Probucol combined with valsartan in immunoglobulin A nephropathy: a multi-centre, open labelled, randomized controlled study

Nephrology (Carlton). 2014 Jan;19(1):40-6. doi: 10.1111/nep.12177.

Abstract

Aim: Angiotensin receptor antagonists (ARBs) and anti-oxidants reduce urinary protein excretion and delay progression of immunoglobulin A (IgA) nephropathy. We investigated the efficacy and safety of probucol (an anti-oxidant) combined with valsartan (an ARB) on the progression of IgA nephropathy.

Methods: Patients with IgA nephropathy (n = 69) were recruited from five centres and randomly assigned to a treatment group (750 mg/day probucol plus 160 mg/day valsartan) or a control group (160 mg/day valsartan) and were followed for 3 years.

Results: At baseline, the two groups in any measured clinical information were comparable. The primary endpoint (doubling serum creatinine) showed no significant difference between the two groups during 3-year follow-up. The secondary endpoint (50% reduction in 24-h urinary protein) occurred in 23 patients in the treatment group and 20 patients in the control group. The time to the secondary end-point was shorter in the treatment group than the control group (8.13 months vs 19.63 months, P = 0.019). However, at the 3-year follow-up, the 24-h urinary protein levels were not significantly different from the baseline levels (P = 0.99 and P = 0.66, respectively). At the 1-year follow-up, plasma cholesterol in the treatment group was markedly lower than in the control group (4.12 ± 1.28 vs 5.03 ± 1.01, P = 0.02).

Conclusion: Kidney function remained stable and there was no significant difference in two group patients. Probucol combined with valsartan led to a more rapid decrease of 24-h urinary protein excretion than valsartan alone. However, the long-term effect needs further investigation.

Trial registration: ClinicalTrials.gov NCT00426348.

Keywords: IgA nephropathy; anti-oxidation; probucol; randomized controlled study; valsartan.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Angiotensin II Type 1 Receptor Blockers / administration & dosage*
  • Antioxidants / administration & dosage*
  • Drug Therapy, Combination
  • Female
  • Glomerulonephritis, IGA / drug therapy*
  • Glomerulonephritis, IGA / mortality
  • Glomerulonephritis, IGA / physiopathology
  • Humans
  • Male
  • Middle Aged
  • Probucol / administration & dosage*
  • Probucol / adverse effects
  • Tetrazoles / administration & dosage*
  • Tetrazoles / adverse effects
  • Valine / administration & dosage
  • Valine / adverse effects
  • Valine / analogs & derivatives*
  • Valsartan

Substances

  • Angiotensin II Type 1 Receptor Blockers
  • Antioxidants
  • Tetrazoles
  • Valsartan
  • Valine
  • Probucol

Associated data

  • ClinicalTrials.gov/NCT00426348