WARNING: AVOID USE IN PREGNANCY
When pregnancy is detected,
as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus
Warnings and Precautions
DIOVAN HCT SUMMARY
Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.
Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension.
Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy.
Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.
The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks.
Patients with stage 2 hypertension are at a 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 the high dose multifactorial trial [ see Clinical Studies ] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 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.
Probability of Achieving Systolic Blood Pressure <140 mmHg at Week
Probability of Achieving Diastolic Blood Pressure
<90 mmHg at Week
Probability of Achieving Systolic Blood Pressure <130 mmHg at Week
Probability of Achieving Diastolic Blood Pressure
<80 mmHg at Week
For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of <140 mmHg (systolic) and 60% likelihood of achieving <90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).
Media Articles Related to Diovan HCT (Valsartan / Hydrochlorothiazide)
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Source: Hypertension News From Medical News Today [2015.07.03]
With the number of individuals affected by cognitive decline expected to rise over the next few decades, investigating its potential causes is of major public health interest.
Source: MedicineNet Cirrhosis Specialty [2015.05.29]
Title: Portal Hypertension
Category: Diseases and Conditions
Created: 1/31/2005 12:00:00 AM
Last Editorial Review: 5/29/2015 12:00:00 AM
Published Studies Related to Diovan HCT (Valsartan / Hydrochlorothiazide)
Aliskiren as add-on therapy in the treatment of hypertensive diabetic patients inadequately controlled with valsartan/HCT combination: a placebo-controlled study. [2011.10.01]
BACKGROUND: Hypertension frequently coexists with diabetes mellitus, resulting in increased cardiovascular risk. Thus, BP control is crucial in decreasing morbidity and mortality in this difficult-to-treat patient population. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of aliskiren in hypertensive patients with diabetes not adequately responsive to the combination of valsartan and hydrochlorothiazide (HCT)... CONCLUSION: The reductions in BP with aliskiren added to valsartan/HCT in this study were numerically greater compared with placebo added to valsartan/HCT, although not statistically significant. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00219102.
Chronotherapy with valsartan/hydrochlorothiazide combination in essential hypertension: improved sleep-time blood pressure control with bedtime dosing. [2011.08]
Administration of angiotensin receptor blockers at bedtime results in greater reduction of nighttime blood pressure than dosing upon awakening, independent of the terminal half-life of each individual medication. To obtain blood pressure (BP) target goals most patients require treatment with more than one hypertension medication...
Effect of valsartan, hydrochlorothiazide, and their combination on 24-h ambulatory blood pressure response in elderly patients with systolic hypertension: a ValVET substudy. [2011.08]
BACKGROUND: Stage 2 hypertension often requires combination antihypertensive therapy. Ambulatory blood pressure monitoring (ABPM) is a useful tool for studying antihypertensive drugs and their combinations. OBJECTIVE: This multicenter, double-blind, parallel-group, prompted-titration study of patients of at least 70 years of age with systolic hypertension compared the efficacy of valsartan, hydrochlorothiazide, and their combination on ambulatory blood pressure (ABP) reduction... CONCLUSION: In elderly hypertensives, starting combination therapy with valsartan/hydrochlorothiazide provides more effective 24-h blood pressure control than the monotherapy components, with few therapy-related side-effects.
Achieving blood pressure goal: initial therapy with valsartan/hydrochlorothiazide combination compared with monotherapy. [2010.12]
The benefits of valsartan (Val)/hydrochlorothiazide (HCTZ) combination as initial treatment for hypertension were evaluated in a post hoc analysis of an 8-week, double-blind, placebo-controlled, parallel-group trial. The highest dose of Val/HCTZ combination (320/25 mg), component monotherapies (Val 320 mg, HCTZ 25 mg) and placebo were selected for this analysis (N=675, 52.1% men, 68.6% Caucasians, mean age 52.9 years, baseline blood pressure (BP) 150.6/99.1 mm Hg)...
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...
Clinical Trials Related to Diovan HCT (Valsartan / Hydrochlorothiazide)
Demonstrate Non-inferiority of Combination of 5 mg Amlodipine and 80 mg Valsartan to 160 mg Valsartan [Recruiting]
The purpose of the present study is to assess the non-inferiority of the efficacy and safety
of fixed dose combination of 5 mg amlodipine and 80 mg valsartan compared to 160 mg
valsartan in lowering blood pressure in Taiwanese patients.
Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension [Recruiting]
This will be a multi-center, prospective, randomized, open-label, parallel design, two arm
comparator trial. In the proposed study, the investigators will compare low-dose combination
therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan
with respect to their blood pressure-decreasing effects in patients with essential
hypertension. The study consists of a screening visit, followed by randomization and
administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or
Valsartan 160 mg for 12 weeks of treatment. The primary efficacy parameters will be mean SBP
and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.
Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease [Recruiting]
Primary Hypothesis: Aldosterone breakthrough will occur at a far lower frequency during
renin inhibition (0-10% over 9 months), alone or in combination with an ARB, compared to
conventional ARB therapy (35-45% over 9 months). The investigators hypothesize that
aldosterone breakthrough occurs due to accumulation of active precursor substances, most
notably angiotensin II, produced in response to conventional RAAS blockade with
ACEinhibitors and ARBs. The investigators believe that direct renin inhibition (DRI) should
minimize this accumulation and therefore significantly lower or possibly eliminate the
Interruption of the renin-angiotensin-aldosterone system (RAAS) with angiotensin-converting
enzyme inhibitors (ACE-Is) and angiotensin receptor blockers (ARBs), alone and in
combination, has become a leading therapy to slow the progression of chronic heart and
kidney disease. Both types of drugs inhibit the formation of aldosterone, a hormone, which
has been shown to have harmful effects on patients with chronic heart and kidney disorders.
This treatment is effective but not perfect since, even after an initial improvement, many
patients become worse over the long term. This may be due to an unexpected increase in
aldosterone, a phenomenon called "aldosterone breakthrough."
The purpose of this study is to find out whether the use of a direct renin inhibitor (DRI)
alone, or in combination with an angiotensin receptor blocker (ARB), will lessen the
occurrence of aldosterone breakthrough since direct renin inhibitors inhibit the formation
of aldosterone at a very early step. This study will compare the effectiveness of adding
Diovan (valsartan) or Tekturna (aliskiren) or a combination of Diovan and Tekturna to the
usual antihypertensive treatment. The investigators will follow blood pressure, aldosterone
levels, and urinary protein levels over 9 months to evaluate which of these therapies is
most effective for treating hypertension in patients with proteinuric kidney disease.
Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus [Recruiting]
The purpose of the study is to evaluate the blood pressure (BP)-lowering efficacy of the
combination of aliskiren and valsartan, as initial therapy, compared to valsartan
monotherapy in Type II Diabetic patients with Stage II hypertension.
A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-Term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide. [Active, not recruiting]
Assessment of the long-term safety and tolerability of the combination of aliskiren and
valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of
long-term safety and tolerability of the combination of aliskiren/valsartan/HCTZ.
Reports of Suspected Diovan HCT (Valsartan / Hydrochlorothiazide) Side Effects
Diabetes Mellitus (106),
Blood Pressure Increased (100),
Cerebrovascular Accident (74),
Blood Pressure Inadequately Controlled (50),
Dizziness (49), more >>
Page last updated: 2015-07-31