Azilsartan medoxomil

(Edarbi®)

Edarbi®

Drug updated on 12/11/2024

Dosage Form Tablet (oral; 40 mg and 80 mg)
Drug ClassAngiotensin II receptor blockers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of hypertension in adults to lower blood pressure, either alone or in combination with other antihypertensive agents.

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Summary
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  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • Azilsartan medoxomil (AZL-M) 80 mg demonstrated superior efficacy in office blood pressure reduction, with a 93% probability of being the most effective for systolic blood pressure (BP) and a 90% probability for diastolic BP. In 24-hour ambulatory monitoring, 80 mg AZL-M resulted in a mean systolic reduction of -3.59 mmHg and diastolic reduction of -2.62 mmHg, outperforming lower doses and control.
  • The combination of AZL-M with chlorthalidone (AZL-M/CLD) showed greater systolic BP reduction in clinic measurements (-35.1 mmHg) compared to AZL-M with hydrochlorothiazide (-29.5 mmHg). This combination was also effective for chronic kidney disease patients, providing better BP management and adherence.
  • For patients with hypertension and diabetes, AZL-M provided superior BP control, while maintaining a safety and tolerability profile similar to that of the control therapy.
  • The 80 mg AZL-M group showed an increased incidence of dizziness (odds ratio (OR): 1.56), while the 40 mg AZL-M group reported a higher occurrence of urinary tract infections (OR: 1.82); other adverse events did not differ significantly from the control group.
  • The AZL-M and chlorthalidone combination therapy was described as safe and did not raise significant safety concerns, with similar tolerability to other antihypertensive therapies.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Edarbi (azilsartan medoxomil) Prescribing Information.2024Azurity Pharmaceuticals, Inc., Woburn, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines