Literature DB >> 20156514

Proposed dose equivalence between clonazepam and pramipexole in patients with restless legs syndrome.

Hideto Shinno1, Yasunori Oka, Manabu Otsuki, Satoshi Tsuchiya, Soichi Mizuno, Seiichi Kawada, Toshihiko Innami, Akira Sasaki, Takashi Hineno, Tetsuro Sakamoto, Yasushi Inami, Yu Nakamura, Jun Horiguchi.   

Abstract

BACKGROUND: Dopamine agonists are accepted as the first-line medications for restless legs syndrome (RLS). In some Asian countries, clonazepam is one of the prevalent medications for RLS because of its effect on sleep disturbances. To date, there have not been any studies that examined equivalent doses of pramipexole and clonazepam. To evaluate equivalent doses of pramipexole and clonazepam in RLS, we investigated the efficacy and tolerability after conversion from clonazepam to pramipexole, and examined dose equivalence between the two prescriptions.
METHODS: In a prospective, open-label, multicenter study, 26 RLS patients treated with clonazepam (mean age: 69.2+/-11.0years old) were enrolled and then rapidly switched to pramipexole using a conversion calculation of 4:1 for daily doses. Then the daily dose of pramipexole was up titrated or tapered by 0.125mg/day at each subsequent examination. RLS symptoms and daytime somnolence were evaluated using the International RLS Study Group rating scale (IRLS), Clinical Global Impressions - Severity of illness (CGI-S) and the Epworth Sleepiness Scale (ESS), respectively.
RESULTS: Conversion from clonazepam to pramipexole resulted in significant reductions of IRLS (16.3+/-8.7 to 9.1+/-6.3) and ESS (6.5+/-4.2 to 4.4+/-3.2). CGI scores demonstrated improvement after conversion. In 4 patients (15%), adverse events such as somnolence, sensation of oppression in the lower limbs, diarrhea, or nausea were present. Correlation analysis demonstrated a significant relationship between these daily doses. Spearman's correlation coefficient was 0.662. Our study, however, has some limitations since it is an open-label trial and includes only 26 patients. Further studies using a double-blind design or a crossover design are recommended.
CONCLUSIONS: Statistical analysis demonstrated a 4:1 conversion for clonazepam to pramipexole. When switchover from clonazepam to pramipexole is done, this conversion ratio may be helpful to determine the initial dose of pramipexole for treating RLS. Copyright 2010 Elsevier Inc. All rights reserved.

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Year:  2010        PMID: 20156514     DOI: 10.1016/j.pnpbp.2010.02.011

Source DB:  PubMed          Journal:  Prog Neuropsychopharmacol Biol Psychiatry        ISSN: 0278-5846            Impact factor:   5.067


  5 in total

Review 1.  The treatment of restless legs syndrome and periodic limb movement disorder in adults--an update for 2012: practice parameters with an evidence-based systematic review and meta-analyses: an American Academy of Sleep Medicine Clinical Practice Guideline.

Authors:  R Nisha Aurora; David A Kristo; Sabin R Bista; James A Rowley; Rochelle S Zak; Kenneth R Casey; Carin I Lamm; Sharon L Tracy; Richard S Rosenberg
Journal:  Sleep       Date:  2012-08-01       Impact factor: 5.849

Review 2.  Clonazepam for the management of sleep disorders.

Authors:  Alberto Raggi; Maria Paola Mogavero; Lourdes M DelRosso; Raffaele Ferri
Journal:  Neurol Sci       Date:  2022-09-16       Impact factor: 3.830

3.  The seasonal pattern of restless legs syndrome in a sample from the Korean Health Insurance Review and Assessment Service national database.

Authors:  Seong Min Oh; Kyung-Lak Son; Seok-Jin Choi; Mi Hyun Lee; So Young Yoon; Yu Jin Lee
Journal:  J Clin Sleep Med       Date:  2021-05-01       Impact factor: 4.062

4.  A Prospective, Randomized, Open-Label Study Comparing the Efficacy and Safety of Clonazepam versus Nortriptyline on Quality of Life in 40+ Years old Women Presenting with Restless Leg Syndrome.

Authors:  Vishal R Tandon; Annil Mahajan; Sudhaa Sharma; Vijay Khajuria
Journal:  J Midlife Health       Date:  2018 Jul-Sep

5.  Comparative Efficacy and Safety of Clonazepam versus Nortriptyline in Restless Leg Syndrome among Forty Plus Women: A Prospective, Open-Label Randomized Study.

Authors:  Vishal R Tandon; Annil Mahajan; Sudhaa Sharma; Vijay Khajuria
Journal:  J Midlife Health       Date:  2019 Oct-Dec
  5 in total

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