From the Guidelines
Aliskiren (brand name Tekturna) is still available on the market in the United States. It is an oral direct renin inhibitor approved by the FDA for the treatment of hypertension, either alone or in combination with other antihypertensive medications. Aliskiren works by inhibiting renin, an enzyme that initiates the renin-angiotensin-aldosterone system (RAAS), thereby reducing the production of angiotin I and II, which leads to vasodilation and decreased blood pressure. The typical dosage ranges from 150 mg to 300 mg once daily, as indicated in the 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults 1. However, it's essential to note that aliskiren should not be used in combination with ACE inhibitors or ARBs in patients with diabetes or moderate to severe renal impairment due to increased risk of adverse outcomes including hypotension, hyperkalemia, and renal dysfunction, as highlighted in the 2012 KDOQI clinical practice guideline for diabetes and CKD 1. Additionally, aliskiren is contraindicated during pregnancy as it can cause injury and death to the developing fetus. Key considerations for the use of aliskiren include:
- Monitoring serum creatinine/estimated glomerular filtration rate and serum potassium levels at least annually in patients treated with an ACE inhibitor, angiotensin receptor blocker, or diuretic 1
- Avoiding the use of aliskiren in patients with severe bilateral renal artery stenosis, as it may cause acute renal failure 1
- Being cautious when using aliskiren in patients with heart failure, as the evidence for its use in this population is limited 1
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Availability of Aliskiren in the United States
- The studies provided do not directly address whether aliskiren is currently on the market in the United States 2, 3, 4, 5, 6.
- However, it is mentioned that aliskiren was approved by the Food and Drug Administration in 2007 for the treatment of hypertension 3, 4.
- There is no information in the provided studies about aliskiren being withdrawn from the market or its current availability in the United States.
- The studies focus on the efficacy, safety, and clinical development of aliskiren as a treatment for hypertension, rather than its market status 2, 3, 4, 5, 6.
Regulatory Approval and Clinical Use
- Aliskiren is described as the first orally active direct renin inhibitor approved for the treatment of hypertension 3, 4, 6.
- It has been shown to be effective in reducing blood pressure, both as monotherapy and in combination with other antihypertensive agents 2, 3, 4, 5.
- The studies suggest that aliskiren is well tolerated, with a safety profile similar to that of placebo 3, 5.