WARNING: AVOID USE IN PREG NANCY
When pregnancy is detected, discontinue
as soon as possible.
rugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
See Warnings and Precautions
TEKTURNA HCT SUMMARY
Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic.
Tekturna HCT is indicated for the treatment of hypertension.
A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna HCT.
A patient whose blood pressure is controlled with hydrochlorothiazide alone but who experiences hypokalemia may be switched to combination therapy with Tekturna HCT.
A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Tekturna HCT containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions.
Tekturna HCT may be substituted for the titrated components.
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 300/25 mg, 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) and 61% 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) and 74% (diastolic). The chance of achieving these goals on placebo is about 34% (systolic) and 37% (diastolic). [See Dosage and Administration and Clinical Studies
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Published Studies Related to Tekturna HCT (Aliskiren / Hydrochlorothiazide)
Aliskiren as add-on therapy in the treatment of hypertensive diabetic patients inadequately controlled with valsartan/HCT combination: a placebo-controlled study. [2011.10.01]
BACKGROUND: Hypertension frequently coexists with diabetes mellitus, resulting in increased cardiovascular risk. Thus, BP control is crucial in decreasing morbidity and mortality in this difficult-to-treat patient population. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of aliskiren in hypertensive patients with diabetes not adequately responsive to the combination of valsartan and hydrochlorothiazide (HCT)... CONCLUSION: The reductions in BP with aliskiren added to valsartan/HCT in this study were numerically greater compared with placebo added to valsartan/HCT, although not statistically significant. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00219102.
Peripheral and central blood pressure responses of combination aliskiren/hydrochlorothiazide and amlodipine monotherapy in African American patients with stage 2 hypertension: the ATLAAST trial. [2011.05]
Efficacy of antihypertensive agents on central blood pressure (BP) in African Americans is not well studied. The authors report on an 8-week double-blind, randomized study of African American patients with stage 2 hypertension that compared brachial and central BP responses (substudy of 53 patients) to combination aliskiren/hydrochlorthiazide (HCTZ) and amlodipine monotherapy...
Comparison of aliskiren/hydrochlorothiazide combination therapy with hydrochlorothiazide monotherapy in older patients with stage 2 systolic hypertension: results of the ACTION study. [2011.03]
Patients with stage 2 systolic hypertension require sizable blood pressure (BP) reductions to achieve recommended targets. This randomized double-blind study compared a single-pill combination of the direct renin inhibitor aliskiren and hydrochlorothiazide (aliskiren/HCTZ) with HCTZ monotherapy in older patients (older than 55 years) with systolic BP >/=160 mm Hg and <200 mm Hg...
Aliskiren alone or in combination with hydrochlorothiazide in patients with the lower ranges of stage 2 hypertension: The ACQUIRE randomized double-blind study. [2010.12]
Patients with stage 2 hypertension (systolic blood pressure [SBP] >/=160mm Hg and/or diastolic blood pressure [DBP] >/=100mm Hg) are at high cardiovascular risk and require intensive blood pressure (BP)-lowering therapy. This randomized double-blind study is the first prospective trial specifically designed to evaluate the direct renin inhibitor aliskiren in patients with a mean sitting SBP >/=160 mm Hg and <180mm Hg (the lower ranges of stage 2 systolic hypertension)...
Antihypertensive efficacy and tolerability of aliskiren/hydrochlorothiazide (HCT) single-pill combinations in patients who are non-responsive to HCT 25 mg alone. [2009.04]
OBJECTIVE: Thiazide diuretics such as hydrochlorothiazide (HCT) are a widely used first-line treatment for hypertension, but most patients will not achieve blood pressure (BP) control with HCT alone and so will require combination therapy. In this study the efficacy, safety and tolerability of a single-pill combination (SPC) of the direct renin inhibitor aliskiren with HCT were investigated in patients non-responsive to HCT 25 mg therapy... CONCLUSION: Aliskiren/HCT SPCs provide clinically significant BP reductions and improved BP control rates in patients who are non-responsive to HCT 25 mg monotherapy. Limitations of the study were the mainly Caucasian patient population and the non-responder design.
Clinical Trials Related to Tekturna HCT (Aliskiren / Hydrochlorothiazide)
Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension [Terminated]
Part 1 determined: aliskiren, amlodipine and angiotensin II concentrations in interstitial
fluid of fat and skeletal muscle; aliskiren and angiotensin II concentrations, and renin
activity and concentration in fat and skeletal muscle tissues (biopsies); aliskiren,
amlodipine and angiotensin II concentrations, and renin activity and concentration in
Part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone
system (RAAS) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle
tissue in obese patients with hypertension in comparison to amlodipine.
Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension [Recruiting]
In this research study, the goal is to find out if a currently FDA-approved medication
called Tekturna(Aliskiren) along with the addition of Vitamin D will lower blood pressure
and improve heart function in the African American population. High blood pressure occurs
earlier in life in African Americans, is more severe, and is associated with greater organ
damage in relation to uncontrolled hypertension. Having low levels of Vitamin D is also very
common in the African American population. Research has shown that there may be a link
between low Vitamin D levels and the ability of high blood pressure medications to be fully
The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis [Terminated]
We will study the hypothesis that long-term Tekturna treatment will improve endothelial
function and the production and function of endothelial progenitor cells (EPCs) in patients
with early atherosclerosis. Specifically, long-term Tekturna treatment will increase the
Reactive Hyperemia Peripheral Arterial Tonometry indexes and increase the numbers and the
function of circulating endothelial progenitor cells, compared to placebo, in association
with a reduction in inflammation and oxidative stress.
A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus [Completed]
The study objective was to assess the effect of single and multiple doses of aliskiren on
renal plasma flow, glomerular filtration rate and to compare the effects of single and
multiple doses of aliskiren versus captopril or irbesartan on renal blood flow, glomerular
filtration rate, and retinal blood flow in patients with type 2 diabetes mellitus.
Pharmacokinetics, Safety and Tolerability of Aliskiren (SPP100) in Patients With End Stage Renal Disease on Hemodialysis and Matched Healthy Subjects [Completed]
This study will assess the pharmacokinetics, safety and tolerability of aliskiren in healthy
subjects and patients with End Stage Renal Disease on hemodialysis.
Reports of Suspected Tekturna HCT (Aliskiren / Hydrochlorothiazide) Side Effects
Feeling Abnormal (7),
Blood Pressure Increased (5),
Oedema Peripheral (4),
Diabetes Mellitus (3),
Drug Ineffective (3),
Blood Pressure Inadequately Controlled (3), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Tekturna HCT has an overall score of 1. The effectiveness score is 2 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
Tekturna HCT review by 75 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Ineffective|
|Side effects:|| || Severe Side Effects|
|Condition / reason:|| || high blood pressure|
|Dosage & duration:|| || 300mg/12.5 mg taken 1 x daily for the period of 3 weeks |
|Other conditions:|| || dermatomyositis,hypothyroidism |
|Other drugs taken:|| || levothyroxine, prednisone|
|Benefits:|| || none,pressure never came down to acceptable range and had wide swings throughout the day|
|Side effects:|| || pounding headache, nausea, dizziness while walking and arising from bed/chair, spots in eye, uncontrollable eye tearing. The latter two are still present after6 weeks on not taking meds.|
|Comments:|| || they didn't work even after dossage was increased, Monitored at home and in doctor's office, results were the same.|
Page last updated: 2016-04-19