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 with EDARBI or EDARBYCLOR in patients with diabetes.

Fetal Toxicity: Use of drugs that act on the renin-angiotensin system during the second and third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity 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.

In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, EDARBI or EDARBYCLOR can cause excessive hypotension. Correct volume or salt depletion prior to administration of EDARBI or EDARBYCLOR.

Monitor for worsening renal function in patients with renal impairment. In patients whose renal function may depend on the activity of the renin-angiotensin system, treatment with ACE inhibitors and ARBs has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. In patients with renal artery stenosis, EDARBI and EDARBYCLOR may cause renal failure. In patients with renal disease, chlorthalidone may precipitate azotemia; consider withholding or discontinuing EDARBYCLOR if progressive renal impairment becomes evident. Avoid use of aliskiren with EDARBI or EDARBYCLOR in patients with renal impairment (GFR <60 mL/min).

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. Coadministration of digitalis may exacerbate the adverse effects of hypokalemia. EDARBYCLOR attenuates chlorthalidone-associated hypokalemia. Monitor electrolytes periodically.

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

Incidence of consecutive elevations of creatinine with EDARBYCLOR (≥50% from baseline and >ULN) was 2% and was typically transient, or nonprogressive and reversible, and associated with large blood pressure reductions. With EDARBI 80mg, small reversible increases were seen.

Drug Interactions:

  • 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.
  • 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 interfere with antihypertensive effect.
  • Dual blockade of the RAAS 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. Closely monitor blood pressure, renal function and electrolytes in patients on Edarbi.

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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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