Saito I, Saruta T

Controlled release nifedipine and valsartan combination therapy in patients with essential hypertension: the Adalat CR and Valsartan Cost-Effectiveness Combination (ADVANCE-Combi) study

Hypertens Res 2006;29:789–96

Essential hypertension

To compare the clinical efficacy and safety of the combination of nifedipine CR plus valsartan with that of amlodipine plus valsartan in Japanese patients with essential hypertension

Randomised, double-blind, parallel-group

16 weeks

505 patients (245 nifedipine CR, 260 amlodipine), 292 aged < 60 years, 213 ≥ 60 years, with SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg for previously untreated patients or SBP ≥ 150 mm Hg or DBP ≥ 95 mm Hg for patients previously treated with antihypertensive drugs

Nifedipine CR, 20 mg/day, or amlodipne, 2.5 mg/day for 4 weeks, then titration to nifedipine CR, 20 mg/day plus valsartan, 40 mg/day, or amlodipine, 2.5 mg/day plus valsartan, 40 mg/day for 4 weeks if target BP not achieved, then titration to nifedipine CR, 40 mg/day plus valsartan, 40 mg/day, or amlodipine, 5 mg/day plus valsartan, 40 mg/day for 4 weeks if target BP not achieved, then titration to nifedipine CR, 40 mg/day plus valsartan, 80 mg/day, or amlodipine, 5 mg/day plus valsartan, 80 mg/day for 4 weeks if target BP not achieved

Target BP achievement rates were significantly higher in the nifedipine CR group than in the amlodipine group (69.8% SBP, 75.1% DBP, 61.2% for both SBP and DBP vs 48.5% SBP, 50.0% DBP, 34.6% for both SBP and DBP; p < 0.001). Mean reduction in BP from baseline was also significantly higher in the nifedipine CR group than in the amlodipine group (SBP/DBP -34.0 ± 15.0/-20.1 ± 9.5 mm Hg vs SBP/DBP -27.0 ± 14.5/-15.9 ± 9.7 mm Hg; p < 0.05). There was no significant difference in the incidence of drug-related adverse events between groups