Adverse event profiles of dipeptidyl peptidase-4 inhibitors: data mining of the public version of the FDA adverse event reporting system
BMC PHARMACOLOGY & TOXICOLOGY
Authors: Huang, Jing; Jia, Yuntao; Sun, Shusen; Meng, Long
Abstract
Background To describe and analyze the patterns of adverse events associated with dipeptidyl peptidase-4 inhibitors (DPP-4is) (sitagliptin, saxagliptin, linagliptin, vildagliptin, and alogliptin) from the FDA Adverse Event Reporting System (FAERS) and to highlight areas of safety concerns. Methods Adverse events spontaneously submitted to the FAERS between 2004 Q1 to 2019 Q2 were included. The online tool OpenVigil 2.1 was used to query the database. The research relied on definitions of preferred terms (PTs) specified by the Medical Dictionary for Regulatory Activities (MedDRA) and the standardized MedDRA Queries (SMQ). The reporting odds ratio (ROR), with 95% confidence intervals (CIs) was calculated for disproportionality analysis. Results Over 16 years, a total of 9706 adverse event reports were identified. Alogliptin was excluded from further analysis due to insufficient sample size. Compared with the non-insulin antidiabetic drugs, the four DPP-4is were all disproportionately associated with four SMQs: "gastrointestinal nonspecific inflammation and dysfunctional conditions," "hypersensitivity," "severe cutaneous adverse reactions," and "noninfectious diarrhoea". As for PT level analyses, DPP-4is are associated with higher reporting of the gastrointestinal tract, pancreas, malignancies, infection, musculoskeletal disorders, general disorders, hypersensitivity, and skin AEs. Conclusions Data mining of the FAERS is useful for examining DPP-4 inhibitors-associated adverse events. The findings of the present study are compatible with clinical experience, and it provides valuable information to decision-makers and healthcare providers in clinical practice.
Get Me Off This Medication!: A Comparison Between Gastroenterology and Primary Care Regarding Patient's Perceptions of Proton Pump Inhibitor Therapy
CUREUS
Authors: Khan, Raja Samir; Hadi, Yousaf; Gayam, Swapna
Abstract
Background Not much is known about patient perceptions regarding proton pump inhibitor (PPI) de-escalation. We sought to determine the knowledge of adverse effects (AEs) and willingness to de-escalate therapy among patients presenting to primary care and subspecialty clinics. Methods We conducted an anonymous survey of patients presenting to family medicine, internal medicine, and gastroenterology clinics who use PPIs. Survey topics included awareness of and concern for AEs of PPIs, and willingness to de-escalate PPI therapy. Results The sample comprised 206 participants presenting to the gastroenterology (29.8%), internal medicine (32.2%), and family medicine clinics (38%). Of the participants, 16% were "extremely concerned" about AEs and 28.2% reported attempting to stop PPIs by themselves in the past. Many patients (54.9%) reported that providers had not discussed AEs before initiation. Patients visiting digestive disease clinics were no more likely to report discussions on AEs and de-escalation or discontinuation attempts compared to primary care patients (p-values > 0.05). On logistic regression analysis, concern for AEs and counseling regarding PPI discontinuation were found to be significantly associated with attempts to discontinue PPI. Conclusions Although many patients on PPIs are concerned about AEs, a low number of patients reported provider-initiated discussions on AEs of PPI at initiation.