Frequency of migraine and the use of preventive medication in a UK primary care population

Study type
Protocol
Date of Approval
Study reference ID
21_000567
Lay Summary

Migraine is a common long-term health condition which usually involves attacks of painful, throbbing, one-sided headaches; sensitivity to light, sounds and smells, feeling sick and being sick; and in some individuals problems with sight such as seeing flashing lights. Migraine is complex and there are different treatments available. There are treatments for the individual migraine attacks (acute treatments) and treatments to help prevent the attacks from occurring (preventative treatments). If patients have tried at least 3 different preventive treatments (such as beta-blockers, anti-depressants and anti-convulsant medicines) but continue to have significant symptoms they may be tried on a calcitonin gene-related peptide monoclonal anti-body (CGRP-mAb). This is typically a monthly injectable medicine that blocks the action of a nerve protein (CGRP) that is thought to be involved in causing and maintaining migraine attacks.
There are currently wide estimates on the number of patients in the UK who may be eligible for CGRP mAbs which makes it difficult for local health authorities to estimate the demand that could be placed on local headache services. The purpose of the current study is to provide a more accurate estimate of the number of migraine patients who have tried 3 preventive treatments as of Jan 1, 2020 in the UK population. In addition, the study will describe characteristics of this patient population in terms of age, gender, body mass index and geographical region.

Technical Summary

Recent data on the epidemiology of migraine in the UK is scarce. The intention of this study is to provide reliable, current data on the epidemiology and treatment patterns of migraine in the adult UK population treated by general practitioners (GPs) focusing mainly on the prevalence of the population who have ceased at least 3 oral migraine preventive classes.
This is an observational study using data from the CPRD with cross-sectional prevalence assessment (1 Jan 2020), one year cumulative incidence assessment (1 Jan 2019 to 31 Dec 2019) and longitudinal preventive treatment patterns assessment (12 Sep 2012 to 1 Jan 2020).
Numerator and denominator populations for the prevalence and cumulative incidence of migraine calculations and study cohorts for the longitudinal assessment of migraine preventive treatment patterns will be identified from the total CPRD population. Migraine will be ascertained through history of Read codes and preventive medications will be identified using medication codes.
Study variables include migraine, preventive medications (name and duration), age, gender, BMI, region, and referral to neurologist.
The statistical analysis in the study will be descriptive. Prevalence and cumulative incidence calculations will be reported as n/1,000 (95% CI). Treatment patterns will be tabulated and illustrated using a histogram and Sankey diagram. Patient characteristics and frequency of referrals will be described using standard univariate descriptive statistics.
This study will generate evidence on the prevalence of adult migraine in a UK primary care population.

Health Outcomes to be Measured

• Migraine
• Migraine preventive medication use
• Age
• Gender
• BMI
• Region
• Referral to neurologist

Collaborators

Julie Mount - Chief Investigator - Eli Lilly & Co - UK
Julie Mount - Corresponding Applicant - Eli Lilly & Co - UK
Andrew Pain - Collaborator - Eli Lilly & Co - UK
Camilla Kristine Appel - Collaborator - Eli Lilly & Co - UK
david kernick - Collaborator - NHS DEVON CCG
Michael Ranopa - Collaborator - Eli Lilly and Company Ltd. (UK)
Tania Gulati - Collaborator - Eli Lilly & Co Ltd - US Headquarters