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Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson's disease: a double blind, placebo controlled, randomised, multicentre study.
J Neurol Neurosurg Psychiatry 1999; 66(4):436-41JN

Abstract

OBJECTIVES

Pramipexole, a non-ergot dopamine D2/D3 receptor agonist, was investigated as an add on drug in advanced parkinsonian patients with motor fluctuations to assess efficacy, safety, and tolerance.

METHODS

Seventy eight patients of either sex with advanced Parkinson's disease and treatment complications such as motor fluctuations were enrolled into a double blind, placebo controlled, randomised, multicentre study (phase II) and assigned to add on treatment with pramipexole (n=34) versus placebo (n=44) to a previously stabilised antiparkinsonian medication (7 week dose titration interval, 4 week maintenance period). The primary end point of efficacy was the change from baseline in the total score of the unified Parkinson's disease rating scale (UPDRS) in the on "period" (2 hours after intake of study medication). Safety and tolerability were assessed on the basis of adverse events, vital signs, laboratory measurements, and ECG recordings.

RESULTS

There was a significant improvement of the pramipexole group in UPDRS total scores, subscores part II, III (activities of daily living and motor examination), and IV (complications of therapy). Mean UPDRS total score decreased by 37.3% under pramipexole compared with 12.2% under placebo (p<0.001). Patients under pramipexole reported an overall reduction in "off" periods of 12%--resulting in 1.7 more hours "on" time a day--compared with an increase in "off" periods of 2% under placebo. There were no unexpected safety results. The adverse event profile disclosed a high tolerability. The most important adverse events under pramipexole were fatigue, dyskinesia, and vivid dreams.

CONCLUSION

Pramipexole administration is an efficacious and well tolerated add on therapy in patients with advanced Parkinson's disease with an improvement in activities of daily living, motor function, and treatment associated complications.

Authors+Show Affiliations

Ludwig-Boltzmann-Institute for Restorative Neurology and Neuromodulation, Neurological Hospital Maria Theresien Schloessl, Vienna, Austria. 101606.3024@compuserve.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase II
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

10201413

Citation

Pinter, M M., et al. "Efficacy, Safety, and Tolerance of the Non-ergoline Dopamine Agonist Pramipexole in the Treatment of Advanced Parkinson's Disease: a Double Blind, Placebo Controlled, Randomised, Multicentre Study." Journal of Neurology, Neurosurgery, and Psychiatry, vol. 66, no. 4, 1999, pp. 436-41.
Pinter MM, Pogarell O, Oertel WH. Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson's disease: a double blind, placebo controlled, randomised, multicentre study. J Neurol Neurosurg Psychiatry. 1999;66(4):436-41.
Pinter, M. M., Pogarell, O., & Oertel, W. H. (1999). Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson's disease: a double blind, placebo controlled, randomised, multicentre study. Journal of Neurology, Neurosurgery, and Psychiatry, 66(4), pp. 436-41.
Pinter MM, Pogarell O, Oertel WH. Efficacy, Safety, and Tolerance of the Non-ergoline Dopamine Agonist Pramipexole in the Treatment of Advanced Parkinson's Disease: a Double Blind, Placebo Controlled, Randomised, Multicentre Study. J Neurol Neurosurg Psychiatry. 1999;66(4):436-41. PubMed PMID: 10201413.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson's disease: a double blind, placebo controlled, randomised, multicentre study. AU - Pinter,M M, AU - Pogarell,O, AU - Oertel,W H, PY - 1999/4/14/pubmed PY - 1999/4/14/medline PY - 1999/4/14/entrez SP - 436 EP - 41 JF - Journal of neurology, neurosurgery, and psychiatry JO - J. Neurol. Neurosurg. Psychiatry VL - 66 IS - 4 N2 - OBJECTIVES: Pramipexole, a non-ergot dopamine D2/D3 receptor agonist, was investigated as an add on drug in advanced parkinsonian patients with motor fluctuations to assess efficacy, safety, and tolerance. METHODS: Seventy eight patients of either sex with advanced Parkinson's disease and treatment complications such as motor fluctuations were enrolled into a double blind, placebo controlled, randomised, multicentre study (phase II) and assigned to add on treatment with pramipexole (n=34) versus placebo (n=44) to a previously stabilised antiparkinsonian medication (7 week dose titration interval, 4 week maintenance period). The primary end point of efficacy was the change from baseline in the total score of the unified Parkinson's disease rating scale (UPDRS) in the on "period" (2 hours after intake of study medication). Safety and tolerability were assessed on the basis of adverse events, vital signs, laboratory measurements, and ECG recordings. RESULTS: There was a significant improvement of the pramipexole group in UPDRS total scores, subscores part II, III (activities of daily living and motor examination), and IV (complications of therapy). Mean UPDRS total score decreased by 37.3% under pramipexole compared with 12.2% under placebo (p<0.001). Patients under pramipexole reported an overall reduction in "off" periods of 12%--resulting in 1.7 more hours "on" time a day--compared with an increase in "off" periods of 2% under placebo. There were no unexpected safety results. The adverse event profile disclosed a high tolerability. The most important adverse events under pramipexole were fatigue, dyskinesia, and vivid dreams. CONCLUSION: Pramipexole administration is an efficacious and well tolerated add on therapy in patients with advanced Parkinson's disease with an improvement in activities of daily living, motor function, and treatment associated complications. SN - 0022-3050 UR - https://www.unboundmedicine.com/medline/citation/10201413/Efficacy_safety_and_tolerance_of_the_non_ergoline_dopamine_agonist_pramipexole_in_the_treatment_of_advanced_Parkinson's_disease:_a_double_blind_placebo_controlled_randomised_multicentre_study_ L2 - http://jnnp.bmj.com/cgi/pmidlookup?view=long&amp;pmid=10201413 DB - PRIME DP - Unbound Medicine ER -