Shortened length of hospital stay with rivaroxaban in Japan with symptomatic venous thromboembolism: the J-EINSTEIN PE and DVT program.
Curr Med Res Opin. 2015 Apr 8;:1-15
Authors: Matsuo H, Prins M, Lensing AW, Fujinuma EW, Miyamoto Y, Kajikawa M
BACKGROUND: In Japan, the standard of care for the treatment of PE and/or DVT consists of intravenous unfractionated heparin (UFH) followed by and warfarin, which was recently compared with rivaroxaban, an oral factor Xa inhibitor, in randomized trials.
AIM: To examine the length of hospital stay in patients in Japan receiving rivaroxaban as compared to Japanese standard therapy in patients with PE and/or DVT (J-EINSTEIN PE and DVT program).
METHODS: Open-label, randomized clinical trials that compared 3, 6, or 12 months of rivaroxaban with UFH and warfarin in patients with acute, confirmed symptomatic proximal PE and/or DVT. Decisions regarding hospital admission and/or discharge were left to the clinical judgment of attending physicians. Analyses were conducted in the intention-to-treat (ITT) population.
RESULTS: In the ITT population, overall patient characteristics were similar in both treatment arms. The median length of stay in rivaroxaban patients was 10.0 days (Interquartile range (IQR 6.0 to 15.0 days) while it was 15.0 days (IQR 9.0 to 22.0) for patients on standard therapy (p=0.016). All of the 4 DVT patients who were not hospitalized for the index event were in rivaroxaban arm.
CONCLUSIONS: Our results suggests that treatment with rivaroxaban may significantly reduce the length of hospital stay in patients hospitalized for PE and/or DVT compared with the current standard of care in Japan, thereby reducing the burden on patients and the healthcare system. The limitations of our study include small sample size and the generalizability of the findings to the real-world setting. Further research is warranted to identify PE and/or DVT patients in Japanese clinical practice who may potentially be managed as outpatients.
TRIAL REGISTRATION: Clinicaltrials.gov: NCT01516814 and NCT01516840.
PMID: 25851062 [PubMed - as supplied by publisher]