Dataset Information

The burden of sialorrhoea in chronic neurological conditions: current treatment options and the role of incobotulinumtoxinA (Xeomin®).

ABSTRACT: Sialorrhoea is a frequent symptom of neurological diseases (e.g. Parkinson's disease, motor neuron disease, cerebral palsy, and stroke) and is defined as excessive saliva accumulation leading to unintentional loss of saliva from the mouth. Sialorrhoea increases the overall burden on the patient and their caregivers, the impact of which can be both physical and psychosocial. Treatments for sialorrhoea range from lifestyle and behavioural guidance, to medications, surgery or radiation. Nonpharmacological interventions include advice on posture, swallowing control, cough management, dietary changes, eating and drinking techniques, and behavioural modification; however, these conservative measures may be ineffective for people with progressive neurological conditions. The pharmacological treatment of sialorrhoea is challenging because medications licensed for this purpose are limited, but treatments can include anticholinergic drugs and botulinum toxins. Surgical treatment of sialorrhoea is typically reserved as a last resort for patients. IncobotulinumtoxinA (Xeomin®) is the first botulinum toxin type A to receive US and UK marketing authorization for the symptomatic treatment of chronic sialorrhoea due to neurological disorders in adults. In this review, we discuss and compare the frequency and method of administration, location of treatment delivery, approximate annual costs and main side effects of botulinum toxin and different anticholinergic drugs. Management of patients with chronic neurological conditions requires input from multiple specialist teams and thus a multidisciplinary team (MDT) approach is considered fundamental to ensure that care is consistent and tailored to patients' needs. To ensure that adult patients with neurological conditions receive the best care and sialorrhoea is well managed, we suggest a potential clinical care pathway for sialorrhoea with a MDT approach, which healthcare professionals could aspire to.

SUBMITTER: Morgante F

PROVIDER: S-EPMC6883364 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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The burden of sialorrhoea in chronic neurological conditions: current treatment options and the role of incobotulinumtoxinA (Xeomin®).

Morgante Francesca F Bavikatte Ganesh G Anwar Fahim F Mohamed Biju B

Therapeutic advances in neurological disorders 20191128

Sialorrhoea is a frequent symptom of neurological diseases (e.g. Parkinson's disease, motor neuron disease, cerebral palsy, and stroke) and is defined as excessive saliva accumulation leading to unintentional loss of saliva from the mouth. Sialorrhoea increases the overall burden on the patient and their caregivers, the impact of which can be both physical and psychosocial. Treatments for sialorrhoea range from lifestyle and behavioural guidance, to medications, surgery or radiation. Nonpharmaco ...[more]

PMID: 31819763

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Project description:BackgroundIncobotulinumtoxinA (Xeomin(®)) is a purified botulinum neurotoxin type A formulation, free from complexing proteins, with proven efficacy and good tolerability for the treatment of neurological conditions such as blepharospasm, cervical dystonia (CD), and post-stroke spasticity of the upper limb. This article provides a comprehensive overview of incobotulinumtoxinA based on randomized controlled trials and prospective clinical studies.SummaryIncobotulinumtoxinA provides clinical efficacy in treating blepharospasm, CD, and upper-limb post-stroke spasticity based on randomized, double-blind, placebo-controlled trials with open-label extension periods (total study duration up to 89 weeks). Adverse events were generally mild or moderate. The most frequent adverse events, probably related to the injections, included eyelid ptosis and dry eye in the treatment of blepharospasm, dysphagia, neck pain, and muscular weakness in patients with CD, and injection site pain and muscular weakness when used for treating spasticity. In blepharospasm and CD, incobotulinumtoxinA was investigated in clinical trials permitting flexible intertreatment intervals based on the individual patient's clinical need; the safety profile of intervals shorter than 12 weeks was comparable to intervals of 12 weeks and longer. There were no cases of newly formed neutralizing antibodies during the Phase III and IV incobotulinumtoxinA trials. Phase III head-to-head trials of incobotulinumtoxinA versus onabotulinumtoxinA for the treatment of blepharospasm and CD have demonstrated therapeutic equivalence of both formulations. Additional Phase III trials of incobotulinumtoxinA in conditions such as lower-limb spasticity, spasticity in children with cerebral palsy, and sialorrhea in various neurological disorders are ongoing.ConclusionIncobotulinumtoxinA is an effective, well-tolerated botulinum neurotoxin type A formulation. Data from randomized clinical trials and further observational studies are expected to help physicians to optimize treatment by tailoring the choice of formulation, dose, and treatment intervals to the patient's clinical needs.

Project description:BACKGROUND: Persons with neurological conditions and their families face a number of challenges with the provision of health and community-based services. The purpose of this study was to understand the existing health and community service needs and gaps in care and to use this information to develop a model to specify factors and processes that may improve the quality of care and health and well-being for persons with neurological conditions. METHODS: We conducted semi-structured interviews with health care professionals, community-based non-health care professionals working with individuals with neurological conditions, and policy makers -from the Ministries of Health, Community and Social Services, Transportation and Education- across Canada. We used a purposive sampling and snowballing approach to obtain maximum variation across professions, sector and geography (provinces and territories, rural and urban). Data analysis was an iterative, constant comparative process involving descriptive and interpretive analyses and was initially guided by the components of the Expanded Chronic Care Model. RESULTS: A total of 180 individuals completed the interviews: 39% (n = 70) health care professionals, 47% (n = 85) community-based non-health care professionals, and 14% (n = 25) policy makers. Based on the data we developed the Chronic Care Model for Neurological Conditions (CCM-NC). The major needs/gaps are represented by the following themes: acceptance and openness to neurological conditions, evidence informed policy, investments and funding, supported transitions, caregiver support, and life enhancing resources (education, employment, housing and transportation), knowledge and awareness of neurological conditions and availability and access to health services. The model maintains that intersectoral collaboration across the health system, community and policy components is needed. It recognizes that attitudes, policies, enhanced community integration and health system changes are needed to develop activated patients and families, proactive service delivery teams, a person-centred health system and healthy public policy for persons with neurological conditions. CONCLUSION: The CCM-NC will generate debate and discussion about the actions needed in each of the model components to enable people with neurological conditions to sustain healthier lives. Next steps include validating the model with persons with neurological conditions, in and outside of the Canadian context and developing and evaluating interventions to test the model.

Dataset Information

The burden of sialorrhoea in chronic neurological conditions: current treatment options and the role of incobotulinumtoxinA (Xeomin®).

Publications

The burden of sialorrhoea in chronic neurological conditions: current treatment options and the role of incobotulinumtoxinA (Xeomin®).

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