Key result
Benidipine significantly improved the composite ranking of relative risk according to KDIGO guidelines compared to amlodipine, with 20% of patients showing risk reduction versus 10% (P=0.043).
Why the study?
Does the addition of benidipine improve the composite ranking of relative risk according to KDIGO guidelines compared to amlodipine in patients with CKD and hypertension already on maximum ARB therapy?
RCT (n=104)
Open-label
Dynamic balancing randomization
No
Does the addition of benidipine improve the composite ranking of relative risk according to KDIGO guidelines compared to amlodipine in patients with CKD and hypertension already on maximum ARB therapy?
Absolute Event Rate: 20% vs 10%
p-value: p=0.043
In patients with CKD and hypertension on maximum ARB therapy, the addition of the L/T-type calcium channel blocker benidipine reduced albuminuria and improved KDIGO risk categories more effectively than the L-type calcium channel blocker amlodipine.
Benidipine add-on may shift KDIGO risk categories in CKD; leaves open whether T/L-type blockade offers advantage over amlodipine.
BACKGROUND: Recently, the Kidney Disease: Improving Global Outcomes (KDIGO) group recommended that patients with chronic kidney disease (CKD) be assigned according to stage and composite relative risk on the basis of glomerular filtration rate (GFR) and albuminuria criteria. The aim of this post-hoc analysis was to investigate the effects of add-on therapy with calcium channel blockers (CCBs) on changes in the composite ranking of relative risk according to KDIGO guidelines. Benidipine, an L- and T-type CCB, and amlodipine, an L-type CCB to angiotensin II receptor blocker (ARB), were examined. METHODS: Patients with blood pressure (BP) > 130/80 mmHg, an estimated GFR (eGFR) of 30-90 mL/min/1.73 m2, and albuminuria > 30 mg/gCr, despite treatment with the maximum recommended dose of ARB, were randomly assigned to two groups. Each group received one of two treatments: 2 mg benidipine daily, increased to 8 mg daily (n = 52), or 2.5 mg amlodipine daily, increased to 10 mg daily (n = 52). RESULTS: After 6 months of treatment, a significant and comparable reduction in systolic and diastolic BP was observed in both groups. The eGFR was significantly decreased in the amlodipine group, but there was no significant change in the benidipine group. The decrease in albuminuria in the benidipine group was significantly lower than in the amlodipine group. The composite ranking of relative risk according to the new KDIGO guidelines was significantly improved in the benidipine group; however, no significant change was noted in the amlodipine group. Moreover, significantly fewer cases in the benidipine group than the amlodipine group showed a reduced risk category score. CONCLUSION: The present post-hoc analysis showed that compared to amlodipine benidipine results in a greater reduction in albuminuria accompanied by an improved composite ranking of relative risk according to the KDIGO CKD severity classification. TRIAL REGISTRATION NUMBER: UMIN000002644.
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Abe et al. (2013) conducted an RCT in Chronic kidney disease with hypertension and albuminuria (n=104). Benidipine vs. Amlodipine (2.5 mg daily, increased to 10 mg daily) was evaluated on Proportion of patients with risk reduction according to KDIGO composite ranking (p=0.043). Benidipine significantly improved the composite ranking of relative risk according to KDIGO guidelines compared to amlodipine, with 20% of patients showing risk reduction versus 10% (P=0.043).
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