"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Azor.
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 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).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Azor may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.
Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk.
Data from an 8-week, placebo-controlled, parallel-group factorial study [see Clinical Studies] provide estimates of the probability of reaching a blood pressure goal with Azor compared to amlodipine or olmesartan medoxomil monotherapy. The figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with Azor 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. The right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures.
Figure 1: Probability of Achieving Systolic Blood Pressure (SBP) < 140 mmHg at Week 8 With LOCF
Figure 2: Probability of
Achieving Diastolic Blood Pressure (DBP) < 90 mmHg at Week 8 With LOCF
Figure 3: Probability of Achieving Systolic Blood Pressure
(SBP) < 130 mmHg at Week 8 With LOCF
Figure 4: Probability of Achieving Diastolic Blood Pressure
(DBP) < 80 mmHg at Week 8 With LOCF
The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 SBP < 140 mmHg or < 130 mmHg or a DBP < 90 mmHg or < 80 mmHg) for the high-dose treatment groups evaluated in the study. Azor 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg.
For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 48% likelihood of achieving a goal of < 140 mmHg (systolic) and a 51% likelihood of achieving a goal of < 90 mmHg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of < 140 mmHg (systolic) and a 60% likelihood of achieving a goal of < 90 mmHg (diastolic) on monotherapy with amlodipine 10 mg. The likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on Azor 5/20 mg, and to 68% (systolic) and 85% (diastolic) on Azor 10/40 mg.
DOSAGE AND ADMINISTRATION
The side effects of olmesartan medoxomil are generally rare and apparently independent of dose. Those of amlodipine are generally dose-dependent (mostly edema).
Maximum antihypertensive effects are attained within 2 weeks after a change in dose.
Azor may be taken with or without food.
Azor may be administered with other antihypertensive agents.
Dosage may be increased after 2 weeks. The maximum recommended dose of Azor is 10/40 mg.
Azor may be substituted for its individually titrated components.
When substituting for individual components, the dose of one or both of the components can be increased if blood pressure control has not been satisfactory.
Azor may be used to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with olmesartan medoxomil (or another angiotensin receptor blocker) alone.
The usual starting dose of Azor is 5/20 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of one 10/40 mg tablet once daily as needed to control blood pressure [See Clinical Studies].
Dosage Forms And Strengths
Azor tablets are formulated for oral administration in the following strength combinations:
|Amlodipine equivalent (mg)||5||5||10||10|
|Olmesartan medoxomil (mg)||20||40||20||40|
Storage And Handling
Azor tablets contain amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine and olmesartan medoxomil in the strengths described below.
Azor tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Azor tablets are supplied for oral administration in the following strength and package configurations:
|Tablet Strength (amlodipine equivalent/ olmesartan medoxomil) mg||Package Configuration||NDC#||Product Code||Tablet Color|
|5/20 mg||Bottle of 30||65597-110-30||C73||White|
|Bottle of 90||65597-110-90|
|10 blisters of 10||65597-110-10|
|Bottle of 1000||65597-110-11|
|10/20 mg||Bottle of 30||65597-111-30||C74||Grayish Orange|
|Bottle of 90||65597-111-90|
|10 blisters of 10||65597-111-10|
|Bottle of 1000||65597-111-11|
|5/40 mg||Bottle of 30||65597-112-30||C75||Cream|
|Bottle of 90||65597-112-90|
|10 blisters of 10||65597-112-10|
|Bottle of 1000||65597-112-11|
|10/40 mg||Bottle of 30||65597-113-30||C77||Brownish Red|
|Bottle of 90||65597-113-90|
|10 blisters of 10||65597-113-10|
|Bottle of 1000||65597-113-11|
Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].
Manufactured for Daiichi Sankyo, Inc., Parsippany, New Jersey 07054. Manufactured by Daiichi Sankyo Europe GmbH, Germany. Revised: May 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/27/2014
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