Resistant hypertension (RH) is defined as above-goal elevated blood pressure (BP) in a patient despite the concurrent use of 3 antihypertensive drug classes, commonly including a long-acting calcium channel blocker, a blocker of the renin-angiotensin system (angiotensin-converting enzyme inhibitor or angiotensin receptor blocker), and a diuretic. The antihypertensive drugs should be administered at maximum or maximally tolerated daily doses. RH also includes patients whose BP achieves target values on ≥4 antihypertensive medications. The diagnosis of RH requires assurance of antihypertensive medication adherence and exclusion of the "white-coat effect" (office BP above goal but out-of-office BP at or below target). The importance of RH is underscored by the associated risk of adverse outcomes compared with non-RH. This article is an updated American Heart Association scientific statement on the detection, evaluation, and management of RH. Once antihypertensive medication adherence is confirmed and out-of-office BP recordings exclude a white-coat effect, evaluation includes identification of contributing lifestyle issues, detection of drugs interfering with antihypertensive medication effectiveness, screening for secondary hypertension, and assessment of target organ damage. Management of RH includes maximization of lifestyle interventions, use of long-acting thiazide-like diuretics (chlorthalidone or indapamide), addition of a mineralocorticoid receptor antagonist (spironolactone or eplerenone), and, if BP remains elevated, stepwise addition of antihypertensive drugs with complementary mechanisms of action to lower BP. If BP remains uncontrolled, referral to a hypertension specialist is advised.

Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association.

Angiotensin-Converting Enzyme Inhibitors in Hypertension: To Use or Not to Use?

Role of angiotensin-converting enzyme 2/angiotensin-(1–7)/Mas axis in the hypotensive effect of azilsartan

/pdf/role-of-angiotensin-converting-enzyme-2-angiotensin-1-7-mas-4s7lvthpml.pdf

Azilsartan medoxomil (Edarbi®; Ipreziv™) is an orally administered angiotensin II receptor type 1 antagonist (blocker) used in the treatment of adults with essential hypertension. This article reviews data on the clinical efficacy and tolerability of azilsartan medoxomil in adults with essential hypertension and provides a summary of its pharmacological properties. Azilsartan medoxomil is a prodrug that undergoes rapid hydrolysis in the gastrointestinal tract after oral administration to the bioactive moiety azilsartan, before systemic absorption. Azilsartan medoxomil produces antihypertensive effects by selectively blocking the binding of angiotensin II to the angiotensin type 1 (AT(1)) receptor, thereby antagonizing the pressor response activity of angiotensin II. In vitro, azilsartan produced greater and more sustained AT(1) receptor binding/blockade activity than several comparator angiotensin II receptor antagonists. Azilsartan medoxomil reduces blood pressure (BP) in hypertensive adults. In addition, the drug has been shown to have pleiotropic effects (i.e. effects beyond AT(1) receptor blockade). In adults with essential hypertension, azilsartan medoxomil 20, 40 or 80 mg effectively reduced BP over a 24-hour period with once-daily administration in three major, randomized, controlled trials in which the primary endpoints were changes from baseline in 24-hour mean systolic BP (SBP) at week 6 (two trials) or week 24, assessed by ambulatory BP monitoring (ABPM). In the two 6-week trials, azilsartan medoxomil showed dose-dependent efficacy over all evaluated dosages and was more effective than placebo in lowering SBP. At the maximum approved dosage of 80 mg once daily, azilsartan medoxomil was significantly more effective than maximum dosages of olmesartan medoxomil (40 mg once daily) or valsartan (320 mg once daily), based on primary endpoint assessments. Mean reductions in clinic measurements of SBP and diastolic BP (DBP) measurements were also generally greater with azilsartan medoxomil 80 mg once daily than with the comparator drugs in these 6-week studies. Over a longer treatment period of 24 weeks, azilsartan medoxomil showed sustained BP-lowering efficacy, with the reduction in 24-hour mean SBP at week 24 significantly greater with azilsartan medoxomil 40 or 80 mg once daily than with valsartan 320 mg once daily. Mean reductions from baseline in mean clinic SBP and DBP as well as DBP by ABPM were also significantly greater with azilsartan medoxomil 40 or 80 mg once daily than with valsartan. Azilsartan medoxomil was generally well tolerated, with a tolerability profile similar to that of placebo in the 6-week trials. Across the three major trials, headache and dizziness were among the most common adverse events. Overall, rates of treatment discontinuation as a result of adverse events were low in the 6-week and 24-week trials. In conclusion, once-daily azilsartan medoxomil effectively lowers BP in adults with essential hypertension and has shown better antihypertensive efficacy than maximum therapeutic dosages of olmesartan medoxomil or valsartan in major trials of up to 24 weeks' duration. Azilsartan medoxomil is generally well tolerated and the low rates of discontinuation due to adverse events suggest that patients are likely to persist with long-term treatment. Azilsartan medoxomil is therefore a useful and attractive new option for lowering BP in patients with essential hypertension, particularly for those not able to tolerate other antihypertensive drugs. Further studies are required to evaluate the effects of azilsartan medoxomil on cardiovascular morbidity and mortality.

Azilsartan medoxomil: a review of its use in hypertension.

Hypertension affects approximately one in three adults in the U.S. and is a major risk factor for cardiovascular disease. Each year, hypertension contributes to one of every seven deaths in the U.S. and to nearly half of all cardiovascular disease-related deaths, including stroke.1 If all hypertensive patients were treated effectively to reach the blood pressure (BP) goals established in current clinical guidelines, 46,000 deaths might be averted each year.2 In addition to the cost in lives lost, hypertension is costly to the health care system in terms of dollars spent. The American Heart Association recently estimated that the direct and indirect costs of hypertension total more than $93.5 billion per year and that cardiovascular disease and stroke account for 17% of total annual health expenditures in the U.S.3

Eight classes of medications are currently used in the treatment of hypertension. They include diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-adrenergic blockers, alpha-adrenergic blockers, calcium-channel blockers (CCBs), central alpha-adrenergic receptor agonists (also called central adrenergic inhibitors), and direct renin inhibitors (DRIs). Until recently, the ARB class consisted of seven agents: candesartan (Atacand, AstraZeneca), eprosartan (Teveten, Abbott), irbesartan (Avapro, Bristol-Myers Squibb/Sanofi), losartan (Cozaar, Merck), olmesartan (Benicar, Daiichi Sankyo), telmisartan (Micardis, Boehringer Ingelheim), and valsartan (Diovan, Novartis). Many of these drugs are available in combination with other antihypertensive agents, such as the DRI aliskiren (Tekturna, Novartis), the CCB amlodipine (Nor vasc, Pfizer), and the thiazide diuretic hydrochlorothiazide (HCTZ).

Four ARBs have been approved for indications other than hypertension. Candesartan and valsartan may be used for the treatment of heart failure,4,5 and irbesartan and losartan are indicated for the treatment of nephropathy in patients with type-2 diabetes and hypertension.6,7

Azilsartan medoxomil (Edarbi, Takeda) is a new addition to the ARB class of antihypertensive agents. It received FDA approval in February 2011.8

Azilsartan Medoxomil (Edarbi): The Eighth Angiotensin II Receptor Blocker.

Drug therapy often fails to control hypertension. Azilsartan medoxomil (AZL-M) is a newly developed angiotensin II receptor blocker with high efficacy and good tolerability. This double-blind, controlled, randomised trial compared its antihypertensive efficacy and safety vs the angiotensin-converting enzyme inhibitor ramipril (RAM) in patients with clinic systolic blood pressure (SBP) 150–180 mm Hg. Patients were randomised (n=884) to 20 mg AZL-M or 2.5 mg RAM once daily for 2 weeks, then force-titrated to 40 or 80 mg AZL-M or 10 mg RAM for 22 weeks. The primary endpoint was change in trough, seated, clinic SBP. Mean patient age was 57±11 years, 52.4% were male, 99.5% were Caucasian. Mean baseline BP was 161.1±7.9/94.9±9.0 mm Hg. Clinic SBP decreased by 20.6±0.95 and 21.2±0.95 mm Hg with AZL-M 40 and 80 mg vs12.2±0.95 mm Hg with RAM (P<0.001 for both AZL-M doses). Adverse events leading to discontinuation were less frequent with AZL-M 40 and 80 mg (2.4% and 3.1%, respectively) than with RAM (4.8%). These data demonstrated that treatment of stage 1–2 hypertension with AZL-M was more effective than RAM and better tolerated.

/pdf/antihypertensive-efficacy-of-the-angiotensin-receptor-dd97t2kqqu.pdf

Antihypertensive efficacy of the angiotensin receptor blocker azilsartan medoxomil compared with the angiotensin-converting enzyme inhibitor ramipril

Objective:We compared the blood pressure (BP)–lowering efficacy and safety of the new angiotensin II receptor blocker (ARB) azilsartan medoxomil (AZL-M), with the angiotensin-converting enzyme inhibitor ramipril (RAM) in patients with stages 1–2 systolic hypertension.Design and Method:In this 24-wee

Comparison of antihypertensive efficacy of the new angiotensin receptor blocker azilsartan medoxomil with ramipril: pp.16.112

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Antihypertensive efficacy of the angiotensin receptor blocker azilsartan medoxomil compared with the angiotensin-converting enzyme inhibitor ramipril

Comparison of antihypertensive efficacy of the new angiotensin receptor blocker azilsartan medoxomil with ramipril: pp.16.112