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Diovan HCT (Valsartan / Hydrochlorothiazide) - Summary

 
 



WARNING: AVOID USE IN PREGNANCY

When pregnancy is detected, discontinue Diovan   HCT ® as soon as possible. Drugs that act directly on the renin - angiotensin system can cause injury and even death to the developing fetus . [ See Warnings and Precautions (5.1) ]

 

DIOVAN HCT SUMMARY

Diovan HCT® (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.

Diovan HCT® (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).
See all Diovan HCT indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Diovan HCT (Valsartan / Hydrochlorothiazide)

New Hypertension After 80 Linked to Lower Dementia Risk
Source: Medscape NeurologyHeadlines [2014.07.14]
New results from the 90+ Study show new hypertension after 80 years of age not only doesn't increase dementia risk but is actually associated with reduced risk.
Medscape Medical News

Treatment-resistant hypertension requires proper diagnosis
Source: Hypertension News From Medical News Today [2014.07.09]
High blood pressure - also known as hypertension - is widespread, but treatment often fails. One in five people with hypertension does not respond to therapy.

Hypertension, antihypertension medication and risk of psoriasis
Source: Hypertension News From Medical News Today [2014.07.04]
Women with long-term high blood pressure (hypertension) appear to be at an increased risk for the skin condition psoriasis, and long-term use of beta (β)-blocker medication to treat hypertension...

Risk of hypertension increased in pregnancies resulting from egg donation
Source: Fertility News From Medical News Today [2014.07.02]
With an ever-ageing female patient population, egg donation is an increasingly common treatment in infertility.

Genetic study suggests causal link between vitamin D deficiency and hypertension
Source: Hypertension News From Medical News Today [2014.06.27]
New genetic research provides compelling evidence that low levels of vitamin D have a causal role in the development of high blood pressure (hypertension).

more news >>

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...

more studies >>

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 breakthrough effect.

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.

more trials >>

Reports of Suspected Diovan HCT (Valsartan / Hydrochlorothiazide) Side Effects

Death (108)Diabetes Mellitus (106)Blood Pressure Increased (100)Malaise (84)Hypertension (77)Cerebrovascular Accident (74)Fall (71)Dyspnoea (66)Blood Pressure Inadequately Controlled (50)Dizziness (49)more >>


Page last updated: 2014-07-14

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