ORCID Profile
0000-0002-0118-4986
Current Organisation
University of California, San Diego
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Publisher: Springer Science and Business Media LLC
Date: 14-09-2016
Publisher: Elsevier BV
Date: 07-2018
DOI: 10.1016/J.AMJCARD.2018.03.012
Abstract: The objective of the study was to examine how the comparative effectiveness and safety of direct oral anticoagulants (DOACs) and warfarin differ across subgroups of patients with atrial fibrillation defined by stroke risk (CHA2DS2-VASc score ≤3, 4 to 5, ≥6). Using Medicare claims data, we identified patients newly diagnosed with atrial fibrillation in 2013 to 2014 who initiated warfarin (n=12,354), apixaban (n=2,358), dabigatran (n=1,415), or rivaroxaban (n=5,139), and categorized them according to their CHA2DS2-VASc score (≤3, 4 to 5, ≥6). Primary outcomes included the combined risk of ischemic stroke, other thromboembolic event and death, and the risk of bleeding. We constructed Cox proportional hazard models that included terms for treatment, CHA2DS2-VASc subgroup, and the interaction between them, and controlled for demographics and a comprehensive list of clinical characteristics. We found that DOACs were generally more effective than warfarin, but this effect was most pronounced in the lowest risk subgroup. Specifically, the hazard ratio for the primary effectiveness outcome with apixaban compared with warfarin was 0.46 (95% confidence interval [CI] 0.32 to 0.65) for CHA2DS2-VASc ≤3, 0.71 (95% CI 0.61 to 0.86) for 4 to 5, and 0.86 (95% CI 0.74 to 1.01) for ≥6 (p value for interaction = 0.005). The comparative safety profile of DOACs versus warfarin did not change with CHA2DS2-VASc score. In conclusion, DOACs are more effective than warfarin, but this effect is more pronounced in patients with lower risk of stroke. Further research is needed to validate these findings in other patient cohorts and uncover their underlying mechanisms.
Publisher: Elsevier BV
Date: 02-2017
DOI: 10.1016/J.THROMRES.2016.10.006
Abstract: The comparative cost-effectiveness of all oral anticoagulants approved up to date has not been evaluated from the US perspective. The objective of this study was to compare the cost-effectiveness of edoxaban 60mg, apixaban 5mg, dabigatran 150mg, dabigatran 110mg, rivaroxaban 20mg and warfarin in stroke prevention in atrial fibrillation patients at high-risk of bleeding (defined as HAS-BLED score≥3). We constructed a Markov state-transition model to evaluate lifetime costs and quality-adjusted life years (QALYs) with each of the six treatments from the perspective of US third-party payers. Probabilities of clinical events were obtained from the RE-LY, ROCKET-AF, ARISTOTLE and ENGAGE AF-TIMI trials costs were derived from the Healthcare Cost and Utilization Project, and other studies. Because edoxaban is only indicated in patients with creatinine clearance ≤95ml/min, we re-ran our analyses after excluding edoxaban from the analysis. Treatment with edoxaban 60mg cost $77,565/QALY gained compared to warfarin, and apixaban 5mg cost $108,631/QALY gained compared to edoxaban 60mg. When edoxaban was not included in the analysis, treatment with apixaban 5mg cost $84,128/QALY gained, compared to warfarin. Dabigatran 150mg, dabigatran 110mg and rivaroxaban 20mg were dominated strategies. For patients with creatinine clearance between 50 and 95ml/min, apixaban 5mg was the most cost-effective treatment for willingness-to-pay thresholds (WTP) above $115,000/QALY gained, and edoxaban 60mg was cost-effective when the WTP was between $75,000 and $115,000/QALY gained. For patients with creatinine clearance >95ml/min, apixaban 5mg was the most cost-effective treatment for WTP thresholds above $80,000/QALY gained.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-01-2018
Abstract: In March 2014, the American Heart Association updated their guidelines for the management of oral anticoagulation ( OAC ) in atrial fibrillation, recommending OAC for all patients with CHA 2 DS 2 ‐ VAS c ≥2. Previously, only patients with CHADS 2 ≥2 were recommended for anticoagulation. This study compared effectiveness and safety outcomes of OAC among patients who would receive OAC using the 2014 guidelines but not the 2011 guidelines. Using claims data from a 5% s le of 2013–2014 Medicare beneficiaries, we identified patients with initially diagnosed atrial fibrillation between 2013 and 2014 and selected those who would receive OAC under the 2014 guidelines but not the 2011 guidelines (those with CHA 2 DS 2 ‐ VAS c score ≥2 or CHADS 2 score ). Patients were categorized according to their use of OAC after first atrial fibrillation diagnosis (2937 users and 2914 nonusers). Primary outcomes included the composite of ischemic stroke, systemic embolism and death, and any bleeding event. Cox proportional hazard models were constructed to compare the risk of primary outcomes between the 2 groups, while controlling for patient demographic and clinical characteristics. There was no difference in the combined risk of stroke, systemic embolism, and death between the treatment groups (hazard ratio, 1.00 95% confidence interval, 0.84–1.20). The risk of bleeding was higher for patients receiving OAC than for patients not receiving OAC (hazard ratio, 1.70, 95% confidence interval, 1.46–1.97). The benefit of OAC is not well defined in this patient population, and new studies that minimize residual confounding are needed to fully understand the risk/benefit of OAC in patients with atrial fibrillation and low to moderate stroke risk.
Publisher: Academy of Managed Care Pharmacy
Date: 02-2017
DOI: 10.18553/JMCP.2017.23.2.247
Abstract: Global pharmaceutical sales for anticancer drugs were $74.4 billion in 2014, ranking first for drugs by therapeutic class. Countries may differ substantially in the approval and coverage decisions for anticancer drugs. To compare the approval and coverage decisions for new anticancer drugs between the United States and 4 other countries: the United Kingdom, France, Australia, and Canada. We identified all new anticancer drug indications approved by the FDA between January 1, 2009, and December 31, 2013. For each country, we reviewed the organizations, processes, criteria, and special considerations used to make approval and coverage decisions for the drug indications approved. We further quantified and compared the variations across the 5 countries in the approval and coverage decisions as of June 30, 2014, for new anticancer drug indications. "Of 45 anticancer drug indications approved in the United States between January 1, 2009, and December 31, 2013, 67% (30) were approved by the European Medicines Agency, and 53% (24) were approved in Canada and Australia before December 31, 2013. The U.S. Medicare program covered all 45 drug indications, and as of June 30, 2014, the United Kingdom covered 87% (26) of those approved in Europe- 58% (26) of the drug indications covered by Medicare. France, Canada, and Australia covered 42% (19), 29% (13), and 24% (11) of the drug indications covered by Medicare, respectively". [corrected]. Approval and reimbursement decisions vary substantially by country. The United States had the fewest access restrictions, and Australia was the most restrictive of the 5 countries that were examined. No outside funding supported this study, and the authors report no conflicts of interest. Study concept and design were contributed primarily by Zhang, along with Hernandez and Hueser. All authors participated in data collection, and data interpretation was performed by Zhang and Hernandez, along with Hueser. The manuscript was written and revised by Zhang and Hernandez, along with Hueser.
Publisher: Elsevier BV
Date: 10-2018
DOI: 10.1016/J.DRUGALCDEP.2018.06.033
Abstract: Concurrent opioid and benzodiazepine use is associated with a three-fold increase in the risk of opioid-related overdose. No study has evaluated geographic variation in the concurrent use of opioids and benzodiazepines in US Medicare. We compared state, hospital-referral region (HRR), and county-level variation in concurrent opioid and benzodiazepine use among US Medicare opioid users and examined the heterogeneity in concurrent use within states. Using 2013-2014 US Medicare Part D claims, we identified non-cancer beneficiaries who used opioids in 2014 (n = 268,678). The outcome was concurrent opioid and benzodiazepine use. We constructed logistic regression models to isolate state, HRR, and county-level variation not explained by patient characteristics, and evaluated how county and HRR quintiles are distributed within state quintiles. The adjusted probability of concurrent use ranged from 16.7%-29.6% across states, 12.1%-37.0% across HRRs, and 0%-65.2% across counties. State-level variation masks substantial county-level variation: only 18% of counties located in the lowest state quintile were in the lowest county quintile, and only 23% of counties located in the highest state quintile were in the highest county quintile. We also observed variation in concurrent use across HRRs within states, but it was not as dispersed. For ex le, 52% of the HRRs located in the highest state quintile were in the highest HRR quintile. Large variation in concurrent use of opioids and benzodiazepines exists across the US. State variation masks substantial local variation, which beckons for polices to monitor concurrent opioid and benzodiazepine use at the county level.
Publisher: Oxford University Press (OUP)
Date: 15-09-2017
DOI: 10.2146/AJHP161011
Abstract: The steps involved, the resources needed, and the challenges associated with applying predictive analytics in healthcare are described, with a review of successful applications of predictive analytics in implementing population health management interventions that target medication-related patient outcomes. In healthcare, the term Predictive analytics that leverage big data will become an indispensable tool for clinicians in mapping interventions and improving patient outcomes.
Publisher: Elsevier BV
Date: 11-2017
DOI: 10.1016/J.AMJCARD.2017.07.092
Abstract: No studies have performed direct pairwise comparisons of the effectiveness and safety of warfarin and the new oral anticoagulants (NOACs) apixaban, dabigatran, and rivaroxaban. Using 2013 to 2014 claims from a 5% random s le of Medicare beneficiaries, we identified patients newly diagnosed with atrial fibrillation who initiated apixaban, dabigatran, rivaroxaban, warfarin, or no oral anticoagulation therapy in 2013 to 2014. Outcomes included the composite of ischemic stroke, systemic embolism (SE) and death, any bleeding event, gastrointestinal bleeding, intracranial bleeding, and treatment persistence. We constructed Cox proportional hazard models to compare outcomes between each pair of treatment groups. The composite risk of ischemic stroke, SE, and death was lower for NOACs than for warfarin: hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.76 to 0.98 for apixaban 0.73, 95% CI 0.63 to 0.86 for dabigatran and 0.82, 95% CI 0.75 to 0.89 for rivaroxaban, all compared with warfarin. There were no differences in effectiveness across NOACs. The risk of any bleeding was lower with apixaban than with warfarin, but higher with rivaroxaban than with warfarin. Apixaban (HR 0.69, 95% CI 0.60 to 0.79) and dabigatran (HR 0.79, 95% CI 0.69 to 0.92) were associated with lower bleeding risk than rivaroxaban. Treatment persistence was highest for apixaban (82%), and lowest for dabigatran and warfarin (64%) (p value <0.001). Compared with warfarin, NOACs are more effective in preventing stroke but their risk of bleeding varies, with rivaroxaban having higher risk than warfarin. Altogether, apixaban had the most favorable effectiveness, safety, and persistence profile.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2017
DOI: 10.1161/STROKEAHA.116.015150
Abstract: Little is known about the clinical outcomes associated with posthemorrhage anticoagulation resumption for atrial fibrillation. This study had 2 objectives: first, to evaluate anticoagulation use after a first major bleed on warfarin or dabigatran and, second, to compare effectiveness and safety outcomes between patients discontinuing anticoagulation after a major bleed and patients restarting warfarin or dabigatran. Using 2010 to 2012 Medicare Part D data, we identified atrial fibrillation patients who experienced a major bleeding event while using warfarin (n=1135) or dabigatran (n=404) and categorized them by their posthemorrhage use of anticoagulation. We followed them until an ischemic stroke, recurrent hemorrhage, or death through December 31, 2012. We constructed logistic regression models to evaluate factors affecting anticoagulation resumption and Cox proportional hazard models to compare the combined risk of ischemic stroke and all-cause mortality and the risk of recurrent bleeding between treatment groups. Resumption of anticoagulation with warfarin (hazard ratio [HR] 0.76 95% confidence interval [CI] 0.59–0.97) or dabigatran (HR 0.66 95% CI 0.44–0.99) was associated with lower combined risk of ischemic stroke and all-cause mortality than anticoagulation discontinuation. The incidence of recurrent major bleeding was higher for patients prescribed warfarin after the event than for those prescribed dabigatran (HR 2.31 95% CI 1.19–4.76) or whose anticoagulation ceased (HR 1.56 95% CI 1.10–2.22), but did not differ between patients restarting dabigatran and those discontinuing anticoagulation (HR 0.65 95% CI 0.32–1.33). Dabigatran was associated with a superior benefit/risk ratio than warfarin and anticoagulation discontinuation in the treatment of atrial fibrillation patients who have survived a major bleed.
Publisher: American Medical Association (AMA)
Date: 03-2019
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2017
DOI: 10.1161/STROKEAHA.117.017683
Abstract: Underuse of oral anticoagulation in stroke prevention in atrial fibrillation is common however, it remains unknown how it varies geographically. The objective of this study was to evaluate geographic variation in oral anticoagulation use and in the initiation of new oral anticoagulants (NOACs). Using 2013 to 2014 claims data from a 5% random s le of Medicare beneficiaries, we identified patients newly diagnosed with atrial fibrillation who initiated NOACs (n=8659), warfarin (n=11 771) or no oral anticoagulation therapy (n=18 226) in 2013 to 2014. Each patient was assigned to 1 of the 306 Dartmouth hospital-referral regions based on his/her zip code. We constructed logistic regressions to calculate the mean adjusted probability of initiating oral anticoagulation and the mean adjusted probability of initiating an NOAC among patients on oral anticoagulation in each hospital-referral region, after adjustment for demographic, clinical, and provider characteristics and type of insurance. Finally, we computed the correlation between 2 probabilities. Higher in the Midwest (0.54) and Northeast (0.54) and lowest in the South (0.47), the mean adjusted probability of initiating oral anticoagulation was 0.51, ranging from 0.32 to 0.72. The mean adjusted probability of being prescribed an NOAC among those on oral anticoagulation was 0.42 and was highest in the South (0.50) and lowest in the Midwest (0.36) and Northeast (0.39). In areas with the lower use of oral anticoagulation, patients on any oral anticoagulation therapy had a higher likelihood of being prescribed an NOAC (correlation coefficient, −0.16 P =0.006). Large geographic variation exists in oral anticoagulation use in atrial fibrillation. The use of oral anticoagulation is lower in the South, where the rates of stroke are unusually high. In the future, it will be important to analyze whether the high rates of stroke in the South can be partially attributed to the underuse of oral anticoagulation in this region.
Publisher: Springer Science and Business Media LLC
Date: 09-05-2018
DOI: 10.1007/S40256-018-0279-Y
Abstract: Several studies have compared the cost effectiveness of non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin using results from clinical trials evaluating NOACs. However, the time in therapeutic range (TTR) of warfarin groups ranged across clinical trials, and all were below the therapeutic goal of 70%. We compared the cost effectiveness of edoxaban 60 mg, apixaban 5 mg, dabigatran 150 mg, dabigatran 110 mg, rivaroxaban 20 mg, and well-managed warfarin with a TTR of 70% in preventing stroke among patients with atrial fibrillation at high risk of bleeding. For the six treatments, we used a Markov state-transition model to quantify lifetime costs in $US and effectiveness in quality-adjusted life-years (QALYs). We simulated relative risk ratios of clinical events with each NOAC versus warfarin with a TTR of 70% using published regression models that predict how the incidence of thrombotic or hemorrhagic events changes for each unit change in TTR. We re-ran our analysis for two other estimates of TTR: 65 and 75%. Treatment with edoxaban 60 mg cost $US127,520/QALY gained compared with warfarin with a TTR of 70% and cost $US41,860/QALY gained compared with warfarin with a TTR of 65%. However, warfarin with a TTR of 75% was more effective and less expensive than all NOACs. For three levels of TTR, apixaban 5 mg, dabigatran 150 mg, dabigatran 110 mg, and rivaroxaban 20 mg were dominated strategies. The comparative cost effectiveness of edoxaban and warfarin is highly sensitive to TTR. At the $US100,000/QALY willingness-to-pay threshold, our results suggest that warfarin is the most cost-effective treatment for patients who can achieve a TTR of 70%.
Publisher: Wiley
Date: 09-06-2015
DOI: 10.1111/JEP.12389
Publisher: SAGE Publications
Date: 2020
Abstract: To identify characteristics associated with an increased risk of cardiovascular events in patients diagnosed with Alzheimer disease (AD) and treated with antidementia medications. Demographics, diagnoses, and medication usage of 30 433 Medicare patients were analyzed using 2006 to 2013 claims data and a combined model of screening, ranking and stepwise logistic regressions to evaluate factors associated with composite outcomes of 6 cardiovascular events. Incidence rate of at least 1 cardiovascular event was 25.1%. Fifty-five factors were identified from the 10 381 candidate variables by the combined model with a c-statistic of 67% and an accuracy of 75%. Factors associated with increased risk of cardiovascular events include history of heart rhythm disorders, alteration of consciousness (odds ratio [OR]: 1.25 95% confidence interval [CI]: 1.14-1.36), and usage of β-blockers (OR: 1.19 95% CI: 1.13-1.27). Clinicians should consider the increased risk of cardiovascular events in patients with AD with heart rhythm disorders and on β-blockers.
Publisher: American Medical Association (AMA)
Date: 2015
Publisher: SAGE Publications
Date: 2017
Abstract: Objectives: The aim of the study was to examine the trend in incidence and prevalence of dementia, use and spending of antidementia and antipsychotic drugs among dementia patients. Methods: Using 2006-2012 Medicare claims data, we identified in iduals with diagnosis of dementia and collected their pharmacy claims in 2006-2012. We built regression models to test the trend in number of prescriptions and spending on antidementia, antipsychotic, and other drugs. Results: The prevalence of dementia did not change during our study period. Spending on antidementia and antipsychotic drugs creased to increase in 2011, following the patent expiration of Aricept, Zyprexa, and Seroquel and total pharmaceutical spending did not change in 2006-2012. Use of antidementia drugs increased during our study period however, the off-label use of antipsychotic drugs did not decrease. Discussion: Pharmaceutical spending associated with dementia may not be as concerning for Medicare as previously thought nevertheless, policies that discourage the nonevidence-based off-label use of drugs are warranted.
Publisher: Springer Science and Business Media LLC
Date: 13-02-2017
Publisher: Elsevier BV
Date: 07-2020
Publisher: American Medical Association (AMA)
Date: 22-06-2018
Publisher: American Medical Association (AMA)
Date: 07-2015
Publisher: Academy of Managed Care Pharmacy
Date: 03-2016
Location: United States of America
No related grants have been discovered for Inmaculada Hernandez.