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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].
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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 Programs 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 patients 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.
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NEWS HIGHLIGHTSMedia Articles Related to Azor (Amlodipine / Olmesartan)
High Blood Pressure (Hypertension) Quiz: Symptoms, Signs & Causes
Source: MedicineNet Facial Nerve Problems Specialty [2017.09.19]
Title: High Blood Pressure (Hypertension) Quiz: Symptoms, Signs & Causes
Category: MedicineNet Quiz
Created: 2/9/2011 12:00:00 AM
Last Editorial Review: 9/19/2017 6:02:11 PM
Pulmonary Hypertension (Symptoms, Treatment Medications, Life Expectancy)
Source: MedicineNet Congenital Heart Disease Specialty [2017.07.26]
Title: Pulmonary Hypertension (Symptoms, Treatment Medications, Life Expectancy)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 7/26/2017 12:00:00 AM
High Blood Pressure (Hypertension)
Source: MedicineNet Polycystic Ovary Specialty [2017.03.31]
Title: High Blood Pressure (Hypertension)
Category: Symptoms and Signs
Created: 1/15/2014 12:00:00 AM
Last Editorial Review: 3/31/2017 12:00:00 AM
Portal Hypertension
Source: MedicineNet nitroglycerin Specialty [2016.09.06]
Title: Portal Hypertension
Category: Diseases and Conditions
Created: 1/31/2005 12:00:00 AM
Last Editorial Review: 9/6/2016 12:00:00 AM
Picture of Hypertension
Source: MedicineNet betaxolol ophthalmic Specialty [2014.12.09]
Title: Picture of Hypertension
Category: Images
Created: 2/3/2011 12:00:00 AM
Last Editorial Review: 12/9/2014 12:00:00 AM
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...
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.
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 >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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. |
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Page last updated: 2017-09-19
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