Opicapone is a treatment for Parkinson’s disease patients which is added to other therapies when symptoms are not controlled (known as end of dose on-off phenomena). Although Parkinson’s disease is diagnosed by its motor symptoms, non-motor symptoms such as sleep disturbances are also prevalent and can be more disabling than the motor symptoms.
This study aims to provide further information on the effectiveness of opicapone in Parkinson’s disease in a ‘real world’ setting. The study will evaluate the effectiveness of starting opicapone, compared to starting an alternative treatment, entacapone, and will also compare people who are treated with opicapone without previously taking entacapone to those who have switched to opicapone from entacapone. Effectiveness will be measured in three ways: the number of people who have a change in the overall dose of other Parkinson’s disease treatments, the number of people who have a reduction or discontinuation in sleep medications and the rate of contacts with a hospital neurology outpatient department. We will also report the age, sex, disease duration, and compare healthcare resource use and Parkinson’s prescription treatment use, in the two groups before opicapone and entacapone were started. The results of the study will provide information on how these two treatments are used and on the effectiveness of opicapone compared to usual treatment in routine care and so will help support clinicians in their prescribing choices.
Parkinson’s disease is associated with disabling motor and non-motor symptoms (including sleep disturbances). Opicapone is a catechol-O-methyltransferase (COMT) inhibitor indicated in Parkinson’s disease as an adjunct to levodopa and dopa-decarboxylase inhibitors in patients with end-of-dose motor fluctuations. This study aims to evaluate the effectiveness of opicapone in Parkinson’s disease in routine practice.
The study is a comparative cohort study of new users of opicapone and entacapone as recorded in CPRD Aurum or Gold (CPRD) prescription records. As a secondary objective, first-line opicapone users, i.e. no previous COMT inhibitor, will be compared to opicapone users with a previous entacapone prescription. Outcomes will be markers for effectiveness; number of neurology outpatient contacts (HES outpatient file), a reduction in sleep medication (reduced dose or discontinuation), and a change in daily levodopa equivalent dose (LEDD) (both from CPRD prescribing records). LEDD will be estimated using published methodology. Treatment effectiveness in Parkinson’s disease may be demonstrated by improved sleep and management of symptoms on a lower LEDD. Symptoms improvement and better tolerability should lead to fewer outpatient contacts.
The opicapone exposed cohort will be propensity score matched to up to four comparators based on greedy nearest neighbour methods including age, sex, disease duration. The mean annual number of neurology outpatient contacts per person and changes in LEDD, will be compared between treatment groups using mixed generalised linear modelling. The proportion with a sleep medication reduction will be compared between treatment groups using conditional logistic regression. Adjustment will be performed for potential confounders not included in the propensity matching. Exposure cohorts will be described in terms of baseline characteristics, healthcare resource use (HCRU), and non-COMT Parkinson’s disease prescription treatments pre-matching, with the HCRU, and Parkinson’s disease prescribing compared.
Reduction in sleep medication; outpatient contacts (neurology and all); and change in LEDD; increase in sleep medication; number of inpatient stays; number of inpatient bed days (elective and, separately, non-elective by neurology and all); accident and emergency contacts.
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
David Heaton - Collaborator - Harvey Walsh Ltd
Francesca Morgante - Collaborator - St George's, University of London
K Ray Chaudhuri - Collaborator - King's College London (KCL)
Matthew O'Connell - Collaborator - Harvey Walsh Ltd
Myriam Alexander - Collaborator - Harvey Walsh Ltd
Rhiannon Thomason - Collaborator - Harvey Walsh Ltd
Stoyan Minchev - Collaborator - Bial Phama UK Ltd
Valentina Di Foggia - Collaborator - Bial Phama UK Ltd
Xiaocong Marston - Collaborator - Harvey Walsh Ltd
Myriam Alexander - Collaborator - Harvey Walsh Ltd
Rhiannon Thomason - Collaborator - Harvey Walsh Ltd
Xiaocong Marston - Collaborator - OPEN Health Group
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient