Products from Noden Pharma

Noden Pharma—Current Products

Hypertension

Hypertension is a chronic condition with serious long-term cardiovascular implications. It is associated with a number of serious risk factors including increased risk of cardiovascular disease, such as congestive heart failure, stroke and myocardial infarction (heart attack) as well as increased risk of chronic renal insufficiency and end stage renal disease.1,2 Importantly, hypertension is largely asymptomatic, which often leads to a lack of diagnosis and low patient compliance rates for treatments.3 The majority of these patients are seen by primary care physicians with infrequent referrals to other specialties driven by severe comorbidities or suspected secondary causes of the hypertension.2

In the United States, hypertension affects about 1/3 of the population or almost 78 million people.4 While evidence-based guidelines do not provide specific direction governing the order of the use of medicines for initial hypertension treatment, many physicians initiate treatment with either a diuretic, a calcium channel blocker (CCB), an angiotensin-converting-enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB). There are less expensive generic versions of all of these classes of drugs available.  It is estimated that nearly one half (46%) of US adults with hypertension are not controlled.5 Many patients will require treatment with more than one antihypertensive drug to achieve blood pressure control.2 Drug-related side effects may limit adherence to antihypertensive therapies and are an important contributor to the lack of BP control in patients with hypertension.6,7

Tekturna® and Tekturna HCT®

Tekturna (aliskiren) is approved for the treatment of hypertension or high blood pressure in adults.8 It is the only approved drug for hypertension that is a direct renin inhibitor. Renin is an enzyme in certain tissues and the bloodstream that can start a process which results in the narrowing of blood vessels. Tekturna inhibits renin which helps blood vessels relax, thus allowing blood to flow more freely and lowering blood pressure.8

Tekturna HCT (aliskiren and hydrochlorothiazide) is also approved for the treatment of hypertension or high blood pressure in adult patients who are not adequately controlled by monotherapy or who are likely to need multiple drugs in their initial treatment to achieve their goals of lower blood pressure.9 It contains two approved medicines – aliskiren, the direct renin inhibitor that is the active ingredient of Tekturna, and hydrochlorothiazide, a diuretic. The hydrochlorothiazide assists in reducing blood pressure by reducing sodium and water in the body thereby reducing blood volume and blood pressure.9

The prescribing information for TEKTURNA and TEKTURNA HCT includes a boxed warning for fetal toxicity, a contraindication against the use of aliskiren with ARBs or ACEIs in patients with diabetes, and a warning to avoid the use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment.8,9

Rasilez® and Rasilez HCT®

Rasilez and Rasilez HCT are the ex-US brand names of Tekturna and Tekturna HCT, respectively.

  1. http://emedicine.medscape.com/article/241381-overview ; accessed June, 2017
  2. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults, JAMA Vol 311 Number 5, Dec. 2013, p. 507.
  3. American Heart Association: http://www.heart.org/HEARTORG/Conditions/HighBloodPressure/GettheFactsAboutHighBloodPressure/The-Facts-About-High-Blood-Pressure_UCM_002050_Article.jsp#.WVZImGcm7IU ; Accessed June 2017.
  4. American Heart Association: http://www.heart.org/idc/groups/heart-public/@wcm/@sop/@smd/documents/downloadable/ucm_319587.pdf ; Accessed June 2017.
  5. Mozaffarian et al. Circulation. 2015;27:131:e29-e322.
  6. Neutel J, Smith D. J Clin Hypertens. 2003;5:127-132
  7. Thomopoulos et al. J Hypertension. 2016; 34:1921-1932
  8. Tekturna Prescribing Information; November, 2016; Noden Pharma, Dublin, Ireland.
  9. Tekturna HCT Prescribing Information; November, 2016; Noden Pharma; Dublin, Ireland.