SUMATRIPTAN – From Molecule to Man
Evaluation of a Multiple-Dose Regimen of Oral Sumatriptan for the Acute Treatment of Migraine
the Oral Sunatrptan International Multiple-Dose Study Group
Do you have an account?
- Rent for 48h to view
- Buy Cloud Access for unlimited viewing via different devices
- Synchronizing in the ReadCube Cloud
- Printing and saving restrictions apply
Rental: USD 8.50
Cloud: USD 20.00
In a multinational, placebo-controlled, double-blind, parallel-group study of oral sumatriptan (GR43175), given as a dispersible tablet, in the acute treatment of migraine, 149 patients were randomized to receive 100 mg sumatriptan and 84 to placebo. Each patient was provided with three tablets: one to be taken as soon as possible after headache onset; one to be taken 2 h later if the headache persisted and one to be taken if the headache recurred within 24 h. Patients recorded details of the attack and response to treatment on a diary card. Sumatriptan was significantly more effective than placebo in relieving headache (moderate/severe reduced to mild/none) at 2 h (50 vs. 19%; p < 0.001) and at 4 h (75 vs. 30%; p < 0.001). Of the sumatriptan group, 59% took the second dose compared with 80% of the placebo group (p < 0.001). Compared with placebo, more patients on sumatriptan were pain-free by 2 h(26 vs. 5%; p < 0.001) and by 4 h(48 vs. 13%; p < 0.001). Headache improvement was apparent by 1 h in 42% of sumatriptan-treated patients and 17% of patients on placebo. Headache relief was significantly (p < 0.001) better in patients taking sumatriptan, irrespective of the type of migraine (with or without aura), or the time the drug was taken (less than or more than 4 h after onset). There was no significant difference in the number of patients who took placebo or sumatriptan and whose headache recurred within 24 h of initial resolution (42 vs. 48 %; p = 0.535). Accompanying symptoms of nausea, vomiting, photophobia and phonophobia were significantly (p < 0.001) improved in the sumatriptan-treated group. Sumatriptan was well tolerated; 38% of sumatriptan-treated patients reported one or more events compared with 23% in the placebo group (p = 0.019). Most of these events were minor and transient in nature. The occurrence of adverse effects was not dose-related and no significant effects were observed on heart rate, blood pressure, electrocardiogram (ECG), or biochemical or haematological parameters. It is concluded that a repeat-dose oral regimen of sumatriptan provides an effective acute treatment for migraine, while allowing patients considerable flexibility in the treatment of individual attacks.
© 1991 S. Karger AG, Basel
Article / Publication Details
Copyright / Drug Dosage / DisclaimerCopyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.