A 24-week, multicentre, open evaluation of the clinical effectiveness of the rivastigmine patch in patients with probable Alzheimer's disease

Konstantin Articus (1) , Monika Baier (1) , Ferenc Tracik (1) , Frank Kühn (2) , Ulrich Preuss (3) , Alexander Kurz (4)

1 Novartis Pharma GmbH
2 Facharzt für Psychiatrie
3 Department of Psychiatry
4 Department of Psychiatry and Psychotherapy

Background: Cholinesterase inhibitors form the mainstay of treatment for persons with mild-to-moderate Alzheimer's disease (AD). The rivastigmine patch may increase compliance and the proportion of patients maintaining an efficacious dose compared with oral cholinesterase inhibitors. Objective: To investigate the proportion of patients who reached and maintained the target rivastigmine patch dose compared with the target rivastigmine capsule dose reported in clinical trials. Methods: This was a multicenter, 24-week, open-label study in persons with probable AD and a Mini-Mental State Examination (MMSE) score of ≥10 and ≤26. The primary outcome was the proportion of patients (ITT population) treated with 9.5 mg/24 h rivastigmine patch for at least 8 weeks at Week 24. Secondary outcomes included Week 24 MMSE, Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC), Trail Making Test Part A (TMT-A), and Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scores. Results: Overall, 208 participants received treatment and 155 (74.5%) completed the study. Within the ITT population, 147/182 patients (80.8%; 95%CI 75.0-86.5%) were treated for at least 8 weeks with the 9.5 mg/24 h rivastigmine patch; 135/182 patients (74.2%; 95%CI 67.8-80.5%) were treated for at least 8 weeks and completed the study. The most common adverse events were nausea (10.1% of patients), erythema (8.7%), pruritus (8.2%) and vomiting (7.2%). At Week 24, patients treated with the rivastigmine patch showed improvements on MMSE, ADCS-ADL, ADCS-CGIC and TMT-A scores. Caregivers reported acceptance, preference, and satisfaction with the patch. Conclusion: Transdermal delivery may allow more patients to reach and maintain therapeutic doses of rivastigmine compared with oral rivastigmine.

Mots clés: Medicine

Konstantin Articus, Monika Baier, Ferenc Tracik, Frank Kühn, Ulrich Preuss, et al.. A 24-week, multicentre, open evaluation of the clinical effectiveness of the rivastigmine patch in patients with probable Alzheimer's disease. International Journal of Clinical Practice, 2011, 65 (7), pp.790. ⟨10.1111/j.1742-1241.2011.02713.x⟩. ⟨hal-00648535⟩