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New Data Compare Aliskiren & HCTZ

Posted by medliorator on January 25, 2009

The new direct renin inhibitor aliskiren (Tekturna, Novartis)—when given as first-line monotherapy—reduced blood pressure to a greater degree than one of the usually recommended first-line agents, hydrochlorothiazide, in a new year-long study of patients with essential hypertension. The results were published online January 12, 2009 in Circulation

Schmieder and colleagues randomized 1124 patients with essential hypertension (mean diastolic BP, 95 to 109 mm Hg) to aliskiren 150 mg (n=459), hydrochlorothiazide 12.5 mg (n=444), or placebo (n=221) once daily. Forced titration (to 300 mg for aliskiren or 25 mg for hydrochlorothiazide) occurred at week three; at week six, patients receiving placebo were reassigned (1:1 ratio) to aliskiren 300 mg or to hydrochlorothiazide 25 mg. From week 12, the calcium channel blocker amlodipine 5 mg was added and titrated to 10 mg from week 18 for patients whose BP remained uncontrolled.

At the end of the monotherapy period, aliskiren 300 mg was superior to hydrochlorothiazide 25 mg in reducing BP (-17.4/-12.2 vs -14.7/-10.3 mm Hg; p<0.001).

Criticisms include the fact that the study looked only at a surrogate end points (i.e., mm Hg), and that hydrochlorothiazide is not the ideal comparator. Despite the fact that it is the most commonly prescribed antihypertensive drug, there is little evidence that it favorably affects clinical outcomes, said Dr Franz Messerli (St Luke-Roosevelt’s Hospital, New York). Also, most hypertension patients are controlled on at least two agents, which makes the comparison of monotherapies somewhat futile, said Cockcroft.

New Data on Aliskiren Provoke Debate [HeartWire]

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