New Data Show Patients With Chronic Low Back Pain
Maintained Pain Reduction on Duloxetine
Further Pain Reductionon Duloxetine Shown During Study's Extension Phase
Sept. 09,2009
New data show patients with chronic low back pain on duloxetine hydrochloride (Cymbalta®) maintained reductions in pain for 41 weeks. In patients who initially responded to duloxetine, this maintenance of pain reduction was accompanied by further reduction in pain that was statistically significant as measured by the Brief Pain Inventory (BPI) average pain rating.1 The data will be presented today at the sixth triennial congress of the European Federation of InternationalAssociation for the Study of Pain Chapters (EFIC®).
A total of 181 patients enrolled in the open-label 41-week extension phase of
the study, designed to evaluate long-term maintenance of effect in patients
with chronic low back pain taking duloxetine 60 mg or 120 mg once daily.
Maintenance of effect was assessed in the responders - 58 duloxetine patients
who had experienced at least 30 percent pain reduction from baseline during the
13-week, placebo-controlled acute phase of the study.
The most common adverse events in the study (those occurring in more than 5
percent of study participants) included headache, nausea, upper abdominal pain,
excessive sweating (hyperhidrosis), back pain, diarrhoea and fatigue. Adverse
events were similar to those seen in previous duloxetine studies.1 A total of
18 patients in the study discontinued due to adverse events during the
extension phase.
"Chronic low back pain is a painful and debilitating condition and this study
is an important step in the fight against it," said Vladimir Skljarevski, M.D.,
lead study author and a neurologist and medical fellow at Lilly Research
Laboratories.
Experts estimate chronic low back pain affects between 4 percent and 33 percent
of the world's population at any one time. According to the International
Association for the Study of Pain (IASP), the pain is an unpleasant sensory and
emotional experience associated with actual or potential tissue damage, or
described in terms of such damage. Chronic pain is defined as pain that
persists beyond acute pain or beyond the expected time for an injury to heal.
Men and women are equally affected by chronic low back pain, and it occurs most
often between the ages of 30 and 50.
In Europe, duloxetine is approved for the treatment of diabetic peripheral
neuropathic pain (DPNP), major depressive disorder (MDD), generalised anxiety
disorder (GAD) and stress urinary incontinence (SUI)
Duloxetine is approved in various countries outside of Europe for the
management of DPNP, for the treatment of MDD, for the treatment of GAD and for
the management of fibromyalgia.