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Selective cyclooxygenase-2 inhibitor anti-inflammatory drugs: trend of use and safety

Grant number: 22/06933-8
Support Opportunities:Scholarships in Brazil - Doctorate
Start date: November 01, 2022
End date: October 31, 2027
Field of knowledge:Health Sciences - Pharmacy - Medicines Analysis and Control
Principal Investigator:Tais Freire Galvao
Grantee:Tayanny Margarida Menezes Almeida Biase
Host Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil
Associated scholarship(s):23/16469-0 - Renal effects of selective cyclooxygenase-2 inhibitors: analysis of Portuguese Pharmacovigilance System, BE.EP.DR

Abstract

This research aims to evaluate the use of selective cyclooxygenase-2 inhibitor anti-inflammatory drugs in Brazil and the scientific evidence on the safety of these drugs. Four main approaches will be used: (i) analysis of national consumption trends, (ii) systematic review with meta-analysis, (iii) international and (iv) national pharmacovigilance. The national consumption trend will be investigated through the analysis of data from the Sistema Nacional de Gerenciamento de Produtos Controlados, from 2014 to 2020. Segmented regression model will estimate the temporal trend based on the defined daily dose (DDD) of each drug and the DDD per 1,000 inhabitants/day (DID). The trends in the consumption of anti-inflammatory drugs in DID will be evaluated by a segmented regression model (Joinpoint regression) and subsequent calculation of the average annual percentage change (average annual percent change, AAPC) with a confidence interval of 95% (95%CI). A systematic review will be carried out on the renal effects of the use of selective cyclooxygenase-2 inhibitors. The systematic review will guide pharmacovigilance research from the Portuguese adverse reaction reporting system, in order to analyze adverse reactions and reporting trends in Portugal. An internship in research abroad was planned to make this stage possible. A similar approach will be adopted to investigate such adverse reactions to selective cyclooxygenase-2 inhibitors in the Brazilian population, based on the records available at the Agência Nacional de Vigilância Sanitária. The results will be statistically analyzed and interpreted for the elaboration and publication of the manuscript.

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
BIASE, TAYANNY MARGARIDA MENEZES ALMEIDA; ROCHA, JOAO GABRIEL MENDES; SILVA, MARCUS TOLENTINO; RIBEIRO-VAZ, INES; GALVAO, TAIS FREIRE. Renal effects of selective cyclooxygenase-2 inhibitor anti-inflammatory drugs: A systematic review and meta-analysis. EXPLORATORY RESEARCH IN CLINICAL AND SOCIAL PHARMACY, v. 15, p. 10-pg., . (22/06933-8)
BIASE, TAYANNY MARGARIDA MENEZES ALMEIDA; SILVA, MARCUS TOLENTINO; LOPES, LARISSA; GALVAO, TAIS FREIRE. Temporal Trend in Selective Cyclooxygenase-2 Inhibitors Sales in Brazilian Drugstores. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, v. 34, n. 6, p. 7-pg., . (22/06933-8)