Safety and tolerability of rivastigmine transdermal patch compared with rivastigmine capsules in patients switched from donepezil

Data from three clinical trials

C. H. Sadowsky, Martin Farlow, X. Meng, J. T. Olin

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Objectives: To compare the safety and tolerability of switching patients with mild-to-moderate Alzheimer's disease from donepezil to either rivastigmine capsule or transdermal patch. Methods: Three studies investigated the switch from donepezil to rivastigmine; study US13 was a 26-week, single-arm, immediate-switch study; US18 was a 26-week, sequential cohort study (both studies evaluated rivastigmine capsules 3-12 mg/day); study US38 was a 25-week, randomised, parallel-group, open-label study which investigated switch (immediate or after 7 days' withdrawal) from donepezil to rivastigmine transdermal patch (4.6 mg/24 hr). Safety outcomes included adverse events (AEs), discontinuations caused by AEs and serious AEs (SAEs). Results: Patient groups receiving rivastigmine patch (n = 261) or capsules (n = 331) had mean ± SD ages of 77.3 ± 8.0 and 78.1 ± 7.8 years, dementia durations of 3.9 ± 2.6 and 3.6 ± 2.2 years and Mini-Mental State Examination scores of 18.3 ± 4.00 and 17.9 ± 4.4 respectively. Overall, 184 (70.5%) and 276 (83.4%) patients experienced at least one AE, and 23 (8.8%) and 55 (16.6%) patients experienced an SAE with the rivastigmine patch and capsules respectively. Of the patients who experienced an AE, 10 (3.8%) and 109 (32.9%) experienced nausea, and 11 (4.2%) and 80 (24.1%) experienced vomiting with the rivastigmine patch and capsules respectively. Discontinuations because of AEs occurred in 64 (19.3%) patients receiving capsules and 38 (14.6%) patients in the transdermal patch group. The most common reasons for discontinuation with the transdermal patch were application site reaction and disease progression, and nausea and vomiting with the capsules. Conclusions: The rivastigmine transdermal patch appears to have better tolerability than rivastigmine capsules, with fewer gastrointestinal AEs and discontinuations because of these AEs. Simple daily rotation of patch location will likely reduce the frequency of skin reactions. This post hoc analysis was carried out by Novartis Pharmaceuticals Corporation. Data for the analysis were collected from the US13 study (CENA713B US13), the US18 study (CENA713B US18) and the US38 study (CENA713D US38).

Original languageEnglish
Pages (from-to)188-193
Number of pages6
JournalInternational Journal of Clinical Practice
Volume64
Issue number2
DOIs
StatePublished - Jan 2010

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Rivastigmine
Transdermal Patch
Capsules
Clinical Trials
Safety
Nausea
Vomiting
donepezil

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{6e8783e7158742238039f2ba88fa2839,
title = "Safety and tolerability of rivastigmine transdermal patch compared with rivastigmine capsules in patients switched from donepezil: Data from three clinical trials",
abstract = "Objectives: To compare the safety and tolerability of switching patients with mild-to-moderate Alzheimer's disease from donepezil to either rivastigmine capsule or transdermal patch. Methods: Three studies investigated the switch from donepezil to rivastigmine; study US13 was a 26-week, single-arm, immediate-switch study; US18 was a 26-week, sequential cohort study (both studies evaluated rivastigmine capsules 3-12 mg/day); study US38 was a 25-week, randomised, parallel-group, open-label study which investigated switch (immediate or after 7 days' withdrawal) from donepezil to rivastigmine transdermal patch (4.6 mg/24 hr). Safety outcomes included adverse events (AEs), discontinuations caused by AEs and serious AEs (SAEs). Results: Patient groups receiving rivastigmine patch (n = 261) or capsules (n = 331) had mean ± SD ages of 77.3 ± 8.0 and 78.1 ± 7.8 years, dementia durations of 3.9 ± 2.6 and 3.6 ± 2.2 years and Mini-Mental State Examination scores of 18.3 ± 4.00 and 17.9 ± 4.4 respectively. Overall, 184 (70.5{\%}) and 276 (83.4{\%}) patients experienced at least one AE, and 23 (8.8{\%}) and 55 (16.6{\%}) patients experienced an SAE with the rivastigmine patch and capsules respectively. Of the patients who experienced an AE, 10 (3.8{\%}) and 109 (32.9{\%}) experienced nausea, and 11 (4.2{\%}) and 80 (24.1{\%}) experienced vomiting with the rivastigmine patch and capsules respectively. Discontinuations because of AEs occurred in 64 (19.3{\%}) patients receiving capsules and 38 (14.6{\%}) patients in the transdermal patch group. The most common reasons for discontinuation with the transdermal patch were application site reaction and disease progression, and nausea and vomiting with the capsules. Conclusions: The rivastigmine transdermal patch appears to have better tolerability than rivastigmine capsules, with fewer gastrointestinal AEs and discontinuations because of these AEs. Simple daily rotation of patch location will likely reduce the frequency of skin reactions. This post hoc analysis was carried out by Novartis Pharmaceuticals Corporation. Data for the analysis were collected from the US13 study (CENA713B US13), the US18 study (CENA713B US18) and the US38 study (CENA713D US38).",
author = "Sadowsky, {C. H.} and Martin Farlow and X. Meng and Olin, {J. T.}",
year = "2010",
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T1 - Safety and tolerability of rivastigmine transdermal patch compared with rivastigmine capsules in patients switched from donepezil

T2 - Data from three clinical trials

AU - Sadowsky, C. H.

AU - Farlow, Martin

AU - Meng, X.

AU - Olin, J. T.

PY - 2010/1

Y1 - 2010/1

N2 - Objectives: To compare the safety and tolerability of switching patients with mild-to-moderate Alzheimer's disease from donepezil to either rivastigmine capsule or transdermal patch. Methods: Three studies investigated the switch from donepezil to rivastigmine; study US13 was a 26-week, single-arm, immediate-switch study; US18 was a 26-week, sequential cohort study (both studies evaluated rivastigmine capsules 3-12 mg/day); study US38 was a 25-week, randomised, parallel-group, open-label study which investigated switch (immediate or after 7 days' withdrawal) from donepezil to rivastigmine transdermal patch (4.6 mg/24 hr). Safety outcomes included adverse events (AEs), discontinuations caused by AEs and serious AEs (SAEs). Results: Patient groups receiving rivastigmine patch (n = 261) or capsules (n = 331) had mean ± SD ages of 77.3 ± 8.0 and 78.1 ± 7.8 years, dementia durations of 3.9 ± 2.6 and 3.6 ± 2.2 years and Mini-Mental State Examination scores of 18.3 ± 4.00 and 17.9 ± 4.4 respectively. Overall, 184 (70.5%) and 276 (83.4%) patients experienced at least one AE, and 23 (8.8%) and 55 (16.6%) patients experienced an SAE with the rivastigmine patch and capsules respectively. Of the patients who experienced an AE, 10 (3.8%) and 109 (32.9%) experienced nausea, and 11 (4.2%) and 80 (24.1%) experienced vomiting with the rivastigmine patch and capsules respectively. Discontinuations because of AEs occurred in 64 (19.3%) patients receiving capsules and 38 (14.6%) patients in the transdermal patch group. The most common reasons for discontinuation with the transdermal patch were application site reaction and disease progression, and nausea and vomiting with the capsules. Conclusions: The rivastigmine transdermal patch appears to have better tolerability than rivastigmine capsules, with fewer gastrointestinal AEs and discontinuations because of these AEs. Simple daily rotation of patch location will likely reduce the frequency of skin reactions. This post hoc analysis was carried out by Novartis Pharmaceuticals Corporation. Data for the analysis were collected from the US13 study (CENA713B US13), the US18 study (CENA713B US18) and the US38 study (CENA713D US38).

AB - Objectives: To compare the safety and tolerability of switching patients with mild-to-moderate Alzheimer's disease from donepezil to either rivastigmine capsule or transdermal patch. Methods: Three studies investigated the switch from donepezil to rivastigmine; study US13 was a 26-week, single-arm, immediate-switch study; US18 was a 26-week, sequential cohort study (both studies evaluated rivastigmine capsules 3-12 mg/day); study US38 was a 25-week, randomised, parallel-group, open-label study which investigated switch (immediate or after 7 days' withdrawal) from donepezil to rivastigmine transdermal patch (4.6 mg/24 hr). Safety outcomes included adverse events (AEs), discontinuations caused by AEs and serious AEs (SAEs). Results: Patient groups receiving rivastigmine patch (n = 261) or capsules (n = 331) had mean ± SD ages of 77.3 ± 8.0 and 78.1 ± 7.8 years, dementia durations of 3.9 ± 2.6 and 3.6 ± 2.2 years and Mini-Mental State Examination scores of 18.3 ± 4.00 and 17.9 ± 4.4 respectively. Overall, 184 (70.5%) and 276 (83.4%) patients experienced at least one AE, and 23 (8.8%) and 55 (16.6%) patients experienced an SAE with the rivastigmine patch and capsules respectively. Of the patients who experienced an AE, 10 (3.8%) and 109 (32.9%) experienced nausea, and 11 (4.2%) and 80 (24.1%) experienced vomiting with the rivastigmine patch and capsules respectively. Discontinuations because of AEs occurred in 64 (19.3%) patients receiving capsules and 38 (14.6%) patients in the transdermal patch group. The most common reasons for discontinuation with the transdermal patch were application site reaction and disease progression, and nausea and vomiting with the capsules. Conclusions: The rivastigmine transdermal patch appears to have better tolerability than rivastigmine capsules, with fewer gastrointestinal AEs and discontinuations because of these AEs. Simple daily rotation of patch location will likely reduce the frequency of skin reactions. This post hoc analysis was carried out by Novartis Pharmaceuticals Corporation. Data for the analysis were collected from the US13 study (CENA713B US13), the US18 study (CENA713B US18) and the US38 study (CENA713D US38).

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