Renal effects of selective cyclooxygenase-2 inhibitors: analysis of Portuguese Pharmacovigilance System

Abstract

A systematic review of randomized clinical trials conducted in the context of the doctoral project observed higher risks of renal adverse reactions by selective cyclooxygenase-2 inhibitor anti-inflammatory compared to placebo. There is little real-world evidence on the renal effects of these drugs. This research aims to assess the renal effects of selective cyclooxygenase-2 inhibitor anti-inflammatory by means of a pharmacovigilance study in Portugal. The study will be based on disproportionality analysis, using reports of adverse reactions sent to the Portuguese National Authority for Medicines and Health Products, from 2018 to 2023. Reports of adverse reactions to selective cyclooxygenase-2 inhibitor anti-inflammatory (celecoxib, etoricoxib, lumiracoxib, parecoxib, rofecoxib and valdecoxib) will be eligible. The variables will include information about the regional units, notifier, age and sex of the patient, drugs involved, types of renal reactions, severity of reactions and causality attributed. The data will be encoded according to the Medical Dictionary of Regulatory Activities, with descriptive statistical analysis and use of the chi-square test to test differences in distributions. The disproportionality analysis will be performed to identify statistical associations between selective cyclooxygenase-2 inhibitor anti-inflammatory and adverse renal events. The most frequent reactions will be investigated through reported odds ratio to verify the statistical association between drugs and kidney damage. After returning to the country, with the expertise acquired in an internationally consolidated system, a similar analysis will be used to study such reactions from the Brazilian notification system.