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...
Introduction: Non-ST-elevation myocardial infarction (NSTEMI) patients have more comorbidities an... more Introduction: Non-ST-elevation myocardial infarction (NSTEMI) patients have more comorbidities and extensive CAD than STEMI patients. However, there is a need for comparative data on the long-term ...
Background: Exposure to corticosteroids is recognised to increase the risk of developing type 2 d... more Background: Exposure to corticosteroids is recognised to increase the risk of developing type 2 diabetes (T2DM). Our aim was to evaluate the short-term absolute risk of T2DM over the course of people’s first continuous exposure to corticosteroids. Methods: This was an observational study using UK data from the Clinical Practice Research Datalink. Adult patients were selected if exposed to systemic corticosteroids for any condition and had no prior T2DM. Non-exposed adults matched on age, sex, disease burden were selected from the general population. Patients were followed from their first exposure to corticosteroid to 90 days following the end of continuous prescribing. Absolute risk rates were calculated by age, sex and BMI category. Results: In total, 536,852 exposed patients were matched 1:1 to non-exposed controls. Mean age was 51 years; 59% were female. Obese males aged 43-67 years exposed to corticosteroids had the highest absolute risk of T2DM (41.8 per 1,000 patient years (PKPY)); in matched non-exposed controls this was 24.0 PKPY. Generally, patients taking steroids had greater risk of T2DM compared with those in the same age, sex and BMI category never exposed to steroids. Conclusions: Whilst it is understood that exposure to corticosteroids increases the risk of T2DM, there are large differences in risk in accordance with age, sex and BMI. Alternatives to corticosteroids are urgently needed. Disclosure E. Berni: Consultant; Self; AstraZeneca. S. Jenkins-jones: Consultant; Self; AstraZeneca. C. Astbury: Employee; Self; AstraZeneca. M. N. Brown: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca. P. R. Hunt: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca. C. J. Currie: Consultant; Self; AstraZeneca. S. Adamsson eryd: Employee; Self; AstraZeneca. P. Ambery: Employee; Self; AstraZeneca.
OBJECTIVE To assess the burden of disease for adults with type 1 diabetes in a U.S. electronic he... more OBJECTIVE To assess the burden of disease for adults with type 1 diabetes in a U.S. electronic health record database by evaluating acute and microvascular complications stratified by age and glycemic control. RESEARCH DESIGN AND METHODS This is a retrospective observational study of adults with type 1 diabetes (1 July 2014–30 June 2016) classified using a validated algorithm, with disease duration ≥24 months and, during a 12-month baseline period, not pregnant and having one or more insulin prescriptions and one or more HbA1c measurements. Demographic characteristics, acute complications (severe hypoglycemia [SH], diabetic ketoacidosis [DKA]), and microvascular complications (neuropathy, nephropathy, retinopathy) were stratified by age (18–25, 26–49, 50–64, ≥65 years) and glycemic control (HbA1c <7%, 7% to <9%, ≥9%). RESULTS Of 31,430 patients, ∼20% had HbA1c <7%. Older patients had lower HbA1c values than younger patients (P < 0.001). Patients with poor glycemic contro...
Background Firefighters are known to be exposed to recognized or probable carcinogens. Previous s... more Background Firefighters are known to be exposed to recognized or probable carcinogens. Previous studies have found elevated risks of several types of cancers in firefighters. Methods Standardized morbidity odds ratio (SMORs) were used to evaluate the cancer risk in white, male firefighters compared to police and all other occupations in the Massachusetts Cancer Registry from 1986 to 2003. Firefighters and police were identified by text search of the usual occupation field. All other occupations included cases with identifiable usual occupations not police or firefighter. Control cancers were those not associated with firefighters in previous studies. Results Risks were moderately elevated among firefighters for colon cancer
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...
Introduction: Non-ST-elevation myocardial infarction (NSTEMI) patients have more comorbidities an... more Introduction: Non-ST-elevation myocardial infarction (NSTEMI) patients have more comorbidities and extensive CAD than STEMI patients. However, there is a need for comparative data on the long-term ...
Background: Exposure to corticosteroids is recognised to increase the risk of developing type 2 d... more Background: Exposure to corticosteroids is recognised to increase the risk of developing type 2 diabetes (T2DM). Our aim was to evaluate the short-term absolute risk of T2DM over the course of people’s first continuous exposure to corticosteroids. Methods: This was an observational study using UK data from the Clinical Practice Research Datalink. Adult patients were selected if exposed to systemic corticosteroids for any condition and had no prior T2DM. Non-exposed adults matched on age, sex, disease burden were selected from the general population. Patients were followed from their first exposure to corticosteroid to 90 days following the end of continuous prescribing. Absolute risk rates were calculated by age, sex and BMI category. Results: In total, 536,852 exposed patients were matched 1:1 to non-exposed controls. Mean age was 51 years; 59% were female. Obese males aged 43-67 years exposed to corticosteroids had the highest absolute risk of T2DM (41.8 per 1,000 patient years (PKPY)); in matched non-exposed controls this was 24.0 PKPY. Generally, patients taking steroids had greater risk of T2DM compared with those in the same age, sex and BMI category never exposed to steroids. Conclusions: Whilst it is understood that exposure to corticosteroids increases the risk of T2DM, there are large differences in risk in accordance with age, sex and BMI. Alternatives to corticosteroids are urgently needed. Disclosure E. Berni: Consultant; Self; AstraZeneca. S. Jenkins-jones: Consultant; Self; AstraZeneca. C. Astbury: Employee; Self; AstraZeneca. M. N. Brown: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca. P. R. Hunt: Employee; Self; AstraZeneca, Stock/Shareholder; Self; AstraZeneca. C. J. Currie: Consultant; Self; AstraZeneca. S. Adamsson eryd: Employee; Self; AstraZeneca. P. Ambery: Employee; Self; AstraZeneca.
OBJECTIVE To assess the burden of disease for adults with type 1 diabetes in a U.S. electronic he... more OBJECTIVE To assess the burden of disease for adults with type 1 diabetes in a U.S. electronic health record database by evaluating acute and microvascular complications stratified by age and glycemic control. RESEARCH DESIGN AND METHODS This is a retrospective observational study of adults with type 1 diabetes (1 July 2014–30 June 2016) classified using a validated algorithm, with disease duration ≥24 months and, during a 12-month baseline period, not pregnant and having one or more insulin prescriptions and one or more HbA1c measurements. Demographic characteristics, acute complications (severe hypoglycemia [SH], diabetic ketoacidosis [DKA]), and microvascular complications (neuropathy, nephropathy, retinopathy) were stratified by age (18–25, 26–49, 50–64, ≥65 years) and glycemic control (HbA1c <7%, 7% to <9%, ≥9%). RESULTS Of 31,430 patients, ∼20% had HbA1c <7%. Older patients had lower HbA1c values than younger patients (P < 0.001). Patients with poor glycemic contro...
Background Firefighters are known to be exposed to recognized or probable carcinogens. Previous s... more Background Firefighters are known to be exposed to recognized or probable carcinogens. Previous studies have found elevated risks of several types of cancers in firefighters. Methods Standardized morbidity odds ratio (SMORs) were used to evaluate the cancer risk in white, male firefighters compared to police and all other occupations in the Massachusetts Cancer Registry from 1986 to 2003. Firefighters and police were identified by text search of the usual occupation field. All other occupations included cases with identifiable usual occupations not police or firefighter. Control cancers were those not associated with firefighters in previous studies. Results Risks were moderately elevated among firefighters for colon cancer
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