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Benicar (Olmesartan Medoxomil) - Summary

 



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, BENICAR HCT® should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

 

BENICAR SUMMARY

BENICAR® (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.

BENICAR® is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Benicar (Olmesartan)

New Consortium Paves The Way For Improved Treatment Of Hypertension And Associated Vascular Complications
Source: Hypertension News From Medical News Today [2009.11.18]
Top Institute Pharma (TI Pharma) has formed a consortium with Actelion Pharmaceuticals Ltd, Erasmus Medical Centre and Maastricht University to define new modalities for the treatment of hypertension (high blood pressure) and associated vascular complications such as heart and kidney failure, myocardial infarction and stroke.

Kids with CKD Often Have Masked Hypertension (CME/CE)
Source: MedPage Today Nephrology [2009.11.13]
Many children with chronic kidney disease may have undetected hypertension, placing them at risk for enlarged hearts and future cardiovascular disease, a cross-sectional study showed.

Key Player Identified In Cascade That Leads To Hypertension-Related Kidney Damage
Source: Hypertension News From Medical News Today [2009.11.06]
A key player in a cascade that likely begins with stress and leads to high blood pressure and kidney damage has been identified by researchers who say the finding may lead to better ways to control both. Medical College of Georgia researchers have found endothelin, a powerful blood vessel constrictor and inflammatory peptide, increases the number of T cells in the kidneys, which helps recruit other immune cells, causing inflammation and destruction.

A Recipe For Hypertension: High Fructose Corn Syrup
Source: Hypertension News From Medical News Today [2009.10.31]
A diet high in fructose increases the risk of developing high blood pressure (hypertension), according to a paper presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition in San Diego, California. The findings suggest that cutting back on processed foods and beverages that contain high fructose corn syrup (HFCS) may help prevent hypertension.

Hypertension Guidelines Reappraised In Light Of New Research
Source: Hypertension News From Medical News Today [2009.10.30]
A Task Force of the European Society of Hypertension have released the official European guidelines on the management and treatment of hypertension. The guidelines are an update of those published in 2007, and will be published in the November issue of the Journal of Hypertension.

more news >>

Published Studies Related to Benicar (Olmesartan)

Comparison of olmesartan medoxomil versus amlodipine besylate on regression of ventricular and vascular hypertrophy. [2009.08.01]
Reversal of left ventricular (LV) hypertrophy is an important goal of antihypertensive therapy. This phase 3b study compared the ability of the angiotensin receptor blocker olmesartan medoxomil with the calcium channel blocker amlodipine besylate to induce regression of LV hypertrophy and vascular hypertrophy after achieving blood pressure (BP) goal...

Rationale, design and patient baseline characteristics of OlmeSartan and calcium antagonists randomized (OSCAR) study: a study comparing the incidence of cardiovascular events between high-dose angiotensin II receptor blocker (ARB) monotherapy and combination therapy of ARB with calcium channel blocker in Japanese elderly high-risk hypertensive patients (ClinicalTrials. gov no. NCT00134160). [2009.07]
Higher doses of angiotensin II receptor blockers (ARBs) are expected to exert more protective effects against cardiovascular diseases. However, the significance of treatment of hypertension with high-dose ARB remains to be defined... The OSCAR study is the first large clinical trial comparing the efficacy of high-dose ARB monotherapy with that of an ARB plus CCB combination therapy in elderly high-risk hypertensive patients.

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...

Pharmacokinetics of olmesartan medoxomil in hemodialysis patients: little effect of dialysis upon its pharmacokinetics. [2009.02]
Olmesartan medoxomil is a new angiotensin-2 receptor blocker (ARB)...

Antihypertensive efficacy of olmesartan medoxomil or valsartan in combination with amlodipine: a review of factorial-design studies. [2009.01]
BACKGROUND: Most patients with hypertension require more than one drug to attain recommended blood pressure (BP) targets. Initiating therapy with two agents is recommended for patients at high risk of a cardiovascular event or with a BP > 20/10 mmHg above goal. Combination therapy is effective when comprised of agents with complementary mechanisms of action, such as calcium channel blockers (CCBs) and angiotensin II-receptor blockers (ARBs). Two fixed-dose CCB/ARB combinations are approved in the US: amlodipine/valsartan (AML/VAL) and amlodipine/olmesartan medoxomil (AML/OM). OBJECTIVES: To review and describe the efficacy of AML/VAL and AML/OM combinations by discussing similarly designed clinical trials... CONCLUSIONS: This review of published factorial-design studies showed that the maximal marketed doses of an amlodipine/olmesartan medoxomil combination (10/40 mg) and an amlodipine/valsartan combination (10/320 mg) produced large reductions in BP from baseline. Limitations of this review include the small number of studies analyzed and the inherent heterogeneity between patient populations. Further research is warranted to directly compare the efficacy of these combinations in a randomized, controlled trial, or additional published clinical trials are required to provide larger data sets for robust meta-analyses and to overcome heterogeneity observed within these studies.

more studies >>

Clinical Trials Related to Benicar (Olmesartan)

Olmesartan in Essential Hypertension [Completed]
To test the efficacy and safety of olmesartan in patients with essential hypertension.

An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension [Completed]
Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension

Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions.

Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions.

Olmesartan and an Add-on Treatment in Patients With Mild to Moderate Hypertension [Completed]
This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension.

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Benicar has an overall score of 9. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

Benicar review by 58 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   high blood pressure
Dosage & duration:   40 mg taken once a day for the period of still taking it
Other conditions:   none
Other drugs taken:   furosemide, atenolol
  
Reported Results
Benefits:   The treatment benefits are to help lower blood pressure. Blood pressure is being monitored by the physician and the patient. So far, the benicar has shown to be as beneficial as the previous medicine patient has been on for the last seven years. Since the pill is considerably larger than previous medicine I was on, I do have to chew the pill.
Side effects:   I have not noticed any side effects so far. I have been taking the medicine about one month. I plan to visit the doctor in eight weeks again at which time I am sure the doctor will check my blood for any changes that may have occurred. But so far, nothing has been noticed.
Comments:   I have been on blood pressure medication for about seven years now. Each doctor that I went to has changed my medication several times. My blood pressure has been lower since visiting a nephrologist. Recently I went to a regular general practitioner and she changed my medicine once again to the Benicar. It seems to be helping somewhat with very few, if any, sign effects.

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Page last updated: 2009-11-18

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