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Cozaar (Losartan Potassium) - 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, COZAAR should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

 

COZAAR SUMMARY

What is the most important information I should know about COZAAR?

COZAAR (losartan potassium) is an angiotensin II receptor (type AT1) antagonist.

COZAAR is indicated for the following:

Hypertension

COZAAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.

Hypertensive Patients with Left Ventricular Hypertrophy

COZAAR is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See PRECAUTIONS, Race and CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race.)

Nephropathy in Type 2 Diabetic Patients

COZAAR is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio >/=300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, COZAAR reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects).


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NEWS HIGHLIGHTS

Media Articles Related to Cozaar (Losartan)

Heart Failure Drug May Help More in Higher Doses (HealthDay)
Source: Y! Health Heart & Vascular Health News [2009.11.18]
HealthDay - TUESDAY, Nov. 17 (HealthDay News) -- For people with heart failure, high doses of the drug losartan, an angiotensin-receptor blocker (ARB), reduce the risk for hospital admission and death, a new study shows.

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Published Studies Related to Cozaar (Losartan)

Renal and retinal effects of enalapril and losartan in type 1 diabetes. [2009.07.02]
BACKGROUND: Nephropathy and retinopathy remain important complications of type 1 diabetes. It is unclear whether their progression is slowed by early administration of drugs that block the renin-angiotensin system... CONCLUSIONS: Early blockade of the renin-angiotensin system in patients with type 1 diabetes did not slow nephropathy progression but slowed the progression of retinopathy. (ClinicalTrials.gov number, NCT00143949.) 2009 Massachusetts Medical Society

A randomized, comparative study evaluating the efficacy and tolerability of losartan-low dose chlorthalidone (6.25 mg) combination with losartan-hydrochlorothiazide (12.5 mg) combination in Indian patients with mild-to-moderate essential hypertension. [2009.07]
OBJECTIVE: The relationship of blood pressure (BP) to cardiovascular risk is linear, positive, and continuous. Lowering elevated BP reduces the risk of cardiovascular events. The primary objective of this randomized, multicenter, comparative, 3-month, open-label study was to evaluate the antihypertensive efficacy of losartan/chlorthalidone versus losartan/hydrochlorothiazide in mild-to-moderate essential hypertension... CONCLUSIONS: The losartan/low-dose chlorthalidone (6.25 mg) combination is as effective as the widely used losartan/hydrochlorothiazide combination in lowering BP and is well tolerated, thus providing a useful therapeutic option for treating mild-to-moderate hypertension.

Beneficial effects of high-dose losartan in IgA nephritis. [2009.06]
CONCLUSION: Data from this study suggest that high-dose ARB therapy is more efficacious in reducing proteinuria and preserving renal function when compared with normal dose ARB and ACEI. In Year 5, patients on high-dose ARB had a gain in eGFR suggesting that there is possibility of recovery of renal function in these patients on long-term high-dose therapy.

Effect of silymarin on the pharmacokinetics of losartan and its active metabolite E-3174 in healthy Chinese volunteers. [2009.06]
PURPOSE: To investigate the effects of silymarin on the pharmacokinetics of losartan and its active metabolite E-3174 and its relationship with CYP2C9 genotypes... CONCLUSION: Silymarin inhibits the metabolism of losartan to E-3174, with the magnitude of the interaction differing in individuals with different CYP2C9 genotypes.

Adiponectin is positively associated with insulin resistance in subjects with type 2 diabetic nephropathy and effects of angiotensin II type 1 receptor blocker losartan. [2009.06]
BACKGROUND: Plasma adiponectin concentration is inversely associated with renal function. There is little literature on adiponectin levels and regulation by anti-hypertensive medication with an angiotensin II type 1 receptor blocker (ARB), especially in subjects with type 2 diabetes in different stages of chronic kidney disease (CKD)... CONCLUSION: Our results demonstrate that serum adiponectin levels in type 2 diabetic nephropathy are strongly positively associated with fasting insulin levels and insulin resistance. Declines in fasting insulin and HOMA-IR by losartan are accompanied by decreased adiponectin levels, might offer potential protection in humans. The paradoxical phenomenon merits further ascertainment in future studies.

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Clinical Trials Related to Cozaar (Losartan)

Losartan Therapy in Pulmonary Hypertension [Completed]
In addition to being effective vasodilators, angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) exert neurohumoral inhibitory actions, such as the inhibition of vascular remodeling and smooth muscle cell proliferation and the amelioration of endothelial dysfunction. These beneficial effects, render those agents appropriate for use in the treatment of pulmonary hypertension. However, data regarding the use of ACEIs or ARBs in the treatment of PHT are limited. In this study, efficacy of an ARB, losartan was compared with those of the calcium channel blocker, nifedipine in the treatment of pulmonary hypertension using echocardiographic, 6-minute walk test (6MWT), cardiopulmonary exercise test, and endothelin-1 levels. Losartan is as effective as nifedipine for reducing Doppler echocardiographically measured PAP and improving exercise capacity on 6MWT and CPET. However the short-term use of losartan or nifedipine had no statistically significant effect on endothelin-1 levels in patients with PHT.

An Open Label Study to Assess the Efficacy, Safety and Tolerability of COZAAR Plus (Losartan Potassium 50mg/Hydrochlorothiazide 12.5mg) Possibly Titrated up to COZAAR Plus-F (Losartan Potassium 100mg/Hydrochlorothiazide 25mg) in Patients With Essential Hypertension [Terminated]
Evaluate blood pressure after 6 weeks of treatment with COZAAR plus.

A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension [Terminated]
The purpose of this study is to test the safety and effectiveness of Losartan as compared to Losartan/HCTZ in pediatric patients (6 to 17 years) with high blood pressure.

A Prospective, Randomised, Double-Blind, Double-Dummy, Forced-Titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study) [Completed]
A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The purpose of this research study is to determine if after one year of treatment telmisartan (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg, another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR) 100 mg in reducing the level of urinary protein (indicative of improved kidney function).

Study to Evaluate the Effectiveness of Diet Management With a Losartan Titration Regimen Versus Losartan Titration Regimen Alone on Blood Pressure Reduction in Hypertensives [Recruiting]
To evaluate the effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Cozaar has an overall score of 9.50. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

Cozaar review by 56 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   high blood pressure
Dosage & duration:   50 mg taken one time a day for the period of over 9 years
Other conditions:   Crohn's disease
Other drugs taken:   Boniva
  
Reported Results
Benefits:   Within a few weeks of starting, my pressure was under control and has remained that way for over 5 years.
Side effects:   I had no side effects that I noticed.
Comments:   I was diagnosed with high blood pressure (145/90) over 10 years ago, a few years after experiencing early menopause. Severe headaches were also commmon. First treatment: dietary changes and increasing daily exercise--not adequate; in fact, it increased. I was prescribed Cozaar, 50 mg/day, with the reminder that the first dosage tried was rarely the correct one. In my case, it was and I get checked now every 6 months. My blood pressure stays around 118/70 range.

 

Cozaar review by 56 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   blood pressure
Dosage & duration:   100 mg daily taken daily for the period of 5 years
Other conditions:   hypothyroid
Other drugs taken:   atenolol, furosimide, procrit, hectorol, ferrous sulfate, sodium polystyrene sulfonte, ecotrin, leoy
  
Reported Results
Benefits:   Lower blood pressure
Side effects:   None
Comments:   Cozaar, an angeotensin receptor blocker, lowered my blood pressure without side effects.

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Page last updated: 2009-11-18

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