title: Risk of gastric cancer, gastrointestinal cancers and other cancers: a comparison of treatment with pantoprazole and other proton pump inhibitors.
abstract: BACKGROUND
  Proton pump inhibitors (PPIs) have been shown to be carcinogenic in rodent studies.
  
  
  OBJECTIVE
  As part of a long-term post-marketing surveillance study requested by the US Food and Drug Administration, to compare incidence rates of gastric and other cancers after sustained exposures to pantoprazole, a long-acting PPI, compared with other shorter acting PPIs.
  
  
  METHODS
  We conducted a cohort study within the membership of the Kaiser Permanente Northern California healthcare system and compared rates of gastric and other cancers among pantoprazole users and users of other PPI medications. The Cox proportional hazards model was used to adjust for potential confounders such as sex, age, receipt of treatment for Helicobacter pylori, cumulative PPI dose, total years PPI treatment and year of index date. The study was developed in consultation with, and approved by, the FDA.
  
  
  RESULTS
  A total of 61 684 persons with at least a 240-day supply of medication (34 178 pantoprazole and 27 686 other PPIs) were followed up for a total of 547 020 person-years (274 700 vs. 272 321 person-years, respectively). The primary analyses demonstrated comparable risks between the pantoprazole and other PPI groups for gastric cancer [hazard ratio (HR) = 0.68, 95% CI 0.24-1.93); colorectal, liver, pancreatic, or small bowel cancers (HR = 0.95, 95% CI 0.65-1.40) or any cancer (HR = 1.06, 95% CI 0.93-1.21).
  
  
  CONCLUSIONS
  We found no evidence that pantoprazole, a longer acting PPI, compared with shorter-acting agents, conferred an excess risk of gastric cancer, other gastrointestinal cancers or all cancers for pantoprazole compared with other shorter-acting PPIs.
authors.affiliation: Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
authors.forename: J L
authors.initials: JL
authors.lastname: Schneider
authors.affiliation: Pfizer Inc., New York, NY, USA.
authors.forename: F
authors.initials: F
authors.lastname: Kolitsopoulos
authors.affiliation: Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
authors.forename: D A
authors.initials: DA
authors.lastname: Corley
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage; D000293:Adolescent; D000328:Adult; D000368:Aged; D002140:California; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology; D000077402:Pantoprazole; D016016:Proportional Hazards Models; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D013274:Stomach Neoplasms / Q000453:epidemiology*; D013997:Time Factors; D014481:United States; D055815:Young Adult
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; D000077402:Pantoprazole