A Retrospective Study to Compare the Tolerability of Switching From Levodopa/carbidopa or Levodopa/benserazide to Stalevo
Objectives: End of dose deterioration and motor fluctuations are a major complication in the treatment in Parkinsons disease. Although the efficacy of Stalevo in the management of this problem has been previously demonstrated there has been little published regarding the safety and tolerability. Previous studies have looked at either a Stalevo arm or levodopa/carbidopa arm without crossover and there have been no studies comparing Stalevo to levodopa/benserazide. The aim of this study was to assess the side-effect profile of Stalevo in comparison to immediate release levodopa and determine whether patients will remain on this preparation or choose to go back to their previous regime.
Methods: A retrospective analysis was made of 55 consecutive patients with idiopathic Parkinsons disease who were switched form Madopar or Sinemet to Stalevo ( M32,F23). Assessments included tolerability measures, adverse events profile and patient global clinical assessments.
Results: 25% of patients experienced side-effects which included dizziness, nausea, vomiting, fatigue, diarrhoea, depression and mood changes, confusion and 22% had new onset dyskinesia. 18 patients (33%) ceased taking Stalevo on the basis of side-effects and perceived lack of efficacy.
This open label study suggests a higher rate of side-effects from Stalevo than previously reported and a 33% dropout rate compared to 8% previously reported. This is an important finding in view of the potential for Stalevo to reduce time to the onset of motor fluctuations and improve on time. Measures to reduce drop-out rate will be discussed.