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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 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 patient’s 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.


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 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).


See all Diovan HCT indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Diovan HCT (Valsartan / Hydrochlorothiazide)

Medical News Today: Aircraft noise may cause hypertension and organ damage
Source: Featured Health News from Medical News Today [2016.06.18]
The negative health implications of exposure to aircraft sound are slowly being uncovered. Hypertension and organ damage are the latest to join the list.

Aircraft noise may cause hypertension and organ damage
Source: Cardiovascular / Cardiology News From Medical News Today [2016.06.18]
The negative health implications of exposure to aircraft sound are slowly being uncovered. Hypertension and organ damage are the latest to join the list.

Hepatitis C: Once the viral infection has healed, high-risk portal vein hypertension also diminishes
Source: Hypertension News From Medical News Today [2016.06.16]
This inflammatory viral infection of the liver causes inflexible scar tissue to form. This in turn impedes blood flow through the organ, with resulting hypertension in the portal vein.

European Society of Hypertension (ESH) 2016 Annual Meeting
Source: theheart.org | Medscape Cardiology Headlines [2016.06.13]
Read clinically focused news coverage of key developments from ESH 2016.
theheart.org on Medscape

Study finds wide geographic differences in treatment of diabetes, hypertension, depression
Source: Depression News From Medical News Today [2016.06.07]
An international observational study led by Columbia University researchers has uncovered widespread differences in the treatment of patients with common chronic diseases, including type 2...

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)

ADDM Study - Amtrel and Co-Diovan in Type 2 Diabetes Mellitus Hypertension Patients With Microalbuminuria [Completed]
The purpose of the study is to compare the change from baseline in blood pressures (DBP/SBP) to 16-week regimen between Amtrel and Co-Diovan. The secondary objectives were listed as the following.

- To compare the response rate (defined as SBP < 130 mmHg and DBP < 80 mmHg) at the end

of study

- To evaluate the change from baseline in albumin-to-creatinine ratio with

antihypertensive medications in whole group (combined treatment groups) and each treatment group (Amtrel, Co-Diovan) at Week 16

- The change from baseline in glycosylated hemoglobin (HbA1c) at Week 16

- The change from baseline in fasting plasma glucose (FPG) at Week 16

- The change from baseline in fasting lipid profiles (triglyceride, total cholesterol,

high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) at Week 16

- The change from baseline in arteriosclerosis marker (brachial-ankle pulse-wave velocity

(ba-PWV) and ankle-brachial pressure index (ABI), using Colin-VP1000) at Week 16

- The change from baseline on the body mass index (BMI) and waist-hip ratio (WHR) at each

specified study time point

- To ascertain the safety and tolerability of Amtrel® versus Co-Diovan® including AE/SAE,

and laboratory examinations

Valsartan for Attenuating Disease Evolution In Early Sarcomeric HCM [Recruiting]
The purpose of this trial is to determine whether treatment with valsartan will have beneficial effect in early hypertrophic cardiomyopathy (HCM) by assessing many domains that reflect myocardial structure, function and biochemistry.

To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone [Completed]
The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood pressure in Taiwanese patients.

Efficacy/Safety Study of Valsartan and Chlorthalidone Conjugate Treatment Compared to Simple Treatment for Hypertension [Recruiting]
This trial is aimed to assess the efficacy and safety of a fixed-dose combination therapy with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone alone for treatment of adult patients with diagnosis of arterial hypertension.

Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers [Completed]

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: 2016-06-18

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