Pharmaco-epidemiology of sumatriptan Cardiovascular adverse reactions to a new antimigrainous ...

176 Pages·2010·3.24 MB·English

Pharmaco-epidemiology of sumatriptan
Cardiovascular adverse reactions to a new antimigrainous drug
Jan Paul Oltervanger
Acknowledgements
Financial support by the Netllerlands Heart Foundation and the Rotterdam Medical Research
Foundation (ROMERES) for tlle publication of this tllesis is gratefully acknowledged.
The studies described in this tllesis could not have been performed without the assistance of tlle
Dutch drug-dispensing general practitioners.
ISBN 90-9009261-7
'" J. P. Ottervanger
No part of this thesis may be reproduced, stored in a retrieval system or transmitted in any otller
form or by any means, without written permission of the author. or, when appropriate. of the
publishers of the publications.
PHARMACO-EPIDEMIOLOGY OF SUMATRIPTA N
CARDIOVASCULAR ADVERSE REACTIONS TO A NEW ANTI MIGRAINOUS DRUG
Farmaco-epidemiologie van sumatriptan
Cardiovasculaire bijwerkingen van een nieuw anti-migrainemiddel
Proefschrift
ter verkrijging van de graad van doctor
aan de Erasmus Universiteit Rotterdam
op gezag van de rector magnificus
Prof. dr P.W.C. Akkermans M.A.
en vol gens besluit van het College voor Promoties.
De openbare verdediging zal plaatsvinden op
woensdag 13 maart 1996 om 15.45 uur
door
Jan Paul Ottervanger
geboren te Rotterdam.
Promotie conllnissie
Promotor: Prof. dr D .E. Orobbee
Co-promotor: Dr B.H.Ch. Stricker
Overige leden: Prof. J.H.P. Wilson
Prof. dr P.R. Saxena
Dr H.O.M. Leufkens
Ter nagedachtenis van mijn Quders,
D.G. Ottervanger (maart 1937 - febmari 1971)
D.W. Ottervanger-Gerritsen (januari 1937 - febmari 1971)
Vaa/' Annette en Wendy

CONTENTS
PART J, BACKGROUND
1. Introduction and outline of the project 13
2. Post Marketing Surveillance 17
PART lJ, REPORTS TO A NATIONAL VOLUNTARY REPORTING SCHEME
3. The Netherlands Centre for Monitoring of Adverse Reactions to Dmgs 39
4. Dmg-induced chest pain and myocardial infarction: A review of reports
to a national centre 47
S. Adverse reactions to sumatriptan: Reports to the Netherlands Centre
for Monitoring of Adverse Reactions to Dmgs
5.1 Chest pain attributed to sumatriptan 61
5.2 Acute myocardial infarction to sumatriptan 67
6. Cardiovascular adverse reactions to sumatriptan: Cause for concern? 75
PART JJJ, EXPLORATION OF THE PROBLEM
7. Frequency and character of adverse reactions to sumatriptan
7.1 Adverse reactions as reported by dmg dispensing general practitioners 97
7.2 Adverse reactions as reported by patients 103
7.3 Differences between perceived and presented adverse reactions to dmgs 113
8. Determinants of ovelUse of sumatriptan 123
9. Characteristics and determinants of sumatriptan associated chest pain 131
10. Cardiac exercise testing in patients with chest pain due to sumatriptan 145
General discussion 153
Sununary 159
Nederlandse Samenvatting 163
Epiloog 167
Curriculum vitae 171
List of publications 173

Manuscripts based on the resnlts presented in tllis thesis
Chapter 3
Stricker BHCh, Ottervanger JP. Meldingen van vermoedelijke bijwerkingen bij het
Bureau Bijwerldngen Geneesmiddelen en onderzoeksactiviteiten in 1992. Ned Tijdschr
Geneeskd 1993;137:1784-7.
Stricker BHCh, Ottervanger JP, van del' Klauw M. Meldingen van vermoedelijke
bijwerkingen bij het Bureau Bijwerkingen Geneesmiddelen in onderzoeksactiviteiten in
1993. Ned Tijdschr Geneeskd 1994;138:2110-13.
Chapter 4
Ottervanger JP, Wilson JHP, Stricker BHCh. Drug-induced chest pain and myocardial
infarction: A review of reports to a national centre. (submitted).
Chapter 5
Stricker BHCh, Ottervanger JP. Pijn op de borst door sumatriptan. Ned Tijdschr
Geneeskd 1992; 136: 1774-6.
Stricker BHCh, Ottervanger JP. Hartinfarct door sumatriptan. Ned Tijdschr Geneeskd
1993; 137:141.
Ottervanger JP, Paalman HJA, Boxma GL, Stricker BHCh. Transmural myocardial
infarction with sumatriptan. Lancet 1993;341:861-62.
Chapter 6
Ottervanger JP, Stricker BHCh. Cardiovascular adverse reactions to sumatriptan:
Cause for concern? CNS Drugs 1995;3:90-98.
Chapter 7
Stricker BHCh, Ottervanger JP, Witsen van TB, Hoeven van del' ACJ, Valkenburg
HA. De betekenis van apotheekhoudende huisartsen voor de postmarketing
surveillance. Med Contact 1993;48:169-71.
Ottervanger JP, Witsen van TB, Valkenburg HA, Stricker BHCh. Postmarketing study
of cardiovascular adverse reactions associated with sumatriptan. BMJ 1993;307: 1185.
9
Ollervanger JP, Valkenburg HA, Grobbee DE, Stricker BHCh. Adverse reaclions
attributed to sumatriptan: A poslmarketing study in general practice. Eur J Clin
Pharmacol 1994;47:305-9.
Ottervanger JP, Valkenburg HA, Grobbee DE, Stricker BHCh. Differences in
perceived and presented adverse reactions to drugs in general practice. (submitted).
Chapter 8
Ottervanger JP, Valkenburg HA, Grobbee DE, Stricker BHCh. Pattern of sumatriptan
use and overuse in general practice. Eur J Clin Pharmacol (in press).
Chapter 9
Ottervanger JP, Valkenburg HA, Grobbee DE, Stricker BHCh. Characteristics and
determinants of sumatriptan associated chest pain. (submitted).
Chapter 10
Ottervanger JP, Hoorntje JAC, Valkenburg HA, Grobbee DE, Stricker BHCh.
Cardiac exercise testing in patients with chest pain due to sumatriptan. (submitted).
10