Diabetes is the leading cause of neuropathy in developed countries, and neuropathy is the most common complication and greatest source of morbidity and mortality in diabetes patients. It is estimated that the prevalence of neuropathy in diabetes patients is approximately 20%. Diabetic neuropathy is implicated in 50-75% of nontraumatic amputations.
The main risk factor for diabetic neuropathy is hyperglycemia. In the DCCT (Diabetes Control and Complications Trial, 1995) study, the annual incidence of neuropathy was 2% per year, but dropped to 0.56% with intensive treatment of Type 1 diabetics. The progression of neuropathy is dependent on the degree of glycemic control in both Type 1 and Type 2 diabetes. Duration of diabetes, age, cigarette smoking, hypertension, height and hyperlipidemia are also risk factors for diabetic neuropathy.
Agents for pain caused by sensorimotor neuropathy include tricyclic antidepressants (TCAs), serotonin reuptake inhibitors (SSRIs) and antiepileptic drugs (AEDs).The SSNRI Duloxetine (Cymbalta) is approved for Diabetic neuropathy.
Duloxetine appears to be a safe and effective treatment for diabetes-related pain caused by damage to the peripheral nervous system, according to a report in the journal Neurology.
This damage, also called diabetic peripheral neuropathy, occurs when the communication network that transmits information back and forth from the peripheral nerves to the central nervous system is damaged. This can result in a variety of symptoms including pain, numbness or tingling sensations.
Duloxetine, the active ingredient in Cymbalta, is a selective serotonin and norepinephrine reuptake inhibitor that treats depression by increasing levels of serotonin and norepinephrine, and treats neuropathy by blocking pain signals to the brain.
To investigate how effective duloxetine is in treating pain from diabetic peripheral neuropathy, Dr. Joachim Wernicke of Eli Lily and Company, Indianapolis, Indiana, evaluated 334 non-depressed patients with diabetic peripheral neuropathic pain who were randomly assigned to 60 mg duloxetine once or twice daily, or placebo.
"A 50-percent reduction in the 24-hour average pain response was achieved by 27 percent of patients in the placebo-treated group," they report, compared with 43 percent of patients in the once-day duloxetine group and 53 percent in the twice-daily duloxetine group.
Treatment with duloxetine, at either frequency, also reduced pain rapidly. The benefits of the drug over placebo in reducing the 24-hour average pain severity score became apparent during the first week of treatment.
With the exception of overall increased sensitivity to pain, all secondary measures of pain, such as night pain and the severity of the worst pain, were significantly improved with duloxetine compared with placebo. The benefits with once- versus twice-daily duloxetine appeared to be comparable.
Duloxetine therapy had an acceptable safety profile with no association with any serious side effects. However, nausea, dizziness, constipation, fatigue, drowsiness, diarrhea, and increased sweating were significantly more common with the drug than with placebo.
The results support the use of once daily duloxetine for patients with diabetic peripheral neuropathic pain, the authors conclude. While the twice-daily dosing may raise the risk of side effects, it may provide additional benefits in some patients, they add
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