PPT | Integrative Med

October 30, 2020

Fotini Gialama and Nikos Maniadakis

Written by: Dr. Jenina Anne S. Ignacio, R.N., M.D.

A Summary of Comprehensive Overview: Efficacy, Tolerability, and Cost-effectiveness of Irbesartan written by Fotini Gialama and Nikos Maniadakis 

Vascular Health Risk Management. 2013; 9: 575–592. Published online 2013 Oct 7. doi:  10.2147/VHRM.S50831 


Evaluate the efficacy, safety and tolerability profile, and cost-effectiveness of treatment with Irbesartan in hypertension.




Safety and tolerability


The overall incidence of adverse events with irbesartan was comparable with that of placebo.

Overall incidence of adverse events and tolerability for the following comparative studies did not have difference:  

  • irbesartan and enalapril.
  • irbisartan and atenolol
  • irbesartan compared with amlodipine and valsartan
  • irbesartan and losartan treatment,
  • irbesartan/HCTZ and valsartan/HCTZ
  • irbesartan/HCTZ and losartan/HCTZ

Long-term treatment with irbesartan/HCTZ did not have a negative effect on tolerability or safety.

In irbesartan/amlodipine combination therapy, most treatment emergent adverse events were of mild or moderate intensity and only a few were considered severe.


Efficacy in treatment of cardiovascular disease


Efficacy of irbesartan monotherapy in hypertension


  • Results from placebo-controlled studies show that irbesartan treatment, at doses ranging from 75 mg to 300 mg, achieves a statistically significant reduction in both systolic and diastolic BP in patients with mild-tomoderate hypertension.
  • Irbesartan 300 mg in patients with mild-to moderate hypertension resulted in greater reductions in trough seated diastolic BP and systolic BP compared with losartan.
  • Irbesartan demonstrated significant greater reductions in mean systolic ambulatory BP compared with valsartan.
  • Compared with enalapril, atenolol, and amlodipine, irbesartan demonstrated comparable efficacy in reducing both diastolic and systolic blood pressure and normalized seated diastolic BP at dosages up to 300 mg.
  • Irbesartan compared with the newest angiotensin II antagonist, olmesartan, showed similar reductions in ambulatory BP, as well as in seated systolic BP.
  • Olmesartan achieved significant greater reductions in seated diastolic BP than irbesartan.


Efficacy of irbesartan in combination therapy for hypertension

  • Results from three placebo-controlled studies showed that reductions from baseline trough seated diastolic BP and systolic BP with irbesartan/HCTZ combination were greater compared with placebo/HCTZ.
  • In comparative studies, the fixed combination of irbesartan/HCTZ had a superior BP-lowering effect compared with valsartan/HCTZ.
  • Results from the I-ADD and the I-COMBINE studies suggest greater efficacy with the fixed-dose combination of irbesartan 150 mg/amlodipine 5 mg over amlodipine 5 mg and irbesartan 150 mg monotherapies.

Efficacy in hypertensive patients with type 2 diabetes and nephropathy  

  • Results from the IDNT (Irbesartan in Diabetic Nephropathy Trial) and IRMA (Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria) trials show that irbesartan was associated with better renal outcomes compared with amlodipine, placebo, and other antihypertensive agents.
  • Further, irbesartan provided a significantly slower increase in serum creatinine concentration and decrease in creatinine clearance and reduced the rate of progression to albuminuria.
  • Irbesartan was also found to reduce microalbuminuria both in diabetic and nondiabetic patients, resulting in an increase in the percentage of patients with normoalbuminuria and in a decrease in patients with microalbuminuria.
  • Irbesartan was found to reduce significantly the albumin excretion rate in both microalbuminuric normotensive and hypertensive patients as well as 24-hour mean systolic and diastolic BP.


Effects of irbesartan on left ventricular hypertrophy  

  • In the SILVHIA trial, patients treated with irbesartan showed a greater reduction in left ventricular mass and BP than those treated with atenolol.
  • Four studies evaluated the cost-effectiveness of three alternative strategies for the management of hypertensive patients with type 2 diabetes and microalbuminuria; these alternative strategies were early irbesartan treatment, late irbesartan treatment, and conventional antihypertensive treatment.
  • Results from these studies showed that early irbesartan treatment is cost-effective compared with late irbesartan treatment and conventional antihypertensive therapy.
  • Two studies evaluating irbesartan in combination with HCTZ for the treatment of patients with hypertension showed that irbesartan is a cost-effective antihypertensive treatment strategy compared with alternative hypertension therapies, losartan and valsartan.





Evidence from this review suggests that irbesartan represents not only an effective and well tolerated treatment for patients with hypertension and those with type 2 diabetes and nephropathy, but also a cost-saving and cost-effective treatment compared with other conventional treatment options. 


 Vascular Health Risk Management. 2013; 9: 575–592. Published online 2013 Oct 7. doi:  10.2147/VHRM.S50831

AUTHOR: Fotini Gialama and Nikos Maniadakis

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