USE IN PREGNANCY: When used in pregnancy drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Tekturna should be discontinued as soon as possible. See WARNING S : Fetal/Neonatal Morbidity and Mortality.
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.
Media Articles Related to Tekturna (Aliskiren)
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Published Studies Related to Tekturna (Aliskiren)
Effect of naproxen and acetaminophen on blood pressure lowering by ramipril,
valsartan and aliskiren in hypertensive patients. 
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. 
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. 
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.
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 â‰¥ 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.
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
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
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.
Bioavailability of Aliskiren and Valsartan Combined as a Single Tablet vs. the Same Medications Given Separately to Healthy Subjects. [Completed]
This study will assess the bioavailability of aliskiren and valsartan as a single tablet
compared to the same doses of the two drugs given as two separate tablets in healthy
Reports of Suspected Tekturna (Aliskiren) Side Effects
Blood Pressure Increased (33),
Drug Ineffective (21),
Cerebrovascular Accident (19),
Diabetes Mellitus (16),
Blood Pressure Inadequately Controlled (14),
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
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|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|
|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!|
Page last updated: 2015-07-09