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Emerging Therapies and Preventive Treatments for Migraine

Emerging Therapies and Preventive Treatments for Migraine

Migraine headache episodes can have serious and debilitating effects on a patient, which include a pulsating headache of moderate to severe pain intensity accompanied by nausea and/or vomiting and photophobia or phonophobia. The episodes may be aggravated by movement, such as walking or climbing stairs, which may lead to the avoidance of these activities during an episode.3,10
A migraine can be categorized based on its frequency of occurrence. An episodic migraine (EM) occurs when a patient with a migraine has fewer than 15 headache days per month.11,12 Conversely, very frequent attacks are characterized as chronic migraine (CM) headaches. The International Classification of Headache Disorders (ICHD-II) system defines CM as headaches that occur 15 or more days per month for more than 3 months. These headaches must have the features of a migraine headache for at least 8 days of the month to be considered a CM.10

In population-based studies, the prevalence of CMs in the global population has been shown to be between 1.4% and 2.2%.11 However, using data from the American Migraine Prevalence and Prevention (AMPP) study, the United States was at 0.91%, with a higher prevalence in females (1.29% vs 0.48% of males).11

A CM is categorized as a complication of an EM. In patients with EMs, 2.5% per year will progress to CMs.13 Evidence suggests that an increase in the frequency of EM headaches and the repetitive state of headaches can lead to progression.7 Excessive symptomatic medication use has also been proposed as a theory to explain the transformation to CMs.13 Reports show that 1.5% of CM sufferers use acute medications more than 10 to 15 days per month.13 Use of opioids and barbiturates has been associated with an overall increase in risk for progressing to CMs, although the use of nonsteroidal anti-inflammatory drugs (NSAIDs) appears to have a protective effect in some migraine sufferers, albeit only in those who had fewer than 10 to 14 headache days per month.13

Comorbidities associated with EMs have been well documented and include psychiatric disorders, neurological disorders, chronic pain, asthma, and heart disease.11 In another examination of the differences in the rates of comorbidities between EMs versus CMs, Buse et al found significant differences in a wide range of conditions after adjusting for age, gender, and income (Table 114).11 Individuals with CMs were found to be twice as likely to suffer from anxiety and depression.14 There was a greater frequency of other comorbidities in patients with CMs compared with patients with EMs.14 Prior to this study, there was a general lack of evidence contrasting the comorbidities associated with the 2 classifications. These data support the fact that CMs are more burdensome, with their increased rates of comorbidities, and provide a greater insight into the overall impact and treatment of CMs. The associated increased risk of comorbidities may influence healthcare providers in clinical decision making and therapy with regard to concomitantly treating multiple disease states, optimizing drug therapy, and minimizing AEs.15

Treatment Approaches
There are 2 goals to migraine therapy: shortening or stopping an acute attack, and preventing future attacks to decrease migraine frequency and possible severity.7,16 Because migraine attacks are best treated with preventive therapy, patients with CMs or EMs are candidates for this type of treatment.5 Evidence suggests that migraine sufferers in the United States are consistently undertreated, with focus placed on acute treatments rather than preventive measures.

Despite discussion in the US Headache Consortium Guidelines about indications for preventive treatment, prevention therapy largely remains a therapeutic area with many opportunities.5 As of March 2017, an estimated 32 million adults in the United States have been affected by a migraine; one-third of those meet the criteria for preventive therapy.17 However, of those 32 million patients, only 3.5 million are currently receiving preventive therapy, further illustrating an existing opportunity to improve care.17 Proposed rationales for the lack of preventive therapy include low confidence in the contents of clinical guidelines and a lack of provider awareness of the methodology and quality of clinical guidelines.12 To date, there is no cure; however, improvements in health outcomes and quality of life have been demonstrated through the use of preventive treatments.12

Literature recommends preventive migraine therapies for patients who have 4 or more days of migraines per month with at least some impairment.5 As part of the AMPP study, Lipton et al established guidelines for preventive medication based on migraine frequency and level of impairment during an acute migraine using a panel of 12 physicians specializing in headaches along with leading experts in the field of headache research.5 In these guidelines, level of impairment was defined as severe impairment, some impairment, and no impairment. This guideline classified patients into 1 of 3 categories: 1) patients who should be offered preventive treatment, 2) patients who should have preventive treatment considered, and 3) patients who do not need preventive treatment (Table 2).5

No migraine treatments have been developed with prevention in mind. Prevention treatments with the most evidence of established efficacy are anticonvulsants and beta-blockers. Other medications that are considered effective include tricyclic and serotonin and norepinephrine reuptake inhibitor antidepressants (Table 3).12,15

Hepp et al examined pharmacy claims for 8688 patients with diagnosed CMs from Truven MarketScan Databases in order to assess adherence to oral migraine prophylaxis medications. The proportion of days covered (PDC), a nationally recognized standard for measuring adherence, was 26% to 29% at 6 months, a rate that fell over time. At 12 months, the PDC had declined to 17% to 20%.18

In the second International Burden of Migraine Study, Blumenfeld et al evaluated survey responses from 1165 adults with EMs and CMs during 2010. A total of 43.4% of respondents with CMs reported current treatment with a preventive migraine drug, while 65.9% reported current or prior preventive treatment.19 The number of respondents reporting discontinuation of 1 or more preventive medication was significant, especially when comparing EMs to CMs (24% vs 40.8%, respectively).20 Complete discontinuation, defined as prior preventive therapy use but no current use, was reported by 21.1% and 15.2% of EM and CM respondents, respectively. AE and lack of efficacy were the most common reasons for discontinuing preventive treatment.20

Headache accounts for 5 million emergency department (ED) visits per year, with a majority of those visits associated with migraine occurrence. More than 50% of these visits result in treatment with an opioid instead of a migraine-specific medication.21 A retrospective cohort study using claims from January 2008 to June 2013 from Truven MarketScan Databases found migraine-related ED visits were more common in patients without acute or prophylactic use (29.9%) than patients receiving only acute treatment (13.2%), prevention-only treatment (9.1%), or acute and preventive therapy (11.1%).22 This study also noted opioid use occurred in almost half of patients with migraines and that these patients had an average supply exceeding 90 days. Annual costs also were higher in patients with migraines who used an opioid (approximately $20,000 vs $70,000, respectively). ED visits and opioid use could be minimized by utilizing appropriate prevention therapy. Data from the 2009 AMPP study showed that of the 5591 patients with EMs, 32% met the ICHD-II criteria for excessive opioid or barbiturate use and may have had opioid dependence.23

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