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Disease-Modifying Therapy Lacks Efficacy for Treating Moderate Parkinson Disease
Daily simvastatin over 23 months is futile as a disease-modifying therapy in patients with moderate Parkinson disease, concluded the authors of a randomized clinical trial published in JAMA Neurology.
Prompted by preclinical and epidemiological studies that appeared to suggest statins offered disease-modifying effects in Parkinson disease, the investigators conducted a double-blind, placebo-controlled futility trial of simvastatin in England.
Patients with Parkinson disease of moderate severity were assigned to simvastatin or placebo. Those randomized to simvastatin began with 40 mg daily for 1 month, followed by 23 months of 80 mg daily, and ended the study with a 2-month washout period.
Among 178 patients in the primary outcome analysis, those in the simvastatin group worsened an additional 1.52 points on the Movement Disorder Society Unified Parkinson Disease Rating Scale part III while not taking medication at 24 months compared with patients in the placebo group, study authors found.
“We found no evidence of statistically significant differences between the simvastatin and placebo groups at 24 months in other motor or nonmotor measures, quality of life, or levodopa-equivalent daily dose,” reported researchers.
The frequency and severity of adverse events did not differ between the treatment groups, according to study authors.
“The relationship between Parkinson disease and cardiovascular risk factors, including cholesterol level, is complicated,” wrote researchers. “A better understanding of the interplay between the potential protective effect of statins, the potential negative effect of low cholesterol level, the stage of disease, and relevant comorbidities might inform whether, when, and in whom statins merit further investigation as disease-modifying therapy in Parkinson disease.”
Reference:
Stevens KN, Creanor S, Jeffery A, et al. Evaluation of simvastatin as a disease-modifying treatment for patients with Parkinson disease: a randomized clinical trial. JAMA Neurol. Published online October 31, 2022. doi:10.1001/jamaneurol.2022.3718
