PMID- 22845494
OWN - NLM
STAT- MEDLINE
DCOM- 20130501
LR  - 20181201
IS  - 1526-4637 (Electronic)
IS  - 1526-2375 (Linking)
VI  - 13
IP  - 9
DP  - 2012 Sep
TI  - Pain relief and tolerability balance of immediate release tapentadol or oxycodone 
      treatment for patients with moderate to severe osteoarthritis or low back pain.
PG  - 1110-20
LID - 10.1111/j.1526-4637.2012.01454.x [doi]
AB  - PURPOSE: Opioid treatment effectiveness may be best compared using definitions of 
      treatment response, which combine measures assessing pain reduction and the 
      occurrence of adverse events (AEs). This analysis of data from two phase III 
      clinical trials was conducted to examine the pain relief and tolerability (PRT) 
      balance of immediate release (IR) tapentadol and oxycodone in patients with 
      moderate to severe osteoarthritis (OA) or low back pain. METHODS: This was a post 
      hoc analysis of two multicenter, randomized, double-blind studies (10-day and 
      90-day) that evaluated the efficacy and safety of tapentadol IR in patients with 
      moderate-severe OA pain. PRT was defined as adequate pain reduction (30% or 50% 
      pain intensity improvement from baseline) and no gastrointestinal AE or other 
      type of treatment-emergent AE. The percentage of patients and mean number of days 
      per patient meeting the PRT criteria were summarized. RESULTS: In the 10-day 
      trial, the percentages of patients meeting PRT criteria (30% reduction) for both 
      tapentadol groups were consistently above that for oxycodone 10 mg, although only 
      significantly different for the 50 mg formulation. The mean number of days per 
      patient meeting the PRT criteria was 3.7, 3.2, and 2.3 days for tapentadol 50 mg, 
      75 mg and oxycodone 10 mg, respectively. No significant difference between the 
      groups was observed using the 50% pain reduction criterion. For the 90-day trial, 
      using multiple definitions, tapentadol IR showed a significantly higher 
      proportion of days meeting PRT criteria. CONCLUSION: Pain reduction and 
      tolerability are both important attributes of an effective analgesic treatment. 
      Based on data from two trials, tapentadol IR produced an improved PRT balance 
      compared with oxycodone IR.
CI  - Wiley Periodicals, Inc.
FAU - Kavanagh, Shane
AU  - Kavanagh S
AD  - Janssen Global Services, Beerse, Belgium. skavanag@its.jnj.com
FAU - Kwong, W Jackie
AU  - Kwong WJ
FAU - Hammond, Geoffrey C
AU  - Hammond GC
FAU - Nelson, Winnie
AU  - Nelson W
FAU - Upmalis, David
AU  - Upmalis D
FAU - Yang, Min
AU  - Yang M
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20120730
PL  - England
TA  - Pain Med
JT  - Pain medicine (Malden, Mass.)
JID - 100894201
RN  - 0 (Analgesics)
RN  - 0 (Phenols)
RN  - CD35PMG570 (Oxycodone)
RN  - H8A007M585 (Tapentadol)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Low Back Pain/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis/*drug therapy
MH  - Oxycodone/*administration & dosage/adverse effects
MH  - Phenols/*administration & dosage/adverse effects
MH  - Tapentadol
MH  - Young Adult
EDAT- 2012/08/01 06:00
MHDA- 2013/05/02 06:00
CRDT- 2012/08/01 06:00
PHST- 2012/08/01 06:00 [entrez]
PHST- 2012/08/01 06:00 [pubmed]
PHST- 2013/05/02 06:00 [medline]
AID - 10.1111/j.1526-4637.2012.01454.x [doi]
PST - ppublish
SO  - Pain Med. 2012 Sep;13(9):1110-20. doi: 10.1111/j.1526-4637.2012.01454.x. Epub 
      2012 Jul 30.