL-C due to heterozygous familial hypercholesterolemia. Pitavastatin calcium (Livalo®) is FDA-approved for use in children/adolescents over 8 years of age as an adjunct to diet to manage heterozygous familial hypercholesterolemia by lowering total cholesterol, LDL-C, and apo B1,2,13. Rosuvastatin has expanded FDA approval for use in children as young as 8 years of age with heterozygous familial hypercholesterolemia, and has gained FDA approval for homozygous familial hypercholesterolemia in pediatric patients 7-17 years of age.1,2,10 Simvastatin oral suspension (FloLipid®) has been approved for use in conjunction with diet to improve total cholesterol, LDL-C, and ApoB in pediatric patients 10-17 years (females at least one year post-menarche) with heterozygous familial hypercholesterolemia1,2,12. Safety and efficacy of pitavastatin magnesium (Zypitamag®) or rosuvastatin sprinkle capsules (Ezallor Sprinkle™) in pediatric patients have not been established1,2,13,14 . Safety and effectiveness of HMG-CoA reductase inhibitors in pre-menarchal girls or children younger than 10 years of age (for pravastatin and rosuvastatin in heterozygous familial hypercholesterolemia, younger than 8 years of age regardless of menarchal status; for rosuvastatin in homozygous familial hypercholesterolemia, younger than 7 years of age) have not been well established1,2,9,10.

Ezetemibe/simivastatin (Vytorin®) combination therapy has been effectively used to manage children and adolescents with heterozygous familial hypercholesterolemia 1,2,15. The amlodipine/atorvastatin (Caduet®) combination has not been FDA-approved for the pediatric population as safety and efficacy have not been established with this combination therapy1,2,16. The safety and efficacy of ezetimibe/ rosuvastatin (Roszet®) in children has not been established, and it is currently not FDA-approved in the pediatric population 1,2,17.

Maximum recommended doses for HMG-CoA reductase inhibitors as both monotherapy and combination therapy in pediatric patients are summarized in Tables 3 and 4.

Table 3. Maximum Recommended HMG-CoA Reductase Inhibitor Pediatric Dosages: Monotherapy1-6, 8-12
Treatment Indication Drug Name Maximum Recommended Dosage
Heterozygous familial hypercholesterolemia atorvastatin 10-17 years of age:  
20 mg once daily
Heterozygous familial hypercholesterolemia fluvastatin 10-17 years of age:  
80 mg daily, as single evening dose or two divided doses
Heterozygous familial hypercholesterolemia lovastatin (immediate-release only) 10-17 years of age:  
40 mg once daily with evening meal
Heterozygous familial hypercholesterolemia pitavastatin Greater than 8 years to 17 years of age:
4 mg once daily
Heterozygous familial hypercholesterolemia pitavastatin Greater than 8 years to 17 years of age:
4 mg once daily
Heterozygous familial hypercholesterolemia pravastatin

8-13 years of age:  
20 mg once daily

14-17 years of age:  
40 mg once daily
Heterozygous familial hypercholesterolemia rosuvastatin (tablets only)

8-9 years of age:
10 mg once daily

10-17 years of age:
20 mg once daily
Homozygous familial hypercholesterolemia rosuvastatin (tablets only) 7-17 years of age:
20 mg once daily
Heterozygous familial hypercholesterolemia simvastatin 10-17 years of age:
40 mg once daily in evening
Table 4. Maximum Recommended HMG-CoA Reductase Inhibitor Pediatric Dosages: Combination Therapy1,2,15
Treatment Indication Drug Name Maximum Recommended Dosage
Heterozygous familial hypercholesterolemia ezetimibe/simvastatin 10-17 years of age (females postmenarchal):
10 mg/40 mg once daily