Key points for decision makers
* Although its acute nature needs to be kept in mind when comparing it with other diseases, migraine is one of the most prevalent and disabling neurological disorders worldwide
* In spite of the important progress in the abortive treatment of acute migraine episodes since the appearance of triptans, in many cases reduction of pain and associated symptoms is still not as effective nor as fast as would be desirable
* Recently, early triptan treatment when pain is still mild has been found more efficacious than the usual strategy of waiting for the attack to develop to a higher pain intensity level
* The present cost-effectiveness and cost-utility analysis suggests that early treatment is also the preferred strategy from an economic perspective
Migraine is one of the most prevalent neurological disorders worldwide. The WHO estimated that in 2004 there were over 324 million migraine sufferers across the world. Its prevalence in the US and Europe is estimated to be 18% in women and 6% in men; therefore, around 37 million US inhabitants and 60 million EU inhabitants suffer from migraine.
Individuals with migraine experience substantial pain and disability during migraine headaches. The WHO ranks migraine as one of the most disabling diseases (disability class VII on a scale of I to VII) and, even though it does not reduce life expectancy, it is included in the same class as active psychosis, quadriplegia and terminal-stage cancer. Despite the disabling nature of this disorder, 50-60% of migraineurs remain undiagnosed.[2,3]
The financial burden of migraine on society comprises direct costs associated with medical care and indirect costs caused by absence from work and reduced productivity. With a total cost of [euro]27 billion in 2005, it has been estimated to be the most costly neurological disorder in Europe. Conservative estimates for the burden of migraine in the US range between $US14 and $US20 billion per year. In many studies that analyse the burden of migraine, indirect costs have been found to be far greater than the direct costs of care, accounting for over 90% of the total costs.[4-9]
The main objectives of acute migraine therapy are to reduce/eliminate pain and associated symptoms, to prevent recurrence of the attack and to rapidly restore the patient to normal functioning with minimal or no adverse effects. Triptans (serotonin, 5-HT1B/1D agonists) are highly effective and well tolerated agents for the abortive treatment of acute episodes,[11,12] and current guidelines recommend their use, particularly in patients who reported that NSAIDs were not effective in past attacks. However, reduction of pain and associated symptoms is in many cases still not as effective and rapid as would be desirable.
The triptan clinical trial programmes used a substantially uniform approach that typically involved asking patients to wait for the development of moderate or severe pain prior to treating an attack, and this approach to timing has been used as a standard for treatment of acute migraine in clinical practice. Essentially, the rationale for this approach is that fully developed attacks are more easily distinguished from other types of headaches. While justified in the context of a clinical trial, waiting for the development of moderate or severe pain prior to treating an attack is not necessarily the ideal strategy in clinical practice. On the contrary, in retrospective analyses, observational studies[17-19] and clinical trials,[20-27] early treatment when pain is still mild has been recognized to provide superior outcomes. Consequently, it is now increasingly advocated that patients treat their migraine attacks when pain is still mild.[28,29]
Migraine attacks typically evolve, with differing speeds, from mild pain to moderate/severe pain, followed by stabilization and then finally resolution, unless treated with medications to shorten the duration of the episode and/or to avoid pain reaching high levels. …