TY - JOUR

T1 - Patient characteristics and safety outcomes in new users of ticagrelor and clopidogrel

T2 - An observational cohort study in Sweden

AU - Linder, Marie

AU - Andersen, Morten

N1 - Funding Information: M.L. is an employee of the Centre for Pharmacoepidemiology, Karolinska Institutet, which receives grants from several entities (pharmaceutical companies, regulatory authorities, and contract research organizations), including AstraZeneca, for performance of drug safety and drug utilization studies. M.A. was an employee at the Centre for Pharmacoepidemiology, Karolinska Institutet at the time the study was conducted. Morten Andersen reports grants from AstraZeneca, Novartis, Pfizer, Janssen, H. Lundbeck & Mertz, and the Novo Nordisk Foundation (NNF15SA0018404) outside the submitted work, and personal fees from Atrium and the Danish Pharmaceutical Industry Association for leading and teaching pharmacoepidemiology courses. Funding Information: This study was funded by AstraZeneca. The authors acknowledge the input of Saga Johansson (a former employee of AstraZeneca Gothenburg, Mölndal, Sweden), and Jie Mei, Marianne Jahreskog, and Karolina Andersson Sundell (all AstraZeneca). Editorial support was provided by Anja Becher, PhD, and Nesta Hughes, PhD, of Oxford PharmaGenesis, Oxford, UK, funded by AstraZeneca. Publisher Copyright: © 2021 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

PY - 2022

Y1 - 2022

N2 - Purpose: We aimed to describe characteristics of new users of ticagrelor or clopidogrel following a recent coronary event, and to compare incidences of selected safety outcomes. Methods: This observational cohort study used data from national Swedish registers. Patients first dispensed ticagrelor or clopidogrel (June 2011–December 2013) were identified from the Prescribed Drug Register and followed until censoring or 31 December 2014. Cohorts were restricted to patients with a recent coronary event-related hospital contact identified in the Patient Register. Results: The study included 45 987 unique, naïve users of ticagrelor (73% men; mean age 66 years) or clopidogrel (69% men; mean age 69 years). Corresponding to indication, diagnoses before initiation were acute coronary syndrome (93%), myocardial infarction (76%), and percutaneous coronary intervention (69%). The most common medications used in the year before initiation of study therapy were antithrombotic agents (clopidogrel 62%, ticagrelor 43%), mainly low-dose acetylsalicylic acid. Ticagrelor users had a higher incidence (per 1000 person-years) of respiratory bleeding (24.6 [95% confidence interval (CI): 22.1–27.3]; vs clopidogrel users: 14.4 [13.1–15.8]) and dyspnea (25.9 [23.3–28.7]; vs clopidogrel users: 16.8 [15.4–18.4]). Epistaxis accounted for 83–93% of respiratory bleeds. Adjusted analyses found increased risks of gout and acute renal failure with ticagrelor. Conclusions: Clopidogrel users were older with a higher prevalence of concomitant medications than ticagrelor users. Our study showed increased incidences of dyspnea and respiratory bleeding (mainly epistaxis) among current ticagrelor users compared with clopidogrel users, and increased risks of gout and acute renal failure after adjustment.

AB - Purpose: We aimed to describe characteristics of new users of ticagrelor or clopidogrel following a recent coronary event, and to compare incidences of selected safety outcomes. Methods: This observational cohort study used data from national Swedish registers. Patients first dispensed ticagrelor or clopidogrel (June 2011–December 2013) were identified from the Prescribed Drug Register and followed until censoring or 31 December 2014. Cohorts were restricted to patients with a recent coronary event-related hospital contact identified in the Patient Register. Results: The study included 45 987 unique, naïve users of ticagrelor (73% men; mean age 66 years) or clopidogrel (69% men; mean age 69 years). Corresponding to indication, diagnoses before initiation were acute coronary syndrome (93%), myocardial infarction (76%), and percutaneous coronary intervention (69%). The most common medications used in the year before initiation of study therapy were antithrombotic agents (clopidogrel 62%, ticagrelor 43%), mainly low-dose acetylsalicylic acid. Ticagrelor users had a higher incidence (per 1000 person-years) of respiratory bleeding (24.6 [95% confidence interval (CI): 22.1–27.3]; vs clopidogrel users: 14.4 [13.1–15.8]) and dyspnea (25.9 [23.3–28.7]; vs clopidogrel users: 16.8 [15.4–18.4]). Epistaxis accounted for 83–93% of respiratory bleeds. Adjusted analyses found increased risks of gout and acute renal failure with ticagrelor. Conclusions: Clopidogrel users were older with a higher prevalence of concomitant medications than ticagrelor users. Our study showed increased incidences of dyspnea and respiratory bleeding (mainly epistaxis) among current ticagrelor users compared with clopidogrel users, and increased risks of gout and acute renal failure after adjustment.

KW - clopidogrel

KW - cohort study

KW - patient characteristics

KW - safety

KW - ticagrelor

U2 - 10.1002/pds.5387

DO - 10.1002/pds.5387

M3 - Journal article

C2 - 34802175

AN - SCOPUS:85120490398

VL - 31

SP - 235

EP - 246

JO - Pharmacoepidemiology and Drug Safety

JF - Pharmacoepidemiology and Drug Safety

SN - 1053-8569

IS - 2

ER -