Migraine is a common and painful long-term condition of the brain affecting approximately 15% of the global population. Considered one of the main causes of disability, frequent migraine occurrences (“episodes”) result in reduced quality of life, negative impacts to mental health and increased burden on patients, families and society. An estimated total of 43 million days of work and education are lost each year due to migraine.
While there are no cures for migraine, several treatments for managing symptoms (“acute”) and preventing future migraines (“preventive”) are available. However, delays in diagnosis, lack of response to treatment and the development of headaches resulting from the frequent use of medicines or painkillers make managing the condition difficult. Triptans are a type of drug commonly used as acute treatment. However, not all patients respond to the first triptan they are prescribed and so patients may subsequently be prescribed a different type of triptan or composition (tablet, injection or nasal sprays) or receive concomitant painkillers or other drugs to combat nausea and vomiting. As previous treatments, patients’ medical history and side effects of each drug need to be taken into consideration, it can take a long time before the condition is managed.
This feasibility study aims to explore sequences of treatments prescribed, use of triptans and management in patients with migraine using routinely collected healthcare data. Findings will inform a future study investigating treatment characteristics and use of healthcare services and associated medical costs of migraine care in the UK, by triptan use.
There is limited published evidence on the number, type and formulation of triptans prescribed as acute treatment for migraine or the use of triptans within migraine treatment sequencing of acute and preventative treatments in UK clinical practice. Furthermore, some patients with migraine are also managed in secondary care and may purchase treatments over-the-counter. Previous Clinical Practice Research Datalink (CPRD) studies in migraine do not adequately address current evidence needs; the findings do not reflect latest available treatments and guidelines, triptan use is not explored explicitly, and both acute and preventative treatments are not considered.
Therefore, this feasibility study aims to a) describe the treatment sequencing for migraine in primary care and explore the derivation of robust definitions for triptan failure to understand whether subgroup analyses by triptan use/failure may be possible, and b) explore the extent to which migraine care can be comprehensively captured using linked CPRD Aurum and Hospital Episode Statistics (HES) data. These findings will inform a future retrospective cohort study aiming to investigate treatment characteristics (e.g. wastage, and temporal patterns in migraine management across care settings) and quantify healthcare resource utilisation and direct medical costs of migraine care in the UK, by triptan status.
Adult patients with an incident diagnosis of migraine (i.e. no prior diagnoses in medical history) in primary care between 2018 and 2021 will be identified. Migraine treatment sequences, including triptan use/failure (triptan naïve, no triptan failure, one failure, two failures, three or more failures), will be described in the 12 months (minimum) following the first/earliest diagnosis of migraine. Linked HES data will be used to observe migraine-related healthcare events in the secondary care setting; namely, inpatient stays, outpatient visits and A&E attendances.
All analysis will be descriptive in nature. Values representing <5 patients will be suppressed (including secondary suppression).
Prescribed migraine treatments; Treatment sequencing (at class-level and at drug and formulation levels for triptans); Healthcare events among patients with migraine (consultations in primary care, inpatient admissions, outpatient visits, A&E attendances).
This feasibility study is intended to determine whether there are sufficient patient numbers and quality/availability of data for subgroup analyses by triptan use/failure. Therefore, we intend to explore the recording of treatment sequencing and healthcare events by triptan use/failure groups if data allows.
While many patients with migraine are largely managed in the primary care setting, some will also be cared for in the secondary care setting. Therefore, linkage to each HES dataset (inpatient, outpatient and A&E) is required to observe healthcare events that occur within the secondary care setting. Counts of secondary care interactions will inform the design of a future study looking to comprehensively quantify the economic burden of migraine and demonstrate the burden of migraine on the secondary care setting in clinical practice with the aim of influencing care management of migraine in the UK.
Carmen Tsang - Chief Investigator - Pfizer Ltd - UK
Robert Wood - Corresponding Applicant - Adelphi Real World
Amisha Patel - Collaborator - Adelphi Real World
David Hayflinger - Collaborator - Pfizer Inc - US Headquarters
Lucy Massey - Collaborator - Adelphi Real World
Robert Pawinski - Collaborator - Pfizer Ltd - UK
Shazia Afridi - Collaborator - Guy's & St Thomas' NHS Foundation Trust
Shuk-Li Collings - Collaborator - Pfizer Ltd - UK
Thang Tran - Collaborator - Pfizer Ltd - UK
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient