Re: Parkinson's Drug Reduces Fibromyalgia Pain - CME Teaching Brief - MedPage Today

[Guest guest]

I have been on Mirapex for over 6 months now and I do

think it has helped me with the fibro..........and

fatigue.........I only take it at night and it does

help me sleep.......the adverse affect of weight loss

is defintely not one that I had...............IF

ONLY!!!

Pat in so Ore.

--- a <a54@...> wrote:

> Parkinson's Drug Reduces Fibromyalgia Pain

>

>

> By Neil Osterweil, Senior Associate Editor, MedPage

> Today

> Reviewed by Jasmer, MD; Assistant Professor

> of Medicine,

> University of California, San Francisco

> July 28, 2005

>

> MedPage Today Action Points

>

> * Inform patients that in this small, short

> duration study, Mirapex

> was associated with a greater degree of pain relief

> than placebo.

>

> * Understand that Mirapex is approved by the

> FDA only for the

> treatment of idiopathic Parkinson's disease.

>

> * Be aware that in this study, subjects were

> allowed to continue on

> their existing medications, which could have altered

> the results.

>

> * Be aware that the lead author of the study

> holds patents on the

> use of this category of medication in the treatment

> of fibromyalgia.

>

> Review

> RENTON, Wash. July 28-The Parkinson's disease drug

> Mirapex

> (pramipexole) reduced pain and fatigue and improved

> function in some

> patients with fibromyalgia in a small study,

> reported investigators in

> a private rheumatology practice here.

>

> In a randomized trial comparing Mirapex with placebo

> in 49 patients

> with fibromyalgia, patients who received Mirapex

> experienced gradual

> and more significant improvements in measures of

> pain, fatigue,

> function, and global status than patients on

> placebo, according to

> J. Holman, M.D., and Robin R. Myers, M.S., of

> Pacific

> Rheumatology Associates here.

>

> Their findings were published in the August issue of

> Arthritis &

> Rheumatism.

>

> Recent research suggests that pain associated with

> fibromyalgia may be

> caused by abnormal sensory processing in the central

> nervous system.

> Mirapex, a dopamine receptor agonist with particular

> affinity for the

> dopamine3 receptor agonist, could theoretically

> mitigate symptoms of

> fibromyalgia through its effects on dopamine

> stimulation.

>

> Dr. Holman holds a U.S. patent for the use of

> dopamine2 and dopamine3

> receptor agonists in the treatment of fibromyalgia.

> Mirapex is

> indicated by the FDA only for treatment of

> idiopathic Parkinson's

> disease.

>

> Based on observations of Mirapex's efficacy in

> treating fibromyalgia in

> open-label studies, and for the treatment of

> restless leg syndrome

> (which is more common in patients with fibromyalgia

> than in healthy

> controls) in placebo-controlled trials, the

> investigators designed the

> randomized study.

>

> In this placebo-controlled, parallel group,

> dose-escalation trial, 60

> patients were randomly assigned on a 2:1 basis to

> either Mirapex or

> placebo, respectively. Patients given the active

> drug were started at a

> dose of 0.25 mg at bedtime the first week, with the

> dose increasing by

> 0.25 mg/day weekly, to a maximum dose of 4.5 mg/day

> at weeks 12, 13 and

> 14. The dose was then tapered to 0 over week 15.

> Evaluations were

> conducted every two weeks, with the final evaluation

> at week 15.

>

> Exclusion criteria included uncontrolled thyroid

> disease, substance

> abuse, sleep apnea, and cervical myelopathy or

> severe cervical pain on

> extension, among others.

>

> Participants who were on a stable dose of

> concomitant medications such

> as analgesics for at least six weeks prior to study

> entry were allowed

> to continue on those medications during the study,

> but patients who

> started new medications during the study period were

> dropped. In all,

> 49 of 60 patients completed the study, which

> included an

> intent-to-treat analysis.

>

> Concomitant medications included narcotics,

> antiepileptics, NSAIDs,

> antidepressants, SSRIs, anxiolytics, muscle

> relaxants, and hypnotics.

>

> Both placebo-treated and Mirapex-treated patients

> reported significant

> decreases in pain, but the decrease was

> significantly greater among

> patients treated with the active drug. At 14 weeks

> the decrease in pain

> as measured by the pain score on the visual analog

> scale (VAS) was 36%

> among Mirapex-treated patients, and 9% among those

> on placebo. In the

> active drug group, 42% reported a decrease in pain

> of at least 50%,

> compared with 14% of the placebo group.

>

> A post hoc analysis of VAS pain scores showed that

> 82% of patients

> taking Mirapex noted some improvement compared with

> 57% of those taking

> placebo (P =0.04).

>

> Mirapex also appeared to have the edge over placebo

> in secondary

> measures of efficacy, including the Fibromyalgia

> Impact Questionnaire

> score, pain improvement scale, Multidimensional

> Health Assessment

> Questionnaire, VAS fatigue, and VAS global scores.

>

> The most common adverse events in patients taking

> Mirapex were weight

> loss and nausea; patients on placebo also reported

> nausea, possibly due

> to the influence of potentially suggestive language

> on the consent

> form, the authors speculated.

>

> Patients taking Mirapex did not report

> hallucinations or sleep attacks

> that are commonly seen in those taking the drug for

> Parkinson's

> disease.

>

> The authors acknowledged that the study results are

> limited by the

> concomitant use of other medications and by the

> short duration.

>

> " Finally, it should be noted that some exclusion

> criteria in this study

> were particularly important, " the authors wrote.

> " Both positional

> cervical myelopathy and untreated obstructive sleep

> apnea are potent

> adrenergic arousals that commonly contribute to

> autonomic

> dysregulation. Both conditions limit the efficacy

> and tolerability of a

> D3 agonist when used to treat fibromyalgia. Given

> the significant

> prevalence of cervical pain and obstructive sleep

> apnea in patients

> with fibromyalgia, many may not respond to treatment

> with pramipexole. "

>

> Primary source: Arthritis & Rheumatism

> Source reference:

> Arthritis & Rheumatism 2005;52;2495-2505

>

>

http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/tb1/1441

>

>

____________________________________________________

Start your day with - make it your home page

http://www./r/hs

[Guest guest]

I have been on Mirapex for over 6 months now and I do

think it has helped me with the fibro..........and

fatigue.........I only take it at night and it does

help me sleep.......the adverse affect of weight loss

is defintely not one that I had...............IF

ONLY!!!

Pat in so Ore.

--- a <a54@...> wrote:

> Parkinson's Drug Reduces Fibromyalgia Pain

>

>

> By Neil Osterweil, Senior Associate Editor, MedPage

> Today

> Reviewed by Jasmer, MD; Assistant Professor

> of Medicine,

> University of California, San Francisco

> July 28, 2005

>

> MedPage Today Action Points

>

> * Inform patients that in this small, short

> duration study, Mirapex

> was associated with a greater degree of pain relief

> than placebo.

>

> * Understand that Mirapex is approved by the

> FDA only for the

> treatment of idiopathic Parkinson's disease.

>

> * Be aware that in this study, subjects were

> allowed to continue on

> their existing medications, which could have altered

> the results.

>

> * Be aware that the lead author of the study

> holds patents on the

> use of this category of medication in the treatment

> of fibromyalgia.

>

> Review

> RENTON, Wash. July 28-The Parkinson's disease drug

> Mirapex

> (pramipexole) reduced pain and fatigue and improved

> function in some

> patients with fibromyalgia in a small study,

> reported investigators in

> a private rheumatology practice here.

>

> In a randomized trial comparing Mirapex with placebo

> in 49 patients

> with fibromyalgia, patients who received Mirapex

> experienced gradual

> and more significant improvements in measures of

> pain, fatigue,

> function, and global status than patients on

> placebo, according to

> J. Holman, M.D., and Robin R. Myers, M.S., of

> Pacific

> Rheumatology Associates here.

>

> Their findings were published in the August issue of

> Arthritis &

> Rheumatism.

>

> Recent research suggests that pain associated with

> fibromyalgia may be

> caused by abnormal sensory processing in the central

> nervous system.

> Mirapex, a dopamine receptor agonist with particular

> affinity for the

> dopamine3 receptor agonist, could theoretically

> mitigate symptoms of

> fibromyalgia through its effects on dopamine

> stimulation.

>

> Dr. Holman holds a U.S. patent for the use of

> dopamine2 and dopamine3

> receptor agonists in the treatment of fibromyalgia.

> Mirapex is

> indicated by the FDA only for treatment of

> idiopathic Parkinson's

> disease.

>

> Based on observations of Mirapex's efficacy in

> treating fibromyalgia in

> open-label studies, and for the treatment of

> restless leg syndrome

> (which is more common in patients with fibromyalgia

> than in healthy

> controls) in placebo-controlled trials, the

> investigators designed the

> randomized study.

>

> In this placebo-controlled, parallel group,

> dose-escalation trial, 60

> patients were randomly assigned on a 2:1 basis to

> either Mirapex or

> placebo, respectively. Patients given the active

> drug were started at a

> dose of 0.25 mg at bedtime the first week, with the

> dose increasing by

> 0.25 mg/day weekly, to a maximum dose of 4.5 mg/day

> at weeks 12, 13 and

> 14. The dose was then tapered to 0 over week 15.

> Evaluations were

> conducted every two weeks, with the final evaluation

> at week 15.

>

> Exclusion criteria included uncontrolled thyroid

> disease, substance

> abuse, sleep apnea, and cervical myelopathy or

> severe cervical pain on

> extension, among others.

>

> Participants who were on a stable dose of

> concomitant medications such

> as analgesics for at least six weeks prior to study

> entry were allowed

> to continue on those medications during the study,

> but patients who

> started new medications during the study period were

> dropped. In all,

> 49 of 60 patients completed the study, which

> included an

> intent-to-treat analysis.

>

> Concomitant medications included narcotics,

> antiepileptics, NSAIDs,

> antidepressants, SSRIs, anxiolytics, muscle

> relaxants, and hypnotics.

>

> Both placebo-treated and Mirapex-treated patients

> reported significant

> decreases in pain, but the decrease was

> significantly greater among

> patients treated with the active drug. At 14 weeks

> the decrease in pain

> as measured by the pain score on the visual analog

> scale (VAS) was 36%

> among Mirapex-treated patients, and 9% among those

> on placebo. In the

> active drug group, 42% reported a decrease in pain

> of at least 50%,

> compared with 14% of the placebo group.

>

> A post hoc analysis of VAS pain scores showed that

> 82% of patients

> taking Mirapex noted some improvement compared with

> 57% of those taking

> placebo (P =0.04).

>

> Mirapex also appeared to have the edge over placebo

> in secondary

> measures of efficacy, including the Fibromyalgia

> Impact Questionnaire

> score, pain improvement scale, Multidimensional

> Health Assessment

> Questionnaire, VAS fatigue, and VAS global scores.

>

> The most common adverse events in patients taking

> Mirapex were weight

> loss and nausea; patients on placebo also reported

> nausea, possibly due

> to the influence of potentially suggestive language

> on the consent

> form, the authors speculated.

>

> Patients taking Mirapex did not report

> hallucinations or sleep attacks

> that are commonly seen in those taking the drug for

> Parkinson's

> disease.

>

> The authors acknowledged that the study results are

> limited by the

> concomitant use of other medications and by the

> short duration.

>

> " Finally, it should be noted that some exclusion

> criteria in this study

> were particularly important, " the authors wrote.

> " Both positional

> cervical myelopathy and untreated obstructive sleep

> apnea are potent

> adrenergic arousals that commonly contribute to

> autonomic

> dysregulation. Both conditions limit the efficacy

> and tolerability of a

> D3 agonist when used to treat fibromyalgia. Given

> the significant

> prevalence of cervical pain and obstructive sleep

> apnea in patients

> with fibromyalgia, many may not respond to treatment

> with pramipexole. "

>

> Primary source: Arthritis & Rheumatism

> Source reference:

> Arthritis & Rheumatism 2005;52;2495-2505

>

>

http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/tb1/1441

>

>

____________________________________________________

Start your day with - make it your home page

http://www./r/hs