The adverse event and tolerability profile of zolmitriptan

Citation
J. Edmeads et Fn. Johnson, The adverse event and tolerability profile of zolmitriptan, REV CONT PH, 11(2), 2000, pp. 119-132
Citations number
54
Categorie Soggetti
Pharmacology
Journal title
REVIEWS IN CONTEMPORARY PHARMACOTHERAPY
ISSN journal
09548602 → ACNP
Volume
11
Issue
2
Year of publication
2000
Pages
119 - 132
Database
ISI
SICI code
0954-8602(2000)11:2<119:TAEATP>2.0.ZU;2-K
Abstract
Zolmitriptan has a generally favourable tolerability and adverse event prof ile. The incidence of chest-related sensations of tightness, pain, heavines s or pressure is low and does not appear to be dose-related; similar sensat ions in the head and neck have been reported with zolmitriptan use, though the incidence is again low. Some studies have reported slight, transient, a nd clinically nonsignificant increases in blood pressure in association wit h zolmitriptan treatment, though others have failed to find such effects. E ffects on heart rate and rhythm, on cardiac stroke volume, and on regional blood flow are rare and mild; reductions in arterial diameter have no clini cal importance in normal vessels, though zolmitriptan, like other 5-HT1 ago nists, should not be used in patients with coronary artery disease. Signifi cant changes in ECG recordings have not been associated with zolmitriptan u se, and there is no evidence for zolmitriptan-induced ischaemic events. Nau sea has sometimes been reported as a common adverse event associated with z olmitriptan, but in other studies it either did not occur or was mild and o f brief du ration. Asthenia, dizziness, somnolence and paraesthesia are rep orted to be dose-related; however, the incidence of such effects is very lo w and they are mild and transient. Psychomotor effects are also slight and without clinical significance. Acute and longterm treatments with zolmitrip tan have not been associated with any abnormalities in clinical laboratory test results. The incidence of severe adverse events with zolmitriptan is s imilar to that with placebo. Most adverse effects reliably linked to zolmit riptan are mild-to-moderate in intensity, appear within 2 h of drug adminis tration, and are of brief duration; though related to administered dose, th ey appear not to correlate with plasma drug levels. The incidence of advers e events falls progressively with treatment duration. On available evidence , dosage adjustments do not seem to be needed for elderly or adolescent pat ients, patients with renal or mild-to-moderate hepatic impairment (though s ome adjustment is indicated with more severe hepatic insufficiency), or in accordance with the patient's sex. A wide range of other concomitantly admi nistered medications appear to have no clinically significant interactions with zolmitriptan. Zolmitriptan, like other triptans, should not be given d uring pregnancy. it is concluded that zolmitriptan is a well-tolerated drug , the use of which entails few, if any, dosage adjustments in most clinical situations.