TY - JOUR
T1 - Desloratadine Exposure and Incidence of Seizure
T2 - A Nordic Post-authorization Safety Study Using a New-User Cohort Study Design, 2001–2015
AU - Ersbøll, Annette Kjær
AU - Sengupta, Kaushik
AU - Pukkala, Eero
AU - Bolin, Kristian
AU - Aas, Eline
AU - Emneus, Martha
AU - Ramey, Dena Rosen
AU - Brady, Joanne E.
AU - Mines, Daniel
AU - Aasbjerg, Kristian
AU - Vestergaard, Christian
AU - Gislason, Gunnar
AU - Born, Alfred Peter
AU - Kjærulff, Thora Majlund
N1 - Funding Information:
The paper is based on data originating from a PASS that the European Medicines Agency requested from Merck & Co., Inc., Kenilworth, NJ, USA. Merck & Co., Inc., Kenilworth, NJ, USA contracted Applied Economics and Health Research (ApHER), an independent research institute, to conduct the study based on this regulatory request. This study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
PY - 2021
Y1 - 2021
N2 - Introduction: A small number of adverse events of seizure in patients using desloratadine (DL) have been reported. The European Medicines Agency requested a post-authorization safety study to investigate whether there is an association between DL exposure and seizure. Objective: The aim was to study the association between DL exposure and incidence of first seizure. Methods: A new-user cohort study of individuals redeeming a first-ever prescription of DL in Denmark, Finland, Norway, and Sweden in 2001–2015 was conducted. DL exposure was defined as days’ supply plus a 4-week grace period. DL unexposed periods were initiated 27 weeks after DL prescription redemption. Poisson regression was used to estimate the adjusted incidence rate and adjusted incidence rate ratio (aIRR) of incident seizure. Results: A total of 1,807,347 first-ever DL users were included in the study, with 49.3% male and a mean age of 29.5 years at inclusion; 20.3% were children aged 0–5 years. The adjusted incidence rates of seizure were 21.7 and 31.6 per 100,000 person-years during DL unexposed and exposed periods, respectively. A 46% increased incidence rate of seizure was found during DL exposed periods (aIRR = 1.46, 95% confidence interval [CI] 1.34–1.59). The aIRR ranged from 1.85 (95% CI 1.65–2.08) in children aged 0–5 years to 1.01 in adults aged 20 years or more (95% CI 0.85–1.19). Conclusion: This study found an increased incidence rate of seizure during DL exposed periods as compared to unexposed periods among individuals younger than 20 years. No difference in incidence rate of seizure was observed in adults between DL exposed and unexposed.
AB - Introduction: A small number of adverse events of seizure in patients using desloratadine (DL) have been reported. The European Medicines Agency requested a post-authorization safety study to investigate whether there is an association between DL exposure and seizure. Objective: The aim was to study the association between DL exposure and incidence of first seizure. Methods: A new-user cohort study of individuals redeeming a first-ever prescription of DL in Denmark, Finland, Norway, and Sweden in 2001–2015 was conducted. DL exposure was defined as days’ supply plus a 4-week grace period. DL unexposed periods were initiated 27 weeks after DL prescription redemption. Poisson regression was used to estimate the adjusted incidence rate and adjusted incidence rate ratio (aIRR) of incident seizure. Results: A total of 1,807,347 first-ever DL users were included in the study, with 49.3% male and a mean age of 29.5 years at inclusion; 20.3% were children aged 0–5 years. The adjusted incidence rates of seizure were 21.7 and 31.6 per 100,000 person-years during DL unexposed and exposed periods, respectively. A 46% increased incidence rate of seizure was found during DL exposed periods (aIRR = 1.46, 95% confidence interval [CI] 1.34–1.59). The aIRR ranged from 1.85 (95% CI 1.65–2.08) in children aged 0–5 years to 1.01 in adults aged 20 years or more (95% CI 0.85–1.19). Conclusion: This study found an increased incidence rate of seizure during DL exposed periods as compared to unexposed periods among individuals younger than 20 years. No difference in incidence rate of seizure was observed in adults between DL exposed and unexposed.
U2 - 10.1007/s40264-021-01106-7
DO - 10.1007/s40264-021-01106-7
M3 - Article
AN - SCOPUS:85116360015
SN - 0114-5916
VL - 44
SP - 1231
EP - 1242
JO - DRUG SAFETY
JF - DRUG SAFETY
ER -
