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Effectiveness and Tolerability of Nifedipine GITS in Patients with Chronic Kidney Disease and Uncontrolled Hypertension: A Prospective, Multicenter, Observational Study (ADRENAL)

作者:Rong Lv, Jianghua Chen, Huamin Wang, Jijun Wang, Hong Cheng, Rong Li, Wei Li, Tao Zhang, Lixin Wei, Qinkai Chen, Jian Huang, Feng Yu, Shizhong Shen, Henglan Wu, Cuihong Liu, Fu‐Yuan Hong, Jie Liu, Xiaoru Zhang, Hua Xiao, Wenbin Song · 发表于:Advances in Therapy · 年份:2021 · DOI:10.1007/s12325-021-01850-3 · 被引用次数:4 · 研究领域:Diabetes Treatment and Management、Blood Pressure and Hypertension Studies、Restless Legs Syndrome Research

Achieving target blood pressure (BP) goals in patients with chronic kidney disease (CKD) and uncontrolled hypertension is a challenge. Various studies have shown the efficacy of nifedipine gastrointestinal therapeutic system (GITS) 60 mg in patients with hypertension. However, there is a paucity of clinical studies in patients with CKD. Hence, we conducted this study to evaluate the effectiveness and tolerability of nifedipine GITS 60 mg in Chinese patients with CKD and uncontrolled hypertension in real-world clinical settings. In a prospective, multicenter, observational study, Chinese patients with CKD and uncontrolled hypertension were given nifedipine GITS 60 mg with a primary endpoint of change in office systolic BP (SBP) at 12 weeks. The secondary endpoints included changes at 12 weeks in office diastolic BP (DBP), office SBP and DBP in SBP subgroups (140–160 mmHg and ≥ 160 mmHg) and CKD stages subgroups, SBP and DBP control rate, and the adverse events (AEs). Statistical analysis was performed using SAS ® version 9.4. In total, 871 and 622 patients were included in the safety analysis set and efficacy analysis set respectively. The mean office SBP and DBP at baseline were 162.9 and 97.3 mmHg, respectively. At week 12, the mean change in SBP was − 24.0 mmHg (95% confidence interval [CI] − 25.32, − 22.65 mmHg); after missing data were accounted for, it was − 23.9 mmHg (95% CI − 25.25, − 22.60 mmHg). Marked decreases in DBP, and office SBP and DBP in baseline SBP subgroup...