Initial combination therapy with amlodipine/valsartan compared with monotherapy in the treatment of hypertension.

Achieving target blood pressure (BP) is influenced by baseline BP. Post hoc analyses of a placebo-controlled trial of amlodipine/valsartan versus monotherapies were conducted to characterize BP control by baseline BP. Hypertensive patients were randomized to amlodipine 10 mg, valsartan 160 or 320 mg, amlodipine/valsartan 10/160 or 10/320 mg, or placebo. Analysis of BP control rates focused on patients receiving the highest combination and monotherapy doses, with adverse events assessed for all doses. Analyses included 834 patients (mean age: 57 years; male: 51.3%; white: 79.4%; stage 2 hypertension: 61%; mean BP: 157/99 mm Hg). Two weeks after starting therapy, BP control (<140/90 mm Hg) rates were greater with amlodipine/valsartan 10/320 mg (49%) versus monotherapies (32%-38%) and placebo (16%). Consistent results were observed in stage 1 and 2 patients. Among patients receiving combination therapy, statistically significant differences were observed at endpoint versus comparators. At all baseline BP levels, the probability of achieving BP lower than 140/90 or lower than 130/80 mm Hg was greater with amlodipine/valsartan than monotherapies and placebo. Overall adverse events incidence was similar with combination versus monotherapies and placebo. Initial therapy with amlodipine/valsartan results in early, more effective BP control compared with monotherapy, irrespective of baseline BP.