This paper analyzes the Exelon patch as a delivery mechanism for rivastigmine in treating mild to moderate Alzheimer's disease. It explores the drug's mechanism of action, compares Alzheimer's and Parkinson's dementias, reviews clinical evidence from NHS evaluations, and discusses the advantages of transdermal patch delivery over oral capsules. The paper examines economic, social, ethical, and medical implications of rivastigmine therapy and addresses specific concerns for dental hygiene practice, including drug interactions and liability considerations.
The Exelon patch is a transdermal delivery system for rivastigmine, a medication used to treat patients with mild to moderate Alzheimer's disease. The patch allows rivastigmine to enter the bloodstream at a steady level over 24 hours, delivering up to 9.5 mg daily. Rivastigmine is a cholinesterase inhibitor that produces gastrointestinal side effects in some patients who take the oral capsule form. The patch delivery method addresses this concern by providing steady absorption and reducing adverse reactions.
A 2007 article about Novartis' Exelon patch reported that over 70 percent of patients preferred the patch to the oral capsule form. The article emphasized that by 2030 the number of people with Alzheimer's disease is expected to reach 7.7 million, and convenient drug delivery will assist caregivers while minimizing disruption to patients' daily life and ensuring accurate treatment schedules. However, clinical research findings have challenged these marketing claims, with expert reviews questioning the drug's actual effectiveness for mild to moderate Alzheimer's disease.
Parkinson's disease is treated in 70–80 percent of patients with Carbidopa/Levodopa (Sinemet). As noted in clinical literature, "Levodopa is a substance that is converted into dopamine by an enzyme in the brain. It is then released by brain cells and activates dopamine receptors allowing for normal function of the movement control centers of the brain" (Medications, p. 1). Rivastigmine is also prescribed for Parkinson's disease in patients who have developed additional dementia, as it enhances mental functioning.
The use of rivastigmine differs between the two conditions based on the underlying pathology. In Parkinson's disease, the primary motor symptoms dominate, and rivastigmine serves as an adjunctive treatment for cognitive decline. In Alzheimer's disease, rivastigmine is considered a primary therapeutic agent, though clinical evidence questions its benefit. This distinction reflects the different neurobiological mechanisms and symptom profiles of each disease.
Parkinson's disease affects the substantia nigra, causing its progressive deterioration and cell death. It is a progressive, chronic movement disorder whose primary symptoms include tremors, poor balance, slow movement (bradykinesia), rigidity, and difficulty walking, referred to as "Parkinsonian gait." The disease is fundamentally a disorder of motor control, originating in specific midbrain structures.
Alzheimer's disease is also progressive, but it is not confined to the movement control center of the brain. Rather, it destroys brain cells in the memory, thinking, and behavior areas of the brain. Unlike Parkinson's disease, Alzheimer's is fatal and represents the seventh leading cause of death in the United States today. Parkinson's disease does not appear among the leading causes of death. This fundamental difference in lethality and anatomical scope reflects the distinct neuropathological mechanisms underlying each disease.
Rivastigmine is a cholinesterase inhibitor similar to neostigmine (Prostigmin), physostigmine (Antilirium, Isopto Eserine), and pyridostigmine (Mestinon, Regonol), all of which treat disorders of the brain and nervous system. It is sometimes used to treat Lewy body dementia. The drug comes in capsule, solution (syringe), and patch formulations and is usually taken twice daily in carefully controlled doses, as excessive amounts may cause gastrointestinal disorders.
The clinical evidence supporting rivastigmine has evolved significantly. Rivastigmine was first evaluated in 2001 and was reanalyzed in 2005 by the National Institute for Clinical Excellence (now NICE), which found that "Donepezil, rivastigmine and galantamine are not recommended for use for the treatment of mild to moderate Alzheimer's disease." The 2001 Committee had found that rivastigmine and related drugs could delay the need for full-time care. However, the 2005 analysis disputed this, finding that "Data acquired since 2001 show that improvements in cognition (memory)...could be less than originally observed and was certainly no more" (NHS, 2005, p. 2).
In essence, the updated study concluded that rivastigmine had no demonstrable effect on improving memory, did not delay the need for full-time care, and did not improve the quality of life for patients with Alzheimer's disease. The latest appraisal in 2007 reinforced this finding, again concluding that Donepezil, rivastigmine, and galantamine are not recommended in the treatment of people with mild to moderately severe Alzheimer's disease (NHS, 2007, p. 1).
Currently, clinical trials sponsored by the U.S. National Library of Medicine, the U.S. National Institutes of Health, and the U.S. Department of Health and Human Services are ongoing to determine the drug's actual effectiveness. These studies are necessary given manufacturer claims and the drug's commercial importance to Novartis.
Rivastigmine causes gastrointestinal side effects, but the patch allows only a small amount to be steadily absorbed into the bloodstream, thereby creating fewer negative reactions. The Novartis marketing strategy emphasizes convenience, stating: "On average, an older American takes 5 prescription medicines. These medicines may need to be taken at different times and managing them all may seem overwhelming" (Novartis, para. 1). In this context, a patch eliminates the need to remember multiple doses of one medication throughout the day.
The transdermal delivery system addresses two significant clinical problems: first, it reduces gastrointestinal adverse effects that limit oral dosing, and second, it improves medication adherence by eliminating the need for multiple daily doses. These practical advantages may be particularly valuable for elderly patients and their caregivers, even if the drug's cognitive benefits remain uncertain.
"Definition and symptom progression in dementia disorders"
"Systemic effects on patients, caregivers, policy and liability"
"Drug interactions and professional liability for hygiene providers"
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