Tekturna (Aliskiren Hemifumarate) - Summary

TEKTURNA SUMMARY

Aliskiren, the active component of Tekturna ^® Tablets, is an orally active, nonpeptide, potent renin inhibitor. Aliskiren is present in Tekturna Tablets as its hemifumarate salt.

Tekturna ^® (aliskiren) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Use with maximal doses of ACE inhibitors has not been adequately studied.

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NEWS HIGHLIGHTS

Media Articles Related to Tekturna (Aliskiren)

Viagra, Aliskiren Not Helpful for Heart Failure After All: Studies
Source: MedicineNet Impotence (ED) Specialty [2013.03.12]
Title: Viagra, Aliskiren Not Helpful for Heart Failure After All: Studies
Category: Health News
Created: 3/11/2013 4:36:00 PM
Last Editorial Review: 3/12/2013 12:00:00 AM

ESH/ESC Publish Hypertension Guidelines
Source: Medscape Medical News Headlines [2013.06.15]
The new guidelines make <140 mm Hg the treatment target for all individuals, with a few minor exceptions, and say that all the drug classes have a role in reducing blood pressure. In addition, the ESH/ESC guidelines emphasize a role for ABPM and reiterate their emphasis on combination therapy.
Heartwire

Vitamin D Can Help Prevent Hypertension
Source: Health News from Medical News Today [2013.06.15]
The world's largest study to examine the link between vitamin D levels and hypertension has found that low levels of Vitamin D can be a major cause of hypertension. Researchers presented their findings at the annual conference of the European Society of Human Genetics (ESHG). Data were gathered from 35 studies, which included more than 155,000 participants from different parts of Europe and North America. Dr. Vimal Karani S, from the Institute of Child Health, University College London, London, UK, led the study...

Hypertension Risk Drops with Volunteer Work (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2013.06.14]
(MedPage Today) -- Older adults had a significantly lower risk of developing hypertension if they performed at least 200 hours of volunteer service in the previous year, a longitudinal survey showed.

Link Clarified Between Hypertension And Vitamin D Deficiency
Source: Hypertension News From Medical News Today [2013.06.12]
Low levels of vitamin D can trigger hypertension, according to the world's largest study to examine the causal association between the two. Although observational studies have already shown this link, a large-scale genetic study was necessary before the cause and effect could be proven, the annual conference of the European Society of Human Genetics (ESHG) heard. Dr...

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Published Studies Related to Tekturna (Aliskiren)

Comparison of the effects of aliskiren/valsartan in combination versus valsartan alone in patients with stage 2 hypertension. [2012]
The extent to which the combination of a renin inhibitor with an angiotensin receptor blocker (ARB) lowers clinic and ambulatory blood pressure (BP) versus an ARB alone in stage 2 hypertension is not well known. Hence, we performed an 8-week, randomized, double-blind study in 451 patients with stage 2 hypertension to compare the efficacy of the combination of aliskiren/valsartan 300/320 mg versus valsartan 320 mg...

Long-Term Safety and Tolerability of the Oral Direct Renin Inhibitor Aliskiren with Optional Add-On Hydrochlorothiazide in Patients with Hypertension: A Randomized, Open-Label, Parallel-Group, Multicentre, Dose-Escalation Study with an Extension Phase. [2011.10.13]
BACKGROUND: Most patients with hypertension will require combination therapy with at least two agents from different antihypertensive classes to achieve blood pressure (BP) control. Thiazide diuretics, such as hydrochlorothiazide (HCTZ), are widely used in combination therapy. The volume reduction with these agents stimulates the renin-angiotensin system (RAS), making RAS inhibitors such as the direct renin inhibitor aliskiren a logical choice for combination therapy with HCTZ. OBJECTIVE: The aim of this study was to investigate the long-term safety, tolerability and efficacy of the direct renin inhibitor aliskiren, with or without addition of the diuretic HCTZ... CONCLUSION: In patients with hypertension, long-term treatment with aliskiren, with or without add-on HCTZ, is well tolerated and provides effective BP lowering that is sustained over 12 months. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00219037.

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.

Neurohumoral effects of aliskiren in patients with symptomatic heart failure receiving a mineralocorticoid receptor antagonist: the Aliskiren Observation of Heart Failure Treatment study. [2011.07]
CONCLUSION: Aliskiren 150 mg added to standard HF therapy was well tolerated over 12 weeks and provided beneficial changes in neurohumoral biomarkers regardless of concomitant MRA treatment.

Associations of albuminuria in patients with chronic heart failure: findings in the ALiskiren Observation of heart Failure Treatment study. [2011.07]
CONCLUSIONS: Increased UACR is common in patients with heart failure, including non-diabetics. Urinary albumin creatinine ratio is independently associated with HbA1c and NT-proBNP, even in non-diabetic patients.

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Clinical Trials Related to Tekturna (Aliskiren)

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.

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Reports of Suspected Tekturna (Aliskiren) Side Effects

Blood Pressure Increased (33),  Hypertension (27),  Drug Ineffective (21),  Dizziness (21),  Cerebrovascular Accident (19),  Diabetes Mellitus (16),  Rash (15),  Blood Pressure Inadequately Controlled (14),  Diarrhoea (13),  Blood Pressure Fluctuation (13), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Tekturna review by 49 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		hypertension
Dosage & duration:		300mg taken once per day for the period of 2 years
Other conditions:		high cholesterol
Other drugs taken:		terazosin, Niaspan
		Reported Results
Benefits:		Very well managed blood pressure within normal, healthy range. I had an allergic reaction to a more common blood pressure medication, Lisinopril (which is a combination of a thiazide diuretic and an ACE inhibitor). The newer Tekturna has worked perfectly for me with only the slightest dizziness when I rose too quickly early on, but no side effects at all after the first few weeks.
Side effects:		I had a very slight issue, early on in treatment (in the first few weeks only), of slight dizziness when rising quickly from either laying down or from bending over with my head down (such as when petting my cat when she was laying on the floor), but that fully resolved quite quickly. I have not had any other side effects at all.
Comments:		I take one 300mg Tekturna per day, in the morning, along with 10mg of Terazosin (Hytrin) and my blood pressure is wonderfully under control. My last blood pressure reading was 110/66 which is perfect!