A double-blind, placebo-controlled study in 214 patients (100 boys and 114 girls) with heterozygous familial hypercholesterolemia (HeFH), aged 8 to 18 years was conducted for 2 years. The children (aged 8-13 years) were randomized to placebo (N=63) or 20 mg of pravastatin daily (N=65) and the adolescents (aged 14-18 years) were randomized to placebo (N=45) or 40 mg of pravastatin daily (N=41). Inclusion in the study required an LDL-C level >95th percentile for age and sex and one parent with either a clinical or molecular diagnosis of familial hypercholesterolemia. The mean baseline LDL-C value was 239 mg/dL and 237 mg/dL in the pravastatin (range: 151-405 mg/dL) and placebo (range: 154-375 mg/dL) groups, respectively.
Pravastatin significantly decreased plasma levels of LDL-C, Total-C, and ApoB in both children and adolescents (see Table 10). The effect of pravastatin treatment in the 2 age groups was similar.
|Pravastatin 20 mg(Aged 8-13 years) N=65||Pravastatin 40 mg(Aged 14-18 years)||Combined Pravastatin (Aged 8-18 years) N=106||Combined Placebo (Aged 8-18 years) N=108||95% CI of the Difference Between Combined Pravastatin and Placebo|
|ApoB (N)||−23.16(61)†||−18.08(39)||−21.11(100)||−0.97(106)||(−24.29, −16.18)|
The mean achieved LDL-C was 186 mg/dL (range: 67-363 mg/dL) in the pravastatin group compared to 236 mg/dL (range: 105-438 mg/dL) in the placebo group.
The safety and efficacy of pravastatin doses above 40 mg daily have not been studied in children. The long-term efficacy of pravastatin therapy in childhood to reduce morbidity and mortality in adulthood has not been established.
- Fredrickson DS, Levy RI, Lees RS. Fat transport in lipoproteins — An integrated approach to mechanisms and disorders. N Engl J Med. 1967;276: 34-44, 94-103, 148-156, 215-225, 273-281.
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- Jukema JW, Bruschke AVG, van Boven AJ, et al, for the Regression Growth Evaluation Statin Study Group (REGRESS). Effects of lipid lowering by pravastatin on progression and regression of coronary artery disease in symptomatic man with normal to moderately elevated serum cholesterol levels. Circ. 1995;91:2528-2540.
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Pravastatin Sodium Tablets, USP are supplied as:
10 mg tablets: White to off-white, rounded, rectangular-shaped, biconvex tablets debossed with “B 10” on one side and plain on other side. They are suppliedin bottles of 30’s Count (NDC 70377-045-11), 90’s Count (NDC 70377-045-12) and 1000’s Count (NDC 70377-045-14). Bottles contain a desiccant canister.
20 mg tablets: White to off-white, rounded, rectangular-shaped, biconvex tablets debossed with “B 20” on one side and plain on other side. They are suppliedin bottles of 30’s Count (NDC 70377-046-11), 90’s Count (NDC 70377-046-12) and 1000’s Count (NDC 70377-046-14). Bottles contain a desiccant canister.
40 mg tablets: White to off-white, rounded, rectangular-shaped, biconvex tablets debossed with “B 40” on one side and plain on other side. They are supplied in bottles of 30’s Count (NDC 70377-047-11), 90’s Count (NDC 70377-047-12) and 1000’s Count (NDC 70377-047-14). Bottles contain a desiccant canister.
80 mg tablets: White to off-white, oval-shaped, biconvex tablets, debossed with “B 80” on one side and plain on other side. They are suppliedin bottles of 30’s Count (NDC 70377-048-11), 90’s Count (NDC 70377-048-12) and 500’s Count (NDC 70377-048-13). Bottles contain a desiccant canister.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.
Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing Pravastatin Sodium [see Warnings and Precautions (5.1) ].
It is recommended that liver enzyme tests be performed before the initiation of Pravastatin Sodium, and thereafter when clinically indicated. All patients treated with Pravastatin Sodium should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.3) ].
Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4.3), Use in Specific Populations (8.1,8.3)].
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