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Azor (Amlodipine Besylate / Olmesartan Medoxomil) - Summary

 



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

USE IN PREGNANCY

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.


This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).


See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Azor (Amlodipine / Olmesartan)

New Consortium Paves The Way For Improved Treatment Of Hypertension And Associated Vascular Complications
Source: Hypertension News From Medical News Today [2009.11.18]
Top Institute Pharma (TI Pharma) has formed a consortium with Actelion Pharmaceuticals Ltd, Erasmus Medical Centre and Maastricht University to define new modalities for the treatment of hypertension (high blood pressure) and associated vascular complications such as heart and kidney failure, myocardial infarction and stroke.

Kids with CKD Often Have Masked Hypertension (CME/CE)
Source: MedPage Today Nephrology [2009.11.13]
Many children with chronic kidney disease may have undetected hypertension, placing them at risk for enlarged hearts and future cardiovascular disease, a cross-sectional study showed.

Key Player Identified In Cascade That Leads To Hypertension-Related Kidney Damage
Source: Hypertension News From Medical News Today [2009.11.06]
A key player in a cascade that likely begins with stress and leads to high blood pressure and kidney damage has been identified by researchers who say the finding may lead to better ways to control both. Medical College of Georgia researchers have found endothelin, a powerful blood vessel constrictor and inflammatory peptide, increases the number of T cells in the kidneys, which helps recruit other immune cells, causing inflammation and destruction.

A Recipe For Hypertension: High Fructose Corn Syrup
Source: Hypertension News From Medical News Today [2009.10.31]
A diet high in fructose increases the risk of developing high blood pressure (hypertension), according to a paper presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition in San Diego, California. The findings suggest that cutting back on processed foods and beverages that contain high fructose corn syrup (HFCS) may help prevent hypertension.

Hypertension Guidelines Reappraised In Light Of New Research
Source: Hypertension News From Medical News Today [2009.10.30]
A Task Force of the European Society of Hypertension have released the official European guidelines on the management and treatment of hypertension. The guidelines are an update of those published in 2007, and will be published in the November issue of the Journal of Hypertension.

more news >>

Published Studies Related to Azor (Amlodipine / Olmesartan)

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.

Pharmacokinetics of amlodipine and olmesartan after administration of amlodipine besylate and olmesartan medoxomil in separate dosage forms and as a fixed-dose combination. [2008.11]
The pharmacokinetics of amlodipine and olmesartan in healthy volunteers after coadministration of amlodipine besylate and olmesartan medoxomil concomitantly as separate dosage forms and together in a fixed-dose combination tablet were characterized in 5 phase I, randomized, crossover studies... From a pharmacokinetic perspective, the 2 drugs are well suited to coadministration in a fixed-dose combination.

Amlodipine/ARB fixed-dose combinations for the treatment of hypertension: focus on amlodipine/olmesartan combination. [2008.06]
The incidence of hypertension continues to increase worldwide and, according to recent estimates, its incidence is approximately 30% of the U.S.In addition, due to the metabolic neutrality of both component drugs, these preparations are preferable for the treatment of hypertensive patients with diabetes or the metabolic syndrome, in addition to other cardiovascular risk factors.

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 [Recruiting]
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.

Parallel-Group Comparison of Olmesartan, Amlodipine and Hydrochlorothiazide in Hypertension [Recruiting]
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.

more trials >>

Page last updated: 2009-11-18

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