Simvastatin (Page 9 of 10)

14.2 Clinical Studies in Adolescents

In a double-blind, placebo-controlled study, 175 patients (99 adolescent boys and 76 post-menarchal girls) 10 to 17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolemia (HeFH) were randomized to simvastatin (n=106) or placebo (n=67) for 24 weeks (base study). Inclusion in the study required a baseline LDL-C level between 160 and 400 mg/dL and at least one parent with an LDL-C level >189 mg/dL. The dosage of simvastatin (once daily in the evening) was 10 mg for the first 8 weeks, 20 mg for the second 8 weeks, and 40 mg thereafter. In a 24-week extension, 144 patients elected to continue therapy with simvastatin 40 mg or placebo.

Simvastatin tablets significantly decreased plasma levels of total-C, LDL-C, and Apo B (see Table 8). Results from the extension at 48 weeks were comparable to those observed in the base study.

Table 8: Lipid-Lowering Effects of Simvastatin in Adolescent Patients with Heterozygous Familial Hypercholesterolemia (Mean Percent Change from Baseline)

Dosage

Duration

N

Total-C

LDL-C

HDL-C

TG *

Apo B

*
median percent change

Placebo

24 Weeks

67

% Change from Baseline (95% CI) 1.6 (-2.2, 5.3) 1.1 (-3.4, 5.5) 3.6 (-0.7, 8.0) -3.2 (-11.8, 5.4) -0.5 (-4.7, 3.6)
Mean baseline, mg/dL (SD)

278.6

211.9

46.9

90.0

186.3

Simvastatin Tablets 24 Weeks 106

% Change from Baseline (95% CI)

-26.5

(-29.6, -23.3)

-36.8

(-40.5, -33.0)

8.3

(4.6, 11.9)

-7.9

(-15.8, 0.0)

-32.4

(-35.9, -29.0)

Mean baseline, mg/dL (SD)

270.2

203.8

47.7

78.3

179.9

After 24 weeks of treatment, the mean achieved LDL-C value was 124.9 mg/dL (range: 64.0 to 289.0 mg/dL) in the simvastatin tablets 40 mg group compared to 207.8 mg/dL (range: 128.0 to 334.0 mg/dL) in the placebo group.

The safety and efficacy of doses above 40 mg daily have not been studied in children with HeFH. The long-term efficacy of simvastatin therapy in childhood to reduce morbidity and mortality in adulthood has not been established.

16. HOW SUPPLIED/STORAGE AND HANDLING

Simvastatin tablets USP 20 mg are brick red coloured oval shaped, biconvex, film-coated tablets, debossed “S 5” on one side and plain on other side.

Bottles of 30 Tablets (NDC 67046-669-30)

Simvastatin tablets USP 40 mg are brick red coloured, oval shaped, biconvex, film-coated tablets, debossed “S 6” on one side and plain on other side.

Bottles of 30 Tablets (NDC 67046-676-30)

Storage

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

“Dispense in tight containers as defined in the USP”

17. PATIENT COUNSELING INFORMATION

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.

Patients should be advised about substances they should not take concomitantly with simvastatin [see Contraindications (4) and Warnings and Precautions (5.1)]. Patients should also be advised to inform other healthcare professionals prescribing a new medication or increasing the dose of an existing medication that they are taking simvastatin tablets.

17.1 Muscle Pain

All patients starting therapy with simvastatin tablets should be advised of the risk of myopathy , including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing simvastatin tablets.

Patients using the 80-mg dose should be informed that the risk of myopathy, including rhabdomyolysis, is increased with use of the 80-mg dose. The risk of myopathy, including rhabdomyolysis, occurring with use of simvastatin tablets are increased when taking certain types of medication or consuming grapefruit juice. Patients should discuss all medication, both prescription and over the counter, with their healthcare professional.

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