Lipid Regulating Drugs

Statins:

Simvastatin:

Indications: primary hypercholesterolaemia, homozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia in patients who have not responded adequately to diet and other appropriate measures;

prevention of cardiovascular events in patients with atherosclerotic cardiovascular disease or diabetes mellitus.

Contraindications: Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. Women who are pregnant or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Nursing mothers. It is not known whether simvastatin is excreted into human milk; however, a small amount of another drug in this class does pass into breast milk

Dose and Administration: Primary hypercholesterolaemia, combined hyperlipidaemia, 10–20 mg daily at night, adjusted at intervals of at least 4 weeks; usual range 10–80 mg once daily at night. Homozygous familial hypercholesterolaemia, 40 mg daily at night or 80 mg daily in 3 divided doses. Prevention of cardiovascular events, initially 20–40 mg once daily at night, adjusted at intervals of at least 4 weeks; max. 80 mg once daily at night.

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Atorvastatin:

Indications: primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia, homozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia in patients who have not responded adequately to diet and other appropriate measures; prevention of cardiovascular events in patients with type 2 diabetes and at least one additional risk factor for cardiovascular disease

Contraindications: Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. Women who are pregnant or may become pregnant. atorvastatin may cause fetal harm when administered to a pregnant woman.

Dose and Administration: Primary hypercholesterolaemia and combined hyperlipidaemia, usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily; child 10–17 years usually 10 mg once daily. Familial hypercholesterolaemia, initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia); child 10–17 years initially 10 mg daily, increased if necessary after at least 4 weeks to 20 mg once daily. Prevention of cardiovascular events in type 2 diabetes, 10 mg once daily.

Fluvastatin:

Indications: adjunct to diet in primary hypercholesterolaemia or combined (mixed) hyperlipidaemia (types IIa and IIb); adjunct to diet to slow progression of coronary atherosclerosis in primary hypercholesterolaemia and concomitant coronary heart disease; prevention of coronary events after percutaneous coronary intervention.

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Contraindications: in patients with active liver disease or unexplained, persistent elevations in serum transaminases. If the patient becomes pregnant while taking this class of drug, therapy should be discontinued and the patient apprised of the potential hazard to the fetus.

Dose and Administration: Hypercholesterolaemia or combined hyperlipidaemia, initially 20–40 mg daily in the evening, adjusted at intervals of at least 4 weeks; up to 80 mg daily may be required; child and adolescent under 18 years, not recommended. Prevention of progression of coronary atherosclerosis, 40 mg daily in the evening. Following percutaneous coronary intervention, 80 mg daily.

Rosuvastatin:

Indications: primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia), mixed dyslipidaemia (type IIb), or homozygous familial hypercholesterolaemia in patients who have not responded adequately to diet and other appropriate measures.

Contraindications: Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels. Women who are pregnant or may become pregnant. Nursing mothers.

Dose and Administration: Initially 5–10 mg once daily increased if necessary at intervals of at least 4 weeks to 20 mg once daily, increased after further 4 weeks to 40 mg daily only in severe hypercholesterolaemia with high cardiovascular risk and under specialist supervision; elderly initially 5 mg once daily; patient of asian origin, initially 5 mg once daily increased if necessary to max. 20 mg daily.

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Ezetimibe:

Indications: administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with mixed hyperlipidemia. The combination with simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments.

Contraindications: Women who are pregnant or may become pregnant. Nursing mothers.

Dose and Administration: adult and child over 10 years, 10 mg once daily.

Simvastatin-Ezetimibe:

Indications: indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

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Contraindications: Active liver disease or unexplained persistent elevations in hepatic transaminase levels. Women who are pregnant or may become pregnant.

Dose and Administration: The recommended usual starting dose is 10/20 mg/day as a single daily dose in the evening, with or without food. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day.

Atorvastatin-Amlodipine:

Indications: indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.

Contraindications: Pregnancy and Lactation. in patients with active liver disease or unexplained persistent elevations of serum transaminases.

Dose and Administration: Dosage should be adjusted according to each patient’s need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient’s response to each dose level.

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Fibrates:

Gemfibrozil:

Indications: hyperlipidaemias of types IIa, IIb, III, IV and V in patients who have not responded adequately to diet and other appropriate measures; primary prevention of cardiovascular disease in men with hyperlipidaemias that have not responded to diet and other appropriate measures.

Contraindications: alcoholism, biliary-tract disease including gallstones; photosensitivity to fibrates; hepatic impairment; pregnancy; breast-feeding.

Dose and Administration: 1.2 g daily, usually in 2 divided doses; range 0.9– 1.2 g daily; child not recommended

Fenofibrate:

Indications: hyperlipidaemias of types IIa, IIb, III, IV, and V in patients who have not responded adequately to diet and other appropriate measures.

Contraindications: gall bladder disease; photosensitivity to ketoprofen; severe hepatic impairment; pregnancy; breast-feeding.

Dose and Administration: 200mg once daily.