Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

caduet_product

Indications¹

Patients at increased cardiovascular (CV) risk due to the presence of two modifiable risk factors, hypertension and dyslipidaemia, and/or patients with increased CV risk due to the presence of symptomatic coronary heart disease (CHD) expressed as angina with an additional modifiable risk factor of dyslipidaemia.

Amlodipine

First-line treatment of hypertension, alone or in combination with other antihypertensive agents
Vasospastic angina (Prinzmetal's or variant angina), alone or in combination with other antianginal drugs

Atorvastatin

In adult patients without clinically evident coronary heart disease but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low high-density lipoprotein-cholesterol (HDL-C) or a family history of early coronary heart disease, atorvastatin is indicated to:

Reduce the risk of myocardial infarction
Reduce the risk of stroke
Reduce the risk for revascularization procedures and angina

An adjunct to diet to treat patients with elevated total cholesterol, low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B) and triglycerides (TG) and to increase HDL-C in patients with:

Primary hypercholesterolaemia (heterozygous familial and nonfamilial);
Combined (mixed) hyperlipidaemia (Fredrickson Types IIa and IIb);
Elevated serum TG levels (Fredrickson Type IV); and
Patients with dysbetalipoproteinaemia (Fredrickson Type III) who do not respond adequately to diet

Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia when response to diet and other nonpharmacological measures are inadequate
Adjunct to diet to reduce total-C, LDL-C and apo B levels in boys and post-menarchal girls 10–17 years with heterozygous familial hypercholesterolaemia after an adequate trial of diet therapy

Clinical Evidence

The combination of amlodipine and atorvastatin reduced the risk of nonfatal myocardial infarction (MI) and fatal CHD more than amlodipine alone

Atorvastatin reduced the relative risk of the primary endpoint of nonfatal MI and fatal CHD events by 36% (p=0.0005), total CV events by 21% (p=0.0005) and stroke by 27% (p=0.024)²
Compared with placebo, atorvastatin reduced the relative risk of CHD events by 53% (p<0.0001) among those allocated the amlodipine-based regimen, and by 16% (not significant) among those allocated the atenolol-based regimen²

Synergy achieved in increasing nitric dioxide release, arterial wall compliance and tissue plasminogen activator (t-PA), and in decreasing insulin resistance, which may lead to beneficial effects on atherosclerotic plaque formation and molecular markers of endothelial function³
Patients taking single-pill Caduet were 2 to 3 times more likely to be adherent to treatment vs those taking two-pill regimens⁴

Safety Profile¹

CI:	Known hypersensitivity to dihydropyridines, amlodipine, atorvastatin or any component of Caduet. Active liver disease or unexplained persistent elevations of serum transaminases >3x the upper limit of normal. Pregnancy, lactation or women of childbearing potential who are not using adequate contraceptive measures.

SP:	Heart failure, impaired hepatic function. Perform liver function tests before initiating treatment and periodically thereafter. Patient who consume substantial quantities of alcohol and/or have a history of liver disease. Discontinue drug if markedly elevated creatine phosphokinase (CPK) levels occur or myopathy is diagnosed or suspected. Acute, serious condition suggestive of myopathy or risk factor predisposing to development of renal failure secondary to rhabdomyolysis.

AR:	Amlodipine Flushing, fatigue, oedema, dizziness, headache, abdominal pain, nausea, palpitations, somnolence. Atorvastatin Insomnia, headache, gastrointestinal disturbances, myalgia, asthenia.

DI:	Risk of myopathy increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals or niacin. Decreased atorvastatin plasma concentration with oral antacid suspension containing magnesium and aluminum hydroxides, and colestipol. Increases steady-state plasma digoxin concentration. Increases atorvastatin plasma concentration with erythromycin and clarithromycin and protease inhibitors. Increases area under the curve (AUC) values for norethindrone and ethinyl-oestradiol.

Dosages¹

5 mg/10 mg to a max dose of 10 mg/80 mg once daily.

Strengths¹

5/10 mg (amlodipine besilate 5 mg, atorvastatin Ca 10 mg), 5/20 mg,
10/10 mg, 10/20 mg.

Packing¹

Tab 5/10 mg x 30's. 5/20 mg x 30's. 10/10 mg x 30's. 10/20 mg x 30's.

References

1. MIMS Annual Hong Kong. 2007/2008 edition.
2. Sever P, et al. Eur Heart J 2006;27:2982-2988.
3. McKeage K, Siddiqui MA. Am J Cardiovasc Drugs 2008;8:51-67.
4. Patel BV, et al. Vasc Health Risk Manag 2008;4:673-681.

Please review the full product information or package insert before prescribing.