No announcement yet.

Restless Leg Syndrome drug, REQUIP®, approved by FDA

  • Filter
  • Time
  • Show
Clear All
new posts

    Restless Leg Syndrome drug, REQUIP®, approved by FDA

    Restless Leg Syndrome drug, REQUIP®, approved by FDA

    07 May 2005

    The US FDA has approved Requip® (ropinirole HCl) Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults, GlaxoSmithKline announced today. Requip is the first and only FDA-approved treatment for those patients with moderate-to-severe primary RLS, a chronic and disruptive neurological condition.

    RLS, which encompasses a range of severity that includes mild, moderate and severe symptoms, affects approximately one in ten adults in the U.S. Identified in the early 1940's by neurologist Dr. Karl Ekbom, RLS is characterized by a compelling urge to move the legs and by uncomfortable or sometimes painful sensations in the legs often described as creeping-crawling, tingling, pulling or tightening.

    Symptoms of RLS generally occur at rest, such as when sitting, lying or sleeping, and are temporarily relieved by movement. These symptoms can significantly disrupt a patient's sleep and daily activities.

    People with RLS often have difficulty falling and staying asleep and can feel less alert during the day. Requip is a second-generation dopamine agonist that directly stimulates dopamine receptors in the brain. Although its exact cause is unknown, researchers believe that the underlying cause of RLS may be related to dopamine, a chemical that carries the signals between nerve cells that control body movement. When the dopamine system does not function properly, it may upset the normal communication of these signals.


    The approval of Requip for moderate-to-severe primary Restless Legs Syndrome is supported by data from four double-blind, randomized, placebo-controlled clinical trials in adults diagnosed with RLS. Patients with RLS secondary to other conditions (e.g. iron deficiency, pregnancy and renal failure) were excluded from the study groups. "One of the principal benefits of treatment with Requip is relief of the urge to move the legs," said Dr. William Ondo, Associate Professor of Neurology at Baylor College of Medicine, Houston, Texas. "Requip targets what doctors believe may be an underlying cause of the disorder, which is dysfunction of a system involving the brain chemical dopamine. Now there is an approved treatment specifically for moderate-to-severe primary RLS which should help to validate this under-recognized and misunderstood condition."

    In the most recently completed U.S. trial, Requip significantly improved symptoms of moderate-to-severe primary RLS in patients from baseline to week 12, according to two validated measurement tools: the International RLS Rating Scale (IRLS Scale) and Clinical Global Impression-Global Improvement (CGI-I) scale. Patients taking Requip achieved a significantly greater mean improvement in IRLS Rating Scale total score compared to the placebo group (-13.5 points versus -9.8 points, respectively; p<0.0001) and significantly more patients taking Requip showed a "much improved" or "very much improved" score on the CGI-I scale compared with the placebo group (73.3 percent versus 56.5 percent, respectively; p=0.0006). In two other similarly designed trials that took place in centers largely outside of the U.S., Requip also significantly improved IRLS Rating Scale and CGI-I scale scores from baseline to week 12. Long-term maintenance of efficacy in the treatment of RLS was demonstrated in a 36-week relapse prevention study.

    In this trial, patients taking Requip demonstrated a significantly lower relapse rate compared with patients randomized to placebo (32.6 percent vs. 57.8 percent, p=0.0156). In clinical trials in the treatment of moderate-to-severe primary RLS, the most commonly observed adverse events for Requip (n=496) versus placebo (n=500) were nausea (40 percent versus 8 percent), somnolence (12 percent versus 6 percent), vomiting (11 percent versus 2 percent) ,dizziness (11 percent versus 5 percent) and fatigue (8 percent versus 4 percent). Occurrences of nausea in clinical trials were generally mild to moderate in intensity. About RLS In general, many people with RLS report a significant impact on their daily activities. In addition to feeling less alert during the day, RLS sufferers may also have difficulty with activities that require prolonged sitting such as movies, long car rides or airline flights. Difficulty falling asleep may frequently be associated with moderate-to-severe primary RLS.

    Women account for approximately two-thirds of RLS sufferers, although RLS occurs in both men and women. RLS is generally a chronic condition, and the frequency of RLS symptoms tends to increase with age. In addition, a genetic component has been suggested for patients with primary RLS. Clinical data demonstrate a positive family history of the disorder in as many as 50 percent of affected individuals. When evaluating patients' symptoms of RLS, it is important for health care providers to rule out other underlying conditions that are associated with secondary RLS symptoms, such as iron deficiency, pregnancy and renal failure. Despite the prevalence of RLS, it frequently remains under-diagnosed. A wide range of other diagnoses, including back pain, depression, arthritis, nocturnal cramps, insomnia and neuropathy have been given to patients who present with symptoms of RLS.


    Wise, can you paraphrase
    what might be the implications for SCI?

    And the truth shall set you free.


      Restless leg syndrome sometimes occur in people with spinal cord injury.

      Mello MT, Silva AC, Rueda AD, Poyares D and Tufik S (1997). Correlation between K complex, periodic leg movements (PLM), and myoclonus during sleep in paraplegic adults before and after an acute physical activity. Spinal Cord 35: 248-52. K complex is the characteristic wave of stage II of sleep. The relationship between periodic limb movements (PLM) and the restless legs syndrome (RLS), and the incidence of K complexes and alpha activity has been previously described. The aim of the present study was to evaluate the effect of an acute physical activity upon K complex, PLM, and myoclonus during sleep in individuals who were paraplegic. We evaluated 84 polysomnograms from 28 volunteers with a spinal cord injury at the level of T7-T12, obtained during three consecutive nights. On day 3, the volunteers were submitted to a test of maximum effort (manual cycloergometer, with the equipment Cybex Met 300, with a progressive load increase of 12.5 w, every 2 min). The analysis of the polysomnographic recordings showed a positive correlation between the incidence of K complex and limb movements on nights 1, 2 and 3. Similarly, a correlation between the incidence of K complex and myoclonus was observed on nights 1, 2 and 3. An increased incidence of the total K complex was seen on night 3, 36 h after the test maximum effort. Both total K complex and K complex/h were reduced on night 2, compared to basal recording (night 1). There was a reduction of sleep latency on night 2, whereas total sleeping time increased progressively on night 3, as well as REM phase on nights 2 and 3. These findings indicate that physical activity can effect or modulate the incidence of K complex and suggest that a positive correlation between PLM and K complex may occur in those who are paraplegic from a spinal cord injury. In conclusion, sleep can be consolidated after physical activity. UNIFESP-EPM, Department of Psychobiology, Universidade Federal de Goias-Catalac, Brazil.

      de Mello MT, Lauro FA, Silva AC and Tufik S (1996). Incidence of periodic leg movements and of the restless legs syndrome during sleep following acute physical activity in spinal cord injury subjects. Spinal Cord 34: 294-6. The purpose of the present study was to evaluate sleep patterns and complaints, and Periodic Limb Movement (PLM) and the Restless Legs Syndrome (RLS) in subjects with complete spinal cord injury. Volunteers were submitted to two polysomnograms (Oxford Medilog SAC system--EEG, EMG, EOC): (1) basal night, when the volunteer arrived at the Sleep Center, and (2) after a maximal physical test (Cybex Met 300/increase of 12.5 watts/2 min until exhaustion). Eleven volunteers with complete spinal cord injury between T7-T12 were evaluated. Data were analyzed by the paired Student's test (total sleeping time) and by the Wilcoxon matched paired test (change of sleep states, number of awakenings during sleep, latency to REM sleep and leg movements--PLM + RLS). Comparison of sleep recordings from the night before with that from the night after (12 h) practice of physical activity, showed a significant reduction in all of the sleep parameters. The results indicate that physical activity improves the sleep patterns of spinal cord injured volunteers. In particular, we noticed that PLM and RLS after physical activity were inhibited during sleep. Department of Psychobiology--UNIFESP, Escola Paulista de Medicina, Sao Paulo, Brazil.


        Dr Young
        I have or had restless leg syndrome. I was taking Mirapex to help me sleep. When my legs bothered me, I would have to get up and walk around. My Dr. told me that because of my SCI I would have to worry about RLS. I am L1 T12 incomplete. What do you think?



          Yes, you may have restless leg syndrome.