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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NEWS HIGHLIGHTS
Published Studies Related to Diovan (Valsartan)
Usefulness of beta blockers in high-risk patients after myocardial infarction in conjunction with captopril and/or valsartan (from the VALsartan In Acute Myocardial Infarction [VALIANT] trial). [2009.07.15]
Concern has been raised about combining beta blockers with angiotensin-receptor blockers in patients with heart failure. The VALsartan In Acute myocardial infarction (VALIANT) trial enrolled 14,703 patients with myocardial infarction complicated by heart failure or documented left ventricular systolic dysfunction...
Triple antihypertensive therapy with amlodipine, valsartan, and hydrochlorothiazide: a randomized clinical trial. [2009.07]
Many patients with hypertension require > or =3 agents to achieve target blood pressure (BP). The efficacy/safety of the dual combinations of valsartan (Val)/hydrochlorothiazide (HCTZ) and amlodipine (Aml)/Val in hypertension are well established... In conclusion, this study demonstrates the efficacy/safety of treating moderate and severe hypertension with Aml/Val/HCTZ 10/320/25 mg.
Efficacy and safety of initial combination therapy with amlodipine/valsartan compared with amlodipine monotherapy in black patients with stage 2 hypertension: the EX-STAND study. [2009.07]
The strategy of initiating hypertension treatment with combination versus single-drug therapy was formally tested in a prospective, double-blind, parallel-group trial in blacks with stage 2 hypertension (mean sitting systolic BP (MSSBP) >or=160 and <200 mm Hg)... In conclusion, the strategy of initiating combination antihypertensive drug therapy in blacks with stage 2 hypertension with amlodipine /valsartan achieves greater and quicker reductions in BP as well as significantly higher BP control rates than starting treatment with amlodipine monotherapy.
Combination therapy with various combinations of aliskiren, valsartan, and hydrochlorothiazide in hypertensive patients not adequately responsive to hydrochlorothiazide alone. [2009.06]
This study investigated the efficacy and safety of several different multi-drug regimens including aliskiren, valsartan, and hydrochlorothiazide (HCTZ) in patients not adequately responsive to HCTZ as monotherapy. After 4 weeks of HCTZ treatment, patients (N=641) whose diastolic blood pressure (DBP) was > or =95 mm Hg were treated for 8 weeks with either aliskiren/valsartan/HCTZ, aliskiren/HCTZ, valsartan/HCTZ, or HCTZ alone...
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.
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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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 5 ratings/reviews, Diovan has an overall score of 6.40. The effectiveness score is 8.40 and the side effect score is 6.80. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | 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 79 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | High BP |
| Dosage & duration: | | 360 (dosage frequency: daily) for the period of 3 days |
| Other conditions: | | ICD installed |
| Other drugs taken: | | Carvedilol, Warfarin, Levothyroxine, Pravastatin | | |
Reported Results |
| Benefits: | | After taking Altase, then Lisinopril, began Diovan, first 80 MG, then 160. The "ACE" cough disappeared with the 80 MG almost immediately. However morning surge BP continued. |
| Side effects: | | Three days after increasing dosage from 160MG to 320 MG experienced a sudden rash outburst along left rib cage and lower chest. |
| Comments: | | Sprayed rash with HC Derma-Pax and applied Hydrocortisone Cream afterward. Continued med and random daily BP reading to advise cardiologist if BP altered by increased dosage. If hives recur, will call Dr. and request lower dosage. |
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Page last updated: 2009-10-20
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