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.

Weight-based discrimination and disordered eating behaviors in a cohort of U.S. sexual minority young adults.

OBJECTIVE: Though prevalent, weight-based discrimination is understudied and has been linked to disordered eating behaviors (DEB) among adolescents and adults. Sexual minority populations experience elevated risk of DEB, but little is known about the role of weight discrimination in this elevated risk. METHODS: Participants were 1257 sexual minority women and men (ages 18-31 years) in the US Growing Up Today Study cohort. We examined cross-sectional associations between weight discrimination victimization and three DEB in the past year: unhealthy weight control behaviors, overeating, and binge eating. Generalized estimating equations, adjusted for potential confounders, were used to estimate prevalence ratios (PRs) and 95% confidence intervals (CIs). RESULTS: Three in 10 participants (31%) reported weight-based discrimination victimization. Sexual minority young adults who reported weight-based discrimination had greater relative prevalence of unhealthy weight control behaviors (PR [95% CI]: 1.92 [1.35, 2.74]), overeating (3.15 [2.24, 4.44]), and binge eating (3.92 [2.51, 6.13]), compared with those who reported no weight-based discrimination. Associations with overeating and binge eating remained significant after adjusting for BMI. DISCUSSION: The role of weight-based discrimination, and its intersections with other forms of stressors for sexual minority young adults, must be included in efforts to advance eating disorder prevention for this underserved population. PUBLIC SIGNIFICANCE: Three in 10 sexual minority young adults in this study had experienced weight-based discrimination, a common but understudied form of discrimination. Sexual minority young adults who experienced weight-based discrimination were at greater risk of disordered eating behaviors than those who had not experienced weight-based discrimination. These findings suggest that weight-based discrimination may be an important-and preventable-risk factor for disordered eating behaviors among sexual minority young adults.

Risk of Thyroid Cancer Associated with Use of Liraglutide and Other Antidiabetic Drugs in a US Commercially Insured Population.

BACKGROUND: Quantify association between the glucagon-like peptide-1 receptor agonist liraglutide and risk of thyroid cancer (TC) compared to other antidiabetics. PATIENTS AND METHODS: Initiators of liraglutide, exenatide, metformin, pioglitazone or groups of dipeptidyl peptidase-4 inhibitors or sulfonylureas were identified in a US health plan (2010-2014) and followed for a median of 17 months. Thyroid cancer cases during follow-up were identified via a validated algorithm. Incidence rates of TC among liraglutide and comparators were assessed using relative risks estimated within propensity score-matched cohorts using intention to treat (ITT) and time on drug analyses. Latency effects and potential surveillance bias were evaluated. RESULTS: Relative risks from ITT analyses ranged from 1.00 (95% confidence interval (CI) 0.56-1.79) versus metformin to 1.70 (95% CI 1.03-2.81) versus all comparators excluding exenatide. Effect estimates from latency analyses were slightly attenuated. Time on drug analyses suggested no increased risk for either longer duration or higher cumulative dose of liraglutide. Medical record review found 85% were papillary or a follicular variant of papillary or both; 46% were microcarcinomas (≤10 millimeters), which were more prevalent in the liraglutide cohort (67% versus 43% in all comparators). CONCLUSION: Relative risks were elevated for several comparisons, which should be interpreted cautiously because of potential residual confounding and surveillance bias. Liraglutide cases had smaller thyroid nodules and shorter time-to-diagnosis, suggesting increased surveillance for TC among liraglutide initiators, especially shortly after the drug´s approval. After adjusting the primary analyses (ITT) for latency, no significant elevated risk of TC was observed among liraglutide initiators.

Post-approval Safety Surveillance Study of Golimumab in the Treatment of Rheumatic Disease Using a United States Healthcare Claims Database.

BACKGROUND AND OBJECTIVE: Golimumab is a fully human anti-tumor necrosis factor monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). This study estimated rates of prespecified outcomes in patients with RA, PsA or AS initiating golimumab versus matched patients initiating non-biologic systemic (NBS) medications. METHODS: Patients enrolled in a US health plan with rheumatic disease who initiated a study medication were accrued between April 2009 and November 2014. Golimumab initiators were matched by propensity score to NBS initiators in a 1:4 ratio. Outcomes were identified through September 2015. As-treated, as-matched, and nested case-control (NCC) analyses were conducted in the matched cohorts. Sensitivity analyses evaluated the impact of residual confounding and nondifferential misclassification of exposure and outcomes. RESULTS: Risks of outcomes were similar between golimumab and NBS initiators. In the as-treated analysis, the rate ratio (RR) for depression was elevated during current golimumab use versus golimumab non-use in the NBS cohort [RR 1.45, 95% confidence interval (CI) 1.31-1.61]. This finding was not replicated in as-matched (RR 1.08, 95% CI 0.97-1.19) or NCC (odds ratio 1.01, 95% CI 0.78-1.31) analyses, which focused on incident cases. Sensitivity analyses suggest that depression was sensitive to misclassification, and the RR changed from greater than to less than one across a plausible range of specificity. CONCLUSIONS: This study suggests that there is no association between exposure to golimumab and an increased risk of prespecified outcomes. Increased depression risk in the as-treated analysis was not replicated in other analyses and may be associated with residual imbalance in baseline history or severity of depression.

Indoor Ultraviolet Tanning Among U.S. Adolescents and Young Adults: Results From a Prospective Study of Early Onset and Persistence.

PURPOSE: The purpose of the study was to test whether those who initiate tanning during adolescence are more likely to continue tanning in young adulthood, potentially increasing their risk for melanoma. METHODS: The study included prospective data from the Growing Up Today Study, a cohort study started in 1996 (N = 5,882). RESULTS: Among men and women who ever indoor UV tanned, those who indoor UV tan by age 17 years consistently indoor tanned at least twice the prevalence as those who did not indoor UV tan by age 17 years. Indoor tanning prevalence at age 27 years was nearly 4 times as high (18.8% vs. 4.8%) among men who started indoor tanning by age 17 years than those who did not indoor tan by age 17 years. These differences persisted through age 27 years and are more pronounced in men (18.8% vs. 4.8%) than in women (30.5% vs. 13.0%). CONCLUSION: Adolescents who indoor UV tan by age 17 years are more likely to continue to indoor tan through young adulthood than those who begin indoor UV tanning at age 18 years or older. Our findings suggest that interventions to prevent indoor UV tanning among minors may substantially reduce years of exposure to this carcinogenic behavior in young adults.

Liraglutide use and evaluation of pancreatic outcomes in a US commercially insured population.

AIMS: Both acute pancreatitis (AP) and pancreatic cancer (PC) have been areas of focus for studies of incretin drugs. This 5-year prospective cohort study aimed to quantify possible associations between liraglutide and risk of AP and PC as compared to other antidiabetic drugs (ADs). MATERIALS AND METHODS: Patients initiating liraglutide or other ADs who were enrolled in a US health plan (2010-2014) were included. Comparisons of AP and PC incidence rates were made between matched cohorts of liraglutide initiators and initiators of other ADs. Adjudicated AP cases and algorithm-based PC cases were identified. Propensity score-matched intention-to-treat (ITT) and time-on-drug (TOD) analyses were completed using Poisson regression. A latency analysis was performed for PC. RESULTS: Median follow-up was 405 days for AP cohorts (9995 liraglutide, 1:1 matched to all comparators) and 503 days for PC cohorts (35 163 liraglutide, 1:1 matched to all comparators). In the primary AP analysis, "current" use of liraglutide was not significantly associated with elevated risk across comparators (all comparators relative risk [RR] = 1.2; 95% confidence interval [CI], 0.6-2.3). ITT results were similar where, in the primary analysis, no RRs were significantly associated with PC (all comparators RR = 0.7; 95% CI, 0.3-1.4); latency and TOD analyses did not alter findings. There was no evidence of a dose-response effect. CONCLUSIONS: Liraglutide was not associated with an increased risk of AP or PC, although risk estimates were more variable for AP, and numbers of cases for both outcomes were limited because of the rarity of outcomes.

Screening high school students for eating disorders: validity of brief behavioral and attitudinal measures.

BACKGROUND: Early identification can greatly impact the trajectory of eating disorders, and school-based screening is 1 avenue for identifying those at risk. To be feasible in a school setting, a screening program must use a brief, valid screening tool. The aim of this study was to assess how well brief attitudinal and behavioral survey items identify adolescents at risk in a large sample of high school students from across the United States. METHODS: Data were drawn from the National Eating Disorder Screening Program, the first-ever national eating disorders screening initiative for US high schools. A 2-stage, clustered sampling method was used to randomly select a subset of student screening forms (n = 5740), which included the Eating Attitudes Test (EAT-26), behavioral questions assessing the frequency of vomiting and binge eating in the past 3 months, and an attitudinal item that assessed preoccupation with thinness. RESULTS: Nearly 12% of females and 3% of males reported vomiting to control their weight and 17% of females and 10% of males reported binge eating 1 or more times per month. Approximately 24% of females and 8% of males report being preoccupied with being thinner. We found that the attitudinal measure yielded high sensitivity and specificity. Combined screening measures that used both the attitudinal and behavioral items yielded slightly higher sensitivity values than those found with the attitudinal measure alone. CONCLUSION: High school administrators should include items that assess both preoccupation with thinness as well as behavioral items that deal with eating disorders on student health surveys.