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INDICATIONS AND USAGE
TekturnaHCT is indicated for the treatment of hypertension.
Add-On Therapy
A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with TekturnaHCT.
A patient whose blood pressure is controlled with hydrochlorothiazide alone but who experiences hypokalemia may be switched to combination therapy with TekturnaHCT.
A patient who experiences dose-limiting adverse reactions on either component alone may be switched to TekturnaHCTcontaining a lower dose of that component in combination with the other to achieve similar blood pressure reductions.
Replacement Therapy
TekturnaHCT may be substituted for the titrated components.
Initial Therapy
Tekturna HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
The choice of Tekturna HCT as initial therapy should be based on an assessment of potential benefits and risks.
Patients with Stage 2 hypertension are at a 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 the high-dose multifactorial study [see Clinical Studies (14)] provides estimates of the probability of reaching a target blood pressure with Tekturna HCT compared to aliskiren or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Tekturna HCT 300/25mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at 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
Figure 2: Probability of Achieving Systolic Blood Pressure (SBP) <130 mmHg
Figure 3: Probability of Achieving Diastolic Blood Pressure (DBP) <90 mmHg
Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) <80 mmHg
At all levels of baseline blood pressure, the probability of achieving any given diastolic or systolic goal is greater with the combination than for either monotherapy.For example, the mean baseline msSBP/msDBP for patients participating in this multifactorial study was 154/99 mmHg.A patient with a baseline blood pressure of 154/99 mmHg has about a 62% chance of achieving a goal of <140 mmHg (systolic) and61% chance of achieving <90 mmHg (diastolic) on aliskiren alone, and the chance of achieving these goals on hydrochlorothiazide alone is about 54% (systolic) and 49% (diastolic). The chance of achieving these goals on Tekturna HCT rises to about 77% (systolic) and74% (diastolic). The chance of achieving these goals on placebo is about 34% (systolic) and37% (diastolic).[See Dosage and Administration (2) and Clinical Studies (14)
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TekturnaHCTis a combination of aliskiren, a direct renin inhibitor, and hydrochlorothiazide (HCTZ), a thiazide diuretic,indicated for the treatment of hypertension:
In patients not adequately controlled with monotherapy
As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals(1)
Figure 1: Probability of Achieving Systolic Blood Pressure (SBP) <140 mmHg
Figure 2: Probability of Achieving Systolic Blood Pressure (SBP) <130 mmHg
Figure 3: Probability of Achieving Diastolic Blood Pressure (DBP) <90 mmHg
Figure 4: Probability of Achieving Diastolic Blood Pressure (DBP) <80 mmHg