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Benidipine Improves Augmentation Index in Hypertensive Chronic Kidney Disease Patients

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Benidipine Improves Augmentation Index and Urinary Albumin Excretion in Hypertensive Patients with Chronic Kidney Disease

Background Information

Chronic kidney disease is associated with the significant cardiovascular disease. It is important to consider organ protective effects in the treatment of hypertensive chronic kidney disease. Urinary albumin has been reported as an independent determinant of cardiovascular events, as well as blood pressure.

The augmentation index (AI) is the ratio calculated from the blood pressure waveform and it is a measure of wave reflection and arterial stiffness. It is commonly accepted as a measure of the enhancement of central aortic pressure by a reflected pulse wave.

Benidipine is a T-type/L-type calcium channel blockers and is reported to result in a potentially greater reduction in urinary protein or albumin than amlodipine.

Objective of the Study

The main objective of the study was to compare the effect of T-type/L-type calcium channel blockers benidipine and L-type calcium channel blocker amlodipine in the treatment of hypertensive chronic kidney failure as measured by the augmentation index and urinary albumin excretion.

Methods and Materials

Study Design

The study was a prospective, open-label, randomized, parallel-comparison study.

Sample Size

A total of 108 patients were selected for the study.

Inclusion Criteria

Male or female patients aged ≥ 20 years and who satisfied the following criteria were enrolled in the study

  • Receiving RAS (Renin-angiotensin system) inhibitors for at least 3 months and
    DHP(dihydropyridine) calcium channel blocker for ≥ 4 weeks before enrolment
  • Urinary albumin excretion ≥ 30 mg/g Cr
  • Glomerular filtration rate < 60 mL/minute

Exclusion Criteria

Patients of the following category were excluded from the study:

  • Receiving DHP CCB for the treatment of coronary spasms
  • Underwent coronary angiography within the last six months
  • History of serious adverse drug reactions to CCBs, ARBs, or ACE inhibitors
  • Liver Dysfunction
  • Concurrent severe heart failure or arrhythmia
  • Pregnant and childbearing age

Study Procedure

The eligible patients were asked to stop the calcium channel blockers that had been administered before study enrollment. The patients were randomized to the amlodipine or benidipine group by using a dynamic allocation procedure based on the minimization method according to assignment factors of blood pressure and renal function. The treatment was either amlodipine 2.5-10 mg/day or benidipine 4-16 mg/day and was administered for 12 months. Measurement of augmentation index was performed by using an HEM-9000AI. Blood pressure and pulse rate were measured twice a day after resting and while sitting. The estimated glomerular filtration rate (eGFR) was calculated by using the formula for estimating glomerular filtration rate. Urinary albumin excretion was determined at the baseline and after 12 months.

Statistical Analysis

The baseline characteristics at the study enrollment were compared between the groups using unpaired t-test or chi-square test. The paired t-test was used to compare the mean values before and after the treatment. The correlation between augmentation index and pulse rate and its P value were calculated using least-squares method.

Results

Augmentation Index

Evaluation of systolic blood pressure at the baseline and after the treatment

There was a significant difference in change in the systolic blood pressure before and after study treatment in the amlodipine and benidipine groups. There was decreased in the patients who were treated with benidipine.

Evaluation of diastolic blood pressure at the baseline and after the treatment

There was a significant difference in change in the diastolic blood pressure before and after study treatment in the amlodipine and benidipine groups. There was decreased in the patients who were treated with benidipine.

Evaluation of pulse rate at the baseline and after the treatment

There was no any significant difference in change in the pulse rate before and after study treatment in the amlodipine and benidipine groups. There was decreased in the patients who were treated with benidipine.

Urinary Albumin Excretion

There was slight increase in the amlodipine group and decrease in benidipine group. There was significant difference between the groups.

Conclusion

The overall study suggested that benidipine decreases the augmentation index significantly. There was greater improvement in urinary albumin excretion in patients using benidipine than amlodipine.

Reference

Takayama T, et al. Improvements in Augmentation Index and Urinary Albumin Excretion with Benidipine in Hypertensive Patients with Chronic Kidney Disease. Int Heart J. Jan 2016; 57(1):53-60

Available at: http://www.ncbi.nlm.nih.gov/pubmed/26742700/

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