High-dose (40â
mg) versus low-dose (20â
mg) prednisolone for treating sarcoidosis: a randomised trial (SARCORT trial).
Eur Respir J
; 62(3)2023 09.
Article
em En
| MEDLINE
| ID: mdl-37690784
ABSTRACT
BACKGROUND:
Current guidelines recommend 20-40â mg·day-1 of oral prednisolone for treating pulmonary sarcoidosis. Whether the higher dose (40â mg·day-1) can improve outcomes remains unknown.METHODS:
We conducted an investigator-initiated, single-centre, open-label, parallel-group, randomised controlled trial (ClinicalTrials.gov identifier NCT03265405). Consecutive subjects with pulmonary sarcoidosis were randomised (11) to receive either high-dose (40â mg·day-1 initial dose) or low-dose (20â mg·day-1 initial dose) oral prednisolone, tapered over 6â months. The primary outcome was the frequency of relapse or treatment failure at 18â months from randomisation. Key secondary outcomes included the time to relapse or treatment failure, overall response, change in forced vital capacity (FVC, in litres) at 6 and 18â months, treatment-related adverse effects and health-related quality of life (HRQoL) scores using the Sarcoidosis Health Questionnaire and Fatigue Assessment Scale.FINDINGS:
We included 86 subjects (43 in each group). 42 and 43 subjects completed treatment in the high-dose and low-dose groups, respectively, while 37 (86.0%) and 41 (95.3%), respectively, completed the 18-month follow-up. 20 (46.5%) subjects had relapse or treatment failure in the high-dose group and 19 (44.2%) in the low-dose group (p=0.75). The mean time to relapse/treatment failure was similar between the groups (high-dose 307â days versus low-dose 269â days, p=0.27). The overall response, the changes in FVC at 6 and 18â months and the incidence of adverse effects were also similar. Changes in HRQoL scores did not differ between the study groups.INTERPRETATION:
High-dose prednisolone was not superior to a lower dose in improving outcomes or the HRQoL in sarcoidosis and was associated with similar adverse effects.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Prednisolona
/
Sarcoidose Pulmonar
Tipo de estudo:
Clinical_trials
/
Guideline
/
Prognostic_studies
/
Qualitative_research
Limite:
Adult
/
Humans
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article