PMID- 34331258 OWN - NLM STAT- MEDLINE DCOM- 20210915 LR - 20220218 IS - 1865-8652 (Electronic) IS - 0741-238X (Print) IS - 0741-238X (Linking) VI - 38 IP - 9 DP - 2021 Sep TI - Effectiveness and Tolerability of Nifedipine GITS in Patients with Chronic Kidney Disease and Uncontrolled Hypertension: A Prospective, Multicenter, Observational Study (ADRENAL). PG - 4771-4785 LID - 10.1007/s12325-021-01850-3 [doi] AB - 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03194633. CI - (c) 2021. The Author(s). FAU - Lv, Rong AU - Lv R AD - Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun road, Hangzhou, 310003, China. FAU - Chen, Jianghua AU - Chen J AD - Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun road, Hangzhou, 310003, China. chenjianghua@zju.edu.cn. FAU - Wang, Huamin AU - Wang H AD - Department of Nephrology, Beijing Huairou Hospital, Beijing, China. FAU - Wang, Jijun AU - Wang J AD - Department of Nephrology, Zaozhuang Municipal Hospital, Zaozhuang, China. FAU - Cheng, Hong AU - Cheng H AD - Department of Nephrology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. FAU - Li, Rong AU - Li R AD - Department of Nephrology, The Second Hospital of Tianjin Medical University, Tianjin, China. FAU - Li, Wei AU - Li W AD - Department of Nephrology, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China. FAU - Zhang, Tao AU - Zhang T AD - Department of Nephrology, Weihai Central Hospital, Weihai, China. FAU - Wei, Lixin AU - Wei L AD - Department of Nephrology, Fujian Medical University Union Hospital, Fuzhou, China. FAU - Chen, Qinkai AU - Chen Q AD - Department of Nephrology, The First Affiliated Hospital of Nanchang University, Nanchang, China. FAU - Huang, Jian AU - Huang J AD - Department of Nephrology, Jinhua Municipal Central Hospital, Jinhua, China. FAU - Yu, Feng AU - Yu F AD - Department of Nephrology, Peking University International Hospital, Beijing, China. FAU - Shen, Shizhong AU - Shen S AD - Department of Nephrology, Quanzhou First Hospital, Quanzhou, China. FAU - Wu, Henglan AU - Wu H AD - Department of Nephrology, The First Hospital of Jiaxing, Jiaxing, China. FAU - Liu, Cuihong AU - Liu C AD - Department of Nephrology, The Third Hospital of Shijiazhuang, Shijiazhuang, China. FAU - Hong, Fuyuan AU - Hong F AD - Department of Nephrology, Fujian Provincial Hospital, Fuzhou, China. FAU - Liu, Jie AU - Liu J AD - Department of Nephrology, Handan First Hospital, Handan, China. FAU - Zhang, Xiaoru AU - Zhang X AD - Department of Nephrology, Lishui City People's Hospital, Lishui, China. FAU - Xiao, Hua AU - Xiao H AD - Medical Affairs, Bayer Healthcare Limited Company, Beijing, China. FAU - Song, Wenbin AU - Song W AD - Medical Affairs, Bayer Healthcare Limited Company, Beijing, China. LA - eng SI - ClinicalTrials.gov/NCT03194633 PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20210730 PL - United States TA - Adv Ther JT - Advances in therapy JID - 8611864 RN - 0 (Antihypertensive Agents) RN - I9ZF7L6G2L (Nifedipine) MH - Antihypertensive Agents/adverse effects MH - Blood Pressure MH - Humans MH - *Hypertension/drug therapy MH - Nifedipine/pharmacology/therapeutic use MH - Prospective Studies MH - *Renal Insufficiency, Chronic/complications/drug therapy PMC - PMC8408083 OTO - NOTNLM OT - Chronic kidney disease OT - Hypertension OT - Nifedipine GITS OT - Observational study EDAT- 2021/08/01 06:00 MHDA- 2021/09/16 06:00 PMCR- 2021/07/30 CRDT- 2021/07/31 08:38 PHST- 2021/05/24 00:00 [received] PHST- 2021/06/29 00:00 [accepted] PHST- 2021/08/01 06:00 [pubmed] PHST- 2021/09/16 06:00 [medline] PHST- 2021/07/31 08:38 [entrez] PHST- 2021/07/30 00:00 [pmc-release] AID - 10.1007/s12325-021-01850-3 [pii] AID - 1850 [pii] AID - 10.1007/s12325-021-01850-3 [doi] PST - ppublish SO - Adv Ther. 2021 Sep;38(9):4771-4785. doi: 10.1007/s12325-021-01850-3. Epub 2021 Jul 30.