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Effect of a single dose of the interleukin-6 receptor antagonist tocilizumab on inflammation and troponin T release in patients with non-ST-elevation myocardial infarction: a double-blind, randomized, placebo-controlled phase 2 trial

Kleveland, Ola; Kunszt, Gabor; Bratlie, Marte; Ueland, Thor; Broch, Kaspar; Holte, Espen; Michelsen, Annika; Bendz, Bjørn; Amundsen, Brage H.; Espevik, Terje; Aakhus, Svend; Damås, Jan Kristian; Aukrust, Pål; Wiseth, Rune; Gullestad, Lars
Journal article, Peer reviewed
Published version
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URI
http://hdl.handle.net/11250/2476113
Date
2016
Metadata
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  • Institutt for klinisk og molekylær medisin [2016]
  • Institutt for nevromedisin og bevegelsesvitenskap [1657]
  • Publikasjoner fra CRIStin - NTNU [19946]
Original version
European Heart Journal. 2016, 37 (30), 2406-2413.   10.1093/eurheartj/ehw171
Abstract
Aims

Interleukin-6 (IL-6) contributes to atherosclerotic plaque destabilization and is involved in myocardial injury during ischaemia–reperfusion. Interleukin-6 is therefore a potential therapeutic target in myocardial infarction (MI). We hypothesized that the IL-6 receptor antagonist tocilizumab would attenuate inflammation, and secondarily reduce troponin T (TnT) release in non-ST-elevation MI (NSTEMI).

Methods and results

In a two-centre, double-blind, placebo-controlled trial, 117 patients with NSTEMI were randomized at a median of 2 days after symptom onset to receive placebo (n = 59) or tocilizumab (n = 58), administered as a single dose prior to coronary angiography. High sensitivity (hs) C-reactive protein and hsTnT were measured at seven consecutive timepoints between Days 1 and 3. The area under the curve (AUC) for high-sensitivity C-reactive protein was the primary endpoint. The median AUC for high-sensitivity C-reactive protein during hospitalization was 2.1 times higher in the placebo than in the tocilizumab group (4.2 vs. 2.0 mg/L/h, P < 0.001). Also, the median AUC for hsTnT during hospitalization was 1.5 times higher in the placebo group compared with the tocilizumab group (234 vs. 159 ng/L/h, P = 0.007). The differences between the two treatment groups were observed mainly in (i) patients included ≤2 days from symptom onset and (ii) patients treated with percutaneous coronary intervention (PCI). No safety issues in the tocilizumab group were detected during 6 months of follow-up.

Conclusion

Tocilizumab attenuated the inflammatory response and primarily PCI-related TnT release in NSTEMI patients.
Publisher
Oxford University Press (OUP)
Journal
European Heart Journal

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