Role of pharmacoepidemiology studies in addressing pharmacovigilance questions: a case example of pancreatitis risk among ulcerative colitis patients using mesalazine

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• 作者：Leo Russo (1) (3)
  Gary Schneider (2)
  Margarita Hauser Gardiner (1)
  Stephan Lanes (2)
  Paul Streck (1)
  Susan Rosen (1)
  
• 关键词：Pancreatitis ; Ulcerative colitis ; Mesalazine ; Pharmacoepidemiology ; Pharmacovigilance
• 刊名：European Journal of Clinical Pharmacology
• 出版年：2014
• 出版时间：June 2014
• 年：2014
• 卷：70
• 期：6
• 页码：709-717
• 全文大小：
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• 作者单位：Leo Russo (1) (3)
  Gary Schneider (2)
  Margarita Hauser Gardiner (1)
  Stephan Lanes (2)
  Paul Streck (1)
  Susan Rosen (1)
  
  1. Shire Development LLC, Wayne, PA, USA
  3. Department of Health Economics, Outcomes Research and Epidemiology, Shire Research and Development, 725 Chesterbrook Boulevard, Wayne, PA, 19087, USA
  2. Evidera, Lexington, MA, USA
  
• ISSN：1432-1041

文摘

Purpose 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 (5.54-3.21) vs 10.05 (7.54-3.41) per 1000 person-years]; the resulting incidence rate ratio (IRR) was [0.85 (0.48-.47)]. Propensity score-matching had little influence on the IRR [0.84 (0.46-.55)]; nor did further adjustment by demographic characteristics, daily dose, and causes of acute pancreatitis [0.76 (0.41-.43)]. Conclusion 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.