PMID- 25350473
OWN - NLM
STAT- MEDLINE
DCOM- 20141230
LR  - 20141029
IS  - 1551-7489 (Print)
IS  - 1551-7489 (Linking)
VI  - 10
IP  - 5
DP  - 2014 Sep-Oct
TI  - Hydromorphone extended release for neuropathic and non-neuropathic/nociceptive 
      chronic low back pain: a post hoc analysis of data from a randomized, 
      multicenter, double-blind, placebo-controlled clinical trial.
PG  - 311-22
LID - jom.2014.0221 [pii]
LID - 10.5055/jom.2014.0221 [doi]
AB  - OBJECTIVE: The aim of this study was to determine the efficacy and tolerability 
      of hydromorphone extended release (ER) in patients with chronic low back pain 
      (LBP) with or without a neuropathic component. DESIGN: This was a post hoc 
      analysis of data from a multicenter, double-blind, placebo-controlled clinical 
      trial using a randomized withdrawal design, performed in patients with moderate 
      to severe chronic LBP. Patients achieving stable doses of hydromorphone ER during 
      a 2- to 4-week conversion and titration phase were randomized to continue 
      treatment with hydromorphone ER or taper-down to placebo during a 12-week 
      double-blind phase. The primary efficacy outcome was the mean change in 11-point 
      Numeric Rating Scale (NRS) pain intensity score from randomization to the final 
      visit of the double-blind phase. Tolerability was assessed by recording adverse 
      events (AEs). Data were analyzed separately for patients with non-neuropathic and 
      neuropathic LBP. RESULTS: A total of 173 patients with 
      non-neuropathic/nociceptive LBP and 94 with neuropathic LBP were randomized into 
      the double-blind phase. During the conversion and titration phase, mean (SD) NRS 
      scores decreased significantly from 6.5 (1.87) and 6.4 (1.99) at screening to 3.3 
      (0.98) and 3.2 (1.05), respectively. For both LBP subgroups, patients randomized 
      to hydromorphone ER maintained this improvement over the double-blind treatment 
      period, whereas those randomized to placebo reported significant increase in NRS 
      scores. Across subgroups, the incidence of 1 or more AE was 54 percent to 57 
      percent in the conversion and titration phase and 47 percent to 55 percent in the 
      double-blind phase. CONCLUSIONS: The results of this study indicate that 
      hydromorphone ER is efficacious and generally well tolerated in the management of 
      patients with non-neuropathic and neuropathic chronic LBP.
FAU - Nalamachu, Srinivas
AU  - Nalamachu S
AD  - International Clinical Research Institute, Overland Park, Kansas.
FAU - Hale, Martin
AU  - Hale M
AD  - Gold Coast Research, LLC, Weston, Florida.
FAU - Khan, Arif
AU  - Khan A
AD  - Northwest Clinical Research Center, Bellevue, Washington; Duke University Medical 
      Center, Durham, North Carolina.
LA  - eng
SI  - ClinicalTrials.gov/NCT00549042
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Opioid Manag
JT  - Journal of opioid management
JID - 101234523
RN  - 0 (Delayed-Action Preparations)
RN  - Q812464R06 (Hydromorphone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Chronic Pain/*drug therapy
MH  - Delayed-Action Preparations
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hydromorphone/*administration & dosage/adverse effects
MH  - Low Back Pain/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Neuralgia/*drug therapy
EDAT- 2014/10/29 06:00
MHDA- 2014/12/31 06:00
CRDT- 2014/10/29 06:00
PHST- 2013/09/25 00:00 [received]
PHST- 2014/06/30 00:00 [accepted]
PHST- 2014/10/29 06:00 [entrez]
PHST- 2014/10/29 06:00 [pubmed]
PHST- 2014/12/31 06:00 [medline]
AID - jom.2014.0221 [pii]
AID - 10.5055/jom.2014.0221 [doi]
PST - ppublish
SO  - J Opioid Manag. 2014 Sep-Oct;10(5):311-22. doi: 10.5055/jom.2014.0221.