Even patients with the best intentions can’t always achieve their blood pressure (BP) goals. This could be because of multiple reasons, such as:

Nearly 13% of US adults treated with antihypertensive medication still have uncontrolled BP.1 It’s not unusual for patients to require multiple titrations and adjustments to relieve hypertension symptoms, in addition to multiple medications from multiple classes. At least 75% of patients will require combination therapy to achieve guideline BP targets.2 This requires balancing safety and tolerability with efficacy and adherence.3

Performance within the class should be considered before a class switch, particularly in the case of established standard-of-care medications, such as angiotensin II receptor blockers (ARBs) or ARB/diuretic combinations. This is especially true when head-to-head studies in homogenous patient types are available.4

Lifestyle intervention has always been central to hypertension treatment. Maintaining healthier lifestyle choices is an urgent priority, especially as suboptimal BP is responsible for 62% of cerebrovascular disease and 49% of ischemic heart disease worldwide.5 More than 122 million Americans are overweight or obese, and less than 20% of Americans engage in regular physical activity. Mean sodium intake is about 4,100 mg per day for men and 2,750 mg per day for women, most of it coming from processed foods. Less than 25% eat 5 or more servings of fruits and vegetables daily. Smoking and secondhand smoke are well-known risk factors for cardiovascular disease. While smoking does not directly cause high BP, it does cause an acute increase in BP. These challenges are difficult to overcome, but changing these habits could have a substantial benefit in mortality and morbidity. It has been estimated that a 5 mm Hg reduction of systolic BP in the population could reduce stroke mortality by 14%, congestive heart disease mortality by 9%, and all-cause mortality by 7%. However, even the most diligent patients may experience disruptions in their daily routines that affect their lifestyles.

Patients diagnosed with conditions that increase their risk of heart disease should be carefully screened to identify the cause of their hypertension, and treated holistically to reduce the risk of cardiovascular complications. Identifiable causes of hypertension are multiple and varied, including chronic kidney disease, coarctation of the aorta, obstructive uropathy, sleep apnea, and thyroid disease. Underlying conditions may play a part in increasing the risk of death from heart disease or stroke. The higher the BP, the greater the risk of heart attack, heart failure, stroke, and kidney disease.5

Hypertension management is about more than BP numbers

Understanding how to get patients to goal starts with understanding patients

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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.

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.

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

You are encouraged to report side effects of prescription drugs to Arbor Pharmaceuticals, LLC Medical Information at 1-866-516-4950 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

Indications

EDARBI is an angiotensin II receptor blocker (ARB) and EDARBYCLOR is an angiotensin II receptor blocker (ARB) and a thiazide-like diuretic combination product both 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.

References: 1. Persell SD. Prevalence of resistant hypertension in the United States, 2003-2008. Hypertension. 2011;57(6):1076-1080. 2. Gradman AH, Basile JN, Carter BL; American Society of Hypertension Writing Group. Combination therapy in hypertension. J Am Soc Hypertens. 2010;4(1):42-50. 3. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520. 4. Sica DA. Class-effect with antihypertensive medications: pharmacologic considerations. J Clin Hypertens. 2009;11(12)(suppl 1):S13-S18. 5. Chobanian AV, Bakris GL, Black HR, et al. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003;42(6):1206-1252. 6. Primatesta P, Falaschetti E, Gupta S, et al. Association between smoking and blood pressure: evidence from the health survey for England. Hypertension. 2001;37:187-193.

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ABOUT EDARBI AND EDARBYCLOR
Since July 2018, FDA has recalled more than 100 generic versions of the angiotensin II receptor blocker (ARB) medications losartan, irbesartan, and valsartan.1

Reference: 1. FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan. US Food and Drug Administration website. https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm.
Updated January 23, 2019. Accessed February 13, 2019.
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