A real-world study on unmet medical needs in triptan-treated migraine: prevalence, preventive therapies and triptan use modification from a large Italian population along two years

DOI: https://doi.org/10.1186/s10194-019-1027-7

Abstract-Summary The aim of this study was to depict the burden of the unmet medical needs in migraine treated with triptans in a large Italian population.

A 2-year longitudinal analysis of migraineurs with unmet medical needs on

treatment with triptans was performed.

The studied cohort consisted of subjects with ≥4 triptan dose units per month, selected from the general population These patients were stratified into: possible Low-Frequency Episodic Migraine (pLF-EM: 4–9 triptan dose units per month), possible High-Frequency Episodic Migraine (pHF-EM: 10–14 triptan dose units per month) and possible Chronic Migraine (pCM:> 14 triptan dose units per month). Of 10,270,683 adults, 8.0 per 1000 were triptan users and, of these, 38.2% were

migraineurs with unmet medical needs, corresponding to 3.1 per 1000 adults.

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Triptan use reduction was found in 22.3% individuals of the cohort, decreasing with the intensification of need levels (25.8% pLF-EM, 13.6% pHF-EM, 12.0% pCM).

This real-life analysis underlined that the unmet medical needs concern a large part of patients treated with triptans and there is an undertreatment with preventive therapies whose benefit is insufficient, which may be due to the lack of effective preventive strategies, probably still reserved to severe patients.

Extended: The aim of this study was, therefore, to describe the prevalence and characterisation of unmet medical needs in migraine among triptan users by distin- guishing between high (possible CM) and low (possible EM) needs.

Introduction This elevated prevalence is also associated with a huge economic impact, both as direct and indirect costs: a study estimated that for migraine the mean per-person annual costs were €1222 with a total annual cost of €111 billion for 27 European Countries [105].

Pharmacological care of migraine headaches includes acute therapies aimed to relieve the symptoms during the attacks and preventive therapies that should decrease the attack frequency in order to improve responsiveness to acute therapies. The aim of this study was, therefore, to describe the prevalence and characterisa- tion of unmet medical needs in migraine among triptan users by distinguishing between high (possible CM) and low (possible EM) needs.

The study has provided a real-world landscape of the use of headache preven- tive therapies and of an estimate of their effectiveness in terms of reduction in triptan use.

Methods Starting from the index date, the 1-year triptan prescription history was analysed to compute the monthly average number of dose units collected by each patient.

To describe the complete prescription pattern of triptan-treated migraineurs, in the 12 months post-index date the presence of prescriptions of the following oral preventive therapies reimbursed by the Italian National Health System (NHS) was searched: topiramate (ATC: N03AX11), valproic acid (N03AG01), propranolol (C07AA05), metoprolol (C07AB02), atenolol (C07AB03), timolol (C07AA06), amitriptyline (N06AA09) and pizotifen (N02CX01).

For each patient the prescription history of triptans was analysed (with the same strategy described above) in two different periods: from the index date to the 12th month and from the 13th month to the 24th month.

All preventive therapies (oral drugs and botulinum toxin injections) used in the year pre-index date were described as rate of treated subjects, number of different drugs, specific active substance.

Results Triptan users, 31,515 patients turned out to be affected by UMN in migraine (i.e. with 4 or more triptan dose units per month) with a prevalence of 3.1 per 1000 adult inhabitants.

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The mean age of UMN triptan-treated migraineurs increased according to the mean number of triptan dose units per month: from 48 years old for pLF-EM to 50 years old for pCM.

This percentage increased according to the triptan dose units received per month: it was 18.8% among patients with pLF-EM, 25.2% among those with pHF-EM, and it reached the peak of 32.8% among patients with pCM.

In the overall cohort of UMN migraineurs receiving triptans, 22.3% of patients

improved (i.e. with a ≥50% reduction of triptan dose units per month). Discussion This study, based on real-world data collected into healthcare administrative data- bases, provides the actual burden, among triptan users, of the unmet medical needs (UMN) in migraine in Italy, distinguishing for different need levels.

Additional important results of this study concern the actual use of preventive

therapies and the rate of migraine improvement among triptan-treated subjects.

The very low use of all available preventive therapies could reflect a scarce ben- efit of these strategies and it underlines an unmet clinical need, especially for those subjects treated with >14 triptan dose units per month, which are potentially affected by CM.

This was confirmed by the findings on migraine improvement, defined in this study as a reduction in triptan use, which occurred only in a low percentage of UMN migraineurs receiving triptans, with decreasing rates as the triptan treatment intensified.

Strengths and limitation The main strengths of this study were the magnitude of the studied population and the possibility of analysing all triptan prescriptions as the Italian NHS reimburses these drugs.

Another drawback concerns the analysis of preventive therapies: in our study we included only drugs labelled for migraine prevention and reimbursed by the Italian NHS.

An additional strength of this study, based on real-world data, is the provision of

the actual panorama on drug use for migraine acute and preventive treatment.

This analysis was affected by the well-known drawbacks of research studies based on administrative databases [106], in particular, the possible discrepancy between drug dispensation and actual drug intake, or the lack of information on precise indication and other clinical features that could drive the drug choice.

Conclusion In view of the new drugs being introduced for the prevention of migraine [107], this study could represent a model to design future studies aimed to analyse appropriate- ness in the management of migraine and to help policy decision makers in the resource allocation for this disease.

The results of this study could be helpful in the setting of critical pathways for migraine aimed to improve patient outcomes and reduce the direct and indirect costs of this clinical condition.

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Acknowledgement A machine generated summary based on the work of Piccinni, Carlo; Cevoli, Sabina; Ronconi, Giulia; Dondi, Letizia; Calabria, Silvia; Pedrini, Antonella; Esposito, Immacolata; Favoni, Valentina; Pierangeli, Giulia; Cortelli, Pietro; Martini, Nello. 2019 in The Journal of Headache and Pain.

Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials