Press Release
New data show Duloxetine maintained pain reduction for more than six months in patients with diabetic peripheral neuropathic pain
Boehringer IngelheimPosted on:21 Aug 08Study with duloxetine evaluating long-term pain reduction in treatment of DPNP is first to exceed three months
19 August 2008
Indianapolis, 19 August 2008 – Duloxetine hydrochloride maintained pain reduction in the treatment of diabetic peripheral neuropathic pain (DPNP) for more than six months,1 according to new data presented today at the 12th World Congress on Pain in Glasgow, Scotland.
The open-label study, which aimed to evaluate long-term maintenance of effect of duloxetine 60 mg once daily, is the first to assess the efficacy of duloxetine in DPNP beyond three months. The study enrolled 216 patients with DPNP who began eight weeks of treatment with 60 mg of duloxetine once daily. Over this initial eight-week period, 53 percent (N=115) of enrolled patients experienced clinically significant improvement in pain reduction (defined as at least 30 percent pain reduction) as measured by the Brief Pain Inventory (BPI) 24-hour average pain rating.1 This group of responders was maintained on duloxetine 60 mg (N=103) once daily for up to 26 weeks to evaluate sustained pain reduction. Results at study end showed that the reduction in pain was maintained in 74.8 percent (N=77) of the sustained responders with 60 mg duloxetine over the full study period.
“DPNP is a chronic, potentially disabling, condition requiring treatment over a long period of time,” said Vladimir Skljarevski, M.D., lead author of the study and a neurologist and medical fellow at Lilly Research Laboratories. “This study showed duloxetine reduced pain over a six-month period, making this the longest data analysis of duloxetine for the treatment of DPNP.”
During the course of the eight-week acute therapy and 26-week maintenance therapy periods, the most common treatment-emergent adverse events (those occurring in more than 5 percent of patients) for those taking 60 mg of duloxetine were nausea, somnolence, hyperhydrosis (excessive sweating), dry mouth, anorexia, asthenia (weakness), fatigue and headache.2
An estimated 246 million adults worldwide suffer from diabetes.3 By 2025, that number is expected to rise to 380 million, according to the International Diabetes Federation.3Although all diabetics are at risk for DPNP, those most likely to develop the condition are long-term sufferers whose blood-sugar levels have not been adequately controlled, who have high blood pressure or are overweight.4 An estimated 17.2 million to 49.2 million patients with diabetes have been diagnosed with DPNP.5
Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI). Although it does not treat the underlying nerve damage caused by DPNP, duloxetine does help relieve the intense pain often associated with the disorder.6 Scientists believe it does this by increasing levels of serotonin and norepinephrine – two neurotransmitters believed to regulate a person’s sensitivity to pain. Increasing these levels in a balanced way is thought to improve the body’s natural ability to regulate pain by modulating the descending pain pathways in the central nervous system.
In Europe, duloxetine is approved for the treatment of DPNP, major depressive disorder (MDD) and generalised anxiety disorder (GAD).
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.
Editor
PharmiWeb.com
editor@pharmiweb.com
19 August 2008
Indianapolis, 19 August 2008 – Duloxetine hydrochloride maintained pain reduction in the treatment of diabetic peripheral neuropathic pain (DPNP) for more than six months,1 according to new data presented today at the 12th World Congress on Pain in Glasgow, Scotland.
The open-label study, which aimed to evaluate long-term maintenance of effect of duloxetine 60 mg once daily, is the first to assess the efficacy of duloxetine in DPNP beyond three months. The study enrolled 216 patients with DPNP who began eight weeks of treatment with 60 mg of duloxetine once daily. Over this initial eight-week period, 53 percent (N=115) of enrolled patients experienced clinically significant improvement in pain reduction (defined as at least 30 percent pain reduction) as measured by the Brief Pain Inventory (BPI) 24-hour average pain rating.1 This group of responders was maintained on duloxetine 60 mg (N=103) once daily for up to 26 weeks to evaluate sustained pain reduction. Results at study end showed that the reduction in pain was maintained in 74.8 percent (N=77) of the sustained responders with 60 mg duloxetine over the full study period.
“DPNP is a chronic, potentially disabling, condition requiring treatment over a long period of time,” said Vladimir Skljarevski, M.D., lead author of the study and a neurologist and medical fellow at Lilly Research Laboratories. “This study showed duloxetine reduced pain over a six-month period, making this the longest data analysis of duloxetine for the treatment of DPNP.”
During the course of the eight-week acute therapy and 26-week maintenance therapy periods, the most common treatment-emergent adverse events (those occurring in more than 5 percent of patients) for those taking 60 mg of duloxetine were nausea, somnolence, hyperhydrosis (excessive sweating), dry mouth, anorexia, asthenia (weakness), fatigue and headache.2
An estimated 246 million adults worldwide suffer from diabetes.3 By 2025, that number is expected to rise to 380 million, according to the International Diabetes Federation.3Although all diabetics are at risk for DPNP, those most likely to develop the condition are long-term sufferers whose blood-sugar levels have not been adequately controlled, who have high blood pressure or are overweight.4 An estimated 17.2 million to 49.2 million patients with diabetes have been diagnosed with DPNP.5
Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI). Although it does not treat the underlying nerve damage caused by DPNP, duloxetine does help relieve the intense pain often associated with the disorder.6 Scientists believe it does this by increasing levels of serotonin and norepinephrine – two neurotransmitters believed to regulate a person’s sensitivity to pain. Increasing these levels in a balanced way is thought to improve the body’s natural ability to regulate pain by modulating the descending pain pathways in the central nervous system.
In Europe, duloxetine is approved for the treatment of DPNP, major depressive disorder (MDD) and generalised anxiety disorder (GAD).
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.
For more information:
http://www.boehringer-ingelheim.com/corporate/news/press_releases/detail.asp?ID=5834
Editor
PharmiWeb.com
editor@pharmiweb.com
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