1 INDICATIONS AND USAGE
AVALIDE (irbesartan-hydrochlorothiazide)
Tablets is indicated for the treatment of hypertension.
AVALIDE may be used in patients whose blood pressure is not adequately
controlled on monotherapy.
AVALIDE may also be used as initial therapy in patients who are likely to
need multiple drugs to achieve their blood pressure goals.
The choice of AVALIDE as initial therapy for hypertension should be based on
an assessment of potential benefits and risks.
Patients with stage 2 (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 may be shaped by considerations such as the baseline blood
pressure, the target goal, and the incremental likelihood of achieving goal with
a combination compared with monotherapy.
Data from Studies V and VI [see Clinical
Studies
(14.2)
]
provide estimates of the probability of reaching a blood pressure goal with
AVALIDE compared to irbesartan or HCTZ monotherapy. The relationship between
baseline blood pressure and achievement of a SeSBP less than 140or less than 130mmHg or
SeDBP less than 90 or less than 80 mmHg in patients treated with AVALIDE compared to
patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a
through 2b.
Figure 1a: Probability of Achieving SBP
less than 140 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week
7)*
Figure 1b: Probability of Achieving SBP
less than 130 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week
7)*
Figure 2a: Probability of Achieving DBP
less than 90 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week
7)*
Figure 2b: Probability of Achieving DBP
less than 80 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week
7)*
*For all probability curves, patients without blood pressure measurements at
Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal
(intent-to-treat analysis).
The above graphs provide a rough approximation of the likelihood of reaching
a targeted blood pressure goal (eg, Week 8 sitting systolic blood pressure less than or equal to 140
mmHg) for the treatment groups. The curve of each treatment group in each study
was estimated by logistic regression modeling from all available data of that
treatment group. The estimated likelihood at the right tail of each curve is
less reliable due to small numbers of subjects with high baseline blood
pressures.
For example, a patient with a blood pressure of 180/105 mmHg has about a 25%
likelihood of achieving a goal of less than 140 mmHg (systolic) and 50% likelihood of
achieving less than 90 mmHg (diastolic) on irbesartan alone (and lower still
likelihoods on HCTZ alone).
The likelihood of achieving these goals on AVALIDE rises to about 40%
(systolic) or 70% (diastolic).
AVALIDE is a combination of irbesartan, an angiotensin II
receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for
hypertension:
In patients not adequately controlled with monotherapy (1)
As initial therapy in patients likely to need multiple drugs to achieve
their blood pressure goals (1).
image of figure 1a
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