CADUET SUMMARY
CADUET® (amlodipine besylate and atorvastatin calcium) tablets
combine the calcium channel blocker amlodipine besylate with the lipid-lowering
agent atorvastatin calcium.
CADUET (amlodipine and atorvastatin) is indicated in patients for
whom treatment with both amlodipine and atorvastatin is appropriate.
:
Amlodipine is indicated for the treatment of hypertension. It may be used alone
or in combination with other antihypertensive agents;
2.
Coronary Artery Disease (CAD)
Chronic Stable Angina: Amlodipine is indicated for the
treatment of chronic stable angina. Amlodipine may be used alone or in
combination with other antianginal or antihypertensive agents;
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.
Angiographically Documented
CAD: In patients with recently documented CAD by angiography and without
heart failure or an ejection fraction less than 40%, amlodipine is indicated to reduce
the risk of hospitalization due to angina and to reduce the risk of a coronary
revascularization procedure.
AND
Reduce the risk of myocardial infarction
Reduce the risk of stroke
Reduce the risk for revascularization procedures and angina
In
patients with type 2 diabetes, and without clinically evident coronary heart
disease, but with multiple risk factors for coronary heart disease such as
retinopathy, albuminuria, smoking, or hypertension, LIPITOR is indicated to:
- Reduce the risk of myocardial infarction
- Reduce the risk of stroke;
In patients with clinically evident
coronary heart disease, LIPITOR is indicated to:
- Reduce the risk of non-fatal myocardial infarction
- Reduce the risk of fatal and non-fatal stroke
- Reduce the risk for revascularization procedures
- Reduce the risk of hospitalization for CHF
- Reduce the risk of angina
2.
Heterozygous Familial and Nonfamilial
Hyperlipidemia
: 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);
3.
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);
4.
Primary Dysbetalipoproteinemia
: Atorvastatin is indicated for the treatment of patients with
primary dysbetalipoproteinemia (Fredrickson Type III)
who do not respond adequately to diet;
5.
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;
6.
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:
- LDL-C remains greater than or equal to 190 mg/dL or
- LDL-C remains greater than or equal to 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.
The antidyslipidemic component of CADUET has not been studied in conditions
where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).
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NEWS HIGHLIGHTS
Published Studies Related to Caduet (Amlodipine / Atorvastatin)
Simultaneous treatment to attain blood pressure and lipid goals and reduced CV risk burden using amlodipine/atorvastatin single-pill therapy in treated hypertensive participants in a randomized controlled trial. [2010.05.06]
TOGETHER investigated whether targeting multiple cardiovascular (CV) risk factors using single-pill amlodipine/atorvastatin (AML/ATO) and therapeutic lifestyle changes (TLC) results in greater blood pressure (BP)/lipid control and additional reduction in estimated cardiovascular disease (CVD) risk compared with blood pressure intervention only using amlodipine (AML) + TLC...
Amlodipine/Atorvastatin: a review of its use in the treatment of hypertension and dyslipidaemia and the prevention of cardiovascular disease. [2010]
Amlodipine/atorvastatin (Caduet) is a single-tablet, fixed-dose combination of the dihydropyridine calcium channel antagonist amlodipine and the HMG-CoA reductase inhibitor atorvastatin. The bioavailability of amlodipine and atorvastatin with a single-tablet, fixed-dose amlodipine/atorvastatin combination was not significantly different to that with coadministered separate amlodipine and atorvastatin tablets...
Simultaneous treatment to attain blood pressure and lipid goals and reduced CV
risk burden using amlodipine/atorvastatin single-pill therapy in treated
hypertensive participants in a randomized controlled trial. [2010]
TOGETHER investigated whether targeting multiple cardiovascular (CV) risk factors
using single-pill amlodipine/atorvastatin (AML/ATO) and therapeutic lifestyle
changes (TLC) results in greater blood pressure (BP)/lipid control and additional
reduction in estimated cardiovascular disease (CVD) risk compared with blood
pressure intervention only using amlodipine (AML) + TLC...
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.
Clinical Trials Related to Caduet (Amlodipine / Atorvastatin)
Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan) [Completed]
In this survey, to collect the safety and efficacy information of Amlodipine /Atorvastatin
(Caduet® Combination Tablets) in daily medical practice will be examined. In addition, the
necessity of special Investigation and post-marketing clinical studies will be examined,
while investigating unexpected adverse drug reactions during the survey period and
understanding of the status of frequency of adverse drug reactions in daily medical
practice.
Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients [Completed]
The primary objective is to investigate the safety of Caduet (2. 5 mg/5 mg, 2. 5 mg/10 mg, 5
mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period
in Japanese patients with both of hypertension and hypercholesterolemia, or with both angina
pectoris and hypercholesterolemia.
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.
Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors [Completed]
To investigate whether a Caduet based treatment strategy might result in greater reduction
in total cardiovascular risk as compared to usual care in subjects with hypertension and
additional risk factors.
Reports of Suspected Caduet (Amlodipine / Atorvastatin) Side Effects
Death (31),
Malaise (20),
Headache (15),
Diabetes Mellitus (13),
Drug Ineffective (13),
Pain (13),
Cerebrovascular Accident (13),
Hypertension (13),
Blood Cholesterol Increased (12),
Fatigue (11), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Caduet has an overall score of 3. The effectiveness score is 8 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
| | 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. |
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Page last updated: 2013-02-10
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