Caduet (amlodipine/atorvastatin )
Company: Pfizer
Approval Status: Approved January 2004
Treatment for: Hypertension/Angina
Areas: Cardiology/Vascular Diseases
| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |
General Information
Caduet combines the drugs amlodipine (Norvasc, Lotrel) and atorvastatin (Lipitor), two widely prescribed cardiovascular medications. It's the first medicine to treat two different conditions, high blood pressure and high cholesterol.
It is indicated for the treatment of hypertension, chronic stable angina and vasospastic angina (Prinzmetal’s or variant angina). It is also indicated for primary dysbetalipoproteinemia, elevated serum TG levels, hypercholesterolemia and mixed dyslipidemia. In addition, is indicated as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia
The recommened initial antihypertensive oral dose of amlodipine is 5 mg once daily with a maximum dose of 10 mg once daily.
Clinical Results
FDA approval of Caduet was based on a double-blind, placebo-controlled study enrolling 1,600 subjects with co-morbid hypertension and dyslipidemia. Results showed that all combination-treatment groups of amlodipine and atorvastatin demonstrated statistically significant dose-related reductions in systolic blood pressure (SBP), Diastolic Blood pressure (DBP) and LDL-C compared to placebo.
Subjects received once daily treatment with eight dose combinations of amlodipine and atorvastatin (5/10, 10/10, 5/20, 10/20, 5/40, 10/40, 5/80, or 10/80mg), amlodipine alone (5 mg or 10 mg), atorvastatin alone (10 mg, 20 mg, 40 mg, or 80 mg) or placebo.
Side Effects
Adverse events associated with the use of Caduet may include (but are not limited to) the following:
- Headache
- Abdominal Pain
- Rash
- Chest pain,
- Nausea
- Insomnia
- Dizziness
Mechanism of Action
Amlodipine, a long acting calcium ion antagonist, is the active ingredient in Norvasc (Pfizer) and Lotrel (Novartis). Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. The drug binds to dihydropyridine and nondihydropyridine binding sites. In addition, amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Atorvastatin, a HMGCoA reductase inhibitor indicated for lowering cholesterol, is the active ingredient in Lipitor (Pfizer). Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMGCoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL.
Literature References
Delsing DJ, Jukema JW, van de Wiel MA, Emeis JJ, van der Laarse A, Havekes LM, Princen HM. Differential effects of amlodipine and atorvastatin treatment and their combination on atherosclerosis in ApoE*3-Leiden transgenic mice. J Cardiovasc Pharmacol. 2003 Jul;42(1):63-70.
Leibovitz E, Beniashvili M, Zimlichman R, Freiman A, Shargorodsky M, Gavish D. Treatment with amlodipine and atorvastatin have additive effect in improvement of arterial compliance in hypertensive hyperlipidemic patients. Am J Hypertens. 2003 Sep;16(9 Pt 1):715-8.
van de Poll SW, Delsing DJ, Wouter Jukema J, Princen HM, Havekes LM, Puppels GJ, van der Laarse A. Effects of amlodipine, atorvastatin and combination of both on advanced atherosclerotic plaque in APOE*3-Leiden transgenic mice. J Mol Cell Cardiol. 2003 Jan;35(1):109-18.
Additional Information
For additional information regarding Caduet or cardiovascular disorders, please contact The Pfizer Web Site
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
