One-year open-label safety evaluation of the fixed combination of ibuprofen and famotidine with a prospective analysis of dyspepsia

Abstract

Objective:

To assess the long-term safety of the single-tablet combination of ibuprofen 800 mg and famotidine 26.6 mg.

Research design and methods:

A phase 3b open-label study (NCT00984815) was conducted in 86 adults requiring daily non-steroidal anti-inflammatory drug (NSAID) administration for ≥12 months. The combination tablet of ibuprofen/famotidine was self-administered orally three times daily for up to 54 consecutive weeks. Adverse events (AEs) were collected beginning at the first dose and continued through completion (54 weeks). The Severity of Dyspepsia Assessment (SODA) questionnaire was completed by patients to assess tolerability.

Results:

Most patients (65%) finished the trial, with 76% contributing data at 6 months, and 21% withdrew due to adverse effects. Overall and gastrointestinal AE discontinuation rates (21% and 13%, respectively) were lower than that previously reported with ibuprofen 2400 mg given alone. Each of the SODA subscale scores demonstrated improvement by week 6 and improved statistically significantly at week 24 and week 54. Of the cardiovascular AEs, hypertension was reported most frequently (9/86, 9.3%), with 3.5% determined to be drug related. Twelve serious AEs were reported by 9 of 86 (10%) patients; two were considered possibly related to the study medication (unstable angina and gastric ulcer). There were no reports of serious gastrointestinal or CV complications. Most AEs were mild or moderate in severity and not considered drug related.

Conclusions:

These data, together with previously reported findings of a significant decrease in upper gastrointestinal endoscopic ulcer rate at 6 months, support the overall safety, compliance, and tolerability of this single-tablet formulation.

Keywords: :

• Cardiovascular
• Famotidine
• Gastrointestinal
• Ibuprofen
• Osteoarthritis
• Rheumatoid arthritis
• Safety

Transparency

Declaration of funding

The design, study conduct, and financial support for these studies were provided by Horizon Pharma Inc. Horizon participated in the interpretation of data, review, and approval of the manuscript.

Declaration of financial/other relationships

J.K., A.G., and J.B. have disclosed that they are employees of Horizon Pharma Inc. A.B. and R.J.H. have disclosed that they have been consultants for Horizon Pharma Inc. A.B. has also been a speaker for AbbVie, Questcor, and UCB.

CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no relevant financial or other relationships to disclose.

Acknowledgments

The authors thank Tonya Goodman and Cathryn M. Carter MS of Arbor Communications Inc., Ann Arbor, MI, USA, for medical writing support; this support was funded by Horizon Pharma Inc.

Previous presentation: Goldstein J, Lakhampal S, Cohen S, et al. Decreased NSAID associated treatment-emergent dyspepsia and increased patient satisfaction associated with an ibuprofen/famotidine combination tablet: safety and SODA results from a 12 month open label trial. Poster (P59) presented at the American College of Gastroenterology 2012 Annual Scientific Meeting, Las Vegas, NV, USA.