Data Suggest Cymbalta® Reduced Severity Of Night Pain In Patients With Diabetic

[Guest guest]

Data Suggest Cymbalta® Reduced Severity Of Night Pain In Patients

With Diabetic Nerve Pain

http://www.medicalnewstoday.com/medicalnews.php?newsid=70148

Data from a pooled analysis of three studies suggest that in

patients with pain caused by diabetic nerve damage, or diabetic

peripheral neuropathy, who are treated with Cymbalta (duloxetine

HCl), improvements in both average daily pain and night pain

severity were associated with less pain-related sleep interference

than in those patients taking sugar pill. Results from the analysis

of more than 1,000 patients were presented today at the annual

meeting of the American Pain Society in Washington D.C.

The average daily night pain severity and sleep interference

correlation assessments were secondary analyses of data from trials

in which the primary efficacy endpoint was to measure the reduction

in average weekly pain. For these assessments, a subset of

nonsomnolent patients was created by removing those who experienced

treatment-related somnolence (such as daytime sleepiness,

drowsiness, grogginess or difficulty awakening) or who were on other

sedating medications. At the end of the 12-week analysis, this

subset of patients treated with 60 mg of Cymbalta once- and twice-

daily experienced significantly more improvement in 24-hour average

pain scores than those taking sugar pill (47 percent, 50 percent and

29 percent respectively), as measured by reduction of scores on the

self-reported, 11-point Likert scale.

In analyses of the effect of Cymbalta on night pain and pain-related

sleep interference, nonsomnolent/nonsedating drug patients treated

with 60 mg of Cymbalta once- and twice-daily experienced

significantly more improvement in nighttime pain than those taking

sugar pill after one week of treatment (22 percent, 21 percent and

10 percent, respectively) and at the end of the 12 weeks (47

percent, 51 percent compared with 34 percent). Both doses of

Cymbalta reduced pain-related sleep interference at the end of the

12 weeks significantly more than sugar pill (55 percent, 57 percent

and 45 percent respectively), as measured by the Brief Pain

Inventory (BPI). No significant difference was seen between the 60

mg and 120 mg doses of Cymbalta.

Of greatest interest is the fact that for the first time, a clear

correlation between reduction in average daily pain and average

night pain and reduction in pain sleep interference was demonstrated

in a population that was not depressed, did not experience treatment-

emergent somnolence and was not on medications commonly associated

with sedation. Other published studies of the relationship between

pain and sleep interference have been confounded by at least one of

those conditions.

" Patients with diabetic nerve pain often complain of being awoken,

or having difficulty falling asleep because of pain, and it is

difficult for physicians to know whether sleep problems are the

cause or effect of pain, " said Fishbain, M.D., distinguished

professor of psychiatry, adjunct professor of neurological surgery

and anesthesiology at the University of Miami, and lead study

author. " This new analysis is important because it suggests that

interference with sleep generally improves if nighttime pain

improves. "

In this analysis, the most common adverse events experienced in the

entire patient population as a whole were nausea, somnolence,

dizziness, constipation, hyperhidrosis, dry mouth and decreased

appetite. The median duration of nausea, somnolence and dizziness in

Cymbalta-treated patients was six days, 14 days and five days,

respectively, with the majority of patients who experienced these

adverse events rating them as mild to moderate in severity. The

overall discontinuation rate for patients on Cymbalta was 14

percent, while the overall discontinuation rate for patients on

placebo was 7 percent. The most common adverse event cited as a

reason for discontinuation was nausea (4 percent), followed by

somnolence (2 percent), dizziness (2 percent), fatigue (1 percent)

and vomiting (1 percent).

Methods:

Data were pooled from three double-blind, randomized, placebo-

controlled, 12-week studies, to investigate associations between

pain and sleep. In the first study, patients were treated with

Cymbalta 20 mg once daily, 60 mg once daily, 60 mg twice daily and

sugar pill. The second and third studies compared Cymbalta 60 mg

once daily and 60 mg twice daily with sugar pill. A subset of

nonsomnolent patients was created by removing patients reporting

treatment-emergent somnolence or who were on sedating concomitant

medications (No patients in any of the trials reported baseline

somnolence.).

In the pooled data, the primary efficacy measure was the reduction

in the weekly mean of the 24-hour average pain scores, calculated

from daily patient diary entries and measured by an 11-point Likert

scale. Secondary measures included average daily night pain severity

measured by an 11-point Likert scale and the BPI sleep interference

item.

Patients with diabetic nerve pain who also had major depressive

disorder (MDD) were excluded from this study, since depression could

have had an effect on sleep interference, and improvements in

depression could have improved sleep interference in these patients.

(1,2,3)

Data on treatment-emergent adverse events, including reports of

somnolence, were collected by spontaneous report, and while

spontaneous reporting is the standard practice for evaluating

treatments, solicited scales specifically designed for particular

adverse events would have been preferable for the investigation.

About Diabetic Peripheral Neuropathy

According to the National Institute of Diabetes & Digestive & Kidney

Diseases, approximately half of those with diabetes have some form

of nerve damage, or neuropathy, but not all will develop symptoms.

While nerve problems can occur at any time, the highest rates are

among those who have had diabetes for at least 25 years. People who

have had problems controlling their blood sugar levels, have high

blood pressure, are overweight, have high levels of blood fat or are

over the age of 40, may also have a greater risk of developing

diabetic peripheral neuropathy. Symptoms can include numbness,

tingling or pain and weakness in the toes, feet, legs, hands, arms

and fingers. These symptoms are often worse at night.(4)

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are

believed to both help regulate the perception of pain and mediate

core mood symptoms. Based on pre-clinical studies, duloxetine is a

balanced and potent reuptake inhibitor of serotonin and

norepinephrine that is believed to potentiate the activity of these

chemicals in the central nervous system (brain and spinal cord).

While the mechanism of action of duloxetine is not fully known,

scientists believe its effect on pain perception, as well as its

effects on depression and anxiety symptoms, may be due to increasing

the activity of serotonin and norepinephrine in the central nervous

system.

Cymbalta is approved in the United States for the treatment of major

depressive disorder, the management of diabetic peripheral

neuropathic pain and the treatment of generalized anxiety disorder,

all in adults. Cymbalta is not approved for use in pediatric

patients.