Direct renin inhibitor/diuretic combo gets FDA nod

January 23, 2008

Aliskiren and hydrochlorothiazide combination approved

Combination antihypertensive, Tekturna HCT, has been approved by the FDA and contains both direct renin inhibitor aliskiren (Tekturna, Novartis) and diuretic hydrochlorothiazide in a single tablet. The approval was based on results of clinical trials involving more than 2,700 patients. According to the manufacturer, in one study evaluating rebound hypertension, the antihypertensive effect of Tekturna HCT was maintained for up to four days after the drug was discontinued, with blood pressure gradually returning to baseline. The new combination tablet will be available at wholesalers by early February and will be marketed in four strengths (aliskiren/HCTZ): 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, and 300 mg/25 mg. More information is available online at