Gastrointestinal side effects in postmenopausal women using osteoporosis therapy: 1-year findings in the POSSIBLE US study

Abstract

Objective:

To characterize gastrointestinal side effects (GI SEs) and its associations with medication discontinuation, health-related quality of life (HRQoL), and treatment) satisfaction in postmenopausal women prescribed osteoporosis (OP) therapies.

Methods:

Prospective Observational Scientific Study Investigating Bone Loss Experience (POSSIBLE US

*POSSIBLE US is a trade mark of Amgen Inc., Thousand Oaks, CA, USA.

) participants enrolled October 27, 2004 – January 25, 2007 and complete questionnaires for up to 3 years. GI SEs for women new to or stable on therapy at entry were characterized at 6 and 12 months. Adjusted odds of experiencing GI SEs; mean HRQoL and treatment satisfaction scores; and risk of discontinuing therapy for bisphosphonate (BP) versus non-BP users were compared with logistic and generalized linear models.

Results:

About 20% of women reported ≥1 GI SE at entry. GI SEs at month 6 were more common in BP than non-BP users (new: OR = 1.5, 95% CI: 1.2–2.0; stable: OR = 1.7, 95% CI: 1.3–2.1). Women new to OP therapy with GI SEs at month 6 had lower LS Mean HRQoL (OPAQ-SV Emotional Status: 72.3 vs. 78.2, p = 0.005) and treatment satisfaction scores (SEs: 71.4 vs. 82.9; Efficacy: 58.6 vs. 65.6; Global: 55.0 vs. 64.4; all p ≤ 0.02) than those without GI SEs. Women reporting any GI SE had higher therapy discontinuation than those without GI SEs (6-month OR = 1.39, 95% CI: 1.05–1.84; 12-month OR = 1.30, 95% CI: 1.03–1.63; both p ≤ 0.03).

Conclusion:

GI SEs were common among women on OP therapy, were more common in BP than non-BP users, and were associated with increased therapy discontinuation. Lower HRQoL and treatment satisfaction associated with GI SEs may influence medication discontinuation.

Key words::

• Gastrointestinal side effects
• Health-related quality of life
• Medication discontinuation
• Osteoporosis therapy
• Treatment satisfaction

Transparency

Declaration of funding

This study was funded by Amgen Inc.

Declaration of financial/other relationships

C.W. and G.G. have disclosed that they are employees of Amgen Inc.; S.W. has disclosed that she is a consultant to Amgen Inc.; M.H. has disclosed that he is a consultant to Amgen Inc., Eli Lilly Co., Merck & Co. Inc., Novartis Pharma AG, Roche Pharmaceutical Co. Inc. and Wyeth Pharmaceuticals.

The CMRO peer reviewers 1 and 2 have not received honoraria for their review work on this manuscript. Both have disclosed that they have no relevant financial relationships.

Acknowledgements

The authors would like to acknowledge the other members of the POSSIBLE US Steering Committee: Elizabeth Barrett-Connor, Robert Downs, Ted Ganiats, Barbara Lukert, Robert Recker, Robert Rubin, and Anna Tosteson. The authors are also grateful to Richard Baumann, Anthony Soo, and Mary Anthony of Amgen Inc. for their contributions to framing the research questions and analyzing the data for this study. The authors thank Michelle N. Bradley of Amgen Inc. for providing editing and submission assistance.

This study was presented at the American Society for Bone and Mineral Research (Montréal, QC, Canada; September 12–16, 2008); American Academy of Nurse Practitioners (Nashville, TN; June 17–21, 2009); North American Menopause Society (San Diego, CA; September 30 – October 3, 2009).

Notes

*POSSIBLE US is a trade mark of Amgen Inc., Thousand Oaks, CA, USA.

*POSSIBLE US is a trade mark of Amgen Inc., Thousand Oaks, CA, USA.