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Azor (Amlodipine Besylate / Olmesartan Medoxomil) - Summary

 
 



Azor®
(amlodipine and olmesartan medoxomil) tablets

USE IN PREGNANCY

When pregnancy is detected, discontinue Azor as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus [see Warning and Precautions].

 

AZOR SUMMARY

Azor is a combination of the calcium channel receptor blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil.

Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Azor.

 Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

 Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

 Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

 Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Azor may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.

Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies] provide estimates of the probability of reaching a blood pressure goal with Azor compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with Azor 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures.


Figure 1: Probability of Achieving Systolic Blood Pressure (SBP) <140 mmHg at Week 8 With LOCF


Figure 2: Probability of Achieving Diastolic Blood Pressure (DBP) <90 mmHg at Week 8 With LOCF


Figure 3: Probability of Achieving Systolic Blood Pressure (SBP) <130 mmHg at Week 8 With LOCF



Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) <80 mmHg at Week 8 With LOCF

The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP <140 mmHg or <130 mmHg or a DBP <90 mmHg or <80 mmHg) for the high-dose treatment groups evaluated in the study. Azor 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg.

 For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of <140 mmHg (systolic) and a 51% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmHg (systolic) and a 60% likelihood of achieving a goal of <90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on Azor 5/20 mg, and to 68% (systolic) and 85% (diastolic) on Azor 10/40 mg.




See all Azor indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Azor (Amlodipine / Olmesartan)

ESC: Coffee, Naps, and Depression in Hypertension (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.29]
(MedPage Today) -- Observations support naps but suggest risk with espresso and depression

Medical News Today: Could hypertension during pregnancy signal elevated risk for siblings?
Source: Featured Health News from Medical News Today [2015.08.28]
The male siblings of women who have high blood pressure during pregnancy are at an increased risk of developing cardiovascular disease in later life, a new study finds.

Could hypertension during pregnancy signal elevated risk for siblings?
Source: Biology / Biochemistry News From Medical News Today [2015.08.28]
The male siblings of women who have high blood pressure during pregnancy are at an increased risk of developing cardiovascular disease in later life, a new study finds.

Common 'heart attack' blood test may predict future hypertension
Source: Hypertension News From Medical News Today [2015.08.27]
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressureAnalysis of blood samples from more than 5,000 people suggests that a more sensitive...

ICD-10: Coding for Hypertension and Heart Disease
Source: Medscape Business of Medicine Headlines [2015.08.25]
There are some important elements to be aware of when coding for hypertension, heart disease, and kidney disease in ICD-10.
Medscape Business of Medicine

more news >>

Published Studies Related to Azor (Amlodipine / Olmesartan)

A titrate-to-goal study of switching patients uncontrolled on antihypertensive monotherapy to fixed-dose combinations of amlodipine and olmesartan medoxomil +/- hydrochlorothiazide. [2011.06]
In the prospective, open-label, titrate-to-goal Blood Pressure Control in All Subgroups With Hypertension (BP-CRUSH) study, 999 patients with hypertension uncontrolled on monotherapy (mean age, 55.6 +/- 11.4 years; baseline blood pressure [BP], 153.7 +/- 9.2/91.9 +/- 8.6 mm Hg) were switched to fixed-dose amlodipine/olmesartan medoxomil (AML/OM) 5/20 mg...

Antihypertensive efficacy of olmesartan medoxomil or valsartan in combination with amlodipine: a review of factorial-design studies. [2009.01]
BACKGROUND: Most patients with hypertension require more than one drug to attain recommended blood pressure (BP) targets. Initiating therapy with two agents is recommended for patients at high risk of a cardiovascular event or with a BP > 20/10 mmHg above goal. Combination therapy is effective when comprised of agents with complementary mechanisms of action, such as calcium channel blockers (CCBs) and angiotensin II-receptor blockers (ARBs). Two fixed-dose CCB/ARB combinations are approved in the US: amlodipine/valsartan (AML/VAL) and amlodipine/olmesartan medoxomil (AML/OM). OBJECTIVES: To review and describe the efficacy of AML/VAL and AML/OM combinations by discussing similarly designed clinical trials... CONCLUSIONS: This review of published factorial-design studies showed that the maximal marketed doses of an amlodipine/olmesartan medoxomil combination (10/40 mg) and an amlodipine/valsartan combination (10/320 mg) produced large reductions in BP from baseline. Limitations of this review include the small number of studies analyzed and the inherent heterogeneity between patient populations. Further research is warranted to directly compare the efficacy of these combinations in a randomized, controlled trial, or additional published clinical trials are required to provide larger data sets for robust meta-analyses and to overcome heterogeneity observed within these studies.

Changes in biomarkers and 24 hours blood pressure in hypertensive African Americans with the metabolic syndrome: comparison of amlodipine/olmesartan versus hydrochlorothiazide/losartan. [2013]
We evaluated the efficacy of amlodipine and olmesartan (A/O; Azor) versus losartan and hydrochlorothiazide (L/H; Hyzaar), on changes in serum and urine biomarkers of inflammation and oxidation, neutrophil reactive oxygen species generation, and changes in systolic blood pressure (BP), diastolic BP, and heart rate as measured with 24 hours ambulatory BP monitoring in a high-risk, hypertensive African-American population with the metabolic syndrome...

Efficacy of amlodipine and olmesartan medoxomil in hypertensive patients with diabetes and obesity. [2011.06]
A subgroup analysis of a prospective, open-label, single-arm titration study in patients with hypertension and type 2 diabetes or obesity is reported. The primary end point was the change from baseline in mean 24-hour ambulatory systolic blood pressure (BP) after 12 weeks... The SeBP goal of < 130/80 mm Hg was achieved by 26.1% of patients with diabetes and <140/90 mm Hg was achieved by 78.1% of obese patients.

Management of hypertension in patients with diabetes using an amlodipine-, olmesartan medoxomil-, and hydrochlorothiazide-based titration regimen. [2011.05.01]
The safety and efficacy of an amlodipine/olmesartan medoxomil (OM)-based titration regimen was assessed in patients with type 2 diabetes mellitus and hypertension. After a 2- to 3-week placebo run-in period, 207 patients received amlodipine 5 mg and were uptitrated to amlodipine/OM 5/20, 5/40, and 10/40 mg and then amlodipine/OM 10/40 mg plus hydrochlorothiazide 12.5 and 25 mg in a step-wise manner at 3-week intervals if the seated blood pressure (BP) remained >/=120/70 mm Hg...

more studies >>

Clinical Trials Related to Azor (Amlodipine / Olmesartan)

A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure [Completed]
The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.

Changes in Endothelial Function and Biomarkers in African Americans (AA) With Metabolic Syndrome [Active, not recruiting]
The purpose of the study is to compare the effects of Azor (a combination of amlodipine and olmesartan) with Hyzaar ( a combination of losartan and hydrochlorothiazide) on the thin lining on the inside of blood vessels. These cells help keep blood vessels healthy and blood pressure normal.

Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients [Completed]

Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension [Completed]
This study is to determine the change in blood pressure from the administration of Olmesartan/Amlodipine/Hydrochlorothiazide triple combinations compared to dual combinations with Olmesartan/Amlodipine.

18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics [Completed]
To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

more trials >>

Reports of Suspected Azor (Amlodipine / Olmesartan) Side Effects

Diarrhoea (6)Dyspnoea (5)Oedema Peripheral (4)Dehydration (4)Hypersensitivity (3)Pruritus (3)Abdominal Discomfort (3)Dizziness (3)Blood Pressure Increased (3)Weight Decreased (2)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Azor has an overall score of 8. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Azor review by 23 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   anxiety attacks
Dosage & duration:   0.5g/day (dosage frequency: once a day or when needed) for the period of for a total of eight years now
Other conditions:   chronic back pain
Other drugs taken:   nothing
  
Reported Results
Benefits:   Can get a good nights rest and anxiety attacks are supressed. I have been able to lead a normal life and be successfull. I am doing my doctoral now in medical research and belief without Azor it would not be possible. I remember what my life was before Azor and am relieved to know it is behind me. I have been on it for years now, the benefits outweighs the disadvantages- I know Im addicted. Azor was and still is prescribed to me by my psychiatrist.
Side effects:   Some lethargic tendencies and drowsiness at times when taken for anxiety attack. Also, I am addicted to it. I can not sleep witout Azor.
Comments:   I take one tablet (0.5g) Azor whenever I have a anxiety attack or struggle to sleep. I was attacked a few years back, and still have panic attacks on occasion and struggle to sleep considerably. In addition, I have nightmares. However, when I take the azor, I calm down. Furthermore,I did try sleeping medication, however,I was always tired and struggled to wake up. When I take azor, I can sleep without the whooziness the following morning.

See all Azor reviews / ratings >>

Page last updated: 2015-08-29

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