Risk of complications after a peptic ulcer diagnosis: effectiveness of proton pump inhibitors.
BACKGROUND
Few studies have evaluated the prevention of upper gastrointestinal complications (UGIC; bleeding or perforation) in patients with uncomplicated peptic ulcer (PU). We assessed the effect of proton pump inhibitors (PPI) in a non-randomized setting. To maximize exchangeability of exposed and unexposed groups we restricted the study to patients with a new diagnosis of PU, i.e., a clear indication. To minimize selection bias we mimicked an intention to treat approach by assessing the effect of PPI prescription after PU diagnosis.


METHODS
Within a population of subjects aged 40-84 years from The Health Improvement Network database, 1997-2006, we identified 3,850 patients with incident PU. Among them, we confirmed 74 first UGIC episodes during a mean follow-up of 4 years. Exposure was prescription coverage during the month following PU diagnosis. We performed a nested case-control analysis and compared UGIC cases with 400 controls matched for age, sex, year and duration of follow-up. Relative risks (RR) and 95 % confidence intervals (CI) were estimated.


RESULTS
The overall incidence of UGIC was 4.6 cases/1,000 person-years; it was highest during the months after PU diagnosis, increased with age, and it was higher in men and subjects with Helicobacter pylori infection, anemia, and alcohol use at PU diagnosis. The RR for UGIC associated with PPI prescriptions during the month after PU diagnosis was 0.56 (95 % CI 0.31-1.0). The RR for NSAIDs with and without a PPI was 1.72 (0.68-4.45) and 3.27 (0.85-12.67), respectively.


CONCLUSIONS
Findings suggest that prescription of PPIs after a PU diagnosis is associated with a reduced risk of UGIC.
Department of Epidemiology, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA. shernan@hsph.harvard.edu
Sonia
S
Hernández-Díaz
Elisa
E
Martín-Merino
Luis A
LA
García Rodríguez
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D004381:Duodenal Ulcer / Q000150:complications / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010438:Peptic Ulcer Hemorrhage / Q000453:epidemiology / Q000517:prevention & control*; D010439:Peptic Ulcer Perforation / Q000453:epidemiology / Q000517:prevention & control*; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D012306:Risk; D013276:Stomach Ulcer / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
D054328:Proton Pump Inhibitors