Caduet (Amlodipine Besylate / Atorvastatin Calcium) - Summary

CADUET SUMMARY

CADUET®
(amlodipine besylate/atorvastatin calcium) Tablets

CADUET^® (amlodipine besylate and atorvastatin calcium) tablets combine the long-acting calcium channel blocker amlodipine besylate with the synthetic lipid-lowering agent atorvastatin calcium.

CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.

1. Hypertension: Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents;
2. Chronic Stable Angina: Amlodipine is indicated for the treatment of chronic stable angina, for the treatment of confirmed or suspected vasospastic angina and for the treatment of hypertension. Amlodipine may be used alone or in combination with other antianginal or antihypertensive agents;
3. Vasospastic Angina (Prinzmetal's or Variant Angina): Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal drugs.

AND

1. Heterozygous Familial and Nonfamilial: Atorvastatin is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( Fredrickson Types IIa and IIb);
2. Elevated Serum TG Levels: Atorvastatin is indicated as an adjunct to diet for the treatment of patients with elevated serum TG levels ( Fredrickson Type IV);
3. Primary Dysbetalipoproteinemia: Atorvastatin is indicated for the treatment of patients with primary dysbetalipoproteinemia ( Fredrickson Type III) who do not respond adequately to diet;
4. Homozygous Familial Hypercholesterolemia: Atorvastatin is indicated to reduce 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;
5. Pediatric Patients: Atorvastatin 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 if after an adequate trial of diet therapy the following findings are present:
   
   1. LDL-C remains >/= 190 mg/dL or
   2. LDL-C remains >/= 160 mg/dL and:
      
      • there is a positive family history of premature cardiovascular disease or
      • two or more other CVD risk factors are present in the pediatric patients.

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NEWS HIGHLIGHTS

Published Studies Related to Caduet (Amlodipine / Atorvastatin)

Reaching recommended lipid and blood pressure targets with amlodipine/atorvastatin combination in patients with coronary heart disease. [2005.01.15]
The effects of combined atorvastatin and amlodipine on blood pressure (BP) and low-density lipoprotein (LDL) cholesterol levels were investigated in 134 patients with documented coronary heart disease treated for 1 year. BP at baseline was 128 +/- 15/79 +/- 9 mm Hg and was controlled by the treating physician; no calcium channel blockers were allowed...

Effect of amlodipine-atorvastatin combination on fibrinolysis in hypertensive hypercholesterolemic patients with insulin resistance. [2004.09]
BACKGROUND: The aim of this study was to evaluate the effect of the amlodipine-atorvastatin combination on plasma tissue plasminogen activator (t-PA) and plasminogen activator inhibitor type 1 (PAI-1) activity in hypercholesterolemic, hypertensive patients with insulin resistance... CONCLUSIONS: The positive effect on fibrinolytic balance and BP control observed suggests that in hypertensive, hypercholesterolemic patients with impaired fibrinolysis, the combination of amlodipine and atorvastatin could be the treatment of choice. Copyright 2004 American Journal of Hypertension, Ltd.

Amlodipine/Atorvastatin single-pill therapy for blood pressure and lipid goals in African Americans: influence of the metabolic syndrome and type 2 diabetes mellitus. [2009.10]
African Americans with diabetes +/- the metabolic syndrome are at high risk for cardiovascular disease. This subanalysis of the Clinical Utility of Caduet in Simultaneously Achieving Blood Pressure and Lipid End Points (CAPABLE) trial studied attainment of the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) and the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) goals by 8 flexibly titrated doses (5/10-10/80 mg) of amlodipine/atorvastatin single pill in 494 African Americans with hypertension and dyslipidemia, according to the presence of diabetes +/- the metabolic syndrome.

ADDITIVE BENEFICIAL EFFECTS OF AMLODIPINE AND ATORVASTATIN IN REVERSING ADVANCED CARDIAC HYPERTROPHY IN ELDERLY SPONTANEOUSLY HYPERTENSIVE RATS. [2009.04.27]
1.The benefits were likely related with additive suppression of NADPH oxidase-mediated ROS generation.

Single-pill amlodipine/atorvastatin helps patients of diverse ethnicity attain recommended goals for blood pressure and lipids (the Gemini-AALA study). [2009.03]
The Gemini-AALA (Australia, Asia, Latin America, Africa/Middle East) study evaluated the efficacy and safety of single-pill amlodipine/atorvastatin (Caduet) for the treatment of patients of diverse ethnicity with concomitant hypertension and dyslipidaemia... Single-pill amlodipine/atorvastatin therapy was well tolerated and effective for the reduction of blood pressure and lipids to recommended goals in patients from diverse ethnic backgrounds.

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Clinical Trials Related to Caduet (Amlodipine / Atorvastatin)

Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors [Terminated]
To assess the effect of single pill therapy on the management of hypertension and other cardiovascular risk factors (e. g., dyslipidemia) in Indian patients in whom the treating doctor has already considered that the administration of the amlodipine/atorvastatin single pill to be appropriate

Caduet in an Untreated Subject Population. [Completed]
The purpose of this study is to determine if Caduet will lower blood pressure to <140/90 mmHg and lower LDL Cholesterol to <100 mg/dL in subjects with hypertension and dyslipidemia who are not currently being treated for these medical conditions.

A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin [Completed]

Clinical Utility of Caduet in Achieving Blood Pressure and Lipid Endpoints in a Specific Patient Population [Completed]

Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels

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PATIENT REVIEWS / RATINGS / COMMENTS

Caduet review by 56 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		cholesterol/high blood pressure
Dosage & duration:		50/10 (dosage frequency: once daily) for the period of 1 1/2 years
Other conditions:		none
Other drugs taken:		Cozaar, Toprol
		Reported Results
Benefits:		apparently lowered cholesterol and blood pressure
Side effects:		Awful! Difficulty sleeping, extreme fatigue. Weight gain. Swollen knees, ankles and feet. My knees were severely affected -- difficulty getting up and down stairs, could not get out of a car by myself. When I stopped taking the drug, my knees improved to the point where I am freely ambulatory, but they are still stiff with some pain. I have had to consult an orthopedist, who tells me he has seen MANY such cases. X-rays show I have the knees "of a person 20 years younger," but the muscles have been grossly affected.
Comments:		In place of the Caduet, which I stopped against the objections of my internist, I am using natural substances such as policosanol, CoQ10, and pycnogenol. I am also losing weight, and have professional therapy to try to regain strength in my knees.