Atorvastatin Calcium (Page 10 of 11)

14.3 Hypertriglyceridemia

The response to atorvastatin calcium tablets in 64 patients with isolated hypertriglyceridemia (Fredrickson Type IV) treated across several clinical trials is shown in the table below (Table 9). For the atorvastatin calcium tablet-treated patients, median (min, max) baseline TG level was 565 (267-1502).

Table 9. Combined Patients with Isolated Elevated TG: Median (min, max) Percentage Change From Baseline

Placebo

(N = 12)

Atorvastatin Calcium Tablets 10 mg

(N = 37)

Atorvastatin Calcium Tablets 20 mg

(N = 13)

Atorvastatin Calcium Tablets 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-C

3.6 (-31.3, 31.6)

-26.5 (-57.7, 9.8)

-30.4 (-53.9, 0.3)

-40.5 (-60.6, -13.8)

HDL-C

3.8 (-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

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 10).

Table 10. Open-Label Crossover Study of 16 Patients with Dysbetalipoproteinemia (Fredrickson Type III)

Median % Change (min, max)

Median (min, max) at Baseline (mg/dL)

Atorvastatin Calcium Tablets

10 mg

Atorvastatin Calcium Tablets

80 mg

Total-C

442 (225, 1320)

-37 (-85, 17)

-58 (-90, -31)

Triglycerides

678 (273, 5990)

-39 (-92, -8)

-53 (-95, -30)

IDL-C + VLDL-C

215 (111, 613)

-32 (-76, 9)

-63 (-90, -8)

non-HDL-C

411 (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 years to 37 years with HoFH received maximum daily doses of 20 to 80 mg of atorvastatin calcium tablets. 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 years to 17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolemia (HeFH) or severe hypercholesterolemia, were randomized to atorvastatin calcium tablets (n = 140) or placebo (n = 47) for 26 weeks and then all received atorvastatin calcium tablets 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 atorvastatin calcium tablets group compared to 230.0 mg/dL (range: 160.0-324.5 mg/dL) in the placebo group. The dosage of atorvastatin calcium tablets (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 atorvastatin calcium tablet-treated patients who required uptitration to 20 mg after Week 4 during the double-blind phase was 78 (55.7%).

Atorvastatin calcium tablets significantly decreased plasma levels of total-C, LDL-C, triglycerides, and apolipoprotein B during the 26-week double-blind phase (see Table 11).

Table 11. Lipid-altering Effects of Atorvastatin Calcium Tablets in Adolescent Boys and Girls with Heterozygous Familial Hypercholesterolemia or Severe Hypercholesterolemia (Mean Percentage Change From Baseline at Endpoint in Intention-to-Treat Population)

DOSAGE

N

Total-C

LDL-C

HDL-C

TG

Apolipoprotein B

Placebo

47

-1.5

-0.4

-1.9

1.0

0.7

Atorvastatin calcium tablets

140

-31.4

-39.6

2.8

-12.0

-34.0

The mean achieved LDL-C value was 130.7 mg/dL (range: 70.0-242.0 mg/dL) in the atorvastatin calcium tablets 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.

Atorvastatin was also studied in a 3-year open-label, uncontrolled trial that included 163 patients with HeFH who were 10 years to 15 years old (82 boys and 81 girls). All patients had a clinical diagnosis of HeFH confirmed by genetic analysis (if not already confirmed by family history). Approximately 98% were Caucasian, and less than 1% were Black or Asian. Mean LDL-C at baseline was 232 mg/dL. The starting atorvastatin dosage was 10 mg once daily and doses were adjusted to achieve a target of < 130 mg/dL LDL-C. The reductions in LDL-C from baseline were generally consistent across age groups within the trial as well as with previous clinical studies in both adult and pediatric placebo-controlled trials.

The long-term efficacy of atorvastatin calcium tablet therapy in childhood to reduce morbidity and mortality in adulthood has not been established.

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