PMID- 25516006
OWN - NLM
STAT- MEDLINE
DCOM- 20151106
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 31
IP  - 3
DP  - 2015 Mar
TI  - 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.
PG  - 407-20
LID - 10.1185/03007995.2014.1000086 [doi]
AB  - 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. 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). 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. 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.
FAU - Bello, Alfonso E
AU  - Bello AE
AD  - University of Illinois-Chicago, College of Medicine, and Illinois Bone and Joint 
      Institute LLC , Glenview, IL , USA.
FAU - Grahn, Amy Y
AU  - Grahn AY
FAU - Ball, Julie
AU  - Ball J
FAU - Kent, Jeffrey D
AU  - Kent JD
FAU - Holt, Robert J
AU  - Holt RJ
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150112
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Drug Combinations)
RN  - 0 (Histamine H2 Antagonists)
RN  - 5QZO15J2Z8 (Famotidine)
RN  - WK2XYI10QM (Ibuprofen)
SB  - IM
CIN - Curr Med Res Opin. 2015 Mar;31(3):421-2. PMID: 25713982
MH  - Adult
MH  - Aged
MH  - *Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse effects
MH  - Arthritis, Rheumatoid/drug therapy
MH  - Drug Combinations
MH  - Drug Monitoring/methods
MH  - *Dyspepsia/chemically induced/diagnosis/epidemiology/prevention & control
MH  - Endoscopy, Gastrointestinal/methods
MH  - *Famotidine/administration & dosage
MH  - Female
MH  - Histamine H2 Antagonists/*administration & dosage
MH  - Humans
MH  - *Hypertension/chemically induced/diagnosis
MH  - *Ibuprofen/administration & dosage/adverse effects
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Patient Compliance
MH  - Severity of Illness Index
MH  - *Stomach Ulcer/chemically induced/diagnosis/physiopathology/prevention & control
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Arthritis, rheumatoid
OT  - Cardiovascular
OT  - Famotidine
OT  - Gastrointestinal
OT  - Ibuprofen
OT  - Non-steroidal anti-inflammatory agents
OT  - Safety
EDAT- 2014/12/18 06:00
MHDA- 2015/11/07 06:00
CRDT- 2014/12/18 06:00
PHST- 2014/12/18 06:00 [entrez]
PHST- 2014/12/18 06:00 [pubmed]
PHST- 2015/11/07 06:00 [medline]
AID - 10.1185/03007995.2014.1000086 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2015 Mar;31(3):407-20. doi: 10.1185/03007995.2014.1000086. 
      Epub 2015 Jan 12.