Decreased NSAID Associated Treatment Emergent Dyspepsia and Increased Patient Satisfaction Associated with Ibuprofen/Famotidine Combination Tablet: SODA Results from a 12-Month Trial

Abstract

Purpose: Dyspeptic symptoms often lead to the use of co-prescribed acid suppressive agents or discontinuation of NSAID use. Adherence with coprescribed GI protective therapies is often suboptimal and associated with reduced functional efficacy. Double-dose H2 receptor antagonists provide benefit in decreasing NSAID-associated upper GI injury. A single combination tablet of ibuprofen (IBU; 800 mg) and famotidine (FAM; 26.6 mg) tid; total daily dose of 2400 mg IBU and 80 mg FAM (DUEXIS®), was shown previously to significantly reduce endoscopic upper GI ulcers at 6 months as compared to IBU (800 mg) alone tid (REDUCE-1 and REDUCE-2). Here we report SODA (Severity of Dyspepsia Assessment) questionnaire results from a 12-month open label study. Methods: This was an open-label long-term safety study of IBU/FAM single tablet tid for up to 12 months (mos) of treatment (tx) in patients (pts) 40-80 years (yrs) with OA, RA or moderate pain expected to require daily NSAID therapy for ≥12 mos. Pts were to have no history of NSAID GI complications, active cardiac, renal and/or hepatic disease. Pts were allowed to continue on concomitant low-dose aspirin/anticoagulant (LDA/OAC) therapy. Serious adverse events (SAEs), and tx emergent adverse events (TEAEs) were collected. SODA was administered at baseline and every six weeks to assess tolerability. Results: 86 pts enrolled and 56 pts (65.1%) completed one year of tx. 30 pts (34.9%) discontinued early with the highest incidence due to adverse events (dyspepsia/GERD) in 18/86 pts (20.9%). Independent of discontinuations, the most frequently reported TEAEs by preferred term were dyspepsia and abdominal distention (11.6% each). Of the 25 patients who reported dyspepsia related events, approximately half (12/25) reported them within the first 8 weeks of the 54 week trial. At both 24 and 54 weeks, all mean SODA subscale scores improved and the changes from baseline were statistically significant (see Table).Table: Table. SODA subscale mean change from baseline scoresConclusion: Safety results up to 54 weeks with the IBU/FAM combination tablet were consistent with the known safety profiles of famotidine and ibuprofen and US labeling. IBU/FAM as compared to historical data with NSAIDS alone was associated with lower rates of dyspepsia related symptoms. SODA subscale scores improved over time from baseline. In conjunction with the previous findings of a significant decrease in upper GI endoscopic ulcers, these results demonstrate that IBU/FAM combination tablet offers a potential new option for patients who require long-term NSAIDs. Disclosure: Dr. Goldstein - Grant/Research Support: Pozen Inc, Logical Therapeutics, and Pfizer. Honoraria: Pozen, Inc., Boehringer-Ingelheim, and Astra-Zeneca Pharmaceuticals. Consultant/Advisory Board: Pozen, Inc, AstraZeneca Pharmaceuticals, and Horizon Pharma USA, Inc. Dr. Lakhanpal - Consultant: Horizon Pharma USA, Inc Dr. Cohen - Consultant: Horizon Pharma USA, Inc. Dr. Bello - Consultant: Horizon Pharma USA, Inc. Ms. Ball - Employee: Horizon Pharma USA, Inc. Ms. Grahn - Employee: Horizon Pharma USA, Inc. Dr. Kivitz - Consultant: Horizon Pharma USA, Inc. This research was supported by an industry grant from Horizon Pharma USA, Inc.