PMID- 21811391
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20111110
LR  - 20211020
IS  - 1178-7090 (Electronic)
IS  - 1178-7090 (Linking)
VI  - 4
DP  - 2011
TI  - Diclofenac topical solution compared with oral diclofenac: a pooled safety 
      analysis.
PG  - 159-67
LID - 10.2147/JPR.S20965 [doi]
AB  - BACKGROUND: Topical nonsteroidal anti-inflammatory drug (NSAID) formulations, 
      which produce less systemic exposure compared with oral formulations, are an 
      option for the management of osteoarthritis (OA). However, the overall safety and 
      efficacy of these agents compared with oral or systemic therapy remains 
      controversial. METHODS: Two 12-week, double-blind, double-dummy, randomized, 
      controlled, multicenter studies compared the safety and efficacy profiles of 
      diclofenac topical solution (TDiclo) with oral diclofenac (ODiclo). Each study 
      independently showed that TDiclo had similar efficacy to ODiclo. To compare the 
      safety profiles of TDiclo and ODiclo, a pooled safety analysis was performed for 
      927 total patients who had radiologically confirmed symptomatic OA of the knee. 
      This pooled analysis included patients treated with TDiclo, containing 45.5% 
      dimethyl sulfoxide (DMSO), and those treated with ODiclo. Safety assessments 
      included monitoring of adverse events (AEs), recording of vital signs, 
      dermatologic evaluation of the study knee, and clinical laboratory evaluation. 
      RESULTS: AEs occurred in 312 (67.1%) patients using TDiclo versus 298 (64.5%) of 
      those taking ODiclo. The most common AE with TDiclo was dry skin at the 
      application site (24.1% vs 1.9% with ODiclo; P < 0.0001). Fewer gastrointestinal 
      (25.4% vs 39.0%; P < 0.0001) and cardiovascular (1.5% vs 3.5%; P = 0.055) AEs 
      occurred with TDiclo compared with ODiclo. ODiclo was associated with 
      significantly greater increases in liver enzymes and creatinine, and greater 
      decreases in creatinine clearance and hemoglobin (P < 0.001 for all). 
      CONCLUSIONS: These findings suggest that TDiclo represents a useful alternative 
      to oral NSAID therapy in the management of OA, with a more favorable safety 
      profile.
FAU - Roth, Sanford H
AU  - Roth SH
AD  - Arizona Research and Education, Arthritis Laboratory, Arizona State University, 
      Phoenix, AZ, USA.
FAU - Fuller, Philip
AU  - Fuller P
LA  - eng
PT  - Journal Article
DEP - 20110603
PL  - New Zealand
TA  - J Pain Res
JT  - Journal of pain research
JID - 101540514
PMC - PMC3141832
OTO - NOTNLM
OT  - diclofenac
OT  - gastropathy
OT  - oral NSAIDs
OT  - osteoarthritis
OT  - topical NSAIDs
EDAT- 2011/08/04 06:00
MHDA- 2011/08/04 06:01
PMCR- 2011/06/03
CRDT- 2011/08/04 06:00
PHST- 2011/08/04 06:00 [entrez]
PHST- 2011/08/04 06:00 [pubmed]
PHST- 2011/08/04 06:01 [medline]
PHST- 2011/06/03 00:00 [pmc-release]
AID - jpr-4-159 [pii]
AID - 10.2147/JPR.S20965 [doi]
PST - ppublish
SO  - J Pain Res. 2011;4:159-67. doi: 10.2147/JPR.S20965. Epub 2011 Jun 3.