When pregnancy is detected, discontinue Exforge HCT 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 HCT SUMMARY
Exforge HCT is a fixed combination of amlodipine, valsartan, and hydrochlorothiazide.
Exforge HCT contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol.
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 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, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge HCT.
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 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 (e.g., 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.
This fixed combination drug is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].
Media Articles Related to Exforge HCT (Amlodipine / Hydrochlorothiazide / 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...
Published Studies Related to Exforge HCT (Amlodipine / Hydrochlorothiazide / Valsartan)
24-Hour ambulatory blood pressure response to combination valsartan/hydrochlorothiazide and amlodipine/hydrochlorothiazide in stage 2 hypertension by ethnicity: the EVALUATE study. [2010.11]
Several studies reported racial/ethnic differences in blood pressure (BP) response to antihypertensive monotherapy. In a 10-week study of stage 2 hypertension, 320/25 mg valsartan/hydrochlorothiazide (HCTZ) reduced ambulatory BP (ABP) significantly more effectively than 10/25 mg amlodipine/HCTZ...
Effects of force-titrated valsartan/hydrochlorothiazide versus amlodipine/hydrochlorothiazide on ambulatory blood pressure in patients with stage 2 hypertension: the EVALUATE study. [2009.06]
BACKGROUND: Previous studies using the combination of angiotensin-receptor blockers and hydrochlorothiazide (HCTZ) have shown superior ambulatory blood pressure (ABP) reduction in study participants with stage 2 hypertension compared with monotherapy. OBJECTIVE: This multicenter, double-blind, parallel group, forced-titration study of individuals with stage 2 hypertension, compared the efficacy of valsartan and amlodipine in combination with HCTZ on ABP reduction... CONCLUSION: On the basis of ABP monitoring but not office measurements, the fixed-dose combination of valsartan/HCTZ is a significantly more effective treatment regimen than amlodipine/HCTZ, with similar tolerability.
Clevidipine: a review of its use in the management of acute hypertension. 
ABSTRACT: Clevidipine (Cleviprex), a late-generation dihydropyridine calcium channel antagonist available as a lipid emulsion for intravenous infusion, is approved in the US for the reduction of blood pressure (BP) when oral therapy is not feasible or desirable... Most adverse events associated with clevidipine were mild or moderate in severity and considered unrelated to study drug, with the most commonly reported being headache, nausea, chest discomfort, and vomiting.
Effects of valsartan or ramipril addition to amlodipine/hydrochlorothiazide
combination on left ventricular mass in diabetic hypertensive patients with left
ventricular hypertrophy. 
CONCLUSIONS: Valsartan addition to dual therapy with amlodipine + HCTZ was more
24-Hour ambulatory blood pressure control with triple-therapy amlodipine, valsartan and hydrochlorothiazide in patients with moderate to severe hypertension. [2011.10]
To determine the effectiveness and safety of once-daily combination therapy with amlodipine, valsartan and hydrochlorothiazide for reducing ambulatory blood pressure (ABP) in patients with moderate to severe hypertension, a multicenter, double-blind study was performed (N=2271) that included ABP monitoring in a 283-patient subset.
Reports of Suspected Exforge HCT (Amlodipine / Hydrochlorothiazide / Valsartan) Side Effects
Oedema Peripheral (19),
Blood Pressure Increased (18),
Blood Pressure Decreased (15),
Blood Pressure Fluctuation (13),
Back Pain (12),
Pain (11), more >>
Page last updated: 2015-09-29