Monitoring adverse events of low-dose glucocorticoid therapy: EULAR recommendations for clinical trials and daily practice
- M C van der Goes1,
- J W G Jacobs1,
- M Boers2,
- T Andrews3,
- M A M Blom-Bakkers1,
- F Buttgereit4,
- N Caeyers5,
- M Cutolo6,
- J A P Da Silva7,
- L Guillevin8,
- J R Kirwan3,
- J Rovensky9,
- G Severijns10,
- S Webber3,
- R Westhovens10,
- J W J Bijlsma1
- 1Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands
- 2Department of Clinical Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam, The Netherlands
- 3University of Bristol Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK
- 4Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany
- 5EULAR Social Leagues Patients' Representative, Belgium
- 6Research Laboratory and Academic Unit of Clinical Rheumatology, Department of Internal Medicine, University of Genova, Viale Benedetto, Italy
- 7Reumatologia, Hospitais da Universidade de Coimbra, Portugal
- 8Service de médecine interne, centre de référence national, Plan Maladies Rares, vascularites et sclérodermie, hôpital Cochin, Université Paris-V, France
- 9National Institute of Rheumatic Diseases Piest'any, Slovakia
- 10Department of Rheumatology, University Hospitals KU Leuven, Belgium
- Correspondence to Marlies C van der Goes, Department of Rheumatology and Clinical Immunology (F02.127), University Medical Center Utrecht, P O Box 85500, Utrecht 3508 GA, The Netherlands;
- Accepted 9 March 2010
- Published Online First 6 August 2010
Objective To develop recommendations on monitoring for adverse events (AEs) of low-dose glucocorticoid (GC) therapy (≤7.5 mg prednisone or equivalent daily) in clinical trials and daily practice.
Methods Literature was searched for articles containing information on incidence and monitoring of GC-related AEs using PubMed, EMBASE and Cochrane databases. Second, the authors searched for broad accepted guidelines on the monitoring of certain AEs (eg, WHO guidelines on screening for diabetes). Available data were summarised and discussed among experts (rheumatologists and patients) of the EULAR Task Force to decide which potential AEs should be monitored, how and at which interval.
Results Data on monitoring proved to be scarce; most articles were focused on therapeutic effects of GCs, not on occurrence and monitoring of AEs. Most recommendations had to be based on consensus. Those for clinical trials aimed at getting insights into incidence, prevalence and clinical relevance of AEs to create a comprehensive and valid AE-profile of GC therapy. The set of AEs to monitor is therefore more extensive, and often consists of assessments at baseline and at end of trials. Recommendations for daily practice are meant to protect patients from real dangers, which can be prevented or treated. Standard care monitoring needs NOT be extended for patients on low-dose GC therapy, except for osteoporosis (follow national guidelines), and baseline assessments of ankle edema, fasting blood glucose and risk factors for glaucoma.
Conclusion Given the incompleteness of literature data, consensus-based recommendations on monitoring for GC-related AEs were created, separately for daily practice and clinical trials.
Funding The activities of this Task Force are financially supported by EULAR.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.