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They are really pushing Cymbalta

Started by ronr, February 04, 2009, 09:51:43 AM

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ronr

Duloxetine Shows Promise in Musculoskeletal Pain
By John Gever, Senior Editor, MedPage Today
Published: February 03, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.   

HONOLULU, Feb. 3 -- Low back pain and osteoarthritic knee pain can be successfully treated with the antidepressant duloxetine (Cymbalta), a researcher said here. Action Points 
--------------------------------------------------------------------------------
Explain to interested patients that duloxetine is primarily an antidepressant but is FDA-approved for other conditions including certain forms of pain.

Note that the drug is not currently approved for back pain or osteoarthritic knee pain.

Explain that these studies were randomized trials, the strongest form of evidence.

Note that the studies were published as abstracts and presented orally at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
The drug reduced pain scores by more than two points from baseline on a standard 10-point rating scale, reported Durisala Desaiah, Ph.D., of Eli Lilly, at the American Academy of Pain Medicine meeting.

The findings emerged from two separate placebo-controlled studies, one in patients with knee pain and the other in patients with chronic lower back pain.

Both showed that duloxetine was significantly more effective than placebo.

But patients in the duloxetine groups were also more likely than those on placebo to discontinue treatment because of adverse effects.

Duloxetine, a dual inhibitor of serotonin and norepinephrine reuptake, is already approved for two other pain-related conditions -- diabetic neuropathy and fibromyalgia -- as well as anxiety and depression.

Speaking at a poster session here, Dr. Desaiah said the drug is believed to act against pain by activating descending inhibitory pathways in the central nervous system.

In both studies -- involving a total of 492 patients, treated for 13 weeks -- patients were randomized to duloxetine or placebo.

In the active-drug group, patients took a starting dose of 30 mg/day, increased to 60 mg/day after two weeks.

Patients who had not shown a significant response by week 7 had the dose increased again to 120 mg/day.

In the placebo group, nonresponders were given more pills to take.

The 10-point Brief Pain Inventory was used to evaluate pain severity. Patients were also assessed with broader symptom indexes: the Western Ontario and McMaster Universities (WOMAC) scale in the knee pain trial, and the Roland-Morris Disability Questionnaire in the study of back pain.

At the end of treatment, patients with knee pain showed a mean decrease in average pain scores of 2.8 with duloxetine versus 1.9 with placebo (P=0.001).

Similarly, back pain patients showed a mean decrease of 2.4 points with duloxetine compared with 1.4 points in the placebo group (P=0.001).

In both studies, significant differences between groups had emerged by the end of the second treatment week. The gap increased through about week 7 and then was maintained to the end of the studies.

About 43% of the duloxetine group in the knee pain study and 30% of the placebo group showed 50% decreases in average pain scores at week 13 (P=0.068).

Total WOMAC scores decreased 18 points in the duloxetine group versus 14 points with placebo (P=0.044), with the difference primarily in the physical function subscale. Slight, statistically insignificant improvements were seen with duloxetine in the pain and stiffness subscales relative to placebo.

In the study of back pain, patients showed a 3.5-point improvement in Roland-Morris scores, double that seen with placebo (P<0.01).

Duloxetine side effects noted in other studies with the drug were seen in these trials as well, primarily nausea, constipation, fatigue, diarrhea, dizziness, hyperhidrosis, and headache.

Study dropouts because of adverse effects were more common in the duloxetine patients -- about 19% in the knee pain study and 14% in the back pain trial, compared with less than 6% of patients taking placebo.

Ajay Wasan, M.D., of the pain management clinic at Brigham and Women's Hospital in Boston and a discussant for the studies, said it remained unclear how duloxetine fights pain.

The mechanism advanced by Dr. Desaiah is a possibility but not the only one, he said.

"There may be analgesic properties to this that are not appreciated yet," said Dr. Wasan.

The same may apply to other antidepressants known to reduce chronic pain, such as amitriptyline. Its sodium channel blocking effects may be directly analgesic, Dr. Wasan said.

Primary source: American Academy of Pain Medicine
Source reference:
Chappell A, et al "Duloxetine 60 to 120 mg once daily versus placebo in the treatment of patients with osteoarthritis knee pain" AAPM 2009; Abstract 207.

Additional source: American Academy of Pain Medicine
Source reference:
Skljarevski V, et al., "Efficacy and safety of duloxetine 60 to 120 mg once daily versus placebo patients with CLBP" AAPM 2009; Abstract 206. 


http://www.medpagetoday.com/MeetingCoverage/AAPM/12722
Times are tough when "Happy Hour" is your nap.
My mind not only wanders, sometimes it leaves completely!

db

Is the jury still out on this drug?  My Rheumy wants me to try it but I haven't found a good time to try it yet.

db  :mellow: ::) :1115:

ronr

It has been approved for Fibromyalgia.
Times are tough when "Happy Hour" is your nap.
My mind not only wanders, sometimes it leaves completely!

FlyFisher


countryboy

My diabetic Dr. has suggested twice that I go off of gabapentin (Neurontin) and start on the cymbalta (Duloxetine).  This is due to the  peripheral neuropathy that I have in both feet.  This causes numbness to the skin and tissues, but servere pain around the joints and bones.

I have read and read on cymbalta, and it still makes me very nervous about switching. 

First of all, it is a very potent anti-depressant as well as stopping some of the movement of pain signals in the brain.  The mechanism responsible for its effectiveness in this pain state is not known, but is thought to involve its effects on serotonin and norepinephrine in the brain.  Duloxetine was approved by the FDA in August 2004.

In all of the material that I have read, it lists the major reasons for taking Duloxetine as: #1  Depression.  #2 Generalized anxiety disorder.  #3 Neuropathic pain associated mainly with diabetic peripheral neuropathy.

The listing of the most common side effects noted with Duloxetine were:  nausea (30 to 40% of patients),  dry mouth (20 to 25% of patients),  constipation (10 to 12% of patients),  diarrhea (10 to 15% of patients),  fatigue (10 to 15% of patients),  difficulty sleeping (12 to 20% of patients).  It also stated that 4 times as many people receiving Duloxetine during this study had to drop out of the study because of side effects as those taking the placebo.

Some of these stats are taken from a report written by Omudhome Ogbru, PharmD and Jay W Marks MD for MedicineNet.

I certainly don't need the added nausea, dry mouth or constipation.  Diarrhea and any additional fatigue or difficulty sleeping really would be the straw that broke the camel's back as the saying goes.

I am still holding off on any switch.  To me, the cons out weigh the pros so far.


:horse:
IT IS BETTER TO BE CONSIDERED A FOOL, THAN TO
OPEN YOUR MOUTH AND REMOVE ALL DOUBT.   But
UNFORTUNTELY MOST PEOPLE REFUSE TO LEAVE ANY DOUBT.  -unknown-

ANY FOOL CAN CRITICIZE, CONDEM AND COMPLAIN --
AND MOST FOOLS DO.   'Benjamin Franklin'

AchinDude

#5
Maybe this will help.

From the fibro patients I see in the drug store, it is about 50% that it helps.

Like so many meds when it comes to fibro, it is more patient specific.

I'd not call it a wonder drug by far, and say it is going to work for everyone.

It does seem to help with patients we have with PN, it does seem to help most of them.   I've seen lot better results with Lyrica on fibro patients.

I realize that doesn't help at all really, but if you are on something that is about halfway working, you may want to ride that as long as you can, and then consider going on Cymbalta.

It is hard to try something that may or may not work, especially if you are on something that is helping.

I tried it, but it made me yawn so much, I could not carry on a conversation at work.   When it first came out, I was eager to try it, but almost everyhting I've taken for the depression, causes me to yawn something horrible.

And part of it depends on if your doctor wants to ADD it to your regime, or change your meds up entirely, and depend on Cymbalta alone.  AND....... what it will cost you to try the Cymbalta, if your insurance pays fairly well on it, it may be worth the effort to try it.

I really wish I had better advice other than, you've got fibro, and you never know what is gong to work, and what won't, but that is just part of it.


BOB
-------------
MWF ADM/Owner


db

I've been on Neurontin for 3-4 years and can't imagine giving it up.  I've been on Cymbalta for about 2 weeks.  The dose I'm taking supposedly is too low to treat depression, 30 mg.  I was told to give it 3 weeks to see how it works.  So far the only downside I think it causes is if I don't take it in the morning it has made it harder to sleep.  For me, that's not a problem since I can't seem to stay up much past 8.  Also, I had a couple of glasses of wine this week-end and it hit me hard.  I guess I forgot I was on the stuff.

db,  :1115:

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