What is the recommended treatment and dosage for Edarbi (azilsartan) in patients with hypertension?

Edarbi (Azilsartan) Treatment for Hypertension

The recommended dose of Edarbi (azilsartan medoxomil) for hypertension treatment is 80 mg taken orally once daily, with a starting dose of 40 mg for patients on high-dose diuretics. 1

Dosing Guidelines

• The standard recommended dose is 80 mg taken once daily 1
• Consider a starting dose of 40 mg for patients treated with high doses of diuretics 1
• Edarbi may be administered with or without food 1
• Edarbi may be used alone or in combination with other antihypertensive agents 1

Mechanism of Action

• Edarbi is an angiotensin II receptor blocker (ARB) that selectively blocks the binding of angiotensin II to the AT1 receptor 2
• Studies show azilsartan produces greater and more sustained AT1 receptor binding/blockade activity compared to other ARBs 2
• Azilsartan medoxomil is a prodrug that undergoes rapid hydrolysis in the gastrointestinal tract to the bioactive moiety azilsartan 2

Efficacy

• Azilsartan effectively reduces blood pressure over a 24-hour period with once-daily administration 2
• At the maximum approved dosage of 80 mg daily, azilsartan has shown superior efficacy compared to maximum dosages of olmesartan (40 mg) and valsartan (320 mg) 2, 3
• Studies demonstrate azilsartan 80 mg reduces systolic blood pressure by 12-15 mmHg and diastolic blood pressure by 7-8 mmHg 3
• In resistant hypertension, azilsartan medoxomil provides on average an additional 4-8 mmHg systolic BP reduction compared to other ARBs 4

Treatment Algorithm for Hypertension

1. Initial Assessment:

   • For patients with BP ≥140/90 mmHg, start treatment 4
   • For high-risk patients (CVD, CKD, diabetes, organ damage, or aged 50-80 years), start drug treatment immediately 4
   • For low-moderate risk patients, consider lifestyle interventions for 3-6 months before initiating drug therapy if BP remains elevated 4

2. Treatment Steps for Non-Black Patients:

   • First-line: Low dose ARB (such as azilsartan 40 mg) 4
   • If needed, increase to full dose (azilsartan 80 mg) 4
   • Add thiazide/thiazide-like diuretic if BP remains uncontrolled 4
   • Consider fixed-dose combinations to improve adherence 4

3. Treatment Steps for Black Patients:

   • First-line: Low dose ARB (such as azilsartan 40 mg) + dihydropyridine calcium channel blocker (DHP-CCB) or DHP-CCB + thiazide/thiazide-like diuretic 4
   • Increase to full dose if needed 4

Special Considerations

• Target BP: <130/80 mmHg for most patients; individualize for elderly based on frailty 4
• Monitoring: Aim to achieve BP control within 3 months 4
• Pregnancy: Contraindicated during pregnancy due to fetal toxicity; discontinue when pregnancy is detected 1
• Volume-depleted patients: Correct volume or salt depletion prior to administration to prevent symptomatic hypotension 1
• Renal impairment: Monitor for worsening renal function in susceptible patients 1

Adverse Effects

• Generally well-tolerated with a profile similar to placebo in clinical trials 2
• Most common adverse events include headache and diarrhea 1, 3
• Low rates of treatment discontinuation due to adverse events suggest good long-term tolerability 2

Combination Therapy

• When monotherapy is insufficient, azilsartan can be combined with other antihypertensive agents 1
• Azilsartan/chlorthalidone fixed-dose combination has shown greater efficacy than olmesartan/hydrochlorothiazide and azilsartan/hydrochlorothiazide combinations 5
• Do not combine with aliskiren-containing products in patients with diabetes 1

Practical Considerations

• Dispense and store Edarbi in its original container to protect from light and moisture 1
• Monitor for hyperkalemia, especially when combined with other medications that affect potassium levels 1
• If BP remains uncontrolled despite optimal therapy, refer to a provider with hypertension expertise 4