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

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, Fuyuan Hong, Jie Liu, Xiaoru Zhang, Hua Xiao, Wenbin Song, 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, Fuyuan Hong, Jie Liu, Xiaoru Zhang, Hua Xiao, Wenbin Song

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® 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.

Keywords: Chronic kidney disease; Hypertension; Nifedipine GITS; Observational study.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart representing patient disposition
Fig. 2
Fig. 2
Change in office SBP and DBP from baseline to week 12. BP blood pressure, DBP diastolic BP, SBP systolic BP
Fig. 3
Fig. 3
Change in office SBP and DBP from baseline to week 12 in different patient subgroups. DBP diastolic blood pressure, SBP systolic blood pressure
Fig. 4
Fig. 4
Change in office SBP from baseline to week 12 (EFF, stage of CKD subgroups). CKD chronic kidney disease, EFF efficacy analysis set, SBP systolic blood pressure

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Source: PubMed

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