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Avapro (Irbesartan) - Summary

 

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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, AVAPRO should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

 

AVAPRO SUMMARY

AVAPRO (irbesartan) is an angiotensin II receptor (AT1 subtype) antagonist.

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, AVAPRO should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

INDICATIONS AND USAGE

AVAPRO (irbesartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

AVAPRO is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, AVAPRO 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: Clinical Studies).

AVAPRO NEWS HIGHLIGHTS

Published Studies Related to Avapro (Irbesartan)

Irbesartan plus low-dose propranolol versus low-dose propranolol alone in cirrhosis: a placebo-controlled, double-blind study. [2008.05]

Risks and benefits of oral anticoagulation compared with clopidogrel plus aspirin in patients with atrial fibrillation according to stroke risk: the atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events (ACTIVE-W). [2008.05]

The Hong Kong diastolic heart failure study: a randomised controlled trial of diuretics, irbesartan and ramipril on quality of life, exercise capacity, left ventricular global and regional function in heart failure with a normal ejection fraction. [2008.05]

Comparison of angiotensin-converting enzyme inhibitor alone and in combination with irbesartan for the treatment of heart failure. [2008.03.28]

Rationale for and Design of the CREATIVE-AF Trial : Randomized, Double-Blind, Placebo-Controlled, Crossover Study of the Effect of Irbesartan on Oxidative Stress and Adhesion Molecules in Patients with Persistent Atrial Fibrillation. [2008]

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Clinical Trials Related to Avapro (Irbesartan)

Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension [Completed]

Evaluation of Efficacy and Safety of the Dosage Adjustment of AprovelŪ (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice [Completed]

Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF) [Completed]

Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing [Active, not recruiting]

Irbesartan in Hypertension [Completed]

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Page last updated: 2008-08-10

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