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- SGLT2i and GLP1RA: Safety and Effectiveness Profiles Evaluation using Real-World Patient DataPublication . Lopes, António Luís Martins Coutinho Cabral e; Morgado, Manuel Augusto Nunes Vicente Passos; Lourenço, Olga Maria Marques; Roque, Maria de Fátima dos Santos MarquesType 2 Diabetes Mellitus (T2DM) is a highly prevalent chronic disease associated with substantial morbidity and mortality, largely driven by cardiovascular (CV) complications, chronic kidney disease (CKD), and obesity. The global burden of T2DM continues to rise, fueled by aging populations, urbanization, and lifestyle-related risk factors. In this context, newer therapeutic classes such as sodium-glucose cotransporter2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1RA) have transformed the management of T2DM by providing benefits that extend far beyond glycemic control. Robust evidence demonstrates that these agents reduce the risk of major adverse cardiovascular events (MACE), slow CKD progression, promote weight loss, and improve metabolic parameters. As a result, both drug classes have been increasingly repositioned and approved for new clinical indications, broadening their use to diverse and often complex patient populations. Despite substantial evidence from randomized controlled trials, real-world data on the safety and effectiveness of SGLT2i and GLP1RA remain essential, particularly in older individuals, polymedicated patients, and those with multiple comorbidities—groups often underrepresented in clinical trials. Post-marketing safety signals, including genitourinary infections with SGLT2i and gastrointestinal adverse effects with GLP1RA, underscore the need for continued pharmacovigilance. Understanding how these medicines perform in routine care settings is critical to optimizing therapeutic strategies and supporting clinical decision-making. This doctoral thesis aimed to evaluate the safety and effectiveness profiles of SGLT2i and GLP1RA using real-world data from hospital settings and pharmacovigilance reports. Retrospective observational studies were conducted across emergency departments, inpatient hospitalizations, and outpatient consultations, complemented by an analysis of adverse drug reaction (ADR) reports from the EudraVigilance (EV) database. Key findings highlight the effectiveness of SGLT2i in improving renal function, reducing systolic blood pressure, and lowering hospitalization rates for heart failure (HF). GLP1RA were particularly effective in achieving significant weight loss and reducing CV risk scores. Both drug classes demonstrated substantial reductions in glycated hemoglobin (HbA1c), consistent with clinical trial data. Safety analyses revealed low incidences of acute kidney injury (AKI) and major CV events, with gastrointestinal side effects being the most frequently reported ADRs for GLP1RA. These results underscore the critical role of SGLT2i and GLP1RA in comprehensive T2DM management, particularly for high-risk populations with multiple comorbidities. The findings also emphasize the need for ongoing pharmacovigilance and tailored therapeutic strategies to optimize patient outcomes. Future research should focus on mitigating adverse effects and validating these findings across diverse populations and healthcare settings.