Charles Khouri1, Camille Petit2, Michel Tod3, Marion Lepelley2, Bruno Revol4, Matthieu Roustit5, Jean-Luc Cracowski5. 1. Pharmacovigilance Unit, Grenoble Alpes University Hospital, Grenoble, France; Clinical Pharmacology Department INSERM CIC1406, Grenoble Alpes University Hospital, Grenoble, France; UMR 1042-HP2, INSERM, Univ. Grenoble Alpes, Grenoble, France. Electronic address: CKhouri@chu-grenoble.fr. 2. Pharmacovigilance Unit, Grenoble Alpes University Hospital, Grenoble, France. 3. EMR 3738, Ciblage Thérapeutique en Oncologie, Faculté de Médecine et de Maïeutique Lyon-Sud Charles Mérieux, Université Claude Bernard Lyon 1, Oullins, France; Pharmacie Hôpital de la Croix Rousse, Hospices Civils de Lyon, Lyon, France. 4. Pharmacovigilance Unit, Grenoble Alpes University Hospital, Grenoble, France; UMR 1042-HP2, INSERM, Univ. Grenoble Alpes, Grenoble, France. 5. Clinical Pharmacology Department INSERM CIC1406, Grenoble Alpes University Hospital, Grenoble, France; UMR 1042-HP2, INSERM, Univ. Grenoble Alpes, Grenoble, France.
Abstract
OBJECTIVE: We aimed at testing if a correlation between adverse drug reactions relative risks estimated from meta-analyses and disproportionality analyses calculated from pharmacovigilance spontaneous reporting systems databases exist, and if methodological choices modify this correlation. STUDY DESIGN: We extracted adverse drug reactions (ADR) odds ratios (ORs) from meta-analyses used as reference and calculated corresponding Reporting Odds Ratios (RORs) from the WHO pharmacovigilance database according to five different designs. We also calculated the relative bias and agreement of ROR compared to ORs. RESULTS: We selected five meta-analyses which displayed a panel of 13 ADRs. A significant correlation for 7 out of the 13 ADRs studied in the primary analysis was found. The methods for ROR calculation impacted the results but none systematically improved the correlations. Whereas correlation was found between OR and ROR, agreement was poor and relative bias was important. CONCLUSION: Despite the large variation in disproportionality analyses results due to design specification, this study provides further evidence that relative risks obtained from meta-analyses and from disproportionality analyses correlate in most cases, in particular for objective ADR not associated with the underlying pathology.
OBJECTIVE: We aimed at testing if a correlation between adverse drug reactions relative risks estimated from meta-analyses and disproportionality analyses calculated from pharmacovigilance spontaneous reporting systems databases exist, and if methodological choices modify this correlation. STUDY DESIGN: We extracted adverse drug reactions (ADR) odds ratios (ORs) from meta-analyses used as reference and calculated corresponding Reporting Odds Ratios (RORs) from the WHO pharmacovigilance database according to five different designs. We also calculated the relative bias and agreement of ROR compared to ORs. RESULTS: We selected five meta-analyses which displayed a panel of 13 ADRs. A significant correlation for 7 out of the 13 ADRs studied in the primary analysis was found. The methods for ROR calculation impacted the results but none systematically improved the correlations. Whereas correlation was found between OR and ROR, agreement was poor and relative bias was important. CONCLUSION: Despite the large variation in disproportionality analyses results due to design specification, this study provides further evidence that relative risks obtained from meta-analyses and from disproportionality analyses correlate in most cases, in particular for objective ADR not associated with the underlying pathology.
Authors: Laurent Chouchana; Alice Blet; Mohammad Al-Khalaf; Tahir S Kafil; Girish Nair; James Robblee; Milou-Daniel Drici; Marie-Blanche Valnet-Rabier; Joëlle Micallef; Francesco Salvo; Jean-Marc Treluyer; Peter P Liu Journal: Clin Pharmacol Ther Date: 2021-12-27 Impact factor: 6.903