Sophie Trujillo, DO1, Aakash Desai, MD1, Shaman Dalal, MD1, Dalbir S. Sandhu, MD2; 1MetroHealth Medical Center, Cleveland, OH; 2Cleveland Clinic Foundation, Cleveland, OH
Introduction: Clostridium difficile infection (CDI) can cause mild diarrhea to severe colon inflammation. Studies suggest a link between the use of proton pump inhibitors (PPIs) and the development of CDI. It is believed that gastric acid suppression disrupts the intestinal flora and increases the risk of CDI. However, current studies have yielded conflicting results. Our primary aim was to evaluate the prevalence and quantify the risk of CDI with PPI use. Secondary aim was to compare the risk of adverse events (AE) related to CDI in PPI vs non-PPI groups. Methods: We performed a retrospective analysis in the IBM Explorys database 5 (1999-2020), a pooled, national, de-identified clinical database of 72 million unique patients from 26 health care networks and 300 hospitals across the United States. Patient populations were identified using SNOMED and ICD codes. Inclusion criteria were patients >50 years of age who were on a PPI and developed CDI within 1 year. PPI included were esomeprazole, omeprazole, pantoprazole and lansoprazole. Patients on antibiotics and H2-blockers were excluded from the PPI cohort. Our control group was an age-matched non-PPI group, which excluded PPI, H2-blockers, and antibiotics. AE were defined as severe CDI on presentation (white blood cell count >15,000 or Creatinine >1.5), septic shock within 1 week, and colectomy within 2 weeks. Odds ratios with 95% CI were calculated for risk of CDI for each PPI compared to control groups. Chi-squared test was used to compare the risk of AEs in the combined PPI and non-PPI group. Results: CDI in patients exposed to PPIs was 0.75%. Prevalence of CDI among PPI was 9.7 (per 1,000) in lansoprazole, 8.5 (per 1,000) in esomeprazole, 8.4 (per 1,000) in pantoprazole, and 6.6 (per 1,000) in omeprazole. When compared to the control, all PPIs namely lansoprazole (OR 4.81, 95%CI 4.58-5.06), esomeprazole (OR 4.2, 95%CI 4.05-4.36), pantoprazole (OR 4.15, 95%CI 4.02-4.29), and omeprazole (OR 3.24, 95%CI 3.16-3.32) had increased risk of CDI. Additionally, CDI in patients on PPI had an increased risk of presenting with severe CDI infection when compared to non-PPI (10.2 vs 5.25%, p< 0.0001). Patients with CDI in the PPI group were more likely to be female, caucasian, have private insurance, tobacco abuse, obesity, hypertension, hyperlipidemia and type 2 diabetes mellitus. Discussion: Results from our study show that although a rare side effect, PPI therapy has a 3-4 fold increased risk of CDI. Patients exposed to PPI tend to develop a severe CDI.
Comparison of demographic parameters for CDI between PPI vs non-PPI group. PPI - proton pump inhibitor, AA - African American, HTN - hypertension, HLD - hyperlipidemia, T2DM - type 2 diabetes mellitus
Disclosures: Sophie Trujillo indicated no relevant financial relationships. Aakash Desai indicated no relevant financial relationships. Shaman Dalal indicated no relevant financial relationships. Dalbir Sandhu indicated no relevant financial relationships.