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

SUMMARY 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 multicentre, 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. What’s known Rivastigmine is approved for the symptomatic treatment of persons with mild-to-moderate AD and PDD and has recently been approved in patch formulation for treatment of the same groups in the USA. Rivastigmine patch provides similar efficacy to the highest dose of rivastigmine capsule (12 mg ⁄ day) but with a superior tolerability profile. A sub-study of the IDEAL trial showed that the majority of caregivers preferred patches to capsules for drug delivery.