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

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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)
Advances in Therapy ( IF 3.8 ) Pub Date : 2021-07-30 , DOI: 10.1007/s12325-021-01850-3
Rong Lv ₁ , Jianghua Chen ₁ , Huamin Wang ₂ , Jijun Wang ₃ , Hong Cheng ₄ , Rong Li ₅ , Wei Li ₆ , Tao Zhang ₇ , Lixin Wei ₈ , Qinkai Chen ₉ , Jian Huang ₁₀ , Feng Yu ₁₁ , Shizhong Shen ₁₂ , Henglan Wu ₁₃ , Cuihong Liu ₁₄ , Fuyuan Hong ₁₅ , Jie Liu ₁₆ , Xiaoru Zhang ₁₇ , Hua Xiao ₁₈ , Wenbin Song ₁₈

Affiliation

Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun road, Hangzhou, 310003, China.
Department of Nephrology, Beijing Huairou Hospital, Beijing, China.
Department of Nephrology, Zaozhuang Municipal Hospital, Zaozhuang, China.
Department of Nephrology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Department of Nephrology, The Second Hospital of Tianjin Medical University, Tianjin, China.
Department of Nephrology, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.
Department of Nephrology, Weihai Central Hospital, Weihai, China.
Department of Nephrology, Fujian Medical University Union Hospital, Fuzhou, China.
Department of Nephrology, The First Affiliated Hospital of Nanchang University, Nanchang, China.
Department of Nephrology, Jinhua Municipal Central Hospital, Jinhua, China.
Department of Nephrology, Peking University International Hospital, Beijing, China.
Department of Nephrology, Quanzhou First Hospital, Quanzhou, China.
Department of Nephrology, The First Hospital of Jiaxing, Jiaxing, China.
Department of Nephrology, The Third Hospital of Shijiazhuang, Shijiazhuang, China.
Department of Nephrology, Fujian Provincial Hospital, Fuzhou, China.
Department of Nephrology, Handan First Hospital, Handan, China.
Department of Nephrology, Lishui City People's Hospital, Lishui, China.
Medical Affairs, Bayer Healthcare Limited Company, Beijing, China.

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.