Combination Therapy of Prednisone and ACE Inhibitor Versus ACE-Inhibitor Therapy Alone in Patients With IgA Nephropathy: A Randomized Controlled Trial
Received 24 February 2008; accepted 22 July 2008. published online 20 October 2008.
Refers to article:
IgA Nephropathy: A Disease in Search of a Large-Scale Clinical Trial to Reliably Inform Practice
Giovanni F.M. Strippoli, Ausilia Maione, Francesco P. Schena, G. Tognoni, Jonathan C. Craig
American Journal of Kidney Diseases
January 2009 (Vol. 53, Issue 1, Pages 5-8) Full Text |
Full-Text PDF (392 KB)
Background
Recent studies have shown that both steroids and angiotensin-converting enzyme (ACE) inhibitors improve kidney survival and decrease proteinuria in patients with immunoglobulin A nephropathy. In this study, we aim to investigate whether the addition of steroids to ACE-inhibitor therapy produces a more potent antiproteinuric effect and better protection of kidney function than an ACE inhibitor alone.
Study Design
Randomized controlled trial.
Setting & Participants
Patients with biopsy-proven immunoglobulin A nephropathy with proteinuria of 1 to 5 g/d of protein.
Intervention
63 patients were randomly assigned to either cilazapril alone (ACE-inhibitor group; n = 30) or steroid plus cilazapril (combination group; n = 33).
Outcomes & Measurements
The primary end point was kidney survival, defined as a 50% increase in baseline serum creatinine level.
Results
After follow-up for up to 48 months, 7 patients in the ACE-inhibitor group (24.1%) reached the primary end point compared with 1 patient (3%) in the combination group. Kaplan-Meier kidney survival was significantly better in the combination group than the ACE-inhibitor group after 24 and 36 months (96.6% versus 75.7%, 96.6% versus 66.2%; P = 0.001). Urine protein excretion significantly decreased in patients in the combination group compared with the ACE-inhibitor group (time-average proteinuria, 1.04 ± 0.54 versus 1.57 ± 0.86 g/d of protein; P = 0.01). Multivariate analysis showed that combination treatment (hazard ratio, 0.1; 95% confidence interval, 0.014 to 0.946) and time-average proteinuria (hazard ratio, 14.3; 95% confidence interval, 2.86 to 71.92) were independent predictors of kidney survival.
Limitations
Small sample size, a single center, and slight imbalances at baseline.
Conclusions
Our results suggest that the addition of steroid to ACE-inhibitor therapy provided additional benefit compared with an ACE inhibitor alone. However, this was a pilot study with a small number of participants achieving the end points, and thus further validation is necessary.
1Renal Division, Department of Medicine, Peking University First Hospital, Institute of Nephrology, Peking University, Beijing, People's Republic of China
2Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, People's Republic of China
3Renal Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
Address correspondence to Hong Zhang, MD, PhD, Renal Division, Peking University First Hospital, Institute of Nephrology, Peking University, No 8, Xishiku St, Xicheng District, Beijing, 100034 China
ABSTRACT