Pharma Sticky

Use this section to discuss your experiences with prescription drugs, iron injections, and other medical interventions that involve the introduction of a drug or medicine into the body. Discuss side effects, successes, failures, published research, information about drug trials, and information about new medications being developed.

Important: Posts and information in this section are based on personal experiences and recommendations; they should not be considered a substitute for the advice of a healthcare provider.
ViewsAskew
Moderator
Posts: 14889
Joined: Thu Oct 28, 2004 6:37 am
Location: Chicago

Postby ViewsAskew » Thu Mar 06, 2008 7:23 am

I found this related to augmentation. It was published last year, Sleep Med. 2007 Oct 5

Background and purpose: Augmentation is a major problem with dopaminergic therapy for restless legs syndrome (RLS), and predictors of augmentation have not yet been identified. We aimed to analyze the relationship between baseline ferritin level and occurrence of augmentation in a retrospective analysis of a prospective double-blind trial of cabergoline versus levodopa on augmentation in RLS. Patients and methods: Patients who experienced augmentation were compared to patients who did not experience augmentation. Results: Augmentation symptoms causing premature discontinuation from the study or which were tolerated (n=36, ferritin: 85+59ng/ml) were associated with lower levels of serum ferritin compared to patients without augmentation (n=302, ferritin: 118+108ng/ml, p=0.0062). Conclusions: Ferritin as a marker of iron storage may play an important role in the pathophysiology of RLS and may prove to be a biomarker for the development of augmentation under dopaminergic therapy
Ann - Take what you need, leave the rest

Managing Your RLS

Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

User avatar
SquirmingSusan
Posts: 2975
Joined: Sun Nov 12, 2006 4:08 am
Location: Minnesota
Contact:

Antidepressants and RLS

Postby SquirmingSusan » Thu Feb 18, 2010 4:09 pm

Regarding antidepressants and RLS. In online support groups, we tend to more often hear the horror stories about how these medications have worsened someone's RLS. There are individual case studies and lots of anecdotal evidence that this can happen, but there is no need for panic in relation to those medications. Someone just posted on a public RLS Facebook page that “in 98 percent of people SSRIs make their RLS go crazy.” This is just not true and inspired me to seek out and post links to what few studies are out there on the subject, and helpful information.

Basically, SSRIs may worsen RLS in a small percentage of people, and they may help in an even smaller percentage of people. Tricyclics have been linked in case reports to worsened PLMs and PLMD; but not to worsened RLS. (At least that's how I'm reading this information.) Unfortunately, lots of medical practitioners confuse the two disorders and will call PLMD RLS. They are separate, but often related disorders. Obviously anything can happen with meds, so if a particular medication makes your RLS worse, talk to your doctor. Depression is serious, and can often be treated without aggravating your RLS.

http://tinyurl.com/rls-andantidepressants (Modern SSRIs, reboxetine, and mirtazepine and their correlation to worsened RLS. SSRIs caused worsening in 5 to 10% of patients; mirtazepine in 28% of patients, and reboxetine caused no worsening of RLS.)

http://www.journals.elsevierhealth.com/ ... 7/abstract (Although there are anecdotal reports of antidepressant use causing or exacerbating RLS, systematic study of this issue fails to corroborate an association.")

There is a good brochure put out by the RLS Foundation on depression and RLS. It is here: http://www.rls.org/Document.Doc?&id=75

Finally, quoteing Dr. Buchfuhrer at www.rlshelp.org, in regards to treating RLS with antidepressants: "This class of medications should be used with caution in RLS patients. Antidepressants can worsen RLS symptoms more often than help them. As depression is a common problem, especially in patients with severe and persistent RLS problems, antidepressants are often prescribed for RLS patients. RLS patients who are put on antidepressants and notice worsening of their symptoms should inform their physician of this problem immediately."
Susan

User avatar
Hos
Voice Chat Host
Posts: 383
Joined: Fri Oct 27, 2006 9:43 pm
Location: Alvarado, TX
Contact:

Re: Pharma Sticky

Postby Hos » Sun Jun 24, 2012 9:13 pm

Thanks once again Susan and Ann!
I'm doing ok, I refuse to be labeled as my diagnoses' add up, lol. I'm Hos, darn it! (I think I can say that)
Peace to you all tonight and every night.
I'm calling my pdoc tomorrow and see if he'll give me some samples of stuff and thank God for Netflix if (or when) some of these meds don't work and I have a severe RLS attack! Ugh. Oh well, take care,

ViewsAskew
Moderator
Posts: 14889
Joined: Thu Oct 28, 2004 6:37 am
Location: Chicago

Re: Pharma Sticky

Postby ViewsAskew » Tue Jul 23, 2013 2:47 pm

http://www.sacbee.com/2013/07/22/558576 ... s-for.html

Evidence Based Guidelines For Long-Term Management Of Restless Legs Syndrome / Willis-Ekbom Disease Expands Choices For Initial Treatment
By International RLS Study Group Foundation
Published: Monday, Jul. 22, 2013 - 8:38 am

ROCHESTER, Minn., July 22, 2013 -- /PRNewswire-USNewswire/ -- Restless Legs Syndrome or Willis-Ekbom disease (RLS/WED) is a chronic neurological disorder that can affect anyone—from any age, sex, or race. People with RLS/WED experience strong urges to move their legs often with strange disagreeable leg sensations. This gets worse when at rest, like when going to sleep at night, watching television or taking a long car ride. Because the symptoms usually intensify in the evening, they often interfere with the ability to sleep. Moderate to severe RLS patients cannot sleep for more than 5 to 5.5 hours each night and often rather than sleeping end up having to walk around to reduce the feelings in their legs.

Managing Long-Term Treatment

While there is currently no cure for (RLS/WED), there is effective treatment. The International Restless Legs Syndrome Study Group Foundation (IRLSSG) has published a report of long-term management of RLS/WED using evidence-based guidelines and clinical consensus. The report discusses consensus-based strategies for the prevention and treatment of complications, such as augmentation, loss of efficacy, excessive daytime sleepiness, and impulse control disorders that may develop within long-term pharmacologic treatment of RLS/WED.

IRLSSG president Dr. Diego Garcia-Borreguero states, "After 2 years of reviewing 61 peer journals and discussion among international experts, our report provides light on two important questions patients of RLS/WED have been asking for years. What is the efficacy of my treatment? And, what is the safety of this treatment? Our report, published in Sleep Medicine's July 2013 issue, provides the first comprehensive review of long-term treatment options for RLS/WED patients."

One major finding of the report is recommended expansion of first line treatment of RLS/WED for most patients. The use of either a dopamine-receptor agonist or alpha 2 delta calcium-channel ligand is recommended as the first-line treatment on an individual basis considering long term treatment complications.

For more information on treatment guidelines—and a full copy of the IRLSSG's report titled "The long-term treatment of restless legs syndrome/Willis–Ekbom disease: evidence-based guidelines and clinical consensus best practice guidance: a report from the International Restless Legs Syndrome Study Group" paper— visit www.irlssg.org.

SOURCE International RLS Study Group Foundation

And, here is a link to the page with the Summary Guidelines: http://irlssg.org/summary/

And, to the whole article: http://www.sleep-journal.com/article/S1 ... 6/abstract
Ann - Take what you need, leave the rest



Managing Your RLS



Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

User avatar
Hos
Voice Chat Host
Posts: 383
Joined: Fri Oct 27, 2006 9:43 pm
Location: Alvarado, TX
Contact:

Re: Pharma Sticky

Postby Hos » Tue Jul 23, 2013 2:54 pm

Great article. Nice to see a simple and accurate approach to WED.

ViewsAskew
Moderator
Posts: 14889
Joined: Thu Oct 28, 2004 6:37 am
Location: Chicago

Opioid Research!!!!! We NEED this!

Postby ViewsAskew » Mon Sep 30, 2013 10:02 am

http://www.medpagetoday.com/MeetingCoverage/WCN/41941

ublished: Sep 29, 2013
By Cole Petrochko, Staff Writer, MedPage Today
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco
save
|
A
A
Action Points

This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Long-acting oxycodone treatment with naloxone was effective at reducing RLS symptom severity among patients not effectively managed on other treatments.
Note that the effects of opioid therapy continued over the long-term without withdrawal or addiction event.

VIENNA -- Treatment with long-acting oxycodone and naloxone in fixed combination was effective at reducing restless legs syndrome (RLS) symptom severity among patients not effectively managed on other treatments, researchers reported here.

Compared with placebo at week 12, combination oxycodone and naloxone treatment offered significant improvement in International RLS Study Group Rating Scale scores by 8.15 points (95% CI 5.46-10.85, P<0.001), according to Claudia Trenkwalder, MD, of the Center of Parkinsonism and Movement Disorders in Kassel, Germany, and colleagues.

The effects of opioid therapy "were observed within week 1 and continued over the long-term" without withdrawal or addiction events, Trenkwalder said at an oral presentation during the World Congress of Neurology.

Opioid treatment has been used as an off-label treatment for mild to severe RLS symptoms "through interacting with dopamine on a spinal level and acting on the medial pain system centrally for analgesia," she said, noting that they added naloxone to the therapy to aid with opioid-related constipation.

The authors looked at efficacy of opioid treatment on severe RLS symptoms in patients who were not improved by other treatment versus placebo, as well as quality of life outcomes and adverse events related to treatment, in a population of 278 participants.

All participants were 18 or older and met the following criteria:

RLS symptoms for 6 months or more
Symptom onset during the day at least 4 days a week before 6 p.m.
International RLS Group Rating Scale symptom score of 15 or more at baseline
RLS Diagnostic Index score of 11 or more

In addition to the diagnostic index score, patients also had at least one of a positive family history for RLS, had objective findings of periodic limb movements on polysomnography or actigraphy, or had no unusual findings in neurological examination.

After a 7-day washout period, participants were randomized to oxycodone/naloxone or placebo over a 12-week double-blind study, followed by a 40-week open-label extension period. During the 12-week period, mean oxycodone dose was 21.9 mg daily, and 18.1 mg daily over the 40-week extension. The extension period included 197 participants.

In addition to improvements in rating scale scores, adverse events between groups did not significantly differ, with the exception of scores in constipation. In both the 12-week study and 40-week extension, the proportion of patients who experienced constipation were significantly larger (17.3% and 15.7% versus 4.5%).

Quality of life as measured through CGI-2 scores significantly favored oxycodone treatment versus placebo (67% versus 35%, P<0.001), as did score for International RLS Study Group Rating Scale scores for responders (57% versus 31%, P<0.001) and remitters (42% versus 19%, P<0.001).

Among secondary endpoints, which included RLS-6 scores, sleep, and pain scores, only RLS-6 scale scores showed significant improvement from baseline to week 12 and from baseline to week 40 in the extension trial among all patients, with a greater effect size seen in those who received opioids.

Trenkwalder reported relationships with Vifor, UCB, Mundipharma, Britannia, Novartis, Boehringer Ingelheim, GlaxoSmithKline, TEVA, and Destin.
Ann - Take what you need, leave the rest



Managing Your RLS



Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

cornelia

Re: Pharma Sticky

Postby cornelia » Mon Sep 30, 2013 12:36 pm

Thanks for posting this.

I question the Naloxone addition. Dr Walters has written that N, being an opiate blocker, has shown that it worsens RLS symptoms. The researchers have added it to help with constipation side effects. So, if they had done this study withou adding N would the result have been better I wonder?

Corrie

ViewsAskew
Moderator
Posts: 14889
Joined: Thu Oct 28, 2004 6:37 am
Location: Chicago

Re: Pharma Sticky

Postby ViewsAskew » Mon Sep 30, 2013 10:36 pm

cornelia wrote:Thanks for posting this.

I question the Naloxone addition. Dr Walters has written that N, being an opiate blocker, has shown that it worsens RLS symptoms. The researchers have added it to help with constipation side effects. So, if they had done this study without adding N would the result have been better I wonder?

Corrie


It just makes sense that Naloxone wouldn't help. And, lots of other ways to help with constipation, aren't there???? Hmmmm.
Ann - Take what you need, leave the rest



Managing Your RLS



Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

QyX
Posts: 316
Joined: Wed Mar 13, 2013 12:53 pm
Location: Berlin / Germany

Re: Pharma Sticky

Postby QyX » Sat Mar 01, 2014 3:33 am

Hey!

The Naloxone doesn't cross the blood-brain barrier! The amount of Naloxone is so low that it is completely inactivated by the liver. The Naloxone only works in the bowel and avoids constipation by antagonizing the effects of opioids.

I was taking a fixed combination of Oxycodone/Naloxone for a while and it was the best solution I had for constipation ever. Also the Naloxone wasn't worsening my WED, simply because the amount of Naloxone in the pills is so low that it is inactivated in the liver and therefore can't reach the brain.

The liver can inactivate around 40 mg of Naloxone per 24 hours. If you take more Naloxone you risk that Naloxone reaches the brain and antagonizes the effects of the opioid.

badnights
Moderator
Posts: 4569
Joined: Tue Mar 10, 2009 4:20 pm
Location: Northwest Territories, Canada

Re: Pharma Sticky

Postby badnights » Sat Mar 08, 2014 6:48 am

.. The Naloxone only works in the bowel and avoids constipation by antagonizing the effects of opioids.
... the amount of Naloxone in the pills is so low that it is inactivated in the liver and therefore can't reach the brain.

The liver can inactivate around 40 mg of Naloxone per 24 hours. If you take more Naloxone you risk that Naloxone reaches the brain and antagonizes the effects of the opioid.
Finally, an explanation! Thanks! I was puzzled by this apparent paradox.
Beth - Wishing you all restful sleep tonight
WED/RLS AUGMENTATION:
viewtopic.php?f=5&t=6532&p=61601#p61601
Discussion Board Moderator's posts don't reflect the RLS Foundation's opinion & are not medical advice

ViewsAskew
Moderator
Posts: 14889
Joined: Thu Oct 28, 2004 6:37 am
Location: Chicago

Re: Pharma Sticky

Postby ViewsAskew » Mon Mar 10, 2014 6:34 pm

Here is the latest article (Thanks, Steve), about pramipexole compared to pregabalin. To me, this is one more study that suggests we should consider the alpha 2 delta ligands to be our first choice if we choose/need pharma therapy.

http://www.nejm.org/doi/full/10.1056/NEJMoa1303646

We can't post the whole study, but here is a preview and the results from it, included in case the link breaks.
Comparison of Pregabalin with Pramipexole for Restless Legs Syndrome

Richard P. Allen, Ph.D., Crystal Chen, M.D., Diego Garcia-Borreguero, M.D., Ph.D., Olli Polo, M.D., Sarah DuBrava, M.S., Jeffrey Miceli, Ph.D., Lloyd Knapp, Pharm.D., and John W. Winkelman, M.D., Ph.D.

N Engl J Med 2014; 370:621-631February 13, 2014DOI: 10.1056/NEJMoa1303646
Share:

Background
Dopaminergic medications relieve symptoms of the restless legs syndrome (RLS) but have the potential to cause iatrogenic worsening (augmentation) of RLS with long-term treatment. Pregabalin may be an effective alternative.

Methods
In this 52-week, randomized, double-blind trial, we assessed efficacy and augmentation in patients with RLS who were treated with pregabalin as compared with placebo and pramipexole. Patients were randomly assigned to receive 52 weeks of treatment with pregabalin at a dose of 300 mg per day or pramipexole at a dose of 0.25 mg or 0.5 mg per day or 12 weeks of placebo followed by 40 weeks of randomly assigned active treatment. The primary analyses involved a comparison of pregabalin and placebo over a period of 12 weeks with use of the International RLS (IRLS) Study Group Rating Scale (on which the score ranges from 0 to 40, with a higher score indicating more severe symptoms), the Clinical Global Impression of Improvement scale (which was used to assess the proportion of patients with symptoms that were “very much improved” or “much improved”), and a comparison of rates of augmentation with pregabalin and pramipexole over a period of 40 or 52 weeks of treatment.

Results
A total of 719 participants received daily treatment, 182 with 300 mg of pregabalin, 178 with 0.25 mg of pramipexole, 180 with 0.5 mg of pramipexole, and 179 with placebo. Over a period of 12 weeks, the improvement (reduction) in mean scores on the IRLS scale was greater, by 4.5 points, among participants receiving pregabalin than among those receiving placebo (P<0.001), and the proportion of patients with symptoms that were very much improved or much improved was also greater with pregabalin than with placebo (71.4% vs. 46.8%, P<0.001). The rate of augmentation over a period of 40 or 52 weeks was significantly lower with pregabalin than with pramipexole at a dose of 0.5 mg (2.1% vs. 7.7%, P=0.001) but not at a dose of 0.25 mg (2.1% vs. 5.3%, P=0.08). There were six cases of suicidal ideation in the group receiving pregabalin, three in the group receiving 0.25 mg of pramipexole, and two in the group receiving 0.5 mg of pramipexole.

Conclusions
Pregabalin provided significantly improved treatment outcomes as compared with placebo, and augmentation rates were significantly lower with pregabalin than with 0.5 mg of pramipexole. (Funded by Pfizer; ClinicalTrials.gov number, NCT00806026.)

Supported by Pfizer.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

We thank the study centers, investigators, and patients who participated in this study and Joshua Fink, Ph.D., Engage Scientific Solutions, for providing medical writing support (funded by Pfizer).
Source Information

From the Department of Neurology, Johns Hopkins University, Baltimore (R.P.A.); Pfizer Global Research and Development, Groton, CT (C.C., S.D., J.M., L.K.); Sleep Research Institute, Madrid (D.G.-B.); the Department of Pulmonary Medicine, Tampere University Hospital, Tampere, Finland (O.P.); and Massachusetts General Hospital, Boston (J.W.W.).

Address reprint requests to Dr. Allen at the Department of Neurology, Johns Hopkins University, 5501 Hopkins Bayview Cir., Baltimore, MD 21224, or at richardjhu@mac.com.
Ann - Take what you need, leave the rest



Managing Your RLS



Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

ViewsAskew
Moderator
Posts: 14889
Joined: Thu Oct 28, 2004 6:37 am
Location: Chicago

Re: Pharma Sticky

Postby ViewsAskew » Sat Oct 25, 2014 11:50 pm

For those in Europe:

http://www.businesswire.com/news/home/2 ... Ew2gMmPfwo

Mundipharma receives Positive CHMP Opinion for Targin® (oxycodone / naloxone) for the treatment of Restless Legs Syndrome

Basically, this is the first, to my knowledge, decision by a country or continent's drug advisory group saying that opioids are OK to use for WED/RLS.
Ann - Take what you need, leave the rest



Managing Your RLS



Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

cornelia

Re: Pharma Sticky

Postby cornelia » Sun Oct 26, 2014 11:17 am

That's it a very good thing. The research was done by Claudia Trenkwalder from Germany. She is well-known in the world of RLS, in the league of Allen and Early and others.

Corrie

Polar Bear
Moderator
Posts: 6885
Joined: Tue Dec 26, 2006 4:34 pm
Location: N. Ireland

Re: Pharma Sticky

Postby Polar Bear » Sun Oct 26, 2014 2:28 pm

Good news.
Betty
http://www.willis-ekbom.org/about-rls-wed/publications
Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation

ViewsAskew
Moderator
Posts: 14889
Joined: Thu Oct 28, 2004 6:37 am
Location: Chicago

Benzos and dementia

Postby ViewsAskew » Wed Nov 19, 2014 1:14 am

While many of us agree that the benzos do not often help WED, they do help us sleep and we often want/need that.

Here is a study from Harvard that makes a connection to dementia and the use of benzos.

http://www.health.harvard.edu/blog/benz ... 1409107397
Ann - Take what you need, leave the rest



Managing Your RLS



Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.


Return to “Prescription Medications”

Who is online

Users browsing this forum: No registered users and 3 guests