[Safety profile of 311C90 (zolmitriptan)]

A bibliographic review of the safety profile of 311C90 or zolmitriptan is performed in the present study showing the large number of clinical trials carried out in both healthy volunteers and patients with migraine. The molecule, a potent, selective agonist for the 5HT1B/1D receptors with central and peripheral activity does not appear to have significant influence on arterial pressure. ECG and Holter ECG studies did not show any alterations in healthy volunteers. In migraine patients, the ECG did not demonstrate ischemic alterations at any of the dosages of zolmitriptan used. In patients who had undertaken treatment for months, the hemogram and biochemical follow up did not show any changes. This new triptan was well tolerated in a wide spectrum of patients and healthy volunteers. Complaints of subjective side effects usually increase according to an increase in dosage. The most frequent adverse effects were nausea and dizziness. Other discomforts are: dryness of the mouth, sensation of heat, paresthesia, asthenia, drowsiness, and dizziness. The sensation of heaviness, tightness or pressure of the throat and chest have also been reported. The adverse effects reported with 5 mg of zolmitriptan are similar to those found with 100 mg of sumatriptan. The adverse side effects are usually mild, last a short time and remit without therapy. Zolmitriptan used together with the other most often used drugs in migraine patients did not show any important clinical interactions. However, it seems reasonable to limit the daily administration of zolmitriptan with monoaminoxidase inhibitors (MAOI-A) since a possible increase of the levels of zolmitriptan and its metabolites may be detected in the presence of one (moclobemide). At a dose of 2.5 mg, zolmitriptan appears to provide the best relationship between benefits and risk.