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Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: a randomized controlled trial.
Am J Kidney Dis. 2009 Jan; 53(1):26-32.AJ

Abstract

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.

Authors+Show Affiliations

Renal Division, Department of Medicine, Peking University First Hospital, Institute of Nephrology, Peking University, No. 8 Xishiku Street, Xicheng District, Beijing, People's Republic of China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18930568

Citation

Lv, Jicheng, et al. "Combination Therapy of Prednisone and ACE Inhibitor Versus ACE-inhibitor Therapy Alone in Patients With IgA Nephropathy: a Randomized Controlled Trial." American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, vol. 53, no. 1, 2009, pp. 26-32.
Lv J, Zhang H, Chen Y, et al. Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: a randomized controlled trial. Am J Kidney Dis. 2009;53(1):26-32.
Lv, J., Zhang, H., Chen, Y., Li, G., Jiang, L., Singh, A. K., & Wang, H. (2009). Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: a randomized controlled trial. American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, 53(1), 26-32. https://doi.org/10.1053/j.ajkd.2008.07.029
Lv J, et al. Combination Therapy of Prednisone and ACE Inhibitor Versus ACE-inhibitor Therapy Alone in Patients With IgA Nephropathy: a Randomized Controlled Trial. Am J Kidney Dis. 2009;53(1):26-32. PubMed PMID: 18930568.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: a randomized controlled trial. AU - Lv,Jicheng, AU - Zhang,Hong, AU - Chen,Yuqing, AU - Li,Guangtao, AU - Jiang,Lei, AU - Singh,Ajay K, AU - Wang,Haiyan, Y1 - 2008/10/19/ PY - 2008/02/24/received PY - 2008/07/22/accepted PY - 2008/10/22/pubmed PY - 2009/1/9/medline PY - 2008/10/22/entrez SP - 26 EP - 32 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation JO - Am J Kidney Dis VL - 53 IS - 1 N2 - 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. SN - 1523-6838 UR - https://www.unboundmedicine.com/medline/citation/18930568/Combination_therapy_of_prednisone_and_ACE_inhibitor_versus_ACE_inhibitor_therapy_alone_in_patients_with_IgA_nephropathy:_a_randomized_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0272-6386(08)01230-4 DB - PRIME DP - Unbound Medicine ER -