Drug updated on 4/10/2024
| Dosage Form | Tablet (oral; 40 mg and 80 mg) |
| Drug Class | Angiotensin 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.
Summary
- Azilsartan medoxomil (Edarbi) is indicated for the treatment of hypertension in adults to lower blood pressure, either alone or in combination with other antihypertensive agents. It has demonstrated superior efficacy in reducing both office systolic and diastolic blood pressure compared to many other angiotensin-receptor blockers (ARBs), including versions of valsartan, irbesartan, olmesartan, and telmisartan.
- Five systematic reviews/meta-analyses provided comprehensive insights into the safety and effectiveness of azilsartan medoxomil as an antihypertensive agent.
- In a Japanese hypertensive population specifically, azilsartan showed a more favorable efficacy profile in reducing systolic and diastolic blood pressure compared to other ARBs according to one study.
- The safety evaluation revealed that azilsartan medoxomil alone or combined with chlorthalidone was effective at lowering blood pressure while maintaining an acceptable safety profile. Commonly reported side effects included dizziness, headache, and fatigue, but these were considered manageable despite its potent antihypertensive effects.
- Combination therapy involving Edarbi (azilsartan medoxomil) proved efficacious for patients suffering from chronic kidney disease along with hypertension. This combination also showcased superiority over some others regarding adherence rates among patients.
- When comparing ARB-Amlodipine combinations within an Asian population group, it was found that Azilsartan-Amlodipine resulted in significantly higher treatment response than monotherapy or any other ARB-Amlodipine combinations; however, Telmisartan-Amlodipine had fewer adverse events reported.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Edarbi (azilsartan medoxomil) Prescribing Information. | 2022 | Azurity Pharmaceuticals Inc., Worburn, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). | 2023 | Journal of Hypertension |
| AAFP Issues New Clinical Practice Guideline on Hypertension. | 2023 | Annals of Family Medicine |
| RSSDI Guidelines for the management of hypertension in patients with diabetes mellitus. | 2022 | International Journal of Diabetes in Developing Countries |
| Hypertension Canada’s 2020 comprehensive guidelines for the prevention, diagnosis, risk assessment, and treatment of hypertension in adults and children. | 2020 | Canadian Cardiovascular Society |