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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.
- Source :
-
Current medical research and opinion [Curr Med Res Opin] 2015 Mar; Vol. 31 (3), pp. 407-20. Date of Electronic Publication: 2015 Jan 12. - Publication Year :
- 2015
-
Abstract
- Objective: To evaluate the safety of the fixed combination of ibuprofen and famotidine compared with ibuprofen alone from two 24-week, multicenter, double-blind trials designed to evaluate the comparative incidence of endoscopically documented upper gastrointestinal ulcers and a 28-week double-blind extension study.<br />Research Design and Methods: Safety was analyzed by pooling data from the two double-blind trials and the follow-on study. Safety was assessed by monitoring the incidence, causality, and severity of adverse events (AEs).<br />Results: 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. Other than dyspepsia, gastrointestinal and cardiovascular AEs of special interest were similar. Events judged to be treatment related were significantly lower with the ibuprofen/famotidine combination (20.6% vs. 25%). In the safety extension population, there were no differences in the discontinuation rates and the reporting of AEs or serious AEs (SAEs) between the two groups. Gastrointestinal-related events were similar between the groups. Incidence of cardiovascular-related AEs of special interest were 11% (ibuprofen/famotidine) and 2% (ibuprofen) (p=0.06), possibly due to a higher number of rheumatoid arthritis patients in the combination group. Of these, 80% were reports of hypertension (8% ibuprofen/famotidine vs. 2% ibuprofen). Three cases of hypertension in the ibuprofen/famotidine group were considered treatment related. The probability of a cardiovascular event decreased during days 112-167 of treatment and remained low with continued treatment.<br />Conclusions: One-year safety data from two pivotal trials and a long-term extension study indicate that the ibuprofen/famotidine combination demonstrates a favorable gastrointestinal safety profile and more patients continued on therapy compared to ibuprofen alone. No new safety signals have been identified. These data offer additional evidence supporting a new therapeutic option to improve gastrointestinal safety and adherence for patients who require long-term ibuprofen.
- Subjects :
- Adult
Aged
Arthritis, Rheumatoid drug therapy
Drug Combinations
Drug Monitoring methods
Endoscopy, Gastrointestinal methods
Female
Humans
Incidence
Male
Middle Aged
Patient Compliance
Severity of Illness Index
Treatment Outcome
Anti-Inflammatory Agents, Non-Steroidal administration & dosage
Anti-Inflammatory Agents, Non-Steroidal adverse effects
Dyspepsia chemically induced
Dyspepsia diagnosis
Dyspepsia epidemiology
Dyspepsia prevention & control
Famotidine administration & dosage
Histamine H2 Antagonists administration & dosage
Hypertension chemically induced
Hypertension diagnosis
Ibuprofen administration & dosage
Ibuprofen adverse effects
Stomach Ulcer chemically induced
Stomach Ulcer diagnosis
Stomach Ulcer physiopathology
Stomach Ulcer prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1473-4877
- Volume :
- 31
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Current medical research and opinion
- Publication Type :
- Academic Journal
- Accession number :
- 25516006
- Full Text :
- https://doi.org/10.1185/03007995.2014.1000086