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Observational Study
. 2016 Mar;27(3):1227-1238.
doi: 10.1007/s00198-015-3388-3. Epub 2015 Dec 4.

Gastrointestinal symptoms and association with medication use patterns, adherence, treatment satisfaction, quality of life, and resource use in osteoporosis: baseline results of the MUSIC-OS study

A Modi  1 , S Sen  1 , J D Adachi  2 , S Adami  3 , B Cortet  4 , A L Cooper  5 , P Geusens  6 , D Mellström  7 , J Weaver  8 , J P van den Bergh  6   9 , A M Nguyen  1 , S Sajjan  1 ; MUSIC-OS Study Group
Affiliations
Observational Study

Gastrointestinal symptoms and association with medication use patterns, adherence, treatment satisfaction, quality of life, and resource use in osteoporosis: baseline results of the MUSIC-OS study

A Modi et al. Osteoporos Int. 2016 Mar.

Abstract

Summary: The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study (MUSIC-OS) is a prospective, observational study of women with osteoporosis in Europe and Canada. At baseline, patients with gastrointestinal symptoms reported lower adherence to osteoporosis treatment, treatment satisfaction, and health-related quality of life, than those without gastrointestinal symptoms.

Introduction: The aim of the study was to examine gastrointestinal (GI) symptoms and the association between GI symptoms and treatment adherence, treatment satisfaction, and health-related quality of life (HRQoL) among osteoporotic women in Europe and Canada.

Methods: Baseline results are reported here for a prospective study which enrolled postmenopausal, osteoporotic women who were initiating (new users) or continuing (experienced users) osteoporosis treatment at study entry (baseline). A patient survey was administered at baseline and included the occurrence of GI symptoms during 6-month pre-enrolment, treatment adherence (adherence evaluation of osteoporosis (ADEOS), score 0-22), treatment satisfaction (Osteoporosis Treatment Satisfaction Questionnaire for Medications (OPSAT-Q), score 0-100) and HRQoL (EuroQol-5 dimension (EQ-5D) utility, score 0-1; OPAQ-SV, score 0-100). The association between GI symptoms and ADEOS (experienced users), OPSAT-Q (experienced users), and HRQoL (new and experienced users) was assessed by general linear models adjusted for patient characteristics.

Results: A total of 2959 patients (2275 experienced and 684 new users) were included. Overall, 68.1% of patients experienced GI symptoms in the past 6 months. Compared with patients without GI symptoms, patients with GI symptoms had lower mean baseline scores on most measures. The mean adjusted differences were ADEOS, -0.43; OPSAT-Q, -5.68; EQ-5D, -0.04 (new users) and -0.06 (experienced users), all P < 0.01. GI symptoms were also associated with lower OPAQ-SV domain scores: physical function, -4.17 (experienced users); emotional status, -4.28 (new users) and -5.68 (experienced users); back pain, -5.82 (new users) and -11.33 (experienced users), all P < 0.01.

Conclusions: Patients with GI symptoms have lower treatment adherence and treatment satisfaction and worse HRQoL than patients without GI symptoms.

Keywords: Bisphosphonates; Gastrointestinal; Health-related quality of life; Osteoporosis; Postmenopausal; Treatment satisfaction.

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Conflict of interest statement

This study was funded by Merck & Co, Inc. A. Modi, S. Sen, A.M. Nguyen, S. Sajjan, and J. P. Weaver are employees of Merck & Co. 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 and is a consultant for Amgen, Eli Lilly, and Merck & Co., Inc. S. Adami has received consulting honorarium from Merck & Co., Inc. and serves as a board member for Merck & Co., Inc. Bernard Cortet has received consulting fees for work as an expert or speaker for Amgen, Ferring, Lilly, Medtronic, Merck, Novartis, Roche Diagnostics, Rottapharm, and Servier and funding for research programs and investigator fees from Amgen, Merck, Novartis, and Servier. A.L. Cooper has received research grants, advisory board, and/or speaker honorarium from Amgen, Consilient Health, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Proctor and Gamble, ProStrakan, Roche, Servier, and Shire. J.P. van den Bergh is a paid consultant at Amgen and Will Pharma and has received research grants and speaker honorarium from Amgen, Will Pharma, and Eli Lilly. P. Geusens and D. Mellström have declared no competing interests.

Medical writing support was provided by Optum (Eden Prairie, MN, USA) and was funded by Merck & Co., Inc.

Figures

Fig. 1
Fig. 1
a Likelihood of osteoporosis-related health care resource use for new and experienced users with and without GI symptoms. Values are adjusted odds ratios from the logistic regression model with backward elimination. Adjustment variables retained in the model for GP visits were as follows: among new users: treatment class and concomitant medication use; among experienced users: duration of osteoporosis, history of fractures, comorbidities, and treatment class. Adjustment variables retained in the model for specialist visits were as follows: among new users: treatment class, concomitant medication use, and comorbidities; among experienced users: age, race, duration of osteoporosis, history of fractures, and treatment class: GI gastrointestinal, GP general practitioner. b Likelihood of gastrointestinal-related health care resource use for experienced users with and without GI symptoms. Values are adjusted odds ratios from the logistic regression model with backward elimination. Adjustment variables retained in the model for GP visits were as follows: age group, duration of osteoporosis, history of fractures, history of falls, treatment class, and concomitant medication use. Adjustment variables retained in the model for specialist visits were body mass index, duration of osteoporosis treatment, history of fractures, and concomitant medication use. GI gastrointestinal, GP general practitioner
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