Abstract
N-of-1 trials may provide insights into the impact of deprescribing medications in populations where evidence is currently lacking, such as the effect of statins on cognition in people with dementia. For this pilot, N-of-1, double-blinded, deprescribing trial, adults over 80 years of age with dementia taking statins for at least 6-months were recruited from a hospital’s geriatric medicine outpatient clinic in Sydney, Australia. Participants discontinued and restarted statins over the study period. At enrolment, the hospital pharmacy—using a random number generator, randomised recruited participants to their usual statin or placebo regimen, with assessment and switching of treatment every 5 weeks from baseline (0-weeks) until Visit 4 (15-weeks). Primary outcome was measured using the rate of change in Alzheimer’s Disease Assessment Score-Cognitive Subscale (ADAS-CoG). Over 6-months, 81 participants were screened, 14 were eligible, and four were randomised. One participant (female, 88 years) completed all four assessments with no major harms reported. Cognitive impairment, as measured by ADAS-CoG score, was similar on placebo (15.5/70) compared to statin (15/70). This study suggests there are significant challenges in performing N-of-1 trials and recruiting people with dementia into deprescribing trials from outpatient settings.
Highlights
Deprescribing is the supervised discontinuation of inappropriate medication(s) [1]
Older adults with dementia are prone to suffering adverse drug events (ADEs) and subsequently, poorer health outcomes compared to older adults without dementia [2,3]
= Cambridge it was not feasible to recruit the target number of participants in the geriatric outpatient setting used in this trial. In this pilot N-of-1 deprescribing trial, we assessed the feasibility of using the N-of-1 trial method to investigate the short-term impact of discontinuing and rechallenging statins on cognition in older adults with dementia
Summary
Deprescribing is the supervised discontinuation of inappropriate medication(s) [1]. The process of implementing deprescribing into clinical practice and performing clinical trials is challenging, especially in vulnerable patient groups, such as older adults with dementia [1]. One clinical area that continues to be debated is the effect of statins on cognition, especially as there is uncertainty regarding their efficacy for the primary prevention of cardiovascular disease in people over 80 years of age [4]. A recent meta-analysis of 28 trials highlighted the lack of direct benefits among adults older than 75 years [5]. Evidence from an open-label study suggests that cognition may improve upon discontinuation of statins and worsen upon rechallenging [6]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
