Tuesday, September 07, 2004

Cymbalta and Diabetic Peripheral Neuropathy

The Food and Drug Administration (FDA) today announced its approval of this medication as a treatment for a common neurological complication of diabetes. From the press release:

FDA Approves Drug for Neuropathic Pain Associated With Diabetes

Today the Food and Drug Administration (FDA) announced the approval of Cymbalta (duloxetine hydrochloride) capsules for the management of the pain associated with diabetic peripheral neuropathy. This is the first drug specifically approved for this indication. Cymbalta received a priority review.

"Diabetes affect millions of Americans," said Dr. Lester M. Crawford, Acting FDA Commissioner. "With this new treatment we will hopefully be able to help relieve the pain associated with this terrible disease."

Diabetic peripheral neuropathy is a problem associated with long standing diabetes or poor glucose control. Peripheral neuropathy is the most common complication of diabetes mellitus, affecting up to 62% of Americans with diabetes. Diabetic peripheral neuropathy can manifest in a variety of ways but is usually characterized by burning, tingling, and numbing sensations beginning in the feet, and later affecting the legs and/or hands.

The safety and effectiveness of Cymbalta were established in two randomized, controlled studies of approximately 1074 patients. Although the mechanism of action is unknown, patients treated with Cymbalta reported a greater decrease in pain compared to placebo. In these trials, 58 percent of patients treated with Cymbalta reported at least a 30 percent sustained reduction in pain. In comparison, 34 percent of patients treated with placebo reported this magnitude of sustained pain reduction.

The most commonly reported side effects were nausea, dry mouth, constipation, and diarrhea. In some cases, patients experienced dizziness and hot flashes.

Cymbalta is manufactured by Eli Lilly and Company in Indianapolis, Ind.

2 Comments:

Anonymous Anonymous said...

My wife is suffering from Chemo Induced Perirpheral Neuropathy.
Initally treated with Gabapentin @ 600 mg/day.
It was ineffective.
Just perscriped Cymbalta five days ago and after two days experienced the symptons of depression,which she did not exhibit before the Cymbhalta:
Lose of appetite, loss of interest in favorite things, unhappy, sleeping all day.
AND it has not helped the pain.
I know the doctor will tell us we need to give it more time, but I can't tell her she has to suffer despression in addition to the pain of neuropthy

1:53 PM  
Anonymous Anonymous said...

The psychotropic effects of Cymbalta are very dose-dependent. You may want to consult a psychopharmacologist to determine what symptoms may be a result of too high a dose or too quick an introduction and which may go away over time.

The "standard" course for Neuropathy is more aggressive than would be normally prescribed by a Psychiatrist.

12:27 PM  

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