Magazin
2008-04-17
Ingelheim, Germany (ots/PRNewswire) -
- For Healthcare Media Outside the U.S.A.
- Studies Demonstrate Positive and Rapid Impact of Pramipexole onthe Core Symptoms of Restless Legs Syndrome and Sleep Disturbance
A new study has shown that pramipexole (Mirapexin(R)/Sifrol(R))can significantly reduce sleep disturbance, often the mosttroublesome symptom experienced by people with Restless Legs Syndrome(RLS).(1) The important finding, presented today at the 60th AnnualMeeting of the American Academy of Neurology (AAN) in Chicago,U.S.A., highlights the benefit of an RLS treatment which effectivelytargets the core symptoms of the condition, such as an uncontrollableurge to move the legs, as well as secondary symptoms including sleepdisturbance. For the many people affected by RLS, this means thatoverall sleep patterns and quality of life can be greatly improvedwith pramipexole - a fast-acting treatment which has been shown tobring relief already after one night.(2)
According to Professor Luigi Ferini-Strambi from the SleepDisorders Center, Università Vita-Salute, San Raffaele, Milan (Italy)and lead author of the study: "Most people with RLS who seek medicaladvice have often suffered for a long time from sleep deprivation dueto the debilitating impact of RLS. To feel the benefit of a simple,effective treatment right from the start, is a huge step forward forthese patients. Beyond enabling them to sit comfortably through anevening, they can look forward to a night of sleep without beingdisturbed by the uncontrollable urge to move their legs. For manypeople with RLS, this means that they can finally start regainingtheir quality of life."
In the study, a randomised, double blind and placebo controlledtrial in adults with scores >15 on the International RLS Study GroupRating Scale (IRLS) and symptoms at least 2-3 times per week,improvements were assessed based on the MOS* sleep scale. The studywas the first ever evaluating the effect of pramipexole on sleep,using a multi-dimensional patient-reported instrument. Sleepdisturbance scores for the patient group treated with pramipexolewere reduced from 52.5 to 27.8 after 12 weeks from baseline comparedto 55.6 to 38.5 in the placebo group (p=0.0001), i.e. the pramipexoletreated patient group reaching a near to normal level, and in someinstances already after the first night of treatment(2) (a score of24.5 is considered normal).(1)
Although worsening of symptoms at night is a hallmark of RLS,many people with RLS also experience bothersome symptoms during theday. Furthermore, daytime function is disrupted by somnolence due tosleep disturbance, further heightening the need for fast-actingtreatment options that effectively treat both the night and daytimesymptoms of the condition.
In a study assessing the rapid onset and sustained efficacy ofpramipexole, rapid symptom improvements were shown after the firstintake, reached their peak after four weeks and were maintainedthroughout the 12 week trial. Adjusted mean changes from baseline onIRLS were greater for pramipexole at all item points: day 9, day 14,week 4 and week 12 (p<0.0001 for all versus placebo). Patient GlobalImpression (PGI) responder rates were improved over placebo at day 1(16.4% vs 8%), day 5 (36.2% vs 15.2%), day 9 (44.1% vs 19.6%), day 14(53.1% vs 34.1%), week 4 (65.7% vs 39.7%) and week 12 (62.9% vs38%).(2)
The effect of pramipexole on daytime symptoms of RLS was shown inanother study. This study showed a median baseline of 4.0 in bothseverity of daytime symptoms at rest and daytime sleepiness, asmeasured with the RLS-6 scale (0 = none/not at all, 10 = verysevere). At week 12, the median reduction was - 2.0 (pramipexole)versus -1.0 (placebo) for daytime RLS severity (p = 0.0017) and -2.0versus -1.0 (p = 0.0024) for daytime sleepiness.(3)
Overall, the data presented at AAN reaffirm pramipexole as ahighly effective and fast-acting treatment for RLS, in many caseseven at the lowest dose and already after one night. Pramipexole notonly alleviates the very unpleasant and sometimes painful feelings inthe legs experienced by patients with RLS during periods of rest, butcan also improve daytime RLS symptoms.
Please be advised
This release is from Boehringer Ingelheim Corporate Headquartersin Germany. Please be aware that there may be national differencesbetween countries regarding specific medical information, includinglicensed uses. Please take account of this when referring to theinformation provided in this document. This press release is notintended for distribution within the U.S.A.
Notes to the Editor:
*Medical Outcomes Study (MOS) sleep scale
The MOS Sleep Scale is a self-administered scale measuringspecific aspects of sleep (problems with sleep disturbance[initiation and maintenance], adequacy, somnolence, quantity,respiratory impairments and snoring). It was designed for use inpatients who may have varying co-morbidities. The frequency withwhich each problem has been experienced during the previous fourweeks is rated on a 6-point scale ranging from 'none of the time' to'all of the time', except sleep quantity, which is reported in hours.All scores are transformed linearly to range from 0 to 100 with theexception of the sleep quantity subscale, which is scored in hours.Higher scores indicate more of the attribute implied by the scalename (e.g. more sleep disturbance, more adequate sleep, greater sleepquantity).
About Restless Legs Syndrome (RLS)
Restless Legs Syndrome is a neurological disorder characterisedby an uncontrollable urge to move the legs, usually accompanied byunpleasant and sometimes painful sensations in the legs. RestlessLegs Syndrome affects up to ten percent of the population worldwideaged between 30 and 79 years(4) and around one-third of sufferersexperience symptoms more than twice weekly causing moderate to severedistress.(5) The motor-restlessness worsens during the evening andnight causing difficulty initiating and maintaining sleep. The sleepdisruption can lead to excessive daytime sleepiness and compromisework performance. Restless Legs Syndrome also has considerable impacton social activities that require immobility.
About pramipexole
Pramipexole (known in Europe under the trade names Mirapexin(R)and Sifrol(R) and in the U.S.A. as Mirapex(R)) is a compound fromBoehringer Ingelheim research first approved in 1997 for thetreatment of the signs and symptoms of idiopathic Parkinson'sdisease, as monotherapy or in combination with levodopa. Pramipexolewas approved in 2006 for the symptomatic treatment of moderate tosevere idiopathic Restless Legs Syndrome (RLS). Pramipexole iscurrently registered in over 80 countries across the globe.
The most commonly reported adverse reactions in clinical trialsfor Restless Legs Syndrome were nausea, headache, dizziness andfatigue. The most commonly reported adverse reactions in early andlate Parkinson's disease in clinical trials were nausea, dyskinesia,hypotension, dizziness, somnolence, insomnia, constipation,hallucination, headache and fatigue.
Pramipexole may cause patients to fall asleep without anywarning, even while doing normal daily activities such as driving.When taking pramipexole hallucinations may occur and sometimespatients may feel dizzy, sweaty or nauseated upon standing up. Itshould be noted that impulse control disorders/compulsive behavioursmay occur while taking medicines to treat Parkinson's disease,including pramipexole.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leadingpharmaceutical companies. Headquartered in Ingelheim, Germany, itoperates globally with 135 affiliates in 47 countries and 39,800employees. Since it was founded in 1885, the family-owned company hasbeen committed to researching, developing, manufacturing andmarketing novel products of high therapeutic value for human andveterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of 10.9 billioneuro while spending one fifth of net sales in its largest businesssegment Prescription Medicines on research and development.
For more information please visithttp://www.boehringer-ingelheim.com.
References
1. Ferini-Strambi L et al. Pramipexole for Restless Legs Syndromeand associated sleep disturbance. Presented 16 April 2008, 60thAnnual Meeting of the American Academy of Neurology (AAN), Chicago(IL), U.S.A.; Poster # P05.172.
2. Ferini-Strambi L et al. Rapid onset and sustained efficacy ofpramipexole in Restless Legs Syndrome. Presented 16 April 2008, 60thAnnual Meeting of the American Academy of Neurology (AAN), Chicago(IL), U.S.A.; Poster # P05.164.
3. Partinen M et al. Effects of pramipexole on daytime symptomsof Restless Legs Syndrome. Presented 16 April 2008, 60th AnnualMeeting of the American Academy of Neurology (AAN), Chicago (IL),U.S.A.; Poster # P05.165.
4. Phillips B et al. Epidemiology of Restless Legs symptoms inadults. Arch Intern Med 2000; 160(14): 2137-2141.
5. Allen RP et al. Restless Legs Syndrome prevalence and impact:REST general population study. Arch Intern Med 2005; 165(11):1286-1292.
ots Originaltext: Boehringer IngelheimIm Internet recherchierbar: http://www.presseportal.de
Contact:Contact (Please direct all enquiries via email in the first instance): Ursula Bardon, Corporate Division Communications, Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, E-mail: press@boehringer-ingelheim.com, Phone: +49-6132-77-2622
New Data Confirm Pramipexole (Mirapexin(R)/Sifrol(R)) Can Significantly Reduce Sleep Disturbance for People With Restless Legs Syndrome (RLS)
- For Healthcare Media Outside the U.S.A.
- Studies Demonstrate Positive and Rapid Impact of Pramipexole onthe Core Symptoms of Restless Legs Syndrome and Sleep Disturbance
A new study has shown that pramipexole (Mirapexin(R)/Sifrol(R))can significantly reduce sleep disturbance, often the mosttroublesome symptom experienced by people with Restless Legs Syndrome(RLS).(1) The important finding, presented today at the 60th AnnualMeeting of the American Academy of Neurology (AAN) in Chicago,U.S.A., highlights the benefit of an RLS treatment which effectivelytargets the core symptoms of the condition, such as an uncontrollableurge to move the legs, as well as secondary symptoms including sleepdisturbance. For the many people affected by RLS, this means thatoverall sleep patterns and quality of life can be greatly improvedwith pramipexole - a fast-acting treatment which has been shown tobring relief already after one night.(2)
According to Professor Luigi Ferini-Strambi from the SleepDisorders Center, Università Vita-Salute, San Raffaele, Milan (Italy)and lead author of the study: "Most people with RLS who seek medicaladvice have often suffered for a long time from sleep deprivation dueto the debilitating impact of RLS. To feel the benefit of a simple,effective treatment right from the start, is a huge step forward forthese patients. Beyond enabling them to sit comfortably through anevening, they can look forward to a night of sleep without beingdisturbed by the uncontrollable urge to move their legs. For manypeople with RLS, this means that they can finally start regainingtheir quality of life."
In the study, a randomised, double blind and placebo controlledtrial in adults with scores >15 on the International RLS Study GroupRating Scale (IRLS) and symptoms at least 2-3 times per week,improvements were assessed based on the MOS* sleep scale. The studywas the first ever evaluating the effect of pramipexole on sleep,using a multi-dimensional patient-reported instrument. Sleepdisturbance scores for the patient group treated with pramipexolewere reduced from 52.5 to 27.8 after 12 weeks from baseline comparedto 55.6 to 38.5 in the placebo group (p=0.0001), i.e. the pramipexoletreated patient group reaching a near to normal level, and in someinstances already after the first night of treatment(2) (a score of24.5 is considered normal).(1)
Although worsening of symptoms at night is a hallmark of RLS,many people with RLS also experience bothersome symptoms during theday. Furthermore, daytime function is disrupted by somnolence due tosleep disturbance, further heightening the need for fast-actingtreatment options that effectively treat both the night and daytimesymptoms of the condition.
In a study assessing the rapid onset and sustained efficacy ofpramipexole, rapid symptom improvements were shown after the firstintake, reached their peak after four weeks and were maintainedthroughout the 12 week trial. Adjusted mean changes from baseline onIRLS were greater for pramipexole at all item points: day 9, day 14,week 4 and week 12 (p<0.0001 for all versus placebo). Patient GlobalImpression (PGI) responder rates were improved over placebo at day 1(16.4% vs 8%), day 5 (36.2% vs 15.2%), day 9 (44.1% vs 19.6%), day 14(53.1% vs 34.1%), week 4 (65.7% vs 39.7%) and week 12 (62.9% vs38%).(2)
The effect of pramipexole on daytime symptoms of RLS was shown inanother study. This study showed a median baseline of 4.0 in bothseverity of daytime symptoms at rest and daytime sleepiness, asmeasured with the RLS-6 scale (0 = none/not at all, 10 = verysevere). At week 12, the median reduction was - 2.0 (pramipexole)versus -1.0 (placebo) for daytime RLS severity (p = 0.0017) and -2.0versus -1.0 (p = 0.0024) for daytime sleepiness.(3)
Overall, the data presented at AAN reaffirm pramipexole as ahighly effective and fast-acting treatment for RLS, in many caseseven at the lowest dose and already after one night. Pramipexole notonly alleviates the very unpleasant and sometimes painful feelings inthe legs experienced by patients with RLS during periods of rest, butcan also improve daytime RLS symptoms.
Please be advised
This release is from Boehringer Ingelheim Corporate Headquartersin Germany. Please be aware that there may be national differencesbetween countries regarding specific medical information, includinglicensed uses. Please take account of this when referring to theinformation provided in this document. This press release is notintended for distribution within the U.S.A.
Notes to the Editor:
*Medical Outcomes Study (MOS) sleep scale
The MOS Sleep Scale is a self-administered scale measuringspecific aspects of sleep (problems with sleep disturbance[initiation and maintenance], adequacy, somnolence, quantity,respiratory impairments and snoring). It was designed for use inpatients who may have varying co-morbidities. The frequency withwhich each problem has been experienced during the previous fourweeks is rated on a 6-point scale ranging from 'none of the time' to'all of the time', except sleep quantity, which is reported in hours.All scores are transformed linearly to range from 0 to 100 with theexception of the sleep quantity subscale, which is scored in hours.Higher scores indicate more of the attribute implied by the scalename (e.g. more sleep disturbance, more adequate sleep, greater sleepquantity).
About Restless Legs Syndrome (RLS)
Restless Legs Syndrome is a neurological disorder characterisedby an uncontrollable urge to move the legs, usually accompanied byunpleasant and sometimes painful sensations in the legs. RestlessLegs Syndrome affects up to ten percent of the population worldwideaged between 30 and 79 years(4) and around one-third of sufferersexperience symptoms more than twice weekly causing moderate to severedistress.(5) The motor-restlessness worsens during the evening andnight causing difficulty initiating and maintaining sleep. The sleepdisruption can lead to excessive daytime sleepiness and compromisework performance. Restless Legs Syndrome also has considerable impacton social activities that require immobility.
About pramipexole
Pramipexole (known in Europe under the trade names Mirapexin(R)and Sifrol(R) and in the U.S.A. as Mirapex(R)) is a compound fromBoehringer Ingelheim research first approved in 1997 for thetreatment of the signs and symptoms of idiopathic Parkinson'sdisease, as monotherapy or in combination with levodopa. Pramipexolewas approved in 2006 for the symptomatic treatment of moderate tosevere idiopathic Restless Legs Syndrome (RLS). Pramipexole iscurrently registered in over 80 countries across the globe.
The most commonly reported adverse reactions in clinical trialsfor Restless Legs Syndrome were nausea, headache, dizziness andfatigue. The most commonly reported adverse reactions in early andlate Parkinson's disease in clinical trials were nausea, dyskinesia,hypotension, dizziness, somnolence, insomnia, constipation,hallucination, headache and fatigue.
Pramipexole may cause patients to fall asleep without anywarning, even while doing normal daily activities such as driving.When taking pramipexole hallucinations may occur and sometimespatients may feel dizzy, sweaty or nauseated upon standing up. Itshould be noted that impulse control disorders/compulsive behavioursmay occur while taking medicines to treat Parkinson's disease,including pramipexole.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leadingpharmaceutical companies. Headquartered in Ingelheim, Germany, itoperates globally with 135 affiliates in 47 countries and 39,800employees. Since it was founded in 1885, the family-owned company hasbeen committed to researching, developing, manufacturing andmarketing novel products of high therapeutic value for human andveterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of 10.9 billioneuro while spending one fifth of net sales in its largest businesssegment Prescription Medicines on research and development.
For more information please visithttp://www.boehringer-ingelheim.com.
References
1. Ferini-Strambi L et al. Pramipexole for Restless Legs Syndromeand associated sleep disturbance. Presented 16 April 2008, 60thAnnual Meeting of the American Academy of Neurology (AAN), Chicago(IL), U.S.A.; Poster # P05.172.
2. Ferini-Strambi L et al. Rapid onset and sustained efficacy ofpramipexole in Restless Legs Syndrome. Presented 16 April 2008, 60thAnnual Meeting of the American Academy of Neurology (AAN), Chicago(IL), U.S.A.; Poster # P05.164.
3. Partinen M et al. Effects of pramipexole on daytime symptomsof Restless Legs Syndrome. Presented 16 April 2008, 60th AnnualMeeting of the American Academy of Neurology (AAN), Chicago (IL),U.S.A.; Poster # P05.165.
4. Phillips B et al. Epidemiology of Restless Legs symptoms inadults. Arch Intern Med 2000; 160(14): 2137-2141.
5. Allen RP et al. Restless Legs Syndrome prevalence and impact:REST general population study. Arch Intern Med 2005; 165(11):1286-1292.
ots Originaltext: Boehringer IngelheimIm Internet recherchierbar: http://www.presseportal.de
Contact:Contact (Please direct all enquiries via email in the first instance): Ursula Bardon, Corporate Division Communications, Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, E-mail: press@boehringer-ingelheim.com, Phone: +49-6132-77-2622
Boehringer Ingelheim
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