This study provides population data for real-world migraine burden and treatment patterns in Spain and Germany and illustrates the negative effects of migraine/severe headache on QoL, pain, disability, and healthcare resource use, despite the availability of current treatment options.

Pain of moderate or severe intensity was the most frequently reported migraine symptom (92.0% of participants in the total migraine cohort), and pain intensity and the proportion of participants reporting symptoms generally increased with the number of HDs/month. Participants with a higher number of HDs/month also reported poorer QoL (MSQ) and higher interictal burden (MIBS-4). Migraine/severe headache also accounted for just over half of visits to an HCP in the past 12 months; people with higher MIDAS grades were more likely to visit specialists or emergency care, whereas pharmacist or primary care/general practice visits were more likely for those with lower grades.

Our analysis of participants in the moderate to severe attacks subcohort [average pain severity ≥ 5 points (based on the MIDAS question on pain severity), pain duration ≥ 4 h, and at least moderate disability due to migraine (MIDAS score ≥ 11)] also found burden generally increased with increasing headache/migraine severity. Patients with a higher number of HDs/month reported poorer QoL, higher pain levels (MIDAS), and more severe migraine-related disability (MIDAS) than those with fewer HDs/month, although severe interictal burden was reported for ~ 60% of participants regardless of the number of HDs/month.

Despite the high levels of burden reported, the data also highlight a low use of triptans, even in people with moderate to severe headache attacks, and generally poor treatment satisfaction in those who use triptans. These findings are concerning, given that triptans are the recommended treatment for moderate to severe migraine attacks in both Spanish and German guidelines [17, 18], and illustrate an unmet need for new treatment options for patients with migraine or severe headache.

Most participants in the total migraine cohort reported that they were currently using acute migraine/severe headache medication, although less than half of these were using triptans; the most common categories of acute medication were OTC analgesics, NSAIDs on prescription, and paracetamol, with many people taking multiple acute medications. Very few people were using ergot alkaloids, although these are only reimbursed in Germany and are not reimbursed in Spain. Triptans are available on prescription or OTC in Germany but are prescription-only in Spain. Triptan use was more common in participants who were also using preventive medication, and NSAIDs on prescription, OTC analgesics, and suppositories were also commonly used in combination with preventive medication. It could be speculated that the use of preventive medication may be a sign of a more migraine-specific approach to treatment, or that patients using preventive medication had higher disability and were therefore more likely to use triptans than those using acute medication alone. However, our analysis of triptan use in people with moderate to severe headache attacks (defined as average pain severity ≥ 5 points, pain duration ≥ 4 h, and MIDAS score ≥ 11; n = 5547) also found that less than half (48.4%) of those with moderate to severe attacks were using triptans, despite both Spanish and German guidelines recommending their use in this population [17, 18]. This was observed even though > 80% of participants in this subcohort sought medical care, with NSAIDs being the most commonly used acute medication, reflecting an unmet need for people with migraine. Despite seeking care, symptoms may go unrecognized or be underestimated by HCPs, resulting in patients going undiagnosed and not receiving the recommended treatment. Although the proportions of participants using triptans in our study is higher than some other reports from European countries [19, 38], these other reports are based on the general migraine population and migraine severity is not reported in these studies. The Eurolight study also showed considerable variation in medication use according to the population sample, with higher usage reported for general practitioner-based samples and those from lay organizations compared with population-based samples [19]. Triptan use was estimated at < 6% for people with migraine in an Austrian study, but this was based on a general population sample and estimated migraine prevalence, and migraine severity was not reported [38].

A high proportion of participants using triptans reported poor treatment satisfaction, and many people reported that they had stopped using triptans. Treatment satisfaction (according to mTOQ-6) was generally poor regardless of migraine/headache severity, with poor satisfaction being reported by most triptan-using participants in both the total migraine cohort and the moderate to severe attacks subcohort. However, we cannot exclude the possibility that other factors related to migraine severity or the potential concomitant use of triptans and other migraine medications may have impacted the mTOQ-6 score, which is not medication specific. A global real-world study of people using triptans as their only acute migraine medication reported considerably higher rates of satisfaction than ours, even in those considered to be insufficient responders to triptans [59% of insufficient responders (i.e., freedom from headache pain within 2 h of treatment in ≤ 3/5 migraine attacks) reported being satisfied or extremely satisfied, compared with 92% of triptan responders (those with pain freedom within 2 h in ≥ 4/5 attacks)] [39]. However, that study did not use the mTOQ-6, and data for response based on headache freedom after using triptans were not collected in the OVERCOME (EU) study, so the results are not directly comparable.

In the current study, treatment satisfaction in the total migraine cohort was lower in participants currently taking triptans compared with those using acute medications excluding triptans. The most common reasons for discontinuing triptans [in the 5538 patients who had discontinued triptans (8686 patients reported ever having used triptans)] were that other medications were considered more effective, migraine/severe headaches improved, and concerns about side effects (although the incidence of actual adverse events was not reported) and frequent use. Other studies have reported that around 30–40% of people with migraine do not respond to triptans, although some people who do not respond to one triptan find they do respond to an alternative triptan [40, 41]. However, as data on the number of different triptans participants had used, or the sequence of treatments, were not collected in the OVERCOME (EU) study, we were unable to further evaluate any influence of this.

The lack of triptan use may partly be due to the high use of primary care and pharmacist services compared with specialist headache or pain services, even by people with higher MIDAS grades, which again may result from a lack of referrals due to under-recognition of symptoms. Migraine burden in the moderate to severe attacks subcohort generally increased with increasing headache/migraine severity, and interictal burden was high regardless of the number of HDs/month, indicating high levels of burden in patients using existing medications. The unmet treatment need for people with severe headache/migraine was previously highlighted in the American Migraine Prevalence and Prevention study, which found no significant improvement in headache-related disability in people who switched from one triptan to another, an opioid, or a barbiturate, compared with those with consistent triptan use [42]. That study also found that switching from a triptan to an NSAID was associated with an increase in disability, especially among those with ≥ 10 HDs/month [42].

Strengths of the OVERCOME (EU) study include its provision of previously lacking real-world evidence from a population-based sample, allowing further insight into the unmet needs of people with migraine adding to previous data from other settings. The use of an internet-based survey also allowed for a large number of study participants, regardless of whether medical care was sought. These data are important as many people with migraine do not seek professional medical care so would not be represented in registry or observational studies.

However, surveys such as this are subject to limitations. As the survey data are self-reported, they are susceptible to recall, misinterpretation, and prioritization biases. It was also not possible to confirm if participant responses regarding migraine symptoms, severity, or duration were based on treated or untreated migraine attacks, and data regarding the sequence of treatments used were not collected. Although internet access is widely available in Germany and Spain, as with other online surveys the cohort is more likely to include people with greater technical abilities who were willing to be involved in computer surveys. In order to limit bias, the participants were invited and agreed to take part in the study without knowledge of which health topic was being researched. The health topic (migraine) was then disclosed at the screening stage. However, we acknowledge the potential for differences between survey respondents and the broader migraine population in attitudes and tolerance to pain and other symptoms to influence findings regarding treatment satisfaction.

Further analyses of data from the OVERCOME (EU) study will provide important information on essential topics required to improve care for people with migraine, for example the need for targeted care, and in the case of severely affected patients, specialized care.