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Thursday, June 18, 2015

Cholinesterase Inhibitor May Prevent Parkinson's Falls

Rivastigmine improves gait disturbances in early study

      
LAST UPDATED 06.18.2015 
      Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
       In a phase II, randomized, double-blind, placebo-controlled trial involving 130 Parkinson's patients who have fallen in the past year, the cholinesterase inhibitor rivastigmine effectively reduced gait variability, a proxy for fall risk.
    Adverse events were generally mild and consistent with prior clinical experience.
       Though rate of falls was decreased with rivastigmine compared with placebo as a secondary outcome measure, it remains to be seen whether this beneficial effect is borne out in larger studies.

SAN DIEGO -- A cholinesterase inhibitor improved gait in Parkinson's patients and may ultimately help diminish falls in this population, researchers reported here.
In a phase II study, rivastigmine (Exelon) improved gait variability during normal walking and during walking while performing a simple cognitive task, Emily Henderson, MRCP, MBChB, of the University of Bristol, reported at the Movement Disorders Society meeting here.

It also reduced the rate of falls, which was only a secondary endpoint in this study.
"This really just supports the fact that we need to do a larger trial with falls as the primary endpoint to see if this effect actually plays out in day-to-day life," Henderson told MedPage Today.

Falls are a common problem in Parkinson's disease, and Henderson said underlying cholinergic deficits contribute to gait dysfunction and cognitive impairment -- both of which are significant contributors to fall risk. These impairments only worsen as the disease progresses, she added.

The researchers theorized that a cholinesterase inhibitor may be able to mitigate those problems -- and, indeed, a small study of the cholinesterase inhibitor donepezil (Aricept) found that to be the case in 2010. This time, they assessed the effects of another such agent, rivastigmine, which is already approved for the treatment of Parkinson's dementia.

For their phase II, double-blind, randomized, controlled trial, they enrolled 130 patients who'd had a fall in the last year. These patients were randomized to either rivastigmine or placebo, and the drug was uptitrated over 4 months to a maximum of 6 mg twice a day, and then maintained at the highest tolerated dose for the next 4 months.

The primary outcome was step time variability, a proxy marker for risk of falls, measured in three conditions: normal walking, simple cognitive task, and complex cognitive task.
The study had a high retention rate (95%), and the researchers performed an intention-to-treat analysis.
They found that in models adjusted for factors including age, cognition, previous falls, rivastigmine improved step time variability in two of the three walking conditions:

       Normal walk: RR 0.72, 95% CI 0.58-0.88, P=0.002
       Simple cognitive task: RR 0.79, 95% CI 0.62-0.99, P=0.045

The findings were not significant for the complex cognitive task, and Henderson noted that the "greatest treatment effect was seen during normal walking."
There was no evidence of effect modification by age group, cognition, or duration of Parkinson's disease, they added.

For the secondary endpoints, rivastigmine was associated with fewer falls per month (1.4 versus 2.4), and there was a 29% relative reduction in the rate of falls with the drug.

Adverse events were consistent with the literature and were predominantly mild and not related to trial medication, Henderson said. Rivastigmine was associated with more occurrences of gastrointestinal disturbance and urinary tract infection -- both of which are known side effects of the drug.
The researchers concluded that while rivastigmine improved gait variability, it remains to be seen whether that will translate to a more clinically meaningful reduction in fall risk -- which needs to be evaluated in future large-scale phase III trials.

Melissa Nirenberg, MD, PhD, of NYU Langone Medical Center, who was not involved in the study, said cholinesterase inhibitors for gait and falls in Parkinson's is "a hot area of investigation."
"Multiple groups are looking at this, and it would be novel if it works, but we don't know yet," Nirenberg told MedPage Today. "Some people are trying it empirically. Anecdotally, I haven't noticed any improvement in the gait of patients in whom I start those drugs for cognitive impairment."
She added that currently, rehab and safety precautions "are the main ways of averting falls. We don't have any medications for this problem."

Novartis provided the study drug plus placebo.
The researchers disclosed no financial relationships with industry.

         Reviewed by Robert Gross, MD Multiple Sclerosis Fellow, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY

         Primary Source
International Congress on Parkinson's Disease and Movement Disorders
Source Reference: Henderson EJ, et al "The ReSPOnD trial: Rivastigmine to stabilize gait in Parkinson's disease" MDS 2015; Abstract LBA10.
         Staff Writer, MedPage Today 
http://www.medpagetoday.com/MeetingCoverage/MDS/52166

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