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Avapro (Irbesartan) - 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, 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).
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NEWS HIGHLIGHTS

Published Studies Related to Avapro (Irbesartan)

Irbesartan improves arterial compliance more than lisinopril. [2009]
BACKGROUND: Antihypertensive agents can reduce arterial stiffness. We hypothesized that an angiotensin receptor blocker (ARB) irbesartan and an angiotensin converting enzyme inhibitor (ACEI) lisinopril improved arterial compliance... CONCLUSIONS: Irbesartan improved arterial compliance in elastic and muscular arteries, whereas lisinopril improved it only in elastic arteries.

Irbesartan in patients with heart failure and preserved ejection fraction. [2008.12.04]
BACKGROUND: Approximately 50% of patients with heart failure have a left ventricular ejection fraction of at least 45%, but no therapies have been shown to improve the outcome of these patients. Therefore, we studied the effects of irbesartan in patients with this syndrome... CONCLUSIONS: Irbesartan did not improve the outcomes of patients with heart failure and a preserved left ventricular ejection fraction. (ClinicalTrials.gov number, NCT00095238.) 2008 Massachusetts Medical Society

A Randomized Trial of the Effect of an Angiotensin II Receptor Blocker SR47436 (Irbesartan) on 24-Hour Blood Pressure in Patients with Essential Hypertension. [2008.09]
The aim of this placebo-controlled, double-blind randomized study was to evaluate the duration of the effect of once-daily administration of irbesartan in patients with essential hypertension. After a placebo run-in baseline period (of 2-4 weeks), 79 patients were randomized to either irbesartan (one 100 mg tablet per day) or placebo, for 6 weeks.

The relationship between the plasma concentration of irbesartan and the antihypertensive response is disclosed by an angiotensin II type 1 receptor polymorphism: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation vs. Atenolol (SILVHIA) Trial. [2008.07]
BACKGROUND: The aim of this study was to investigate the effect of the plasma concentration of irbesartan, a specific angiotensin II type 1 receptor (AT1R) antagonist, and the blood pressure response in relation to AT1R gene polymorphisms... CONCLUSIONS: There was an association between plasma concentrations of irbesartan and the blood pressure response for hypertensive patients with AT1R 5245 TT. Because of the small sample size, this study needs to be viewed as hypothesis generating. This is the first study, to our knowledge, indicating that the concentration-response relationship of an antihypertensive drug may be genotype dependent.

Irbesartan plus low-dose propranolol versus low-dose propranolol alone in cirrhosis: a placebo-controlled, double-blind study. [2008.05]
OBJECTIVES: Angiotensin II receptor antagonists have been shown to moderately lower portal pressure in some patients with cirrhosis but may have adverse effects on kidney function. This study aimed at comparing the effects of a combined treatment using irbesartan plus propranolol with propranolol monotherapy on portal pressure and kidney function in patients with cirrhosis... CONCLUSIONS: Combination treatment of propranolol plus irbesartan is well tolerated in cirrhotic patients when titrating the angiotensin II antagonist in a step-up manner, and it increases sodium excretion in patients with compensated or moderately decompensated cirrhosis. Addition of irbesartan has no effect on portal pressure.

more studies >>

Clinical Trials Related to Avapro (Irbesartan)

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

- To demonstrate the reduction in office Blood Pressure following a 8-week regimen of

irbesartan / hydrochlorothiazide using irbesartan as a reference.

- To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan

/ hydrochlorothiazide using irbesartan as a reference.

- To compare the response rate (defined as office Systolic Blood Pressure/Diastolic Blood

Pressure reduce more than 10mmHg from Week 0) of patients after 4-week and 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan.

- To compare the proportion of patients requiring titration after 4-week regimen of

irbesartan/hydrochlorothiazide versus irbesartan

- To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus

irbesartan when administered once daily

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

- To evaluate the efficacy of two regimens of irbesartan in patients responding but not

normalized at 6 weeks of treatment (schema N°1: maintenance 150 mg/day, schema n°2: 300 mg/day for 6 more weeks)

Secondary:

- To evaluate the percentage of patients with DBP < 90 mmHg at 6 and 12 weeks

- To evaluate the percentage of patients with SBP < 140 mmHg at 6 and 12 weeks

- To evaluate rate of adverse events during the study

Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF) [Completed]
The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo.

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

1. To compare the change in forearm vascular resistance following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan

2. To assess changes of serum proinflammatory cytokine, markers of cardiovascular risks, oxidative stress and circulating adhesion molecule including thiobarbiturate acid reactive substances (TBARS), C-reactive protein (CRP), interleukin 6 (IL-6), and vascular cell adhesion molecule 1 (VCAM-1).

Secondary:

1. To compare the reduction in office blood pressure following a 12-week regimen of irbesartan/hydrochlorothiazide versus irbesartan

2. To compare the response rate (defined as office Systolic blood pressure(SBP)/diastolic blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined as SBP<140 mmHg and /or DBP<90 mmHg)

3. To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily

4. To determine whether angiotensin II type 1 (AT-1) receptor gene polymorphisms (including A1166C gene with about 4% of the minor allele frequency in Chinese population and other single nucleotide polymorphisms with a higher frequency of about 10% of minor allele) is related to reduction of BP

Irbesartan in Hypertension [Completed]
Study objectives:

- To demonstrate the effect of irbesartan on the regulation of diastolic blood pressure,

in case of missing one dose after a period of administration for 6 to 8 weeks

- To evaluate the safety of irbesartan

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

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

Avapro review by 58 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   hypertension
Dosage & duration:   150mg taken once daily for the period of ongoing - has been one year
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Since I've started the treatment, my tension has stabilized. I've monitored it quite frequently after beginning the treatment to see assess the progress. It seems to also have an impact on my ability to maintain a lower blood pressure than before during physical activities.
Side effects:   None that I've noticed.
Comments:   My doctor has prescribed one tablet daily as an ongoing treatment.

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Page last updated: 2009-10-20

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