RESUMO
BACKGROUND: Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) have acquired a foothold in managing type 2 diabetes mellitus, but few concerns have arisen regarding their overall safety profile. The aim of this study is to assess the potential risk of DPP-4 inhibitors by analyzing data from the FDA Adverse Event Reporting System (FAERS) database. RESEARCH DESIGN AND METHODS: This is a retrospective study which explored the FAERS database till March 2023 for the collection of safety reports. The disproportionality analysis was performed using signal detection algorithms (SDAs) incorporating frequentist-based data mining approach such as relative reporting ratio (RRR), reporting odds ratio (ROR) and proportional reporting ratio (PRR) with 95% confidence interval (CI). RESULTS: A total of 14,573 adverse event reports were reported in the FAERS public dashboard associated with all the included DPP-4 inhibitors. The computed PRR, ROR, and RRR indicated positive signals for DPP-4 inhibitors with cardiac failure, pancreatitis, pemphigoid, hypoglycemia, acute kidney injury and lactic acidosis. Saxagliptin showed a higher signal score for cardiac failure, while sitagliptin was more associated with pancreatitis. Moreover, alogliptin exhibited an elevated signal score associated with pancreatic carcinoma. CONCLUSION: Several significant disproportionality signals were observed with DPP-4 inhibitors. However, clinicians have to consider the comorbidities and concomitant drugs while prescribing these drugs.
RESUMO
BACKGROUND: Chronic low back pain (CLBP) is a common and significant cause of disability globally. In their lifetime, 70% to 80% of adults will have low back discomfort at some point. Even though CLBP is a very disabling disorder, information about its prevalence and associated factors is sparse in the literature. OBJECTIVES: We aimed to determine the prevalence of CLBP and its risk factors among an adult population, as well as related health concerns and health-seeking behaviors. STUDY DESIGN: Cross-sectional study. SETTING: A tertiary care setting in Chandigarh, India from November 2017 through February 2020. METHODS: Adults of either gender who provided informed consent were included in the study. Sociodemographic and CLBP awareness data were collected using a standard questionnaire. Prevalence was expressed as proportion of sample, with 95% CI. For categorical and quantitative data, the chi squared and independent t test were utilized. Logistic regression was applied to identify significant risk variables and outcomes. A P value of <= 0.05 was considered significant. RESULTS: A total of 2,847 patients were enrolled, with a mean (SD) age of 38 (14) years; 61% of them were men. These patients had a CLBP lifetime prevalence of 16% (95% CI, 15-17; 457/2,847). In addition, 62% (285/457) of these patients visited their doctor/physician more than 10 times and 23% (103/457) sought the advice of 2 physicians to treat their CLBP. Increasing age (odds ratio[OR], 1.040, 95% CI, 1.032-1.049; P < 0.001), being underweight (OR, 3.315; 95% CI, 1.494-7.359; P < 0.003) and increasing pain frequency (OR, 1.616; 95% CI, 1.139-2.293; P < 0.007) were identified as potential CLBP risks. LIMITATIONS: The study was carried out in a single tertiary hospital in northern India; hence its results cannot be extrapolated. Also, we were unable to categorize CLBP based on how severe the symptoms were, such as complaint-only or debilitating. CONCLUSION: An effective, supervised program addressing the younger productive population to maintain a healthy weight, give up smoking, and encourage an active lifestyle should be implemented. KEY WORDS: Chronic low back pain, prevalence, health concerns, risk factors, public health.