TY - JOUR

T1 - Ubrogepant and rimegepant

T2 - systematic review, meta-analysis, and meta-regression of clinical studies

AU - Dong, Guojun

AU - Kjærgaard, Naoko Adachi

AU - Shakibfar, Saeed

AU - Sessa, Maurizio

N1 - Publisher Copyright: © 2023 Informa UK Limited, trading as Taylor & Francis Group.

PY - 2023

Y1 - 2023

N2 - Objectives: This study aimed at providing pooled estimates of the incidence of adverse drug reactions (ADRs) of ubrogepant and rimegepant and to use meta-regression to identify correlations between the occurrence of selected ADRs, socio-demographic, and clinical characteristics from data published in clinical studies. Methods: Ovid MEDLINE (up to 03/02/2022) was searched along with the references listed in the reviews identified with the research query. Random intercept and slope logistic regression models were used to estimate the logit transformation of the pooled incidence. To examine how selected clinical and socio-demographic characteristics correlated with the pooled incidence rates, we performed random-effects meta-regression. Results: Significant heterogeneity of incidence estimates was observed in clinical studies along with correlations between ADRs and the sociodemographic and clinical characteristics of patients exposed to ubrogepant. In particular, we observed a correlation between ubrogepant dosage and muscle strain and between Body Mass Index (BMI) and liver function values. For rimegepant, significant correlations were observed between age and infections and having aura symptoms at baseline and nausea/dizziness/diarrhea/muscle strain. Conclusion: This study provided pooled incidence estimates of ubrogepant and rimegepant’s ADRs and highlighted new safety aspects of the pharmacological treatment with ubrogepants and rimigepants from correlations obtained from the meta-regression.

AB - Objectives: This study aimed at providing pooled estimates of the incidence of adverse drug reactions (ADRs) of ubrogepant and rimegepant and to use meta-regression to identify correlations between the occurrence of selected ADRs, socio-demographic, and clinical characteristics from data published in clinical studies. Methods: Ovid MEDLINE (up to 03/02/2022) was searched along with the references listed in the reviews identified with the research query. Random intercept and slope logistic regression models were used to estimate the logit transformation of the pooled incidence. To examine how selected clinical and socio-demographic characteristics correlated with the pooled incidence rates, we performed random-effects meta-regression. Results: Significant heterogeneity of incidence estimates was observed in clinical studies along with correlations between ADRs and the sociodemographic and clinical characteristics of patients exposed to ubrogepant. In particular, we observed a correlation between ubrogepant dosage and muscle strain and between Body Mass Index (BMI) and liver function values. For rimegepant, significant correlations were observed between age and infections and having aura symptoms at baseline and nausea/dizziness/diarrhea/muscle strain. Conclusion: This study provided pooled incidence estimates of ubrogepant and rimegepant’s ADRs and highlighted new safety aspects of the pharmacological treatment with ubrogepants and rimigepants from correlations obtained from the meta-regression.

KW - pharmacovigilance

KW - rimegepant

KW - Safety

KW - ubrogepant

U2 - 10.1080/14740338.2023.2177270

DO - 10.1080/14740338.2023.2177270

M3 - Journal article

C2 - 36737057

AN - SCOPUS:85148058985

VL - 22

SP - 59

EP - 70

JO - Expert Opinion on Drug Safety

JF - Expert Opinion on Drug Safety

SN - 1474-0338

IS - 1

ER -