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Exforge (Amlodipine Besylate / Valsartan) - Summary



  • When pregnancy is detected, discontinue Exforge as soon as possible. (5.1)
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)



Exforge 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 is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Exforge is indicated for the treatment of hypertension, to lower blood pressure:

  • In patients not adequately controlled on monotherapy (1)
  • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1).

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.


Exforge (amlodipine and valsartan) is indicated for the treatment of hypertension, 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 amlodipine and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge.

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

Exforge may be used in patients whose blood pressure is not adequately controlled on either monotherapy.

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

The choice of Exforge as initial therapy for hypertension should be based on an assessment of potential benefits and risks including whether the patient is likely to tolerate the lowest dose of Exforge.

Patients with stage 2 hypertension (moderate or severe) are at a relatively higher 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 the high-dose multifactorial study [ see Clinical Studies (14) ] provide estimates of the probability of reaching a blood pressure goal with Exforge compared to amlodipine or valsartan monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Exforge 10/320 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.

Figure 1:   Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8

Figure 2:   Probability of Achieving Diastolic Blood Pressure   <90 mmHg at Week 8

Figure 3:   Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8

Figure 4:   Probability of Achieving Diastolic Blood Pressure   <80 mmHg at Week 8

For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 67% likelihood of achieving a goal of <140 mmHg (systolic) and 80% likelihood of achieving <90 mmHg (diastolic) on amlodipine alone, and the likelihood of achieving these goals on valsartan alone is about 47% (systolic) or 62% (diastolic). The likelihood of achieving these goals on Exforge rises to about 80% (systolic) or 85% (diastolic). The likelihood of achieving these goals on placebo is about 28% (systolic) or 37% (diastolic).


See all Exforge indications & dosage >>


Media Articles Related to Exforge (Amlodipine / Valsartan)

Targeted Therapies May Ease Severe Pulmonary Hypertension
Source: Medscape Critical Care Headlines [2015.09.29]
A new analysis has spotted a mortality reduction in patients with severe pulmonary hypertension caused by lung disease, but doubts remain.
Medscape Medical News

Targeting hypertension by helping pharmacists deliver enhanced patient care
Source: Hypertension News From Medical News Today [2015.09.21]
Patients with high blood pressure are benefiting from the expanded role played by pharmacists in Alberta, according to a new study from the University of Alberta's Faculty of Medicine & Dentistry.

Hypertension drug reduces inflammation from traumatic brain injury
Source: Hypertension News From Medical News Today [2015.09.21]
A new study on the processes causing inflammation after a TBI identifies a protein produced in the liver that can be blocked using a drug for hypertension.

New imaging technique reveals early brain damage caused by hypertension
Source: Hypertension News From Medical News Today [2015.09.18]
Researchers have found that a new imaging technique known as diffusion tensor imaging can show when high blood pressure causes early damage to neural pathways in the brain.

Popular hypertension drugs linked to worse heart health in blacks compared to whites
Source: Hypertension News From Medical News Today [2015.09.16]
Drugs commonly used to treat high blood pressure, and prevent heart attacks and strokes, are associated with significantly worse cardiovascular outcomes in hypertensive African Americans compared...

more news >>

Published Studies Related to Exforge (Amlodipine / Valsartan)

Indirect treatment comparison between fixed-dose-combinations of amlodipine/losartan and amlodipine/valsartan in blood pressure control. [2014]
compared amlodipine/losartan with other FDCs... CONCLUSIONS: The BP lowering effect with amlodipine/losartan and

Initial combination therapy with amlodipine/valsartan compared with monotherapy in the treatment of hypertension. [2011.09]
Achieving target blood pressure (BP) is influenced by baseline BP. Post hoc analyses of a placebo-controlled trial of amlodipine/valsartan versus monotherapies were conducted to characterize BP control by baseline BP...

Moderate versus intensive treatment of hypertension using amlodipine/valsartan and with the addition of hydrochlorothiazide for patients uncontrolled on angiotensin receptor blocker monotherapy: results in racial/ethnic subgroups. [2011.07]
Combination therapy may reduce racial/ethnic differences in response to antihypertensives. In this post-hoc analysis, we evaluated treatment response by race/ethnicity among hypertensive adults enrolled in a 12-week, double-blind study in which patients previously uncontrolled (mean sitting systolic blood pressure [MSSBP] >/=150 and <200 mm Hg) on angiotensin receptor blocker (ARB) monotherapy (other than valsartan) for 28 days or more (n = 728) were randomized to amlodipine/valsartan 10/320 mg (intensive) or 5/160 mg (moderate)...

Evaluation of pharmacokinetic interactions between amlodipine, valsartan, and hydrochlorothiazide in patients with hypertension. [2011.06]
The steady-state pharmacokinetic (PK) interaction potential between amlodipine (10 mg), valsartan (320 mg), and hydrochlorothiazide (HCTZ; 25 mg) was evaluated in patients with hypertension in a multicenter, multiple-dose, open-label, 4-cohort, parallel-group study... All treatments were safe and well tolerated.

The role of ambulatory blood pressure monitoring compared with clinic and home blood pressure measures in evaluating moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. [2011.04]
OBJECTIVES: Ambulatory blood pressure monitoring (ABPM) has greater predictive value than office blood pressure (BP) with respect to hypertension-related target-organ damage and morbidity. ABPM in a subset of 80 patients from the Exforge Target Achievement trial (N=728) was used to compare the efficacy of intensive-treatment and moderate-treatment regimens of amlodipine/valsartan, and to determine whether treatment differences could be better assessed with ABPM than with office or home BP. Home BP was measured on the morning of clinic visits to minimize differences that timing might have on home versus office BP measures... CONCLUSION: In this first randomized trial evaluating the effects of intensive versus moderate dosing of the combination of amlodipine/valsartan, our data suggest that ABPM was a better method for assessing between-treatment differences than clinic or home BP recordings, although measurement of home BP as a single recording was a limitation of our trial.

more studies >>

Reports of Suspected Exforge (Amlodipine / Valsartan) Side Effects

Blood Pressure Increased (85)Death (64)Oedema Peripheral (57)Cerebrovascular Accident (57)Fall (46)Hypertension (45)Diabetes Mellitus (44)Malaise (40)Pneumonia (35)Dyspnoea (33)more >>

Page last updated: 2015-09-29

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