Comparative safety of conjugated estrogens/bazedoxifene versus estrogen/progestin combination hormone therapy among women in the United States: a multidatabase cohort study.

OBJECTIVE: To assess the risk of select safety outcomes including endometrial cancer, endometrial hyperplasia, and breast cancer among women using conjugated estrogens/bazedoxifene (CE/BZA) as compared with estrogen/progestin combination hormone therapy (EP). METHODS: We conducted a new-user cohort study in five US healthcare claims databases representing more than 92 million women. We included CE/BZA or EP new users from May 1, 2014, to August 30, 2019. EP users were propensity score (PS) matched to users of CE/BZA. Incidence of endometrial cancer, endometrial hyperplasia, breast cancer, and eight additional cancer and cardiovascular outcomes were ascertained using claims-based algorithms. Rate ratios (RR) and differences pooled across databases were estimated using random-effects models. RESULTS: The study population included 10,596 CE/BZA and 33,818 PS-matched EP new users. Rates of endometrial cancer and endometrial hyperplasia were slightly higher among CE/BZA users (1.6 and 0.4 additional cases per 10,000 person-years), although precision was limited because of small numbers of cases (endometrial cancer: RR, 1.50 [95% confidence interval {CI}, 0.79-2.88]; endometrial hyperplasia: RR, 1.69 [95% CI, 0.51-5.61]). Breast cancer incidence was lower in CE/BZA users (9.1 fewer cases per 10,000 person-years; RR, 0.79; 95% CI, 0.58-1.05). Rates of other outcomes were slightly higher among CE/BZA users, but with confidence intervals compatible with a wider range of possible associations. CONCLUSIONS: CE/BZA users might experience slightly higher rates of endometrial cancer and endometrial hyperplasia, and a lower rate of breast cancer, than EP users in the first years of use.

Patterns of Opioid Use and Risk of Opioid Overdose Death Among Medicaid Patients.

BACKGROUND: The Centers for Disease Control and Prevention recognizes Medicaid as a high-risk population for fatal opioid overdose. Further research is needed to identify factors that put Medicaid patients at increased risk. OBJECTIVE: To determine whether patterns of opioid use are associated with risk of opioid-related mortality among opioid users. DESIGN: This is a retrospective cohort study. PATIENTS: In total, 150,821 noncancer pain patients aged 18-64 years with ≥1 opioid prescription, April 2006 to December 2010, Washington Medicaid. MEASURES: Average daily dose (morphine equivalents), opioid schedule/duration of action, sedative-hypnotic use. RESULTS: Compared with patients at 1-19 mg/d, risk of opioid overdose death significantly increased at 50-89 mg/d [adjusted hazard ratio (aHR), 2.3; 95% confidence interval (CI), 1.4-4.1], 90-119 mg/d (aHR, 4.0; 95% CI, 2.2-7.3), 120-199 mg/d (aHR, 3.8; 95% CI, 2.1-6.9), and ≥200 mg/d (aHR, 4.9; 95% CI, 2.9-8.1). Patients using long-acting plus short-acting Schedule II opioids had 4.7 times the risk of opioid overdose death than non-Schedule II opioids alone (aHR, 4.7; 95% CI, 3.3-6.9). Sedative-hypnotic use compared with nonuse was associated with 6.4 times the risk of opioid overdose death (aHR, 6.4; 95% CI, 5.0-8.4). Risk was particularly high for opioids combined with benzodiazepines and skeletal muscle relaxants (aHR, 12.6; 95% CI, 8.9-17.9). Even at opioid doses 1-19 mg/d, patients using sedative-hypnotics concurrently had 5.6 times the risk than patients without sedative-hypnotics (aHR, 5.6; 95% CI, 1.6-19.3). CONCLUSIONS: Our findings support Federal guideline-recommended dosing thresholds in opioid prescribing. Concurrent sedative-hypnotic use even at low opioid doses poses substantially greater risk of opioid overdose.

Trends in Opioid Dosing Among Washington State Medicaid Patients Before and After Opioid Dosing Guideline Implementation.

UNLABELLED: By 2007, opioid-related mortality in Washington state (WA) was 50% higher than the national average, with Medicaid patients showing nearly 6 times the mortality of commercially-insured patients. In 2007, the WA Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain was released, which recommended caution in prescribing >120 mg morphine-equivalent dose per day for patients not showing clinically meaningful improvement in pain and function. We report on opioid dosing in the WA Medicaid fee-for-service population for 273,200 adults with a paid claim for an opioid prescription between April 1, 2006 and December 31, 2010. Linear regression was used to test for trends in dosing over that time period, with quarter-year as the independent variable and median daily dose as the dependent variable. Prescription opioid use among WA Medicaid adults peaked in 2009, as evidenced by the unique number of opioid users (105,232), the total number of prescriptions (556,712), and the total person-years of prescription opioid use (29,442). Median opioid dose was unchanged from 2006 to 2010 at 37.5 mg morphine-equivalent dose, but doses at the 75th, 90th, 95th, and 99th percentiles declined significantly (P < .001). These results suggest that opioid treatment guidelines with dosing guidance may be able to reduce high-dose opioid use without affecting the median dose used. PERSPECTIVE: Some fear that opioid dosing guidelines might restrict access to opioid therapy for patients who could benefit. However, there is evidence that high-dose opioid therapy entails significant risks without demonstrated benefit. These findings indicate that high-dose opioid therapy can be reduced without altering median opioid dose in a Medicaid population.

Opioid poisonings in Washington State Medicaid: trends, dosing, and guidelines.

BACKGROUND: Opioid poisonings have increased as use of prescription opioid medications have increased. To reduce these poisonings, guidelines for chronic opioid use have been implemented. However, if opioid poisonings occur in individuals who do not have high prescribed doses and who are not chronic opioid users, the current guidelines may need revision. OBJECTIVES: To examine changes in rates of methadone and other opioid poisonings after implementation of the WA State Opioid Guideline in 2007 and to examine the prescription history before poisonings. METHODS: The study sample consisted of individuals who had at least 1 paid claim for an opioid prescription in the Medicaid fee-for-service system between April 2006 and December 2010 and had an emergency department or inpatient hospital claim for an opioid poisoning. RESULTS: Methadone poisonings occurred at 10 times the rate of other prescription opioid poisonings and increased between 2006 and 2010. Rates of other prescription opioid poisonings appeared to level off after implementation of the WA opioid guideline in 2007. Among individuals with nonmethadone opioid poisonings, only 44% had chronic opioid use, 17% had prescribed doses in the week before the poisoning >120 mg/d morphine-equivalent dose (MED), 28% had doses <50 mg/d MED, and 48% had concurrent sedative prescriptions. CONCLUSIONS: It may be prudent to revise guidelines to address opioid poisonings occurring at relatively low prescribed doses and with acute and intermittent opioid use. Research is needed to establish the best strategies to prevent opioid poisonings.

Changes in opioid prescribing for Washington workers' compensation claimants after implementation of an opioid dosing guideline for chronic noncancer pain: 2004 to 2010.

UNLABELLED: An opioid overdose epidemic emerged in the United States following increased opioid prescribing for chronic noncancer pain. In 2007, Washington State agencies implemented an opioid dosing guideline on safe prescribing for chronic noncancer pain. The objective of this population-based observational study was to evaluate opioid use and dosing before and after guideline implementation. We identified 161,283 workers aged 18 to 64 years with ≥1 opioid prescriptions in Washington Workers' Compensation, April 1, 2004, to December 31, 2010. Prevalence and incidence rates of opioid use were assessed. We compared pre- and postguideline chronic and high-dose use (≥120 mg/d) among incident users. The mean monthly prevalence of opioid use declined by 25.6% between 2004 (14.4%) and 2010 (10.7%). Fewer incident users went on to chronic opioid therapy in the postguideline period (4.7%; 95% confidence interval [CI], 4.5-5.0%) than in the preguideline period (6.3%; 95% CI, 6.1-6.6%). Compared with preguideline incident users, postguideline incident users were 35% less likely to receive high doses (adjusted odds ratio = .65; 95% CI, .59-.71). Although the extent to which decreases were due to the guidelines is uncertain, to our knowledge, this is the first report of significant decreases in chronic and high-dose prescription opioid use among incident users. PERSPECTIVE: Evidence-based strategies for opioid risk management are needed to help abate the epidemic of opioid-related morbidity and mortality. The study findings suggest that opioid dosing guidelines that specify a "yellow flag" dosing threshold may be a useful tool in preventing escalation of doses into ranges associated with increased mortality risk.

Opioid poisonings and opioid adverse effects in workers in Washington state.

OBJECTIVE: To examine trends in opioid poisonings and adverse effects in Washington (WA) State and nationally. METHODS: We calculated rates of opioid poisonings and adverse effects and examined opioid prescriptions in the WA workers' compensation system, 2004-2010. Using Health Care Cost and Utilization Project (HCUP), Nationwide Inpatient Sample (NIS) data, we also calculated national rates of opioid poisonings and adverse effects, 1993-2010. RESULTS: We identified 96 opioid poisonings and 312 opioid-related adverse effects in WA, 2004-2010. The rates did not change substantially over these years. Most poisonings and adverse effects occurred in cases without chronic opioid use and with prescribed doses <120 mg/day morphine-equivalent dose. Nationally, the rates of opioid poisonings and adverse effects increased significantly from 1993 to 2010. CONCLUSIONS: Many poisonings and adverse effects occurred in patients without high dose or long-term opioid therapy, suggesting that opioid dosing and duration guidelines may not be sufficient to reduce morbidity related to prescription opioid use.

Measures of adiposity and cardiovascular disease risk factors, New York City Health and Nutrition Examination Survey, 2004.

INTRODUCTION: Body mass index (BMI) and indicators of central adiposity have been associated with cardiovascular disease (CVD) risk factors, but ambiguity remains about which measure optimally predicts CVD risk and is best suited for different racial/ethnic groups. We sought to characterize excess adiposity among New York City adults and assess the potential associations between multiple adiposity indicators and CVD risk factors, by race/ethnicity. METHODS: The New York City Health and Nutrition Examination Survey (NYC HANES) is a population-based survey of noninstitutionalized New York City adult residents aged 20 years or older. We compared the prevalence of obesity (BMI ≥ 30 kg/m(2)), elevated waist circumference (>102 cm for men, >88 cm for women), and elevated waist-to-height ratio (≥ 0.5) for participants in the 2004 NYC HANES (n = 1,912) and the 2003-2004 National Health and Nutrition Examination Survey (n = 4,075). Logistic regression was used to assess potential associations between each of these indicators of excess adiposity and CVD risk factors (diabetes, impaired fasting glucose, hypertension, and hypercholesterolemia), overall and by race/ethnicity. RESULTS: The prevalence of obesity among NYC HANES participants was 26% and of elevated waist circumference was 46%, both significantly lower than national estimates (31% and 52%, respectively), whereas the prevalence of elevated waist-to-height ratio was higher (82% vs 79%). Most measures of excess adiposity were significantly associated with all CVD risk factors. No single measure of excess adiposity emerged as most consistently predictive of CVD risk in the general population or by race/ethnicity. CONCLUSION: New York City has a lower prevalence of obesity and elevated waist circumference but a higher prevalence of elevated waist-to-height ratio than found nationally. Further investigation into the optimal adiposity measure to predict CVD risk across racial/ethnic populations may be warranted.

Ascertainment of warfarin and aspirin use by medical record review compared with automated pharmacy data.

PURPOSE: Automated pharmacy databases are increasingly available for assessing medication use, but research on the validity of these data is incomplete. This study aimed to measure agreement on warfarin and aspirin use between medical records and automated pharmacy data among patients with newly detected atrial fibrillation (AF). METHODS: Patients with newly detected AF (n = 1953) were previously identified in a cohort study at Group Health (GH) in Washington State. Medical records were reviewed for information on risk factors and medication use, as well as clinical care during the 6 months after AF onset. Medication data were also obtained from the GH pharmacy database. We determined the sensitivity, specificity, and positive predictive value (PPV) as measures of the validity of the GH pharmacy database as compared with medical records for warfarin and aspirin use during the first 6 and 3 months after AF onset. We also calculated the κ statistic. RESULTS: For warfarin use, in comparison with the medical record review, the sensitivity, specificity, and PPV for the GH pharmacy database were excellent, and agreement was almost perfect in the 3- and 6-month periods after AF onset (κ = 0.92 and 0.93, respectively). For aspirin use, the GH pharmacy database had low sensitivity but high specificity, and agreement was only fair for these two periods (κ = 0.28 and 0.31, respectively). CONCLUSIONS: The GH pharmacy database is a valuable source of data for pharmacoepidemiologic research on warfarin use among patients with AF. However, the database cannot be recommended for assessment of aspirin use. Copyright © 2010 John Wiley & Sons, Ltd.

Erratum: "A Biomonitoring Study of Lead, Cadmium, and Mercury in the Blood of New York City Adults".

[This corrects the article DOI: 10.1289/ehp.10056.].

Prevalence of hepatitis C infection in New York City, 2004.

Hepatitis C virus (HCV) is the leading cause of chronic liver disease in the United States. Accurate hepatitis C prevalence estimates are important to guide local public health programs but are usually unavailable to local health jurisdictions. National surveys may not reflect local variation, a particular challenge for urban settings with disproportionately large numbers of residents in high-risk population groups. In 2004, the New York City Department of Health and Mental Hygiene conducted the NYC Health and Nutrition Examination Survey, a population-based household survey of non-institutionalized NYC residents ages 20 and older. Study participants were interviewed and blood specimens were tested for antibody to HCV (anti-HCV); positive participants were re-contacted to ascertain awareness of infection and to provide service referrals. Of 1,786 participants with valid anti-HCV results, 35 were positive for anti-HCV, for a weighted prevalence of 2.2% (95% confidence interval [CI] 1.5% to 3.3%). Anti-HCV prevalence was high among participants with a lifetime history of injection drug use (64.5%, 95% CI 39.2% to 83.7%) or a lifetime history of incarceration as an adult (8.4%, 95% CI 4.3% to 15.7%). There was a strong correlation with age; among participants born between 1945 and 1954, the anti-HCV prevalence was 5.8% (95% CI 3.3% to 10.0%). Of anti-HCV positive participants contacted (51%), 28% (n = 5) first learned of their HCV status from this survey. Continued efforts to prevent new infections in known risk behavior groups are essential, along with expansion of HCV screening and activities to prevent disease progression in people with chronic HCV.

Secondhand smoke exposure among nonsmokers nationally and in New York City.

INTRODUCTION: We describe smoking prevalence and secondhand smoke (SHS) exposure among adult nonsmokers in New York City (NYC) across key demographic strata and compare exposure estimates with those found nationally. METHODS: We used serum cotinine data from the 2004 NYC Health and Nutrition Examination Survey (n = 1,767 adults aged 20 years or older) and the 2003-2004 National Health and Nutrition Examination Survey (n = 4,476 adults aged 20 years or older) to assess and compare smoking prevalence and the prevalence of elevated cotinine levels (> or =0.05 ng/ml) among nonsmokers. We conducted multivariate logistic regression to assess independent predictors of elevated cotinine levels in NYC. RESULTS: Although the smoking prevalence in NYC was lower than that found nationally (23.3% vs. 29.7%, p < .05), the proportion of nonsmoking adults in NYC with elevated cotinine levels was greater than the national average overall (56.7% vs. 44.9%, p < .05) and was higher for most demographic subgroups. In NYC, the highest cotinine levels among nonsmokers were among adults aged 20-39 years, males, and Asians. DISCUSSION: Although NYC enacted comprehensive smoke-free workplace legislation in 2003, findings suggest that exposure to SHS remains a significant public health issue, especially among certain subgroups. The finding of a higher prevalence of SHS exposure in NYC despite lower smoking rates is puzzling but suggests that SHS exposure in dense, urban settings may pose a particular challenge.

Contributions of a local health examination survey to the surveillance of chronic and infectious diseases in New York City.

OBJECTIVES: We sought to evaluate the contribution of the New York City Health and Nutrition Examination Survey (NYC-HANES) to local public health surveillance. METHODS: Examination-diagnosed estimates of key health conditions from the 2004 NYC-HANES were compared with the National Health and Nutrition Examination Survey (NHANES) 2003-2004 national estimates. Findings were also compared with self-reported estimates from the Community Health Survey (CHS), an annually conducted local telephone survey. RESULTS: NYC-HANES estimated that among NYC adults, 25.6% had hypertension, 25.4% had hypercholesterolemia, 12.5% had diabetes, and 25.6% were obese. Compared with US adults, NYC residents had less hypertension and obesity but more herpes simplex 2 and environmental exposures (P<.05). Obesity was higher and hypertension was lower than CHS self-report estimates (P<.05). NYC-HANES and CHS self-reported diabetes estimates were similar (9.7% vs 8.7%). CONCLUSIONS: NYC-HANES and national estimates differed for key chronic, infectious, and environmental indicators, suggesting the need for local data. Examination surveys may provide more accurate information for underreported conditions than local telephone surveys. Community-level health and nutrition examination surveys complement existing data, providing critical information for targeting local interventions.

Prevalence, diagnosis, and treatment of depression and generalized anxiety disorder in a diverse urban community.

OBJECTIVE: This study assessed the prevalence, diagnosis, and treatment of major depressive disorder and generalized anxiety disorder among New York City adults. METHODS: As part of the first community-specific Health and Nutrition Examination Survey in the United States, depression and anxiety were assessed in a representative sample of 1,817 noninstitutionalized adults in 2004. RESULTS: A total of 8% had major depressive disorder and 4% had generalized anxiety disorder. Respondents with depression were more likely to be formerly married, publicly insured, younger, and U.S. born. Only 55% of adults with depression were diagnosed, and 38% of those with depression or anxiety were in treatment; individuals with a diagnosis of depression were more likely to receive treatment than those without a diagnosis (61% versus 7%; p<.001). Immigrants with depression were 60% less likely to be diagnosed than their U.S.-born counterparts; immigrants arriving in this country ten or more years ago had slightly more anxiety than immigrants arriving less than ten years ago (3% versus 2%, not significant). Among respondents with anxiety, 23% reported disability compared with 15% of those with depression. Compared with adults with neither diagnosis, adults with depression or anxiety were twice as likely to smoke tobacco (p<.05), adults with depression were twice as likely to have diabetes (p<.01), and those with anxiety were twice as likely to have asthma (p<.01). CONCLUSIONS: Mental disorders are often disabling and inadequately diagnosed and treated. Foreign-born adults experience barriers to diagnosis and treatment despite having less depression; anxiety may increase with time since immigration. Increased awareness of and linkage to mental health services are needed, especially in larger, more diverse urban communities.

Population prevalence of reported and unreported HIV and related behaviors among the household adult population in New York City, 2004.

BACKGROUND: Surveillance for HIV likely underestimates infection among the general population: 25% of US residents are estimated to be unaware of their HIV infection. OBJECTIVE: To determine the prevalence of HIV infection and risk behaviors among New York City (NYC) adults and compare these with surveillance findings. METHODS: The NYC Health and Nutrition Examination Survey (HANES) provided the first opportunity to estimate population-based HIV prevalence among NYC adults. It was conducted in 2004 among a representative sample of adults > 20 years. Previously reported HIV infection was identified from the NYC HIV/AIDS Surveillance Registry. A blinded HIV serosurvey was conducted on archived blood samples of 1626 NYC HANES participants. Data were used to estimate prevalence for HIV infection, unreported infections, high-risk activities, and self-perceived risk. RESULTS: Overall, 18.1% engaged in one or more risky sexual/needle-use behaviors, of which 92.2% considered themselves at low or no risk of HIV or another sexually transmitted disease. HIV occurred in 21 individuals (prevalence 1.4%; 95% confidence interval (CI), 0.8-2.5]; one infection (5%; 95% CI, 0.7-29.9) was not reported previously and possibly undiagnosed. HIV infection was significantly elevated in those with herpes simplex virus 2 (4%), men who have sex with men (14%), and needle-users (21%) (P < 0.01). CONCLUSIONS: Among NYC adults, HIV prevalence was consistent with surveillance findings overall. The proportion of unreported HIV was less than estimated nationally, but findings were limited by sample size. Most adults with risky behaviors perceived themselves to be at minimal risk, highlighting the need for risk reduction and routine HIV screening.

Prevalence, awareness, treatment, and predictors of control of hypertension in New York City.

BACKGROUND: Hypertension-related risk in urban areas may vary from national estimates; however, objective data on prevalence and treatment in local areas are scarce. We assessed hypertension prevalence, awareness, treatment, and control among New York City (NYC) adults. METHODS AND RESULTS: The NYC Health And Nutrition Examination Survey (HANES), modeled on the national HANES, was conducted in 2004 with a representative sample of noninstitutionalized NYC residents > or =20 years of age. Hypertension outcomes were examined with interview and examination data (n=1975). Multiple logistic regression was used to assess factors associated with control among adults with hypertension. We found that 25.6% of NYC adults had hypertension. Blacks had a higher prevalence than whites (32.8% versus 21.1%, P<0.001), as did Hispanics (26.5% versus 21.1%, P<0.05). Foreign-born residents who had lived in the United States for <10 years had lower rates than those who had lived in the United States longer (20.0% versus 27.5%, P<0.05). Among adults with hypertension, 83.0% were diagnosed, 72.7% were treated, and 47.1% had hypertension controlled. Of those treated, 64.8% had hypertension controlled. After adjustment for sociodemographic variables among all adults with treated hypertension, lack of a routine place of medical care was most strongly associated with poor control levels (adjusted odds ratio 0.21, 95% confidence interval 0.07 to 0.66). Among nonelderly adults with treated hypertension, blacks had 4-fold lower odds than whites of having hypertension controlled (adjusted odds ratio 0.24, 95% confidence interval 0.06 to 0.92). CONCLUSIONS: In NYC, hypertension is common and frequently uncontrolled. Low levels of control are associated with poor access to care. Racial disparities in prevalence and control are evident among nonelderly adults.

A biomonitoring study of lead, cadmium, and mercury in the blood of New York city adults.

OBJECTIVES: We assessed the extent of exposure to lead, cadmium, and mercury in the New York City (NYC) adult population. METHODS: We measured blood metal concentrations in a representative sample of 1,811 NYC residents as part of the NYC Health and Nutrition Examination Survey, 2004. RESULTS: The geometric mean blood mercury concentration was 2.73 microg/L [95% confidence interval (CI), 2.58-2.89]; blood lead concentration was 1.79 microg/dL (95% CI, 1.73-1.86); and blood cadmium concentration was 0.77 microg/L (95% CI, 0.75-0.80). Mercury levels were more than three times that of national levels. An estimated 24.8% (95% CI, 22.2-27.7%) of the NYC adult population had blood mercury concentration at or above the 5 microg/L New York State reportable level. Across racial/ethnic groups, the NYC Asian population, and the foreign-born Chinese in particular, had the highest concentrations of all three metals. Mercury levels were elevated 39% in the highest relative to the lowest income group (95% CI, 21-58%). Blood mercury concentrations in adults who reported consuming fish or shellfish 20 times or more in the last 30 days were 3.7 times the levels in those who reported no consumption (95% CI, 3.0-4.6); frequency of consumption explained some of the elevation in Asians and other subgroups. CONCLUSIONS: Higher than national blood mercury exposure in NYC adults indicates a need to educate New Yorkers about how to choose fish and seafood to maximize health benefits while minimizing potential risks from exposure to mercury. Local biomonitoring can provide valuable information about environmental exposures.