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Effects of celecoxib on hematoma and edema volumes in primary intracerebral hemorrhage: a multicenter randomized controlled trial
Author(s) -
Lee S.H.,
Park H.K.,
Ryu W.S.,
Lee J.S.,
Bae H.J.,
Han M.K.,
Lee Y.S.,
Kwon H.M.,
Kim C. K.,
Park E.S.,
Chung J.W.,
Jung K.H.,
Roh J.K.
Publication year - 2013
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/ene.12140
Subject(s) - medicine , celecoxib , intracerebral hemorrhage , randomized controlled trial , clinical endpoint , edema , anesthesia , end point , clinical trial , subarachnoid hemorrhage , geometry , mathematics
Background and purpose We investigated the effect of celecoxib, a selective inhibitor of cyclo‐oxygenase 2, in patients with intracerebral hemorrhage ( ICH ). Methods We conducted a multicenter, randomized, controlled, and open with blinded end‐point trial of 44 Korean patients 18 years or older with ICH within 24 h of onset. The intervention group ( n = 20) received celecoxib (400 mg twice a day) for 14 days. The control group ( n = 24) received the standard medical treatment for ICH . The primary end‐point was the number of patients with a change in the volume of perihematomal edema ( PHE ) from the 1st to the 7th ± 1 day (cut‐off value, 20%). Results The time from onset to computed tomography scan slightly differed between groups (177 ± 160 min for control vs. 297 ± 305 min for the celecoxib group; P = 0.10). In the primary end‐point analysis using cut‐off values, there was a significant shift to reduced expansion of PHE in the celecoxib group ( P = 0.005). With respect to the secondary end‐points, there was also a significant shift to reduced expansion of ICH in the celecoxib group ( P = 0.046). In addition, the expansion rate of PHE at follow‐up tended to be higher in the control group than in the celecoxib group (90.6 ± 91.7% vs. 44.4 ± 64.9%; P = 0.058). Conclusions In our small, pilot trial, administration of celecoxib in the acute stage of ICH was associated with a smaller expansion of PHE than that observed in controls.