Published Research - Pharmaceutical

[cornelia]

I wonder if this lowering of blood pressure is different from the shorter acting DA's? Do these meds not act in the same way?

Corrie

[ViewsAskew]

I wonder if this lowering of blood pressure is different from the shorter acting DA's? Do these meds not act in the same way?

Corrie

Interesting question. I do not know.

[badnights]

This study finds that rotigotine/Neupro patch has a low risk of augmentation (5 people out of 185) over a one-year period. They call this "long term"; be aware that in this case, it means one year. If anyone knows of any longer-term studies that address the issue of augmentation on the rotigotine patch, please post.

Studies of pramipexole and ropinirole that lasted 2-3 years showed augmentation rates of 20-25%; but longer-term studies show that 75% of people augment after 8-10(?) years (I forget exactly).


Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome.
Yuichi Inoue; Koichi Hirata; Kenichi Hayashida; Nobutaka Hattori; Takayuki Tomida; Diego Garcia-Borreguero;
Prog. Neuropsychopharmacol. Biol. Psychiatry 40, 326 (2013)
Department of Somnology, Tokyo Medical University, 6-1-1 Shinjuku, Tokyo 160-8402, Japan. inoue@somnology.com
Abstract
The present study aimed to examine the long-term efficacy and safety of rotigotine treatment for restless legs syndrome (RLS), as well as the rate of clinically significant augmentation, in a 1-year open-label study of Japanese subjects. Japanese patients with RLS who had been treated with rotigotine or placebo in a double-blind trial were enrolled in a 1-year, open-label, uncontrolled extension study and treated with rotigotine at a dose of up to 3 mg/24 h after an 8-week titration phase. Outcomes included International Restless Legs Syndrome Study Group rating scale (IRLS scale), Pittsburgh Sleep Quality Index (PSQI), safety, and investigator-/expert panel-assessed augmentation (including Augmentation Severity Rating Scale). Overall, 185 patients entered the open-label study and 133 completed the study. IRLS and PSQI total scores improved throughout the 52-week treatment period (IRLS, from 23.2±5.1 to 7.8±7.6 and PSQI, from 8.0±3.1 to 5.0±2.9). Treatment-emergent adverse events were mild to moderate in severity, and included application site reactions (52.4%) and nausea (28.6%). Clinically significant augmentation occurred in five patients (2.7%). These results indicate a good long-term efficacy of rotigotine for treating RLS, with a relatively low risk of clinically significant augmentation.

[ViewsAskew]

New Study Shows Lyrica Is Effective

http://www.nlm.nih.gov/medlineplus/news ... 44576.html

But, here's what I found most interesting about the story. They compared Lyrica (pregabalin) to Mirapex (pramipexole) in this study. Here is a quote from it regarding that, "Moreover, over 40 or 52 weeks of treatment, significantly fewer patients taking Lyrica saw their condition worsen compared to those taking Mirapex (2 percent versus nearly 8 percent), the authors noted."

AH! So, in this study, in one year or less, they saw 8% of people with augmentation with pramipexole. So, when we say it can happen fast, it really can. For any doctor who thinks augmentation takes a lot of time, they need to see this result.

BUT - why the worsening with pregabalin? Maybe because it wasn't working? It shouldn't cause augmentation....that's a brain teaser.

[cornelia]

I don't know but my gut feeling is that Lyrica just doesn't work a long time for RLS. It's only a gut feeling, but I really think Pramipexol can work much longer than Lyrica if you don't have to deal with augmentation of course. Never seen a patient on long term Lyrica (and it has been on the market for several years) and enough patients seen long term on Pramipexol: I know a few personally.

Corrie

[cornelia]

Beth, there is a 5 year study done on Rotigotine and this is said about augmentation:

The 5-year incidence of augmentation with rotigotine was consistent with that observed in a previous 6-month, placebo-controlled study on rotigotine and is far lower than the incidences of augmentation observed in shorter studies with other dopamine agonists," he told Medscape Medical News. "Augmentation led to discontinuation in only 4% of patients. The incidence of augmentation with rotigotine may be even lower when low doses are used."

This is a comment from dr García Borreguero on the augmentation issue in this study.

Corrie

[ViewsAskew]

I don't know but my gut feeling is that Lyrica just doesn't work a long time for RLS. It's only a gut feeling, but I really think Pramipexol can work much longer than Lyrica if you don't have to deal with augmentation of course. Never seen a patient on long term Lyrica (and it has been on the market for several years) and enough patients seen long term on Pramipexol: I know a few personally.

Corrie

A few of us here have commented on that with gabapentin. I don't remember the exact details of how I used it - I think I used it with another drug at the time. I just remember that it helped, then it didn't and I increased it. Again, it helped, but then it stopped. But, for me, it stopped quickly - like in a week or so. I remember SquirmingSusan saying the same thing and am thinking I've heard it from someone else.

[badnights]

I don't know but my gut feeling is that Lyrica just doesn't work a long time for RLS.

If you look at my topic somewhere else, no one has posted back that they successfully use nothing but an anti-convulsant to treat their WED. Maybe they're not on this forum because they're so happy! The anti-convulsants weren't very effective for me. the main effect was a dulling of the nasty sensations, but I still had that urge to move.

AH! So, in this study, in one year or less, they saw 8% of people with augmentation with pramipexole. So, when we say it can happen fast, it really can. For any doctor who thinks augmentation takes a lot of time, they need to see this result.

BUT - why the worsening with pregabalin? Maybe because it wasn't working? It shouldn't cause augmentation....that's a brain teaser.

Maybe it was just natural progression? But I for one will not be surprised if they finally realize that anti-convulsants can cause augmentation.

Beth, there is a 5 year study done on Rotigotine....The 5-year incidence of augmentation with rotigotine was consistent with that observed in a previous 6-month, placebo-controlled study on rotigotine and is far lower than the incidences of augmentation observed in shorter studies with other dopamine agonists

Thanks corrie! this is good information for us to have.

[cornelia]

I guess that for people who augmented before on a short working DA the augmentation rate will be higher. At least I gathered that from posts from dr B.

Corrie

[badnights]

New Study Shows Lyrica Is Effective

http://www.nlm.nih.gov/medlineplus/news ... 44576.html
.......

BUT - why the worsening with pregabalin? Maybe because it wasn't working? It shouldn't cause augmentation....that's a brain teaser.

chipmunk has posted a different summary of the same research at viewtopic.php?f=4&t=8499&p=73161#p73161
In that summary, they state clearly that the 1-2% who worsened on Lyrica is consistent with expected natural progression.

[ViewsAskew]

Good to know. Thanks, Beth.

[crl363]

I have the article on the Comparison of Pregabalin with Pramipexole. I’m just not sure how and where to post it.

Bob

[Polar Bear]

Bob...go ahead and post it here. It can be moved to a stickie later, if appropriate.
As to how.... can you copy and paste it.
Or, copy and paste the link.

[crl363]

Hi Polar Bear.

I have the article in pdf. The full article is not available online so I can’t insert the link. I can copy and paste it but its 11 pages. Not sure how to post the pdf. Do you want me to email the pdf to you as an attachment?

Bob

[Polar Bear]

Bob - I will PM you.