A POWERFUL ARB
+ DIURETIC

Discover effective control across
multiple patient populations1
Abbreviation: ARB, angiotensin II receptor blocker
Actor Portrayal
EDARByclor® (azilsartan
medoxomil
/chlorthalidone)
Efficacy
Seize the power to help lower hypertension in your appropriate patients*
*Based on clinical trial data
vs Benicar HCT® (olmesartan
medoxomil-hydrochlorothiazide)1
EDARBYCLOR Head-to-Head Clinical Trial Results

EDARBYCLOR delivered statistically superior blood pressure control when compared to Benicar HCT® in a clinical study.1

Primary endpoint: clinic systolic blood pressure
(SBP) reduction at week 121
See Study Design
Week 12 reduction in mean SBP at each hour over 24 hours1

*This is a secondary endpoint. The study was not powered to dectect a difference in this endpoint; therefore, the ability to interpret the n value as significant is reduced.

See Study Design
Likelihood of reaching target SBP: <130 mm Hg at week 82
See Study Design
EDARBYCLOR Efficacy in Patient Subpopulations1Effective control across multiple patient populations1

EDARBYCLOR 40/25 mg was effective in treating multiple patient populations.1,3

Subgroup analyses of clinic SBP by baseline characteristics at week 121,†

†Treatment difference (95% confidence interval) at week 12 in clinic SBP reduction, mm Hg.

‡P<0.05.

Abbreviations: BMI, body mass index; eGFR, estimated glomerular filtration rate.

See Study Design
Demonstrated effectiveness in African American patients3

SBP reduction in the African American patient subgroup was evaluated in a secondary analysis. EDARBYCLOR 40/25 mg was effective in treating African American patients, usually a low-renin population.3

This is a subgroup analysis. The study was not powered to detect a difference in these subgroups; therefore, the ability to interpret the P value as significant is reduced.

SUBGROUP ANALYSIS SHOWED CLINIC SBP REDUCTION IN AFRICAN AMERICAN PATIENTS AT WEEK 123

Based on this post hoc subgroup analysis, EDARBYCLOR 40/25 mg delivered statistically superior clinic SBP reduction in self-identified Black patients with hypertension versus Benicar HCT 40/25 mg at week 12.

See Study Design
EDARBYCLOR SAFETY
AND TOLERABILITY
Demonstrated safety profile2

Safety was evaluated in more than 3900 patients.

Adverse events were generally mild and transient in clinical trials.
ADVERSE EVENTS2
Common adverse reactions that occurred in the 8-week factorial design trial in at least 2% of EDARBYCLOR-treated patients and that are greater than EDARBI or chlorthalidone
CLINICAL LABORATORY FINDINGS2
BL: baseline; Cr: creatinine; ULN: upper limit of normal
Benefits of 2 agents in a single tablet2

EDARBYCLOR is a once-daily oral medication that can help more of your patients achieve their BP goals.2

  • May be administered with or without food.
  • May be administered with other antihypertensive agents. 
  • Dose may be increased to 40/25 mg after 2 to 4 weeks as needed to achieve BP goals.
  • Correct volume depletion in patients prior to use.
  • Doses above maximum are probably not useful.
40/12.5 mg Once Daily
Starting dose
40/25 mg Once Daily
Maximal dose
Pills are not shown at actual size.

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EDARBI®
(azilsartan medoxomil)
When your patients need
single-agent power

EDARBI is an effective choice for a single-agent antihypertensive that delivers superior SBP control. EDARBI may be used as a monotherapy or in combination with other antihypertensive agents.4
Learn about EDARBi
edarbi logo

1. Cushman WC, Bakris GL, White WB, et al. Azilsartan medoxomil plus chlorthalidone reduces blood pressure more effectively than olmesartan plus hydrochlorothiazide in stage 2 systolic hypertension. Hypertension. 2012;60(2):310-318.
2. Edarbyclor [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC; [2020].
3. Ferdinand KC, Bakris GL, Cushman WC, et al. Comparison of effectiveness of azilsartan medoxomil and olmesartan in Blacks versus whites with systemic hypertension. Am J Cardiol. 2018;122(9):1496-1505.
4. Edarbi [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC; [2020].

INDICATIONS

EDARBI is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adults, to lower blood pressure and EDARBYCLOR is an angiotensin II receptor blocker (ARB) and a thiazide-like diuretic combination product indicated for the treatment of hypertension to lower blood pressure. EDARBI may be used either alone or in combination with other antihypertensive agents. EDARBYCLOR may be used if a patient is not adequately controlled on monotherapy or as initial therapy if multiple drugs are needed to help achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. There are no controlled trials demonstrating risk reduction with EDARBI or EDARBYCLOR, but trials with chlorthalidone and at least one antihypertensive agent pharmacologically similar to azilsartan medoxomil have demonstrated such benefits. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on hypertension goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). EDARBI and EDARBYCLOR may be used with other antihypertensive agents.

IMPORTANT SAFETY INFORMATION

WARNING: FETAL TOXICITY

See full Prescribing Information for complete boxed warnings.

  • When pregnancy is detected, discontinue EDARBI or EDARBYCLOR as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

WARNINGS AND PRECAUTIONS

EDARBYCLOR is contraindicated in patients with anuria.

Do not coadminister aliskiren-containing products with EDARBI or EDARBYCLOR in patients with diabetes.

Fetal Toxicity: EDARBI or EDARBYCLOR can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue EDARBI or EDARBYCLOR as soon as possible. Thiazides cross the placental barrier and appear in cord blood and may be associated with adverse reactions, including fetal or neonatal jaundice and thrombocytopenia.

Hypotension in Volume - or Salt-Depleted Patients: In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with EDARBI or EDARBYCLOR. Such patients are probably not good candidates to start therapy with more than one drug; therefore, correct volume prior to administration of EDARBYCLOR. Correct volume or salt depletion prior to administering EDARBI, or start treatment at 40 mg. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Impaired Renal Function: Monitor for worsening renal function in patients with renal impairment. Consider withholding or discontinuing EDARBYCLOR if progressive renal impairment becomes evident. As a consequence of inhibiting the renin-angiotensin system, changes in renal function may be anticipated in susceptible individuals treated with EDARBI or EDARBYCLOR. In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g., patients with severe congestive heart failure, renal artery stenosis, or volume depletion), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. Similar results may be anticipated in patients treated with EDARBI or EDARBYCLOR. In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported. There has been no long-term use of azilsartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results are expected. In patients with renal disease, chlorthalidone may precipitate azotemia. If progressive renal impairment becomes evident, as indicated by increased blood urea nitrogen, consider withholding or discontinuing diuretic therapy.

Serum Electrolyte Imbalances: Thiazide diuretics can cause hyponatremia and hypokalemia. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. Hypokalemia is a dose-dependent adverse reaction that may develop with chlorthalidone. Co-administration of digitalis may exacerbate the adverse effects of hypokalemia. Monitor serum electrolytes periodically. EDARBYCLOR attenuates chlorthalidone-associated hypokalemia. In patients with normal potassium levels at baseline, 1.7% of EDARBYCLOR-treated patients, 0.9% of azilsartan medoxomil-treated patients, and 13.4% of chlorthalidone-treated patients shifted to low potassium values (less than 3.4 mmol/L).

Hyperuricemia: Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics.

ADVERSE REACTIONS (AEs):

- The most common AE that occurred more frequently with EDARBI than placebo in adults was
diarrhea (2% vs 0.5%).

- AEs occurred at an incidence of ≥2% of EDARBYCLOR-treated patients and greater than
azilsartan medoxomil or chlorthalidone were dizziness (8.9%) and fatigue (2.0%).

The incidence of consecutive increases of creatinine (≥50% from baseline and >ULN) was 2.0% in patients treated with the recommended doses of Edarbyclor compared with 0.4% and 0.3% with azilsartan medoxomil and chlorthalidone, respectively.

DRUG INTERACTIONS:

- Monitor renal function periodically in patients receiving EDARBI or EDARBYCLOR and NSAIDs who are also elderly, volume-depleted (including those on diuretics), or who have compromised renal function, as deterioration of renal function, including possible acute renal failure, may result. These effects are usually reversible. NSAIDs may reduce the antihypertensive effect of EDARBI or EDARBYCLOR.
- Dual blockade of the renin-angiotensin system (RAS) with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on EDARBI or EDARBYCLOR and other agents that affect the RAS. Do not coadminister aliskiren with EDARBI or EDARBYCLOR in patients with diabetes or renal impairment (GFR ❮ 60 mL/min).
- Renal clearance of lithium is reduced by diuretics, such as chlorthalidone, increasing the risk of lithium toxicity. Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor agonists. Monitor serum lithium levels during concomitant use.

The Important Safety Information does not include all the information needed to use EDARBI and EDARBYCLOR safely and effectively.

For further information, please see accompanying complete Prescribing Information for EDARBI and EDARBYLCOR.

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

PP-EDB-US-0664

EDARBI and EDARBYCLOR are exclusively marketed in the United States by Azurity Pharmaceuticals, Inc.

EDARBI and EDARBYCLOR are a trademark of Takeda Pharmaceutical Company Limited, registered with the US Patent and Trademark Office and used under license by Azurity Pharmaceuticals, Inc.

© {current_year} Azurity Pharmaceuticals, Inc. All Rights Reserved. All Trademarks referred to are the property of the irrespective owners. Product packaging and imagery are for representation purposes only and shall constitute the property of Azurity and all applicable affiliates. PP-EDB-US-0664.

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IMPORTANT SAFETY INFORMATION

WARNING: FETAL TOXICITY
See full Prescribing Information for complete boxed warnings.

  • When pregnancy is detected, discontinue EDARBI or EDARBYCLOR as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

EDARBYCLOR is contraindicated in patients with anuria.

INDICATIONS

EDARBI is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adults, to lower blood pressure and EDARBYCLOR is an angiotensin II receptor blocker (ARB) and a thiazide-like diuretic combination product indicated for the treatment of hypertension to lower blood pressure. EDARBI may be used either alone or in combination with other antihypertensive agents. EDARBYCLOR may be used if a patient is not adequately controlled on monotherapy or as initial therapy if multiple drugs are needed to help achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. There are no controlled trials demonstrating risk reduction with EDARBI or EDARBYCLOR, but trials with chlorthalidone and at least one antihypertensive agent pharmacologically similar to azilsartan medoxomil have demonstrated such benefits. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on hypertension goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). EDARBI and EDARBYCLOR may be used with other antihypertensive agents.

IMPORTANT SAFETY INFORMATION

WARNING: FETAL TOXICITY

See full Prescribing Information for complete boxed warnings.

  • When pregnancy is detected, discontinue EDARBI or EDARBYCLOR as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

WARNINGS AND PRECAUTIONS

EDARBYCLOR is contraindicated in patients with anuria.

Do not coadminister aliskiren-containing products with EDARBI or EDARBYCLOR in patients with diabetes.

Fetal Toxicity: EDARBI or EDARBYCLOR can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue EDARBI or EDARBYCLOR as soon as possible. Thiazides cross the placental barrier and appear in cord blood and may be associated with adverse reactions, including fetal or neonatal jaundice and thrombocytopenia.

Hypotension in Volume - or Salt-Depleted Patients: In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with EDARBI or EDARBYCLOR. Such patients are probably not good candidates to start therapy with more than one drug; therefore, correct volume prior to administration of EDARBYCLOR. Correct volume or salt depletion prior to administering EDARBI, or start treatment at 40 mg. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Impaired Renal Function: Monitor for worsening renal function in patients with renal impairment. Consider withholding or discontinuing EDARBYCLOR if progressive renal impairment becomes evident. As a consequence of inhibiting the renin-angiotensin system, changes in renal function may be anticipated in susceptible individuals treated with EDARBI or EDARBYCLOR. In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g., patients with severe congestive heart failure, renal artery stenosis, or volume depletion), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. Similar results may be anticipated in patients treated with EDARBI or EDARBYCLOR. In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported. There has been no long-term use of azilsartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results are expected. In patients with renal disease, chlorthalidone may precipitate azotemia. If progressive renal impairment becomes evident, as indicated by increased blood urea nitrogen, consider withholding or discontinuing diuretic therapy.

Serum Electrolyte Imbalances: Thiazide diuretics can cause hyponatremia and hypokalemia. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. Hypokalemia is a dose-dependent adverse reaction that may develop with chlorthalidone. Co-administration of digitalis may exacerbate the adverse effects of hypokalemia. Monitor serum electrolytes periodically. EDARBYCLOR attenuates chlorthalidone-associated hypokalemia. In patients with normal potassium levels at baseline, 1.7% of EDARBYCLOR-treated patients, 0.9% of azilsartan medoxomil-treated patients, and 13.4% of chlorthalidone-treated patients shifted to low potassium values (less than 3.4 mmol/L).

Hyperuricemia: Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics.

ADVERSE REACTIONS (AEs):

- The most common AE that occurred more frequently with EDARBI than placebo in adults was
diarrhea (2% vs 0.5%).

- AEs occurred at an incidence of ≥2% of EDARBYCLOR-treated patients and greater than
azilsartan medoxomil or chlorthalidone were dizziness (8.9%) and fatigue (2.0%).

The incidence of consecutive increases of creatinine (≥50% from baseline and >ULN) was 2.0% in patients treated with the recommended doses of Edarbyclor compared with 0.4% and 0.3% with azilsartan medoxomil and chlorthalidone, respectively.

DRUG INTERACTIONS:

- Monitor renal function periodically in patients receiving EDARBI or EDARBYCLOR and NSAIDs who are also elderly, volume-depleted (including those on diuretics), or who have compromised renal function, as deterioration of renal function, including possible acute renal failure, may result. These effects are usually reversible. NSAIDs may reduce the antihypertensive effect of EDARBI or EDARBYCLOR.
- Dual blockade of the renin-angiotensin system (RAS) with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on EDARBI or EDARBYCLOR and other agents that affect the RAS. Do not coadminister aliskiren with EDARBI or EDARBYCLOR in patients with diabetes or renal impairment (GFR ❮ 60 mL/min).
- Renal clearance of lithium is reduced by diuretics, such as chlorthalidone, increasing the risk of lithium toxicity. Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor agonists. Monitor serum lithium levels during concomitant use.

The Important Safety Information does not include all the information needed to use EDARBI and EDARBYCLOR safely and effectively.

For further information, please see accompanying complete Prescribing Information for EDARBI and EDARBYLCOR.

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

PP-EDB-US-0664

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