Large-scale stopping and switching treatment with COX-2 inhibitors after the rofecoxib withdrawal

• Published in: Pharmacoepidemiology and drug safety Vol. 17; no. 1; pp. 9 - 19
• Main Authors: Sukel, Myrthe P. P., van der Linden, Michiel W., Chen, Connie, Erkens, Joëlle A., Herings, Ron M. C.
• Format: Journal Article
• Language: English
• Published: Chichester, UK John Wiley & Sons, Ltd 01-01-2008
• Subjects: Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Arthritis, Rheumatoid - drug therapy; cardiovascular; Cardiovascular Diseases - prevention & control; Cohort Studies; COX-2-inhibitors; Cyclooxygenase 2 Inhibitors - administration & dosage; Cyclooxygenase 2 Inhibitors - adverse effects; Databases, Factual; Drug and Narcotic Control; Drug Prescriptions - statistics & numerical data; Drug Therapy, Combination; drug utilization; Drug Utilization Review; Female; gastrointestinal; Gastrointestinal Diseases - chemically induced; Gastrointestinal Diseases - prevention & control; Humans; Lactones - administration & dosage; Lactones - adverse effects; Male; Middle Aged; non-steroidal anti-inflammatory drugs; pharmacoepidemiology; Practice Patterns, Physicians' - statistics & numerical data; Proton Pump Inhibitors; Sulfones - administration & dosage; Sulfones - adverse effects; Vioxx withdrawal
• ISSN: 1053-8569; 1099-1557
• DOI: 10.1002/pds.1508

Purpose
To compare treatment changes after the rofecoxib withdrawal with changes occurring normally and to re‐assess 12 months afterwards.
Methods
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.
Results
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).
Conclusions
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.