USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin -angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Diovan should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.
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DIOVAN SUMMARY
Diovan®
Diovan® (valsartan) is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype.
Diovan® (valsartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Diovan is indicated for the treatment of heart failure (NYHA class II-IV) in patients who are intolerant of angiotensin converting enzyme inhibitors. In a controlled clinical trial, Diovan significantly reduced hospitalizations for heart failure. There is no evidence that Diovan provides added benefits when it is used with an adequate dose of an ACE inhibitor.
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DIOVAN NEWS HIGHLIGHTS Media Articles Related to Diovan (Valsartan)
New Data Confirm That Diovan(R) And Valsartan-Based Combinations Offer Patients Sustained, 24-hr BP-lowering Efficacy
Source: Hypertension News From Medical News Today [2009.06.15]
Data presented at the 19th Scientific Meeting of the European Society of Hypertension (ESH) confirm that Diovan® (valsartan) and valsartan-based combinations deliver sustained, 24-hr blood pressure (BP)-lowering efficacy2-6. Studies have suggested that the relative risks of acute myocardial infarction, stroke and sudden cardiac death are 40%, 49% and 29% higher, respectively, when the period between 6 a.m. and noon is compared to the rest of the day1.
Published Studies Related to Diovan (Valsartan)
Efficacy and safety of the single pill combination of amlodipine 10 mg plus valsartan 160 mg in hypertensive patients not controlled by amlodipine 10 mg plus olmesartan 20 mg in free combination. [2009.02]
ABSTRACT Background and objective: For patients with moderate hypertension (grade 2, defined as systolic blood pressure [SBP] 160-179 mmHg and/or diastolic blood pressure [DBP] 100-109 mmHg), current guidelines recommend initial combination therapy and rapid dose-adjustment to achieve blood pressure goal...
Combination antihypertensive therapy with valsartan and hydrochlorothiazide in Chinese patients with mild-to-moderate hypertension. [2008.10]
CONCLUSION: In Chinese patients with mild-to-moderate essential hypertension not adequately controlled by VAL 80 mg alone, VAL80/HCTZ12.5 mg combination was well tolerated and showed additional BP reduction. The limitations of this study were the inability to include an HCTZ arm as a control group and the short trial duration.
Prevention of diabetes and cardiovascular disease in patients with impaired glucose tolerance: rationale and design of the Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Trial. [2008.10]
Patients with impaired glucose tolerance (IGT) have increased risk for developing type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). Lifestyle modification and medication can prevent or delay progression to diabetes (PD), but whether such interventions also reduce the risk of CVD has not been rigorously tested... The study was designed to evaluate whether reducing postprandial hyperglycemia, blockade of the renin-angiotensin-aldosterone system, or both interventions reduce the risk of T2DM or cardiovascular events in patients with IGT.
Prognostic value of changes in N-terminal pro-brain natriuretic peptide in Val-HeFT (Valsartan Heart Failure Trial). [2008.09.16]
OBJECTIVES: This study sought to evaluate the association between changes over time of N-terminal pro-brain natriuretic peptide (NT-proBNP) expressed in different ways and outcome in patients with stable and chronic heart failure (HF). BACKGROUND: Although previous studies examined the prognostic value of repeated determinations of BNP in HF, there are only limited data on the clinical utility of serial measurements of the inactive peptide NT-proBNP in a large population of ambulatory patients with chronic HF with sufficient follow-up time... CONCLUSIONS: Serial determinations of NT-proBNP concentration and classification into few categories of changes according to threshold levels may be a superior strategy for risk stratification of patients with chronic and stable HF.
Valsartan in combination with lisinopril versus the respective high dose monotherapies in hypertensive patients with microalbuminuria: the VALERIA trial. [2008.09]
OBJECTIVES: Microalbuminuria is known as an independent predictor for stroke, myocardial infarction, and death. The purpose of the VALERIA trial was a comparison of the efficacy and safety of combination therapy of valsartan [generic for Diovan] and lisinopril with valsartan and lisinopril high-dose monotherapy in patients with hypertension and microalbuminuria... CONCLUSION: The combination of valsartan and lisinopril provided a significantly better reduction of urine albumin creatinine ratio and more than doubled the rate of patients with normalized urine albumin creatinine ratio compared with lisinopril alone. All treatments were safe and well tolerated.
Clinical Trials Related to Diovan (Valsartan)
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.
A Study in Chinese Mild to Moderate Hypertensive Patients Comparing the Efficacy of Co-Diovan With Diovan. [Completed]
Valsartan, an orally active angiotensin II receptor blocker, is registered in most countries
worldwide for the treatment of hypertension. In China the usual recommended starting and
maintenance dose is 80 mg o. d. The combination of HCTZ 12. 5 mg with valsartan 80 mg has been
shown to have additive effects in lowering blood pressure compared to valsartan 80 mg in
patients not adequately controlled by valsartan 80 mg monotherapy5 or in non-selected
patients6. This fixed combination is registered in most countries worldwide.
The potential benefits of these combinations should be evaluated in patients not adequately
controlled by valsartan 80 mg monotherapy. This study will compare the efficacy, safety and
tolerability of adding HCTZ 12. 5 mg to valsartan 80 mg in those hypertensive patients.
This study is not recruiting in the US.
To Compare the Blood Level of Marketed Japanese Valsartan Tablet Formulation vs Global Valsartan Tablet Formulation in Healthy Volunteers [Completed]
The purpose of this study is to assess how the body changes the blood level of single dose of
valsartan 160 mg tablet Japanese formulation and valsartan 160 mg tablet global formulation
under fasting condition in healthy volunteers.
8-Week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension [Completed]
The purpose of this study is to determine the safety and efficacy of the various combinations
of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.
Bioavailability of Aliskiren and Valsartan Combined as a Single Tablet vs. the Same Medications Given Separately to Healthy Subjects. [Completed]
This study will assess the bioavailability of aliskiren and valsartan as a single tablet
compared to the same doses of the two drugs given as two separate tablets in healthy
subjects.
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DIOVAN PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Diovan has an overall score of 7.33. The effectiveness score is 8.67 and the side effect score is 7.33. The scores are on ten point scale: 10 - best, 1 - worst.
| | Diovan review by 38 year old male patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | high blood pressure |
| Dosage & duration: | | 80mg taken daily for the period of 5 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Some of the treatment benefits were: lower blood pressure, less headaches, less fatigue |
| Side effects: | | The first few weeks of treatment, I felt a little dizzy. After that phase, there were no treatment side effects. |
| Comments: | | The doctor asked me to take 80mg daily. He also asked me to lower my salt intake and exercise regularly. |
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| | Diovan review by 78 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | hypertension |
| Dosage & duration: | | 320 mg taken once/day for the period of 1 month |
| Other conditions: | | none |
| Other drugs taken: | | aspirin | | |
Reported Results |
| Benefits: | | lower blood pressure |
| Side effects: | | hives |
| Comments: | | qd |
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| | Diovan review by 78 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | hypertension |
| Dosage & duration: | | 320 mg taken once/day for the period of 1 month |
| Other conditions: | | none |
| Other drugs taken: | | aspirin | | |
Reported Results |
| Benefits: | | lower blood pressure |
| Side effects: | | hives |
| Comments: | | qd |
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Page last updated: 2009-06-15
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