PMID- 21804104 OWN - NLM STAT- MEDLINE DCOM- 20120131 LR - 20230808 IS - 1522-9645 (Electronic) IS - 0195-668X (Linking) VI - 32 IP - 23 DP - 2011 Dec TI - Characterization of dyspnoea in PLATO study patients treated with ticagrelor or clopidogrel and its association with clinical outcomes. PG - 2945-53 LID - 10.1093/eurheartj/ehr231 [doi] AB - AIMS To describe the incidence of dyspnoea and its associations with demographic characteristics and clinical outcomes in patients with acute coronary syndromes (ACS) treated with ticagrelor or clopidogrel in the PLATelet inhibition and patient Outcomes (PLATO) study. METHODS AND RESULTS In the PLATO study, 18 624 patients were randomized to receive either clopidogrel [300-600 mg loading dose (LD), 75 mg daily] or ticagrelor (180 mg LD, 90 mg b.i.d.). The occurrence of reported dyspnoea adverse events (AEs) was analysed in the 18 421 patients who received at least one dose of study medication in relation to demographic characteristics, clinical outcomes and other associations of patients with and without dyspnoea. A total of 1339 ticagrelor-treated patients (14.5%) and 798 clopidogrel-treated patients (8.7%) had a dyspnoea AE following randomization, with respectively 39 (0.4%) and 24 (0.3%) classified as severe in intensity. Excluding dyspnoea AEs occurring after the secondary endpoint of myocardial infarction (MI), the yearly rates of the efficacy endpoints in dyspnoea AE patients in the ticagrelor and clopidogrel groups were: for the primary composite of CV death, MI, and stroke, 8.8 and 10.4% (unadjusted P = 0.25; adjusted P = 0.54); for CV death, 3.1 and 4.8% (unadjusted P = 0.024; adjusted P = 0.18); and for total death 3.7 and 6.2% (unadjusted P = 0.004; adjusted P = 0.06), respectively. CONCLUSIONS Ticagrelor-related dyspnoea is usually mild or moderate in intensity and does not appear to be associated with differences concerning any efficacy or safety outcomes with ticagrelor compared with clopidogrel therapy in ACS patients. FAU - Storey, Robert F AU - Storey RF AD - Department of Cardiovascular Science, University of Sheffield, UK. r.f.storey@sheffield.ac.uk FAU - Becker, Richard C AU - Becker RC FAU - Harrington, Robert A AU - Harrington RA FAU - Husted, Steen AU - Husted S FAU - James, Stefan K AU - James SK FAU - Cools, Frank AU - Cools F FAU - Steg, Philippe Gabriel AU - Steg PG FAU - Khurmi, Nardev S AU - Khurmi NS FAU - Emanuelsson, Hakan AU - Emanuelsson H FAU - Cooper, Anna AU - Cooper A FAU - Cairns, Richard AU - Cairns R FAU - Cannon, Christopher P AU - Cannon CP FAU - Wallentin, Lars AU - Wallentin L LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20110730 PL - England TA - Eur Heart J JT - European heart journal JID - 8006263 RN - 0 (Platelet Aggregation Inhibitors) RN - 0 (Purinergic P2Y Receptor Antagonists) RN - A74586SNO7 (Clopidogrel) RN - GLH0314RVC (Ticagrelor) RN - K72T3FS567 (Adenosine) RN - OM90ZUW7M1 (Ticlopidine) SB - IM MH - Acute Coronary Syndrome/*drug therapy MH - Adenosine/adverse effects/*analogs & derivatives MH - Aged MH - Clopidogrel MH - Double-Blind Method MH - Dyspnea/*chemically induced MH - Female MH - Humans MH - Male MH - Middle Aged MH - Platelet Aggregation Inhibitors/*adverse effects MH - Purinergic P2Y Receptor Antagonists/*adverse effects MH - Ticagrelor MH - Ticlopidine/adverse effects/*analogs & derivatives MH - Treatment Outcome EDAT- 2011/08/02 06:00 MHDA- 2012/02/01 06:00 CRDT- 2011/08/02 06:00 PHST- 2011/08/02 06:00 [entrez] PHST- 2011/08/02 06:00 [pubmed] PHST- 2012/02/01 06:00 [medline] AID - ehr231 [pii] AID - 10.1093/eurheartj/ehr231 [doi] PST - ppublish SO - Eur Heart J. 2011 Dec;32(23):2945-53. doi: 10.1093/eurheartj/ehr231. Epub 2011 Jul 30.