Safety of the Up-titration of Nifedipine GITS and Valsartan or Low-dose Combination in Uncontrolled Hypertension: the FOCUS Study

Park, Jeong Bae; Shin, Joon Han; Kim, Dong Soo; Youn, Ho Joong; Park, Seung Woo; Shim, Wan Joo; Park, Chang Gyu; Kim, Dong Ho; Lee, Hae Young; Choi, Dong Ju; Rim, Se Joong; Lee, Sung Yun; Kim, Ju Han

doi:10.1016/j.clinthera.2016.02.025

Cited by 2 publications

(3 citation statements)

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“…Studies have shown that with increase in dosage, the magnitude of lowering BP with CCB monotherapy also increases [ 18 , 27 ]. Our study evaluated the effectiveness and tolerability of nifedipine GITS 60 mg in a relatively large cohort of Chinese patients with CKD and uncontrolled hypertension and filled the data gap for high-dose CCB treatment in Chinese patients with CKD.…”

Section: Discussionmentioning

confidence: 99%

“…The Chinese general practice clinical guideline/expert consensus on the application of long-acting dihydropyridine CCBs in patients with CKD and hypertension recommended that long-acting CCBs (e.g., nifedipine GITS) can protect the renal function and play an important role in the treatment of renal failure [ 17 ]. The previously conducted studies such as FOCUS [ 18 ] and EXACT trial [ 19 ] have demonstrated the efficacy of nifedipine GITS 60 mg very well. However, clinical studies with nifedipine 60 mg in Chinese patients with CKD are limited.…”

Section: Introductionmentioning

confidence: 99%

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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)

et al. 2021

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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. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01850-3.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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“…However, although magnesium sulfate is clinically effective in the treatment of HDCP, it has a slow effect and its therapeutic dose greatly influences the patients' blood concentration (8,9). According to recent studies, nifedipine, a long-acting calcium antagonist, inhibits angiotensin converting enzymes and significantly lowers blood pressure, and its safety is better than that of antihypertensive drugs of the same type (10,11). Phentolamine, a blocker that is mainly used for treating peripheral vascular diseases (12), blocks norepinephrine, increases myocardial contractility and reduces the related resistance of peripheral vessels, effectively dilating blood vessels (13).…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of combination of magnesium sulfate, phentolamine and nifedipine in treatment of patients with hypertensive disorder complicating pregnancy

Zhang

2019

Exp Ther Med

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Efficacy and safety of the combination of magnesium sulfate, phentolamine and nifedipine in the treatment of patients with hypertensive disorder complicating pregnancy (HDCP) and its effect on hemodynamics and urinary protein level were investigated. One hundred and six patients with HDCP diagnosed at the Affiliated Hospital of Beihua University from February 5, 2016 to May 9, 2017 were retrospectively analyzed. Patients were divided into the magnesium sulfate group and the combination group, according to the therapeutic schemes. The efficacy 1 week later was observed. The general clinical data of the patients were recorded, and data were acquired with respect to hemodynamic indexes before and after treatment [changes of S/D ratio of umbilical artery flow, and cardiac index and total peripheral resistance (TPR)], the 24-h urinary protein level, clinical efficacy and safety [adverse drug reactions (ADR) and maternal and neonatal outcomes]. Before treatment, there was no statistically significant difference between the two groups in terms of S/D ratio of umbilical artery flow (P>0.05), while after treatment the S/D ratio was significantly lower than that before treatment in both groups (P<0.05). Before treatment, there was no statistically significant difference between the two groups in terms of cardiac index (P>0.05). TPR after treatment was significantly lower than that before treatment in both groups (P<0.001). Compared with the magnesium sulfate group, patients in the combination group had significantly lower 24-h urinary protein level after treatment (P<0.001), significantly higher total effective rate (P<0.05), significantly lower incidence rate of ADR (P<0.001), and significantly lower incidence rate of adverse maternal and neonatal outcomes (P<0.001). In conclusion, the combination of magnesium sulfate, phentolamine and nifedipine can significantly improve the hemodynamic indexes, the 24-h urinary protein level, the clinical efficacy, ADR and maternal and neonatal outcomes of patients with HDCP, therefore it is worthy of use in the clinic.

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Safety of the Up-titration of Nifedipine GITS and Valsartan or Low-dose Combination in Uncontrolled Hypertension: the FOCUS Study

Cited by 2 publications

References 24 publications

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

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

Efficacy and safety of combination of magnesium sulfate, phentolamine and nifedipine in treatment of patients with hypertensive disorder complicating pregnancy

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