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Clinical experiences with levodopa methylester (melevodopa) in patients with Parkinson disease experiencing motor fluctuations: an open-label observational study.
Clin Neuropharmacol. 2010 Mar-Apr; 33(2):61-6.CN

Abstract

INTRODUCTION

Slow gastric emptying decreasing levodopa (LD) bioavailability contributes to motor fluctuations in Parkinson disease (PD). Melevodopa (LD methylester), ensuring rapid duodenal absorption, has been proposed as rescue therapy for afternoon off periods.

OBJECTIVE

To assess daily motor fluctuations by multiple administrations of Sirio (Chiesi Farmaceutici SpA, Parma, Italy) (melevodopa/carbidopa) in PD patients.

PATIENTS AND METHODS

In this open-label naturalistic study, 75 PD patients (group A) completely switched standard LD (Sinemet or Madopar) with Sirio at an equivalent dosage (800-1000 mg/d). One hundred nineteen PD patients (group B) partially replaced their standard LD (Sinemet) with Sirio at an equivalent dosage (400-500 mg/d) while continuing Stalevo 100. In both groups, the observational period lasted 6 months. Assessments included an on/off diary, the Unified Parkinson's Disease Rating Scale (motor examination [UPDRS II] and activities of daily living [UPDRS III]), the dyskinesia scale, and an adverse event profile.

RESULTS

Group A showed a significant reduction of afternoon off hours at 6 months (P < 0.05). Forty-five patients (69%) reported a subjective early onset of on motor response. Twelve patients (18.5%) reported its shorter duration. The dyskinesia scale score remained unchanged. Ten patients (13.3%) discontinued melevodopa for gastric intolerance. Group B showed at 6 months a significant reduction of total hours of daily off periods (P < 0.05), particularly in the morning (P < 0.01) and afternoon (P < 0.05). Seventy subjects (59%) expressed positive judgment on quickness of onset of on motor response. The dyskinesia scale score was unchanged. No significant adverse events were reported.

CONCLUSIONS

Switching PD patients with motor fluctuations to melevodopa, particularly in the presence of entacapone, could optimize critical periods of the day such as the morning delay on and afternoon off periods.

Authors+Show Affiliations

Parkinson's Disease and Movement Disorders Unit, IRCCS Neurological Institute C. Mondino, Pavia, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article

Language

eng

PubMed ID

19935405

Citation

Zangaglia, Roberta, et al. "Clinical Experiences With Levodopa Methylester (melevodopa) in Patients With Parkinson Disease Experiencing Motor Fluctuations: an Open-label Observational Study." Clinical Neuropharmacology, vol. 33, no. 2, 2010, pp. 61-6.
Zangaglia R, Stocchi F, Sciarretta M, et al. Clinical experiences with levodopa methylester (melevodopa) in patients with Parkinson disease experiencing motor fluctuations: an open-label observational study. Clin Neuropharmacol. 2010;33(2):61-6.
Zangaglia, R., Stocchi, F., Sciarretta, M., Antonini, A., Mancini, F., Guidi, M., Martignoni, E., & Pacchetti, C. (2010). Clinical experiences with levodopa methylester (melevodopa) in patients with Parkinson disease experiencing motor fluctuations: an open-label observational study. Clinical Neuropharmacology, 33(2), 61-6. https://doi.org/10.1097/WNF.0b013e3181c5e60c
Zangaglia R, et al. Clinical Experiences With Levodopa Methylester (melevodopa) in Patients With Parkinson Disease Experiencing Motor Fluctuations: an Open-label Observational Study. Clin Neuropharmacol. 2010 Mar-Apr;33(2):61-6. PubMed PMID: 19935405.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical experiences with levodopa methylester (melevodopa) in patients with Parkinson disease experiencing motor fluctuations: an open-label observational study. AU - Zangaglia,Roberta, AU - Stocchi,Fabrizio, AU - Sciarretta,Massimo, AU - Antonini,Angelo, AU - Mancini,Francesca, AU - Guidi,Marco, AU - Martignoni,Emilia, AU - Pacchetti,Claudio, PY - 2009/11/26/entrez PY - 2009/11/26/pubmed PY - 2010/7/9/medline SP - 61 EP - 6 JF - Clinical neuropharmacology JO - Clin Neuropharmacol VL - 33 IS - 2 N2 - INTRODUCTION: Slow gastric emptying decreasing levodopa (LD) bioavailability contributes to motor fluctuations in Parkinson disease (PD). Melevodopa (LD methylester), ensuring rapid duodenal absorption, has been proposed as rescue therapy for afternoon off periods. OBJECTIVE: To assess daily motor fluctuations by multiple administrations of Sirio (Chiesi Farmaceutici SpA, Parma, Italy) (melevodopa/carbidopa) in PD patients. PATIENTS AND METHODS: In this open-label naturalistic study, 75 PD patients (group A) completely switched standard LD (Sinemet or Madopar) with Sirio at an equivalent dosage (800-1000 mg/d). One hundred nineteen PD patients (group B) partially replaced their standard LD (Sinemet) with Sirio at an equivalent dosage (400-500 mg/d) while continuing Stalevo 100. In both groups, the observational period lasted 6 months. Assessments included an on/off diary, the Unified Parkinson's Disease Rating Scale (motor examination [UPDRS II] and activities of daily living [UPDRS III]), the dyskinesia scale, and an adverse event profile. RESULTS: Group A showed a significant reduction of afternoon off hours at 6 months (P < 0.05). Forty-five patients (69%) reported a subjective early onset of on motor response. Twelve patients (18.5%) reported its shorter duration. The dyskinesia scale score remained unchanged. Ten patients (13.3%) discontinued melevodopa for gastric intolerance. Group B showed at 6 months a significant reduction of total hours of daily off periods (P < 0.05), particularly in the morning (P < 0.01) and afternoon (P < 0.05). Seventy subjects (59%) expressed positive judgment on quickness of onset of on motor response. The dyskinesia scale score was unchanged. No significant adverse events were reported. CONCLUSIONS: Switching PD patients with motor fluctuations to melevodopa, particularly in the presence of entacapone, could optimize critical periods of the day such as the morning delay on and afternoon off periods. SN - 1537-162X UR - https://www.unboundmedicine.com/medline/citation/19935405/Clinical_experiences_with_levodopa_methylester__melevodopa__in_patients_with_Parkinson_disease_experiencing_motor_fluctuations:_an_open_label_observational_study_ L2 - https://doi.org/10.1097/WNF.0b013e3181c5e60c DB - PRIME DP - Unbound Medicine ER -