Aliskiren (ah LIS ker in; Tekturna - Novartis), the first direct renin inhibitor, has been approved by the FDA for treatment of hypertension. It is indicated for oral use either as monotherapy or in combination with other antihypertensive agents.

Aliskiren (Tekturna - Novartis), the first direct renin inhibitor for treatment of hypertension, has been approved for use in a fixed-dose combination with the diuretic hydrochlorothiazide (Tekturna HCT - Novartis). Many angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) are also available in fixed-dose combinations with hydrochlorothiazide (HCTZ).

A randomized, placebo-controlled trial evaluating the addition of the direct renin inhibitor aliskiren (Tekturna – Novartis) to an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) in 8606 patients with type 2 diabetes and renal impairment (ALTITUDE) was terminated prematurely by the manufacturer because the combined incidence of cardiovascular and renal events was higher in patients who received aliskiren than in those who received placebo.1Combining two different types of drugs that block the renin angiotensin system in patients at high-risk for...

The FDA has approved Tekamlo (Novartis), an oral fixed-dose combination of the direct renin inhibitor aliskiren (Tekturna) and the calcium channel blocker amlodipine (Norvasc, and others), for treatment of hypertension in patients not adequately controlled on monotherapy or already taking both drugs, and as initial therapy in those likely to need multiple drugs to control their blood pressure (BP). Both aliskiren and amlodipine are available in combinations with other antihypertensive agents.

The FDA has approved the use of aliskiren (Tekturna), a direct renin inhibitor, with valsartan (Diovan), an angiotensin-receptor blocker (ARB), in a fixed-dose combination as Valturna (Novartis) for treatment of hypertension in patients already taking both drugs or not adequately controlled on monotherapy, and as initial therapy in those likely to need multiple drugs to control their blood pressure.

A once-daily oral formulation of mesalamine (Lialda - Shire) was recently approved by the FDA for induction of remission in patients with mild to moderate ulcerative colitis.

The dopamine agonist pramipexole (Mirapex - Boehringer Ingelheim) is the second drug approved by the FDA for treatment of moderate to severe restless legs syndrome (RLS). Ropinirole (Requip), another dopamine agonist, was approved for RLS in 2005. Both of these drugs were first approved for treatment of Parkinson's disease.

American College of Cardiology/American Heart Association (ACC/AHA) guidelines for treatment of hypertension were last published in 2018. Treatment of hypertensive urgencies and emergencies is not discussed here.