Monotherapie der Parkinsonschen Erkrankung mit Budipin

 

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Zusammenfassung:

In einem randomisierten, doppelblinden Parallelgruppenvergleich an drei Zentren wurden Budipin, ein Diphenylpiperidin-Derivat, und Amantadin auf Wirksamkeit und Verträglichkeit bei oraler Monotherapie der Parkinsonschen Krankheit verglichen. Von 53 Patienten beider Geschlechter mit leichter bis mittelschwerer idiopathischer Parkinsonscher Krankheit erhielten 27 Patienten 3 × 20 mg/Tag Budipin und 26 Patienten 3 × 100 mg/Tag Amantadin. Die Prüfdauer betrug in einem Zentrum (21 Patienten) 4 Wochen, in den beiden anderen (32 Patienten) 12 Wochen für jeden Patienten.

Beide Substanzen erzielten eine vergleichbare, klinisch relevante und hochsignifikante Besserung der Parkinson-Symptomatik hinsichtlich der Scoresumme der Webster-Rating-Skala. Budipin hatte nach 12 Wochen den Tremor deutlicher und statistisch signifikant besser beeinflusst als Amantadin. Unter Amantadin traten mehr Nebenwirkungen auf als unter Budipin. 2 Patienten verließen die Studie, einer aus der Amantadingruppe wegen starker Deliranz und einer aus der Budipin-Gruppe wegen unbefriedigender Wirksamkeit. Budipin ist wirksam und gut verträglich bei der Monotherapie der Parkinsonschen Krankheit.

Monotherapy of Parkinson's Disease with Budipine - A Randomised Double-Blind Comparision to Amantadine:

In a randomised double blind parallel-group study in three centers budipine, a diphenylpiperidin derivate, was compared to amantadine with respect to efficacy and safety in the monotherapy of mild to moderate Parkinson's disease (PD). From 53 patients of either sex 27 patients were randomised to 3 × 20 mg/d budipine and 26 patients to 3 × 100 mg/d amantadine. The duration of treatment was 4 weeks in 1 center (21 patients) and 12 weeks in the other 2 centers (32 patients). Safety was measured by vital signs, ECG, adverse event recording and clinical laboratory.

Both drugs caused a clinically relevant and statistically significant (p < 0.001) improvement of Parkinsonian symptoms according to the Webster-Rating-Scale (WRS) as compared to pretreatment values. With respect to the total WRS score sum there was no difference betweeen the groups (p > 0.05; n. s.), while budipine showed a significantly (p < 0.05) better effect on the main symptom tremor after 12 weeks. During amantadine treatment more adverse events were observed than after budipine intake. Two patients left the study prematurely, one in the amantadine group due to psychiatric adverse events and one in the budipine group because of insufficient efficacy.

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