title: Gastrointestinal events and association with initiation of treatment for osteoporosis.
abstract: BACKGROUND
  Preexisting gastrointestinal (GI) events may deter the use of pharmacologic treatment in patients diagnosed with osteoporosis (OP). The objective of this study was to examine the association between preexisting GI events and OP pharmacotherapy initiation among women diagnosed with OP.
  
  
  METHODS
  The study utilized claims data from a large US managed care database to identify women aged ≥55 years with a diagnosis code for OP (index date) during 2002-2009. Patients with a claim for pharmacologic OP treatment in the 12-month pre-index period (baseline) were excluded. OP treatment initiation in the post-index period was defined as a claim for bisphosphonates (alendronate, ibandronate, risedronate, zoledronic acid), calcitonin, raloxifene, or teriparatide. During the post-index period (up to 12 months), GI events were identified before treatment initiation. A time-dependent Cox regression model was used to investigate the likelihood of initiating any OP treatment. Among patients initiating OP treatment, a discrete choice model was utilized to assess the relationship between post-index GI events and likelihood of initiating with a bisphosphonate versus a non-bisphosphonate.
  
  
  RESULTS
  In total, 65,344 patients (mean age 66 years) were included; 23.7% had a GI event post diagnosis and before treatment initiation. Post-index GI events were associated with a 75% lower likelihood of any treatment initiation (hazard ratio 0.25; 95% confidence interval 0.24-0.26). Among treated patients (n=23,311), those with post-index GI events were 39% less likely to receive a bisphosphonate versus a non-bisphosphonate (odds ratio 0.61; 95% confidence interval 0.54-0.68).
  
  
  CONCLUSIONS
  GI events after OP diagnosis were associated with a decreased likelihood of OP treatment initiation and an increased likelihood of treatment initiation with a non-bisphosphonate versus a bisphosphonate.
authors.affiliation: Center for Observational and Real-World Evidence, Merck & Co., Inc, Kenilworth, NJ, USA.
authors.forename: Ankita
authors.initials: A
authors.lastname: Modi
authors.affiliation: Toni Stabile Osteoporosis Center, Columbia University Medical Center, NY Presbyterian Hospital, New York, NY, USA.
authors.forename: Ethel S
authors.initials: ES
authors.lastname: Siris
authors.affiliation: Asclepius Analytics Ltd, Brooklyn, NY, USA.
authors.forename: Jackson
authors.initials: J
authors.lastname: Tang
authors.affiliation: Center for Observational and Real-World Evidence, Merck & Co., Inc, Kenilworth, NJ, USA.
authors.forename: Shiva
authors.initials: S
authors.lastname: Sajjan
authors.affiliation: Center for Observational and Real-World Evidence, Merck & Co., Inc, Kenilworth, NJ, USA.
authors.forename: Shuvayu S
authors.initials: SS
authors.lastname: Sen
keywords: bisphosphonates; osteoporosis; postmenopausal; prescribing patterns