Published Research - Pharmaceutical

[ViewsAskew]

Here is a new drug in the works that I haven't heard of before. It's still in the DA category, but the way it works is hoped to result in less side effect problems:

http://www.earthtimes.org/articles/show ... 6887.shtml

[ViewsAskew]

Well, when the doctors doing studies think things like this, we're in trouble. Thank goodness all researchers do not believe this:L

http://www.websciences.org/cftemplate/N ... D=20064310

Quote from the end of the abstract: "In practice, ropinirole has a negative risk-benefit balance in restless legs syndrome, which is a minor health disorder. "

Now, I might agree that Ropinerole may have more adverse consequences than the drug companies report. Since none of the studies was for longer than 3 months, and many of the severe side effects start after that, we do have a skewed view regarding safety. But, RLS as a minor health disorder???? According to those who don't have it? Bah.

[brandy]

Okay, I know I'm a minister and I'm not supposed to say things like this, but my first thought to your post, Ann, was, "Let's let a bucket of ants loose on the writers' legs and let's do it at night so the ants' biting will keep them awake. Let's do this every day for a month. And, for good measure, let's do it a few times each day, as well - just to make sure they aren't sneaking any naps or starting to relax. And let's require them to continue to live their daily lives - with school, work, family, church, etc. And, for good measure, let's throw in a long business trip in which we strap electrodes to their legs and buzz them throughout the entire travel time. At the end of that month we can talk about whether or not this is a minor health problem.
Sorry, my angry side just came out. It's people like that that make things so difficult for the rest of us.

[tazzer]

well brandy i will say it, they should be dipped in honey and strapped down to one our famous Texas Fire Ant mounds and leave em there. hmmmm it's only minor pain.! you twits! what do they know, they can't feel my legs, aaaaggghh biting my tongue now.



dee

[ctravel12]

Like I have said many many times. Until they walk in your shoes, they have no idea what you are going through. Some people can be so insensitive to others needs.

Brandy, your last sentence is so true.

[jan3213]

Like I have said many many times. Until they walk in your shoes, they have no idea what you are going through. Some people can be so insensitive to others needs.

Amen!!!!!!

Jan

[ViewsAskew]

This is an interesting study on a new antidepressant:

http://www.websciences.org/cftemplate/N ... D=20064378

Sounds like this works completely differently. It could be that it will be tolerated by those with RLS.

[becat]

Found this on the We Move site.

Subject: Announcement: Launch of IS IT RLS? Website

Date: 11/9/2006


WE MOVE is proud to announce the launch of “IS IT RLS?” (http://www.is-it-rls.org) an interactive assessment tool designed to aide physicians in determining if their patients have restless legs syndrome. An estimated thirty million Americans are affected by this movement disorder, which is characterized by the urge to move the legs and arms and can be accompanied by uncomfortable and unpleasant sensations. Despite the high prevalence of this condition, it can go undiagnosed and untreated for years, in part due to lack of awareness of RLS among physicians.

To improve diagnosis of RLS, The International RLS Study Group developed and published four essential diagnostic criteria for RLS in adults; members of the Study Group and other interested parties revised these criteria in 2002 at a workshop held at the National Institutes of Health. The WE MOVE “IS IT RLS?” assessment tool is based on these diagnostic criteria. “IS IT RLS?” is available online at www.is-it-rls.org

In addition to the assessment tool, the web site also provides a practical guide to diagnosis and management.

“IS IT RLS?” is funded by an unrestricted educational grant from Boehringer Ingelheim.
*****************************************************
This may already be here and I haven't read it, but yeah some help.

[ViewsAskew]

Another drug in the pipeline! This makes at least five, maybe more. And, at least two are completely new drugs.

http://www.conntact.com/article_page.lasso?id=40528
Content reprinted below in case the link fails:
BRANFORD - For the first time, Neurogen Corp. has bought the rights to a drug developed by another company. Neurogen announced last month that it would pay an initial licensing fee of $3 million to Wyeth Pharmaceuticals for worldwide development and commercialization rights to a new drug, Aplindore, that Neurogen believes may treat Parkinson's disease and restless legs syndrome (RLS). The license covers worldwide development and commercialization rights for the compound. In addition, Wyeth would receive milestone payments and royalties on the resulting product if it reaches the marketplace.

Wyeth, headquartered in Madison, N.J., created and tested Aplindore for the treatment of schizophrenia, but trials showed it was not efficacious for that malady. Wyeth scientists believe Aplindore may prove effective against Parkinson's and RLS, but the company decided to license out the drug rather than develop it further, partly because those markets are much smaller than the market for schizophrenia treatments.

Neurogen expects to start Phase II trials in Parkinson's disease and RLS with Aplindore next year. Wyeth already completed Phase I testing.

Neurogen has two additional drugs in Phase II trials as well as one in Phase I trials. The company is developing treatments for insomnia, pain, depression and obesity.

[ViewsAskew]

Here is some new research about Mirapex. This was a great study - six whole months! This is much longer than many of them have been. In it, almost 70% felt that they RLS was greatly improved. So, more evidence that the DAs do work quite well for a goodly amount of the population:

http://allergy-articles.blogspot.com/20 ... inger.html

New data presented today show patients taking pramipexole (Mirapexin®/ Sifrol®) can experience significant improvements in a broad range of symptoms associated with Restless Legs Syndrome (RLS).1 In an additional study presented today, pramipexole was also shown to be well tolerated in RLS patients affected by concomitant diseases, which are commonly experienced in this patient group.2 The results of the studies were presented at the 10th International Congress of Parkinson's Disease and Movement Disorders (MDS) in Kyoto, Japan.

In all studies presented, patients taking pramipexole rated clinically meaningful improvements to their night and day-time symptoms, as measured on the International Restless Legs Scale (IRLS). The IRLS measures several aspects of the condition, ranging from discomfort, the need to move around, and relief by moving around, to specific RLS symptoms such as sleep disturbance, day-time tiredness, mood disorder, as well as addressing overall severity, weekly frequency, daily severity, and impact on daily activities.1

"Patients with Restless Legs Syndrome need treatment that will help to improve all of their symptoms in the night and day-time. The new evidence presented today gives both clinicians and patients the confidence that pramipexole can be used to address the key aspects of this chronic condition," said Professor John W. Winkelman, MD, PhD, Medical Director of the Sleep Health Centre of Brigham and Women's Hospital, Boston, Massachusetts/USA and Harvard Medical School.

IRLS data were pooled from a total of 564 pramipexole recipients and 220 placebo recipients, all of whom had participated in one of three placebo-controlled double-blind randomised trials of pramipexole in RLS. Pramipexole improved symptoms across all IRLS subscores (range 0 to 4 points), versus placebo. The mean improvement in the pramipexole arm ranged from 0.9 points for 'impact on daily activities' and 1.0 for 'mood disturbance' to 1.8 points for 'need to move due to discomfort'.1 These results, confirmed by patients themselves, reinforce the overall benefits of pramipexole.

Broad range of patients

According to another study presented today at MDS, RLS patients with concomitant diseases, or who are taking additional therapies, benefited from treatment with pramipexole.2 It is very common for RLS patients to suffer from additional conditions, including seasonal allergy, hypertension and gastroesophageal reflux.2 Furthermore, patients frequently take medication for other conditions, including analgesics, anti-inflammatory and anti-rheumatic drugs, and agents affecting cardiovascular function.2

Results from a 12-week randomised, double-blind, placebo-controlled trial show that even with the high frequencies of concomitant diagnoses and therapies, pramipexole was associated with a significant 12-week reduction of IRLS by an adjusted mean of -13.5, compared with -9.3 for placebo (P<0.0001) .2 Therefore, patients with concomitant diseases or who are taking additional therapies can be effectively treated with pramipexole for their RLS symptoms.

"When you consider RLS is a chronic condition for which patients may need to take treatment over a long period of time, it is crucial that we explore how a drug clinically interacts with other treatments," Dr Winkelman added. "The data presented today add to our extensive knowledge on the safety of pramipexole and provide us with the reassurance that it can be used in the broadest range of patients."

Sustained symptom relief

The advantages of using pramipexole over an extended length of time were also demonstrated by data from three trials presented today at MDS.3,4,5 The results demonstrate that, over a 6-month period, pramipexole showed a substantial improvement in symptoms of RLS compared to placebo. This improvement was judged by both patients and their treating clinicians using specific RLS rating tools. Across all three trials at least 67 percent of patients judged themselves to be much better, or very much better, after completing 6 months of therapy.3,4,5 Additionally, clinicians rated improvements between 12.5 points3 and 16.9 points5 on the IRLS scale.

The data presented at MDS demonstrate that pramipexole addresses the broad range of RLS symptoms, can provide significant benefits to patients with RLS and comorbid conditions, and can also offer sustained relief from this chronic condition.

About Restless Legs Syndrome (RLS)

Restless Legs Syndrome is a neurological disorder characterised by an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs. Restless Legs Syndrome affects up to ten percent of the population worldwide aged between 30 and 79 years6 and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress7. The motor-restlessness worsens during the evening and night causing difficulty initiating and maintaining sleep. The sleep disruption can lead to excessive daytime sleepiness and compromise work performance. Restless Legs Syndrome also has considerable impact on social activities that require immobility.

About pramipexole

Pramipexole (known in Europe under the trade names Sifrol® and Mirapexin® and in the U.S.A. as Mirapex®) is a compound from Boehringer Ingelheim research first licenced in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s Disease, as monotherapy or in combination with levodopa. Pramipexole was licenced in April 2006 throughout the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) and is also licenced in Australia, Brazil, Canada, Mexico and others.

The most commonly reported adverse reactions in early and late Parkinson's disease in clinical trials were dizziness, involuntary movement, postural hypotension, constipation, hallucinations, headache, difficulty falling asleep, sleepiness, nausea and fatigue. The most commonly reported adverse reactions in clinical trials for Restless Legs Syndrome were nausea, headache, and tiredness.

Pramipexole may cause patients to fall asleep without any warning, even while doing normal daily activities such as driving. When taking pramipexole hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. It should be noted that impulse control disorders/compulsive behaviours may occur while taking medicines to treat Parkinson`s disease, including pramipexole.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.

References:

1 -- Winkelman JW et al. Pramipexole improves a broad range of facets of restless legs syndrome. Abstract #P374. Presented at MDS 2006, Kyoto, Japan.

2 -- Winkelman JW et al. Pramipexole is not affected by therapy for concomitant disease in patients with restless legs syndrome. Abstract #P400. Presented at MDS 2006, Kyoto, Japan.

3 -- Oertel WH et al. Six-month efficacy of pramipexole for restless legs syndrome: results from a 20-week extension of a 6-week study. Abstract #P405. Presented at MDS 2006, Kyoto, Japan.

4 -- Kupsch A., et al. Six-month efficacy of pramipexole in restless legs syndrome: results from a run-in phase for a 12-week study. Abstract #P373. Presented at MDS 2006, Kyoto, Japan.

5 -- Partinen M., et al. Sustained efficacy of pramipexole in restless legs syndrome: results from a 6-month extension of a 3-week trial. Abstract #P390. Presented at MDS 2006, Kyoto, Japan.

6 -- Phillips B et al. Epidemiology of restless legs symptoms in adults. Arch Intern Med 2000; 160(14): 2137-2141.

7 -- Allen RP, Walters AS, Montplaisir J, Hening W, Myers A, Bell TJ, et al. Restless Legs Syndrome prevalence and impact: REST general population study. Arch Intern Med 2005; 165: 1286-1292.

Boehringer Ingelheim

[ViewsAskew]

Interesting results regarind SSRIs:

http://www.websciences.org/cftemplate/N ... D=20065262


(copied below in case the link ceases to work in the future)

OBJECTIVE: The objective of this case report is to create awareness on restless legs syndrome (RLS) among clinicians working in emergency units. METHOD: We describe a case reporting important aggravation of RLS associated with citalopram, 60 mg/day, in a 48-year-old woman who was sent to the emergency unit by her general practitioner. Citalopram was replaced by bupropion, 150 mg/day, and sertraline, 50 mg/day. RESULTS: Three days later, symptoms of RLS started to diminish and, after 3 weeks, clinical symptoms had disappeared entirely. On 6-month follow-up, the patient did not manifest clinically significant RLS. Ignoring RLS could lead to a worsening of symptoms and could increase the risk for iatrogenic conditions. The prevalence of RLS in the general population is 3-9%; nevertheless, this syndrome is frequently underdiagnosed. CONCLUSION: This case report suggests that RLS could be considered as a possible "dopamine-dependent side effect" of selective serotonin reuptake inhibitors (SSRIs). Bupropion could potentially "correct" dopaminergic dysfunction in RLS, and sertraline appears to be the SSRI that provides the least risk of RLS by blocking dopamine reuptake.

[Neco]

2 days on that stuff and I couldn't go to the bathroom for a long, LONG time

[SquirmingSusan]

Thank you Ann! I'm printing that out and taking it to the new doctor tomorrow. I was going to ask about combining Welbutrin with an SSRI, and this is just the information I need.

Susan

[ViewsAskew]

Well, here's one that isn't good if your RLS is untreated. They seem to confuse RLS and PLMD in the article, but that seems more common lately.

http://news.sky.com/skynews/article/0,, ... 75,00.html

Reprinted below in case the link fails at some point:

People with a problem that causes fidgety legs could be at greater risk of heart disease, a study has shown.

Restless leg syndrome (RLS) is a neurological disorder that produces a strong urge to move the legs.

It tends to be accompanied by a feeling of tingling or "crawling" under the skin.

Researchers found that RLS leg movements could push up blood pressure to potentially dangerous levels, especially in the elderly.

Periodic leg movements are typically most severe at night, when they can occur every 20 to 40 seconds.

For the study, scientists monitored their leg movements and blood pressure of 10 people with untreated RLS.

During periodic leg movements, systolic blood pressure rose by an average of 20 points and diastolic pressure by 11 points.

The first reading measures blood pressure with each beat of the heart. The second shows the pressure between beats.

Researcher Dr Paola Lanfranchi, from the University of Montreal, Canada, said: "The repetitive rise in blood pressure during periodic leg movements could be harmful to the cardiovascular system.

"Past studies have shown that significant blood pressure changes, as shown in our study, are associated with the development of vascular and heart damage."

The doctor added that "drastic blood pressure" surges at night have been associated with a higher rate of strokes in the elderly.

[ViewsAskew]

Well, a second study that confirms augmentation with tramadol. . .

Link To PubMed Abstract

Here is the text in case the link fails to work in some way at some time:

Restless legs syndrome (RLS) augmentation, defined as a kind of suppression of the circadian rhythm of the disease in which sensory and motor symptoms appear earlier during the day (and over previously unaffected body parts), with a progressive phase advance until, backwards, the symptoms may cover the entire day, has been described only after treatment with dopaminergic drugs. We report clinical and polysomnographic accounts of a patient developing RLS augmentation after long-term treatment with tramadol, an opioid agonist with selectivity for mu-receptor and added norepinephrine and serotonin reuptake inhibition properties. Polysomnographic measures showed an improvement of RLS and a disappearance of diurnal sensory and motor RLS symptoms after tramadol was stopped. Our case confirms a recent retrospective report of augmentation of RLS after treatment with tramadol, and begs the question whether augmentation is truly restricted to dopaminergic drugs.