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Exforge (Amlodipine Besylate / Valsartan) - Summary

 



USE IN PREGNANCY

When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.   When pregnancy is detected, Exforge ®  (amlodipine and valsartan) should be discontinued as soon as possible.

See WARNINGS: Fetal/Neonatal Morbidity and Mortality

 

EXFORGE SUMMARY

Exforge

Exforge® (amlodipine and valsartan) is a fixed combination of amlodipine and valsartan. Exforge® contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol.

Exforge® (amlodipine and valsartan) is indicated for the treatment of hypertension.   

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 Exforge (Amlodipine / Valsartan)

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.

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Published Studies Related to Exforge (Amlodipine / Valsartan)

Triple antihypertensive therapy with amlodipine, valsartan, and hydrochlorothiazide: a randomized clinical trial. [2009.07]
Many patients with hypertension require > or =3 agents to achieve target blood pressure (BP). The efficacy/safety of the dual combinations of valsartan (Val)/hydrochlorothiazide (HCTZ) and amlodipine (Aml)/Val in hypertension are well established... In conclusion, this study demonstrates the efficacy/safety of treating moderate and severe hypertension with Aml/Val/HCTZ 10/320/25 mg.

Efficacy and safety of initial combination therapy with amlodipine/valsartan compared with amlodipine monotherapy in black patients with stage 2 hypertension: the EX-STAND study. [2009.07]
The strategy of initiating hypertension treatment with combination versus single-drug therapy was formally tested in a prospective, double-blind, parallel-group trial in blacks with stage 2 hypertension (mean sitting systolic BP (MSSBP) >or=160 and <200 mm Hg)... In conclusion, the strategy of initiating combination antihypertensive drug therapy in blacks with stage 2 hypertension with amlodipine /valsartan achieves greater and quicker reductions in BP as well as significantly higher BP control rates than starting treatment with amlodipine monotherapy.

Efficacy and tolerability of amlodipine/valsartan combination therapy in hypertensive patients not adequately controlled on valsartan monotherapy. [2009.02]
OBJECTIVE: To demonstrate additional BP-lowering effects of amlodipine/valsartan combination in patients whose BP was not adequately controlled on valsartan alone... CONCLUSIONS: The combination of amlodipine/valsartan in this 8-week double-blind study provided additional BP control and was well-tolerated in patients inadequately controlled with valsartan monotherapy.

Long-term tolerability and efficacy of the combination of amlodipine/valsartan in hypertensive patients: a 54-week, open-label extension study. [2009.01]
OBJECTIVE: To evaluate the long-term tolerability and efficacy of the amlodipine/valsartan 5/320 mg once daily (o.d.) combination in hypertensive patients... CONCLUSIONS: Long-term treatment with the amlodipine/valsartan 5/320 mg combination was well-tolerated. Clinically significant and persistent reductions in blood pressure were achieved. Limitations included an open-label design and inclusion of only those patients at or near goal blood pressure after the preceding core trial.

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.

more studies >>

Clinical Trials Related to Exforge (Amlodipine / Valsartan)

Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)
The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.

Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension [Completed]
The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2. 5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies and placebo.

Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension. [Completed]
This trial will compare valsartan and amlodipine combination therapies to both valsartan and amlodipine, and placebo for the treatment of hypertension.

The Effects of Systolic Blood Pressure Lowering on Diastolic Function Using Valsartan + Amlodipine in Patients With Hypertension and Diastolic Dysfunction
The purpose of this study is to determine the effects of treatment with valsartan + amlodipine to a target systolic blood pressure (SBP)<130 mmHg compared to the Joint National Commission on the Treatment of Hypertension 7 recommended target SBP of <140 mmHg on the intrinsic diastolic properties of the myocardium in patients with hypertension and echocardiographic evidence of diastolic dysfunction.

One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension [Completed]

more trials >>

Page last updated: 2009-11-18

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