WARNING: FETAL TOXICITY
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When pregnancy is detected, discontinue Diovan as soon as possible. (5.1)
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Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
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DIOVAN SUMMARY
Diovan (valsartan) is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype.
Hypertension
Diovan® (valsartan) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Diovan.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education ProgramÂ’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Diovan may be used alone or in combination with other antihypertensive agents.
Heart Failure
Diovan is indicated for the treatment of heart failure (NYHA class II-IV). 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. [SeeÂ
Clinical Studies
]
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Post-Myocardial Infarction
In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality. [SeeÂ
Clinical Studies
(14.3
)
]
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NEWS HIGHLIGHTS
Published Studies Related to Diovan (Valsartan)
Indirect treatment comparison between fixed-dose-combinations of
amlodipine/losartan and amlodipine/valsartan in blood pressure control. [2014] compared amlodipine/losartan with other FDCs... CONCLUSIONS: The BP lowering effect with amlodipine/losartan and
Effect of valsartan on systemic right ventricular function: a double-blind,
randomized, placebo-controlled pilot trial. [2013] CONCLUSIONS: There was no significant treatment effect of valsartan on right
Effect of naproxen and acetaminophen on blood pressure lowering by ramipril,
valsartan and aliskiren in hypertensive patients. [2013] CONCLUSIONS: Both naproxen and acetaminophen can affect anti-hypertensive therapy
Effect of valsartan on systemic right ventricular function: a double-blind,
randomized, placebo-controlled pilot trial. [2013] CONCLUSIONS: There was no significant treatment effect of valsartan on right
Comparison of the effects of aliskiren/valsartan in combination versus valsartan
alone in patients with stage 2 hypertension. [2012] The extent to which the combination of a renin inhibitor with an angiotensin
receptor blocker (ARB) lowers clinic and ambulatory blood pressure (BP) versus an
ARB alone in stage 2 hypertension is not well known. Hence, we performed an
8-week, randomized, double-blind study in 451 patients with stage 2 hypertension
to compare the efficacy of the combination of aliskiren/valsartan 300/320 mg
versus valsartan 320 mg...
Clinical Trials Related to Diovan (Valsartan)
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]
Reports of Suspected Diovan (Valsartan) Side Effects
Blood Pressure Increased (164),
Cerebrovascular Accident (143),
Hypertension (140),
Death (139),
Malaise (111),
Dizziness (110),
Fall (103),
Diabetes Mellitus (101),
Dyspnoea (87),
Headache (74), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 8 ratings/reviews, Diovan has an overall score of 6.38. The effectiveness score is 8.25 and the side effect score is 6.50. 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 50 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Highly Effective |
Side effects: | | No Side Effects | | Treatment Info |
Condition / reason: | | high blood pressure |
Dosage & duration: | | 160 mg taken 1 per day for the period of 1 year |
Other conditions: | | high cholesterol |
Other drugs taken: | | crestor | | Reported Results |
Benefits: | | For over a period of several years my blood pressure has gone down and has stayed down. Follow up visits to the doctor have proven to be much better when blood pressure was checked. The doctor has recommended that I stay on this product and along with exercise should be highly effective. |
Side effects: | | The side effects of Diovan were so minimal I cannot detect them; however, I cannot take the Diovan HCT because it messes up my eletrolytes and I get leg and foot cramps. I try to follow dosage instructions which recommends that this pill be taken at night before going to bed, if possible. |
Comments: | | The treatment with Diovan is very simple. One pill at night before going to bed.The reason for that is most people's blood pressure increases at night and many people die in their sleep at night because of high blood pressure. The problem I have is that the pills get stuck in my throat and I have to eat something like a grape or anything really that will help the pill go down.It does not seem to keep me awake at night which is good. |
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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 66 year old male patient | | Rating |
Overall rating: | | |
Effectiveness: | | Moderately Effective |
Side effects: | | Extremely Severe Side Effects | | Treatment Info |
Condition / reason: | | High Blood pressure |
Dosage & duration: | | 80mg daily taken one tablet daily for the period of one month |
Other conditions: | | None |
Other drugs taken: | | None | | Reported Results |
Benefits: | | Marginally lowered my blood pressure. |
Side effects: | | After day three, I noticed a burning sensation with both feet. After week two, pain arrived in both feet, with swelling and joint pain. Stopped medication after week 3. Went to a neurologist for 2 hrs. of neurologic testing of my nerves. Peripheral neuropathy was the diagnosis. I have been fighting the pain and burning in my feet with no reversal for about a year now. |
Comments: | | I refused the drug treatments suggested by my neurologist. The potential side effects were just to much for my taste. As a Pharmacist, I've opted for 2 different treatments. One is a product called Solleve, which are vibrating insoles for your shoes. I have found some relief as well as reversal of my condition after 2 weeks of treatment. I also put myself on a daily specific vitamin regimen. I am also going to add a product called the ReBuilder to my therapy. |
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Page last updated: 2015-08-10
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