INDICATIONS AND USAGE
WelChol® , administered alone or in combination with an HMG-CoA reductase inhibitor, is indicated as adjunctive therapy to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type IIa).
Therapy with lipid lowering agents should be a component of multiple risk-factor intervention in patients at significant increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol and when the response to diet and other non-pharmacological means has been inadequate.
Prior to initiating therapy with WelChol® , secondary causes of hypercholesterolemia (i.e., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile obtained to assess total-C, HDL-C, and TG. For individuals with TG less than 400 mg/dL, LDL-C can be estimated using the following equation.3
LDL-C = Total-C - [(TG/5) + HDL-C]
Periodic determination of serum cholesterol levels in patients as outlined in the National Cholesterol Education Program (NCEP) guidelines should be done to confirm a favorable initial and long-term response. The NCEP treatment guidelines are presented in Table 3.
Table 3: NCEP Guidelines
| RISK CATEGORY |
LCL-C GOAL |
LDL LEVEL AT WHICH
TO INITIATE
THERAPEUTIC
LIFESTYLE CHANGES (TLC) |
LDL LEVEL AT WHICH
TO CONSIDER DRUG THERAPY |
CHD or CHD Risk
Equivalents
(10-year risk >20%)
|
<100 mg/dL
|
>/=100 mg/dL
|
>/=130 mg/dL
(100-129 mg/dL: drug
optional) * |
2+ Risk Factors
(10-year risk
|
<130 mg/dL
|
>/=130 mg/dL
|
10-year risk 10-20%:
>/=130 mg/dL
|
|
|
|
|
10-year risk <10%:
>/=160 mg/dL
|
|
0-1 Risk Factor**/* |
<160 mg/dL
|
>/=160 mg/dL
|
>/=190 mg/dL
(160-189 mg/dL: LDL-
lowering drug optional) |
|
*Some authorities recommended use of LDL cholesterol-lowering drugs in the category if LDL cholesterol <100 mg/dL cannot be achieved by therapeutic lifestyle changes. Other prefer use of drugs that primarily modify triglycerides and HDL cholesterol e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory. |
| **/* Almost all people with 0-1 risk factor have a 10-year risk <10%, thus 10-year risk assessment in people with 0-1 risk factor is not necessary. |
|
MAJOR RISK FACTORS (EXCLUSIVE OF LDL CHOLESTEROL) THAT MODIFY LDL GOALS*
|
-
Cigarette smoking
-
Hypertension (BP >/=140/90 mmHg or on anti-hypertensive medication)
-
Low HDL cholesterol (<40 mg/dL) **/*
-
Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years)
-
Age (men >/=45 years; women >/=55 years)
|
* In ATP III, diabetes is regarded as a CHD risk equivalent.
**/* HDL cholesterol >/=60 mg/dL counts as a "negative" risk factor; its presence removes one risk factor from the total count.
After the LDL-C goal has been achieved, if the TG is still >/=200mg/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.
|
