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Tekturna HCT (Aliskiren / Hydrochlorothiazide) - Summary

 
 



WARNING:   AVOID USE IN PREG NANCY

When pregnancy is detected, discontinue Tekturna  HCT   as soon as possible. D rugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.   [ See Warnings and Precautions (5.1) ]

 

TEKTURNA HCT SUMMARY

TekturnaHCT is a fixed combination of aliskiren, an orally active, nonpeptide, potent direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic.

TekturnaHCT is indicated for the treatment of hypertension.

Both aliskiren and hydrochlorothiazide are associated with dose-dependent and dose-independent adverse effects. Patients treated with TekturnaHCT may experience any or all of these adverse effects. For dose-dependent adverse effects, using a strength of TekturnaHCT with a lower dose of the component suspected of causing the adverse effect may produce better tolerability.

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.

Limitation of Use

This fixed dose combination is not indicated for initial therapy.


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NEWS HIGHLIGHTS

Media Articles Related to Tekturna HCT (Aliskiren / Hydrochlorothiazide)

Deaths from pulmonary hypertension have increased, say CDC
Source: Cardiovascular / Cardiology News From Medical News Today [2014.04.04]
A study from the CDC finds that deaths from pulmonary hypertension - high blood pressure in the arteries leading from the heart to the lungs - have increased over the past decade.

Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Source: MedicineNet Brain Aneurysm Specialty [2014.04.02]
Title: Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Category: Diseases and Conditions
Created: 11/8/1998 8:47:00 PM
Last Editorial Review: 4/2/2014 12:00:00 AM

Children with glomerular kidney disease more likely to have hypertension as adults
Source: Hypertension News From Medical News Today [2014.03.20]
Men who as children had glomerular disease, a disorder of the portion of the kidney that filters blood and one that usually resolves with time, were more likely than men without childhood...

First guidelines for patients with pulmonary hypertension in sickle cell disease
Source: Blood / Hematology News From Medical News Today [2014.03.19]
Boston Medical Center (BMC) and Boston University School of Medicine (BUSM) physicians have helped create the first set of clinical guidelines for treating patients with pulmonary hypertension in...

Guidelines on the management of pulmonary hypertension of sickle cell disease
Source: Hypertension News From Medical News Today [2014.03.18]
The American Thoracic Society has developed clinical practice guidelines to help clinicians identify and manage patients with sickle cell disease who are at increased risk for mortality from...

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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.

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Clinical Trials Related to Tekturna HCT (Aliskiren / Hydrochlorothiazide)

Effects of Aliskiren on Patient With Heart Failure and a Normal Ejection Fraction [Recruiting]
The primary objective of this study is to determine whether treatment with aliskiren (300 mg) compared to placebo will improve treadmill exercise time in older (age ≥ 55 years) patients with heart failure and normal ejection fraction (HFNEF).

The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis [Recruiting]
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.

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 effective.

Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease [Recruiting]
Primary Hypothesis: Aldosterone breakthrough will occur at a far lower frequency during renin inhibition (0-10% over 9 months), alone or in combination with an ARB, compared to conventional ARB therapy (35-45% over 9 months). The investigators hypothesize that aldosterone breakthrough occurs due to accumulation of active precursor substances, most notably angiotensin II, produced in response to conventional RAAS blockade with ACEinhibitors and ARBs. The investigators believe that direct renin inhibition (DRI) should minimize this accumulation and therefore significantly lower or possibly eliminate the breakthrough effect.

Interruption of the renin-angiotensin-aldosterone system (RAAS) with angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin receptor blockers (ARBs), alone and in combination, has become a leading therapy to slow the progression of chronic heart and kidney disease. Both types of drugs inhibit the formation of aldosterone, a hormone, which has been shown to have harmful effects on patients with chronic heart and kidney disorders. This treatment is effective but not perfect since, even after an initial improvement, many patients become worse over the long term. This may be due to an unexpected increase in aldosterone, a phenomenon called "aldosterone breakthrough."

The purpose of this study is to find out whether the use of a direct renin inhibitor (DRI) alone, or in combination with an angiotensin receptor blocker (ARB), will lessen the occurrence of aldosterone breakthrough since direct renin inhibitors inhibit the formation of aldosterone at a very early step. This study will compare the effectiveness of adding Diovan (valsartan) or Tekturna (aliskiren) or a combination of Diovan and Tekturna to the usual antihypertensive treatment. The investigators will follow blood pressure, aldosterone levels, and urinary protein levels over 9 months to evaluate which of these therapies is most effective for treating hypertension in patients with proteinuric kidney disease.

Comparison of Aliskiren vs Hydrochlorothiazide in Hypertensive Type II Diabetic Patients on Resistance Arteries and Endothelial Dysfunction [Not yet recruiting]
This study will be performed only at the Jewish General Hospital. It will investigate the effect of treatment with aliskiren, an inhibitor of renin, a substance produced by the kidney that constricts arteries and raises blood pressure, on the blood vessels, specifically the arteries, of subjects who have diabetes and elevated blood pressure (hypertension).

To investigate blood vessels, different techniques will be used. For large arteries, these will be studied by non invasive methods using detection of the pulse wave or using ultrasound over the skin of the neck, the wrist and the groin. To study small vessels, the investigators will perform a biopsy on the buttock, under local anesthesia, and obtain a small sample of tissue from under the skin, from which the vessels will be dissected. The investigators have performed many hundreds of these small biopsies over the past 20 years for similar studies without any complications. The biopsies are very well tolerated. From this research the investigators will thus be able to learn what the structure and function of these vessels is in these patients, in comparison to a normal healthy group.

The hypertensive diabetic subjects will then be assigned by chance (randomized trial) to treatment with the renin inhibitor aliskiren or a comparator, the diuretic hydrochlorothiazide. Aliskiren is a relatively new drug used to treat hypertension that is very well tolerated and is now being evaluated in numerous trials in hypertensive diabetic individuals. The diuretic is a well-know agent used to treat high blood pressure now for many years, and which is very well tolerated. Physicians, nurses and scientists involved in the study will be unaware of who is receiving which drug, as will be the patients (this is the meaning of double-blind trial). However, if there is any problem, the secret code will be broken and the individual withdrawn from the study. Subjects will be treated for a year, and the study procedures (non invasive and the biopsy) repeated at 6 months and after one year of treatment. During the study, blood samples will be drawn and urine collected at certain intervals to ensure safety of the treatment.

Once tissues are obtained they will be studied in the laboratory. The study of the vessels will allow treatment us to determine how the treatment with the renin inhibitor aliskiren affects the structure and function as well as cellular and molecular aspects of arteries of hypertensive diabetic persons. The investigators expect these studies to provide us knowledge on mechanisms and perhaps new targets for future therapies of cardiovascular disease and hypertension.

more trials >>

Reports of Suspected Tekturna HCT (Aliskiren / Hydrochlorothiazide) Side Effects

Feeling Abnormal (7)Blood Pressure Increased (5)Headache (4)Oedema Peripheral (4)Dizziness (4)Hypertension (4)Hypersensitivity (3)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

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
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
  
Reported Results
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.

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Page last updated: 2014-04-04

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