Increasing monotherapy dose in accordance with the guidelines is a paramount for improving blood pressure (BP) control. Nifedipine Gastrointestinal Therapeutic System (GITS) has shown dose-effect relationship in hypertension treatment but has limited data availability on uncontrolled BP. We are evaluating the antihypertensive efficacy and tolerability of nifedipine GITS (60 mg) 8-weeks treatment in Chinese hypertensive patients with uncontrolled BP (ADEPT study).Design and Method:
ADEPT (NCT02413515) is an ongoing phase IV, prospective, multicenter, open-label, single-arm study in Chinese hypertensive patients (aged, 18 to 65 years) with uncontrolled BP after initial starting-dose of antihypertensive mono-therapy, at least 4-weeks prior (uncontrolled BP is defined as mean sitting systolic BP [MSSBP] ≥140 mmHg and <160mmHg; or ≥130 mmHg and <160 mmHg in the presence of diabetes mellitus). This study will have screening phase (1–2 weeks) and nifedipine GITS (60 mg) treatment phase (8-week) with a minimum enrollment of 276 patients. The primary endpoint is MSSBP control rate at week 8 (the percentage of patients reached MSSBP target of <140 mmHg, or <130 mmHg in patients with diabetes). Secondary endpoint is changes in MSSBP and MSDBP from baseline at Week 8 and MSSBP/MSDBP control rate at early visits (week 2 and 4). Safety will be assessed based on the incidence of all treatment-emergent adverse events (TEAEs) and incidence of drug-related TEAEs. Change in 24-hour, daytime, night-time, average SBP/ DBP will be assessed by ambulatory BP monitoring from baseline and Week 8.Results:
Our study findings may indicate that higher dosage of nifedipine GITS monotherapy has favorable benefit-risk profile in improving BP control rate in Chinese population leading to improved treatment compliance and reduced CV events in China.Conclusions:
ADEPT will guide physicians in optimizing treatment strategy for uncontrolled BP in China. Nonetheless, it will provide insight for future guideline recommendations.