by Isabella Colonna
For October we selected Transdermal Nicotine Treatment and Progression of Early Parkinson’s Disease, Wolfgang H. Oertel, Hans-Helge Muller, Marcus M. Unger, Carmen Schade-Brittinger, Kerstin Balthasar, Konstantin Articus, Marc Brinkman, C.S. Venuto, Ferenc Tracik, Jamie Eberling, Karla M. Eggert, Cornelia Kamp, Karl Kieburtz, James T. Boyd for the NIC-PD Study Group*,NEJM Evid 2023; Aug 2023; DOI: 10.1056/EVIDoa2200311.
Previous evidence showed that Parkinson’s disease (PD) occurs less frequently among smokers than among never smokers; further, preclinical studies on rodent models of PD found that nicotine could upregulate antiapoptotic proteins and protect against nigrostriatal degeneration.
This multicentre, prospective, randomised clinical trial aimed to investigate whether transdermal nicotine may have a disease-modifying effect in early (Hoehn and Yahr stage less than or equal to 2), therapy-naïve (except MAO-B inhibitors) PD.
After screening for eligibility, participants were randomly assigned to receive transdermal placebo patches (n=83) or transdermal nicotine patches (n=79) for 52 weeks; the dose of the latter was initiated at 7mg/day and increased every four weeks up to the maximal dose of 28mg/day.
End points were the difference between groups in the change in the total Unified Parkinson’s Disease Rating Scale (UPDRS) parts I-III between baseline and week 60 (primary outcome) and between baseline and week 52 (secondary outcome). Further secondary end points were assessed for additional motor and non-motor features of PD at 60 and 52 weeks with other validated scales (Scales for Outcomes in Parkinson’s Disease–Cognition, Beck Depression Inventory II, Parkinson’s Disease Questionnaire-8, Parkinson’s Disease Sleep Scale-2).
The difference in mean worsening of Total UPDRS at 60 and 52 weeks was in favour of the placebo group (placebo group: 3.5 and 5.4 at 60 and 52 weeks, respectively; nicotine group: 6.0 and 9.1 at 60 and 52 weeks, respectively). No differences between groups were observed for the other secondary end points.
In conclusion, the results of this randomised clinical trial showed that one-year treatment with transdermal nicotine patches was not effective in slowing the progression of early PD.