SUMMARY
Amlodipine besylate/atorvastatin calcium tablets combine the calcium channel blocker amlodipine besylate with the lipid-lowering agent atorvastatin calcium.
Amlodipine besylate/atorvastatin calcium tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.
Amlodipine
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1.
Hypertension
: Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents;
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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 <40%, amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.
AND
Atorvastatin
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, the atorvastatin component of amlodipine besylate/atorvastatin calcium tablets can be started simultaneously with diet restriction.
1.
Prevention of Cardiovascular Disease:
In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low 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
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, atorvastatin calcium tablets are indicated to:
- Reduce the risk of myocardial infarction
- Reduce the risk of stroke;
In patients with clinically evident coronary heart disease, atorvastatin calcium tablets are 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:
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a.LDL-C remains ≥ 190 mg/dL or
b.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.
The antidyslipidemic component of amlodipine besylate/atorvastatin calcium tablets 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 Amlodipine and Atorvastatin (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]
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...
A randomized, placebo-controlled trial to evaluate the efficacy, safety, and
pharmacodynamic interaction of coadministered amlodipine and atorvastatin in 1660
patients with concomitant hypertension and dyslipidemia: the respond trial. [2007]
Guidelines stress the importance of the simultaneous management of multiple
cardiovascular risk factors. This can in part be achieved by coadministration of
lipid-lowering and antihypertensive treatments... Overall,
coadministered atorvastatin and amlodipine was well tolerated and without adverse
pharmacodynamic interaction; combination treatment did not affect the low-density
lipoprotein cholesterol-lowering efficacy and safety of atorvastatin, or the
systolic blood pressure-lowering efficacy and safety of amlodipine.
Improving adherence with amlodipine/atorvastatin therapy: IMPACT study. [2011]
Hypertension is prevalent in the United States and remains uncontrolled. The
primary objective of the study was to determine the effect of once-daily dosing
of a combination therapy for blood pressure (BP) and dyslipidemia using home BP
monitoring on reaching clinical BP and the effect of daily dosing of combination
therapy on reaching lipid goals...
Additive beneficial effects of atorvastatin combined with amlodipine in patients
with mild-to-moderate hypertension. [2011]
monotherapy in patients with hypertension... CONCLUSIONS: Atorvastatin combined with amlodipine therapy improves endothelial
Clinical Trials Related to Amlodipine and Atorvastatin (Amlodipine / Atorvastatin)
CKD-330 Drug-Drug Interaction Study (Amlodipine) [Completed]
The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of
Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine
monotherapy.
Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension [Completed]
Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in
combination with amlodipine in patients with essential hypertension.
Study to Determine the Bioequivalence of Two Fixed Dose Combination (FDC) Tablet Formulations of Amlodipine and Losartan FDC5/50 and FDC5/100 Under Fasting Conditions [Completed]
This is a three-period, three sequence, reference replicated, cross-over study to determine
the bioequivalence of two amlodipine and losartan FDC tablet formulations FDC5/50 and
FDC5/100 (GSK2944406; 5 mg amlodipine and 50 mg and 100 mg losartan) to reference amlodipine
and losartan tablets co-administered in two groups enrolling 102 healthy adult male and
female subjects under fasting conditions.
A description of each treatment is provided below:
A (Reference) = 1 x 5 mg amlodipine tablet and 1 x 50 mg losartan tablet. B (FDC5/50) = 1 x
5 mg amlodipine and 50 mg losartan tablet C (Reference) = 1 x 5 mg amlodipine tablet and 1 x
100 mg losartan tablet D (FDC5/100) = 1 x 5 mg amlodipine and100 mg losartan tablet The
treatments will be administered in accordance with the randomisation schedule as.
Group 1: A → A → B or A → B → A or B → A → A Group 2: C → C → D or C → D → C or D → C → C
All subjects will attend a screening visit within 28 days of their first dosing period (Day
1). The baseline assessments will be conducted the day before the first dosing.
In each treatment period, subjects will be admitted to the clinic in the evening before Day
1. All subjects will receive a single oral dose of amlodipine and losartan in the morning on
Day 1. All the subjects will remain in the clinical unit until completion of all assessments
at 24 hours post-dose on Day 2 including collection of the 24 hour post-dose PK sample.
Subjects will return to the clinic for pharmacokinetic samples at 36, 48, 72 and 96 hours
post-dose.
The three treatment periods will be separated by a washout period of 10-17 days. Upon
completion of the last dosing period, or early withdrawal, subjects will return to the
clinical unit within 14-21 days for a follow up visit.
Drug-drug Interaction Study(CKD-501, Amlodipine) [Completed]
The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501
and amlodipine after oral administration in healthy male volunteers.
Study of the Efficacy and Safety of LCZ696 Alone and in Combination With Amlodipine in Patients With Hypertension [Withdrawn]
To evaluate the blood pressure lowering effect and safety of LCZ696 when given alone and in
combination with amlodipine in patients with essential hypertension.
Reports of Suspected Amlodipine and Atorvastatin (Amlodipine / Atorvastatin) Side Effects
Death (2),
Completed Suicide (2),
Confusional State (1),
Drug Ineffective (1),
Fall (1),
Fatigue (1),
Dizziness (1),
Blood Cholesterol Increased (1),
Musculoskeletal Stiffness (1),
Acute Myocardial Infarction (1), more >>
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Page last updated: 2013-02-10
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