Risk of hospitalization with peptic ulcer disease or gastrointestinal hemorrhage associated with nabumetone, Arthrotec, diclofenac, and naproxen in a population based cohort study.
OBJECTIVE
To identify the unbiased differences in the risk of hospitalization with peptic ulcer disease (PUD) or gastrointestinal (GI) hemorrhage among populations using 4 nonsteroidal antiinflammatory drugs (NSAID): nabumetone, Arthrotec, diclofenac plus a cytoprotective agent dispensed separately (diclo+coRx), and naproxen.


METHODS
A population based historical cohort study using linked data from provincial healthcare databases. The population of the province of Saskatchewan, Canada, entitled to drug plan benefits in 1995 was eligible (roughly 91% of 1 million people). Participants were identified if they filled a prescription for one of the 4 study NSAID (18,424 individuals). They were then followed for 6 months to determine outcomes. Logistic regression was used to produce estimates of the risk of admission to hospital with a primary diagnosis of PUD or GI hemorrhage associated with the study drugs unbiased by known confounders.


RESULTS
Compared to Arthrotec the adjusted odds of hospitalization for PUD for participants taking nabumetone was 2.6 (95% CI 1.0-6.6), diclo+coRx 6.8 (95% CI 3.5-13.4), and naproxen 7.9 (95% CI 3.9-15.9). Compared to nabumetone the adjusted odds of hospitalization for PUD for participants taking diclo+coRx was 2.7 (95% CI 1.2-6.0) and naproxen 3.1 (95% CI 1.3-7.1). No significant differences were noted in terms of admissions for GI hemorrhage.


CONCLUSIONS
Participants taking nabumetone and Arthrotec had significantly lower risk of hospitalization for PUD than those taking the other study drugs. Arthrotec was superior to nabumetone in a head to head comparison and especially when compared with the diclo+coRx and naproxen groups. No short term differences were seen in the rates of admission for GI hemorrhage. It appears that inherent gastroprotective strategies with Arthrotec and to a lesser extent with nabumetone do translate into decreased serious GI side effects at the population level in the short term.
Ashworth
Nigel L
NL
Division of Physical Medicine and Rehabilitation, University of Alberta, Edmonton, Alberta, Canada. ashworth@cha.ab.ca
Peloso
Paul M
PM
Muhajarine
Nazeem
N
Stang
Maryrose
M
D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D002074:Butanones / Q000009:adverse effects; D015331:Cohort Studies; D016208:Databases, Factual; D004008:Diclofenac / Q000009:adverse effects; D004338:Drug Combinations; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D016595:Misoprostol / Q000009:adverse effects; D000077430:Nabumetone; D009288:Naproxen / Q000009:adverse effects; D010437:Peptic Ulcer / Q000139:chemically induced* / Q000453:epidemiology*; D012307:Risk Factors; D012525:Saskatchewan / Q000453:epidemiology
D000894:Anti-Inflammatory Agents, Non-Steroidal; C078133:Arthrotec; D002074:Butanones; D004338:Drug Combinations; D016595:Misoprostol; D004008:Diclofenac; D009288:Naproxen; D000077430:Nabumetone