Cabergoline versus pergolide: A video-blinded, randomised multicenter cross-over study

The efficacy and tolerability of cabergoline was investigated in a crossove r trial versus pergolide. The investigation was performed in 48 patients wi th progressed Parkinson syndrome, suffering from late motor complications a fter L-dopa therapy (wearing off, on/off-fluctuations and dyskinesias). Pri mary endpoint was the UPDRS Ill-score (motor performance) in a video-blinde d assessment. For this blinded evaluation, patients were investigated accor ding to the items of UPDRS III in a standardized mode and this investigatio n was documented on videotapes. The videocassettes were randomized and a si ngle experienced evaluator scored the tapes in a blinded manner. Results: C abergoline showed at least equal efficacy when given once daily up to 6 mg compared to pergolide, given t. i. d. up to 5 mg in total. The trend showed a superiority for the cabergoline group for improvement of Off-phases. The same is true for the unblinded evaluation of UPDRS i. The unblinded evalua tion of UPDRS III reached statistical significance (p < 0.05). The tolerabi lity of cabergoline was better than the one of pergolide with less withdraw als, less serious adverse events and less adverse events. The duration and severity of the dyskinesias measured by UPDRS IV was lower with cabergoline . This finding was supported by the evaluation of the patient's diaries. In these diaries, the On-periods with obvious or very obvious dyskinesias wer e reduced up to 50% compared to pergolide. Conclusion: The theoretic advant age of a continuous receptor-stimulation with thus reduced dyskinesias coul d be supported by this clinical trial. Consequently, after having finished the second treatment period, 63 % of all patients preferred a long-term tre atment with cabergoline.