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.
Author(s): Nalamachu S(1), Hale M(2), Khan A(3).
Affiliation(s): Author information:
(1)International Clinical Research Institute, Overland Park, Kansas. (2)Gold
Coast Research, LLC, Weston, Florida. (3)Northwest Clinical Research Center,
Bellevue, Washington; Duke University Medical Center, Durham, North Carolina.
Publication date & source: 2014, J Opioid Manag. , 10(5):311-22
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.
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