1 INDICATIONS AND USAGE
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 Programs 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 patients risk.
Data from an 8-week, placebo-controlled, parallel-group factorial
study [see Clinical
Studies (14.1)] 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.
Azor is a dihydropyridine calcium channel
blocker and angiotensin II receptor blocker combination product
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. (1).
Azor is indicated
as initial therapy in patients likely to need multiple
antihypertensive agents to achieve their blood pressure goals (1).
image of figure 1
image of figure 2
image of figure 3
image of figure 4