Risk of severe gastrointestinal events in women treated with monthly ibandronate or weekly alendronate and risedronate

Ann Pharmacother. 2009 Apr;43(4):577-85. doi: 10.1345/aph.1L555. Epub 2009 Mar 24.

Abstract

Background: Bisphosphonate (BP)-related gastrointestinal (GI) adverse events can lead to discontinuation of osteoporosis treatment. Irritation of the GI tract related to BPs may be worsened by more frequent administration.

Objective: To compare the number of women who experienced severe GI events within 3 months of starting once-monthly oral ibandronate with those starting once-weekly oral BP (alendronate or risedronate).

Methods: In a retrospective database study design, eligible women with a new prescription for monthly ibandronate were propensity-matched to women with a new weekly BP prescription. Patients had continuous health plan enrollment for 6 months prior to the index date and for 3 months after the index date. Women with previous intravenous BP treatment, Paget's disease, or oral BP treatment within the 6-month preindex period were excluded. Severe GI events (including acute events involving perforation or bleeding/perforation) within 3 months of treatment initiation were identified by ICD-9 and Current Procedural Terminology codes. A post hoc analysis assessed treatment discontinuation after severe GI events. GI-related healthcare utilization rates and costs were also compared.

Results: Of the 8608 patients per group, 45 (0.52%) who were receiving monthly ibandronate and 70 (0.81%) of those receiving weekly BP treatment experienced a severe GI event. Ibandronate patients had a 36% reduction in the risk of severe GI events compared with weekly BP users (OR 0.64, 95% CI 0.44 to 0.93). Significantly more women receiving a weekly BP discontinued treatment after a severe GI event compared with those receiving ibandronate (100% vs 55.6%; p < 0.001). Most healthcare utilization outcomes were not significantly different between the 2 groups; outpatient visits were significantly higher for ibandronate (p = 0.02). Costs were not significantly different between the 2 groups.

Conclusions: Patients receiving monthly ibandronate therapy had a significantly reduced risk of severe GI events compared with those receiving weekly BP treatment. In addition, patients receiving a weekly BP were more likely to discontinue treatment after a severe GI event.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Alendronate / administration & dosage
  • Alendronate / adverse effects*
  • Cohort Studies
  • Diphosphonates / administration & dosage
  • Diphosphonates / adverse effects*
  • Drug Administration Schedule
  • Etidronic Acid / administration & dosage
  • Etidronic Acid / adverse effects
  • Etidronic Acid / analogs & derivatives*
  • Female
  • Gastrointestinal Diseases / chemically induced*
  • Gastrointestinal Diseases / epidemiology
  • Gastrointestinal Diseases / physiopathology
  • Humans
  • Ibandronic Acid
  • Middle Aged
  • Osteoporosis / drug therapy
  • Osteoporosis / physiopathology
  • Retrospective Studies
  • Risedronic Acid
  • Risk Factors

Substances

  • Diphosphonates
  • Risedronic Acid
  • Etidronic Acid
  • Ibandronic Acid
  • Alendronate