Ubrogepant and rimegepant: systematic review, meta-analysis, and meta-regression of clinical studies

ABSTRACT

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.

KEYWORDS:

• Safety
• ubrogepant
• rimegepant
• pharmacovigilance

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

M Sessa and G Dong had the preliminary idea for this study and all authors contributed to its development. All authors drafted the paper, revised it critically for intellectual content, approved the final version to be published, and agreed to be accountable for all aspects of the work. NA Kjærgaard and M Sessa performed the data analysis and interpreted the results.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2177270

Additional information

Funding

This paper was not funded.