PMID- 22104466
OWN - NLM
STAT- MEDLINE
DCOM- 20120123
LR  - 20131121
IS  - 1941-9260 (Electronic)
IS  - 0032-5481 (Linking)
VI  - 123
IP  - 6
DP  - 2011 Nov
TI  - Diclofenac sodium topical solution 1.5% w/w with dimethyl sulfoxide compared with 
      placebo for the treatment of osteoarthritis: pooled safety results.
PG  - 180-8
LID - 10.3810/pgm.2011.11.2507 [doi]
AB  - Oral nonsteroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2-selective 
      inhibitors are frequently recommended for management of osteoarthritis (OA). 
      However, serious gastrointestinal and cardiovascular systemic adverse events 
      (AEs) are associated with oral NSAIDs and can be treatment limiting. The efficacy 
      of diclofenac sodium topical solution 1.5% w/w with dimethyl sulfoxide (TDiclo) 
      has been established as superior to placebo and comparable with oral NSAIDs in 
      the management of OA. This study characterizes the safety and tolerability 
      profile of TDiclo compared with placebo through a pooled analysis of data from 
      1252 patients in 7 randomized controlled trials across 61 centers in the United 
      States and 97 centers in Canada. Patients received TDiclo (n = 911) or placebo (n 
      = 341) for 4 to 12 weeks for management of OA of the hand or knee. The most 
      frequently reported AE was dry skin, occurring in 33.0% of patients receiving 
      TDiclo and 5.0% of patients receiving placebo (P < 0.001). Dyspepsia was the most 
      common gastrointestinal reaction, reported by 7.7% of patients receiving TDiclo 
      and 2.9% of patients receiving placebo (P = 0.002). Changes in vital signs and 
      laboratory assessments of hepatic and renal function were similar between the 2 
      groups; TDiclo did not increase mean blood pressure, nor was it associated with 
      hypertension. The rate of serious AEs favored placebo in both groups (0.9% for 
      TDiclo vs 1.5% for placebo; P = 0.358), as did the rate of severe AEs (4.4% vs 
      7.6%; P = 0.023). The most common reason for study discontinuation was dry skin 
      (2.5% vs 0.3%). Results from this analysis suggest that TDiclo is well tolerated 
      in a large population and may offer an alternative to oral NSAID therapy for OA 
      of the knee or hand, particularly for patients at increased risk for serious 
      systemic AEs. Larger head-to-head, long-term, multicenter trials would be 
      beneficial to further evaluate safety data comparing both topical and oral 
      NSAIDs.
FAU - Roth, Sanford H
AU  - Roth SH
AD  - Arizona Research and Education, Arthritis Research Laboratory, Arizona State 
      University, Phoenix, AZ, USA. sroth16@cox.net
FAU - Fuller, Philip
AU  - Fuller P
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Postgrad Med
JT  - Postgraduate medicine
JID - 0401147
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Pharmaceutical Solutions)
RN  - 144O8QL0L1 (Diclofenac)
RN  - YOW8V9698H (Dimethyl Sulfoxide)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Inflammatory Agents, Non-Steroidal/adverse effects/*therapeutic use
MH  - Diclofenac/adverse effects/*therapeutic use
MH  - Dimethyl Sulfoxide/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis/*drug therapy
MH  - Pharmaceutical Solutions
EDAT- 2011/11/23 06:00
MHDA- 2012/01/24 06:00
CRDT- 2011/11/23 06:00
PHST- 2011/11/23 06:00 [entrez]
PHST- 2011/11/23 06:00 [pubmed]
PHST- 2012/01/24 06:00 [medline]
AID - 10.3810/pgm.2011.11.2507 [doi]
PST - ppublish
SO  - Postgrad Med. 2011 Nov;123(6):180-8. doi: 10.3810/pgm.2011.11.2507.