Safety and tolerability of rivastigmine transdermal patch formulation in newly diagnosed patients with Alzheimer's dementia in naturalistic conditions

Abstract

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 MiniMental 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.

An update on the safety of current therapies for Alzheimer’s disease: focus on rivastigmine

“…In fact, adverse skin reactions reports are shown to be more frequent in naturalistic open-label studies or those lacking doubleblinding, hence the importance of the study design in minimizing any risk of bias. [39][40][41][42][43] Educating patients and caregivers at the time of patch prescription about the characteristics of benign versus serious skin reactions contributes to decreasing the rate of patch discontinuation with non-allergic skin lesions, in which case the advantages of continued adherence outweigh the risks. They also need to know that dermatitis is manageable with cold compresses, moisturizing cream and/or topical corticosteroids, and is often preventable by avoiding alcohol or soap use on the skin immediately before patch application, changing the application site every day, alternating between the upper back and lower back, chest, shoulders and upper arms, which are thought to be associated with the least skin irritation, removing the patch gently and moisturizing the skin afterwards.…”

“…In fact, adverse skin reactions reports are shown to be more frequent in naturalistic open-label studies or those lacking double-blinding, hence the importance of the study design in minimizing any risk of bias. 39–43…”