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Benicar (Olmesartan Medoxomil) - Summary

 
 



WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue Benicar as soon as possible [see Warnings and Precautions ]
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ]
 

BENICAR SUMMARY

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, 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 this drug principally belongs. There are no controlled trials demonstrating risk reduction with Benicar.

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 Program’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 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 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.

It may be used alone or in combination with other antihypertensive agents.


See all Benicar indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Benicar (Olmesartan)

ESC: Coffee, Naps, and Depression in Hypertension (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.29]
(MedPage Today) -- Observations support naps but suggest risk with espresso and depression

Medical News Today: Could hypertension during pregnancy signal elevated risk for siblings?
Source: Featured Health News from Medical News Today [2015.08.28]
The male siblings of women who have high blood pressure during pregnancy are at an increased risk of developing cardiovascular disease in later life, a new study finds.

Could hypertension during pregnancy signal elevated risk for siblings?
Source: Biology / Biochemistry News From Medical News Today [2015.08.28]
The male siblings of women who have high blood pressure during pregnancy are at an increased risk of developing cardiovascular disease in later life, a new study finds.

Common 'heart attack' blood test may predict future hypertension
Source: Hypertension News From Medical News Today [2015.08.27]
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressureAnalysis of blood samples from more than 5,000 people suggests that a more sensitive...

ICD-10: Coding for Hypertension and Heart Disease
Source: Medscape Business of Medicine Headlines [2015.08.25]
There are some important elements to be aware of when coding for hypertension, heart disease, and kidney disease in ICD-10.
Medscape Business of Medicine

more news >>

Published Studies Related to Benicar (Olmesartan)

Results from a 12 months, randomized, clinical trial comparing an olmesartan/amlodipine single pill combination to olmesartan and amlodipine monotherapies on blood pressure and inflammation. [2014]
profile, insulin sensitivity, and inflammation compared to singles monotherapies... CONCLUSION: Other than to be more effective in reducing blood pressure,

Olmesartan vs. ramipril in elderly hypertensive patients: review of data from two published randomized, double-blind studies. [2014]
Hypertension is a frequent condition among individuals over 65 years of age worldwide and is one of the most important risk factors for cardiovascular (CV) disease. Effective drug treatment of elderly hypertensives is usually associated with a marked reduction in CV morbidity and mortality...

Olmesartan/amlodipine combination versus olmesartan or amlodipine monotherapies on blood pressure and insulin resistance in a sample of hypertensive patients. [2013]
Despite the wide range of antihypertensive medications, about 45.5% of treated patients fail to achieve the desired blood pressure (BP) target...

A titrate-to-goal study of switching patients uncontrolled on antihypertensive monotherapy to fixed-dose combinations of amlodipine and olmesartan medoxomil +/- hydrochlorothiazide. [2011.06]
In the prospective, open-label, titrate-to-goal Blood Pressure Control in All Subgroups With Hypertension (BP-CRUSH) study, 999 patients with hypertension uncontrolled on monotherapy (mean age, 55.6 +/- 11.4 years; baseline blood pressure [BP], 153.7 +/- 9.2/91.9 +/- 8.6 mm Hg) were switched to fixed-dose amlodipine/olmesartan medoxomil (AML/OM) 5/20 mg...

Efficacy and safety of olmesartan medoxomil plus amlodipine in age, gender and hypertension severity defined subgroups of hypertensive patients. [2011.06]
Effective antihypertensive therapy is crucial for preventing cardiovascular events; however, blood pressure (BP) control rates remain poor. The objective of this analysis was to determine the efficacy of olmesartan/amlodipine in age, severity and gender-based subgroups of patients with moderate-to-severe hypertension uncontrolled by amlodipine monotherapy...

more studies >>

Clinical Trials Related to Benicar (Olmesartan)

Drug Interaction Study of Olmesartan in Healthy Chinese Volunteers [Completed]
Hypertension and hyperuricaemia are widespread conditions. There is significant overlap between the two conditions. Serum uric acid (SUA) is currently recognized as a risk factor for cardiovascular disease. Thus, at some point in their therapy, hypertensive patients with hyperuricaemia are likely to require concurrent treatment with anti-hypertensive and hypouricaemic agents. For this reason, it is important to determine whether there are any pharmacokinetic interactions resulting from the concomitant administration of such agents. Olmesartan is an angiotensin II receptor antagonist and effective and well tolerated in the treatment of arterial hypertension. Probenecid is a well-established hypouricaemic agent for the treatment of hyperuricaemia and gout. The goal of this study was to examine the impact of coadministration of probenecid on the pharmacokinetic parameters and tolerability of olmesartan in healthy volunteers.

Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis and Epicardial Adipose Tissue(EAT) [Recruiting]
The purpose of this study is to determine whether olmesartan medoxomil is effective in the treatment of coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume reduction in patients with coronary atherosclerosis detected by coronary CT angiography(CCTA).

Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure [Completed]
This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16 with high blood pressure. After a 5-week blinded treatment period of up to 5 weeks participants can continue to take olmesartan medoxomil (OM) for up to an additional 46 weeks.

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension [Completed]
This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension

Olmesartan Comparison to Losartan in Hypertensive Subjects [Completed]
This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.

more trials >>

Reports of Suspected Benicar (Olmesartan) Side Effects

Drug Ineffective (79)Weight Decreased (43)Blood Pressure Increased (38)Hypotension (36)Headache (29)Dizziness (28)Hypertension (23)Oedema Peripheral (22)Insomnia (21)Loss of Consciousness (20)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Benicar has an overall score of 9. The effectiveness score is 8 and the side effect score is 9.33. The scores are on ten point scale: 10 - best, 1 - worst.
 

Benicar review by 48 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Hypertension
Dosage & duration:   20mg taken once per day for the period of Ongoing
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   My BP is in a normal range when I take this medication. I only require a very low dose.
Side effects:   I had no side effects. This seems to be a highly effective medication that works at a low dose.
Comments:   I took the pill once per day with or with out food. No other treatment was prescribed.

 

Benicar review by 48 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   hypertension/high blood pressure
Dosage & duration:   20mg then 40mg taken once daily for the period of three years and still taking it
Other conditions:   anxiety disorder-obesity-sleep apnea
Other drugs taken:   ativan, lasix
  
Reported Results
Benefits:   lowers blood pressure and helps prevent strokes. Helps the patient to function without the tingling, headaches, and chest pain that comes from having blood pressure too high.
Side effects:   The only side effects I felt was a drained feeling when my blood pressure went down.
Comments:   I take one 40 mg Benicar in the evening because that is when my blood pressure comes up. If I wake up in the middle of the night and my blood pressure is up again from my sleep apnea, then I take another half. I have to drink a lot more water too, as this helps the Benicar to break down quicker.

 

Benicar review by 48 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   hypertension/high blood pressure
Dosage & duration:   20mg then 40mg taken once daily for the period of three years and still taking it
Other conditions:   anxiety disorder-obesity-sleep apnea
Other drugs taken:   ativan, lasix
  
Reported Results
Benefits:   lowers blood pressure and helps prevent strokes. Helps the patient to function without the tingling, headaches, and chest pain that comes from having blood pressure too high.
Side effects:   The only side effects I felt was a drained feeling when my blood pressure went down.
Comments:   I take one 40 mg Benicar in the evening because that is when my blood pressure comes up. If I wake up in the middle of the night and my blood pressure is up again from my sleep apnea, then I take another half. I have to drink a lot more water too, as this helps the Benicar to break down quicker.

See all Benicar reviews / ratings >>

Page last updated: 2015-08-29

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