Factors Influencing Skin Tolerability to the Rivastigmine Patch in Patients with Alzheimer’s Disease
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Background and Purpose The one-day rivastigmine patch is reportedly well tolerated and has minimal side effects. However, Asian patientsshow more side effects than those in Western countries. We evaluated tolerability of the rivastigmine patch in South Korean patientswith Alzheimer’s disease (AD) and the specific factors affecting adverse events of the skin. Methods A 6-month, open labeled, multi-centered, observational study was carried out in 440 patients with probable AD from July 2009to September 2010 (NCT01312363). Results A total of 25.9% of the patients experienced adverse skin events at the rivastigmine patch application site and 17.0% discontinuedtreatment due to adverse events at the skin application site. The most common adverse events were itching and erythema. Patients with an allergichistory and users of electric heating appliances reported skin discomfort. Older age was associated with discontinuing treatment. Conclusions These results suggest that the rivastigmine patch induced some adverse skin events and may contribute to understanding andimproving skin tolerability to the rivastigmine patch.
Abstract
Background and Purpose The one-day rivastigmine patch is reportedly well tolerated and has minimal side effects. However, Asian patientsshow more side effects than those in Western countries. We evaluated tolerability of the rivastigmine patch in South Korean patientswith Alzheimer’s disease (AD) and the specific factors affecting adverse events of the skin. Methods A 6-month, open labeled, multi-centered, observational study was carried out in 440 patients with probable AD from July 2009to September 2010 (NCT01312363). Results A total of 25.9% of the patients experienced adverse skin events at the rivastigmine patch application site and 17.0% discontinuedtreatment due to adverse events at the skin application site. The most common adverse events were itching and erythema. Patients with an allergichistory and users of electric heating appliances reported skin discomfort. Older age was associated with discontinuing treatment. Conclusions These results suggest that the rivastigmine patch induced some adverse skin events and may contribute to understanding andimproving skin tolerability to the rivastigmine patch.
참고문헌 (31)
- Oertel W, "Rationale for transdermal drug administration in Alzheimer disease", Neurology, 69(4 Suppl 1), pp.S44~S9 (2007)
- Choi SH, "Tolerability and efficacy of memantine add-on therapy to rivastigmine transdermal patches in mild to moderate Alzheimer’s disease: a multicenter, randomized, open-label, parallel-group study", Curr Med Res Opin, 27, pp.1375~1383 (2011)
- Winblad B, "Caregiver preference for rivastigmine patch relative to capsules for treatment of probable Alzheimer’s disease", Int J Geriatr Psy-chiatry, 22, pp.485~491 (2007)
- Lee JH, "Effects of body weight on tolerability of rivastigmine transdermal patch: a post-hoc analysis of a double-blind trial in patients with Alzheimer disease", Alzheimer Dis Assoc Disord, 25, pp.58~62 (2011)
- Winblad B, "A six-month double-blind, randomized, placebocontrolled study of a transdermal patch in Alzheimer’s disease--rivastigmine patch versus capsule", Int J Geriatr Psychiatry, 22, pp.456~467 (2007)
- Cummings JL, "Rivastigmine transdermal patch skin tolerability: results of a 1-year clinical trial in patients with mild-to-moderate Alzheimer’s disease", Clin Drug Investig, 30, pp.41~49 (2010)
- Widman TJ, "Allergic contact dermatitis from medical adhesive bandages in patients who report having a reaction to medical bandages", Dermatitis, 19, pp.32~37 (2008)
- McKhann G, "Clinical diagnosis of Alzheimer’s disease: report of the NINCDSADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer’s Disease", Neurology, 34, pp.939~944 (1984)
- Kang Y, "A validity study on the Korean Mini-Mental State Examination (K-MMSE) in dementia patients", J Korean Neurol Assoc, 15, pp.300~308 (1997)
- Morris JC, "The Clinical Dementia Rating (CDR): current version and scoring rules", Neurology, 43, pp.2412~2414 (1993)
- Choi SH, "Estimating the Validity of the Korean Version of Expanded Clinical Dementia Rating (CDR) Scale", J Korean Neurol Assoc, 19, pp.585~591 (2001)
- Bae JN, "Development of the Korean version of the Geriatric Depression Scale and its short form among elderly psychiatric patients", J Psychosom Res, 57, pp.297~305 (2004)
- 구형모, "일상활동평가-복합(Seoul-Instrumental Activities of Daily Living ; S-IADL)의 신뢰도 및 타당도 연구", 신경정신의학, 43(2), pp.189~199 (2004), 대한신경정신의학회
- Winblad B, "IDEAL: a 6-month, double-blind, placebo-controlled study of the first skin patch for Alzheimer disease", Neurology, 69(4 Suppl 1), pp.S14~S22 (2007)
- Choi SH, "Effect of ApoE genotype on response to donepezil in patients with Alzheimer’s disease", Dement Geriatr Cogn Disord, 25, pp.445~450 (2008)
- Darreh-Shori T, "Safety and tolerability of transdermal and oral rivastigmine in Alzheimer’s disease and Parkinson’s disease dementia", Expert Opin Drug Saf, 9, pp.167~176 (2010)
- Nakamura Y, "A 24-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of the rivastigmine patch in Japanese patients with Alzheimer’s disease", Dement Geriatr Cogn Dis Extra, 1, pp.163~179 (2011)
- Articus K, "A 24-week, multicentre, open evaluation of the clinical effectiveness of the rivastigmine patch in patients with probable Alzheimer’s disease", Int J Clin Pract, 65, pp.790~796 (2011)
- Pregelj P, "Safety and tolerability of rivastigmine transdermal patch formulation in newly diagnosed patients with Alzheimer’s dementia in naturalistic conditions", Psychogeriatrics, 12, pp.165~171 (2012)
- Kulkantrakorn K, "Rivastigmine patch for treatment of Alzheimer’s disease in clinical practice in Thailand", Psychogeriatrics, 13, pp.1~8 (2013)
- Gauthier S, "Real-life effectiveness and tolerability of the rivastigmine transdermal patch in patients with mild-to-moderate Alzheimer’s disease:the EMBRACE study", Curr Med Res Opin, 29, pp.989~1000 (2013)
- Segers K, "Do local meteorological conditions influence skin irritation caused by transdermal rivastigmine? A retroprospective, pilot study", J Clin Psychopharmacol, 32, pp.412~415 (2012)
- Upadhye MR, "Influence of area of application of allergen on sensitization in contact dermatitis", Contact Dermatitis, 27, pp.281~286 (1992)
- Hurkmans JF, "Skin irritation caused by transdermal drug delivery systems during long-term (5 days) application", Br J Dermatol, 112, pp.461~467 (1985)
- Ale I, "Skin tolerability associated with transdermal drug delivery systems: an overview", Adv Ther, 26, pp.920~935 (2009)
- Waller JM, "Age and skin structure and function, a quantitative approach (I): blood flow, pH, thickness, and ultrasound echogenicity", Skin Res Technol, 11, pp.221~235 (2005)
- Waller JM, "Age and skin structure and function, a quantitative approach (II): protein, glycosaminoglycan, water, and lipid content and structure", Skin Res Technol, 12, pp.145~154 (2006)
- Fisher AA, "Dermatitis due to transdermal therapeutic systems", Cutis, 34, pp.526~527 (1984)
- Beltrani VS, "Contact dermatitis", Ann Allergy Asthma Immunol, 78, pp.160~173 (1997)
- Di Giampaolo L, "Follow up study on the immune response to low frequency electromagnetic fields in men and women working in a museum", Int J Immunopathol Pharmacol, 19(4 Suppl), pp.37~42 (2006)
- Gangi S, "A theoretical model based upon mast cells and histamine to explain the recently proclaimed sensitivity to electric and", or magnetic fields in humans, 2000, pp.54, 663~671
