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Objective: Based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, we analyzed the signals of potential adverse events (AEs) of orlistat in the real world to provide a reference for its safe clinical use. Methods: The FAERS database and OpenVigil 2.1 were used to obtain data on adverse events of orlistat from the first quarter of 2004 to the first quarter of 2023, and to analyze the population in which the adverse events occurred. And the signals of their potential adverse events were mined using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and empirical Bayesian geometric mean (EBGM). Result: A total of 21,079 reports of adverse events with orlistat as the primary suspected drug were collected in this study. Using four disproportionate analyses, we screened 117 preferred terms (PTs) involving 18 system organ classes (SOCs). We found that the most common adverse events at SOC level for orlistat remained "gastrointestinal disorders", while "metabolism and nutrition disorders", "renal and urinary disorders", "musculoskeletal and connective tissue disorders" and "hepatobiliary disorders" also ranked high in the number of case reports. In addition, at the PT level, we identified several new signals of adverse events not mentioned in the specification, including "lipiduria", "anal haemorrhage", "rectal haemorrhage", "haematochezia", "sigmoiditis", "diverticulitis" and "muscle spasms". Conclusion: Most of the adverse events found in this study are consistent with the results described in the drug label. At the same time, we also found some new adverse events, which require more prospective studies to verify and elucidate their relationship with orlistat.
RESUMEN
OBJECTIVES: Predictors of gestational diabetes mellitus (GDM) recurrence (GDMR) was determined in southern Chinese women. MATERIAL AND METHODS: A total of 376 women with GDM who had two consecutive singleton deliveries at our hospital between January 2014 and October 2020 were enrolled in the current study. We retrospectively compared the clinical characteristics, fasting plasma glucose level (FPG-1), and oral glucose tolerance test-1h-1 and -2h-1 (OGTT 1hr-1: 1-h post-load glucose level during the first pregnancy and OGTT 2hr-1: 2-h post-load glucose level during the first pregnancy) for the first pregnancy between patients in the GDMR group (n = 166) and the non-GDMR group (n = 210). RESULTS: The incidence of GDMR in the study population was 44.15%. During the first pregnancy, women in the GDMR group had significantly higher OGTT 1h-1, OGTT 2h-1, and FPG-1 + OGTT 1h + 2h-1 compared to the non-GDMR group. When the threshold of the FPG-1 + OGTT 1h + 2h-1 level in the first pregnancy was > 23.6 mmol/L, the specificity for predicting GDMR was 0.85, the sensitivity was 0.45, and the area under the receiver operating characteristic curve (ROC-AUC) was 0.70, indicating a 70% probability of predicting GDMR in the next pregnancy. Logistic regression analysis showed that patients with a combined abnormal FPG-1 + OGTT 1h + 2 h-1 level had a 10-fold increased risk for GDMR in subsequent pregnancies than patients with normal indicators (OR: 10.542, 95% CI: 3.097-35.881; p < 0.0001). CONCLUSIONS: The OGTT 1h-1 and OGTT 2h-1 are independent risk factors for GDMR in southern Chinese women. Women with an FPG-1 + OGTT 1h + 2h-1 threshold level > 23.6 mmol/L in the first pregnancy had a 10-fold greater probability of developing GDMR in the second pregnancy than women in the non-GDMR group.