Transdermal rotigotine for the perioperative management of restless legs syndrome

Birgit Högl, Wolfgang H Oertel, Erwin Schollmayer, Lars Bauer, Birgit Högl, Wolfgang H Oertel, Erwin Schollmayer, Lars Bauer

Abstract

Background: Immobilisation, blood loss, sleep deficiency, and (concomitant) medications during perioperative periods might lead to acute exacerbation of symptoms in patients with the restless legs syndrome (RLS). Continuous transdermal delivery of the dopamine agonist rotigotine provides stable plasma levels over 24 h and may provide RLS patients with a feasible treatment option for perioperative situations. To assess the feasibility of use of rotigotine transdermal patch for the perioperative management of moderate to severe RLS, long-term data of an open-label extension of a rotigotine dose-finding study were retrospectively reviewed.

Methods: The data of all 295 patients who had entered the 5-year study were screened independently by two reviewers for the occurrence of surgical interventions during the study period. The following data were included in this post-hoc analysis: patient age, sex, surgical intervention and outcome, duration of hospital stay, rotigotine maintenance dose at the time of surgery, rotigotine dose adjustment, and continuation/discontinuation of rotigotine treatment. All parameters were analysed descriptively. No pre-specified efficacy assessments (e.g. IRLS scores) were available for the perioperative period.

Results: During the study period, 61 surgical interventions were reported for 52 patients (median age, 63 years; 67% female); the majority of patients (85%) had one surgical intervention. The mean rotigotine maintenance dose at time of surgery was 3.1 ± 1.1 mg/24 h. For most interventions (95%), rotigotine dosing regimens were maintained during the perioperative period. Administration was temporarily suspended in one patient and permanently discontinued in another two. The majority (96%) of the patients undergoing surgery remained in the study following the perioperative period and 30 of these patients (61%) completed the 5-year study.

Conclusions: Although the data were obtained from a study which was not designed to assess rotigotine use in the perioperative setting, this post-hoc analysis suggests that treatment with rotigotine transdermal patch can be maintained during the perioperative period in the majority of patients and may allow for uninterrupted alleviation of RLS symptoms.

Trial registration: The 5-year rotigotine extension study is registered with ClinicalTrials.gov, identifier NCT00498186.

Figures

Figure 1
Figure 1
Design of the 5-year open-label extension study with rotigotine transdermal patch in restless legs syndrome (adapted from Oertel et al. [[19,21]]). Patients completing the double-blind study had the option of long-term treatment with their optimal dose of transdermal rotigotine (0.5-4 mg/24 h) in the open-label extension.
Figure 2
Figure 2
Reported outcome of surgical interventions.

References

    1. Ohayon MM, O’Hara R, Vitiello MV. Epidemiology of restless legs syndrome: a synthesis of the literature. Sleep Med Rev. 2012;16:283–295. doi: 10.1016/j.smrv.2011.05.002.
    1. Reinhold T, Müller-Riemenschneider F, Willich SN, Brüggenjürgen B. Economic and human costs of restless legs syndrome. Pharmacoeconomics. 2009;27:267–279. doi: 10.2165/00019053-200927040-00001.
    1. Dodel R, Happe S, Peglau I, Mayer G, Wasem J, Reese JP, Giani G, Geraedts M, Trenkwalder C, Oertel WH, Stiasny-Kolster K. Health economic burden of patients with restless legs syndrome in a German ambulatory setting. Pharmacoeconomics. 2010;28:381–393. doi: 10.2165/11531030-000000000-00000.
    1. García-Borreguero D, Stillman P, Beneš H, Buschmann H, Chaudhuri KR, Gonzalez Rodríguez VM, Högl B, Kohnen R, Monti GC, Stiasny-Kolster K, Trenkwalder C, Williams A-M, Zucconi M. Algorithms for the diagnosis and treatment of restless legs syndrome in primary care. BMC Neurol. 2011;11:28. doi: 10.1186/1471-2377-11-28.
    1. Trenkwalder C, Paulus W. Restless legs syndrome: pathophysiology, clinical presentation and management. Nat Rev Neurol. 2010;6:337–346. doi: 10.1038/nrneurol.2010.55.
    1. Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisir J. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med. 2003;4:101–119. doi: 10.1016/S1389-9457(03)00010-8.
    1. Michaud M, Lavigne G, Desautels A, Poirier G, Montplaisir J. Effects of immobility on sensory and motor symptoms of restless legs syndrome. Mov Disord. 2002;17:112–115. doi: 10.1002/mds.10004.
    1. Högl B, Gschliesser V. In: Restless Legs Syndrome. Hening WA, Allen RP, Chokroverty S, Earley C, editor. Saunders/Elsevier; 2009. Management of restless legs syndrome in the hospital and during surgery; pp. 279–283.
    1. Högl B, Falkenstetter T. In: Acute and Emergent Events in Sleep Disorders. Chokroverty S, Sahota P, editor. Oxford University Press; 2010. Restless legs syndrome and surgery; pp. 436–443.
    1. Högl B, Frauscher B, Seppi K, Ulmer H, Poewe W. Transient restless legs syndrome after spinal anesthesia: a prospective study. Neurology. 2002;59:1705–1707. doi: 10.1212/01.WNL.0000036606.56405.3D.
    1. Raux M, Karroum EG, Arnulf I. Case scenario: anesthetic implications of restless legs syndrome. Anesthesiology. 2010;112:1511–1517. doi: 10.1097/ALN.0b013e3181de2d66.
    1. Karroum EG, Raux M, Riou B, Arnulf I. Acute exacerbation of restless legs syndrome during perioperative procedures: case reports and suggested management [In French] Ann Fr Anesth Reanim. 2010;29:920–924. doi: 10.1016/j.annfar.2010.09.002.
    1. Restless Legs Syndrome Foundation. Surgery and RLS. .
    1. Boroojerdi B, Wolff H-M, Braun M, Scheller DKA. Rotigotine transdermal patch for the treatment of Parkinson’s disease and restless legs syndrome. Drugs Today. 2010;46:483–505. doi: 10.1358/dot.2010.46.7.1463530.
    1. Elshoff J-P, Braun M, Andreas J-O, Middle M, Cawello W. Steady-state plasma concentration profile of transdermal rotigotine – an integrated analysis of three Phase 1 multiple dose studies. Clin Ther. 2012;34:966–978. doi: 10.1016/j.clinthera.2012.02.008.
    1. Wüllner U, Kassubek J, Odin P, Schwarz M, Naumann M, Häck H-J, Boroojerdi B, Reichmann H. Transdermal rotigotine for the perioperative management of Parkinson’s disease. J Neural Transm. 2010;117:855–859. doi: 10.1007/s00702-010-0425-4.
    1. Korczyn AD, Reichmann H, Boroojerdi B, Häck H-J. Rotigotine transdermal system for perioperative administration. J Neural Transm. 2007;114:219–221. doi: 10.1007/s00702-006-0606-3.
    1. Oertel W, Trenkwalder C, Beneš H, Ferini-Strambi L, Högl B, Poewe W, Stiasny-Kolster K, Fichtner A, Schollmayer E, Kohnen R, García-Borreguero D. Long-term safety and efficacy of rotigotine transdermal patch for moderate-to-severe idiopathic restless legs syndrome: a 5-year open-label extension study. Lancet Neurol. 2011;10:710–720. doi: 10.1016/S1474-4422(11)70127-2.
    1. Oertel WH, Beneš H, García-Borreguero D, Geisler P, Högl B, Saletu B, Trenkwalder C, Sommerville KW, Schollmayer E, Kohnen R, Stiasny-Kolster K. Efficacy of rotigotine transdermal system in severe restless legs syndrome: a randomized, double-blind, placebo-controlled, six-week dose-finding trial in Europe. Sleep Med. 2008;9:228–239. doi: 10.1016/j.sleep.2007.04.010.
    1. Walters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, Trenkwalder C. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med. 2003;4:121–132.
    1. Oertel WH, Beneš H, García-Borreguero D, Geisler P, Högl B, Trenkwalder C, Tacken I, Schollmayer E, Kohnen R, Stiasny-Kolster K. One year open-label safety and efficacy trial with rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome. Sleep Med. 2008;9:865–873. doi: 10.1016/j.sleep.2008.04.012.
    1. National Center for Health Statistics. .
    1. Watanabe S, Sakai K, Ono Y, Seino H, Naito H. Alternating periodic leg movement induced by spinal anesthesia in an elderly male. Anesth Analg. 1987;66:1031–1032.
    1. Shin YK. Restless leg syndrome: unusual cause of agitation under anesthesia. South Med J. 1987;80:278–279.
    1. Ward NG. Akathisia associated with droperidol during epidural anesthesia. Anesthesiology. 1989;71:786–787. doi: 10.1097/00000542-198911000-00027.
    1. Watanabe S, Ono A, Naito H. Periodic leg movements during either epidural or spinal anesthesia in an elderly man without sleep-related (nocturnal) myoclonus. Sleep. 1990;13:262–266.
    1. Moorthy SS, Dierdorf SF. Restless legs during recovery from spinal anesthesia. Anesth Analg. 1990;70:337. doi: 10.1213/00000539-199003000-00024.
    1. Martinez LP, Koza M. Anesthesia-related periodic involuntary movement in an obstetrical patient for caesarean section under epidural anesthesia: a case report. J Am Assoc Nurse Anesth. 1997;65:150–153.
    1. LeWitt PA, Boroojerdi B, MacMahon D, Patton J, Jankovic J. Overnight switch from oral dopaminergic agonists to transdermal rotigotine patch in subjects with Parkinson disease. Clin Neuropharmacol. 2007;30:256–265. doi: 10.1097/wnf.0b013e318154c7c4.
    1. Kim H-J, Jeon BS, Lee WY, Lee MC, Kim JW, Kim J-M, Ahn T-B, Cho J, Chung SJ, Grieger F, Whitesides J, Boroojerdi B. Overnight switch from ropinirole to transdermal rotigotine patch in patients with Parkinson disease. BMC Neurol. 2011;11:100. doi: 10.1186/1471-2377-11-100.

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