INDICATIONS AND USAGE
Therapy withPravastatin Sodium Tablets, USP 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 Events
In hypercholesterolemic patients without clinically evident coronary heart disease,Pravastatin Sodium Tablets, USP areindicated 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.
Hyperlipidemia
Pravastatin Sodium Tablets, USPare 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).8
Pravastatin Sodium Tablets, USP are indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV).
Pravastatin Sodium Tablets, USP areindicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.
Pravastatin Sodium Tablets, USP 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 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 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 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) <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, 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 patient's response to therapy.
The National Cholesterol Education Program's 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 toInitiate TherapeuticLifestyle Changes(mg/dL)
LDL Level at Which toConsider Drug Therapy(mg/dL)
a CHD, coronary heart disease.
b 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.
c 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.
CHDa or CHD riskequivalents(10-year risk >20%)
<100
100
130(100-129: drug optional)b
2+ Risk factors(10-year risk 20 %)
<130
130
10-year risk 10%-20%: 130
10-year risk <10%: 160
0-1 Risk factorc
<160
160
190(160-189: LDL-loweringdrug optional)
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 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 130 mg/dL (see NCEP 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 sodiumtablets arenot 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
<170
<110
Borderline
170-199
110-129
High
200
130