Personalised Variable vs Fixed Dose Systemic Corticosteroid Therapy in Hospitalized Patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Prospective, Multicentered, Randomised, Open-Label Clinical Trial

Link to article at PubMed

Chest. 2021 May 20:S0012-3692(21)00951-X. doi: 10.1016/j.chest.2021.05.024. Online ahead of print.


BACKGROUND: Systemic corticosteroids for treatment of chronic obstructive pulmonary disease (COPD) exacerbations decrease treatment failure and shorten the length of hospitalization. However, the optimal dose is unclear.

RESEARCH QUESTION: Is personalized-dose corticosteroid by a dosing scale more effective than fixed-dose in hospitalized COPD patients with exacerbations?

STUDY DESIGN AND METHODS: This was a prospective, randomised, open-labeled trial. In-hospital COPD patients with exacerbations were randomly assigned in a 1:1 ratio to either fixed-dose group (40mg prednisolone equivalent) or personalised-dose group for 5 days. The primary endpoint was a composite measure of treatment failure that included in-hospital treatment failure and medium-term (post-discharge) failure. Secondary endpoints were length of stay and cost.

RESULTS: A total of 248 patients were randomly assigned to the fixed-dose group (n = 124) or personalised-dose group (n = 124). One patient in each group was not included in the intention-to-treat (ITT) population because of incorrect initial COPD diagnosis. Failure of therapy occurred in 27.6% in the personalised-dose group, compared to 48.8% in the fixed-dose group (RR 0.40, 95% CI 0.24-0.68, p = 0.001). The in-hospital failure of therapy was significantly lower in the personalised-dose group (10.6% vs 24.4%, p = 0.005), whilst the medium-term failure rate, adverse event rate, hospital length of stay and costs were similar between two groups. Following treatment failure, a lower additional dose of corticosteroids and a shorter duration of treatment was needed in the personalised-dose group to achieve control of the exacerbation. In the personalized cohort, those receiving 40 mg or less had an average failure rate of 44.4%, compared to 22.9% in those receiving higher than 40mg (p=0.027).

INTERPRETATION: Personalised dosing of corticosteroids reduces the risk of failure because more patients were provided with a higher initial dose, especially >60mg, while 40mg or less was too low in either group.

PMID:34023318 | DOI:10.1016/j.chest.2021.05.024

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