Factors Affecting the Efficacy of Pramipexole in Patients with Restless Legs Syndrome

  • Mohammad Rezvani Department of Neurology, Rasool-e Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.
  • Babak Zamani Department of Neurology, Rasool-e Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.
  • Seyed-Mohammad Fereshtehnejad Mail Division of Clinical Geriatrics, Department of neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden. AND Firoozgar Clinical Research Development Center, Iran University of Medical Sciences, Tehran, Iran.
Keywords:
Efficacy, Pramipexole, Restless legs syndrome (RLS), Treatment

Abstract

Dopamine agonists, particularly nonergot dopamine agonists such as pramipexole, have become the mainstay of therapy for patients with symptoms of restless legs syndrome (RLS). This study was designed to evaluate the factors affecting the efficacy of pramipexole in patients with RLS. Fifty-nine eligible RLS patients referred to neurology clinic of Rasoul-e-Akram Hospital (Tehran, Iran) were recruited in this study. All of the patients received an oral dose of 0.18 mg pramipexole. The severity of RLS symptoms were evaluated including sleep disorder, symptomatic days per week and symptomatic hours per day, both at the beginning and at the end of follow-up time. Different baseline and follow-up variables were also recorded and their relationships with the outcomes were assessed. The mean severity values of different symptoms significantly decreased after treatment with pramipexole (P<0.001). Female gender (P<0.05) and duration of treatment (P<0.05) were significant factors to achieve >50% reduction in symptomatic days per week and symptomatic hours per day. Moreover, the cutoff point of 3.5 mo for duration of treatment could potentially differentiate >50% reduction in severity of sleep disorder from the ones with <50% reduction with sensitivity and specificity of 56.8% and 78.6%, respectively. Our findings show that female gender and duration of treatment were the factors affecting the effectiveness of pramipexole in RLS patients. If tolerated by the patients, a longer duration of treatment with pramipexole is more effective in RLS.

References

Sönmez E, Yakinci C, Aladağ M, Evliyaoğlu E, Yoloğlu S, Köksal N. Restless legs syndrome prevalence and impact:REST general population study. Arch Intern Med 2005;165(11):1286-92.

Berger K, Kurth T. RLS epidemiology, frequencies, risk factors and methods in population studies. Mov Disord 2007;22 Suppl 18:S420-3.

Zamani B, Fereshtehnejad SM, Jamali Danesh Y, Bakhti S, Mehrabani M. Determination of the prevalence and,associated factors of restless legs syndrome (RLS) in Iranian non-traumatic patients who referred to neurology and orthopedic clinics. Iran J Neurol 2007; 6:91-9.

Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisi J; Restless Legs Syndrome Diagnosis and Epidemiology workshop at the National Institutes of Health; International Restless Legs Syndrome Study Group. . 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(2):101-19.

Abetz L, Allen R, Follet A, Washburn T, Earley C, Kirsch J, Knight H. Evaluating the quality of life of patients with restless legs syndrome. Clin Ther 2004;26(6):925-35.

Yee B, Killick R, Wong K. Restless legs syndrome. Australian Family Physician 2009;38(5):296-300.

Baker WL, White CM, Coleman CI. Effect of nonergot dopamine agonists on symptoms of restless legs syndrome. Ann Fam Med 2008;6(3):253-62.

Montplaisir J, Nicolas A, Denesle R, Gomez-Mancilla B. Restless legs syndrome improved by pramipexole: a double-blind randomized trial. Neurology 1999;52(5):938-43.

Partinen M, Hirvonen K, Jama L, Alakuijala A, Hublin C, Tamminen I, Koester J, Reess J. Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study - the PRELUDE study. Sleep Med 2006;7(5):407-17.

Winkelman JW, Sethi KD, Kushida CA, Becker PM, Koester J, Cappola JJ, Reess J. Efficacy and safety of pramipexole in restless legs syndrome. Neurology 2006;67(6):1034-9.

Trenkwalder C, Stiasny-Kolster K, Kupsch A, Oertel WH, Koester J, Reess J. Controlled withdrawal of pramipexole after 6 months of open-label treatment in patients with restless legs syndrome. Mov Disord 2006;21(9):1404-10.

Oertel WH, Stiasny-Kolster K, Bergtholdt B, Hallström Y, Albo J, Leissner L, Schindler T, Koester J, Reess J. Pramipexole RLS Study Group. Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter,randomized, double-blind study (effect-RLS study). Mov Disord 2007;22(2):213-9.

Allen RP, Kushida CA, Atkinson MJ. RLS QoL Consortium. Factor analysis of the International RestlessLegs Syndrome Study Group's scale for restless legs severity. Sleep Med 2003;4(2):133–5.

Quilici S, Abrams KR, Nicolas A, Martin M, Petit C, Lleu PL, Finnern HW. Meta-analysis of the efficacy and tolerability of pramipexole versus ropinirole in the treatment of restless legs syndrome. Sleep Med 2008;9(7):715-26.

McCormack PL, Siddiqui MA. Pramipexole: in restless legs syndrome. CNS Drugs 2007; 21(5): 429-37.

Ferini-Strambi L, Aarskog D, Partinen M, Chaudhuri KR, Sohr M, Verri D, Albrecht S. Effect of pramipexole on RLS symptoms and sleep: a randomized, doubleblind, placebo-controlled trial. Sleep Med 2008;9(8):874-81.

Jama L, Hirvonen K, Partinen M, Alakuijala A, Hublin C, Tamminen I, Koester J, Reess J. A dose-ranging study of pramipexole for the symptomatic treatment of restless legs syndrome: Polysomnographic evaluation of periodic leg movements and sleep disturbance. Sleep Med 2009;10(6):630-6.

Montplaisir J, Karrasch J, Haan J, Volc D. Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial. Mov Disord2006;21(10):1627-35.

Montplaisir J, Denesle R, Petit D. Pramipexole in the treatment of restless legs syndrome: a follow-up study. Eur J Neurol 2000;7(Suppl 1):27-31.

Silber MH, Girish M, Izurieta R. Pramipexole in the management of restless legs syndrome: an extended study. Sleep 2003;26(7):819-21.

Partinen M, Hirvonen K, Jama L, Alakuijala A, Hublin C, Tamminen I et al. Open-label study of the long-term efficacy and safety of pramipexole in patients with Restless Legs Syndrome (extension of the PRELUDE study). Sleep Med 2008;9(5):537-41.

Kompoliti K, Adler CH, Raman R, Pincus JH, Leibowitz MT, Ferry JJ, Blasucci L, Caviness JN, Leurgans S, Chase WM, Yones LC, Tan E, Carvey P, Goetz CG. Gender and pramipexole effects on levodopa pharmacokinetics and pharmacodynamics. Neurology 2002;58(9):1418-22.

Van Hartesveldt C, Joyce JN. Effects of estrogen on the basal ganglia. Neurosci Biobehav Rev 1986;10:1–14.

Wright CE, Sisson TL, Ichhpurani AK, Peters GR. Steadystate pharmacokinetic properties of pramipexole in healthy volunteers. J Clin Pharmacol 1997;37:520-5.

How to Cite
1.
Rezvani M, Zamani B, Fereshtehnejad S-M. Factors Affecting the Efficacy of Pramipexole in Patients with Restless Legs Syndrome. Acta Med Iran. 51(6):377-385.
QRcode
Section
Articles