title: Role of pharmacoepidemiology studies in addressing pharmacovigilance questions: a case example of pancreatitis risk among ulcerative colitis patients using mesalazine.
abstract: OBJECTIVE
  Well-designed pharmacoepidemiology studies address several limitations of postmarketing spontaneous reports in regard to signal evaluation. This study evaluated a signal of disproportionate reporting of acute pancreatitis cases observed in patients with ulcerative colitis (UC) treated with MMX Multi Matrix System® (MMX®) mesalazine and demonstrated how inherent limitations of postmarketing reports were overcome.
  
  
  METHODS
  Adults with UC who were new users of MMX mesalazine or another branded mesalazine (controlled-release, delayed-release, or extended-release mesalazine; balsalazide disodium; olsalazine sodium; sulfasalazine; or sulfasalazine delayed-release) were identified from a large US administrative healthcare claims database. Acute pancreatitis incidence rates were compared between patients on MMX mesalazine versus comparator therapies. Propensity scores were used to match patients on MMX mesalazine with patients on comparator drugs to achieve a balance of baseline patient factors.
  
  
  RESULTS
  Crude incidence rates [95 % confidence interval (CI)] of acute pancreatitis among patients on MMX mesalazine were similar to those of patients on comparator therapies [8.55 (5.54-13.21) vs 10.05 (7.54-13.41) per 1000 person-years]; the resulting incidence rate ratio (IRR) was [0.85 (0.48-1.47)]. Propensity score-matching had little influence on the IRR [0.84 (0.46-1.55)]; nor did further adjustment by demographic characteristics, daily dose, and causes of acute pancreatitis [0.76 (0.41-1.43)].
  
  
  CONCLUSIONS
  Findings of no increase in pancreatitis risk with MMX mesalazine demonstrate the value of pharmacoepidemiology studies for evaluating a drug's postmarket safety profile when confronted with spontaneous reporting data suggestive of a safety issue.
authors.affiliation: Shire Development LLC, Wayne, PA, USA, lrusso@shire.com.
authors.forename: Leo
authors.initials: L
authors.lastname: Russo
authors.forename: Gary
authors.initials: G
authors.lastname: Schneider
authors.forename: Margarita Hauser
authors.initials: MH
authors.lastname: Gardiner
authors.forename: Stephan
authors.initials: S
authors.lastname: Lanes
authors.forename: Paul
authors.initials: P
authors.lastname: Streck
authors.forename: Susan
authors.initials: S
authors.lastname: Rosen
mesh_terms: D000208:Acute Disease; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000453:epidemiology; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D008875:Middle Aged; D010195:Pancreatitis / Q000139:chemically induced / Q000453:epidemiology*; D017891:Pharmacoepidemiology; D060735:Pharmacovigilance; D057216:Propensity Score; D012189:Retrospective Studies; D012306:Risk; D014481:United States
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine