PMID- 25913498
OWN - NLM
STAT- MEDLINE
DCOM- 20150820
LR  - 20220316
IS  - 1941-9260 (Electronic)
IS  - 0032-5481 (Linking)
VI  - 127
IP  - 5
DP  - 2015 Jun
TI  - Low-dose SoluMatrix diclofenac in the treatment of osteoarthritis: A 1-year, 
      open-label, Phase III safety study.
PG  - 517-28
LID - 10.1080/00325481.2015.1040716 [doi]
AB  - INTRODUCTION: Diclofenac is used for the treatment of osteoarthritis (OA); 
      however, like other nonsteroidal anti-inflammatory drugs (NSAIDs) it can be 
      associated with serious dose-related adverse events (AEs). Low-dose SoluMatrix(R) 
      diclofenac has been developed to provide efficacy at lower diclofenac doses. A 
      recently published Phase III study evaluated the efficacy and safety of 
      SoluMatrix diclofenac 35 mg twice daily (b.i.d.) and thrice daily (t.i.d.) in 
      patients with OA pain treated for 12 weeks. METHODS: This Phase III multicenter, 
      open-label study assessed the safety of SoluMatrix diclofenac in patients with OA 
      dosed up to 52 weeks (ClinicalTrials.gov: NCT01510912). The study enrolled 602 
      chronic NSAID/acetaminophen users, aged >/=40 years with OA of the knee or hip. 
      Patients received SoluMatrix diclofenac 35 mg b.i.d., which could be increased to 
      t.i.d. and subsequently reduced to b.i.d. as needed. Safety assessments included 
      AEs, vital signs, physical examination findings, 12-lead electrocardiogram, and 
      clinical laboratory test results. Patient-reported outcomes were evaluated by the 
      Short Form-36 (SF-36). RESULTS: A total of 601 patients received SoluMatrix 
      diclofenac; 373 of 601 patients (62.1%) received treatment for >/=11 months. The 
      most frequent AEs included upper respiratory tract infection, headache, urinary 
      tract infection, diarrhea, nasopharyngitis, and nausea. Serious gastrointestinal, 
      cardiovascular, renal, and hepatic AEs were uncommon. A small proportion (99 
      patients, 16.5%) of patients discontinued participation in the study due to AEs. 
      Clinically meaningful improvements from baseline in Physical Component Summary 
      Scores of the SF-36 were noted at week 12 and were sustained through week 52. 
      Improvements in six of the eight individual physical and mental SF-36 domains 
      were also noted. CONCLUSION: SoluMatrix diclofenac treatment for up to 1 year was 
      generally well tolerated in patients with OA pain and associated with improvement 
      in quality of life measures. TRIAL REGISTRATION: www.clinicaltrials.gov 
      identifier: NCT01510912.
FAU - Altman, Roy D
AU  - Altman RD
AD  - University of California, David Geffen School of Medicine , Los Angeles, CA , 
      USA.
FAU - Strand, Vibeke
AU  - Strand V
FAU - Hochberg, Marc C
AU  - Hochberg MC
FAU - Gibofsky, Allan
AU  - Gibofsky A
FAU - Markenson, Joseph A
AU  - Markenson JA
FAU - Hopkins, William E
AU  - Hopkins WE
FAU - Cryer, Byron
AU  - Cryer B
FAU - Kivitz, Alan
AU  - Kivitz A
FAU - Nezzer, Jennifer
AU  - Nezzer J
FAU - Imasogie, Olaolu
AU  - Imasogie O
FAU - Young, Clarence L
AU  - Young CL
LA  - eng
SI  - ClinicalTrials.gov/NCT01510912
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150427
PL  - England
TA  - Postgrad Med
JT  - Postgraduate medicine
JID - 0401147
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 144O8QL0L1 (Diclofenac)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/adverse effects
MH  - Diclofenac/*administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis, Hip/*drug therapy
MH  - Osteoarthritis, Knee/*drug therapy
MH  - Pain Measurement
MH  - Quality of Life
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Diclofenac
OT  - Short Form-36
OT  - SoluMatrix
OT  - osteoarthritis
OT  - pain
OT  - safety
EDAT- 2015/04/29 06:00
MHDA- 2015/08/21 06:00
CRDT- 2015/04/28 06:00
PHST- 2015/04/28 06:00 [entrez]
PHST- 2015/04/29 06:00 [pubmed]
PHST- 2015/08/21 06:00 [medline]
AID - 10.1080/00325481.2015.1040716 [doi]
PST - ppublish
SO  - Postgrad Med. 2015 Jun;127(5):517-28. doi: 10.1080/00325481.2015.1040716. Epub 
      2015 Apr 27.