PRAVASTATIN SODIUM (Page 6 of 8)

14.3 Primary Hypercholesterolemia (Fredrickson Types IIa and IIb)

Pravastatin Sodium is highly effective in reducing Total-C, LDL-C, and TG in patients with heterozygous familial, presumed familial combined, and non-familial (non-FH) forms of primary hypercholesterolemia, and mixed dyslipidemia. A therapeutic response is seen within 1 week, and the maximum response usually is achieved within 4 weeks. This response is maintained during extended periods of therapy. In addition, Pravastatin Sodium is effective in reducing the risk of acute coronary events in hypercholesterolemic patients with and without previous MI.

A single daily dose is as effective as the same total daily dose given twice a day. In multicenter, double-blind, placebo-controlled studies of patients with primary hypercholesterolemia, treatment with pravastatin in daily doses ranging from 10 to 40 mg consistently and significantly decreased Total-C, LDL-C, TG, and Total-C/HDL-C and LDL-C/HDL-C ratios (see Table 7).

In a pooled analysis of 2 multicenter, double-blind, placebo-controlled studies of patients with primary hypercholesterolemia, treatment with pravastatin at a daily dose of 80 mg (N=277) significantly decreased Total-C, LDL-C, and TG. The 25th and 75th percentile changes from baseline in LDL-C for pravastatin 80 mg were −43% and −30%. The efficacy results of the individual studies were consistent with the pooled data (see Table 7).

Treatment with Pravastatin Sodium modestly decreased VLDL-C and Pravastatin Sodium across all doses produced variable increases in HDL-C (see Table 7).

Table 7: Primary Hypercholesterolemia Studies: Dose Response of Pravastatin Sodium Once Daily Administration
*
A multicenter, double-blind, placebo-controlled study.
Pooled analysis of 2 multicenter, double-blind, placebo-controlled studies.
Dose Total-C LDL-C HDL-C TG
Mean Percent Changes From Baseline After 8 Weeks *
Placebo (N=36) −3% −4% +1% −4%
10mg (N=18) −16% −22% +7% −15%
20mg (N=19) −24% −32% +2% −11%
40mg (N=18) −25% −34% +12% −24%
Mean Percent Changes From Baseline After 6 Weeks
Placebo (N=162) 0% −1% -1% +1%
80mg (N=277) −27% −37% +3% −19%

In another clinical trial, patients treated with pravastatin in combination with cholestyramine (70% of patients were taking cholestyramine 20 or 24 g per day) had reductions equal to or greater than 50% in LDL-C. Furthermore, pravastatin attenuated cholestyramine-induced increases in TG levels (which are themselves of uncertain clinical significance).

14.4 Hypertriglyceridemia (Fredrickson Type IV)

The response to pravastatin in patients with Type IV hyperlipidemia (baseline TG >200 mg/dL and LDL-C <160 mg/dL) was evaluated in a subset of 429 patients from the CARE study. For pravastatin-treated subjects, the median (min, max) baseline TG level was 246.0 (200.5, 349.5) mg/dL (see Table 8).

Table 8: Patients with Fredrickson Type IV Hyperlipidemia Median (25th , 75th percentile) % Change from Baseline
Pravastatin 40 mg (N=429) Placebo (N=430)
TG −21.1 (−34.8, 1.3) −6.3 (−23.1, 18.3)
Total-C −22.1 (−27.1, −14.8) 0.2 (−6.9, 6.8)
LDL-C −31.7 (−39.6, −21.5) 0.7 (−9.0, 10.0)
HDL-C 7.4 (−1.2, 17.7) 2.8 (−5.7, 11.7)
Non-HDL-C −27.2 (−34.0, −18.5) −0.8 (−8.2, 7.0)

14.5 Dysbetalipoproteinemia(Fredrickson Type III)

The response to pravastatin in two double-blind crossover studies of 46 patients with genotype E2/E2 and Fredrickson Type III dysbetalipoproteinemia is shown in Table 9.

Table 9: Patients with FredricksonType III Dysbetalipoproteinemia Median (min,max) % Change from Baseline

Median (min, max) at Baseline (mg/dL) Median % Change(min, max) Pravastatin 40 mg (N=20)
Study 1
Total-C 386.5 (245.0, 672.0) −32.7 (−58.5, 4.6)
TG 443.0 (275.0, 1299.0) −23.7 (−68.5, 44.7)
VLDL-Ca 206.5 (110.0, 379.0) −43.8 (−73.1, −14.3)
LDL-Ca 117.5 (80.0,170.0) −40.8 (−63.7, 4.6)
HDL-C 30.0 (18.0,88.0) 6.4 (−45.0,105.6)
Non-HDL-C 344.5 (215.0, 646.0) −36.7 (−66.3, 5.8)
a N=14
Median (min, max) at Baseline (mg/dL) Median % Change(min, max) Pravastatin 40 mg (N=26)
Study 2
Total-C 340.3 (230.1, 448.6) −31.4 (−54.5, −13.0)
TG 343.2 (212.6, 845.9) −11.9 (−56.5, 44.8)
VLDL-C 145.0 (71.5,309.4) −35.7 (−74.7, 19.1)
LDL-C 128.6 (63.8,177.9) −30.3 (−52.2, 13.5)
HDL-C 38.7 (27.1,58.0) 5.0 (−17.7, 66.7)
Non-HDL-C 295.8 (195.3, 421.5) −35.5 (−81.0, −13.5)

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