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Association of Antiosteoporotic Medication Bisphosphonates and Denosumab with Primary Breast Cancer: An Electronic Health Record Cohort Study.

ABSTRACT: Background: The risks of osteoporosis and breast cancer are increasing in elderly women. Bisphosphonates and denosumab are recommended for treatment of osteoporosis. They have different and overlapping pharmacodynamics and previous studies have shown conflicting results regarding their risk association with breast cancer. We intend to further look into this issue through a comparative study. Methods: Electronic health records of 91,626 women older than 50 years with no previous history of malignancy and no nonbreast cancer during follow-up were retrieved from southern California and retrospectively analyzed using univariate, bivariate, and log-rank tests. Medication use, breast cancer risk, and associated demographic and clinical history were assessed. Results: Over an average of 3.6 years follow-up, the breast cancer relative risks (RRs) counted after 365 days of latency are 1.12 (95% confidence interval [CI]: 0.64-1.97) for denosumab ever users and 0.37 (95% CI: 0.21-0.66) for bisphosphonates ever users, when covariates are comparable. The significant difference is supported by the Log-rank test (p = 0.0004). Excluding statins coprescribers, the breast cancer RR is 1.31 (0.71, 2.43) in denosumab group and 0.26 (0.11, 0.62) in bisphosphonates group. There is a reduced RR in statins ever users (0.47, 95% CI: 0.38-0.58), and the breast cancer risk difference is not significant between concomitant denosumab/statins and bisphosphonates/statins ever users with RR 0.65 (0.16, 2.58) versus 0.55 (0.26, 1.16), p = 0.692. Conclusions: Our data support an association of lower breast cancer risk with bisphosphonates use in elderly women. We did not observe a lower breast cancer risk in denosumab group; however, our data revealed a potential lower breast cancer risk in denosumab users with concurrent statins use and this requires further study.

SUBMITTER: Stanoyevitch A

PROVIDER: S-EPMC8409235 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceDespite billions spent in public investment, electronic health records (EHRs) have not delivered on the promise of large quality and safety improvement. Simultaneously, there is debate on whether public quality reporting is a useful tool to incentivize quality improvement.ObjectiveTo evaluate whether publicly reported feedback was associated with hospital improvement in an evaluation of medication-related clinical decision support (CDS) safety performance.Design, settings, and participantsThis nonrandomized controlled trial included US hospitals that participated in the Computerized Provider Order Entry (CPOE) Evaluation Tool in the Leapfrog Hospital Survey, a national quality reporting program that evaluates safety performance of hospital CDS using simulated orders and patients, in 2017 to 2018. A sharp regression discontinuity design was used to identify the association of receiving negative feedback with hospital performance improvement in the subsequent year. Data were analyzed from January through September 2020.ExposuresPublicly reported quality feedback.Main outcomes and measuresThe main outcome was improvement from 2017 to 2018 on the Leapfrog CPOE Evaluation Tool, using regression discontinuity model estimates of the association of receiving negative publicly reported feedback with quality improvement.ResultsA total of 1183 hospitals were included, with a mean (SD) CPOE score of 59.3% (16.3%) at baseline. Hospitals receiving negative feedback improved 8.44 (95% CI, 0.09 to 16.80) percentage points more in the subsequent year compared with hospitals that received positive feedback on the same evaluation. This change was driven by differences in improvement in basic CDS capabilities (β = 8.71 [95%CI, 1.67 to 18.73]) rather than advanced CDS (β = 6.15 [95% CI, -9.11 to 26.83]).Conclusions and relevanceIn this nonrandomized controlled trial, publicly reported feedback was associated with quality improvement, suggesting targeted measurement and reporting of process quality may be an effective policy lever to encourage improvement in specific areas. Clinical decision support represents an important tool in ensuring patient safety and decreasing adverse drug events, especially for complex patients and those with multiple chronic conditions who often receive several different drugs during an episode of care.

Project description:Gaps in pharmacological treatment for osteoporosis can reduce effectiveness. Among older adults, we found about half of new users of oral bisphosphonate and denosumab persisted with their treatment at 2 years, with few switching to alternative therapy. Persistence is suboptimal and warrants evaluation of interventions to improve this.PurposeGaps in pharmacological treatment for osteoporosis can reduce effectiveness. This study aimed to estimate persistence rates for oral bisphosphonates and denosumab in older primary care patients and identify factors associated with discontinuation.MethodsOlder patients newly prescribed oral bisphosphonates or denosumab during 2012-2017 were identified from 44 general practices (GP) in Ireland. Persistence without a coverage gap of >90 days was calculated for both medications from therapy initiation. Factors associated with time to discontinuation were explored using Cox regression analysis. Exposures included age group, osteoporosis diagnosis, fracture history, calcium/vitamin D prescription, number of other medications, health cover, dosing frequency (bisphosphonates) and previous bone-health medication (denosumab).ResultsOf 41,901 patients, n=1569 were newly initiated on oral bisphosphonates and n=1615 on denosumab. Two-year persistence was 49.4% for oral bisphosphonates and 53.8% for denosumab and <10% were switched to other medication. Having state-funded health cover was associated with a lower hazard of discontinuation for both oral bisphosphonates (HR=0.49, 95% CI=0.36-0.66, p<0.01) and denosumab (HR=0.71, 95% CI=0.57-0.89, p<0.01). Older age group, number of medications and calcium/vitamin D prescription were also associated with better bisphosphonate persistence, while having osteoporosis diagnosed was associated with better denosumab persistence.ConclusionPersistence for osteoporosis medications is suboptimal. Of concern, few patients are switched to other bone-health treatments when denosumab is stopped which could increase fracture risk. Free access to GP services and medications may have resulted in better medication persistence in this cohort. Future research should explore prescribing choices in primary care osteoporosis management and evaluate cost-effectiveness of interventions for improving persistence.

Project description:BackgroundMedication-wide association studies (MWAS) have been applied to assess the risk of individual prescription use and a wide range of health outcomes, including cancer, acute myocardial infarction, acute liver failure, acute renal failure, and upper gastrointestinal ulcers. Current literature on the use of preconception and periconception medication and its association with the risk of multiple gestation pregnancies (eg, monozygotic and dizygotic) is largely based on assisted reproductive technology (ART) cohorts. However, among non-ART pregnancies, it is unknown whether other medications increase the risk of multifetal pregnancies.ObjectiveThis study aimed to investigate the risk of multiple gestational births (eg, twins and triplets) following preconception and periconception exposure to prescription medications in patients who delivered at Penn Medicine.MethodsWe used electronic health record data between 2010 and 2017 on patients who delivered babies at Penn Medicine, a health care system in the Greater Philadelphia area. We explored 3 logistic regression models: model 1 (no adjustment); model 2 (adjustment for maternal age); and model 3-our final logistic regression model (adjustment for maternal age, ART use, and infertility diagnosis). In all models, multiple births (MBs) were our outcome of interest (binary outcome), and each medication was assessed separately as a binary variable. To assess our MWAS model performance, we defined ART medications as our gold standard, given that these medications are known to increase the risk of MB.ResultsOf the 63,334 distinct deliveries in our cohort, only 1877 pregnancies (2.96%) were prescribed any medication during the preconception and first trimester period. Of the 123 medications prescribed, we found 26 (21.1%) medications associated with MB (using nominal P values) and 10 (8.1%) medications associated with MB (using Bonferroni adjustment) in fully adjusted model 3. We found that our model 3 algorithm had an accuracy of 85% (using nominal P values) and 89% (using Bonferroni-adjusted P values).ConclusionsOur work demonstrates the opportunities in applying the MWAS approach with electronic health record data to explore associations between preconception and periconception medication exposure and the risk of MB while identifying novel candidate medications for further study. Overall, we found 3 novel medications linked with MB that could be explored in further work; this demonstrates the potential of our method to be used for hypothesis generation.

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Association of Antiosteoporotic Medication Bisphosphonates and Denosumab with Primary Breast Cancer: An Electronic Health Record Cohort Study.

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