PMID- 9132322
OWN - NLM
STAT- MEDLINE
DCOM- 19970501
LR  - 20190909
IS  - 0770-3198 (Print)
IS  - 0770-3198 (Linking)
VI  - 16
IP  - 1
DP  - 1997 Jan
TI  - Efficacy and tolerability of a topical NSAID patch (local action transcutaneous 
      flurbiprofen) and oral diclofenac in the treatment of soft-tissue rheumatism.
PG  - 25-31
AB  - The efficacy and safety of local action transcutaneous flurbiprofen 40 mg 
      [flurbiprofen LAT] patches and diclofenac sodium tablets, 50 mg b.d., were 
      compared in an open, multicentre, randomized, parallel-group study in patients 
      with soft-tissue rheumatism. Patches were replaced at 12-hourly intervals. 
      Clinical assessments were performed after 7 and 14 days of treatment. Fifty-six 
      patients were treated with flurbiprofen LAT and 53 with diclofenac. Six 
      withdrawals (three from each group) occurred during the treatment period. A 
      statistically significant difference was observed in favour of flurbiprofen LAT 
      for the principal measure, namely the investigator's opinion of overall change in 
      clinical condition: 49/53 (92%) patients treated with flurbiprofen LAT had 
      improved by day 14 compared with 36/49 (73%) patients receiving diclofenac sodium 
      (p = 0.03; eligible dataset). There were also statistically significant 
      differences in favour of flurbiprofen LAT for the investigator's assessments of 
      the overall severity of the clinical condition (p = 0.03; eligible dataset), for 
      the severity of pain at the region treated (p = 0.04; intent-to-treat), and for 
      the severity of tenderness (p < 0.001; intent-to-treat). Supplementary analgesia 
      (paracetamol) was required by two patients in the flurbiprofen LAT group and by 
      eight diclofenac-treated patients. The difference in favour of flurbiprofen LAT 
      in the average daily consumption of paracetamol was significant (p = 0.04). The 
      patients' assessment of severity of pain on movement also favoured flurbiprofen 
      LAT (p = 0.049; eligible dataset), but there were no statistically significant 
      differences in day or night pain or quality of sleep. For the patients' opinion 
      of treatment there was, however, a statistically significant difference in favour 
      of flurbiprofen LAT (p = 0.02). Of the patients receiving flurbiprofen LAT, 94% 
      regarded it as a convenient form of treatment. With respect to tolerability 8/56 
      (14%) patients applying flurbiprofen patches reported a total of nine adverse 
      effects (AEs) (mainly local, mild skin irritations), vs 9/52 (17%) patients 
      receiving diclofenac, who reported 12 AEs. Most AEs in the enteric-coated 
      diclofenac group were of a gastrointestinal nature (one of which was severe). In 
      terms of the proportion of patients reporting AEs related to the digestive 
      system, there was a statistically significant difference in favour of 
      flurbiprofen LAT (p = 0.011). In conclusion, local treatment of soft-tissue 
      rheumatism with flurbiprofen LAT was demonstrably superior to benchmark oral 
      therapy with diclofenac sodium over a 2-week period in terms of both efficacy and 
      gastrointestinal tolerability. Flurbiprofen LAT provided both an effective and 
      convenient form of topical SAID treatment.
FAU - Martens, M
AU  - Martens M
AD  - Department of Orthopaedics, O-L-Vrouw Middelares, Deurne, Belgium.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Germany
TA  - Clin Rheumatol
JT  - Clinical rheumatology
JID - 8211469
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 144O8QL0L1 (Diclofenac)
RN  - 5GRO578KLP (Flurbiprofen)
SB  - IM
MH  - Administration, Cutaneous
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/therapeutic use
MH  - Confidence Intervals
MH  - Diclofenac/*administration & dosage/therapeutic use
MH  - Drug Administration Schedule
MH  - Female
MH  - Flurbiprofen/*administration & dosage/therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement
MH  - Patient Satisfaction
MH  - Rheumatic Diseases/*drug therapy/physiopathology
MH  - Treatment Outcome
EDAT- 1997/01/01 00:00
MHDA- 1997/01/01 00:01
CRDT- 1997/01/01 00:00
PHST- 1997/01/01 00:00 [pubmed]
PHST- 1997/01/01 00:01 [medline]
PHST- 1997/01/01 00:00 [entrez]
AID - 10.1007/BF02238759 [doi]
PST - ppublish
SO  - Clin Rheumatol. 1997 Jan;16(1):25-31. doi: 10.1007/BF02238759.