Oral methylprednisolone in patients with IgA nephropathy

Oral methylprednisolone in patients with IgA nephropathy Reactions 1664, p11 - 12 Aug 2017 Oral methylprednisolone in patients with IgA nephropathy Although oral methylprednisolone potentially has renal benefits in patients with IgA nephropathy, according to study results reported in JAMA, there is an increased risk of serious adverse effects, particularly infections. The double-blind TESTING trial randomised 262 patients from China or Australia to receive oral methylprednisolone or placebo for 2 months. There were 28 serious adverse events in 20 methylprednisolone recipients (14.7%) and 4 events in 4 placebo recipients (3.2%), for a risk difference of 11.5% (p=0.001). Due to the excess of serious adverse events, recruitment was discontinued. At that time, the primary composite renal outcome had occurred in 8 methylprednisolone recipients (5.9%) and 20 placebo recipients (15.9%), a risk difference of 10.0% (p=0.02). The authors note that "there were too few primary outcomes to draw definitive conclusions about treatment efficacy from this trial," and that the possible clinical benefits "will be further clarified by the ongoing follow-up of study participants". Most of the serious adverse events occurred during the first 3 months of treatment. Of the 28 events, 13 infection-related events occurred in methylprednisolone recipients, with no infections in placebo recipients. There were 4 vs 1 gastrointestinal events, 3 vs 0 bone disorders, and 8 vs 3 other events, respectively. The authors note that the excess serious adverse events, mostly infections, have "implications for clinical decision making and treatment guidelines for the use of corticosteroids in IgA nephropathy". They add that "future studies could also consider the use of prophylactic antibiotic therapy". In an accompanying editorial reported in JAMA, Michelle O’Shaughnessy and Richard Lafayette (Stanford University School of Medicine) note that the study findings "highlight the importance of delivering the right drug, to the right patient, at the right time," and raise "some important questions regarding how best to adjudicate risks and benefits when evaluating study outcomes". They suggest that existing treatment guidelines "should likely be tempered in light of the safety signals raised," and that "the pursuit of safer and more effective alternatives to corticosteroids should also continue". * Therapeutic Evaluation of Steroids in IgA Nephropathy Global study; NCT01560052 1. Lv J, et al. Effect of Oral Methylprednisolone on Clinical Outcomes in Patients With IgA Nephropathy - The TESTING Randomized Clinical Trial. Journal of the American Medical Association 318: 432-442, No. 5, 1 Aug 2017. Available from: URL: http://dx.doi.org/10.1001/jama.2017.9362. 2. O’Shaughnessy MM, et al. Corticosteroids for IgA Nephropathy - TESTING for Benefit, Discovering Harm. Journal of the American Medical Association 318: 429-431, No. 5, 1 Aug 2017. Available from: URL: http://dx.doi.org/10.1001/ jama.2017.9359. 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

Oral methylprednisolone in patients with IgA nephropathy

Reactions Weekly , Volume 1664 (1) – Aug 12, 2017
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Publisher
Springer International Publishing
Copyright
Copyright © 2017 by Springer International Publishing AG
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
D.O.I.
10.1007/s40278-017-34291-0
Publisher site
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Abstract

Reactions 1664, p11 - 12 Aug 2017 Oral methylprednisolone in patients with IgA nephropathy Although oral methylprednisolone potentially has renal benefits in patients with IgA nephropathy, according to study results reported in JAMA, there is an increased risk of serious adverse effects, particularly infections. The double-blind TESTING trial randomised 262 patients from China or Australia to receive oral methylprednisolone or placebo for 2 months. There were 28 serious adverse events in 20 methylprednisolone recipients (14.7%) and 4 events in 4 placebo recipients (3.2%), for a risk difference of 11.5% (p=0.001). Due to the excess of serious adverse events, recruitment was discontinued. At that time, the primary composite renal outcome had occurred in 8 methylprednisolone recipients (5.9%) and 20 placebo recipients (15.9%), a risk difference of 10.0% (p=0.02). The authors note that "there were too few primary outcomes to draw definitive conclusions about treatment efficacy from this trial," and that the possible clinical benefits "will be further clarified by the ongoing follow-up of study participants". Most of the serious adverse events occurred during the first 3 months of treatment. Of the 28 events, 13 infection-related events occurred in methylprednisolone recipients, with no infections in placebo recipients. There were 4 vs 1 gastrointestinal events, 3 vs 0 bone disorders, and 8 vs 3 other events, respectively. The authors note that the excess serious adverse events, mostly infections, have "implications for clinical decision making and treatment guidelines for the use of corticosteroids in IgA nephropathy". They add that "future studies could also consider the use of prophylactic antibiotic therapy". In an accompanying editorial reported in JAMA, Michelle O’Shaughnessy and Richard Lafayette (Stanford University School of Medicine) note that the study findings "highlight the importance of delivering the right drug, to the right patient, at the right time," and raise "some important questions regarding how best to adjudicate risks and benefits when evaluating study outcomes". They suggest that existing treatment guidelines "should likely be tempered in light of the safety signals raised," and that "the pursuit of safer and more effective alternatives to corticosteroids should also continue". * Therapeutic Evaluation of Steroids in IgA Nephropathy Global study; NCT01560052 1. Lv J, et al. Effect of Oral Methylprednisolone on Clinical Outcomes in Patients With IgA Nephropathy - The TESTING Randomized Clinical Trial. Journal of the American Medical Association 318: 432-442, No. 5, 1 Aug 2017. Available from: URL: http://dx.doi.org/10.1001/jama.2017.9362. 2. O’Shaughnessy MM, et al. Corticosteroids for IgA Nephropathy - TESTING for Benefit, Discovering Harm. Journal of the American Medical Association 318: 429-431, No. 5, 1 Aug 2017. Available from: URL: http://dx.doi.org/10.1001/ jama.2017.9359. 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664

Journal

Reactions WeeklySpringer Journals

Published: Aug 12, 2017

References

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