Presented at the 2012 AAPM Annual Meeting « Back

Efficacy, Safety, and Tolerability of A Single-Tablet Combination of Ibuprofen-Famotidine: Results in Patients Who Require Nonsteroidal Anti-Inflammatory Drugs for Osteoarthritis, Rheumatoid Arthritis, or Chronic Pain

Michael H. Schiff, MD, lmschiff@aol.com¹, Mark C. Genovese, MD², Alfonso E. Bello, MD MHS³, Amy Y. Grahn, MS⁴, Kenneth E. Johnson, PharmD⁴, Alan J. Kivitz, MD⁵, (1) University of Colorado School of Medicine, Greenwood Village, Colorado, (2) Stanford University Medical Center, Palo Alto, California, (3) Illinois Bone and Joint Institute, Glenview, Illinois, (4) Horizon Pharma, Northbrook, Illinois, (5) Altoona Center for Clinical Research, Duncansville, Pennsylvania

Background/Purpose: Gastrointestinal (GI) toxicity remains a major concern with nonsteroidal anti-inflammatory drugs (NSAIDs) used in the treatment of osteoarthritis (OA), rheumatoid arthritis (RA) and chronic pain A combination tablet of ibuprofen (IBU) plus a high-dose H2RA may decrease IBU induced ulcer disease and improve compliance in patients who require chronic NSAIDs (Weinblatt et al 2010). Methods: Two 24-week, double-blind, randomized trials of HZT-501, a single-tablet combination of ibuprofen (800mg) and famotidine (FAM; 26.6mg) given three times daily, were undertaken (REDUCE-1 and REDUCE-2). Patients 40–80 years old expected to require daily NSAID therapy ≥6 months with no history of ulcer complications, negative H. pylori test and baseline endoscopy (EGD) showing no ulcers and <5 erosions in the upper GI (UGI) tract were enrolled. Concomitant LDA (≤325 mg daily) and oral anticoagulants (OAC) therapies were permitted. Study EGDs were done at 8, 16, and 24 weeks of therapy. Results: The studies enrolled 906 and 627 patients. Total patients were 1533, of which 1022 received HZT-501 and 511 received IBU. The NSAID indication subgroups of interest included 761 for OA+RA and 521 for chronic pain in the primary analysis population. Table 1 shows the differences in the development of UGI ulcers, discontinuation, serious adverse events (SAE) and treatment emergent adverse events (TEAEs) over 24 weeks. Conclusion: HZT-501 reduces NSAID-associated UGI ulcers overall and in the subset of patients taking NSAIDS for OA, RA and chronic pain. Combination therapy may improve adherence and compliance in patients taking NSAIDs ± LDA who require gastroprotection. References: 1)Weinblatt et al Arthritis Rheum 2010;62 Suppl 10: 945

Funding: Horizon Pharma provided funding support for these clinical trials.