Comparison of two doses of leucovorin in severe low-dose methotrexate toxicity – a randomized controlled trial
Primary result · DeathsResult — go to the resultOdds ratio 1.2 95% CI 0.3–4.5Authors' conclusion
There was no significant difference in survival or time-to hematological recovery between the two doses of leucovorin. Severe low-dose methotrexate toxicity carried a significant mortality.
Study context
- Population
- Patients with severe low-dose (≤ 50 mg/week) MTX toxicity (WBC ≤ 2 × 10^9/L or platelet ≤ 50 × 10^9/L), most with underlying RA who inadvertently overdosed MTX (daily instead of weekly)
- Participants
- 38 patients
- Comparison
- High-dose vs usual IV leucovorin every 6 h
- Usual-dose leucovorinn = 19reference
- High-dose leucovorinn = 19
- Primary endpoint
- Mortality
- Follow-up
- 30 days
Methodological detailsopen-label
- Open-label
Primary result
Deaths
Odds ratio
1.2
95% CI 0.3–4.5
P = 0.74
Events by treatment group
High-dose leucovorinvs Usual-dose leucovorin
OR 1.2 (95% CI 0.3–4.5); P = 0.74
As reported in the abstract
Secondary outcomes
Survival (Kaplan-Meier), usual vs high-dose leucovorin · 30 days
- No significant difference in survival between the groups
- hazard ratio 1.1, 95% CI 0.4 to 2.9, p = 0.84
- Direction of HR not stated
Hematological and mucositis recovery
- No significant difference in hematological or mucositis recovery between the two groups
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Comparison of two doses of leucovorin in severe low-dose methotrexate toxicity – a randomized controlled trial. Arthritis Res Ther. Published 19 May 2023. doi:10.
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