Christine Lu | Harvard Medical School and Harvard Pilgrim Health Care (original) (raw)
Papers by Christine Lu
© 2008 Lu et al; licensee BioMed Central Ltd. This is an Open Access article distributed under th... more © 2008 Lu et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License
BMJ open, Jan 27, 2016
This study examined the recent trend in use and costs of antineoplastic agents for treatment of e... more This study examined the recent trend in use and costs of antineoplastic agents for treatment of eye malignancies in Taiwan from 2009 to 2012. We also forecasted use and costs of targeted therapies up to and including year 2016 based on the current patterns. Retrospective observational study focusing on the usage of targeted therapies for treatment of eye malignancy. The monthly claims data for eye malignancy-related antineoplastic agents were retrieved from Taiwan's National Health Insurance Research Database (2009-2012). We calculated the number of prescriptions and costs for each class of medications, and analysed their time trends. In addition, using a time series design with ARIMA models, we estimated the market share by prescription volume and the proportion of costs for targeted therapies for year 2016. The market share by prescription volume of targeted therapies grew from 1.56% in 2009 to 9.98% in 2012 among all antineoplastic agents, and the proportion of costs for targ...
BMJ Open, 2017
On behalf of the HER2 therapy observational study (HER2-OBS) investigators To cite: Daniels B, Lo... more On behalf of the HER2 therapy observational study (HER2-OBS) investigators To cite: Daniels B, Lord SJ, Kiely BE, et al. Use and outcomes of targeted therapies in early and metastatic HER2-positive breast cancer in Australia: protocol detailing observations in a whole of population cohort. BMJ
American Journal of Ophthalmology, 2010
To summarize observational studies that focus on the use of glaucoma medications and to identify ... more To summarize observational studies that focus on the use of glaucoma medications and to identify gaps in knowledge to guide future investigation. • DESIGN: Literature study. • METHODS: We searched the electronic databases MEDLINE, EMBASE, and PubMed for English language articles published through December 2009 using the search terms physician's practice patterns, drug prescriptions, pharmaceutical services, medication adherence, ophthalmology, glaucoma, and ophthalmic solutions. We categorized studies by areas of focus and extracted and summarized key features: study population, data sources, and main findings. • RESULTS: We identified 2224 articles by the search. Fiftyfive described glaucoma medication use using large databases. Predominant areas of focus were: trends in prescription choices (n ؍ 13); adherence, persistence, or both (n ؍ 31); rational use of medications (n ؍ 9); and policy-related issues (n ؍ 2). Over the last decade, use of -blockers and miotics has decreased substantially, whereas new agents, particularly prostaglandin analogs, have become more popular. Nonadherence was an issue in more than 25% of patients. A significant proportion of patients with comorbidities, contraindications, or both had received topical -blockers. • CONCLUSIONS: To date, most studies have focused on adherence to glaucoma medications and changes in treatment choices. Major gaps in knowledge include prescribing patterns by prescriber specialty (ophthalmologists, primary care physicians, and optometrists), medicationrelated problems, and subsequent adverse health outcomes. Well-designed longitudinal observational studies addressing these gaps are warranted to improve patient safety.
BMJ open, Jan 17, 2016
In 2008, the Thai government introduced the 'high-cost medicines E2 access program' as a ... more In 2008, the Thai government introduced the 'high-cost medicines E2 access program' as a part of the National List of Essential Medicines to increase patient access to medicines, improve clinical outcomes and make medicines more affordable. Our objective was to examine whether the 'high-cost medicines E2 access program' achieved its goals. Interrupted time-series design study. 3 tertiary hospitals in different regions of Thailand, January 2006 to December 2012. Patients with target acute and chronic disease diagnoses who newly met E2 program criteria for selected study medicines. High-cost medicines E2 access program. Level and trend changes over time in the proportions of eligible patients who received the indicated E2 medicines and who improved clinically, as well as in costs of treatment. A total of 2024 patients were included in utilisation analyses and 1375 patients with selected acute diseases contributed to analyses of clinical outcome. After 1 year of the E2 ...
Genetics in medicine : official journal of the American College of Medical Genetics, 2016
BMJ (Clinical research ed.), 2015
Pharmaceutical Prices in the 21st Century, 2014
The Breast, 2013
To manage the potential trastuzumab mediated cardiotoxicity, clinical guidelines recommend pre-tr... more To manage the potential trastuzumab mediated cardiotoxicity, clinical guidelines recommend pre-treatment cardiac function assessment and 3-monthly reassessment during therapy. This study examined rates of cardiac function assessment and predictors of assessment among patients receiving trastuzumab for HER2+ metastatic breast cancer treatment in routine clinical care. Our cohort comprised 3418 women receiving trastuzumab for HER2+ metastatic breast cancer under Australia's nationally funded Herceptin Program (2001-2010). We examined rates of pre-treatment and during-treatment assessment. We used logistic regression and zero-inflated Poisson regression to examine predictors of pre-treatment and during-treatment assessment respectively. 37.7% of patients were assessed pre-treatment, 50.4% during therapy, and 26.4% both before and during therapy. Among patients assessed for cardiac function, reassessment occurred regularly (median of 3.9 months). History of cardiovascular conditions and prior anthracycline use predicted pre-treatment assessment (OR = 1.32, 95% CI: 1.08-1.61; OR = 1.23, 95% CI: 1.05-1.44 respectively). Concurrent trastuzumab and taxane use, exposure to anthracyclines, and older age predicted during-treatment assessment (IRR = 1.17, 95% CI: 1.06-1.29; IRR = 1.12, 95% CI: 1.02-1.23; and IRR = 1.05, 95% CI: 1.01-1.09 respectively). Patients with multi-morbidities were less likely to receive during-treatment assessment. Over the last decade, cardiac function assessment in a large cohort of patients receiving trastuzumab was not consistent with guideline recommendations. The association between cardiac monitoring and risk factors for cardiac dysfunction suggest clinicians are triaging patients prior to implementing cardiac assessment. Efforts are needed to identify barriers to implementing current guidelines for cardiac monitoring in metastatic breast cancer patients undergoing trastuzumab treatment, particularly those with multi-morbidities.
PloS one, 2015
To review existing regulations and policies utilised by countries to enable patient access to orp... more To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country's legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan d...
PLOS ONE, 2015
To review existing regulations and policies utilised by countries to enable patient access to orp... more To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country's legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country's pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access. Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.
The Medical journal of Australia
Using shared care to tackle the complexity of optimal patient management.
Pharmacoepidemiology and drug safety, Jan 6, 2015
To evaluate changes in thiazolidinedione use and quality of prescription following safety warning... more To evaluate changes in thiazolidinedione use and quality of prescription following safety warnings for thiazolidinediones and cardiac risk in 2007, Risk Management Plan (RMP) policy for rosiglitazone in 2010, and warning for pioglitazone and bladder cancer risk in 2010 in Taiwan. We obtained 2003-2011 claims data from Taiwan's National Health Insurance Research Database. Using an interrupted time series design and segmented regression, we estimated changes in monthly prescribing rates for thiazolidinediones among all and prevalent diabetes patients with and without cardiovascular disease history (CV history). We also compared time to prescription of thiazolidinediones among new diabetes patients with CV history before and after each regulatory action using survival analysis. Among prevalent patients with and without CV history, the prescribing rates of rosiglitazone decreased 36.88% and 28.92% after safety warnings in 2007 respectively. Pioglitazone prescriptions increased 13% a...
Health Policy and Technology, 2015
Journal of pharmaceutical policy and practice, 2015
Taiwan's National Health Insurance (NHI) has encouraged physicians to use "chronic medic... more Taiwan's National Health Insurance (NHI) has encouraged physicians to use "chronic medication prescriptions" for patients with stable chronic diseases since 1995. Patients are allowed to refill such prescriptions at community pharmacies for a maximum of three months' supply of medications without revisiting the doctor. In 2006, NHI initiated strategies targeting the public, doctors, and healthcare facilities to enhance the overall rate of chronic medication prescriptions, aiming to achieve 30% by 2010. We examined prescribing and dispensing of oral antidiabetic drugs from 2001 to 2010, before and after the start of the promotion strategies for chronic medication prescriptions in 2006. Using outpatient care data from the NHI database and the interrupted time series design, we analyzed changes in rate of chronic medication prescriptions, share of prescriptions filled at community pharmacies, and share of reimbursed expenditures accounted by community pharmacies. Duri...
Clinical therapeutics, Jan 11, 2015
The US Food and Drug Administration (FDA) communicated the potential cardiovascular risk of thiaz... more The US Food and Drug Administration (FDA) communicated the potential cardiovascular risk of thiazolidinediones (rosiglitazone and pioglitazone) in 2007 and required a Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone in 2010. It also communicated in 2010 the potential risk of bladder cancer with pioglitazone use. This study examined the effects of these multiple FDA actions on utilization and reimbursed costs of thiazolidinediones in state Medicaid programs. State Drug Utilization Data from the Centers for Medicare & Medicaid Services were assessed. An interrupted time series design and segmented linear regression models were used to examine changes in market shares according to both prescription volume and reimbursed costs for rosiglitazone and pioglitazone in the Northeast and Midwest regions of the United States after multiple FDA actions. Compared with expected rates, there were relative reductions of 65.84% (Northeast region) and 55.09% (Midwest region) in the us...
Clinical Therapeutics, 2015
In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene inhibi... more In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene inhibitors (LTIs) to include neuropsychiatric adverse events (eg, depression and suicidality) as a precaution. This study investigated how this label change affected the use of LTIs and other asthma controller medications, mental health visits, and suicide attempts. We analyzed data (2005-2010) from 5 large health plans in the US Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) Network. The study cohort included children and adolescents (n = 30,000), young adults (n = 20,000), and adults (n = 90,000) with asthma. We used interrupted time series to examine changes in rates of LTI dispensings, non-LTI dispensings, mental health visits, and suicide attempts (using a validated algorithm based on a combination of diagnoses of injury or poisoning and psychiatric conditions). The label change was associated with abrupt reductions in LTI use among all age groups (relative reductions of 8.3%, 15.1%, and 6.0% among adolescents, young adults, and adults, respectively, compared with expected rates at 1 year after the warnings). Although we detected immediate offset increases in non-LTI asthma medication use, these increases were not sustained among adolescents and young adults. There were small increases in mental health visits among LTI users. The FDA label change for LTIs communicated possible risk of neuropsychiatric events. Communication and enhanced awareness may have increased reporting of mental health symptoms among young adults and adults. It is important to assess intended and unintended consequences of FDA warnings and label changes.
PloS one, 2015
This study quantitatively evaluated the comparative efficacy and safety of new oral anticoagulant... more This study quantitatively evaluated the comparative efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, and apizaban) and warfarin for treatment of nonvalvular atrial fibrillation. We also compared these agents under different scenarios, including population with high risk of stroke and for primary vs. secondary stroke prevention. We used multiple criteria decision analysis (MCDA) to assess the benefit-risk of these medications. Our MCDA models contained criteria for benefits (prevention of ischemic stroke and systemic embolism) and risks (intracranial and extracranial bleeding). We calculated a performance score for each drug accounting for benefits and risks in comparison to treatment alternatives. Overall, new agents had higher performance scores than warfarin; in order of performance scores: dabigatran 150 mg (0.529), rivaroxaban (0.462), apixaban (0.426), and warfarin (0.191). For patients at a higher risk of stroke (CHADS2 score≥3), apixaban had the highes...
Journal of Pharmacy Practice and Research, 2007
© 2008 Lu et al; licensee BioMed Central Ltd. This is an Open Access article distributed under th... more © 2008 Lu et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License
BMJ open, Jan 27, 2016
This study examined the recent trend in use and costs of antineoplastic agents for treatment of e... more This study examined the recent trend in use and costs of antineoplastic agents for treatment of eye malignancies in Taiwan from 2009 to 2012. We also forecasted use and costs of targeted therapies up to and including year 2016 based on the current patterns. Retrospective observational study focusing on the usage of targeted therapies for treatment of eye malignancy. The monthly claims data for eye malignancy-related antineoplastic agents were retrieved from Taiwan's National Health Insurance Research Database (2009-2012). We calculated the number of prescriptions and costs for each class of medications, and analysed their time trends. In addition, using a time series design with ARIMA models, we estimated the market share by prescription volume and the proportion of costs for targeted therapies for year 2016. The market share by prescription volume of targeted therapies grew from 1.56% in 2009 to 9.98% in 2012 among all antineoplastic agents, and the proportion of costs for targ...
BMJ Open, 2017
On behalf of the HER2 therapy observational study (HER2-OBS) investigators To cite: Daniels B, Lo... more On behalf of the HER2 therapy observational study (HER2-OBS) investigators To cite: Daniels B, Lord SJ, Kiely BE, et al. Use and outcomes of targeted therapies in early and metastatic HER2-positive breast cancer in Australia: protocol detailing observations in a whole of population cohort. BMJ
American Journal of Ophthalmology, 2010
To summarize observational studies that focus on the use of glaucoma medications and to identify ... more To summarize observational studies that focus on the use of glaucoma medications and to identify gaps in knowledge to guide future investigation. • DESIGN: Literature study. • METHODS: We searched the electronic databases MEDLINE, EMBASE, and PubMed for English language articles published through December 2009 using the search terms physician's practice patterns, drug prescriptions, pharmaceutical services, medication adherence, ophthalmology, glaucoma, and ophthalmic solutions. We categorized studies by areas of focus and extracted and summarized key features: study population, data sources, and main findings. • RESULTS: We identified 2224 articles by the search. Fiftyfive described glaucoma medication use using large databases. Predominant areas of focus were: trends in prescription choices (n ؍ 13); adherence, persistence, or both (n ؍ 31); rational use of medications (n ؍ 9); and policy-related issues (n ؍ 2). Over the last decade, use of -blockers and miotics has decreased substantially, whereas new agents, particularly prostaglandin analogs, have become more popular. Nonadherence was an issue in more than 25% of patients. A significant proportion of patients with comorbidities, contraindications, or both had received topical -blockers. • CONCLUSIONS: To date, most studies have focused on adherence to glaucoma medications and changes in treatment choices. Major gaps in knowledge include prescribing patterns by prescriber specialty (ophthalmologists, primary care physicians, and optometrists), medicationrelated problems, and subsequent adverse health outcomes. Well-designed longitudinal observational studies addressing these gaps are warranted to improve patient safety.
BMJ open, Jan 17, 2016
In 2008, the Thai government introduced the 'high-cost medicines E2 access program' as a ... more In 2008, the Thai government introduced the 'high-cost medicines E2 access program' as a part of the National List of Essential Medicines to increase patient access to medicines, improve clinical outcomes and make medicines more affordable. Our objective was to examine whether the 'high-cost medicines E2 access program' achieved its goals. Interrupted time-series design study. 3 tertiary hospitals in different regions of Thailand, January 2006 to December 2012. Patients with target acute and chronic disease diagnoses who newly met E2 program criteria for selected study medicines. High-cost medicines E2 access program. Level and trend changes over time in the proportions of eligible patients who received the indicated E2 medicines and who improved clinically, as well as in costs of treatment. A total of 2024 patients were included in utilisation analyses and 1375 patients with selected acute diseases contributed to analyses of clinical outcome. After 1 year of the E2 ...
Genetics in medicine : official journal of the American College of Medical Genetics, 2016
BMJ (Clinical research ed.), 2015
Pharmaceutical Prices in the 21st Century, 2014
The Breast, 2013
To manage the potential trastuzumab mediated cardiotoxicity, clinical guidelines recommend pre-tr... more To manage the potential trastuzumab mediated cardiotoxicity, clinical guidelines recommend pre-treatment cardiac function assessment and 3-monthly reassessment during therapy. This study examined rates of cardiac function assessment and predictors of assessment among patients receiving trastuzumab for HER2+ metastatic breast cancer treatment in routine clinical care. Our cohort comprised 3418 women receiving trastuzumab for HER2+ metastatic breast cancer under Australia's nationally funded Herceptin Program (2001-2010). We examined rates of pre-treatment and during-treatment assessment. We used logistic regression and zero-inflated Poisson regression to examine predictors of pre-treatment and during-treatment assessment respectively. 37.7% of patients were assessed pre-treatment, 50.4% during therapy, and 26.4% both before and during therapy. Among patients assessed for cardiac function, reassessment occurred regularly (median of 3.9 months). History of cardiovascular conditions and prior anthracycline use predicted pre-treatment assessment (OR = 1.32, 95% CI: 1.08-1.61; OR = 1.23, 95% CI: 1.05-1.44 respectively). Concurrent trastuzumab and taxane use, exposure to anthracyclines, and older age predicted during-treatment assessment (IRR = 1.17, 95% CI: 1.06-1.29; IRR = 1.12, 95% CI: 1.02-1.23; and IRR = 1.05, 95% CI: 1.01-1.09 respectively). Patients with multi-morbidities were less likely to receive during-treatment assessment. Over the last decade, cardiac function assessment in a large cohort of patients receiving trastuzumab was not consistent with guideline recommendations. The association between cardiac monitoring and risk factors for cardiac dysfunction suggest clinicians are triaging patients prior to implementing cardiac assessment. Efforts are needed to identify barriers to implementing current guidelines for cardiac monitoring in metastatic breast cancer patients undergoing trastuzumab treatment, particularly those with multi-morbidities.
PloS one, 2015
To review existing regulations and policies utilised by countries to enable patient access to orp... more To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country's legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan d...
PLOS ONE, 2015
To review existing regulations and policies utilised by countries to enable patient access to orp... more To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country's legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country's pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access. Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.
The Medical journal of Australia
Using shared care to tackle the complexity of optimal patient management.
Pharmacoepidemiology and drug safety, Jan 6, 2015
To evaluate changes in thiazolidinedione use and quality of prescription following safety warning... more To evaluate changes in thiazolidinedione use and quality of prescription following safety warnings for thiazolidinediones and cardiac risk in 2007, Risk Management Plan (RMP) policy for rosiglitazone in 2010, and warning for pioglitazone and bladder cancer risk in 2010 in Taiwan. We obtained 2003-2011 claims data from Taiwan's National Health Insurance Research Database. Using an interrupted time series design and segmented regression, we estimated changes in monthly prescribing rates for thiazolidinediones among all and prevalent diabetes patients with and without cardiovascular disease history (CV history). We also compared time to prescription of thiazolidinediones among new diabetes patients with CV history before and after each regulatory action using survival analysis. Among prevalent patients with and without CV history, the prescribing rates of rosiglitazone decreased 36.88% and 28.92% after safety warnings in 2007 respectively. Pioglitazone prescriptions increased 13% a...
Health Policy and Technology, 2015
Journal of pharmaceutical policy and practice, 2015
Taiwan's National Health Insurance (NHI) has encouraged physicians to use "chronic medic... more Taiwan's National Health Insurance (NHI) has encouraged physicians to use "chronic medication prescriptions" for patients with stable chronic diseases since 1995. Patients are allowed to refill such prescriptions at community pharmacies for a maximum of three months' supply of medications without revisiting the doctor. In 2006, NHI initiated strategies targeting the public, doctors, and healthcare facilities to enhance the overall rate of chronic medication prescriptions, aiming to achieve 30% by 2010. We examined prescribing and dispensing of oral antidiabetic drugs from 2001 to 2010, before and after the start of the promotion strategies for chronic medication prescriptions in 2006. Using outpatient care data from the NHI database and the interrupted time series design, we analyzed changes in rate of chronic medication prescriptions, share of prescriptions filled at community pharmacies, and share of reimbursed expenditures accounted by community pharmacies. Duri...
Clinical therapeutics, Jan 11, 2015
The US Food and Drug Administration (FDA) communicated the potential cardiovascular risk of thiaz... more The US Food and Drug Administration (FDA) communicated the potential cardiovascular risk of thiazolidinediones (rosiglitazone and pioglitazone) in 2007 and required a Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone in 2010. It also communicated in 2010 the potential risk of bladder cancer with pioglitazone use. This study examined the effects of these multiple FDA actions on utilization and reimbursed costs of thiazolidinediones in state Medicaid programs. State Drug Utilization Data from the Centers for Medicare & Medicaid Services were assessed. An interrupted time series design and segmented linear regression models were used to examine changes in market shares according to both prescription volume and reimbursed costs for rosiglitazone and pioglitazone in the Northeast and Midwest regions of the United States after multiple FDA actions. Compared with expected rates, there were relative reductions of 65.84% (Northeast region) and 55.09% (Midwest region) in the us...
Clinical Therapeutics, 2015
In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene inhibi... more In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene inhibitors (LTIs) to include neuropsychiatric adverse events (eg, depression and suicidality) as a precaution. This study investigated how this label change affected the use of LTIs and other asthma controller medications, mental health visits, and suicide attempts. We analyzed data (2005-2010) from 5 large health plans in the US Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) Network. The study cohort included children and adolescents (n = 30,000), young adults (n = 20,000), and adults (n = 90,000) with asthma. We used interrupted time series to examine changes in rates of LTI dispensings, non-LTI dispensings, mental health visits, and suicide attempts (using a validated algorithm based on a combination of diagnoses of injury or poisoning and psychiatric conditions). The label change was associated with abrupt reductions in LTI use among all age groups (relative reductions of 8.3%, 15.1%, and 6.0% among adolescents, young adults, and adults, respectively, compared with expected rates at 1 year after the warnings). Although we detected immediate offset increases in non-LTI asthma medication use, these increases were not sustained among adolescents and young adults. There were small increases in mental health visits among LTI users. The FDA label change for LTIs communicated possible risk of neuropsychiatric events. Communication and enhanced awareness may have increased reporting of mental health symptoms among young adults and adults. It is important to assess intended and unintended consequences of FDA warnings and label changes.
PloS one, 2015
This study quantitatively evaluated the comparative efficacy and safety of new oral anticoagulant... more This study quantitatively evaluated the comparative efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, and apizaban) and warfarin for treatment of nonvalvular atrial fibrillation. We also compared these agents under different scenarios, including population with high risk of stroke and for primary vs. secondary stroke prevention. We used multiple criteria decision analysis (MCDA) to assess the benefit-risk of these medications. Our MCDA models contained criteria for benefits (prevention of ischemic stroke and systemic embolism) and risks (intracranial and extracranial bleeding). We calculated a performance score for each drug accounting for benefits and risks in comparison to treatment alternatives. Overall, new agents had higher performance scores than warfarin; in order of performance scores: dabigatran 150 mg (0.529), rivaroxaban (0.462), apixaban (0.426), and warfarin (0.191). For patients at a higher risk of stroke (CHADS2 score≥3), apixaban had the highes...
Journal of Pharmacy Practice and Research, 2007