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Observational Study
. 2017 Oct;28(10):2867-2876.
doi: 10.1007/s00198-017-4116-y. Epub 2017 Jun 22.

Association of gastrointestinal events with quality of life and treatment satisfaction in osteoporosis patients: results from the Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study (MUSIC OS)

A Modi  1 , S Sen  2 , J D Adachi  3 , S Adami  4 , B Cortet  5 , A L Cooper  6 , P Geusens  7 , D Mellström  8 , J P Weaver  2 , J P van den Bergh  7   9 , P A Keown  10 , S Sajjan  2
Affiliations
Observational Study

Association of gastrointestinal events with quality of life and treatment satisfaction in osteoporosis patients: results from the Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study (MUSIC OS)

A Modi et al. Osteoporos Int. 2017 Oct.

Abstract

The purpose of this study was to assess the association of GI events with HRQoL and treatment satisfaction. The effect of baseline GI events persisted through 1 year of follow-up, as indicated by lower EQ-5D, OPAQ-SV, and treatment satisfaction scores among patients with vs without baseline GI events. The presence of GI events is an independent predictor of decreased HRQoL and treatment satisfaction in patients being treated for osteoporosis.

Introduction: The goal of this study was to assess the association of gastrointestinal (GI) events with health-related quality of life (HRQoL) and treatment satisfaction in patients being treated for osteoporosis.

Methods: MUSIC OS was a multinational, prospective, observational study examining the impact of GI events on osteoporosis management in postmenopausal women. In this analysis, HRQoL and treatment satisfaction were assessed at baseline, 6, and 12 months and compared between patients with and without GI events. Covariate-adjusted scores were calculated using multivariate least-squares regression analysis, and differences between the mean scores of patients with and without baseline and post-baseline GI events were determined.

Results: Among the 2959 patients in the analysis, unadjusted scores at each time point were lower (i.e., worse) for patients with GI events than patients without GI events. In adjusted analyses, the effect of baseline GI events persisted through 1 year of follow-up, as indicated by lower EQ-5D and OPAQ-SV scores at 12 months among patients with vs without baseline GI events (-0.04 for the EQ-5D utility score, -5.07 for the EQ-5D visual analog scale, -3.35 for OPAQ physical function, -4.60 for OPAQ emotional status, and -8.50 for OPAQ back pain; P ≤ 0.001 for all values). Decrements in month 12 treatment satisfaction scores were -6.46 for patients with baseline GI events and -7.88 for patients with post-baseline GI events.

Conclusions: The presence of GI events is an independent predictor of decreased HRQoL and treatment satisfaction in patients being treated for osteoporosis.

Keywords: Gastrointestinal diseases; Osteoporosis; Patient satisfaction; Postmenopausal; Quality of life.

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Conflict of interest statement

A. Modi and S. Sen are employees of Merck & Co., Inc. and own stock in the company. J.D. Adachi has received grant support and speaker honorarium from Actavis, Amgen, Eli Lilly, Merck & Co., Inc. and Novartis. J.D. Adachi is a consultant for Amgen, Eli Lilly, and Merck & Co., Inc. S. Adami has received consulting honorarium from Merck & Co., Inc. and served as a board member for Merck & Co., Inc. B. Cortet has received research grants, consulting honorarium, and/or speaker honorarium from Amgen, Expanscience, Ferring, Eli Lilly, Merck & Co., Inc., Merck Sharp & Dohme, Medtronic, and Roche diagnostics. A.L. Cooper has received research grants, advisory board and/or speaker honorarium from Consilient Health and Internis Pharmaceuticals. P. Geusens has received research grants, advisory board and/or speaker honorarium from Pfizer, Abbott, Eli Lilly, Amgen, Merck Sharp & Dohme, Will Pharma, Roche, UCB pharmaceuticals, Bristol-Myers Squibb, and Novaritis. D. Mellström has received consulting honorarium from Merck Sharp & Dohme. J.P. Weaver is an employee of Merck & Co., Inc. J.P. van den Bergh is a paid consultant at Amgen and Will Pharma. J.P. van den Bergh has received research grants and speaker honorarium from Amgen, Will Pharma, and Eli Lilly. P.A. Keown is the director of and employed by Syreon Corporation and has received financial remuneration from Merck & Co., Inc. to conduct the study, participate in study meetings, and perform statistical analysis. S. Sajjan was an employee of Merck & Co., Inc. and owned stock in the company at the time of the study.

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