TY - JOUR
T1 - PAIS 2 (Paracetamol [Acetaminophen] in Stroke 2): Results of a Randomized, Double-Blind Placebo-Controlled Clinical Trial
T2 - Results of a Randomized, Double-Blind Placebo-Controlled Clinical Trial
AU - de Ridder, Inger R.
AU - den Hertog, Heleen M.
AU - van Gemert, H. Maarten A.
AU - Schreuder, A. H. C. M. L. Tobien
AU - Ruitenberg, Annemieke
AU - Maasland, E. Lisette
AU - Saxena, Ritu
AU - van Tuijl, Jordie H.
AU - Jansen, Ben P. W.
AU - van den Berg-Vos, Renske M.
AU - Vermeij, Frederique
AU - Koudstaal, Peter J.
AU - Kappelle, L. Jaap
AU - Algra, Ale
AU - van der Worp, H. Bart
AU - Dippel, Diederik W. J.
AU - AUTHOR GROUP
AU - Lingsma, H. F.
AU - El Ghannouti, N.
AU - Vermey, F.
AU - Vermeulen, M.
AU - Tijssen, J. G. P.
AU - van Dijk, E. J.
PY - 2017/4/1
Y1 - 2017/4/1
N2 - Background and Purpose-Subfebrile body temperature and fever in the first days after stroke are strongly associated with unfavorable outcome. A subgroup analysis of a previous trial suggested that early treatment with paracetamol may improve functional outcome in patients with acute stroke and a body temperature of 36.5 degrees C. In the present trial, we aimed to confirm this finding. Methods-PAIS 2 (Paracetamol [Acetaminophen] in Stroke 2) was a multicenter, randomized, double-blind, placebo-controlled clinical trial. We aimed to include 1500 patients with acute ischemic stroke or intracerebral hemorrhage within 12 hours of symptom onset. Patients were treated with paracetamol in a daily dose of 6 g or matching placebo for 3 consecutive days. The primary outcome was functional outcome at 3 months, assessed with the modified Rankin Scale and analyzed with multivariable ordinal logistic regression. Because of slow recruitment and lack of funding, the study was stopped prematurely. Results-Between December 2011 and October 2015, we included 256 patients, of whom 136 (53%) were allocated to paracetamol. In this small sample, paracetamol had no effect on functional outcome (adjusted common odds ratio, 1.15; 95% confidence interval, 0.74-1.79). There was no difference in the number of serious adverse events (paracetamol n=35 [26%] versus placebo n=28 [24%]). Conclusions-Treatment with high-dose paracetamol seemed to be safe. The effect of high-dose paracetamol on functional outcome remains uncertain. Therefore, a large trial of early treatment with high-dose paracetamol is still needed
AB - Background and Purpose-Subfebrile body temperature and fever in the first days after stroke are strongly associated with unfavorable outcome. A subgroup analysis of a previous trial suggested that early treatment with paracetamol may improve functional outcome in patients with acute stroke and a body temperature of 36.5 degrees C. In the present trial, we aimed to confirm this finding. Methods-PAIS 2 (Paracetamol [Acetaminophen] in Stroke 2) was a multicenter, randomized, double-blind, placebo-controlled clinical trial. We aimed to include 1500 patients with acute ischemic stroke or intracerebral hemorrhage within 12 hours of symptom onset. Patients were treated with paracetamol in a daily dose of 6 g or matching placebo for 3 consecutive days. The primary outcome was functional outcome at 3 months, assessed with the modified Rankin Scale and analyzed with multivariable ordinal logistic regression. Because of slow recruitment and lack of funding, the study was stopped prematurely. Results-Between December 2011 and October 2015, we included 256 patients, of whom 136 (53%) were allocated to paracetamol. In this small sample, paracetamol had no effect on functional outcome (adjusted common odds ratio, 1.15; 95% confidence interval, 0.74-1.79). There was no difference in the number of serious adverse events (paracetamol n=35 [26%] versus placebo n=28 [24%]). Conclusions-Treatment with high-dose paracetamol seemed to be safe. The effect of high-dose paracetamol on functional outcome remains uncertain. Therefore, a large trial of early treatment with high-dose paracetamol is still needed
KW - acetaminophen
KW - body temperature
KW - stroke
KW - therapy
KW - treatment outcome
UR - http://www.scopus.com/inward/record.url?scp=85015206010&partnerID=8YFLogxK
U2 - https://doi.org/10.1161/STROKEAHA.116.015957
DO - https://doi.org/10.1161/STROKEAHA.116.015957
M3 - Article
C2 - 28289240
SN - 0039-2499
VL - 48
SP - 977
EP - 982
JO - Stroke; a journal of cerebral circulation
JF - Stroke; a journal of cerebral circulation
IS - 4
ER -