Baseline characteristics of patients in the reduction of events with darbepoetin alfa in heart failure trial (RED-HF)

<p>Aims: This report describes the baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF) which is testing the hypothesis that anaemia correction with darbepoetin alfa will reduce the composite endpoint of death from any cause or hospital admission for worsening heart failure, and improve other outcomes.</p> <p>Methods and results: Key demographic, clinical, and laboratory findings, along with baseline treatment, are reported and compared with those of patients in other recent clinical trials in heart failure. Compared with other recent trials, RED-HF enrolled more elderly [mean age 70 (SD 11.4) years], female (41%), and black (9%) patients. RED-HF patients more often had diabetes (46%) and renal impairment (72% had an estimated glomerular filtration rate <60 mL/min/1.73 m2). Patients in RED-HF had heart failure of longer duration [5.3 (5.4) years], worse NYHA class (35% II, 63% III, and 2% IV), and more signs of congestion. Mean EF was 30% (6.8%). RED-HF patients were well treated at randomization, and pharmacological therapy at baseline was broadly similar to that of other recent trials, taking account of study-specific inclusion/exclusion criteria. Median (interquartile range) haemoglobin at baseline was 112 (106–117) g/L.</p> <p>Conclusion: The anaemic patients enrolled in RED-HF were older, moderately to markedly symptomatic, and had extensive co-morbidity.</p&gt

Perinatal mood and anxiety disorders, serious mental illness, and delivery-related health outcomes, United States, 2006–2015

Abstract Background National estimates of perinatal mood and anxiety disorders (PMAD) and serious mental illness (SMI) among delivering women over time, as well as associated outcomes and costs, are lacking. The prevalence of perinatal mood and anxiety disorders and serious mental illness from 2006 to 2015 were estimated as well as associated risk of adverse obstetric outcomes, including severe maternal morbidity and mortality (SMMM), and delivery costs. Methods The study was a serial, cross-sectional analysis of National Inpatient Sample data. The prevalence of PMAD and SMI was estimated among delivering women as well as obstetric outcomes, healthcare utilization, and delivery costs using adjusted weighted logistic with predictive margins and generalized linear regression models, respectively. Results The study included an estimated 39,025,974 delivery hospitalizations from 2006 to 2015 in the U.S. PMAD increased from 18.4 (95% CI 16.4–20.0) to 40.4 (95% CI 39.3–41.6) per 1000 deliveries. SMI also increased among delivering women over time, from 4.2 (95% CI 3.9–4.6) to 8.1 (95% CI 7.9–8.4) per 1000 deliveries. Medicaid covered 72% (95% CI 71.2–72.9) of deliveries complicated by SMI compared to 44% (95% CI 43.1–45.0) and 43.5% (95% CI 42.5–44.5) among PMAD and all other deliveries, respectively. Women with PMAD and SMI experienced higher incidence of SMMM, and increased hospital transfers, lengths of stay, and delivery-related costs compared to other deliveries (P < .001 for all). Conclusion Over the past decade, the prevalence of both PMAD and SMI among delivering women increased substantially across the United States, and affected women had more adverse obstetric outcomes and delivery-related costs compared to other deliveries.http://deepblue.lib.umich.edu/bitstream/2027.42/173445/1/12905_2020_Article_996.pd

Trends in Birth Rates After Elimination of Cost Sharing for Contraception by the Patient Protection and Affordable Care Act

ImportanceReducing out-of-pocket costs is associated with improved patterns of contraception use. It is unknown whether reducing out-of-pocket costs is associated with fewer births.ObjectiveTo evaluate changes in birth rates by income level among commercially insured women before (2008-2013) and after (2014-2018) the elimination of cost sharing for contraception under the Patient Protection and Affordable Care Act (ACA).Design, setting, and participantsThis cross-sectional study used data from Clinformatics Data Mart database from January 1, 2008, to December 31, 2018, for women aged 15 to 45 years who were enrolled in an employer-based health plan and had pregnancy benefits for at least 1 year. Women without household income information and women with evidence of having undergone a hysterectomy were excluded.ExposureSection 2713 of the ACA.Main outcomes and measuresThe primary outcome was the proportion of reproductive-aged women with a live birth by year (measured yearly from 2008 to 2018 [11 time points]) within 3 income categories. The secondary outcome was the distribution of contraceptive method fills in 3 categories by year: (1) most effective methods (long-acting reversible contraception or sterilization), (2) moderately effective methods (pill, patch, ring, and injectable), and (3) no prescription or surgical method.ResultsThe analytic sample included 4 590 989 women (mean [SD] age; 30.8 [9.1] years in 2013; 3 069 053 White [66.9%]) enrolled in 47 721 health plans. A total of 500 898 participants (40.8%) resided in households with incomes less than 400% of the federal poverty level in 2013. In all 3 years (2008, 2013, and 2018), women in the lowest income category were younger than women in the other income groups (median range, 21-22 years vs 30-34 years) and in households with a higher median number of dependents (9-10 vs 2-4). There was an associated decrease in births in all income groups in the period after the elimination of out-of-pocket costs. The estimated probability of birth decreased most precipitously among women in the lowest income group from 8.0% (95% CI, 7.4%-8.5%) in 2014 to 6.2% (95% CI, 5.7%-6.7%) in 2018, representing a 22.2% decrease (P &lt; .001). The estimated probability decreased in the middle income group by 9.4%, from 6.4% (95% CI, 6.3%-6.4%) to 5.8% (95% CI, 5.7%-5.8%) (P &lt; .001), and in the highest income group by 1.8%, from 5.6% (95% CI, 5.6%-5.7%) to 5.5% (95% CI, 5.4%-5.5%) (P &lt; .001) in the period after the elimination of cost sharing.Conclusions and relevanceIn this cross-sectional study, the elimination of cost sharing for contraception under the ACA was associated with improvements in contraceptive method prescription fills and a decrease in births among commercially insured women. Women with low income had more precipitous decreases than women with higher income, suggesting that enhanced access to contraception may address well-documented income-related disparities in unintended birth rates

Treatment of Anemia with Darbepoetin Alfa in Systolic Heart Failure

<p>BACKGROUND</p><p>Patients with systolic heart failure and anemia have worse symptoms, functional capacity, and outcomes than those without anemia. We evaluated the effects of darbepoetin alfa on clinical outcomes in patients with systolic heart failure and anemia.</p><p>METHODS</p><p>In this randomized, double-blind trial, we assigned 2278 patients with systolic heart failure and mild-to-moderate anemia (hemoglobin level, 9.0 to 12.0 g per deciliter) to receive either darbepoetin alfa (to achieve a hemoglobin target of 13 g per deciliter) or placebo. The primary outcome was a composite of death from any cause or hospitalization for worsening heart failure.</p><p>RESULTS</p><p>The primary outcome occurred in 576 of 1136 patients (50.7%) in the darbepoetin alfa group and 565 of 1142 patients (49.5%) in the placebo group (hazard ratio in the darbepoetin alfa group, 1.01; 95% confidence interval, 0.90 to 1.13; P = 0.87). There was no significant between-group difference in any of the secondary outcomes. The neutral effect of darbepoetin alfa was consistent across all prespecified subgroups. Fatal or nonfatal stroke occurred in 42 patients (3.7%) in the darbepoetin alfa group and 31 patients (2.7%) in the placebo group (P = 0.23). Thromboembolic adverse events were reported in 153 patients (13.5%) in the darbepoetin alfa group and 114 patients (10.0%) in the placebo group (P = 0.01). Cancer-related adverse events were similar in the two study groups.</p><p>CONCLUSIONS</p><p>Treatment with darbepoetin alfa did not improve clinical outcomes in patients with systolic heart failure and mild-to-moderate anemia. Our findings do not support the use of darbepoetin alfa in these patients. (Funded by Amgen; RED-HF ClinicalTrials.gov number, NCT00358215.)</p>