Diovan (Valsartan) - Summary

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)

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...

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.

Valsartan-induced improvement in insulin sensitivity is not paralleled by changes in microvascular function in individuals with impaired glucose metabolism. [2011.10]
BACKGROUND: Individuals with impaired glucose metabolism (IGM) are at high risk of developing type 2 diabetes (T2DM). The renin-angiotensin system (RAS) is activated in insulin-resistant states and its inhibition resulted in delayed onset of T2DM. The underlying mechanisms may include improvement in microvascular structure and function, which may increase glucose and insulin delivery to insulin-sensitive tissues. We hypothesized that functional and structural capillary density is impaired in insulin-resistant individuals with IGM and that treatment with the angiotensin-receptor blocker valsartan (VAL) will improve insulin sensitivity and microvascular function... CONCLUSION: In insulin-resistant individuals with IGM, impaired functional and structural capillary density was inversely associated with insulin sensitivity. VAL improved insulin sensitivity without affecting the functional and structural capillary density, indicating that other mechanisms may be stronger determinants in the VAL-mediated insulin-sensitizing effect.

Initial combination therapy with amlodipine/valsartan compared with monotherapy in the treatment of hypertension. [2011.09]
Achieving target blood pressure (BP) is influenced by baseline BP. Post hoc analyses of a placebo-controlled trial of amlodipine/valsartan versus monotherapies were conducted to characterize BP control by baseline BP...

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Clinical Trials Related to Diovan (Valsartan)

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.

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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 >>

PATIENT REVIEWS / RATINGS / COMMENTS

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.

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

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.