Aliskiren/hydrochlorothiazide combination: in mild to moderate hypertension.

Aliskiren/hydrochlorothiazide is a single-pill combination of the first in the new class of non-peptide direct renin inhibitors (aliskiren) and a thiazide diuretic (hydrochlorothiazide [HCTZ]) that achieves blood pressure (BP) reductions greater than those seen with either component alone. In double-blind, 8-week clinical trials, aliskiren and HCTZ (as a combination of the individual components or as single-pill combinations) reduced mean sitting systolic and diastolic BP from baseline to a significantly greater extent than placebo, aliskiren monotherapy and HCTZ monotherapy. Aliskiren/HCTZ produced additional BP reductions in patients inadequately responsive to 4 weeks' prior treatment with aliskiren or HCTZ alone. Responder rates and BP control rates further demonstrated the benefits of aliskiren/HCTZ combination therapy over monotherapy with individual components in patients with mild to moderate hypertension. Aliskiren plus HCTZ appeared to be effective as long-term (up to 1 year) combination treatment in an open-label trial. In a 12-week placebo-controlled trial in obese patients with hypertension, BP reductions and responder and control rates were significantly greater with aliskiren/HCTZ than with HCTZ alone. Aliskiren/HCTZ was generally well tolerated in clinical trials, with most adverse events being mild and transient in nature.