Comparison of the antialbuminuric effects of benidipine and hydrochlorothiazide in Renin-Angiotensin System (RAS) inhibitor-treated hypertensive patients with albuminuria: the COSMO-CKD (COmbination Strategy on Renal Function of Benidipine or Diuretics TreatMent with RAS inhibitOrs in a Chronic Kidney Disease Hypertensive Population) study.

Abstract

OBJECTIVE:

This study evaluated the non-inferiority of renoprotection afforded by benidipine versus hydrochlorothiazide in hypertensive patients with chronic kidney disease (CKD).

METHODS:

In this prospective, multicenter, open-labeled, randomized trial, the antialbuminuric effects of benidipine and hydrochlorothiazide were examined in renin-angiotensin system (RAS) inhibitor-treated patients with blood pressure (BP) readings of ≥ 130/80 mmHg and ≤ 180/110 mmHg, a urinary albumin to creatinine ratio (UACR) of ≥ 300 mg/g, and an estimated glomerular filtration rate (eGFR) of ≥ 30 ml/min/1.73m(2). Patients received benidipine (n = 176, final dose: 4.8 mg/day) or hydrochlorothiazide (n = 170, 8.2 mg/day) for 12 months.

RESULTS:

Benidipine and hydrochlorothiazide exerted similar BP- and eGFR-decreasing actions. The UACR values for benidipine and hydrochlorothiazide were 930.8 (95% confidence interval: 826.1, 1048.7) and 883.1 (781.7, 997.7) mg/g at baseline, respectively. These values were reduced to 790.0 (668.1, 934.2) and 448.5 (372.9, 539.4) mg/g at last observation carried forward (LOCF) visits. The non-inferiority of benidipine versus hydrochlorothiazide was not demonstrated (benidipine/hydrochlorothiazide ratio of LOCF value adjusted for baseline: 1.67 (1.40, 1.99)).

CONCLUSIONS:

The present study failed to demonstrate the non-inferiority of the antialbuminuric effect of benidipine relative to that of hydrochlorothiazide in RAS inhibitor-treated hypertensive patients with macroalbuminuria.

• Authors: Katsuyuki Ando, Kosaku Nitta, Hiromi Rakugi, Yoshiki Nishizawa, Hitoshi Yokoyama, Takeshi Nakanishi, Naoki Kashihara, Kimio Tomita, Masaomi Nangaku, Katsutoshi Takahashi, Masashi Isshiki, Tatsuo Shimosawa, Toshiro Fujita
• Journal: International journal of medical sciences (Int J Med Sci) Vol. 11 Issue 9 Pg. 897-904 ( 2014) ISSN: 1449-1907 [Electronic] Australia
• PMID: 25013370 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dihydropyridines
• Hydrochlorothiazide
• Amlodipine
• benidipine

Topics

• Adult
• Aged
• Albuminuria (chemically induced, pathology)
• Amlodipine (therapeutic use)
• Blood Pressure (drug effects)
• Dihydropyridines (administration & dosage)
• Female
• Glomerular Filtration Rate (drug effects)
• Humans
• Hydrochlorothiazide (administration & dosage)
• Hypertension (complications, drug therapy, pathology)
• Male
• Middle Aged
• Renal Insufficiency, Chronic (complications, drug therapy, pathology)
• Renin-Angiotensin System (drug effects)