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Tekturna (Aliskiren Hemifumarate) - Summary

 
 



WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue Tekturna as soon as possible. (5.1)
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
 

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.


See all Tekturna indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Tekturna (Aliskiren)

Medical News Today: Hypertension: have we missed something?
Source: Featured Health News from Medical News Today [2016.02.11]
Hypertension brings to mind cholesterol and heart disease, but scientists are starting to look more closely at the brain for clues. What can neurology offer patients with high BP?

Hypertension: have we missed something?
Source: Cardiovascular / Cardiology News From Medical News Today [2016.02.11]
Hypertension brings to mind cholesterol and heart disease, but scientists are starting to look more closely at the brain for clues. What can neurology offer patients with high BP?

Rat study shows that renal denervation helps to bring drug-resistant hypertension under control
Source: Hypertension News From Medical News Today [2016.02.10]
Treatment failure in clinical trials may be due to incomplete procedure, lead author suggests.

Prehypertension in late pregnancy linked to poorer fetal outcomes
Source: Hypertension News From Medical News Today [2016.02.02]
Women who develop prehypertension after 36 weeks' gestation may be at greater risk of having a stillbirth or an underweight infant, according to researchers from Sweden.

Easily stressed teens have increased hypertension risk later in life
Source: Hypertension News From Medical News Today [2016.02.02]
Being an easily stressed 18-year-old might predict high blood pressure later in life, according to a study following the health of 1.5 million Swedish men.

more news >>

Published Studies Related to Tekturna (Aliskiren)

Effect of naproxen and acetaminophen on blood pressure lowering by ramipril, valsartan and aliskiren in hypertensive patients. [2013]
CONCLUSIONS: Both naproxen and acetaminophen can affect anti-hypertensive therapy

Aliskiren effect on plaque progression in established atherosclerosis using high resolution 3D MRI (ALPINE): a double-blind placebo-controlled trial. [2013]
CONCLUSIONS: MRI quantification of atheroma plaque burden demonstrated that

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.

more studies >>

Clinical Trials Related to Tekturna (Aliskiren)

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 plasma. 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 effective.

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.

more trials >>

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

Based on a total of 1 ratings/reviews, Tekturna has an overall score of 10. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

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!

See all Tekturna reviews / ratings >>

Page last updated: 2016-02-11

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