PMID- 23620668
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20130429
LR  - 20211021
IS  - 1176-6336 (Print)
IS  - 1178-203X (Electronic)
IS  - 1176-6336 (Linking)
VI  - 9
DP  - 2013
TI  - Tolerability of diclofenac sodium 1% gel with concomitant medications known to 
      interact with diclofenac.
PG  - 153-9
LID - 10.2147/TCRM.S41931 [doi]
AB  - BACKGROUND: Topical diclofenac sodium 1% gel (DSG) has demonstrated efficacy and 
      tolerability in patients with osteoarthritis (OA) of the knees or hands, 
      including elderly patients and those with an increased risk of gastrointestinal, 
      cardiovascular, and renal adverse events (AEs). Medications known to interact 
      with diclofenac were disallowed in a clinical trial of DSG for knee OA; however, 
      patients were not to be discontinued for intake of disallowed treatment, unless 
      there was a safety issue. This post hoc analysis examined the frequency and type 
      of AEs in patients who received DSG concomitantly with drugs known to have 
      potential interactions with diclofenac. MATERIALS AND METHODS: This was a post 
      hoc analysis of a randomized controlled trial of DSG for knee OA pain. Patients 
      (n = 254) aged >/= 35 years with OA in one or both knees, but with clinical OA 
      symptoms in only one knee, administered DSG topically to the target knee four 
      times daily (total dose, 16 g/d) for 12 weeks. Drugs with the potential for major 
      or moderate drug-drug interactions (DDIs) were identified via Drugs.com. AE rates 
      were compared in patients with versus those without >/=1 potential DDI. RESULTS: At 
      least one AE was experienced by 62.6% (107/171) of patients with >/=1 DDI and by 
      55.4% (46/83) of patients with no DDIs. Gastrointestinal AEs (upper and lower) 
      were reported in 5.3% (9/171) and 7.2% (6/83), cardiovascular AEs in 4.7% (8/171) 
      and 1.2% (1/83), renal AEs in 1.2% (2/171) and 0%, and hepatic AEs in 0% and 1.2% 
      (1/83) of patients with >/=1 DDI compared with patients with no DDIs, respectively. 
      CONCLUSION: Concurrent use of DSG with medications that had potential for major 
      to moderate DDIs had little impact on the frequency of AEs in this population. 
      Further research is needed to consider how factors such as dose, duration, and 
      timing of concomitant drug administration may affect the likelihood of clinically 
      evident AEs resulting from a potential DDI.
FAU - Peniston, John H
AU  - Peniston JH
AD  - Feasterville Family Health Care Center, Feasterville, PA.
FAU - Gold, Morris S
AU  - Gold MS
FAU - Wieman, Matthew S
AU  - Wieman MS
FAU - Alwine, Lawrence K
AU  - Alwine LK
LA  - eng
PT  - Journal Article
DEP - 20130416
PL  - New Zealand
TA  - Ther Clin Risk Manag
JT  - Therapeutics and clinical risk management
JID - 101253281
PMC - PMC3633539
OTO - NOTNLM
OT  - drug interactions
OT  - knee osteoarthritis
OT  - nonsteroidal anti-inflammatory drugs
OT  - topical administration
EDAT- 2013/04/27 06:00
MHDA- 2013/04/27 06:01
PMCR- 2013/04/16
CRDT- 2013/04/27 06:00
PHST- 2013/04/27 06:00 [entrez]
PHST- 2013/04/27 06:00 [pubmed]
PHST- 2013/04/27 06:01 [medline]
PHST- 2013/04/16 00:00 [pmc-release]
AID - tcrm-9-153 [pii]
AID - 10.2147/TCRM.S41931 [doi]
PST - ppublish
SO  - Ther Clin Risk Manag. 2013;9:153-9. doi: 10.2147/TCRM.S41931. Epub 2013 Apr 16.