Increased risk of all‐cause mortality associated with domperidone use in Parkinson's patients: a population‐based cohort study in the UK

Simeonova, Marina; Vries, Frank de; Pouwels, S.; Driessen, Johanna H M; Leufkens, Hubert G. M.; Cadarette, Suzanne M.; Burden, Andrea M.

doi:10.1111/bcp.13708

Cited by 9 publications

(5 citation statements)

References 33 publications

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“…On the hand, domperidone was associated with an increased risk of mortality in the general population, recently confirmed in the PD population, the current use of domperidone being associated with a 2-fold increase mortality, increasing to 3-fold in the month following initiation [28]. The cause of this higher mortality in PD is not known and the increased risk in this study concerned all causes of mortality.…”

Section: Discussionsupporting

confidence: 53%

“…The cause of this higher mortality in PD is not known and the increased risk in this study concerned all causes of mortality. However, the higher mortality associated with domperidone has been suggested to be related the propensy of domperidone to prolong QT and has been associated with sudden death in the general population [28]. In our study, less than 60% of the neurologists declared taking special precaution regarding this risk, and among all respondents, only a quarter of neurologists declared performing an ECG before initiating domperidone or requesting a consultation with a cardiologist.…”

Section: Discussionmentioning

confidence: 50%

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Evaluation of Prescription Practices of Domperidone in Parkinson’s Disease: A Cross Sectional Study Among French Neurologists

et al. 2020

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Background-Domperidone is used to treat gastrointestinal symptoms in patients withParkinson's disease (PD). Due to increased risk of cardiac adverse events, the European Medicines Agency (EMA) has issued recommendations restricting its use mainly in terms of age and dose and treatment duration. Objective-The aim of this study was to investigate nowadays prescription practices of domperidone in PD among French neurologists. Methods-A cross sectional study based on a questionnaire was conducted among French neurologists from Parkinson Expert Centers from the French NS-Park/FCRIN network, general hospitals and private practice.Results-Among the 253 neurologists who completed the questionnaire, 86 (34%) were physicians from Expert Centers and 167 (66%) from other healthcare settings; 209 (83%) were aware of recommendations restricting domperidone use. The majority of neurologists (92%) declared prescribing domperidone regardless of the age of the patients. Neurologists were 61% to prescribed domperidone beyond 7 days in newly diagnosed patients, 33% in patients with orthostatic hypotension and 79% in patients under continuous apomorphine.They did not follow the recommendation on posology in newly diagnosed patients (7% of neurologists), patients with orthostatic hypotension (10%) and patients under continuous apomorphine therapy (25%). Finally, 58% of neurologists declared taking specific precautions before prescribing domperidone.Conclusions-These findings underline most French neurologists who responded do not fully follow the restrictions on domperidone use, particularly in terms of treatment duration, and in patients with continuous apomorphine. This may reflects unmet needs to prevent nausea in PD patients treated with dopaminergic drugs, particularly continuous apomorphine. key points The European Medicines Agency has issued recommendations restricting domperidone use to patients younger than 60 years-old, at doses below 30 mg/day and for a short period only; making it challenging for neurologists to prescribe domperidone for patients with Parkinson's disease. Our results underline most French neurologists who responded do not fully follow the restrictions on domperidone use and specific precautions are not always taken before prescribing this medicine to Parkinson disease patients. This study highlights the unmet needs to prevent nausea in Parkinson disease patients treated with dopaminergic drugs.

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Section: Discussionsupporting

confidence: 53%

Section: Discussionmentioning

confidence: 50%

Evaluation of Prescription Practices of Domperidone in Parkinson’s Disease: A Cross Sectional Study Among French Neurologists

et al. 2020

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“…Simeonova et al . found a 2-fold death risk in PD patients taking domperidone as compared with those PD patients not taking this drug 52 . Thus, performing screenings of PD patient’s HRV over the course of the disease could greatly improve the management of the disease and perhaps provide further clues to whether or not the administration of domperidone to Parkinson’s patients is associated with sudden unexpected death.…”

Section: Discussionmentioning

confidence: 95%

Cardiovascular alterations in rats with Parkinsonism induced by 6-OHDA and treated with Domperidone

Rodrigues

Oliveira

Shinoda

et al. 2019

Sci Rep

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After Alzheimer, Parkinson disease (PD) is the most frequently occurring progressive, degenerative neurological disease. It affects both sympathetic and parasympathetic nervous systems in a variable fashion. Cardiovascular symptoms are present in almost all stages of PD and narrower heart rate variability is the earliest sign. Administration of Levodopa to PD patients has proven to provide some degree of neurological protection. This drug, however, causes side effects including nausea and vomiting, lessened by the administration of domperidone. Autopsies in PD patients led some researchers to suggest the involvement of the ventricular arrhythmia induced by domperidone. The aim of the present study was to determine the impact of the adjusted human maximal dose of domperidone, on cardiological features of Wistar rats. domperidone was administered to both 6-hydroxydopamine Parkinsonism models and regular Wistar rats. Quantitative analysis of ranges of heart beat variation showed significant abnormal distribution in both groups receiving domperidone as compared with respective sham counterparts. However, qualitative analysis of Poincaré plots showed that 6-hydroxydopamine Parkinsonism models receiving domperidone had the narrowest full range of heart beat and the worst distribution heart beat ranges as compared with all study groups corroborating with previous suggestion that domperidone administration to PD patients is likely to play a role in sudden unexpected death in this group of patients.

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“…However, it is still important to treat in Parkinson’s disease patients with dopamine agonists, nausea and vomiting are important adverse effects of those. Therefore, domperidone use in elderly patients must be prescribed only when necessary and careful monitoring is needed for a better benefit–risk profile [30].…”

Section: Discussionmentioning

confidence: 99%

Impact of Safety Warning on Domperidone Prescribing for Geriatric Patients in South Korea: Analysis of National Insurance Claim Data

Rhew

Han

2019

IJERPH

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Domperidone is a dopamine antagonist used for the symptomatic management of nausea and vomiting. Many countries banned or add a black box warning due to an increased risk of serious adverse cardiac effects. In 2014, the Korea Ministry of Food and Drug Safety also released a safety warning to carefully consider adverse cardiac effects when prescribing domperidone. Therefore, we conducted this study to analyze the impact of the safety warning on domperidone prescribing. This study included patients 65 years or older who used national health insurance services in the years 2011 and 2016, using the national patient sample dataset in South Korea. We analyzed the characteristics of domperidone prescribing and compared on pre- and post-safety warning. Prescribing frequency of domperidone was significantly reduced from 603,962 cases in 2011 to 24,623 cases in 2016. In 2011, 53,272 (8.8%) prescriptions were for greater than 30 mg/day, whereas only 200 (0.8%) prescriptions were in 2016. The number of patients with one or more comorbidities and electrocardiogram monitoring showed positive changes after the safety warning. In conclusion, after the 2014 safety letter was issued, domperidone was more safely prescribed in various aspects in elderly patients, including frequency of prescribing, maximum daily dose, and duration of continuous prescription.

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Increased risk of all‐cause mortality associated with domperidone use in Parkinson's patients: a population‐based cohort study in the UK

Abstract: Current use of domperidone was associated with a two-fold increased mortality risk in PD patients, as compared to PD patients that never used domperidone. The risk is highest in the first month of use and does not appear to be attributable to PD alone.

Cited by 9 publications

References 33 publications

Evaluation of Prescription Practices of Domperidone in Parkinson’s Disease: A Cross Sectional Study Among French Neurologists

Evaluation of Prescription Practices of Domperidone in Parkinson’s Disease: A Cross Sectional Study Among French Neurologists

Cardiovascular alterations in rats with Parkinsonism induced by 6-OHDA and treated with Domperidone

Impact of Safety Warning on Domperidone Prescribing for Geriatric Patients in South Korea: Analysis of National Insurance Claim Data

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