What is the recommended dosing regimen for Edarbi (azilsartan) in a patient with hypertension and potentially impaired renal function?

Edarbi (Azilsartan) Dosing for Hypertension

The recommended dose of Edarbi is 80 mg orally once daily, with a starting dose of 40 mg for patients on high-dose diuretics. 1

Standard Dosing Regimen

• Start with 80 mg once daily for most adults with hypertension 1
• Start with 40 mg once daily if the patient is volume-depleted or on high doses of diuretics 1
• Edarbi may be administered with or without food 1
• The medication should be dispensed in its original container to protect from light and moisture 1

Renal Impairment Considerations

• No dose adjustment is required for mild to moderate renal impairment 2
• Monitor serum creatinine and potassium within 2-4 weeks of starting therapy, particularly in patients with chronic kidney disease 3
• In patients whose renal function depends on the renin-angiotensin system (severe heart failure, renal artery stenosis, volume depletion), treatment may cause oliguria, progressive azotemia, or acute renal failure 1
• Correct volume or salt depletion prior to initiating Edarbi to avoid symptomatic hypotension 1

Monitoring and Titration

• Reassess blood pressure monthly after initiating or changing dose until target is achieved 3
• Monitor every 3-5 months once blood pressure is controlled 3
• Check renal function and potassium within 2-4 weeks of initiation or dose changes 3
• If hypotension occurs, place patient supine and consider IV normal saline; transient hypotensive response is not a contraindication to continued treatment 1

Blood Pressure Targets

• Target <130/80 mmHg for most patients with hypertension and cardiovascular disease or high cardiovascular risk 3
• Target <140/90 mmHg for patients without comorbidities 3
• Target <130/80 mmHg for patients with chronic kidney disease 3

Combination Therapy

• Edarbi may be combined with thiazide diuretics or calcium channel blockers for additional blood pressure reduction 3, 1
• Never combine with ACE inhibitors or aliskiren, especially in diabetic patients, as this increases risk of hyperkalemia and renal dysfunction without additional benefit 3, 1

Comparative Efficacy

• Azilsartan 80 mg once daily was significantly more effective than olmesartan 40 mg or valsartan 320 mg in reducing 24-hour mean systolic blood pressure in 6-week trials 4
• At maximum dosage, azilsartan reduced systolic blood pressure by 12-15 mmHg and diastolic blood pressure by 7-8 mmHg 5
• Azilsartan demonstrated superior and more sustained AT₁ receptor blockade compared to other angiotensin II receptor antagonists in vitro 4

Critical Safety Warnings

• Discontinue immediately if pregnancy is detected - drugs acting on the renin-angiotensin system cause fetal injury and death 1
• Avoid in patients with history of angioedema with ARBs 3
• Watch for hyperkalemia, particularly in patients with CKD or those on potassium supplements or potassium-sparing drugs 3
• Do not coadminister with aliskiren in diabetic patients 1

Tolerability Profile

• Azilsartan is generally well tolerated with a safety profile similar to placebo 4, 2
• The most common adverse reaction is diarrhea (2%) 1
• Headache and dizziness are among the most frequently reported adverse events 4
• Discontinuation rates due to adverse events are low in clinical trials 4