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.
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COZAAR SUMMARY
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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COZAAR NEWS HIGHLIGHTS
Published Studies Related to Cozaar (Losartan)
Prognostic importance of hemoglobin in hypertensive patients with electrocardiographic left ventricular hypertrophy: the Losartan Intervention For End point reduction in hypertension (LIFE) study. [2009.01]
BACKGROUND: The prognostic importance of hemoglobin is controversial. We investigated the prognostic importance of baseline and in-treatment hemoglobin in the LIFE study... CONCLUSIONS: After adjusting for other risk factors, relatively low, but not high, hemoglobin during antihypertensive treatment was associated with higher incidence of all-cause mortality and the composite end point.
Effect of pentoxifylline in addition to losartan on proteinuria and GFR in CKD: a 12-month randomized trial. [2008.09]
BACKGROUND: Pentoxifylline potently inhibits cell proliferation, inflammation, and extracellular matrix accumulation. Human studies have proved its antiproteinuric effect in patients with glomerular diseases. Its benefit in addition to angiotensin receptor blockade in patients with chronic kidney disease is not clear... CONCLUSIONS: Pentoxifylline added to losartan [generic for Cozaar] therapy for 1 year decreased proteinuria in patients with CKD stages 3 to 5. A large-scale clinical trial is necessary to confirm this result.
Low-dose losartan therapy reduces proteinuria in normotensive patients with immunoglobulin A nephropathy. [2008.09]
The present study was designed to assess the antiproteinuric effects of a low dose of an angiotensin II-receptor blocker, losartan [generic for Cozaar], in normotensive patients with immunoglobulin A (IgA) nephropathy.Our data suggest that low-dose losartan therapy for normotensive patients with IgA nephropathy could reduce the amount of urinary protein and NAG excretion without affecting systemic blood pressure.
Design of the heart failure endpoint evaluation of AII-antagonist losartan (HEAAL) study in patients intolerant to ACE-inhibitor. [2008.09]
CONCLUSIONS: The results of HEAAL should facilitate selection of an optimal dosing regimen for losartan [generic for Cozaar] in patients with symptomatic heart failure who are intolerant of ACE-inhibitors.
Telmisartan is more effective than losartan in reducing proteinuria in patients with diabetic nephropathy. [2008.08]
In patients with diabetic nephropathy, lowering blood pressure and reducing proteinuria by over 30% correlates with a slower progression to kidney failure. We compared two different angiotensin receptor-blockers in a double blind, prospective trial of 860 patients with type 2 diabetes whose blood pressure levels was over 130/80 mmHg or who were receiving antihypertensive medication(s) and who had a morning spot urinary protein to creatinine ratio of 700 or more...
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 of Losartan in Pediatric Patients With Hypertension [Not yet recruiting]
This study will explore the dose-response of losartan as well as the safety and tolerability
in children 6 months to 6 years.
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COZAAR PATIENT REVIEWS / RATINGS / COMMENTSBased 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. |
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| | 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: 2009-02-07
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