Effectiveness of denosumab for fracture prevention in real-world postmenopausal women with osteoporosis: a retrospective cohort study

Summary: To determine denosumab’s effectiveness for fracture prevention among postmenopausal women with osteoporosis in East Asia, the risk of fracture was compared between patients continuing denosumab therapy versus patients discontinuing denosumab after one dose. The real-world effectiveness was observed to be consistent with the efficacy demonstrated in the phase III trial. Introduction: After therapeutic efficacy is demonstrated for subjects in global clinical trials, real-world evidence may provide complementary knowledge of therapeutic effectiveness in a heterogeneous mix of patients seen in clinical practice. This retrospective cohort study was conducted to compare the fracture risk in real-world clinical care received in Taiwan and Hong Kong between a treatment cohort (patients receiving denosumab 60 mg subcutaneously every 6 months) versus an off-treatment cohort (patients discontinuing after 1 dose of denosumab, which has no known clinical benefit) among real-world postmenopausal women. Methods: This study included 38,906 and 2,835 postmenopausal women receiving denosumab in Taiwan and Hong Kong, respectively. The primary endpoint was hip fracture, and secondary endpoints were clinical vertebral and nonvertebral fractures. Propensity-score-matched analysis, adjusting for known covariates, was used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). The robustness of findings was evaluated with a series of sensitivity and quantitative bias analyses. Results: In this study, 554 hip fractures were included in the primary Taiwan population analysis. The crude incidence rate was 0.9 per 100 person-years in the treatment cohort (n = 25,059) and 1.7 per 100 person-years in the off-treatment cohort (n = 13,847). After adjusting for prognostic differences between cohorts, denosumab reduced the risk of hip fractures by 38% (HR = 0.62, CI:0.52–0.75). Risk reductions of similar magnitude were observed for the secondary endpoints and for the analysis of the smaller Hong Kong population. Conclusion: The effectiveness of denosumab for fracture reduction among real-world postmenopausal women with osteoporosis was consistent with the efficacy demonstrated in a global clinical trial

Databases in Asia: the potential for distributed network approach

Poster: no. 689This journal suppl. entitled: Special Issue: Abstracts of the 30th International Conference on Pharmacoepidemiology and Therapeutic Risk Management ... 2014BACKGROUND: One of the initial steps to establish a distributed network approach for collaborative multinational studies in Asia is to understand the applicability of a common data model (CDM) to heterogeneous data sources. However, the capacity of database in Asian countries and the feasibility to build or apply existing CDM has not been well described. OBJECTIVES: To describe database availability and characteristics of the databases in Asian countries and to assess the feasibility to apply a CDM in Asian database environments. METHODS: A web-based survey was conducted among investigators using healthcare databases in Asia. The potential survey participants were identified through the Asian Pharmacoepidemiology Network. The survey included questions: 1) characteristics of database, 2) patients demographics, 3) data components and coding system 4) medical expenditure, and 5) the traditional Chinese medicine (TCM) or complementary medicine. RESULTS: A total of 10 data sources from Asian countries participated in the survey, including nationwide databases form Japan, Korea, Taiwan, and Hong Kong. These contained data on approximately 128, 50, 23, and 7 million individuals, respectively, covering all age groups and the majority was Asian. One claims database includes all veterans and dependents (approximately 330,000 individuals) from Australia with predominantly elderly and Caucasian. Others included a hospital based EHR from China (5 million individuals) and two EHRs from Thailand (1 million and 300,000 individuals). Two registries for cancer and stroke were from Taiwan. The majority of databases possesses diagnoses information with the date by either ICD9 or ICD10 codes; and encompasses procedures and prescriptions records with the date by domestic coding systems. Three databases contain dispensing data for TCMs. One EHR includes information of Thai herbal medicine. CONCLUSIONS: There are numerous Asian databases with comprehensive healthcare information to provide an opportunity for applying distributed network approach in Asia. Harmonization of the coding systems as well as understanding practice patterns affecting the interpretation of results will be challenges for multinational database studies