JoC at 09:49, 11 September 2020

2020-09-11T09:49:12Z

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			\|Due to concerns about elevated level of fibrotic heart disease arising from high dosages of Cabergoline in patients suffering from Parkinson's, current recommendations from the MHRA are for an echocardiogram at the start of treatment and then every 6-12 months thereafter.

			If these guidelines were rigidly adhered to, then it is estimated that it would result in an extra 90,000 echocardiograms per year – an enormous burden on the NHS at a time when resources are limited. Furthermore, the repeated scanning is a significant source of anxiety for patients whose perception of risk from Cabergoline medication due to repeated investigations may be heightened. Attendance for multiple investigations also necessitates that patients take time off work.

			The aim of this project is to determine whether there is a link between cabergoline at lower ‘endocrine doses’ (typically used in the treatment of hyperprolactinaemia) and the development of fibrotic heart disease and if so, at what dosage/treatment duration this becomes a clinically significant effect as measured using the following hard endpoints: valve replacement; admission to hospital with heart failure; attendance at cardiac clinic with diagnosis of heart failure; established echocardiographic diagnosis of valvular heart disease.

			The results of this analysis will then be used to inform future iterations of the surveillance strategy for this group of patients and optimise use of resources.

			\|All patients currently registered Newham, Tower Hamlets, Waltham Forest and Hackney & City CCGs.

			\|Patients who have been prescribed Cabergoline (as identified in GP prescription records) and a comparable control cohort (5 controls for every member of the test group) randomly selected from non-Cabergoline users to match across the following dimensions:
			*GP practice location (socio-demographic proxy)
			*Age (+/- 2 years)
			*Sex
			*Ethnicity
			*Associated known drivers of heart disease (Smoking; diabetes; hypertension)

			Exclusions: users of drugs with confounding side effects(e.g. bromocriptine); patients with evidence of IV drug abuse (if available); and anyone with a pre-existing heart condition at the time of first cabergoline use (note: for control group take date of cabergoline usage in the corresponding test subject to define "pre-existing").

			Assumptions/notes:
			*The starting point for the analysis is Cabergoline usage, and not prolactinaemia. This will enable measurement of effects beyond the dosage range of the prolactinoma group (e.g. on patients with Parkinson's and/or restless leg syndrome).
			*Short term usage for 3 or fewer days (e.g. to prevent lactation in women ceasing breastfeeding) is included in this population.

			\|
			*Prolactinoma Diagnoses and Indicators
			*Other Cabergoline-related diagnoses and indicators
			*Cabergoline Usage
			*Comorbidity Data
			*Demographic Data
			*Valvular Disease Diagnoses and Indicators
			*Echocardiagram Data
			*Requested Outcomes Data

			\|Patient identifiable
	}}		}}

JoC at 09:20, 11 September 2020

2020-09-11T09:20:42Z

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Cabergoline - Revision history

JoC at 09:49, 11 September 2020

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