INDICATIONS AND USAGE
Therapy with pravastatin sodium tablets should be considered in
those individuals at increased risk for atherosclerosis-related clinical events
as a function of cholesterol level, the presence or absence of coronary heart
disease, and other risk factors.
Primary Prevention of Coronary EventsIn hypercholesterolemic patients without clinically evident
coronary heart disease, pravastatin sodium tablets are indicated to:
- Reduce the risk of myocardial infarction
- Reduce the risk of undergoing myocardial revascularization procedures
- Reduce the risk of cardiovascular mortality with no increase in death from
non-cardiovascular causes
HyperlipidemiaPravastatin sodium tablets are indicated as an adjunct to diet to
reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in
patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson
Type IIa and IIb).6
Pravastatin sodium tablets are indicated as adjunctive therapy to diet for
the treatment of patients with elevated serum triglyceride levels (Fredrickson
Type IV).
Pravastatin sodium tablets are indicated for the treatment of patients with
primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond
adequately to diet.
Pravastatin sodium tablets are indicated as an adjunct to diet and lifestyle
modification for treatment of HeFH in children and adolescent patients ages 8
years and older if after an adequate trial of diet the following findings are
present:
LDL-C remains greater than or equal to 190 mg/dL or
LDL-C remains greater than or equal to 160 mg/dL and:
there is a positive family history of premature cardiovascular disease or
two or more other CVD risk factors are present in the patient.
Lipid-altering agents should be used in addition to a diet restricted in
saturated fat and cholesterol when the response to diet and other
nonpharmacological measures alone has been inadequate (see NCEP
Treatment Guidelines below).
Prior to initiating therapy with pravastatin, secondary causes for
hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism,
nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug
therapy, alcoholism) should be excluded, and a lipid profile performed to
measure Total-C, HDL-C, and TG. For patients with triglycerides (TG) less than 400
mg/dL (less than 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 greater than 400 mg/dL (greater than 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, HMG-CoA reductase inhibitors are not
indicated.
Lipid determinations should be performed at intervals of no less than four
weeks and dosage adjusted according to the patients response to therapy.
The National Cholesterol Education Programs Treatment Guidelines are
summarized below:
Table 5: NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy 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)
CHDa or CHD risk
equivalents (10 year risk greater than
20%)
less than 100
greater than or equal to 100
greater than or equal to 130 (100 to 129: drug optional)b
2+ Risk factors (10 year risk less than or equal to
20%)
less than 130
greater than or equal to 130
10 year risk 10% to 20%: greater than 130
10 year risk less than 10%: greater thanor equal to 160
0 to 1 Risk factorc
less than 160
greater than or equal to 160
greater than or equal to 190 (160 to 189: LDL-lowering drug optional)
a CHD, coronary heart disease.b Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C
level of less than 100 mg/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.c Almost all people with 0 to 1 risk factor have 10 year risk less than 10%; thus, 10 year
risk assessment in people with 0 to 1 risk factor is not necessary.
After the LDL-C goal has been achieved, if the TG is still greater than or equal to 200 mg/dL,
non-HDL-C (Total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C
goals are set 30 mg/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 is greater than or equal to 130 mg/dL
(see NCEP Treatment Guidelines, above).
Since the goal of treatment is to lower LDL-C, the NCEP recommends that 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.
As with other lipid-lowering therapy, pravastatin sodium tablets are not
indicated when hypercholesterolemia is due to hyperalphalipoproteinemia
(elevated HDL-C).
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)
Acceptable
less than 170
less than 110
Borderline
170 to 199
110 to 129
High
greater than or equal to200
greater than or equal to 130