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The combination of amlodipine (NORVASC) with atorvastatin (LIPITOR), known by the brand name CADUET, was approved by the Food and Drug Administration (FDA) in January 2004. Amlodipine alone is used primarily to lower blood pressure and belongs to the calcium channel blocker family of high blood pressure lowering drugs. Atorvastatin is a popular cholesterol lowering drug that is a member of the group of drugs known as “statins.”
Caduet is sold by Pfizer, Inc. of New York which also markets...
The combination of amlodipine (NORVASC) with atorvastatin (LIPITOR), known by the brand name CADUET, was approved by the Food and Drug Administration (FDA) in January 2004. Amlodipine alone is used primarily to lower blood pressure and belongs to the calcium channel blocker family of high blood pressure lowering drugs. Atorvastatin is a popular cholesterol lowering drug that is a member of the group of drugs known as “statins.”
Caduet is sold by Pfizer, Inc. of New York which also markets amlodipine and atorvastatin separately.
One of the longstanding guiding principles of the pharmaceutical industry has been to protect patents at all costs. One way of doing this is to take two old drugs, such as amlodipine and atorvastatin, combine them, get the mixture approved by the FDA, and thereby reset the patent clock. Technically, the combination of two older drugs is a new drug and entitled to its own patent protection.
Caduet is approved by the FDA for use in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine is approved for the management of high blood pressure and for chest pain (angina). Atorvastatin has received FDA approval to manage elevated cholesterol levels of various types, including use in boys and postmenarchal (first menstrual period) girls, 10 to 17 years of age, with an inherited type of high cholesterol after an adequate trial of diet therapy has not worked.
The Health Research Group has always had concerns about fixed dose combination drugs such as Caduet because of the lack of flexibility of being able to adjust the dose of each drug separately. Additionally with Caduet is the fact that amlodipine is not a first or even second choice drug for the treatment of high blood pressure. A study we reported on in the February 2003 issue of Worst Pills, Best Pills News found that in a head-to-head comparison of amlodipine to the thiazide diuretics, or water pills, the water pills were superior to amlodipine in preventing one or more major forms of cardiovascular disease. This study was published in the in the December 18, 2002 issue of the Journal of the American Medical Association.
Also, we do not consider atorvastatin a first choice drug in the management of high cholesterol. Although there is a recent study showing some clinical benefit to atorvastatin (beyond just lowering cholesterol levels), the standard we use for this recommendation is atorvastatin’s FDA-approved professional product labeling, or package insert. Pfizer, atorvastatin’s manufacturer, can not claim in the professional product labeling that their drug reduces the risk of a first or second heart attack or stroke because they have not received FDA approval to make such a claim. However, several other cholesterol-lowering statin drugs such as lovastatin (MEVACOR), simvastatin (ZOCOR), and pravastatin (PRAVACHOL) can make this type of claim in the professional labeling for their drugs.
Be aware that we have listed the newest statin, rosuvastatin (CRESTOR), as a DO NOT USE drug (see Worst Pills, Best Pills News October 2003) because of its unique danger.
There are several major safety considerations with the atorvastatin component of Caduet. First, is the breakdown of muscles, called rhabdomyolysis, an adverse reaction of all statin drugs that can lead to kidney failure and death. Unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, may be early signals of rhabdomyolysis and should be reported immediately to the prescribing physician.
The statin drugs, including atorvastatin, are also associated with liver toxicity that can lead to liver failure and death. The FDA-approved professional labeling for Caduet recommends that blood tests checking for liver function be performed prior to starting treatment and at 12 weeks following both the start of treatment and any increase in the dose of Caduet. Thereafter, liver function tests should be performed semiannually.
Pfizer appears to be attempting to position Caduet as a less expensive alternative to purchasing each of its components individually.
The editors of The Medical Letter on Drugs and Therapeutics, a highly respected independent source of drug information for physicians and pharmacists, reviewed Caduet in their July 5, 2004 issue and concluded:
The amlodipine/atorvastatin fixed-dose combination (Caduet) offers a single pill once daily for treatment of hypertension, angina and hyperlipidemia [high cholesterol] at a slightly lower price than the individual components would cost. Atorvastatin would almost always be a reasonable choice for a patient with hyperlipidemia, but a calcium-channel blocker is generally not the drug of first choice for treatment of hypertension. The availability and marketing of Caduet could lead to overuse of amlodipine. The combination should be reserved for patients already stabilized on both of its components.
What You Can Do
We can think of no medical reason why you should be taking Caduet unless you are being treated satisfactorily with doses of amlodipine and atorvastatin that are available as Caduet. If you have not been tried on more effective drugs for high blood pressure such as diuretics or beta-blockers, amlodipine is a poor choice.
