All authors have potential study interpretation and financial conflicts relating to this article.
Large-scale stopping and switching treatment with COX-2 inhibitors after the rofecoxib withdrawal†
Article first published online: 25 OCT 2007
Copyright © 2007 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 17, Issue 1, pages 9–19, January 2008
How to Cite
Sukel, M. P. P., van der Linden, M. W., Chen, C., Erkens, J. A. and Herings, R. M. C. (2008), Large-scale stopping and switching treatment with COX-2 inhibitors after the rofecoxib withdrawal. Pharmacoepidem. Drug Safe., 17: 9–19. doi: 10.1002/pds.1508
- Issue published online: 18 DEC 2007
- Article first published online: 25 OCT 2007
- Manuscript Accepted: 10 SEP 2007
- Manuscript Received: 5 APR 2007
- Pfizer Inc., New York, United States. Grant Number: PG007623
- non-steroidal anti-inflammatory drugs;
- drug utilization;
- Vioxx withdrawal;
To compare treatment changes after the rofecoxib withdrawal with changes occurring normally and to re-assess 12 months afterwards.
The PHARMO database comprised medication and hospital discharge records of over 3 million inhabitants in the Netherlands. The Study cohort included chronic coxib users with a coxib prescription on 30th September 2004; the Reference cohort others with a coxib prescription on 1st June 2004. Initial treatment changes were based on first new prescription since cohort entry. Twelve-month changes were studied within the Study cohort only.
The Study cohort (n = 6974) and Reference cohort (n = 5393) had similar demographics, stratified on type of coxib. In the Study cohort, 3341 (48%) initially stopped coxibs, of whom 1121 (16%) stopped all analgesic, versus 13 and 5% in the Reference cohort (p < 0.001). Among ‘other coxib’ users 32% stopped coxibs, and 15% stopped all analgesics, versus 14% and 4%, p < 0.001 in the Reference cohort. Among those who stopped coxibs, 34% switched to non-selective non-steroidal anti-inflammatory drug (nsNSAID) without PPI, 21% to nsNSAID with PPI, and 45% stopped NSAID treatment (Reference cohort: 35, 20, and 44%, respectively). These rates for ‘other coxib users’ were: switching to nsNSAID without PPI 23% (Study Cohort) versus 35% (Reference Cohort), 13 versus 28%, and 64 versus 37% respectively (p < 0.001). Twelve months later, stopping NSAID increased to 43%, stopping all analgesics to 32%. Rheumatologists continued coxibs more frequently than other caregivers (87, 65, 54%, respectively).
The rofecoxib withdrawal resulted in a large proportion of patients who discontinued analgesic treatment altogether regardless of original coxib therapy. Copyright © 2007 John Wiley & Sons, Ltd.