Key messages
- In patients with moderate Parkinson’s disease, 24 months of treatment with simvastatin did not affect motor deterioration.
- The results of the STAT study provide no evidence to support the initiation of phase 3 trials of statins as disease-modifying drugs in Parkinson’s disease.
The trial of simvastatin as a disease-modifying drug for Parkinson’s disease appears to be moving away from phase 3 after the publication of the results of the STAT study.In this randomized trial, statin was not shown to slow the progression of motor alterations in patients with moderate disease.
Neurologists turned their attention to statins after preclinical studies suggested that this class of drugs could have relevant effects on the pathogenesis of Parkinson’s disease. «Most of the evidence was related to simvastatin, one of the most lipophilic statins, capable of crossing the blood-brain barrier – specify the authors of the study, published in the journal JAMA Neurology – Epidemiological studies support a potential protective effect of statins in Parkinson’s disease and some meta-analyses show that the use of statins could be associated with a decrease in the relative risk of incidence of Parkinson’s».
The STAT study, conducted at several centres in the UK, enrolled 235 patients (aged 40-90 years) diagnosed with idiopathic Parkinson’s disease at stage ≤3 (Hoehn and Yahr scale).Participants were randomized (1:1) to receive simvastatin (40 mg/day in the first month, 80 mg/day in the following 23 months) or placebo. The primary outcome was the change in the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS, Part III) at 24 months, measured while patients were not taking medication.
The difference in score between the groups indicates that participants assigned to simvastatin treatment worsened more than participants assigned to placebo. The hypothesis-testing designates the futility of simvastatin as a treatment for Parkinson’s disease. This was true in all predefined sensitivity analyses. «We found no evidence of statistically significant differences between the simvastatin group and the placebo group in other motor or non-motor measures at 24 months, in quality of life, and in the use of parkinsonism drugs (levodopa-equivalent daily doses) – report the authors – Frequency and severity of adverse events were not different in the two groups and were similar to those previously reported».
The authors of the study conclude that based on their results there are no conditions to start a phase 3 study, but also add that the interactions between statins, disease stage and comorbidity should still be investigated to decide if and in which patients statins deserve to be further tested as therapy-modifying drugs in Parkinson’s disease.
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Source — https://www.univadis.it/viewarticle/le-statine-non-cambiano-la-storia-del-morbo-di-parkinson-2022a100258n