| Title | Effectiveness and Tolerability of Nifedipine GITS in Patients with Chronic Kidney Disease and Uncontrolled Hypertension: A Prospective, Multicenter, Observational Study (ADRENAL) |
| Authors | Lv, Rong Chen, Jianghua Wang, Huamin Wang, Jijun Cheng, Hong Li, Rong Li, Wei Zhang, Tao Wei, Lixin Chen, Qinkai Huang, Jian Yu, Feng Shen, Shizhong Wu, Henglan Liu, Cuihong Hong, Fuyuan Liu, Jie Zhang, Xiaoru Xiao, Hua Song, Wenbin |
| Affiliation | Zhejiang Univ, Affiliated Hosp 1, Coll Med, Kidney Dis Ctr, 79 Qingchun Rd, Hangzhou 310003, Zhejiang, Peoples R China Beijing Huairou Hosp, Dept Nephrol, Beijing, Peoples R China Zaozhuang Municipal Hosp, Dept Nephrol, Zaozhuang, Peoples R China Capital Med Univ, Beijing Anzhen Hosp, Dept Nephrol, Beijing, Peoples R China Tianjin Med Univ, Dept Nephrol, Hosp 2, Tianjin, Peoples R China Univ Tradit Chinese Med, Dept Nephrol, Affiliated Hosp Shandong, Jinan, Peoples R China Weihai Cent Hosp, Dept Nephrol, Weihai, Peoples R China Fujian Med Univ, Dept Nephrol, Union Hosp, Fuzhou, Peoples R China Nanchang Univ, Dept Nephrol, Affiliated Hosp 1, Nanchang, Jiangxi, Peoples R China Jinhua Municipal Cent Hosp, Dept Nephrol, Jinhua, Zhejiang, Peoples R China Peking Univ Int Hosp, Dept Nephrol, Beijing, Peoples R China Quanzhou First Hosp, Dept Nephrol, Quanzhou, Peoples R China First Hosp Jiaxing, Dept Nephrol, Jiaxing, Peoples R China Third Hosp Shijiazhuang, Dept Nephrol, Shijiazhuang, Hebei, Peoples R China Fujian Prov Hosp, Dept Nephrol, Fuzhou, Peoples R China Handan First Hosp, Dept Nephrol, Handan, Peoples R China Lishui City Peoples Hosp, Dept Nephrol, Lishui, Peoples R China Bayer Healthcare Ltd Co, Med Affairs, Beijing, Peoples R China |
| Keywords | GASTROINTESTINAL THERAPEUTIC SYSTEM BLOOD-PRESSURE COMBINATION THERAPY PRACTICE GUIDELINES RENAL-DISEASE PREVALENCE TRIAL MANAGEMENT AWARENESS CHINA |
| Issue Date | Jul-2021 |
| Publisher | ADVANCES IN THERAPY |
| Abstract | Introduction 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. Methods 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(R) version 9.4. Results 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 subgroups as well as CKD stages were observed at week 12. The BP control rate at week 12 was 50.0%. Twenty-three (2.6%) patients reported at least one drug-related AEs. No event of hypotension or death occurred during the study. Conclusion Nifedipine GITS 60 mg showed effectiveness and tolerability in reducing office SBP and DBP in Chinese patients with CKD and uncontrolled hypertension. |
| URI | http://hdl.handle.net/20.500.11897/623079 |
| ISSN | 0741-238X |
| DOI | 10.1007/s12325-021-01850-3 |
| Indexed | SCI(E) |
| Appears in Collections: | 国际医院 |
