INDICATIONS AND USAGE
Therapy with lipid-altering agents should be used in addition to
a diet restricted in saturated fat and cholesterol (see National Cholesterol
Education Program [NCEP] Treatment Guidelines, below).
Hypercholesterolemia (heterozygous
familial and nonfamilial) and Mixed Dyslipidemia
Lescol (fluvastatin sodium) and
Lescol XL (fluvastatin sodium) are indicated to reduce
elevated total cholesterol (Total-C), LDL-C, TG and Apo B levels, and to
increase HDL-C in patients with primary hypercholesterolemia and mixed
dyslipidemia (Fredrickson Type IIa and IIb) whose response to dietary
restriction of saturated fat and cholesterol and other nonpharmacological
measures has not been adequate.
Heterozygous Familial
Hypercholesterolemia in Pediatric Patients
Lescol and Lescol XL are indicated as an adjunct to diet to
reduce Total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at
least one year post-menarche, 10-16 years of age, with heterozygous familial
hypercholesterolemia whose response to dietary restriction has not been adequate
and the following findings are present:
LDL-C remains > 190 mg/dL or
LDL-C remains > 160 mg/dL and:
there is a positive family history of premature cardiovascular disease
or
two or more other cardiovascular disease risk factors are
present.
Therapy with lipid-altering agents should be considered only after
secondary causes for hyperlipidemia such as poorly controlled diabetes mellitus,
hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease,
other medication, or alcoholism, have been excluded. Prior to initiation of
fluvastatin sodium, a lipid profile should be performed to measure Total-C,
HDL-C and TG. For patients with TG <400 mg/dL (<4.5 mmol/L), LDL-C can be
estimated using the following equation:
LDL-C = Total-C - HDL-C - 1/5 TG
For TG levels >400 mg/dL (>4.5 mmol/L), this equation is less
accurate and LDL-C concentrations should be determined by ultracentrifugation.
In many hypertriglyceridemic patients LDL-C may be low or normal despite
elevated Total-C. In such cases, Lescol is not indicated.
Lipid determinations should be performed at intervals of no less than 4
weeks and dosage adjusted according to the patients response to therapy.
The National Cholesterol Education Program (NCEP) Treatment Guidelines
are summarized below:
Table 3NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for
Therapeutic LifestyleChanges and DrugTherapy in Different Risk
Categories
Risk
Category
LDL Goal
(mg/dL)
LDL Level at Which
to
Initiate Therapeutic
Lifestyle Changes
(mg/dL)
LDL Level at Which
to Consider
Drug
Therapy
(mg/dL)
CHD or CHD risk equivalents (10-year risk
>20%)
<100
>100
>130
(100-129: drug optional)
2+ Risk factors (10-year risk <20%)
<130
>130
10-year risk 10%-20%:
>13010-year risk <10%: >160
0-1 Risk factor
<160
>160
>190 (160-189: LDL-lowering drug
optional)
CHD, coronary heart disease
Some authorities recommend use of
LDL-lowering drugs in this category if an LDL-C level of <100mg/dL cannot be
achieved by therapeutic lifestyle changes. Others prefer use of drugs that
primarily modify triglycerides and HDL-C, e.g.
,
nicotinic acid or fibrate. Clinical judgement
also may call for deferring drug therapy in this subcategory.
Almost all people with 0-1 risk
factor have 10-year risk <10%; thus, 10-year risk assessment in people with
0
-1 risk factor is not necessary.
After the LDL-C goal has been achieved, if the TG is still >200 mg/dL,
non-HDL-C (Total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C
goals are set 30mg/dL higher than LDL-C goals for each risk category.
At the time of hospitalization for an acute coronary event,
consideration can be given to initiating drug therapy at discharge if the LDL-C
level is >130 mg/dL (NCEP-ATP II).
Since the goal of treatment is to lower LDL-C, the NCEP recommends that
the LDL-C levels be used to initiate and assess treatment response. Only if
LDL-C levels are not available, should the Total-C be used to monitor therapy.
Table 4 Classification of Hyperlipoproteinemias
Lipid
Elevations
Type
Lipoproteins
Elevated
Major
Minor
I (rare)
Chylomicrons
TG
C
IIa
LDL
C
IIb
LDL, VLDL
C
TG
III (rare)
IDL
C/TG
IV
VLDL
TG
C
V (rare)
Chylomicrons, VLDL
TG
C
C = cholesterol, TG = triglycerides, LDL = low density
lipoprotein, VLDL = very low density lipoprotein,
IDL = intermediate density lipoprotein
Neither Lescol nor Lescol XL have been studied in conditions where the
major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e.,
hyperlipoproteinemia Types I, III, IV, or V).
The NCEP classification of cholesterol levels in pediatric patients
with a familial history of hypercholesterolemia or premature cardiovascular
disease is summarized below:
Category
Total-C (mg/dL)
LDL-C (mg/dL)
AcceptableBorderlineHigh
<170170-199
>200
<110110-129
>130
Children treated with fluvastatin in adolescence should be re-evaluated
in adulthood and appropriate changes made to their cholesterol-lowering regimen
to achieve adult treatment goals.
Secondary Prevention of Coronary
Events
In patients with coronary heart disease, Lescol and Lescol XL are
indicated to reduce the risk of undergoing coronary revascularization
procedures.
Atherosclerosis
Lescol and Lescol XL are also indicated to slow the progression
of coronary atherosclerosis in patients with coronary heart disease as part of a
treatment strategy to lower total and LDL cholesterol to target levels.