Dataset Information

Assessing the incidence of osteosarcoma among teriparatide users based on Medicare Part D and US State Cancer Registry Data.

ABSTRACT:

Purpose

During preclinical testing, teriparatide caused a dose-dependent increase in the incidence of osteosarcoma in rats. This study compared the incidence rate of osteosarcoma among patients aged ?65?years treated with teriparatide vs a matched-comparator cohort.

Methods

This population-based comparative-cohort study matched exposure details for each teriparatide user, identified via Medicare Part D prescription claims, and up to four comparators based on age, sex, zip code, date of claim for filled prescription, and number of unique therapeutic classes dispensed. Outcomes were identified via linkage with participating cancer registries. All US state cancer registries were invited to participate.

Results

Overall, 153?316 patients in the teriparatide cohort and 613?247 in the comparator cohort were linked to 811 osteosarcoma cases from 26 participating state cancer registries (68% of US patients aged ?65?years diagnosed 2007-2014). Analysis on a subset of cohorts revealed they were balanced for known osteosarcoma risk factors and Charlson comorbidity index. Mean duration of teriparatide treatment was 10 months. No osteosarcoma cases were observed in the teriparatide cohort; the incidence rate in the comparator cohort was consistent with the background incidence rate among adults aged ?65?years. The incidence rate ratio was 0.0 (95% confidence interval, 0.0-3.2).

Conclusions

For US patients aged ?65?years, incidence of osteosarcoma among those treated with teriparatide ranges from 0 to 3.2 times the incidence of osteosarcoma in those treated with other medications. Given low incidence of osteosarcoma, this range of effect is inconsistent with a large absolute increase in osteosarcoma risk.

SUBMITTER: Gilsenan A

PROVIDER: S-EPMC7754479 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Assessing the incidence of osteosarcoma among teriparatide users based on Medicare Part D and US State Cancer Registry Data.

Gilsenan Alicia A Midkiff Kirk K Harris David D McQuay Lisa L Hunter Shannon S Kellier-Steele Nicole N Andrews Elizabeth E

Pharmacoepidemiology and drug safety 20200907 12

<h4>Purpose</h4>During preclinical testing, teriparatide caused a dose-dependent increase in the incidence of osteosarcoma in rats. This study compared the incidence rate of osteosarcoma among patients aged ≥65 years treated with teriparatide vs a matched-comparator cohort.<h4>Methods</h4>This population-based comparative-cohort study matched exposure details for each teriparatide user, identified via Medicare Part D prescription claims, and up to four comparators based on age, sex, zip code, da ...[more]

PMID: 32894794

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Project description:The Osteosarcoma Surveillance Study was initiated in the United States in 2003 to monitor for a potential association between the osteoporosis treatment teriparatide and osteosarcoma. Osteosarcoma occurs at a background incidence rate of approximately 2.5 cases per million per year in US adults aged 40 years or older. For this study, incident cases of osteosarcoma diagnosed between January 1, 2003, and December 31, 2016, were identified through participating cancer registries in the United States. Information on prior exposure to medications and possible risk factors was obtained by self-report (or proxy report) in telephone interviews. Exposure information was verified through medical record abstraction for a sample of patients. A standardized incidence ratio was estimated to compare the observed and expected numbers of osteosarcoma patients with a prior history of teriparatide treatment. Interviews were completed for 24% (1173) of patients diagnosed with osteosarcoma between 2003 and 2016; three reports of teriparatide use before diagnosis were identified. Based on the background incidence rate, the expected number of osteosarcoma cases among patients treated with teriparatide was 4.17. Given the three observed cases, the standardized incidence ratio was 0.72 (90% confidence interval [CI], 0.20 to 1.86). Demographic characteristics were similar for interviewed and noninterviewed patients. Agreement was >90% between self-reported and chart-recorded exposure to osteoporosis medications. Mean age of interviewed patients was 61 years; 53% of patients were male, 84% were white, and 5% were Hispanic. The prevalence of suspected risk factors for development of osteosarcoma among the osteosarcoma cohort was 19% for history of radiation and 4% for history of Paget's disease of bone. These findings showed that the incidence of osteosarcoma associated with teriparatide use during the 15-year surveillance period was no different than would be expected based on the background incidence rate of osteosarcoma. © 2020 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Project description:BackgroundThe linkage of registries to Medicare claims data can help extend follow-up for patients receiving medical devices. In the present study, we tested and validated an algorithm that does not require patient identifiers to link data from a national vascular registry and Medicare claims data.MethodsWe used data from the Vascular Quality Initiative (VQI), a registry capturing data from >600 centers for several different vascular procedures, and Medicare claims from 2003 to 2018. We restricted the study to patients aged ≥65 years who had fee-for-service entitlement at their procedure. We performed an indirect linkage to combine the VQI and Medicare data at the patient level using a sequential algorithm based on the patient's date of birth, sex, zip code, procedure date, and procedure facility. We compared the indirectly linked cohort against a reference standard of a cohort directly linked using Social Security numbers. We calculated the matching rate and accuracy overall and before and after October 2015 when the International Classification of Diseases, 10th revision (ICD-10) system was adopted in the United States.ResultsA total of 144,045 VQI-Medicare-linked patients were in the reference standard cohort. Using the indirect linking algorithm, we matched 133,966 of the 144,045 VQI patients to their Medicare claims with a matching rate of 93.0%. Of the 133,966 patients, 133,104 were correctly matched (matching accuracy, 99.4%). The matching rate was higher when the indirect linkage was implemented using the ICD-10 coded data than using the ICD-9 coded data (94.0% vs 92.2%). The accuracy of the indirect linkage remained high for all procedure modules after the ICD-10 coding change (overall, 99.4%; range, 99.0%-99.7%).ConclusionsIn the present study, we successfully used indirect identifiers to link the VQI data to Medicare claims with >90% success and >99% accuracy. When direct linkage of the registry claims data using Social Security numbers is not possible because of availability or confidentiality, or both, our algorithm for indirect linkage provides a suitable alternative. The matching rate and accuracy will help ensure the accuracy of long-term follow-up and the completeness and representativeness of linked databases for relevant research and quality improvement initiatives.

Project description:ImportanceOpioid-related mortality increased by 15.6% from 2014 to 2015 and increased almost 320% between 2000 and 2015. Recent research finds that the use of all pain medications (opioid and nonopioid collectively) decreases in Medicare Part D and Medicaid populations when states approve medical cannabis laws (MCLs). The association between MCLs and opioid prescriptions is not well understood.ObjectiveTo examine the association between prescribing patterns for opioids in Medicare Part D and the implementation of state MCLs.Design, setting, and participantsLongitudinal analysis of the daily doses of opioids filled in Medicare Part D for all opioids as a group and for categories of opioids by state and state-level MCLs from 2010 through 2015. Separate models were estimated first for whether the state had implemented any MCL and second for whether a state had implemented either a dispensary-based or a home cultivation only-based MCL.Main outcomes and measuresThe primary outcome measure was the total number of daily opioid doses prescribed (in millions) in each US state for all opioids. The secondary analysis examined the association between MCLs separately by opioid class.ResultsFrom 2010 to 2015 there were 23.08 million daily doses of any opioid dispensed per year in the average state under Medicare Part D. Multiple regression analysis results found that patients filled fewer daily doses of any opioid in states with an MCL. The associations between MCLs and any opioid prescribing were statistically significant when we took the type of MCL into account: states with active dispensaries saw 3.742 million fewer daily doses filled (95% CI, -6.289 to -1.194); states with home cultivation only MCLs saw 1.792 million fewer filled daily doses (95% CI, -3.532 to -0.052). Results varied by type of opioid, with statistically significant estimated negative associations observed for hydrocodone and morphine. Hydrocodone use decreased by 2.320 million daily doses (or 17.4%) filled with dispensary-based MCLs (95% CI, -3.782 to -0.859; P = .002) and decreased by 1.256 million daily doses (or 9.4%) filled with home-cultivation-only-based MCLs (95% CI, -2.319 to -0.193; P = .02). Morphine use decreased by 0.361 million daily doses (or 20.7%) filled with dispensary-based MCLs (95% CI, -0.718 to -0.005; P = .047).Conclusions and relevanceMedical cannabis laws are associated with significant reductions in opioid prescribing in the Medicare Part D population. This finding was particularly strong in states that permit dispensaries, and for reductions in hydrocodone and morphine prescriptions.

Project description:BackgroundPrescribing of medications with anticholinergic properties in older nursing home residents is relatively common, despite an association with an increased risk for falls, delirium, and other outcomes. Few studies have investigated what factors influence different levels of prescribing of these agents.ObjectivesThe primary objective was to identify factors associated with low- and high-level anticholinergic burden in nursing home residents. A secondary objective was to examine in detail the contribution of different medications to low versus high burden to aid in determining which drugs to target in interventions.MethodsThis was a retrospective, cross-sectional analysis of a national sample of 2009-2010 Medicare Part A and B claims, Part D prescription drug events, and Minimum Data Set (MDS) v2.0 assessments. The cohort included 4730 Medicare beneficiaries aged ≥ 65 years with continuous Medicare Parts A, B, and D enrollment, admitted for non-skilled stays of ≥ 14 days between 1 January 2010 and 30 September 2010. Anticholinergic burden was defined using the Anticholinergic Cognitive Burden (ACB) scale. Medication scores were summed at the patient level and categorized as high (score ≥ 3), low (score 1-2), or none. Baseline predisposing factors (age, sex, race/ethnicity), enabling factors (prior year hospitalization, emergency department, primary care, specialist visits; region; Medicaid/low-income subsidy), and medical need factors (dementia severity, anti-dementia medication, Charlson co-morbidity index [CCI], select comorbidities) were evaluated for association with anticholinergic burden using multinomial logistic regression.ResultsOverall, 29.6% of subjects had a high anticholinergic burden and 35.2% had a low burden. High burden was most often (72%) due to one highly anticholinergic medication rather than a cumulative effect. In adjusted analyses, factors associated with increased risk of both low and high anticholinergic burden included comorbidity, antidementia medication, depression, hypertension, and prior year hospitalization. Older age was associated with decreased odds of high anticholinergic burden. Urinary incontinence and prior year specialist visit were associated with increased odds of high anticholinergic burden. Severe and nonsevere dementia were associated with decreased odds of low burden but increased odds of high burden.ConclusionAlmost two-thirds of nursing home patients have some degree of anticholinergic burden. Several medical need variables are significantly associated with increased risk for low and high anticholinergic burden. Interventions should be developed to optimize prescribing for residents at increased risk of receiving medications with anticholinergic properties. Future study is needed to evaluate the difference in the risk of adverse outcomes associated with various levels of anticholinergic burden.

Project description:BackgroundThe Million Hearts Cardiovascular Disease Risk Reduction Model provides financial incentives for practices to lower 10-year atherosclerotic cardiovascular disease (ASCVD) risk for high-risk (ASCVD ≥30%) Medicare patients. To estimate average practice-level ASCVD risk reduction, we applied optimal trial outcomes to a real-world population with high ASCVD risk.MethodsThis study uses observational registry data from the National Cardiovascular Data Registry Practice Innovation and Clinical Excellence Registry from January 2013 to June 2016. We modeled ASCVD risk reductions using historical clinical trial data (reducing cholesterol by 26.5%, reducing systolic blood pressure by 10.9%, reducing smoking rates by 21.8%) the average reduction in ASCVD risk associated with individual and combined risk factor modifications, and then percentage of practices achieving the various incentive thresholds for the Million Hearts Model.ResultsThe final study population included 135 166 patients, with 16 248 (12.0%) with 10-year ASCVD risk of ≥30%, but without existing ASCVD. The mean 10-year ASCVD risk was 41.9% (±1 SD of 11.6). Using risk factor reductions from clinical trials, lowering cholesterol, blood pressure, and smoking rates reduced 10-year ASCVD risk by 3.3% (±3.1), 6.3% (±1.1) and 0.5% (±1.3), respectively. Combining all 3 reductions resulted in a 9.7% (±3.6) reduction, with 67 (27.0%) of practices achieving a patient-level average 10-year ASCVD risk reduction of ≥10%, 181 (73.0%) achieving a 2 to 10% reduction, and no practice achieving <2% reduction.ConclusionsIn cardiology practices, about 1 out of 8 patients have a 10-year ASCVD risk ≥30% and qualify as high risk in the Million Hearts Model. If practices target the three main modifiable risk factors and achieve reductions similar to clinical trial results, ASCVD risk could be substantially lowered and all practices could receive incentive payments. These findings support the potential benefit of the Million Hearts Model and provide guidance to participating practices.

Dataset Information

Assessing the incidence of osteosarcoma among teriparatide users based on Medicare Part D and US State Cancer Registry Data.

Purpose

Methods

Results

Conclusions

Publications

Assessing the incidence of osteosarcoma among teriparatide users based on Medicare Part D and US State Cancer Registry Data.

Similar Datasets

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