Abstract:
BACKGROUND:Thrombocytopenia represents an obstacle for invasive procedures in chronic liver disease (CLD) patients. We aimed to estimate the appropriate dose and evaluate the efficacy and safety of lusutrombopag for the treatment of thrombocytopenia before percutaneous liver radiofrequency ablation (RFA) for primary hepatic cancer in patients with CLD. METHODS:In this multicenter, randomized, double-blind, placebo-controlled study conducted in Japan, 61 CLD patients with platelet count < 50 × 103/µL at screening were randomized to placebo or lusutrombopag 2, 3, or 4 mg once daily for 7 days, followed by a 28-day post-treatment assessment period. The primary efficacy endpoint was the proportion of patients who did not require platelet transfusion before RFA. The pre-specified key secondary efficacy endpoint was the proportion of responders. Adverse events (AEs) and thrombosis-related AEs were evaluated. RESULTS:The proportion of patients who did not require platelet transfusion before RFA and that of responders were significantly higher (p < 0.01) in the 2-mg (80.0, 66.7%), 3-mg (81.3, 68.8%), and 4-mg groups (93.3, 80.0%) compared with the placebo group (20.0, 6.7%) and showed a dose-dependent effect. The incidence of AEs was 97.8 and 100% in the lusutrombopag (all groups) and placebo groups, respectively; no dose-related increase was observed. Four patients experienced thrombosis-related events (one each in the placebo and 2-mg groups, and two in the 4-mg group). A total of 16 (18%) adverse drug reactions occurred in the safety analysis set. CONCLUSIONS:Lusutrombopag 3 mg once daily for 7 days was effective without raising concerns about excessive increases in platelet count. CLINICAL TRIAL REGISTRATION:The study is registered at JapicCTI-121944.
journal_name
J Gastroenteroljournal_title
Journal of gastroenterologyauthors
Tateishi R,Seike M,Kudo M,Tamai H,Kawazoe S,Katsube T,Ochiai T,Fukuhara T,Kano T,Tanaka K,Kurokawa M,Yamamoto K,Osaki Y,Izumi N,Imawari Mdoi
10.1007/s00535-018-1499-2subject
Has Abstractpub_date
2019-02-01 00:00:00pages
171-181issue
2eissn
0944-1174issn
1435-5922pii
10.1007/s00535-018-1499-2journal_volume
54pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:The precise pathogenic mechanism of nonsteroidal antiinflammatory drug-induced small intestinal injury is still unknown. In the present study, we investigated the mechanism by which indomethacin induced mucosal injury by using an in vitro model of small intestine. METHODS:The colon cancer cell line Caco-2, ...
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