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SUMATRIPTAN – From Molecule to Man

Sumatriptan An Oral Dose-Defining Study

The Oral Sumatriptan Dose-Defining Study Group

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Eur Neurol 1991;31:300–305

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Article / Publication Details

First-Page Preview
Abstract of SUMATRIPTAN – From Molecule to Man

Published online: February 08, 2008
Issue release date: 1991

Number of Print Pages: 6
Number of Figures: 0
Number of Tables: 0

ISSN: 0014-3022 (Print)
eISSN: 1421-9913 (Online)

For additional information: http://www.karger.com/ENE

Abstract

Three oral doses of sumatriptan, 100, 200 and 300 mg, given as dispersible tablets, were compared in the acute treatment of migraine in a double-blind, placebo-controlled, parallel-group study of 1,130 patients from 51 centres in eight countries. Patients treated up to three migraine attacks at home over a 3-month period and recorded the results on a diary card. Safety follow-ups were performed monthly at a clinic. All doses of sumatriptan were significantly (p < 0.001) more effective than placebo at relieving headache within 2 h of treatment. Response rates, scored on a 4-point scale, were: placebo 27%; 100 mg sumatriptan 67%; 200 mg sumatriptan 73%; and 300 mg sumatriptan 67%. The proportion of patients who required rescue medication within 2 h of treatment was significantly (p < 0.001) lower in all active treatment groups when compared with placebo. Response rates to sumatriptan were the same irrespective of the type of migraine (with or without aura) or the duration of symptoms prior to treatment (< 4 or > 4 h). Sumatriptan also provided significant (p < 0.001) relief from nausea and photophobia as compared with placebo. The majority of adverse events reported were mild to moderate in severity and were transient. The overall incidence of adverse events was dose-related, the percentage of patients reporting adverse events in the first attack treated being 36, 47 and 53% for 100-, 200- and 300-mg doses of sumatriptan, respectively, compared to 17% of placebo patients (p < 0.001 for each treatment dose compared with placebo). The most commonly reported symptoms were nausea and/or vomiting, and a bad taste. The bad taste was believed to be related to the dispersible tablet formulation; a new, film-coated formulation should overcome this problem. It is concluded that oral sumatriptan was an effective and well-tolerated acute treatment for migraine, with the 100-mg dose providing the best ratio of efficacy to safety.

© 1991 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of SUMATRIPTAN – From Molecule to Man

Published online: February 08, 2008
Issue release date: 1991

Number of Print Pages: 6
Number of Figures: 0
Number of Tables: 0

ISSN: 0014-3022 (Print)
eISSN: 1421-9913 (Online)

For additional information: http://www.karger.com/ENE


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Copyright: 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.
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