Abstract

A randomized, double blind, and active reference-controlled study was carried out among 116 patients suffering from idiopathic Parkinson’s disease (PD). The aim of the study was to compare the safety and efficacy of alpha-dihydroergocryptine (DHEC) vs. pramipexole (PRAM) as an adjunct symptomatic therapy to levodopa in PD patients. The motor symptoms, assessed by the Unified Parkinson’s Disease Rating Scale (UPDRS) III subscale, was identified as efficacy target. Fifty-six patients were randomized to DHEC and 60 to PRAM. Patients included were under constant levodopa dose for at least 3 months before entering the study, with baseline UPDRS III ≥14. They underwent a 16-week treatment. Out of the 116 included patients, 85 (39 in DHEC group and 46 in PRAM group, respectively) completed the study protocol. In DHEC group, UPDRS III decreased by 24.2% from baseline at week 10 and by 28.1% at week 16. In PRAM group, UPDRS III decreased by 27.1% from baseline at week 10 and by 29.2% at week 16. The data were highly significant (p < 0.01) at each time point versus baseline, while no significant difference was noticed between treatments. Overall, the patient population did not show any clinically meaningful mood disturbances at baseline and the fluctuations of UPDRS I during treatment were devoid of clinical significance. Safety was fairly good in both groups. In conclusion, DHEC and PRAM proved to be effective and safe as adjunct therapy to levodopa in idiopathic PD. According to the research result, they have significantly improved the motor function of our patients.

Highlights

  • Since a long time, no new therapies on Parkinson’s disease (PD) have been developed, with the exception of surgical measures limited to few severely ill and complicated patients

  • Dopamine agonists still provide an important option in the treatment of PD, as motor fluctuations and dyskinesia are less common with these medications [1]-[3] than that with levodopa

  • According to the Evidence-based medical (EBM) review update of 2005 [4], PRAM was judged to represent an effective tool in symptomatic monotherapy and adjunct to levodopa therapy, as well as in prevention and treatment of motor complications in PD

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Summary

Introduction

No new therapies on PD have been developed, with the exception of surgical measures limited to few severely ill and complicated patients. Dopamine agonists still provide an important option in the treatment of PD, as motor fluctuations and dyskinesia are less common with these medications [1]-[3] than that with levodopa. Pramipexole (PRAM) is a dopamine D3 agonist which has showed benefit to PD patients both as a monotherapy and as an adjunct therapy to levodopa. According to the Evidence-based medical (EBM) review update of 2005 [4], PRAM was judged to represent an effective tool in symptomatic monotherapy and adjunct to levodopa therapy, as well as in prevention and treatment of motor complications in PD. Its safety is defined as acceptable risk, therapeutic alternatives may be needed in a non-negligible percentage of patients

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