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 Events
In 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.
Secondary Prevention of Cardiovascular Events
In patients with clinically evident coronary heart disease, Pravastatin
Sodium Tablets are indicated to:-Reduce the risk of total mortality by reducing
coronary death-Reduce the risk of myocardial infarction-Reduce the risk of undergoing myocardial revascularization
procedures-Reduce the risk of stroke and stroke/transient
ischemic attack (TIA)-Slow the progression of coronary atherosclerosis.
Hyperlipidemia
Pravastatin 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).8Pravastatin
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 190 mg/dL or LDL-C remains 160 mg/dL and:there is a positive family history of premature cardiovascular disease
ortwo 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
patients response to therapy.The National Cholesterol
Education Programs Treatment Guidelines are summarized below:Table 7: NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for
Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories
Risk CategoryLDL Goal
(mg/dL)LDL Level at Which
to Initiate Therapeutic Lifestyle Changes(mg/dL)LDL Level at
Which to Consider Drug Therapy(mg/dL)
aCHD,
coronary heart disease.
bSome
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.
cAlmost
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%)<100100130
(100-129: drug optional)b
2+ Risk factors(10-year
risk 20 %)<13013010-year risk 10%-20%:130
10-year risk <10%: 160
0-1 Risk factorc<160160190
(160-189:
LDL-lowering
drug 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 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:
CategoryTotal-C
(mg/dL)LDL-C
(mg/dL)
AcceptableBorderlineHigh<170170-199200<110110-129130