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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).
See all Avapro indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Avapro (Irbesartan)

A randomized placebo controlled trial of early treatment of acute ischemic stroke with atorvastatin and irbesartan. [2011.11.02]
Background Cholesterol and blood pressure lowering therapies are effective in the secondary prevention of ischemic stroke. Aim To determine whether 30 days of treatment with atorvastatin, or irbesartan, initiated within 96 h of symptom onset improves recovery from acute ischemic stroke.Conclusions Treatment with atorvastatin and irbesartan, initiated on day 3 after acute ischemic stroke, did not appear to substantially modify infarct growth.

Irbesartan treatment does not influence plasma levels of the advanced glycation end products N(epsilon)(1-carboxymethyl)lysine and N(epsilon)(1-carboxyethyl)lysine in patients with type 2 diabetes and microalbuminuria. A randomized controlled trial. [2011.11]
BACKGROUND: In vitro and animal experiments have shown inhibiting effects of angiotensin receptor blockers (ARBs) on the formation of advanced glycation end products (AGEs), which are known to be involved in the development of cardiovascular complications in diabetes. However, sufficient human data to confirm such beneficial effects of ARBs on AGEs are lacking. Therefore, we investigated the effects of irbesartan treatment on plasma levels of the AGEs N(epsilon)(1-carboxymethyl)lysine (CML) and N(epsilon)(1-carboxyethyl)lysine (CEL) in hypertensive patients with type 2 diabetes and microalbuminuria... CONCLUSIONS: Long-term irbesartan treatment does not influence plasma levels of the AGE CML and CEL in patients with type 2 diabetes and microalbuminuria.

Role of irbesartan in prevention of post-coronary artery bypass graft atrial fibrillation. [2011.08.01]
BACKGROUND AND OBJECTIVE: Atrial fibrillation (AF) is a common complication of cardiothoracic surgery (CTS). Existing evidence about the potential protective role of angiotensin II type 1 receptor antagonists (angiotensin receptor blockers [ARBs]) for post-CTS AF has been limited and conflicting. In this single-blind, open-label, randomized prospective pilot study, we evaluated the potential protective role of irbesartan (an ARB) in post-coronary artery bypass graft (CABG) AF... CONCLUSION: Pretreatment with irbesartan tends to have a significant protective effect against the occurrence of AF during the post-operative period in patients undergoing CABG.

A comparison of the efficacy and safety of irbesartan/hydrochlorothiazide combination therapy with irbesartan monotherapy in the treatment of moderate or severe hypertension in diabetic and obese hypertensive patients: a post-hoc analysis review. [2011.07]
Hypertension is difficult to treat in patients with type 2 diabetes mellitus (T2DM) or obesity. Combination therapies are often required to effectively lower blood pressure (BP) and attain BP goals... In patients with moderate or severe hypertension and with a BMI >/= 30 kg/m(2), initial treatment with irbesartan/HCTZ combination therapy was more effective than irbesartan monotherapy.

Long-term effects of Irbesartan treatment and smoking on nucleic acid oxidation in patients with type 2 diabetes and microalbuminuria: an Irbesartan in patients with type 2 diabetes and Microalbuminuria (IRMA 2) substudy. [2011.05]
CONCLUSIONS: Irbesartan treatment was not significantly more effective than placebo in reducing nucleic acid oxidation. The results indicate that DNA oxidation in diabetes patients is reduced by various components in the treatment of diabetes where glycemic control seems to be important and addition of angiotensin II receptor antagonists does not lead to any substantial additional reduction. Furthermore, the reductions in DNA oxidation and albumin excretion seem to be counteracted by smoking.

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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

A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin [Recruiting]

Evaluation of Efficacy and Safety of the Dosage Adjustment of AprovelŪ (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

Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy [Recruiting]
Primary Objective:

To demonstrate that the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 300/5 mg is superior to that of irbesartan 300 mg monotherapy in lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM) after 10 weeks of treatment (W10)

Secondary Objective:

- To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine

300/5 mg with that of irbesartan 300 mg monotherapy after 10 weeks of treatment (W10)

- To compare the antihypertensive efficacy of the fixed combination therapy

irbesartan/amlodipine 150/5 mg with that of irbesartan 150 mg monotherapy after 5 weeks of treatment (W5)

- To examine in each treatment group the change from week 5 to week 10 in SBP and

diastolic blood pressure (DBP) assessed by HBPM and by office blood pressure measurement (OBPM)

- To determine the incidence and severity of adverse events

Irbesartan and Adhesion Molecules in AF [Recruiting]
Experimental data suggest that angiotensin II-antagonists reduce the atrial expression of prothrombotic adhesion molecules and oxidative stress parameters. The present study is designed to investigate the effects on angiotensin II-antagonist irbesartan to reduce the amounts of circulating oxidative stress markers and adhesion molecules in patients with persistent atrial fibrillation.

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Reports of Suspected Avapro (Irbesartan) Side Effects

Loss of Consciousness (28)Blood Pressure Increased (25)Palpitations (23)Dizziness (20)Weight Decreased (18)Blood Count Abnormal (16)Cystitis (16)Burning Sensation (16)Ingrowing Nail (15)Hyperkalaemia (14)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 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.

 

Avapro review by 41 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   high blood pressure after prewgnancy
Dosage & duration:   150mg taken one a day for the period of on going
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   after being given this treatment there was no coughing no vomitinig like i had experienced with some other bp medication
Side effects:   there were no side effects
Comments:   had blood pressure at 7 month pregnant was taking labetolol after pregnancy tred a few which made me feel ill aprovel makes me feel very well no side effect my blood pressure is now the lowest it has ever been even before i was pregnant

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Page last updated: 2011-12-09

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