Quality of life in raloxifene-treated Japanese women with postmenopausal osteoporosis: a prospective, postmarketing observational study

Abstract

Objective:

To assess changes in quality of life (QOL) and pain in raloxifene-treated Japanese women with postmenopausal osteoporosis.

Research design and methods:

This prospective, postmarketing observational study was conducted at 60 Japanese hospitals from September 2007 to February 2009 and included Japanese women with postmenopausal osteoporosis who were new to standard treatment with raloxifene (60 mg/day). Primary outcome measures (QOL and pain) were assessed using the Short Form-8 (SF-8), European Quality of Life Instrument (EQ-5D), osteoporosis-specific Japanese Osteoporosis Quality of Life Questionnaire (JOQOL), a visual analogue scale (VAS-pain), and a pain frequency survey. Assessments were performed at baseline and 8 (except JOQOL) and 24 weeks after first administration of raloxifene. Adverse drug reactions were recorded. Japan Pharmaceutical Information Center registration number: JapicCTI-070465.

Results:

A total of 506 participants, mean (±standard deviation [SD]) age = 70.7 ± 8.7 years, completed ≥1 follow-up assessment and were included in the analyses. All QOL scores increased from baseline during follow-up. All SF-8 domain scores increased significantly from baseline after 8 and 24 weeks (P < 0.001). Mean (±SD) EQ-5D scores increased significantly from baseline (0.70 ± 0.17) by 0.05 ± 0.15 after 8 weeks and 0.07 ± 0.17 after 24 weeks (P < 0.001). The mean (±SD) total JOQOL score increased significantly from baseline (66.8 ± 16.5) by 3.8 ± 11.3 after 24 weeks (P < 0.001). The percentage of participants with a ≥20 mm reduction in VAS-pain was 32.6% (120/368) and 39.5% (115/291) after 8 and 24 weeks, respectively. The frequency of pain reported by participants decreased after 8 and 24 weeks. Forty adverse drug reactions were reported by 34 participants.

Limitations:

Limitations include the lack of a control group, the possibility of the changes being due to the natural disease course, and potential selection bias.

Conclusions:

Our findings suggest that standard treatment with raloxifene improves QOL and relieves pain in Japanese women with postmenopausal osteoporosis in a real-world clinical setting.

Key words::

• EQ-5D
• Japanese postmenopausal osteoporosis
• JOQOL
• Quality of life
• Raloxifene
• SF-8
• VAS

Transparency

Declaration of funding

This study was sponsored by Eli Lilly Japan K.K. In compliance with the Uniform Requirements for Manuscripts, established by the International Committee of Medical Journal Editors, the sponsor of this study did not impose any impediment, directly or indirectly, on the publication of the study’s results.

In collaboration with the authors, Eli Lilly Japan K.K. was involved in the study design, data collection, data analysis, and preparation of the manuscript. All authors had full access to the data upon request. The authors had final responsibility for the decision to submit for publication.

All authors participated in the interpretation of the study results, and in the drafting, critical revision, and approval of the final version of the manuscript. K.Y., E.H., H.U., N.I., M.T., A.M., and K.T. were involved in designing the study. K.Y. and M.T. conducted the statistical analysis.

Declaration of financial/other relationships

E.H., T.Y., M.T., and H.S. are employees of Eli Lilly Japan K.K. N.I. is an employee of Eli Lilly and Company. H.U., K.Y., and K.T. have been members of advisory panels for Eli Lilly Japan or have received consulting fees from Eli Lilly Japan K.K. A.M. has disclosed that he has no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors acknowledge the medical writing assistance provided by Luke Carey, PhD, and Serina Stretton, PhD, of ProScribe Medical Communications (www.proscribe.com.au), funded by Eli Lilly Japan K.K. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP2).

Notes

*Evista is a registered trade name of Eli Lilly and Company, Indianapolis, USA.

*Evista is a registered trade name of Eli Lilly and Company, Indianapolis, IN, USA.