Pramipexol Retard: Eine neue Therapieoption bei Morbus Parkinson

Zusammenfassung

Pramipexol ist der meistverordnete Dopaminagonist weltweit und darf mittlerweile als Referenzsubstanz bei der Bewertung neuer Substanzen angesehen werden. Das Wirksamkeits- und Sicherheitsprofil dieses non-ergolinen Dopaminagonisten ist aufgrund umfangreicher klinischer Daten und Erfahrungen gut charakterisiert. Seit Oktober 2009 steht in Deutschland Pramipexol in retardierter Form zur symptomatischen Behandlung des Morbus Parkinson zur Verfügung. Die notwendige dreimal tägliche Einnahme von Pramipexol lässt sich durch die neu entwickelte Retardform auf eine Einmalgabe pro Tag reduzieren. Dies ist ein wesentlicher therapeutischer Fortschritt im Hinblick auf eine Reduktion der Tablettenlast und bessere Compliance der Patienten. Bei einer kontinuierlichen Wirkstofffreigabe über 24 Stunden zeigt die Retardform zudem weniger Fluktuationen im Plasmakonzentrationsverlauf als eine dreimal tägliche Gabe des unretardierten Pramipexol. Die vorliegende Arbeit fasst die wesentlichen pharmakologischen, pharmakokinetischen und klinischen Merkmale der Retardform zusammen, stellt die Studiendaten zur Um- und Neueinstellung auf Pramipexol Retard bei idiopathischem Parkinson-Syndrom vor und vergleicht die Wirksamkeits- und Sicherheitsdaten der unretardierten versus der retardierten Pramipexol-Formulierungen.

Summary

Pramipexole, the most commonly prescribed dopamine agonist worldwide, meanwhile serves as a reference substance for evaluation of new drugs. Based on numerous clinical data and vast experiences, efficacy and safety profiles of this non-ergolinic dopamine agonist are well characterized. Since October 2009, an extended-release formulation of pramipexole has been available in Germany for symptomatic treatment of Parkinson’s disease. Pramipexole administration can be cut down from three times to once a day due to the newly developed extended-release formulation. This is considerable progress in regard to minimizing pill burden and enhancing compliance. Moreover, the 24 h continuous drug release of the once-daily extended-release formulation results in fewer fluctuations in plasma concentrations over time compared to immediate-release pramipexole, given three times daily. The present study summarizes pharmacokinetics and all essential pharmacological and clinical characteristics of the extended-release formulation. In addition, it provides all study data, available so far, with regard to transition and de-novo administration of extended-release formulation for patients with Parkinson’s disease. It further compares efficacy and safety data of immediate-release pramipexole with the extendedrelease formulation of pramipexole.

Schlüsselwörter

Dopaminagonist - Pramipexol Retard - Morbus Parkinson - Retardformulierung

Keywords

Dopamin agonist - extended-release pramipexole - Parkinson´s disease - extended release formulation

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