Aim: The majority of available data on safety and tolerability issues regarding cholinesterase inhibitors used for the treatment of Alzheimer's disease has been available for orally administered formulations. The objective of this prospective, 24 week, observational, non-interventional post-marketing surveillance study was to evaluate the safety and tolerability, as well as the efficacy, of the rivastigmine transdermal patch formulation in newly diagnosed patients with Alzheimer's dementia in naturalistic conditions.
Methods: Safety and tolerability assessment included the monitoring and recording of adverse events and withdrawals at any time during the study. The efficacy parameter was determined based on the score of the Mini-Mental State Examination.
Results: Out of the 433 patients, 11 patients (2.54%) suffered serious adverse events. Non-serious adverse events were reported in 179 patients (41.34%). As adverse event is defined as any untoward medical occurrence that may present during treatment with a pharmaceutical product but that does not necessarily have a causal relationship with this treatment. The most common adverse event in the present study was a decline in the Mini-Mental State Examination score in 97 patients (22.40%). The second most common non-serious adverse event was a skin reaction in 61 patients (14.09%). Treatment with rivastigmine continued in 139 cases (32.10%) and was discontinued in 40 cases (9.24%). The median Mini-Mental State Examination score observed at the time of inclusion was 21.0, and after 6 months, it was 22.0 (W 63441; P < 0.001). Because of several limitations, the open-label design of the present study necessitates caution when interpreting the results.
Conclusions: The results of this study suggest that the rivastigmine transdermal patch is safe and tolerable for Alzheimer's dementia patients in naturalistic conditions.
© 2012 The Author. Psychogeriatrics © 2012 Japanese Psychogeriatric Society.