Ideal

Abstract

The rivastigmine patch is the first transdermal treatment for Alzheimer disease (AD). By providing continuous delivery of drug into the bloodstream over 24 hours, transdermal delivery may offer benefits superior to those of oral administration. This study compared the efficacy, safety and tolerability of rivastigmine patches with capsules and placebo. IDEAL (Investigation of transDermal Exelon in ALzheimer's disease) was a 24-week, double-blind, double-dummy, placebo- and active-controlled study. Patients with AD were randomized to placebo or one of three active treatment target dose groups: 10-cm(2) rivastigmine patch (delivering 9.5 mg/24 hours); 20-cm(2) rivastigmine patch (17.4 mg/24 hours); or 6-mg BID rivastigmine capsules. Primary efficacy measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale and Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. Secondary outcome measures assessed a range of domains, including behavior, cognitive performance, attention, executive functions, and activities of daily living. A total of 1,195 AD patients participated. All rivastigmine treatment groups showed significant improvement relative to placebo. The 10-cm(2) patch showed similar efficacy to capsules, with approximately two-thirds fewer reports of nausea (7.2% vs 23.1%) and vomiting (6.2% vs 17.0%), incidences statistically not significantly different from placebo (5.0% and 3.3% for nausea and vomiting, respectively). The 20-cm(2) patch showed earlier improvement and numerically superior cognitive scores vs the 10-cm(2) patch with similar tolerability to capsules. Local skin tolerability was good. The transdermal patch with rivastigmine may offer additional therapeutic benefits and may prove to be the best delivery system for this drug to treat AD.

Rivastigmine for HIV-associated neurocognitive disorders

“…35 The dropout rate (23%) also remained comparable to those reported in clinical trials with patients with AD. 36 Tolerability issues might be solved in future studies by the use of a transdermal form of rivastigmine, currently available for the treatment of patients with AD. Rivastigmine patches provide the advantage of a continuous delivery of drug over 24 hours and were demonstrated to offer a greater tolerability than oral rivastigmine.…”

Guidelines for the Management of Cognitive and Behavioral Problems in Dementia

“…11 Likewise, the tolerability profile is similar between the ChEIs for the oral formulations. However, the 10-cm 2 rivastigmine patch has shown efficacy similar to oral rivastigmine formulations, but with approximately two-thirds fewer reports of nausea and vomiting, with adverse event (AE) rates similar to those of placebo 32 (Table 1). AD often is accompanied and worsened by malnutrition, and weight loss is a frequent complication of AD, occurring in approximately 40% of patients at all stages.…”

Diagnosis and treatment of dementia: 5. Nonpharmacologic and pharmacologic therapy for mild to moderate dementia

“…10,31 Since the consensus conference was held, rivastigmine has become available as a transdermal patch. 32 However, in July 2008 the Canadian Expert Drug Advisory Committee recommended that the patch not be listed by publicly funded drug benefit programs. 33 If one cholinesterase inhibitor is not well tolerated or deemed ineffective, patients can be switched to another one 31 or to memantine.…”

“…The rivastigmine transdermal patch seems to be associated with less nausea and vomiting than the oral form. 32 Weight loss did occur during the clinical trials of all 3 agents. A variety of other adverse effects can occur.…”