Segurança de Antidiabéticos Orais: Análise de Desproporcionalidade no Sistema Português de Farmacovigilância
Introduction: Our objective was to investigate associations between oral antidiabetics and adverse drug reactions through disproportionality analysis in the Portuguese Pharmacovigilance System database. Methods: Spontaneous reports of adverse drug reactions reported for oral antidiabetics (2008–...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Formifarma, LDA.
2019-10-01
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| Series: | Revista Portuguesa de Farmacoterapia |
| Subjects: | |
| Online Access: | http://revista.farmacoterapia.pt/index.php/rpf/article/view/216 |
| _version_ | 1797733188557078528 |
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| author | Diogo Mendes Carlos Alves Francisco Batel Marques |
| author_facet | Diogo Mendes Carlos Alves Francisco Batel Marques |
| author_sort | Diogo Mendes |
| collection | DOAJ |
| description |
Introduction: Our objective was to investigate associations between oral antidiabetics and adverse drug reactions through disproportionality analysis in the Portuguese Pharmacovigilance System database.
Methods: Spontaneous reports of adverse drug reactions reported for oral antidiabetics (2008–2017) were considered. Adverse drug reactions were coded according to MedDRA (preferred term), and oral antidiabetics according to Anatomical Therapeutic Chemical classification (4th level). Associations between oral antidiabetics and adverse drug reactions were assessed through a case/non-case methodology, using reporting odds ratio (ROR) with 95% confidence interval (CI) to identify signals of disproportionate reporting.
Results: A total of 413 cases (262 serious; 63.4%) containing 1047 adverse drug reactions were included. Signals of disproportionate reporting were found: i) alpha-glucosidase inhibitors – abdominal pain (ROR: 9.7 [2.5-37.7]) and flatulence (ROR: 76.1[13.0-444.4]); ii) Dipeptidyl peptidase-4 inhibitors – upper abdominal pain (ROR: 5.5[1.5-20.7]), headache (ROR: 5.5[1.5-20.7]) and acute pancreatitis (ROR: 22.0[2.6-189.9]); iii) Glucagon-like peptide-1 agonists – vomiting (ROR: 3.4[1.4-8.4]; iv) metformin – abdominal pain (ROR: 3.6[1.1-11.6]), diarrhea (ROR: 5.6[2.4-13.2]) and lactic acidosis (ROR: 76.9[4.7-1269.0]); v) SGLT2 inhibitors – candida infection (ROR: 51.5[2.8-950.1], diabetic ketoacidosis(ROR: 84.8[4.8-1487.8]), pollakiuria (ROR: 15.2[1.6-147.1]), somnolence (ROR:30.4[1.5-610.3] and urinary tract infection (ROR: 15.2[1.6-147.1]); vi) sulfonylureas – hypoglycemia (ROR: 44.8[14.4-139.8]).
Conclusion: The results are in line with previous knowledge on the safety profiles of the different classes of oral antidiabetics, reinforcing the need to monitoring closely certain adverse drug reactions in clinical practice depending on the therapy prescribed to diabetic patients.
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| first_indexed | 2024-03-12T12:25:30Z |
| format | Article |
| id | doaj.art-431da7cb3d244ce6917fda05b970884e |
| institution | Directory Open Access Journal |
| issn | 1647-354X 2183-7341 |
| language | English |
| last_indexed | 2024-03-12T12:25:30Z |
| publishDate | 2019-10-01 |
| publisher | Formifarma, LDA. |
| record_format | Article |
| series | Revista Portuguesa de Farmacoterapia |
| spelling | doaj.art-431da7cb3d244ce6917fda05b970884e2023-08-29T22:50:04ZengFormifarma, LDA.Revista Portuguesa de Farmacoterapia1647-354X2183-73412019-10-01112-310.25756/rpf.v11i2-3.217Segurança de Antidiabéticos Orais: Análise de Desproporcionalidade no Sistema Português de FarmacovigilânciaDiogo MendesCarlos AlvesFrancisco Batel Marques Introduction: Our objective was to investigate associations between oral antidiabetics and adverse drug reactions through disproportionality analysis in the Portuguese Pharmacovigilance System database. Methods: Spontaneous reports of adverse drug reactions reported for oral antidiabetics (2008–2017) were considered. Adverse drug reactions were coded according to MedDRA (preferred term), and oral antidiabetics according to Anatomical Therapeutic Chemical classification (4th level). Associations between oral antidiabetics and adverse drug reactions were assessed through a case/non-case methodology, using reporting odds ratio (ROR) with 95% confidence interval (CI) to identify signals of disproportionate reporting. Results: A total of 413 cases (262 serious; 63.4%) containing 1047 adverse drug reactions were included. Signals of disproportionate reporting were found: i) alpha-glucosidase inhibitors – abdominal pain (ROR: 9.7 [2.5-37.7]) and flatulence (ROR: 76.1[13.0-444.4]); ii) Dipeptidyl peptidase-4 inhibitors – upper abdominal pain (ROR: 5.5[1.5-20.7]), headache (ROR: 5.5[1.5-20.7]) and acute pancreatitis (ROR: 22.0[2.6-189.9]); iii) Glucagon-like peptide-1 agonists – vomiting (ROR: 3.4[1.4-8.4]; iv) metformin – abdominal pain (ROR: 3.6[1.1-11.6]), diarrhea (ROR: 5.6[2.4-13.2]) and lactic acidosis (ROR: 76.9[4.7-1269.0]); v) SGLT2 inhibitors – candida infection (ROR: 51.5[2.8-950.1], diabetic ketoacidosis(ROR: 84.8[4.8-1487.8]), pollakiuria (ROR: 15.2[1.6-147.1]), somnolence (ROR:30.4[1.5-610.3] and urinary tract infection (ROR: 15.2[1.6-147.1]); vi) sulfonylureas – hypoglycemia (ROR: 44.8[14.4-139.8]). Conclusion: The results are in line with previous knowledge on the safety profiles of the different classes of oral antidiabetics, reinforcing the need to monitoring closely certain adverse drug reactions in clinical practice depending on the therapy prescribed to diabetic patients. http://revista.farmacoterapia.pt/index.php/rpf/article/view/216Adverse Drug Reaction Reporting Systems; Diabetes Mellitus, Type 2/drug therapy; Drug Monitoring; Drug-Related Side Effects and Adverse Reactions; Hypoglycemic Agents/adverse effects; Hypoglycemic Agents/therapeutic use; Pharmacovigilance; Portugal |
| spellingShingle | Diogo Mendes Carlos Alves Francisco Batel Marques Segurança de Antidiabéticos Orais: Análise de Desproporcionalidade no Sistema Português de Farmacovigilância Revista Portuguesa de Farmacoterapia Adverse Drug Reaction Reporting Systems; Diabetes Mellitus, Type 2/drug therapy; Drug Monitoring; Drug-Related Side Effects and Adverse Reactions; Hypoglycemic Agents/adverse effects; Hypoglycemic Agents/therapeutic use; Pharmacovigilance; Portugal |
| title | Segurança de Antidiabéticos Orais: Análise de Desproporcionalidade no Sistema Português de Farmacovigilância |
| title_full | Segurança de Antidiabéticos Orais: Análise de Desproporcionalidade no Sistema Português de Farmacovigilância |
| title_fullStr | Segurança de Antidiabéticos Orais: Análise de Desproporcionalidade no Sistema Português de Farmacovigilância |
| title_full_unstemmed | Segurança de Antidiabéticos Orais: Análise de Desproporcionalidade no Sistema Português de Farmacovigilância |
| title_short | Segurança de Antidiabéticos Orais: Análise de Desproporcionalidade no Sistema Português de Farmacovigilância |
| title_sort | seguranca de antidiabeticos orais analise de desproporcionalidade no sistema portugues de farmacovigilancia |
| topic | Adverse Drug Reaction Reporting Systems; Diabetes Mellitus, Type 2/drug therapy; Drug Monitoring; Drug-Related Side Effects and Adverse Reactions; Hypoglycemic Agents/adverse effects; Hypoglycemic Agents/therapeutic use; Pharmacovigilance; Portugal |
| url | http://revista.farmacoterapia.pt/index.php/rpf/article/view/216 |
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