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      Persistence with denosumab and persistence with oral bisphosphonates for the treatment of postmenopausal osteoporosis: a retrospective, observational study, and a meta-analysis

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          Abstract

          Summary

          The objectives of this study were to estimate persistence with denosumab and put these results in context by conducting a review of persistence with oral bisphosphonates. Persistence with denosumab was found to be higher than with oral bisphosphonates.

          Purpose

          This study had two objectives: to analyse persistence in Swedish women initiating denosumab for treatment of postmenopausal osteoporosis (PMO) and to put these findings in context by conducting a literature review and meta-analysis of persistence data for oral bisphosphonates.

          Methods

          The study used the Swedish Prescribed Drug Register and included women aged at least 50 years initiating denosumab between May 2010 and July 2012. One injection of denosumab was defined as 6-month persistence. Women were considered persistent for another 6 months if they filled their next prescription within 6 months + 56 days and survival analysis applied to the data. A literature search was conducted in PubMed to identify retrospective studies of persistence with oral bisphosphonates and pooled persistence estimates were calculated using a random-effects model.

          Results

          The study identified 2,315 women who were incident denosumab users. Mean age was 74 years and 61 % had been previously treated for PMO. At 12 and 24 months, persistence with denosumab was 83 % (95 % CI, 81–84 %) and 62 % (95 % CI, 60–65 %), respectively. The literature search identified 40 articles for inclusion in the meta-analysis. At 12 and 24 months, persistence with oral bisphosphonates ranged from 10 % to 78 % and from 16 % to 46 %, with pooled estimates of 45 % and 30 %, respectively.

          Conclusion

          These data from the Swedish Prescribed Drug Register and literature review suggest that persistence was higher with denosumab than with oral bisphosphonates.

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          Most cited references62

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          European guidance for the diagnosis and management of osteoporosis in postmenopausal women

          Summary Guidance is provided in a European setting on the assessment and treatment of postmenopausal women at risk of fractures due to osteoporosis. Introduction The International Osteoporosis Foundation and European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis published guidance for the diagnosis and management of osteoporosis in 2008. This manuscript updates these in a European setting. Methods Systematic literature reviews. Results The following areas are reviewed: the role of bone mineral density measurement for the diagnosis of osteoporosis and assessment of fracture risk, general and pharmacological management of osteoporosis, monitoring of treatment, assessment of fracture risk, case finding strategies, investigation of patients and health economics of treatment. Conclusions A platform is provided on which specific guidelines can be developed for national use.
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            Osteoporosis: burden, health care provision and opportunities in the EU: a report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA).

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              Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases.

              To characterize the relationships between adherence (complance and persistence) to bisphosphonate therapy and risk of specific fracture types in postmenopausal women. Data were collected from 45 employers and 100 health plans in the continental United States from 2 claims databases during a 5-year period (January 1, 1999, through December 31, 2003). Claims from patients receiving a bisphosphonate prescription (alendronate or risedronate) were evaluated for 6 months before the Index prescription and during 24 months of follow-up to determine total, vertebral, and nonvertebral osteoporotic fractures, persistence (no gap in refills for >30 days during 24 months), and refill compliance (medication possession ratio > or = 0.80). The eligible cohort included 35,537 women (age, > or = 45 years) who received a bisphosphonate prescription. A subgroup with a specified diagnosis of postmenopausal osteoporosis was also evaluated. Forty-three percent were refill compliant, and 20% persisted with bisphosphonate therapy during the 24-month study period. Total, vertebral, nonvertebral, and hip fractures were significantly lower in refill-compliant and persistent patients, with relative risk reductions of 20% to 45%. The relationship between adherence and fracture risk remained significant after adjustment for baseline age, concomitant medications, and fracture history. There was a progressive relationship between refill compliance and fracture risk reduction, commencing at refill compliance rates of approximately 50% and becoming more pronounced at compliance rates of 75% and higher. Adherence to bisphosphonate therapy was associated with significantly fewer fractures at 24 months. Increasing refill compliance levels were associated with progressively lower fracture rates. These findings suggest that incremental changes in medication-taking habits could improve clinical outcomes of osteoporosis treatment.
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                Author and article information

                Contributors
                +46 70 982 37 25 , linda.karlsson@quantifyresearch.com
                Journal
                Osteoporos Int
                Osteoporos Int
                Osteoporosis International
                Springer London (London )
                0937-941X
                1433-2965
                18 August 2015
                18 August 2015
                2015
                : 26
                : 10
                : 2401-2411
                Affiliations
                [ ]Quantify Research, Hantverkargatan 8, SE-112 21 Stockholm, Sweden
                [ ]Department of Learning, Informatics, Management and Ethics (LIME), Medical Management Centrum (MMC), Karolinska Institutet, Stockholm, Sweden
                [ ]Department of Pharmacy, Uppsala University, Uppsala, Sweden
                [ ]Amgen (Europe) GmbH, Zug, Switzerland
                Article
                3253
                10.1007/s00198-015-3253-4
                4575381
                26282229
                ed25391c-fbf1-4490-a42b-e64283614ab4
                © The Author(s) 2015

                Open Access This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                : 3 June 2014
                : 15 July 2015
                Categories
                Original Article
                Custom metadata
                © International Osteoporosis Foundation and National Osteoporosis Foundation 2015

                Orthopedics
                bisphosphonates,denosumab,meta-analysis,persistence,retrospective,review
                Orthopedics
                bisphosphonates, denosumab, meta-analysis, persistence, retrospective, review

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