• Corpus ID: 43467403

Representation of patients with dementia in clinical trials of donepezil.

@article{Gill2004RepresentationOP,
  title={Representation of patients with dementia in clinical trials of donepezil.},
  author={Sudeep S. Gill and Susan E. Bronskill and Muhammad M Mamdani and Kathy Sykora and Ping Li and Kenneth I. Shulman and Geoffrey M. Anderson and Michael Hillmer and Walter P. Wodchis and Paula A. Rochon},
  journal={The Canadian journal of clinical pharmacology = Journal canadien de pharmacologie clinique},
  year={2004},
  volume={11 2},
  pages={
          e274-85
        }
}
  • S. Gill, S. Bronskill, P. Rochon
  • Published 2004
  • Medicine
  • The Canadian journal of clinical pharmacology = Journal canadien de pharmacologie clinique
OBJECTIVES To evaluate the representation of frail older adults in randomized controlled trials (RCTs), and to assess consequences of under representation by analyzing drug discontinuation rates. METHODS A cohort of older adults newly dispensed donepezil in Ontario between September 2001 and March 2002 was constructed using administrative data. A systematic review of the literature identified RCTs of donepezil. Patients dispensed donepezil were then compared to clinical trial subjects… 

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References

SHOWING 1-10 OF 35 REFERENCES

Efficacy and Tolerability of Donepezil in Vascular Dementia: Positive Results of a 24-Week, Multicenter, International, Randomized, Placebo-Controlled Clinical Trial

TLDR
These data demonstrate that donepezil is an effective and well-tolerated treatment for VaD and show it may have an important place in the management of this condition.

Efficacy and Tolerability of Donepezil in Vascular Dementia

TLDR
These data demonstrate that donepezil is an effective and well-tolerated treatment for VaD and show it may have an important place in the management of this condition.

The exclusion of the elderly and women from clinical trials in acute myocardial infarction.

TLDR
To determine the extent to which the elderly have been excluded from trials of drug therapies used in the treatment of acute myocardial infarction, to identify factors associated with such exclusions, and to explore the relationship between the exclusion of elderly and the representation of women, a systematic search of the English-language literature was conducted.

A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD.

TLDR
It remains puzzling to me why the investigators restricted the entry criteria and consequently selected a population that was not representative of general clinical practice when excluding patients with frequently coexisting medical conditions such as diabetes, chronic obstructive pulmonary disease, and endocrine diseases.

A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients

TLDR
Treatment with donepezil for 1 year was associated with a 38% reduction in the risk of functional decline compared with placebo, and this was a prospective, 54-week, double-blind, placebo-controlled, survival to endpoint study.

Donepezil therapy in clinical practice: a randomized crossover study.

TLDR
This independent confirmation of data from phase 3 trials suggests that donepezil therapy modestly improves cognition in patients with Alzheimer disease who are encountered in clinical practice.

Clinical Efficacy and Safety of Donepezil on Cognitive and Global Function in Patients with Alzheimer’s Disease

TLDR
The results indicate that the donepezil appears to be effective and well tolerated in patients with mild to moderately severe Alzheimer’s disease.

Canadian study of health and aging: study methods and prevalence of dementia.

  • Medicine
    CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne
  • 1994
TLDR
These Canadian estimates of the prevalence of dementia fall toward the upper end of the range in other studies, whereas the estimates for Alzheimer's disease fall in the middle of the ranges, which may suggest an unusual balance between Alzheimer's and other forms of dementia in the Canadian population.

A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer’s disease

TLDR
The data suggest that donepezil’s benefits extend into more advanced stages of AD than those previously investigated, with very good tolerability.

GETTING DONEPEZIL INTO THE NURSING HOME ‐ (Letter referred to the authors of the original paper

  • T. Finucane
  • Medicine
    Journal of the American Geriatrics Society
  • 2003
TLDR
It is concluded that these data provide further evidence of the stabilization of cognition and overall dementia severity consistently reported with donepezil, an effect that is clinically important in a progressive neurodegenerative disease.