Navigation Links
Rotigotine Skin Patch May Ease Restless Legs Symptoms
Date:5/30/2008

But one expert notes problems with manufacturing, unreliable delivery of the drug

FRIDAY, May 30 (HealthDay News) -- Skin patches that contain the drug rotigotine help relieve restless legs syndrome (RLS), according to a German study.

Dopaminergic drugs -- which stimulate the body's dopamine system -- are currently used as a first-line treatment for RLS, and rotigotine is already used to treat Parkinson's disease. This study of 458 people with moderate to severe RLS examined the efficacy of rotigotine skin patches.

The patients were randomly assigned to apply skin patches with 1 milligrams of rotigotine (115 patients), 2 milligrams (112), or 3 milligrams (114) once a day for six months. A fourth group of 117 patients received a placebo.

The patients were assessed using the International Restless Leg Syndrome study group severity rating scale (IRLS) and the clinical global impressions (CGI) item 1 score, which measures severity of symptoms. At the start of the study, the patients' average IRLS score was 28.1, and their average CGI item 1 score was four or more.

At the end of the study, mean changes in IRLS score were: -13.7 in the 1 mg group; -16.2 in the 2 mg group; -16.8 in the 3 mg group; and -8.6 in the placebo group. Changes in the CGI item 1 score were: -2.09 in the 1 mg group; -2.41 in the 2 mg group; -2.55 in the 3 mg group; and -1.34 in the placebo group.

Of the 341 patients who used the rotigotine skin patches, 145 (43 percent) experienced skin reactions (mostly mild or moderate), compared to two of 117 (2 percent) of those who received the placebo.

Ten patients suffered serious side effects related to rotigotine: elevation of liver enzymes (1 patient); worsening of tinnitus (1); non-response to anticoagulation (1); electrocardiogram changes (1); and skin patch application site reactions (6). All the skin reactions resolved within a short time after the patch was removed.

"The results of this 6-month trial indicate that transdermal delivery of low doses of rotigotine for 24 h per day are more effective than placebo at relieving symptoms of RLS in patients who are moderately to severely affected. This trial, together with a pilot study and dose-finding trial, suggest that, despite differences in treatment duration and other design features, there exists a clear therapeutic window in terms of dose of rotigotine to treat restless legs syndrome between 1 mg over 24 h to 3 mg over 24 h," the study authors wrote.

The study was published online in The Lancet Neurology and was expected to be in the July print issue of the journal.

"The introduction of a patch with a constant delivery of a dopamine agonist is a welcome addition to the armamentarium. Unfortunately, the rotigotine patch has been temporarily withdrawn from the U.S. market because of problems with manufacturing and the unreliable delivery of the drug," Dr. Kapil Sethi, of the Medical College of Georgia, wrote in an accompanying commentary.

"RLS causes significant discomfort and adversely affects the quality of life of patients. Whether it has more ominous consequences is unclear. A recent study showed that RLS is associated with a greater risk of cardiovascular disease, particularly in patients with greater frequency or severity of RLS symptoms. Whether treatment of RLS will reduce this risk is unknown, and further studies should help answer this question," Sethi wrote.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about restless legs syndrome.



-- Robert Preidt



SOURCE: The Lancet Neurology, news release, May 31, 2008


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Patch Form of HRT Poses Less Clotting Risks Than Pill Does
2. The First QPatch HT in China Placed in WuXi PharmaTech (NYSE: WX)
3. Iomai Wins Department of Defense Grant to Develop a Stable, Patch-Based Anthrax Vaccine
4. Study Finds Single Dose of Iomai Patch With Pandemic Flu Vaccine Achieves Protective Levels
5. Mylan Confirms Its Matrix Design Fentanyl Patch Is Not Included In the Widespread Recall Announced February 12th
6. PriCara(TM) Recalls 25 mcg/hr DURAGESIC(R) (fentanyl transdermal system) CII Pain Patches
7. Iomai Study Shows Self-Applied Travelers Diarrhea Vaccine Patch Comparable to Clinician-Applied Vaccine Patch
8. Ringing endorsement: Women prefer contraceptive ring over patch
9. FDA Warns Clot Risk Higher in Birth Control Patch Than Pill
10. FDA Renews Warnings on Pain-Relief Patch
11. Studies of 20,000 smokers show quit rates double with counseling and free nicotine patches
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... ... ... Controlling and maintaining the home’s water heater just got infinitely easier, more ... Controller , a first-of-its-kind system that enables remote and convenient control of a water ... for HVAC systems, Aquanta gives users a much more efficient, versatile way to use ...
(Date:5/24/2016)... Forest Lake, Minnesota (PRWEB) , ... May 24, ... ... his 13th mission trip to the Dominican Republic on September 21, 2016. Dr. ... Biology from Northwestern, serves with ChiroMission, a not-for-profit organization promoting health and wellness ...
(Date:5/24/2016)... , ... May 24, 2016 , ... ... , Out patient Services To Begin In June , Aloria Health, specializing in ... announce the opening of Aloria Milwaukee, its first treatment facility for outpatient, day ...
(Date:5/24/2016)... ... 2016 , ... "ProText Layouts Vol. 3 is a plugin that will keep ... Studios. , ProText Layouts Vol. 3 is a set of 30 self-animating kinetic text ... Layouts, video editors can create an lively typography video with incredible ease. Utilize intuitive ...
(Date:5/24/2016)... ... May 24, 2016 , ... The old expression “a ... problem. A common injury that’s often misunderstood, whiplash should be swiftly diagnosed and treated ... orthopedic spine surgeon at Atlantic Spine Center . , So named because ...
Breaking Medicine News(10 mins):
(Date:5/23/2016)... , May 23, 2016 ... for detection of multiple diseases; ,Technology to be presented ... Yissum Research Development Company of the Hebrew ... into a research agreement with Aurum Ventures MKI, the technology ... development of a new diagnostic approach for early detection ...
(Date:5/23/2016)... , May 23, 2016   Purdue Pharma ... into an agreement with Egalet Corporation and Acura ... As part of the agreement the companies will ... enable all three companies to develop and sell ... "This agreement reflects the commitment of Purdue ...
(Date:5/20/2016)... -- - Revenue Forecasts And R&D ... Recombinant Coagulation Factors and Regenerative Medicine ... Reveals Selling Opportunities and Revenue Prospects to Help ... the future of biologics, especially new drug classes? ... Staying ahead in data and knowledge, you benefit ...
Breaking Medicine Technology: