A drug utilisation study in patients treated with EXELON®/PROMETAX® (rivastigmine) transdermal patch

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Dementia Alzheimer's type

Population studied

• Short description of the study population:
  Physician prescribing patterns and patient use of Exelon/Prometax patches; To be eligible for the study, patients were required to meet all of the following criteria:; 1. Currently using Exelon/Prometax patch (i.e., 4.6 mg/24 hour [5 cm2], 9.5 mg/24 hour [10 cm2], or 13.3 mg/24 hour [15 cm2]) or where an independent decision has been made by their health care professional to initiate treatment with Exelon/Prometax patch at baseline. In Germany (as requested by BfArM) the following will also apply: Exelon/Prometax patch treatment to be in accordance with the approved SmPC.; 2. Have an assistant who is willing to participate in the study and is able to understand and comply with study procedures in the local language and able to provide informed consent for themselves. The patient assistant does not need to be a primary or formal caregiver and can include a family member or other individual who helps with the patient’s activities of daily living.; 3. Able to provide informed consent to participate in the study or have a legal representative who is willing and able to provide informed consent on their behalf.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  To assess appropriate use and estimate amount and type of inappropriate drug use of all doses of Exelon/Prometax patches as recorded by patients and/or their assistantsEstimation of inappropriate use will be stratified by characteristics of patients, patient assistants, and physicians, if possibleTo assess titration patterns of Exelon/Promet
• Outcomes:
  The outcomes of interest include inappropriate use, titration patterns, and perceived usefulness of the Exelon/Prometax patch Patient Reminder Card (e.g. the new educational material).
• Data analysis plan:
  The main analysis will estimate (with 95% confidence intervals) the percentage of patients with inappropriate use and the percentage of days with inappropriate use. Results will be presented both for overall/any inappropriate use as well as by type of inappropriate use (e.g. multiple patches, incorrect anatomical skin site). Results will be stratified by country and other logical variables, such as patient age, severity of dementia, time since diagnosis of dementia, previous patch use, completeness of the Medication Record Sheets, and practice/physician characteristics, where possible.Titration will be described by summarising the time elapsed from lower to higher dose and by describing the main indications for dose change. Elapsed time, as summary measures or distributions, will be presented separately for each type of dose change (e.g. oral to patch, each patch dose to next higher dose, change from higher dose to lower dose).

Documents

Study results

ena713d2409--legacy-clinical-study-report_Redacted2