9 research outputs found
Cervical Screening within HIV Care: Findings from an HIV-Positive Cohort in Ukraine
HIV-positive women have an increased risk of invasive cervical cancer but cytologic screening is effective in reducing incidence. Little is known about cervical screening coverage or the prevalence of abnormal cytology among HIV-positive women in Ukraine, which has the most severe HIV epidemic in Europe
Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials
Aims:
The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials.
Methods and Results:
Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594).
Conclusions:
GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation
High percentage of recent HIV infection leading to onward transmission in Odessa, Ukraine associated with young adults
The proportion of new HIV diagnoses between May and December 2009 across Odessa recently-infected was estimated using the BED-CEIA assay. Logistic regression models were used to explore factors associated with testing as recent. Of 1,313 newly-diagnosed individuals, 321 (24 %) were classified as recent. Recent infection was less likely among older adults [odds ratio (OR) = 0.70 per 10-year increase, 95 % CI 0.60-0.82]. Compared to men residing in Odessa city, women in rural Odessa and non-resident men were more likely to be recently-infected (OR 1.85, 1.26-2.71 and 2.83, 1.15-6.97, respectively). Reason for test was not associated with recent infection. In sensitivity analysis, after excluding individuals tested due to clinical indications, the proportion recently-infected and the association with age remained virtually unchanged. Our findings suggest a high risk of onward transmission, particularly in younger age groups. These findings highlight the need for tailored prevention strategies and ongoing RITA testing to monitor and evaluate effectiveness of prevention programme
Coinfections by cervical screening test report at enrolment.
<p>Coinfections by cervical screening test report at enrolment.</p
Factors associated with an abnormal finding (LSIL or HSIL) on cervical screening, among women with a test reported at study enrolment.
†<p>Limited to 213 women included in the multivariable model.</p>‡<p>Adjusted a priori for age, previous pregnancies, CD4 count, current smoking, oral contraceptive use, HSV-2 and chlamydia and additionally for BV.</p
Factors associated with having a cervical screening test reported at study enrolment.
†<p>Limited to 870 women included in the multivariable model.</p
Cohort characteristics by cervical screening test report.
†<p>Includes non-cohabiting partnerships;</p>‡<p>Previous pregnancies include still births, live births, miscarriages and terminations. OC, oral hormonal contraceptive.</p
Cardiac myosin activation with omecamtiv mecarbil in systolic heart failure
BACKGROUND The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. METHODS We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. RESULTS During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P = 0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro-B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. CONCLUSIONS Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, NCT02929329; EudraCT number, 2016 -002299-28.)