famotidine and Osteoarthritis studies

Famotidine: A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.

Osteoarthritis: A progressive, degenerative joint disease, the most common form of arthritis, especially in older persons. The disease is thought to result not from the aging process but from biochemical changes and biomechanical stresses affecting articular cartilage. In the foreign literature it is often called osteoarthrosis deformans.

Research Excerpts

Excerpt	Relevance	Reference
"We studied the efficacy of two doses of famotidine (20 mg and 40 mg, each given orally twice daily), as compared with placebo, in preventing peptic ulcers in 285 patients without peptic ulcers who were receiving long-term NSAID therapy for rheumatoid arthritis (82 percent) or osteoarthritis (18 percent)."	9.08	Famotidine for the prevention of gastric and duodenal ulcers caused by nonsteroidal antiinflammatory drugs. ( Cottrell, J; Hawkey, CJ; Hudson, N; Mann, SG; Russell, RI; Simon, TJ; Sturrock, RD; Swannell, AJ; Taha, AS; Trye, PN, 1996)
"Although anti-inflammatory doses of ibuprofen are very effective in treating the signs and symptoms of osteoarthritis (OA), they come with an increased risk for gastrointestinal damage which can limit their use and decrease patient adherence to therapy."	8.90	Risk of upper gastrointestinal ulcers in patients with osteoarthritis receiving single-tablet ibuprofen/famotidine versus ibuprofen alone: pooled efficacy and safety analyses of two randomized, double-blind, comparison trials. ( Bello, AE; Grahn, AY; Holt, RJ; Kent, JD; Rice, P, 2014)
"Single-tablet ibuprofen/famotidine is approved by the US Food and Drug Administration for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal (GI) ulcers in patients taking ibuprofen for those indications."	7.79	Budget impact modeling for a single-tablet formulation of ibuprofen and famotidine for prevention of upper gastrointestinal ulcers in patients with osteoarthritis and/or rheumatoid arthritis. ( Holt, RJ; Johnson, KE; Kent, JD; Kuan, R; Malone, D; Peura, DA, 2013)
"We studied the efficacy of two doses of famotidine (20 mg and 40 mg, each given orally twice daily), as compared with placebo, in preventing peptic ulcers in 285 patients without peptic ulcers who were receiving long-term NSAID therapy for rheumatoid arthritis (82 percent) or osteoarthritis (18 percent)."	5.08	Famotidine for the prevention of gastric and duodenal ulcers caused by nonsteroidal antiinflammatory drugs. ( Cottrell, J; Hawkey, CJ; Hudson, N; Mann, SG; Russell, RI; Simon, TJ; Sturrock, RD; Swannell, AJ; Taha, AS; Trye, PN, 1996)
"Although anti-inflammatory doses of ibuprofen are very effective in treating the signs and symptoms of osteoarthritis (OA), they come with an increased risk for gastrointestinal damage which can limit their use and decrease patient adherence to therapy."	4.90	Risk of upper gastrointestinal ulcers in patients with osteoarthritis receiving single-tablet ibuprofen/famotidine versus ibuprofen alone: pooled efficacy and safety analyses of two randomized, double-blind, comparison trials. ( Bello, AE; Grahn, AY; Holt, RJ; Kent, JD; Rice, P, 2014)
"Single-tablet ibuprofen/famotidine is approved by the US Food and Drug Administration for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal (GI) ulcers in patients taking ibuprofen for those indications."	3.79	Budget impact modeling for a single-tablet formulation of ibuprofen and famotidine for prevention of upper gastrointestinal ulcers in patients with osteoarthritis and/or rheumatoid arthritis. ( Holt, RJ; Johnson, KE; Kent, JD; Kuan, R; Malone, D; Peura, DA, 2013)
"The FDA has approved Duexis (Horizon), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the H2-receptor antagonist (H2RA) famotidine, for symptomatic relief of osteoarthritis and rheumatoid arthritis and to decrease the risk of developing gastric and duodenal ulcers in patients at risk for NSAID-associated ulcers."	3.77	A fixed-dose combination ibuprofen and famotidine (Duexis). ( , 2011)

Research

Studies (6)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	1 (16.67)	18.2507
2000's	0 (0.00)	29.6817
2010's	5 (83.33)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Kuan, R	1
Holt, RJ	3
Johnson, KE	1
Kent, JD	3
Peura, DA	1
Malone, D	1
Bello, AE	2
Grahn, AY	1
Rice, P	1
Schiff, M	1
Peura, D	1
Taha, AS	1
Hudson, N	1
Hawkey, CJ	1
Swannell, AJ	1
Trye, PN	1
Cottrell, J	1
Mann, SG	1
Simon, TJ	1
Sturrock, RD	1
Russell, RI	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment[NCT00450658]	Phase 3	627 participants (Actual)	Interventional	2007-03-31	Completed
A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment[NCT00450216]	Phase 3	906 participants (Actual)	Interventional	2007-03-31	Completed
Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer[NCT02418312]		228 participants (Actual)	Interventional	2012-01-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

The secondary efficacy endpoint was the number of subjects with duodenal ulcer at any time throughout the 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed. (NCT00450658)
Timeframe: 24 weeks

Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period.

Intervention	participants (Number)
HZT-501	3
Ibuprofen	9

The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed. (NCT00450658)
Timeframe: 24 weeks

Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.

Intervention	participants (Number)
HZT-501	37
Ibuprofen	34

The primary efficacy endpoint was the number of subjects with upper gastrointestinal (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed. (NCT00450658)
Timeframe: 24 weeks

The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications.

Intervention	participants (Number)
HZT-501	40
Ibuprofen	38

The secondary efficacy endpoint was the number of subjects developing a NSAID-associated serious GI complication at any time throughout 6 months of treatment. A NSAID-associated serious GI complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or GI bleeding. (NCT00450658)
Timeframe: 24 weeks

Number of Participants Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.

Intervention	participants (Number)
HZT-501	0
Ibuprofen	0

The secondary efficacy endpoint was the number of participants with duodenal ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed. (NCT00450216)
Timeframe: 24 weeks

Number of Participants Who Develop Endoscopically-diagnosed Gastric Ulcers

Intervention	participants (Number)
HZT-501	8
Ibuprofen	14

The primary efficacy endpoint was the number of participants with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed. (NCT00450216)
Timeframe: 24 weeks

Number of Participants Who Develop Endoscopically-diagnosed Upper Gastrointestinal (UGI) Ulcers During the 24-week Treatment Period.

Intervention	participants (Number)
HZT-501	55
Ibuprofen	52

The secondary efficacy endpoint was the number of participants with UGI (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed. (NCT00450216)
Timeframe: 24 weeks

The Number of Participants Developing Non-steroidal Anti-inflammatory (NSAID)Associated Serious Gastrointestinal Complications (Perforation of Ulcers, Gastric Outlet Obstruction Due to Ulcers, Gastrointestinal Bleeding)

Intervention	participants (Number)
HZT-501	63
Ibuprofen	61

The secondary efficacy endpoint was the number of participants developing a NSAID-associated serious gastrointestinal complication at any time throughout 24 weeks of treatment. A NSAID-associated serious gastrointestinal complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or gastrointestinal bleeding. (NCT00450216)
Timeframe: 24 weeks

Number of Participants With Healed Peptic Ulcer

Intervention	particpants (Number)
HZT-501	3
Ibuprofen	0

Follow-up endoscopy was performed at the end of the 6th month (NCT02418312)
Timeframe: 6 months

Intervention	participants (Number)
Histamine-2 Receptor Antagonist Group	106
Placebo Group	101

Article	Year
Risk of upper gastrointestinal ulcers in patients with osteoarthritis receiving single-tablet ibuprofen/famotidine versus ibuprofen alone: pooled efficacy and safety analyses of two randomized, double-blind, comparison trials. Postgraduate medicine, 2014, Volume: 126, Issue:4 Topics: Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Drug Combinations; Duodenal Ulcer; Famot	2014
HZT-501 (DUEXIS(®); ibuprofen 800 mg/famotidine 26.6 mg) gastrointestinal protection in the treatment of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Expert review of gastroenterology & hepatology, 2012, Volume: 6, Issue:1 Topics: Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Arthritis, Rheumatoid; Drug Combinations	2012

Article	Year
Gastroprotective efficacy and safety of single-tablet ibuprofen/famotidine vs ibuprofen in older persons. The Physician and sportsmedicine, 2015, Volume: 43, Issue:3 Topics: Adult; Age Factors; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Age	2015
Gastroprotective efficacy and safety of single-tablet ibuprofen/famotidine vs ibuprofen in older persons. The Physician and sportsmedicine, 2015, Volume: 43, Issue:3 Topics: Adult; Age Factors; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Age	2015
Gastroprotective efficacy and safety of single-tablet ibuprofen/famotidine vs ibuprofen in older persons. The Physician and sportsmedicine, 2015, Volume: 43, Issue:3 Topics: Adult; Age Factors; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Age	2015
Gastroprotective efficacy and safety of single-tablet ibuprofen/famotidine vs ibuprofen in older persons. The Physician and sportsmedicine, 2015, Volume: 43, Issue:3 Topics: Adult; Age Factors; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Age	2015
Famotidine for the prevention of gastric and duodenal ulcers caused by nonsteroidal antiinflammatory drugs. The New England journal of medicine, 1996, May-30, Volume: 334, Issue:22 Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Arthriti	1996

Article	Year
Budget impact modeling for a single-tablet formulation of ibuprofen and famotidine for prevention of upper gastrointestinal ulcers in patients with osteoarthritis and/or rheumatoid arthritis. Clinical therapeutics, 2013, Volume: 35, Issue:3 Topics: Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Arthritis, Rheumatoid; Drug Combinations	2013
A fixed-dose combination ibuprofen and famotidine (Duexis). The Medical letter on drugs and therapeutics, 2011, Oct-31, Volume: 53, Issue:1376 Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Drug Combinations; Duodenal Ulcer; F	2011

famotidine and Osteoarthritis