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Hypertension Drug Aliskiren (Tekturna) Fails to Reduce Cardiovascular Deaths or Rehospitalizations

Study finds drug treatment equivalent to placebo (Mar. 20)

In a new study published in JAMA, the initiation of aliskiren (Tekturna, Novartis) in addition to standard therapy did not reduce cardiovascular (CV) deaths or heart failure (HF) rehospitalizations at 6 or 12 months after discharge in patients hospitalized for HF with reduced left ventricular ejection fraction (LVEF).

The double-blind, placebo-controlled ASTRONAUT trial randomized 1,615 hemodynamically stable, hospitalized HF patients in North and South America, Europe, and Asia between May 2009 and December 2011. The follow-up period ended in July 2012. Eligible patients were 18 years old or older with reduced LVEF (40% or less), and with signs and symptoms of fluid overload. The study’s primary endpoint was CV death or HF rehospitalization.

At randomization, the patients were receiving diuretics (96%), beta blockers (83%), angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (84%), or mineralocorticoid receptor antagonists (57%).

All of the patients were treated with 150 mg of aliskiren (increased to 300 mg, if tolerated) or placebo daily in addition to standard therapy. The drug was continued after discharge for a median period of 11.3 months.

At 6 months after discharge, 25% of patients receiving aliskiren met the trial’s primary endpoint (77 CV deaths and 153 HF rehospitalizations), compared with 27% of patients receiving placebo (85 CV deaths and 166 HF rehospitalizations) (hazard ratio [HR]: 0.92; P = 0.41). At 12 months, the event rates were 35% for the aliskiren group (126 CV deaths and 212 HF rehospitalizations) and 37% for the placebo group (137 CV deaths and 224 HF rehospitalizations) (HR: 0.93; P = 0.36). In addition, the aliskiren-treated patients showed higher rates of hyperkalemia, hypotension, and renal impairment or renal failure.

Tekturna (aliskiren) is a renin inhibitor indicated for the treatment of hypertension to lower blood pressure.

Sources: JAMA; March 20, 2013; and Tekturna PI; September 2012.

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