ents with MVE or MCE in the subgroup relative to the number with MVE or MCE, respectively, in the entire study population. The vertical solid line represents a relative risk of one. The vertical dashed line represents the point estimate of relative risk in the entire study population.
Modifications of Lipid Profiles
Primary Hyperlipidemia (Fredrickson type lla and llb)
Simvastatin has been shown to be effective in reducing total-C and LDL-C in heterozygous familial and non-familial forms of hyperlipidemia and in mixed hyperlipidemia. Maximal to near maximal response is generally achieved within 4-6 weeks and maintained during chronic therapy. Simvastatin consistently and significantly decreased total-C, LDL-C, total-C/HDL-C ratio, and LDL-C/HDL-C ratio; simvastatin also decreased TG and increased HDL-C (see Table 17).
Table 17 Mean Response in Patients with Primary Hyperlipidemia and Combined (mixed) Hyperlipidemia (Mean Percent Change from Baseline After 6 to 24 Weeks) TREATMENT N TOTAL-C LDL-C HDL-C TG*
*
median percent change
†
mean baseline LDL-C 244 mg/dL and median baseline TG 168 mg/dL
‡
mean baseline LDL-C 188 mg/dL and median baseline TG 128 mg/dL
§
mean baseline LDL-C 226 mg/dL and median baseline TG 156 mg/dL
¶
Study also included another treatment arm receiving a different dose of simvastatin; baseline mean LDL-C and median TG values were calculated across all treatment arms in study
#
mean baseline LDL-C 156 mg/dL and median baseline TG 391 mg/dL.
Lower Dose Comparative Study†
(Mean % Change at Week 6)
Simvastatin 5 mg q.p.m. 109 -19 -26 10 -12
Simvastatin 10 mg q.p.m. 110 -23 -30 12 -15
Scandinavian Simvastatin Survival Study‡
(Mean % Change at Week 6)
Placebo 2223 -1 -1 0 -2
Simvastatin 20 mg q.p.m. 2221 -28 -38 8 -19
Upper Dose Comparative Study§, ¶
(Mean % Change Averaged at Weeks 18 and 24)
Simvastatin 40 mg q.p.m. 433 -31 -41 9 -18
Multi-Center Combined Hyperlipidemia Study#
(Mean % Change at Week 6)
Placebo 125 1 2 3 -4
Simvastatin 40 mg q.p.m. 123 -25 -29 13 -28
Hypertriglyceridemia (Fredrickson type lV)
The results of a subgroup analysis in 74 patients with type lV hyperlipidemia from a 130-patient, double-blind, placebo-controlled, 3-period crossover study are presented in Table 18.
Table 18 Six-week, Lipid-lowering Effects of Simvastatin in Type lV Hyperlipidemia Median Percent Change (25 th and 75 th percentile) from Baseline * TREATMENT N Total-C LDL-C HDL-C TG VLDL-C Non-HDL-C
*
The median baseline values (mg/dL) for the patients in this study were: total-C = 254, LDL-C = 135, HDL-C = 36, TG = 404, VLDL-C = 83, and non-HDL-C = 215.
Placebo 74 +2
(-7, +7)
+1
(-8, +14)
+3
(-3, +10)
-9
(-25, +13)
-7
(-25, +11)
+1
(-9, +8)
Simvastatin 40 mg/day 74 -25
(-34, -19)
-28
(-40, -17)
+11
(+5, +23)
-29
(-43, -16)
-37
(-54, -23)
-32
(-42, -23)
Dysbetalipoproteinemia (Fredrickson type lll)
The esults of a subgroup analysis in 7 patients with type lll hyperlipidemia (dysbetalipoproteinemia) (apo E2/2) (VLDL-C/TG>0.25) from a 130-patient, double-blind, placebo-con |
