Citations

INTRODUCTION: Elagolix, an oral gonadotropin-releasing hormone antagonist, with and without add-back therapy, was evaluated in premenopausal women with heavy menstrual bleeding (HMB; greater than 80 mL/month menstrual blood loss [MBL]) associated with uterine fibroids (UF). METHODS: This double-blind, randomized, placebo-controlled, parallel group study evaluated the efficacy and safety of 6 months of treatment in 2 cohorts, with four arms/cohort: elagolix alone as 300 mg twice daily in cohort 1 (C1) and 600 mg once daily in cohort 2, and in both cohorts, placebo, elagolix with add-back therapy of estradiol (E2)/norethindrone acetate (NETA), low dose 0.5 mg E2/0.1 mg NETA (LDA), or standard dose 1.0 mg E2/0.5 mg NETA (SDA). The primary endpoint was the percentage of women with less than 80 mL MBL assessed by the alkaline-hematin-method and at least 50% reduction in MBL from baseline to the last 28 days of treatment. Adverse events (AE), changes in bone mineral density (BMD) and quality of life (QoL) were assessed. RESULTS: In C1, 259 women were randomized and treated; 80% completed treatment. C1 responses for the primary endpoint were 92% in elagolix alone, 85% elagolix+LDA, 79% elagolix+SDA, and 27% placebo (all p < .001 vs. placebo). Add-back therapy attenuated hot flushes and lumbar spine BMD decreases in a dose-dependent manner; there were no statistically significant differences in BMD between elagolix+SDA and placebo at month 6. All elagolix treatments were associated with improved QoL. Results were similar in C2. CONCLUSION: Elagolix with or without add-back significantly reduced MBL in UF-associated HMB. Hot flushes and BMD decreases were reduced by add-back in a dose-dependent manner.

Background Healthcare resources vary geographically, but associations between hospital‐based resources and acute stroke quality and outcomes remain unclear. Methods and Results Using Get With The Guidelines‐Stroke and Dartmouth Atlas of Health Care data, we examined associations between healthcare resource availability, stroke care, and outcomes. We categorized hospital referral regions with high‐, medium‐, or low‐resource levels based on the 2006 national per‐capita availability median of 6 relevant acute stroke care resources. Using multivariable logistic regression, we examined healthcare resource level and in‐hospital quality and outcomes. Of 1 480 308 admitted ischemic stroke patients (2006–2013), 28.8% were hospitalized in low‐, 44.4% in medium‐, and 26.9% in high‐resource hospital referral regions. Quality‐of‐care/timeliness metrics, adjusted length of stay, and in‐hospital mortality were similar across all resource levels. Conclusions Significant variation exists in regional availability of healthcare resources for acute ischemic stroke treatment, yet among Get With the Guidelines‐Stroke hospitals, quality of care and in‐hospital outcomes did not differ by regional resource availability.

Background— Reduced low forced expiratory volume in 1 second (FEV 1 ) is reportedly associated with an increased risk of atrial fibrillation (AF). Extant reports do not provide separate estimates for never smokers or for blacks, who incongruously have lower AF incidence than whites. Methods and Results— We examined 15 004 middle-aged blacks and whites enrolled in the Atherosclerosis Risk in Communities (ARIC) cohort study. Standardized spirometry data were collected at the baseline examination. Incident AF was identified from the first among the following: International Classification of Diseases codes for AF on hospital discharge records or death certificates or 12-lead ECGs performed during 3 triennial follow-up visits. Over an average follow-up of 17.5 years, a total of 1691 participants (11%) developed new-onset AF. The rate of incident AF was inversely associated with FEV 1 in each of the 4 race and sex groups. After multivariable adjustment for traditional cardiovascular disease risk factors and height, hazard ratios of AF comparing the lowest with the highest quartile of FEV 1 were 1.37 (95% confidence interval, 1.02–1.83) for white women, 1.49 (95% confidence interval, 1.16–1.91) for white men, 1.63 (95% confidence interval, 1.00–2.66) for black women, and 2.36 (95% confidence interval, 1.30–4.29) for black men. The above associations were observed across all smoking status categories. Moderate/severe airflow obstruction (FEV 1 /forced vital capacity <0.70 and FEV 1 < 80% of predicted value) was also associated with higher AF incidence. Conclusions— In this large population-based study with a long-term follow-up, reduced FEV 1 and obstructive respiratory disease were associated with a higher AF incidence after adjustment for measured confounders.