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» LymeNet Flash » Questions and Discussion » Medical Questions » Cymbalta..anyone taking this?

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Author Topic: Cymbalta..anyone taking this?
missy
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My doctor has just prescribed this medication. He has had good results with his Lyme patients. He said it significantly reduces pain and fatigue. And it improves cognitive function.

I saw a report this a.m. in Medscape Daily newsletter that reported on the study with fibro patients, but accidently deleted it. I found the following article when I googled.

I am optimistic. But I hope it will not become just another failed therapy.

I would like to hear from anyone who is taking Cymbalta or knows anyone who has tried this.
http://www.healthfinder.gov/news/newsstory.asp?docID=521116

THURSDAY, Sept. 9 (HealthDayNews) -- A new antidepressant called duloxetine improved symptoms of fibromyalgia -- a chronic and painful musculoskeletal disorder -- in women but not in men, researchers report.

Duloxetine (brand name Cymbalta) was recently approved by the U.S. Food and Drug Administration to treat major depression and nerve pain suffered by those with diabetes. In the new study, published in the September issue of Arthritis & Rheumatism, the drug was used "off-label," which is legal.

"Antidepressants have been used to treat fibromyalgia for over 10 years," said study author Dr. Lesley Arnold, an associate professor of psychiatry at the University of Cincinnati College of Medicine. "The problem has been those medications are poorly tolerated," she said, adding that side effects include weight gain, potential heart problems and excess sedation.

"We have been looking for alternatives," Arnold said.

Fibromyalgia is marked by body pain and muscle tenderness at several body sites, and there also can be headaches, sleep disturbances and fatigue. An estimated 3 percent to 6 percent of the U.S. population has the disorder and it's far more common in women than in men, according to the National Fibromyalgia Association.

The cause is not known, but the disorder has been linked to abnormalities in the brain neurotransmitters serotonin and norepinephrine. Both are linked to mood and recognized for their role in depression. According to the study authors, there is no FDA-approved treatment for fibromyalgia.

Duloxetine works differently than some other antidepressants, affecting levels of both serotonin and norepinephrine rather than just serotonin, Arnold said. The drug produces the benefits of the other antidepressants without the downsides, according to Arnold, whose colleagues on the study included researchers from Eli Lilly and Co., the drug's manufacturer.

In the study, Arnold and her team evaluated 207 patients, mostly women, with fibromyalgia. About a third had also been diagnosed with depression. The subjects were randomly assigned to a placebo group or to a treatment group, which received 60 milligrams of duloxetine twice a day for 12 weeks.

Then they were evaluated using the Fibromyalgia Impact Questionnaire, commonly used to determine the effect of a treatment. It asks about the ability to perform common activities such as going to work, shopping, doing laundry, preparing meals, driving a car and climbing stairs.

Thirty percent of the women in the duloxetine group had a 50 percent or greater improvement in their pain, Arnold said, compared with just 16.5 percent in the placebo group. And, she said, the improvement in pain reduction seemed to be independent of the effect on mood.

Those who received duloxetine demonstrated greater improvement on most of the measures evaluated on the questionnaire, she said.

Why the treatment didn't work for the men isn't clear, Arnold said, but the answer could lie with the small sample size. Only 23 men were included in the study.

Dr. Daniel J. Clauw, a professor of medicine at the University of Michigan and an expert on fibromyalgia, called the new research "a well-done study."

But he noted there was more improvement with daily activities than pain management. He couldn't predict whether more doctors treating patients with fibromyalgia would be likely to use the new antidepressant off-label.

But the outlook is getting brighter for those with the condition, Clauw said. "Nearly every large pharmaceutical company is testing one or more compounds for fibromylagia," he said.



Posts: 101 | From MS | Registered: Feb 2001  |  IP: Logged | Report this post to a Moderator
missy
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back to the top.
Posts: 101 | From MS | Registered: Feb 2001  |  IP: Logged | Report this post to a Moderator
treepatrol
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uh
Safety concerns have been raised over an incontinence and anti-depressant drug taken by about 40 women in a Sydney trial after a woman participating in a US study committed suicide.

The drug manufacturer, Eli Lilly and Co, has been ordered not to accept new participants in the US trial of the compound duloxetine after the 19-year-old was found hanged in a room at a company research laboratory in Indianapolis this week.

The Sydney women were part of a separate, four-continent trial of the drug involving 458 women, and an Australian researcher involved in that study has dismissed a direct link between the drug and suicide.

The woman who died in the US, a student, was psychologically screened before the test and found not to have depression. She was one of 25 volunteers in the trial of the drug compound, which the company hopes to use as the main ingredient in an anti-depressant, and as a treatment for stress urinary incontinence.

There have been four other suicides of participants in clinical trials of duloxetine, out of about 9000 participants.

The compound belongs to a class of drugs known as selective serotonin and norepinephrine reuptake inhibitors (SNRIs), similar to selective serotonin re-uptake inhibitors (SSRIs), which include anti-depressants such as Paxil and Zoloft.

The British Medicines and Healthcare Products Regulatory Agency and the US Food and Drug Administration have issued recommendations against the use of SSRIs in the treatment of depressed children. There is evidence suggesting a link between some of the drugs and suicidal thoughts in children.

But Kate Moore, an associate professor of obstetrics and gynaecology at the University of NSW, dismissed suggestions the drug could be directly linked to suicide as "illogical".

Professor Moore, who was involved in clinical trials of duloxetine at Sydney's Prince of Wales and St George hospitals, said the compound was revolutionary and offered the first effective drug treatment for stress incontinence - estimated to affect at least 78 million women over the age of 20 worldwide.

"Because the drug has an anti-depressant effect, any relationship with suicide with this drug would be surprising," Professor Moore said.

In the study involving the Sydney women, Professor Moore and her co-researchers found that duloxetine halved the number of incontinence episodes.

"The safety and efficacy data from this study provide evidence for the value of duloxetine as potentially the first widely approved pharmacological treatment for women with bothersome stress urinary incontinence," the researchers wrote in last month's British Journal of Urology.

Professor Moore said the main side-effect of the drug was nausea, and added that the prescribed dosage of the drug for urinary incontinence would not have an anti-depressant effect.

However participants in the US trial were given higher than normal doses of the drug.

A coroner's toxicology report is yet to confirm the drug company's finding that duloxetine did not cause the death.

But Jon Jureidini, head of the department of psychological medicine at Adelaide's Women's and Children's Hospital, said suspicions that the similar SSRI class of drugs may be dangerous and cause suicidal thoughts should not be dismissed.

"We should be attending to the possibility that suicidal thinking might emerge in otherwise normal people," Dr Jureidini said.

The company, yet to receive final approval for the compound from the US FDA, has lodged a submission to the Therapeutic Goods Administration for its use here, a spokeswoman for Eli Lilly in Australia said.


Never used it dont think I will.


Posts: 10564 | From PA Where the Creeks are Red | Registered: Jun 2003  |  IP: Logged | Report this post to a Moderator
   

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