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Chen, I-Chih; Lee, Cheng-Han; Li, Yi-Heng; Chao, Ting-Hsing*

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Journal of the Chinese Medical Association: March 2017 - Volume 80 - Issue 3 - p 185-186
doi: 10.1016/j.jcma.2016.11.004

    Dear Editor,

    We sincerely appreciate the comment by Lombardi et al1 on our published paper.2Table 1 demonstrates the incidence of dyspnea and the discontinuation of ticagrelor due to dyspnea in patients who reported dyspnea in Phase 3/4 clinical trials3–7 of acute coronary syndrome with available relevant data. Our study revealed that the incidence of dyspnea-related discontinuation of P2Y12 antagonist treatment in patients with dyspnea tended to be higher in the ticagrelor group (17.0%),2 which was similar to previous real-world studies.5–7 When compared with clopidogrel treatment, ticagrelor causes a fourfold increase in the incidence of dyspnea requiring discontinuation of a P2Y12 antagonist, according to our study2; the result was very similar to that of the Study of Platelet Inhibition and Patient Outcomes trial (a 3.4-fold increase).3 In light of the advantages and disadvantages of randomized controlled trials and observational studies,8,9 both clinical and observational evidence should not be mutually exclusive and should actually be complementary.

    Table 1
    Table 1:
    Reported incidence of dyspnea and discontinuation of ticagrelor due to dyspnea in the literature.

    Conflicts of interest

    I.-C.C. and C.-H.L. have been on the speakers’ bureau for AstraZeneca and Sanofi. T.-H.C. has been on the speakers’ bureau for AstraZeneca and Sanofi, and ever received travel expenses and others, which are unrelated to research, to attend Annual Scientific Meetings of the European Society of Cardiology from AstraZeneca and Sanofi. Y.-H.L. has been on the speakers’ bureau for AstraZeneca and Sanofi and ever received travel expenses and others, which are unrelated to research, to attend Annual Scientific Meetings of the American College of Cardiology from AstraZeneca.

    References

    1. Lombardi N, Crescioli G, Lucenteforte E, Mugelli A, Vannacci A. Ticagrelor safety profile in real-life setting of acute coronary syndrome patients. J Chin Med Assoc. 2017;80:183-184.
    2. Chen IC, Lee CH, Fang CC, Chao TH, Cheng CL, Chen Y, et al. Efficacy and safety of ticagrelor versus clopidogrel in acute coronary syndrome in Taiwan: a multicenter retrospective pilot study. J Chin Med Assoc. 2016;79:521-530.
    3. Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009;361:1045-1057.
    4. Subiakto I, AsrarulHaq M, Van Gaal WJ. Bleeding risk and incidence in real world percutaneous coronary intervention patients with ticagrelor. Heart Lung Circ. 2015;24:404-406.
    5. Dehghani P, Chopra V, Bell A, Kelly S, Zulyniak L, Booker J, et al. Southern Saskatchewan ticagrelor registry experience. Patient Prefer Adherence. 2014;8:1427-1435.
    6. Gaubert M, Laine M, Richard T, Fournier N, Gramond C, Bessereau J, et al. Effect of ticagrelor-related dyspnea on compliance with therapy in acute coronary syndrome patients. Int J Cardiol. 2014;173:120-121.
    7. Sánchez-Galian MJ, Flores-Blanco PJ, López-Cuenca A, Gómez-Molina M, Guerrero-Pérez E, Cambronero-Sánchez F, et al. Ticagrelor related dyspnea in patients with acute coronary syndromes: incidence and implication on ticagrelor withdrawn. Int J Cardiol. 2015;187:517-518.
    8. Nallamothu BK, Hayward RA, Bates ER. Beyond the randomized clinical trial: the role of effectiveness studies in evaluating cardiovascular therapies. Circulation. 2008;118:1294-1303.
    9. Lombardi N, Crescioli G, Mugelli A, Vannacci A. Ticagrelor recommended over clopidogrel, only in clinical trials or also in a real-world practice? Expert Rev Cardiovasc Ther. 2016;14:1103-1104.
    © 2017 by Lippincott Williams & Wilkins, Inc.