Rivastigmine (Exelon) Transdermal Patch Skin Tolerability

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Rivastigmine Transdermal Patch Skin Tolerability: Results of a 1-Year Clinical

Trial in Patients with Mild-to-Moderate Alzheimer's Disease

1 January 2010

Abstract

Background and Objectives: Transdermal patches provide non-invasive, continuous

drug delivery, and offer significant potential advantages over oral treatments.

With all transdermal treatments a proportion of patients will experience some

form of skin reaction. The rivastigmine patch has been approved for the

treatment of mild-to-moderate Alzheimer's disease (AD) since July 2007 in the

US. The aim of the component of the trial reported here was to evaluate the skin

tolerability of the rivastigmine transdermal patch in patients with

mild-to-moderate AD.

Methods: The pivotal IDEAL trial was a 24-week, randomized, double-blind,

placebo-controlled, multicentre trial of the efficacy and tolerability of the

rivastigmine transdermal patch in 1195 patients with mild-to-moderate AD. This

was followed by a 28-week open-label extension. Although not prospectively

defined as a secondary assessment, during both phases of the study the condition

of the patients' skin at the application site was evaluated. These data are

reviewed in this article.

Results: During the 24-week, double-blind phase of the study, 89.6% of patients

in the target 9.5 mg/24 h patch treatment group had recorded 'no, slight or

mild' signs or symptoms for their most severe application-site reaction.

Erythema and pruritus were the most commonly reported reactions. No patient in

any patch treatment group experienced a skin reaction that was reported as a

serious adverse event. In the 9.5 mg/24 h treatment group, 2.4% of patients

discontinued treatment due to an application-site reaction. During the 28-week

open-label extension, the skin tolerability profile was similar to that seen in

the double-blind phase. Overall, 3.7% of patients discontinued treatment due to

application-site skin reactions. There was no indication that the severity of

the skin reactions increased over time.

Conclusion: Overall, the data support a favourable skin tolerability profile for

the rivastigmine transdermal patch, and provide reassurance that the benefits of

rivastigmine patch therapy for patients with AD are not confounded by

significant skin irritation problems. Nevertheless, care should be taken to

follow manufacturer's advice about patch application, such as daily rotation of

the application site, to minimize the risk of skin reactions.

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