High-dose
calcium channel blocker (CCB) shows strong blood pressure (BP) lowering effect. Currently available of controlled-release (CR)
nifedipine 80 mg per day clinical data are limited to monotherapy and short-term or long-term retrospective studies. We report the safety and efficacy results of a 52-week, prospective open-label study, in which Japanese patients with
essential hypertension were treated with CR
nifedipine [80 mg per day; 40 mg bis in die (BID; twice daily)] in combination with other
antihypertensive drugs. The patients with inadequate BP control despite treatment with CR
nifedipine (40 mg once daily) in combination with other
antihypertensive drugs were enrolled. The primary objective of this study was to assess the long-term safety of CR
nifedipine (80 mg per day). Efficacy variables included changes in the mean sitting BP, the target BP achievement rate and the BP response rate. CR
nifedipine (80 mg per day) was generally well tolerated, with the most common
drug-related treatment-emergent adverse event being
tachycardia (6.9% of patients). Serious treatment-emergent adverse events were reported in three (4.2%) patients. By week 52, the mean reductions in sitting systolic and diastolic BP were 19.4 and 13.6 mm Hg, respectively. The target BP achievement and BP response rates after 52 weeks of treatment were 32.4 and 63.4%, respectively. Based on these findings, long-term treatment with CR
nifedipine at 40 mg BID in combination with
antihypertensive drugs was well tolerated and effective in Japanese patients with
essential hypertension.