famotidine and Rheumatoid Arthritis studies

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

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)
"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)
" Adverse events (AEs) were collected beginning at the first dose and continued through completion (54 weeks)."	6.80	One-year open-label safety evaluation of the fixed combination of ibuprofen and famotidine with a prospective analysis of dyspepsia. ( Ball, J; Bello, AE; Grahn, AY; Holt, RJ; Kent, JD, 2015)
"In the pivotal efficacy and safety trials, discontinuation rates due to any cause and dyspepsia were significantly lower for the ibuprofen/famotidine combination versus ibuprofen alone."	5.20	One-year safety of ibuprofen/famotidine fixed combination versus ibuprofen alone: pooled analyses of two 24-week randomized, double-blind trials and a follow-on extension. ( Ball, J; Bello, AE; Grahn, AY; Holt, RJ; Kent, JD, 2015)
"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)
"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)
" Adverse events (AEs) were collected beginning at the first dose and continued through completion (54 weeks)."	2.80	One-year open-label safety evaluation of the fixed combination of ibuprofen and famotidine with a prospective analysis of dyspepsia. ( Ball, J; Bello, AE; Grahn, AY; Holt, RJ; Kent, JD, 2015)
" This study examined peptic ulcer development in the presence or absence of gastric neutrophils in patients requiring long-term use of NSAIDs."	2.69	Neutrophils, Helicobacter pylori, and nonsteroidal anti-inflammatory drug ulcers. ( Dahill, S; Hawkey, CJ; Hudson, N; Lee, FD; Morran, C; Russell, RI; Sturrock, RD; Taha, AS, 1999)

Research

Studies (12)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	4 (33.33)	18.2507
2000's	2 (16.67)	29.6817
2010's	6 (50.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Kuan, R	1
Holt, RJ	4
Johnson, KE	1
Kent, JD	4
Peura, DA	1
Malone, D	1
Bello, AE	3
Grahn, AY	2
Ball, J	2
Kobata, Y	1
Yajima, H	1
Yamao, J	1
Tanaka, Y	1
Fukui, H	1
Takakura, Y	1
Schiff, M	1
Peura, D	1
Miyake, K	1
Ueki, N	1
Suzuki, K	1
Shinji, Y	1
Kusunoki, M	1
Hiratsuka, T	1
Nishigaki, H	1
Tatsuguchi, A	1
Futagami, S	1
Wada, K	1
Tsukui, T	1
Nakajima, A	1
Yoshino, S	1
Sakamoto, C	1
Taha, AS	2
Hudson, N	2
Hawkey, CJ	2
Swannell, AJ	1
Trye, PN	1
Cottrell, J	1
Mann, SG	1
Simon, TJ	1
Sturrock, RD	2
Russell, RI	2
Singh, G	1
Fries, JF	1
Dahill, S	1
Morran, C	1
Lee, FD	1
Matsukawa, Y	1
Sawada, S	1
Horie, T	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment[NCT00984815]	Phase 3	86 participants (Actual)	Interventional	2009-09-30	Completed
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 non-pain symptom scale of the SODA questionnaire ranges from 7 - 35. Change from baseline compares the score at Week 54 to the baseline score for each participant that completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms. (NCT00984815)
Timeframe: Baseline and 54 Weeks

Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks

Intervention	Scores on a scale (Mean)
HZT-501	-1.44

The pain intensity scale of the SODA questionnaire ranges from 2 - 47. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms. (NCT00984815)
Timeframe: Baseline and 54 Weeks

Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks

Intervention	Scores on a scale (Mean)
HZT-501	-3.22

The satisfaction with dyspepsia-related health scale of the SODA questionnaire ranges from 2 - 23. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the Satisfaction questions of the SODA questionnaire at baseline and Week 54. A positive change from baseline in the SODA satisfaction scale represents a participant's overall improved satisfaction with their dyspepsia-related health. (NCT00984815)
Timeframe: Baseline and 54 Weeks

Number of Participants With Treatment Emergent Adverse Events

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

Intervention	Scores on a scale (Mean)
HZT-501	2.69

Intervention	participants (Number)
HZT-501	76

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
One-year open-label safety evaluation of the fixed combination of ibuprofen and famotidine with a prospective analysis of dyspepsia. Current medical research and opinion, 2015, Volume: 31, Issue:3 Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Drug Combinations; Drug	2015
One-year safety of ibuprofen/famotidine fixed combination versus ibuprofen alone: pooled analyses of two 24-week randomized, double-blind trials and a follow-on extension. Current medical research and opinion, 2015, Volume: 31, Issue:3 Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Drug Combinations; Drug	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
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
Preventive therapy for non-steroidal anti-inflammatory drug-induced ulcers in Japanese patients with rheumatoid arthritis: the current situation and a prospective controlled-study of the preventive effects of lansoprazole or famotidine. Alimentary pharmacology & therapeutics, 2005, Volume: 21 Suppl 2 Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Aged; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer A	2005
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
Neutrophils, Helicobacter pylori, and nonsteroidal anti-inflammatory drug ulcers. Gastroenterology, 1999, Volume: 116, Issue:2 Topics: Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Arthritis, Rheumatoid; Double-Blind Meth	1999

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
Risk factors for the development of gastric mucosal lesions in rheumatoid arthritis patients receiving long-term nonsteroidal anti-inflammatory drug therapy and the efficacy of famotidine obtained from the FORCE study. Modern rheumatology, 2009, Volume: 19, Issue:6 Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Arthritis, Rheumatoid; Famo	2009
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 to prevent peptic ulcer caused by NSAIDs. The New England journal of medicine, 1996, Oct-24, Volume: 335, Issue:17 Topics: Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Arthritis, Rheumatoid; Famotidine; Gastr	1996
Effects of famotidine on various immunological parameters in patients with rheumatic diseases: decreased lymphocyte DR expression by famotidine. Immunopharmacology and immunotoxicology, 1992, Volume: 14, Issue:3 Topics: Adjuvants, Immunologic; Adolescent; Adult; Aged; Arthritis, Rheumatoid; Famotidine; Female; HLA-DR A	1992

famotidine and Rheumatoid Arthritis