Abstract

Around 91% of migraine patients use over-the-counter medicines to treat attacks, often without further treatment or medical consultation. This therapeutic principle is established in most countries, regardless of how the healthcare system is otherwise structured or financed. Using Germany as an example, the basis for an expansion of attack therapy with rizatriptan as an over-the-counter triptan is described. To achieve the best possible tolerability and safety in the context of self-medication, the lowest possible dose should be selected to provide the most favourable tolerability and safety profile in the context of self-medication through low dosages. The lowest approved dose of rizatriptan is 5mg. This was investigated in three randomized controlled trials with 752 patients. The results show that rizatriptan at a dose of 5mg is more effective than the triptans naratriptan 2.5mg, almotriptan 12.5mg and sumatriptan 50mg, which were previously available for self-medication in Germany. There was no significant difference in the frequency of adverse events with rizatriptan 5mg compared to placebo. Rizatriptan 5mg does not have a higher side effect potential than sumatriptan 50mg, which is already exempt from the prescription requirement. The reasons given show that rizatriptan in a dose of 5mg for the treatment of acute migraine attacks fulfils the requirements for a transfer from prescription to pharmacy-only status at least as well as sumatriptan 50mg, naratriptan 2.5mg and almotriptan 12.5mg. From a clinical care perspective, it is desirable for affected patients to have other options available for self-medication. Non-responders to other substances also have a further treatment option with rizatriptan 5mg, with the same or even better risk-benefit profile, to treat migraine attacks safely, effectively and in a tolerable manner as part of self-medication.

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