DUEXIS® (ibuprofen 800 mg, famotidine 26.6 mg): A new approach to gastroprotection for patients with chronic pain and inflammation who require treatment with a nonsteroidal anti-inflammatory drug

Therapeutic Advances in Musculoskeletal Disease

Volumn 4, Issue 5, 2012, Pages 327-339

  Bello, Alfonso E ^a  

^a UNIVERSITY OF ILLINOIS   (United States)

Author keywords

chronic pain; famotidine; gastrointestinal; ibuprofen; proton pump inhibitor; ulcer

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; ESOMEPRAZOLE PLUS NAPROXEN; FAMOTIDINE; FAMOTIDINE PLUS IBUPROFEN; IBUPROFEN; NAPROXEN; PLACEBO; PROTON PUMP INHIBITOR;

ABDOMINAL PAIN; ADVERSE OUTCOME; ANALGESIC ACTIVITY; ANEMIA; ANTIINFLAMMATORY ACTIVITY; ARTHRALGIA; ARTHRITIS; BACKACHE; BIOEQUIVALENCE; BRONCHITIS; CHRONIC INFLAMMATION; CHRONIC PAIN; CLINICAL EFFECTIVENESS; CLOSTRIDIUM DIFFICILE INFECTION; CONSTIPATION; COUGHING; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; DUODENUM ULCER; DYSPEPSIA; ENTERIC COATED TABLET; EROSIVE GASTRITIS; GASTROESOPHAGEAL REFLUX; HEADACHE; HUMAN; HYPERTENSION; INFLUENZA; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; OSTEOARTHRITIS; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PNEUMONIA; PRIORITY JOURNAL; REVIEW; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; RISK ASSESSMENT; RISK FACTOR; RISK REDUCTION; SINGLE DRUG DOSE; SINUSITIS; SORE THROAT; STOMACH DISCOMFORT; STOMACH PROTECTION; STOMACH ULCER; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VOMITING;

EID: 84869775083     PISSN: 1759720X     EISSN: 17597218     Source Type: Journal    
DOI: 10.1177/1759720X12444710     Document Type: Review

References (77)

1. Aabakken L. Bjørnbeth B.A. Weberg R. Viksmoen L. Larsen S. Osnes M. (1990) NSAID-associated gastroduodenal damage: does famotidine protection extend into the mid and distal duodenum? Alimentary Pharmacol Ther 4: 295–303.
2. Abdrabbo M.K. Puera D.A. Wilcox C.M. (2004) NSAID-associated GI complications: available management options and identification of high-risk patients. Gastro Endo News 2: 65–68.
3. Abraham N.S. El-Serag H.B. Johnson M.L. Hartman C. Richardson R. Ray W.A. et al. (2005) National adherence to evidence-based guidelines for the prescription of nonsteroidal antiinflammatory drugs. Gastroenterology 129: 1171–1178.
4. Arthrotec prescribing information (2010) Pfizer: New York, NY. Available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=526 (accessed 10 April 2012).
5. Bangalore S. Kamalakkannan G. Parkar S. Messerli F.H. (2007) Fixed-dose combinations improve medication compliance: a meta-analysis. Am J Med 120: 713–719.
6. Biederman R.E. (2005) Pharmacology in rehabilitation: nonsteroidal anti-inflammatory agents. J Orthop Sports Phys Ther 35: 356–367.
7. Blume H. Donath F. Warnke A. Schug B.S. (2006) Pharmacokinetic drug interaction profiles of proton pump inhibitors. Drug Saf 29: 769–784.
8. Bocanegra T.S. Weaver A.L. Tindall E.A. Sikes D.H. Ball J.A. Wallemark C.B. et al. (1998) Diclofenac/misoprostol compared with diclofenac in the treatment of osteoarthritis of the knee or hip: a randomized, placebo controlled trial. Arthrotec Osteoarthritis Study Group. J Rheumatol 25: 1602–1611.
9. Chiu H.F. Huang Y.W. Chang C.C. Yang C.Y. (2010) Use of proton pump inhibitors increased the risk of hip fracture: a population-based case-control study. Pharmacoepidemiol Drug Saf 19: 1131–1136.
10. Combe B. Landewe R. Lukas C. Bolosiu H.D. Breedveld F. Dougados M. et al. (2007) EULAR recommendations for the management of early arthritis: report of a task force of the European Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 66: 34–45.
11. Dalton B.R. Lye-Maccannell T. Henderson E.A. Maccannell D.R. Louie T.J. (2009) Proton pump inhibitors increase significantly the risk of Clostridium difficile infection in a low endemicity, non-outbreak hospital setting. Aliment Pharmacol Ther 29: 626–634.
12. Daniels S.E. Bandy D.P. Christensen S.E. Boice J. Losada M.C. Liu H. et al. (2011) Evaluation of the dose range of etoricoxib in an acute pain setting using the postoperative dental pain model. Clin J Pain 27: 1–8.
13. Day R. Morrison B. Luza A. Castaneda O. Strusberg A. Nahir M. et al. (2000) A randomized trial of the efficacy and tolerability of the COX-2 inhibitor rofecoxib vs ibuprofen in patients with osteoarthritis. Rofecoxib/Ibuprofen Comparator Study Group. Arch Intern Med 160: 1781–1787.
14. DUEXIS prescribing information (2011) Horizon Pharma: Northbrook, IL. Available at: http://www.duexis.com/DUEXIS%20Prescribing%20Information.pdf (accessed 10 April 2012).
15. Eom C.S. Jeon C.Y. Lim J.W. Cho E.G. Park S.M. Lee K.S. (2011 a) Use of acid suppressive drugs and risk of pneumonia: a systematic review and meta-analysis. CMAJ 183: 310–319.
16. Eom C.S. Park S.M. Myung S.K. Yun J.M. Ahn J.S. (2011 b) Use of acid-suppressive drugs and risk of fracture: a meta-analysis of observational studies. Ann Fam Med 9: 257–267.
17. FDA (1986 a) NDA 19-462 Pepcid (famotidine) review. Available at: http://www.foiservices.com (last accessed 27 March 2012).
18. FDA (1986 b) NDA 19-510 Pepcid IV (famotidine) review. Available at: http://www.foiservices.com (last accessed 27 March 2012).
19. FDA (2009) New Warning on Plavix. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm191169.htm (accessed 10 April 2012).
20. FDA (2010) Possible fracture risk with high dose, long-term use of proton pump inhibitors. Press release. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm (last accessed 27 March 2012).
21. Garcia Rodriguez L.A. Tolosa L.B. (2007) Risk of upper gastrointestinal complications among users of traditional NSAIDs and COXIBs in the general population. Gastroenterology 132: 498–506.
22. Godfrey R.G. de la Cruz S. (1975) Effect of ibuprofen dosage on patient response in rheumatoid arthritis. Arthritis Rheum 18: 135–137.
23. Goldstein J.L. Hochberg M.C. Fort J.G. Zhang Y. Hwang C. Sostek M. (2010) Clinical trial: the incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone. Aliment Pharmacol Ther 32: 401–413.
24. Goldstein J.L. Howard K.B. Walton S.M. McLaughlin T.P. Kruzikas D.T. (2006) Impact of adherence to concomitant gastroprotective therapy on nonsteroidal-related gastroduodenal ulcer complications. Clin Gastroenterol Hepatol 4: 1337–1345.
25. Goldstein J.L. Lakhanpal S. Cohen S.B. Bello A. Ball J. Grahn A. et al. (2011) Long term safety of an NSAID with built-in gastroprotection for treatment of pain and inflammation related to OA and RA: comparative results from blinded and open label one year safety trials of a single-tablet combination of ibuprofen-famotidine. Digestive Disease Week, Chicago, IL, 7–10 May.
26. Gray S.L. LaCroix A.Z. Larson J. Robbins J. Cauley J.A. Manson J.E. et al. (2010) Proton pump inhibitor use, hip fracture, and change in bone mineral density in postmenopausal women: results from the Women's Health Initiative. Arch Intern Med 170: 765–771.
27. Hawkey C.J. Karrasch J.A. Szczepañski L. Walker D.G. Barkun A. Swannell A.J. et al. (1998) Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. Omeprazole versus Misoprostol for NSAID-induced Ulcer Management (OMNIUM) Study Group. N Engl J Med 338: 727–734.
28. Herndon C.M. Hutchison R.W. Berdine H.J. Stacy Z.A. Chen J.T. Farnsworth D.D. et al. (2008) Management of chronic nonmalignant pain with nonsteroidal antiinflammatory drugs. Joint opinion statement of the Ambulatory Care, Cardiology, and Pain and Palliative Care Practice and Research Networks of the American College of Clinical Pharmacy. Pharmacotherapy 28: 788–805.
29. Howden C.W. Tytgat G.N. (1996) The tolerability and safety profile of famotidine. Clin Ther 18: 36–54.
30. Humphries T.J. (1987) Famotidine: a notable lack of drug interactions. Scand J Gastroenterol 22(Suppl. 134): 55–60.
31. Humphries T.J. Merritt G.J. (1999) Review article: drug interactions with agents used to treat acid-related diseases. Aliment Pharmacol Ther 13(Suppl. 3): 18–26.
32. IMS Institute for Healthcare Informatics (2011) The use of medicines in the United States: review of 2010. April: 1–36.
33. Institute of Medicine (IOM) (2011) Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Available at: http://www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research/Report-Brief.aspx (accessed 10 April 2012).
34. Jayatilaka S. Shakov R. Eddi R. Bakaj G. Baddoura W.J. DeBari V.A. (2007) Clostridium difficile infection in an urban medical center: five-year analysis of infection rates among adult admissions and association with the use of proton pump inhibitors. Ann Clin Lab Sci 37: 241–247.
35. Kwok C.S. Loke Y.K. (2010) Meta-analysis: the effects of proton pump inhibitors on cardiovascular events and mortality in patients receiving clopidogrel. Aliment Pharmacol Ther 31: 810–823.
36. Kwok C.S. Yeong J.K. Loke Y.K. (2011) Meta-analysis: risk of fractures with acid suppressing medication. Bone 48: 768–776.
37. Lai K.C. Chu K.M. Hui W.M. Wong B.C. Hu W.H. Wong W.M. et al. (2005) Celecoxib compared with lansoprazole and naproxen to prevent gastrointestinal ulcer complications. Am J Med 118: 1271–1278.
38. Laine L. (2006) GI risk and risk factors of NSAIDs. J Cardiovas Pharmacon 47(Suppl. 1): S60–S66.
39. Laine L. Connors L. Griffin M.R. Curtis S.P. Kaur A. Cannons C.P. (2009 a) Prescription rates of protective co-therapy for NSAID users at high GI risk and results of attempts to improve adherence to guidelines. Alimentary Pharmacol Ther 30: 767–774.
40. Laine L. Curtis S.P. Cryer B. Kaur A. Cannon C.P. (2010) Risk factors for NSAID associated upper GI clinical events in long-term prospective study of 34,701 arthritis patients. Aliment Pharmacol Ther 32: 1240–1248.
41. Laine L. Kivitz A.J. Bello A.E. Grahn A.Y. Schiff M.H. Taha A.S. (2012) Double-blind randomized trials of single-tablet ibuprofen/high- dose-famotidine vs. ibuprofen alone for reduction of gastric and duodenal ulcers. Am J Gastroenterol 107: 379–386.
42. Laine L.A. Schiff M. Genovese M. Kivitz A. Tidmarsh G. Weinblatt M.E. (2009 b) Does high-dose famotidine reduce gastric and duodenal ulcers in NSAID users? Two double-blind six-month trials of single-tablet combination ibuprofen-famotidine vs. ibuprofen alone (REDUCE-1 and 2). Presented at Digestive Disease Week. Abstract 407, American College of Gastroenterology, 25 October 2009, San Diego, CA.
43. Langtry H.D. Grant S.M. Goa K.L. (1989) Famotidine: an updated review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in peptic ulcer disease and other allied diseases. Drugs 38: 551–590.
44. Lanza F.L. Chan F.K.L. Quigley E.M.M. (2009) Guidelines for prevention of NSAID- related ulcer complications. Am J Gastroenterol 104: 728–738.
45. Lee P. Anderson J.A. Miller J. Webb J. Buchanan W.W. (1976) Evaluation of analgesic action and efficacy of antirheumatic drugs. Study of 10 drugs in 684 patients with rheumatoid arthritis. J Rheumatol 3: 283–294.
46. McLaughlin G.E. (1985) A double-blind comparative study of piroxicam and ibuprofen in the treatment of rheumatoid arthritis. Semin Arthritis Rheum 14(3 Suppl.): 11–13.
47. Moore R.A. Moore O.A. Derry S. Peloso P.M. Gammaitoni A.R. Wang H. (2010) Responder analysis for pain relief and numbers needed to treat in a meta-analysis of etoricoxib osteoarthritis trials: bridging a gap between clinical trials and clinical practice. Ann Rheum Dis 69: 374–379.
48. Neustadt D.H. (1997) Double blind evaluation of the long-term effects of etodolac versus ibuprofen in patients with rheumatoid arthritis. J Rheumatol Suppl 47: 17–22.
49. Ng F.H. Wong S.Y. Lam K.F. Chu W.M. Chan P. Ling Y.H. et al. (2010) Famotidine is inferior to pantoprazole in preventing recurrence of aspirin-related peptic ulcers or erosions. Gastroenterology 138: 82–88.
50. O'Donoghue M.L. Braunwald E. Antman E.M. Murphy S.A. Bates E.R. Rozenman Y. et al. (2009) Pharmacodynamic effect and clinical efficacy of clopidogrel and prasugrel with or without a proton-pump inhibitor: an analysis of two randomised trials. Lancet 374: 989–997.
51. Ong C.K.S. Lirk P. Tan C.H. Seymour R.A. (2007) An evidence-based update on nonsteroidal anti-inflammatory drugs. Clin Med Res 5: 19–34.
52. Pan F. Chernew M.E. Fendrick A.M. (2008) Impact of fixed-dose combination drugs on adherence to prescription medications. J Gen Intern Med 23: 611–614.
53. Pepcid SmPC MSD (2011) Merck Sharp and Dohme Limited: Hertfordshire, UK. Available at: http://www.medicines.org.uk/emc/medicine/1187 (accessed 10 April 2012).
54. Puopolo A. Boice J.A. Fidelholtz J.L. Littlejohn T.W. Miranda P. Berrocal A. et al. (2007) A randomized placebo-controlled trial comparing the efficacy of etoricoxib 30 mg and ibuprofen 2400 mg for the treatment of patients with osteoarthritis. Osteoarthritis Cartilage 15:1348–1356.
55. Rainsford K.D. (2009) Ibuprofen: pharmacology, efficacy and safety. Inflammopharmacology 17: 275–342.
56. Rodríguez L.A. Ruigómez A. Wallander M.A. Johansson S. (2009) Acid-suppressive drugs and community-acquired pneumonia. Epidemiology 20: 800–806.
57. Rostom A. Dube C. Wells G. Tugwell P. Welch V. Jolicoeur E. et al. (2002) Prevention of NSAID-induced gastroduodenal ulcers. Cochrane Database Syst Rev CD002296.
58. Schou S. Nielsen H. Nattestad A. Hillerup S. Ritzau M. Branebjerg P.E. et al. (1998) Analgesic dose-response relationship of ibuprofen 50, 100, 200, and 400 mg after surgical removal of third molars: a single-dose, randomized, placebo-controlled, and double-blind study of 304 patients. J Clin Pharmacol 38: 447–454.
59. Schunack W. (1989) Pharmacology of H2-receptor antagonists: an overview. J Int Med Res 17(Suppl. 1): 9A–16A.
60. Singh G. Ramey D.R. Morfeld D. Shi H. Hatoum H.T. Fries J.F. (1996) Gastrointestinal tract complications of nonsteroidal anti-inflammatory drug treatment in rheumatoid arthritis. A prospective observational cohort study. Arch Intern Med 156: 1530–1536.
61. Smith J. Gamal M. Chremos A. Graham D. (1985) Famotidine, a new H2-receptor antagonist. Effect on parietal, nonparietal, and pepsin secretion in man. Dig Dis Sci 30: 308–312.
62. Steinmeyer J. (2000) Pharmacological basis for the therapy of pain and inflammation with nonsteroidal anti-inflammatory drugs. Arthritis Res 2: 379–385.
63. Sturkenboom M. Burke T. Tangelder M. Dieleman J.P. Walton S. Goldstein J.L. (2003) Adherence to proton pump inhibitors or H 2 receptor antagonists during the use of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther 18: 1137–1147.
64. Taha A.S. Hudson N. Hawkey C.J. Swannell A.J. Tyre P.N. Cottrell J. et al. (1996) Famotidine for the prevention of gastric and duodenal ulcers caused by nonsteroidal antiinflammatory drugs. N Engl J Med 334: 1435–1439.
65. Taha A.S. McCloskey C. Prasad R. Bezlyak V. (2009) Famotidine for the prevention of peptic ulcers and oesophagitis in patients taking low-dose aspirin (FAMOUS): a phase III, randomised, double-blind, placebo-controlled trial. Lancet 374: 119–125.
66. Takeda T. Yamashita Y. Shimazaki S. Mitsui Y. (1992) Histamine decreases the permeability of an endothelial cell monolayer by stimulating cyclic AMP production through the H2-receptor. J Cell Sci 101: 745–750.
67. Tidmarsh G. Rodriguez S.B. (2009) HZT-501, a novel combination of Ibuprofen (Ibu) and Famotidine (FAM), provides pharmacokinetics comparable to that of commercially available IBU and Fam in a patient-friendly dosing form: evaluation in healthy and renally-impaired subjects. Abstract 1974 DDW, American Gastroenterology Association, 2 June 2009, Chicago IL.
68. Tsang A. Von Korff M. Lee S. Alonso J. Karam E. Angermeyer M.C. et al. (2008) Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders. J Pain 9: 883–891.
69. United States Department of Health and Human Services (US DHHS) (2008) Health, United States, 2008. Available at:http://www.cdc.gov/nchs/data/hus/hus08.pdf#executivesummary (last accessed 27 March 2012).
70. Vane J.R. (1996) Introduction: mechanism of action of NSAIDs. Br J Rheumatol 35(Suppl. 1–3.
71. van Soest E.M. Valkhoff V.E. Mazzaglia G. Schade R. Molokhia M. Goldstein J.L. et al. (2011) Suboptimal gastroprotective coverage of NSAID use and the risk of upper gastrointestinal bleeding and ulcers: an observational study using three European databases. Gut 60: 1650–1659.
72. VIMOVO prescribing information (2012) AstraZeneca: Wilmington, DE. Available at: http://www1.astrazeneca-us.com/pi/vimovo.pdf (accessed 10 April 2012).
73. Weinblatt M.E. Schiff M. Genovese M. Kivitz A. Bello A. Grahan A. (2009) Significant reduction in upper gastrointestinal (UGI) ulcers with HZT-501, a single-tablet combination of ibuprofen-famotidine, the Reduce 1 and 2 Trials. Ann Rheum Dis 68(Suppl. 2) 704.
74. Wiesenhutter C.W. Boice J.A. Ko A. Sheldon E.A. Murphy F.T. Wittmer B.A. et al. (2005) Evaluation of the comparative efficacy of etoricoxib and ibuprofen for treatment of patients with osteoarthritis: a randomized, double-blind, placebo-controlled trial. Mayo Clin Proc 80: 470–479.
75. Wilcox C.M. Allison J. Benzuly K. Borum M. Cryer B. Grosser T. et al. (2006) Consensus development conference on the use of nonsteroidal anti-inflammatory agents, including cyclooxygenase-2 enzyme inhibitors and aspirin. Clin Gastroenterol Hepatol 4: 1082–1089.
76. Wolfe M.M. Lichtenstein D.R. Singh G. (1999) Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med 340: 1888–1899.
77. Yu E.W. Bauer S.R. Bain P.A. Bauer D.C. (2011) Proton pump inhibitors and risk of fractures: a meta-analysis of 11 international studies. Am J Med 124: 519–526.