Leflunomide use during the first 33 months after food and drug administration approval: experience with a national cohort of 3,325 patients.
OBJECTIVE
To describe leflunomide (LEF) use in a national cohort of 3,325 veterans.


METHODS
Prescriptions for LEF and 9 disease-modifying antirheumatic drugs written between October 1998 and June 2001 at all Veterans Affairs (VA) medical centers were obtained from VA national databases.


RESULTS
LEF was initiated with a loading dose of 100 mg daily for 3 days in 61% of patients, and 42% of patients discontinued LEF. LEF was more likely to be discontinued if a 3-day 100-mg loading dose was prescribed, patients were younger than 44 years or older than 75 years, or reported an annual family income <$60,000. Review of medical records of 291 discontinuers revealed that the most common reasons for discontinuation were inefficacy (30%), gastrointestinal symptoms (29%), medication noncompliance or lost to followup (14%), and elevated liver enzymes (5%).


CONCLUSIONS
LEF is relatively safe in clinical practice. The VA's national databases provide an excellent, inexpensive resource for postmarketing evaluation of rheumatologic medications.
Siva
Chokkalingam
C
St. Louis VAMC (151C) and Washington University School of Medicine, 915 North Grand, St. Louis, MO 63106, USA.
Eisen
Seth A
SA
Shepherd
Rebecca
R
Cunningham
Francesca
F
Fang
Meika A
MA
Finch
William
W
Salisbury
Don
D
Singh
Jasvinder A
JA
Stern
Richard
R
Zarabadi
S Alireza
SA
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D015331:Cohort Studies; D016208:Databases, Factual; D017277:Drug Approval; D004359:Drug Therapy, Combination; D005260:Female; D006787:Hospitals, Veterans; D006801:Humans; D007555:Isoxazoles / Q000627:therapeutic use*; D000077339:Leflunomide; D008297:Male; D008875:Middle Aged; D008887:Military Medicine; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data; D017211:Treatment Failure; D014481:United States; D014493:United States Department of Veterans Affairs
D000894:Anti-Inflammatory Agents, Non-Steroidal; D018501:Antirheumatic Agents; D007555:Isoxazoles; D000077339:Leflunomide