Abstract and Introduction
Objective: Addressing the needs of migraineurs by actively seeking patient feedback on disease-related disability and treatment satisfaction may lead to improved management and treatment outcomes. Patient feedback can be collected in postmarketing surveillance (PMS) studies. The objective of this PMS study was to evaluate the efficacy and tolerability of zolmitriptan 5mg nasal spray in the acute treatment of migraine attacks.
Patients and methods: Patients received zolmitriptan 5mg nasal spray to treat migraine attacks of any severity and were followed up after a maximum of 4 months. Patients evaluated the efficacy and tolerability of zolmitriptan nasal spray, and were asked whether they wished to continue using zolmitriptan nasal spray and their preference compared with previous treatments. Physicians also assessed the efficacy and tolerability of zolmitriptan nasal spray.
Results: A total of 1838 patients (84.8% females) participated in the study. Within 30 minutes of administration of zolmitriptan nasal spray, 85.0% of patients reported improvements in headache pain, with 25.1% reporting an improvement within 10 minutes. At 1 hour post-dose, 57.9% of patients were pain free and 61.7% were able to resume usual daily activities. Most patients (72.9%) rated zolmitriptan nasal spray as 'better' than previous therapy. The majority (88.8%) expressed a wish to continue using zolmitriptan nasal spray. Physicians evaluated the efficacy of zolmitriptan nasal spray as 'excellent' or 'good' in 89.4% of patients. Tolerability was evaluated as 'excellent' or 'good' in 91.6% of patients.
Conclusions: Zolmitriptan 5mg nasal spray provides favourable efficacy and tolerability in the acute treatment of migraine attacks. Most patients assessed zolmitriptan nasal spray as 'better' than previous treatment, with nearly all wishing to continue using it.
The triptans (selective serotonin 5-HT1B/1D receptor agonists) are well established as acute migraine-specific treatments.[1,2] Although of proven efficacy and well tolerated, triptans are underused in primary care. There may be several reasons for this, including an incorrect diagnosis.[3,4,5] Moreover, physicians may not routinely prescribe triptans, partly because of their higher costs compared with analgesics. However, this is a misconception, as inappropriate treatment with analgesics may result in a greater overall cost through increased healthcare utilisation and time off work.[6,7,8,9] Many patients also continue to use over-the-counter medications despite having a prescription for a triptan. Consequently, many migraineurs are dissatisfied with current migraine treatment.[5,10]
When triptans are prescribed, conventional oral tablet formulations are often chosen because of ease of administration, plus patient and physician familiarity. However, oral administration may not be the most appropriate route for all migraine patients, such as those who experience the migraine-associated symptoms of nausea and vomiting. Moreover, the oral route may not necessarily provide a rapid onset of relief from migraine-related symptoms and a quick return to normal activities, which migraineurs identify as the most important attributes of a migraine therapy.[5,11] In one study, for example, migraineurs indicated a willingness to use an alternative formulation, such as a nasal spray, if efficacy and onset of relief were superior compared with oral formulations.
The results of clinical trials have shown that the nasal spray formulation of zolmitriptan is fast acting, highly effective and well tolerated in the acute treatment of migraine attacks.[12,13,14,15,16,17] This formulation demonstrates true (partial) nasopharyngeal absorption, resulting in appearance of zolmitriptan in the plasma within 2 minutes and in the brain within 5 minutes of administration. A headache response has been reported as early as 10 minutes post-dose and pain-free status within 15 minutes of administration. Furthermore, with regard to the particularly stringent endpoint of total symptom relief (defined as freedom from headache pain, nausea, phonophobia and photophobia), significantly higher rates of response have been observed with zolmitriptan nasal spray compared with placebo from as early as 30 minutes post-dose.
To help understand how to achieve the best possible outcomes for migraineurs, it is important to supplement clinical trial data with data from situations that are more representative of real life, such as postmarketing surveillance (PMS) studies. Indeed, by actively seeking patient feedback on disease-related disability and treatment, such studies may facilitate improved management and outcomes. The aim of this PMS study was, therefore, to assess the efficacy and tolerability of zolmitriptan 5mg nasal spray in the acute treatment of migraine, and to determine patient and physician experiences with zolmitriptan nasal spray in a real-life clinical-practice setting.
Clin Drug Invest © 2007 Adis Data Information BV
Cite this: Effectiveness and Satisfaction with Zolmitriptan 5mg Nasal Spray for Treatment of Migraine in Real-Life Practice - Medscape - Feb 07, 2007.