Lipitor (Page 9 of 11)

14.3 Hypertriglyceridemia (Fredrickson Type IV)

The response to LIPITOR in 64 patients with isolated hypertriglyceridemia treated across several clinical trials is shown in the table below (Table 8). For the LIPITOR-treated patients, median (min, max) baseline TG level was 565 (267–1502).

TABLE 8. Combined Patients With Isolated Elevated TG: Median (min, max) Percentage Change From Baseline
Placebo (N=12)LIPITOR 10 mg (N=37)LIPITOR 20 mg (N=13)LIPITOR 80 mg (N=14)
Triglycerides-12.4 (-36.6, 82.7)-41.0 (-76.2, 49.4)-38.7 (-62.7, 29.5)-51.8 (-82.8, 41.3)
Total-C-2.3 (-15.5, 24.4)-28.2 (-44.9, -6.8)-34.9 (-49.6, -15.2)-44.4 (-63.5, -3.8)
LDL-C3.6 (-31.3, 31.6)-26.5 (-57.7, 9.8)-30.4 (-53.9, 0.3)-40.5 (-60.6, -13.8)
HDL-C3.8 (-18.6, 13.4)13.8 (-9.7, 61.5)11.0 (-3.2, 25.2)7.5 (-10.8, 37.2)
VLDL-C-1.0 (-31.9, 53.2)-48.8 (-85.8, 57.3)-44.6 (-62.2, -10.8)-62.0 (-88.2, 37.6)
non-HDL-C-2.8 (-17.6, 30.0)-33.0 (-52.1, -13.3)-42.7 (-53.7, -17.4)-51.5 (-72.9, -4.3)

14.4 Dysbetalipoproteinemia (Fredrickson Type III)

The results of an open-label crossover study of 16 patients (genotypes: 14 apo E2/E2 and 2 apo E3/E2) with dysbetalipoproteinemia (Fredrickson Type III) are shown in the table below (Table 9).

TABLE 9. Open-Label Crossover Study of 16 Patients With Dysbetalipoproteinemia (Fredrickson Type III)
Median % Change (min, max)
Median (min, max) at Baseline (mg/dL)LIPITOR 10 mgLIPITOR 80 mg
Total-C442 (225, 1320)-37 (-85, 17)-58 (-90, -31)
Triglycerides678 (273, 5990)-39 (-92, -8)-53 (-95, -30)
IDL-C + VLDL-C215 (111, 613)-32 (-76, 9)-63 (-90, -8)
non-HDL-C411 (218, 1272)-43 (-87, -19)-64 (-92, -36)

14.5 Homozygous Familial Hypercholesterolemia

In a study without a concurrent control group, 29 patients ages 6 to 37 years with homozygous FH received maximum daily doses of 20 to 80 mg of LIPITOR. The mean LDL-C reduction in this study was 18%. Twenty-five patients with a reduction in LDL-C had a mean response of 20% (range of 7% to 53%, median of 24%); the remaining 4 patients had 7% to 24% increases in LDL-C. Five of the 29 patients had absent LDL-receptor function. Of these, 2 patients also had a portacaval shunt and had no significant reduction in LDL-C. The remaining 3 receptor-negative patients had a mean LDL-C reduction of 22%.

14.6 Heterozygous Familial Hypercholesterolemia in Pediatric Patients

In a double-blind, placebo-controlled study followed by an open-label phase, 187 boys and postmenarchal girls 10–17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolemia (FH) or severe hypercholesterolemia, were randomized to LIPITOR (n=140) or placebo (n=47) for 26 weeks and then all received LIPITOR for 26 weeks. Inclusion in the study required 1) a baseline LDL-C level ≥ 190 mg/dL or 2) a baseline LDL-C level ≥ 160 mg/dL and positive family history of FH or documented premature cardiovascular disease in a first or second-degree relative. The mean baseline LDL-C value was 218.6 mg/dL (range: 138.5–385.0 mg/dL) in the LIPITOR group compared to 230.0 mg/dL (range: 160.0–324.5 mg/dL) in the placebo group. The dosage of LIPITOR (once daily) was 10 mg for the first 4 weeks and uptitrated to 20 mg if the LDL-C level was > 130 mg/dL. The number of LIPITOR-treated patients who required uptitration to 20 mg after Week 4 during the double-blind phase was 80 (57.1%).

LIPITOR significantly decreased plasma levels of total-C, LDL-C, triglycerides, and apolipoprotein B during the 26-week double-blind phase (see Table 10).

TABLE 10. Lipid-altering Effects of LIPITOR in Adolescent Boys and Girls with Heterozygous Familial Hypercholesterolemia or Severe Hypercholesterolemia (Mean Percentage Change From Baseline at Endpoint in Intention-to-Treat Population)
DOSAGENTotal-CLDL-CHDL-CTGApolipoprotein B
Placebo47-1.5-0.4-1.91.00.7
LIPITOR140-31.4-39.62.8-12.0-34.0

The mean achieved LDL-C value was 130.7 mg/dL (range: 70.0–242.0 mg/dL) in the LIPITOR group compared to 228.5 mg/dL (range: 152.0–385.0 mg/dL) in the placebo group during the 26-week double-blind phase.

The safety and efficacy of doses above 20 mg have not been studied in controlled trials in children. The long-term efficacy of LIPITOR therapy in childhood to reduce morbidity and mortality in adulthood has not been established.

15 REFERENCES

  • [1]National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents, Pediatrics. 89(3):495–501. 1992.

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