Objective: To estimate the prevalence, incidence, and describe the characteristics and management... more Objective: To estimate the prevalence, incidence, and describe the characteristics and management of patients with heart failure with preserved (HFpEF), mildly reduced (HFmrEF), and reduced ejection fraction (HFrEF) in Spain. Methods: Adults with ≥1 inpatient or outpatient HF diagnosis between 1 January 2013 and 30 September 2019 were identified through the BIG-PAC database. Annual incidence and prevalence by EF phenotype were estimated. Characteristics by EF phenotype were described in the 2016 and 2019 HF prevalent cohorts and outcomes in the 2016 HF prevalent cohort. Results: Overall, HF incidence and prevalence were 0.32/100 person-years and 2.34%, respectively, but increased every year. In 2019, 49.3% had HFrEF, 38.1% had HFpEF, and 4.3% had HFmrEF (in 8.3%, EF was not available). Compared with HFrEF, patients with HFpEF were largely female, older, and had more atrial fibrillation but less atherosclerotic cardiovascular disease. Among patients with HFrEF, 76.3% were taking reni...
Introduction At the time of dapagliflozin's approval in Europe (2012) to treat patients with type... more Introduction At the time of dapagliflozin's approval in Europe (2012) to treat patients with type 2 diabetes mellitus, concerns regarding acute liver injury and severe complications of urinary tract infection (sUTI) led to two post-authorization safety (PAS) studies of these outcomes to monitor the safety of dapagliflozin in real-world use. Objective To investigate the incidence of hospitalization for acute liver injury (hALI) or sUTI (pyelonephritis or urosepsis) among patients initiating dapagliflozin compared with other glucose-lowering drugs (GLDs). Methods These two noninterventional cohort studies identified initiators of dapagliflozin and comparator GLDs in November 2012-February 2019 using data from three longitudinal, population-based data sources: Clinical Practice Research Datalink (UK), the HealthCore Integrated Research Database (USA), and the Medicare database (USA). Outcomes (hALI and sUTI) were identified with electronic algorithms. Incidence rates were estimated by exposure group. Incidence rate ratios (IRRs) were calculated comparing dapagliflozin to comparator GLDs, using propensity score trimming and stratification to address confounding. The sUTI analyses were conducted separately by sex. Results In all data sources, hALI and sUTI incidence rates were generally lower in dapagliflozin initiators than comparator GLD initiators. The adjusted IRR (95% confidence interval) pooled across data sources for hALI was 0.85 (0.59-1.24) and for sUTI was 0.76 (0.60-0.96) in females and 0.74 (0.56-1.00) in males. Findings from sensitivity analyses were largely consistent with the primary analyses. Conclusions These real-world studies do not suggest increased risks of hALI or sUTI, and they suggest a potential decreased risk of sUTI with dapagliflozin exposure compared with other GLDs.
I n Massachusetts, as in the United States as a whole, the fatal occupational injury rate for His... more I n Massachusetts, as in the United States as a whole, the fatal occupational injury rate for Hispanic workers (3.3 per 100,000 workers per year) is higher than that for white workers (2.2 per 100,000 workers per year). 1 Although some information about the risk of nonfatal occupational injuries among racial and ethnic groups is available nationally, 2 data for Massachusetts are limited. The workers' compensation data set maintained by the Massachusetts Department of Industrial Accidents does not include information about workers' race and ethnicity. By contrast, race and ethnicity information is a data element in the Bureau of Labor Statistics (BLS) Survey of Occupational Injuries and Illnesses, 3 but it is only an optional feature there, and it is missing from more than 25 percent of the cases reported in the Massachusetts BLS survey. 4 This article reports on the use of statewide hospital discharge data to describe patterns of serious occupational injuries (that is, injuries requiring hospitalization) among racial and ethnic groups in Massachusetts. Methods In Massachusetts, discharge records from all acute-care nongovernment hospitals 5 are collected quarterly by the Massachusetts Division of Health Care Finance and Policy, as mandated by regulation. 6 The records are then compiled into
Circulation: Cardiovascular Quality and Outcomes, 2013
OBJECTIVES: Heart Failure (HF) is a leading cause of morbidity and mortality. Hospitalization for... more OBJECTIVES: Heart Failure (HF) is a leading cause of morbidity and mortality. Hospitalization for HF appears to be steadily increasing. We sought to identify HF patients and understand their patterns of care in the “real-world” through analysis of a retrospective observational database. METHODS: Patients in the Medicare 5% database with a primary inpatient diagnosis of HF (428.0, 428.9, 428.20-23, 428.30-33, 428.40-43) during CY05-08 were included. Maximum follow-up was 33 months (6 months baseline, 3 month index and 24 months follow-up ). Minimum follow-up was 9 months . To exclude prevalent cases, patients were required to have no HF diagnoses during baseline. The quarter of the initial HF inpatient diagnosis was designated the “index”. Patients were followed for up to 2 years (8 Quarters) after the “index” or until death or enrolment end. Sub-cohorts were defined based on HF events experienced during follow-up: 0, 1, or 2 or more. RESULTS: 43,819 patients with new primary HF inpa...
A noninterventional postauthorization safety study in patients with type 2 diabetes compared the ... more A noninterventional postauthorization safety study in patients with type 2 diabetes compared the sex-specific incidence of severe complications of urinary tract infections (sUTI) (pyelonephritis or urosepsis) in new users of dapagliflozin and new users of other comparator glucose-lowering drugs (GLDs), matched by index year, age, and region. Comparators included GLDs other than SGLT2 inhibitors, or monotherapy of insulin, metformin, or sulfonylureas. Data from US Medicare (2014-2017), US HealthCore Integrated Research Database (HIRD) (2014-2019), and UK Clinical Practice Research Datalink (CPRD) (2012-2018) were analyzed. Incidence rates of sUTI were compared by exposure group with adjusted incidence rate ratios (aIRRs) with covariate adjustment by propensity score trimming and stratification. Pooled aIRRs were estimated by the Mantel-Haenszel method. The total number of person-years of dapagliflozin and comparator exposure, respectively, was 17,265 and 161,176 for females and 22,594 and 194,388 for males. Mean age (years) in CPRD, HIRD, and Medicare was 58, 52, and 72 in females and 59, 52, and 71 in males, respectively. All aIRR estimates were below the null but imprecise (figure). The pooled aIRR was 0.76 (95% CI, 0.60-0.96) in females and 0.74 (95% CI, 0.56-1.00) in males. This real-world study did not find an increased risk of sUTI in females or males with dapagliflozin compared with other GLDs. Disclosure C. Johannes: Other Relationship; Self; AstraZeneca. H. Chen: None. A. Gilsenan: Other Relationship; Self; AstraZeneca. J. Layton: Other Relationship; Self; AstraZeneca. D. C. Beachler: Employee; Self; Anthem Inc. (HealthCore). R. M. Ziemiecki: Research Support; Self; Astellas Pharma Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Janssen Pharmaceuticals, Inc., Pfizer Inc. L. Li: Other Relationship; Self; Pfizer Inc. H. E. Danysh: Other Relationship; Self; AstraZeneca. J. Dinh: None. P. R. Hunt: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca. C. Karlsson: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca.
Objective: The objective of this study was to describe the rates of adverse clinical outcomes, in... more Objective: The objective of this study was to describe the rates of adverse clinical outcomes, including all-cause mortality, heart failure (HF) hospitalization, myocardial infarction, and stroke, in patients newly diagnosed with HF to provide a comprehensive picture of HF burden. Methods: This was a retrospective and observational study, using the BIG-PAC database in Spain. Adults, newly diagnosed with HF between January 2013 and September 2019 with ≥1 HF-free year of enrolment prior to HF diagnosis, were included. Results: A total of 19,961 patients were newly diagnosed with HF (43.5% with reduced ejection fraction (EF), 26.3% with preserved EF, 5.1% with mildly reduced EF, and 25.1% with unknown EF). The mean age was 69.7 ± 19.0 years; 53.8% were men; and 41.0% and 41.5% of patients were in the New York Heart Association functional classes II and III, respectively. The baseline HF treatments included beta-blockers (70.1%), renin–angiotensin system inhibitors (56.3%), mineralocort...
Circulation: Cardiovascular Quality and Outcomes, 2019
Background: THEMIS is a large randomized controlled trial (NCT01991795) comparing the effect of t... more Background: THEMIS is a large randomized controlled trial (NCT01991795) comparing the effect of ticagrelor vs placebo (both with background acetylsalicylic acid) for the prevention of major cardiovascular (CV) events in patients with coronary artery disease (CAD) and type 2 diabetes (T2D) with no prior myocardial infarction (MI) or stroke. The current study evaluated healthcare resource utilization (HCRU) and cost in patients similar to those eligible for enrollment in THEMIS (THEMIS-like) and in a broader population (T2D-CAD). Methods: This retrospective, observational study included patients, > 50 years old, with pharmacologically treated T2D and no prior MI or stroke collected from the Optum Research Database including Medicare Advantage Part D coverage between January 1, 2007 and December 31, 2017. Both cohorts were followed until disenrollment or end of the study period. The THEMIS-like cohort included patients with evidence of CAD including percutaneous coronary interventio...
OBJECTIVE: Characterize and estimate the prevalence of pseudobulbar affect (PBA) symptoms in a sa... more OBJECTIVE: Characterize and estimate the prevalence of pseudobulbar affect (PBA) symptoms in a sample of OEF/OIF/OND veterans with traumatic brain injury (TBI). BACKGROUND: PBA, characterized by exaggerated or inappropriate involuntary episodes of crying and/or laughing, can occur in persons with TBI or other neurological conditions. DESIGN/METHODS: Cross-sectional survey with patient-level linkage to VA clinical data among veterans screening positive for TBI. Eligible veterans were mailed a questionnaire consisting of the seven-item Center for Neurologic Study-Lability Scale (CNS-LS) with an initial question asking if the veteran had “involuntary episodes of crying and/or laughing that were exaggerated or even contrary to how they felt at the time”. The EQ-5D questionnaire, an international, standardized measure of health-related quality of life (HRQOL) was included. The presence of PBA symptoms is defined as positive response to the “involuntary episodes” question and a CNS-LS sco...
Objective: To estimate the prevalence, incidence, and describe the characteristics and management... more Objective: To estimate the prevalence, incidence, and describe the characteristics and management of patients with heart failure with preserved (HFpEF), mildly reduced (HFmrEF), and reduced ejection fraction (HFrEF) in Spain. Methods: Adults with ≥1 inpatient or outpatient HF diagnosis between 1 January 2013 and 30 September 2019 were identified through the BIG-PAC database. Annual incidence and prevalence by EF phenotype were estimated. Characteristics by EF phenotype were described in the 2016 and 2019 HF prevalent cohorts and outcomes in the 2016 HF prevalent cohort. Results: Overall, HF incidence and prevalence were 0.32/100 person-years and 2.34%, respectively, but increased every year. In 2019, 49.3% had HFrEF, 38.1% had HFpEF, and 4.3% had HFmrEF (in 8.3%, EF was not available). Compared with HFrEF, patients with HFpEF were largely female, older, and had more atrial fibrillation but less atherosclerotic cardiovascular disease. Among patients with HFrEF, 76.3% were taking reni...
Introduction At the time of dapagliflozin's approval in Europe (2012) to treat patients with type... more Introduction At the time of dapagliflozin's approval in Europe (2012) to treat patients with type 2 diabetes mellitus, concerns regarding acute liver injury and severe complications of urinary tract infection (sUTI) led to two post-authorization safety (PAS) studies of these outcomes to monitor the safety of dapagliflozin in real-world use. Objective To investigate the incidence of hospitalization for acute liver injury (hALI) or sUTI (pyelonephritis or urosepsis) among patients initiating dapagliflozin compared with other glucose-lowering drugs (GLDs). Methods These two noninterventional cohort studies identified initiators of dapagliflozin and comparator GLDs in November 2012-February 2019 using data from three longitudinal, population-based data sources: Clinical Practice Research Datalink (UK), the HealthCore Integrated Research Database (USA), and the Medicare database (USA). Outcomes (hALI and sUTI) were identified with electronic algorithms. Incidence rates were estimated by exposure group. Incidence rate ratios (IRRs) were calculated comparing dapagliflozin to comparator GLDs, using propensity score trimming and stratification to address confounding. The sUTI analyses were conducted separately by sex. Results In all data sources, hALI and sUTI incidence rates were generally lower in dapagliflozin initiators than comparator GLD initiators. The adjusted IRR (95% confidence interval) pooled across data sources for hALI was 0.85 (0.59-1.24) and for sUTI was 0.76 (0.60-0.96) in females and 0.74 (0.56-1.00) in males. Findings from sensitivity analyses were largely consistent with the primary analyses. Conclusions These real-world studies do not suggest increased risks of hALI or sUTI, and they suggest a potential decreased risk of sUTI with dapagliflozin exposure compared with other GLDs.
I n Massachusetts, as in the United States as a whole, the fatal occupational injury rate for His... more I n Massachusetts, as in the United States as a whole, the fatal occupational injury rate for Hispanic workers (3.3 per 100,000 workers per year) is higher than that for white workers (2.2 per 100,000 workers per year). 1 Although some information about the risk of nonfatal occupational injuries among racial and ethnic groups is available nationally, 2 data for Massachusetts are limited. The workers' compensation data set maintained by the Massachusetts Department of Industrial Accidents does not include information about workers' race and ethnicity. By contrast, race and ethnicity information is a data element in the Bureau of Labor Statistics (BLS) Survey of Occupational Injuries and Illnesses, 3 but it is only an optional feature there, and it is missing from more than 25 percent of the cases reported in the Massachusetts BLS survey. 4 This article reports on the use of statewide hospital discharge data to describe patterns of serious occupational injuries (that is, injuries requiring hospitalization) among racial and ethnic groups in Massachusetts. Methods In Massachusetts, discharge records from all acute-care nongovernment hospitals 5 are collected quarterly by the Massachusetts Division of Health Care Finance and Policy, as mandated by regulation. 6 The records are then compiled into
Circulation: Cardiovascular Quality and Outcomes, 2013
OBJECTIVES: Heart Failure (HF) is a leading cause of morbidity and mortality. Hospitalization for... more OBJECTIVES: Heart Failure (HF) is a leading cause of morbidity and mortality. Hospitalization for HF appears to be steadily increasing. We sought to identify HF patients and understand their patterns of care in the “real-world” through analysis of a retrospective observational database. METHODS: Patients in the Medicare 5% database with a primary inpatient diagnosis of HF (428.0, 428.9, 428.20-23, 428.30-33, 428.40-43) during CY05-08 were included. Maximum follow-up was 33 months (6 months baseline, 3 month index and 24 months follow-up ). Minimum follow-up was 9 months . To exclude prevalent cases, patients were required to have no HF diagnoses during baseline. The quarter of the initial HF inpatient diagnosis was designated the “index”. Patients were followed for up to 2 years (8 Quarters) after the “index” or until death or enrolment end. Sub-cohorts were defined based on HF events experienced during follow-up: 0, 1, or 2 or more. RESULTS: 43,819 patients with new primary HF inpa...
A noninterventional postauthorization safety study in patients with type 2 diabetes compared the ... more A noninterventional postauthorization safety study in patients with type 2 diabetes compared the sex-specific incidence of severe complications of urinary tract infections (sUTI) (pyelonephritis or urosepsis) in new users of dapagliflozin and new users of other comparator glucose-lowering drugs (GLDs), matched by index year, age, and region. Comparators included GLDs other than SGLT2 inhibitors, or monotherapy of insulin, metformin, or sulfonylureas. Data from US Medicare (2014-2017), US HealthCore Integrated Research Database (HIRD) (2014-2019), and UK Clinical Practice Research Datalink (CPRD) (2012-2018) were analyzed. Incidence rates of sUTI were compared by exposure group with adjusted incidence rate ratios (aIRRs) with covariate adjustment by propensity score trimming and stratification. Pooled aIRRs were estimated by the Mantel-Haenszel method. The total number of person-years of dapagliflozin and comparator exposure, respectively, was 17,265 and 161,176 for females and 22,594 and 194,388 for males. Mean age (years) in CPRD, HIRD, and Medicare was 58, 52, and 72 in females and 59, 52, and 71 in males, respectively. All aIRR estimates were below the null but imprecise (figure). The pooled aIRR was 0.76 (95% CI, 0.60-0.96) in females and 0.74 (95% CI, 0.56-1.00) in males. This real-world study did not find an increased risk of sUTI in females or males with dapagliflozin compared with other GLDs. Disclosure C. Johannes: Other Relationship; Self; AstraZeneca. H. Chen: None. A. Gilsenan: Other Relationship; Self; AstraZeneca. J. Layton: Other Relationship; Self; AstraZeneca. D. C. Beachler: Employee; Self; Anthem Inc. (HealthCore). R. M. Ziemiecki: Research Support; Self; Astellas Pharma Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Janssen Pharmaceuticals, Inc., Pfizer Inc. L. Li: Other Relationship; Self; Pfizer Inc. H. E. Danysh: Other Relationship; Self; AstraZeneca. J. Dinh: None. P. R. Hunt: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca. C. Karlsson: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca.
Objective: The objective of this study was to describe the rates of adverse clinical outcomes, in... more Objective: The objective of this study was to describe the rates of adverse clinical outcomes, including all-cause mortality, heart failure (HF) hospitalization, myocardial infarction, and stroke, in patients newly diagnosed with HF to provide a comprehensive picture of HF burden. Methods: This was a retrospective and observational study, using the BIG-PAC database in Spain. Adults, newly diagnosed with HF between January 2013 and September 2019 with ≥1 HF-free year of enrolment prior to HF diagnosis, were included. Results: A total of 19,961 patients were newly diagnosed with HF (43.5% with reduced ejection fraction (EF), 26.3% with preserved EF, 5.1% with mildly reduced EF, and 25.1% with unknown EF). The mean age was 69.7 ± 19.0 years; 53.8% were men; and 41.0% and 41.5% of patients were in the New York Heart Association functional classes II and III, respectively. The baseline HF treatments included beta-blockers (70.1%), renin–angiotensin system inhibitors (56.3%), mineralocort...
Circulation: Cardiovascular Quality and Outcomes, 2019
Background: THEMIS is a large randomized controlled trial (NCT01991795) comparing the effect of t... more Background: THEMIS is a large randomized controlled trial (NCT01991795) comparing the effect of ticagrelor vs placebo (both with background acetylsalicylic acid) for the prevention of major cardiovascular (CV) events in patients with coronary artery disease (CAD) and type 2 diabetes (T2D) with no prior myocardial infarction (MI) or stroke. The current study evaluated healthcare resource utilization (HCRU) and cost in patients similar to those eligible for enrollment in THEMIS (THEMIS-like) and in a broader population (T2D-CAD). Methods: This retrospective, observational study included patients, > 50 years old, with pharmacologically treated T2D and no prior MI or stroke collected from the Optum Research Database including Medicare Advantage Part D coverage between January 1, 2007 and December 31, 2017. Both cohorts were followed until disenrollment or end of the study period. The THEMIS-like cohort included patients with evidence of CAD including percutaneous coronary interventio...
OBJECTIVE: Characterize and estimate the prevalence of pseudobulbar affect (PBA) symptoms in a sa... more OBJECTIVE: Characterize and estimate the prevalence of pseudobulbar affect (PBA) symptoms in a sample of OEF/OIF/OND veterans with traumatic brain injury (TBI). BACKGROUND: PBA, characterized by exaggerated or inappropriate involuntary episodes of crying and/or laughing, can occur in persons with TBI or other neurological conditions. DESIGN/METHODS: Cross-sectional survey with patient-level linkage to VA clinical data among veterans screening positive for TBI. Eligible veterans were mailed a questionnaire consisting of the seven-item Center for Neurologic Study-Lability Scale (CNS-LS) with an initial question asking if the veteran had “involuntary episodes of crying and/or laughing that were exaggerated or even contrary to how they felt at the time”. The EQ-5D questionnaire, an international, standardized measure of health-related quality of life (HRQOL) was included. The presence of PBA symptoms is defined as positive response to the “involuntary episodes” question and a CNS-LS sco...
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