Tests for Chlamydia trachomatis and Neisseria gonorrhoeae, which can provide results rapidly to guide therapeutic decision-making, offer patient care advantages over laboratory-based tests that require several days to provide results. We compared results from the Cepheid GeneXpert CT/NG (Xpert) assay to results from two currently approved nucleic acid amplification assays in 1,722 female and 1,387 male volunteers. Results for chlamydia in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 97.4%, 98.7%, and 97.6%, respectively, and for urine samples from males, a sensitivity of 97.5%, with all specificity estimates being >99.4%. Results for gonorrhea in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 100.0%, 100.0%, and 95.6%, respectively, and for urine samples from males, a sensitivity of 98.0%, with all estimates of specificity being >99.8%. These results indicate that this short-turnaround-time test can be used to accurately test patients and to possibly do so at the site of care, thus potentially improving chlamydia and gonorrhea control efforts. Chlamydia trachomatis and Neisseria gonorrhoeae are the agents of the two most prevalent bacterial sexually transmitted infections (STIs) reported to the Centers for Disease Control and Prevention (CDC), accounting for Ͼ1.6 million reported infections in the United States in 2010 (1). The CDC estimates that STIs cost the health care system $1.5 billion annually. Since these infections, especially chlamydia, are most often asymptomatic, the CDC recommends yearly screening for chlamydia in all sexually active women aged 16 to 25 years. Further, since coinfections are common, most diagnostic test platforms assay for both organisms. Nucleic acid amplification tests (NAATs) are now recommended by the CDC (2) as the tests of choice; however, current NAATs are classified as being of high or moderate complexity and might take 1 to 2 days for results to become available. New assays and new platforms that provide results at the time of patient visits are urgently needed, since many patients do not return for their results when laboratory-based tests that require several days for their results are performed (3, 4).The Cepheid GeneXpert CT/NG (Xpert) assay is a rapid (Ͻ2 h to results) NAAT assay that can be performed in on-site laboratories. The assay detects the DNA of C. trachomatis and N. gonorrhoeae from endocervical, vaginal, and urine specimens of females, as well as from urine specimens of males, from both symptomatic and asymptomatic individuals. The Xpert test is performed using a modular cartridge-based platform for testing each specimen by nucleic acid amplification, and it can process from 1 to 96 specimens in Ͻ2 h with easy-to-use cartridges that minimize processing steps and contamination. This study compares the clinical performance (as measured by sensitivity, specificity, positive predictive value [PPV] and negative predictive value [NPV]) of the Xpert assay to the patient infection status (PIS)...
Abstract-The current study investigated the efficacy and safety of olmesartan medoxomil in children with hypertension, defined as systolic blood pressure measured at or above the 95th percentile (90th percentile for patients with diabetes, glomerular kidney disease, or family history of hypertension) for age, gender, and height while off any antihypertensive medication. The active treatment phase was conducted in 2 periods, with 2 cohorts in each period (cohort A, 62% white; cohort B, 100% Black). In period 1, patients stratified by weight received low-dose (2.5 or 5 mg) or high-dose (20 or 40 mg) olmesartan medoxomil daily for 3 weeks. In period 2, patients maintained their olmesartan medoxomil dose or initiated placebo washout for an additional 2 weeks. Period 1 efficacy results showed a dose-dependent, statistically significant reduction in seated trough systolic and diastolic blood pressure for both cohorts, with mean blood pressure reductions numerically smaller in cohort B than in cohort A. The olmesartan medoxomil dose response remained statistically significant when adjusted for body weight. In period 2, blood pressure control decreased in those patients switching to placebo, whereas patients continuing to receive olmesartan medoxomil therapy maintained consistent blood pressure reduction. Adverse events were generally mild and unrelated to study medication. Olmesartan medoxomil was safe and efficacious in children with hypertension, resulting in significant blood pressure reductions. Key Words: adolescent Ⅲ angiotensin receptor blocker Ⅲ children Ⅲ hypertension Ⅲ olmesartan medoxomil Ⅲ safety H ypertension is an increasingly recognized disease in children and adolescents, yet it often remains undiagnosed and untreated. 1-4 Contributory factors include genetic background and increased childhood obesity, with a longterm health risk of potentially devastating consequences, including target organ damage. 2,3 The genetic component of hypertension is exemplified by a comparatively greater rise in blood pressure (BP) through adolescence for children of parents with hypertension compared with those of parents with normotension. 5 Considering the long-term impact of hypertension on quality of life, morbidity, and mortality, controlling BP to recommended levels is imperative in children. A major consequence of untreated pediatric hypertension is the development of left ventricular hypertrophy, which has been reported in more than 40% of children with hypertension. 6 However, the current management of pediatric hypertension is inadequate. As recently highlighted by the Chronic Kidney Disease in Children study, 37% of children with chronic kidney disease were diagnosed with elevated BP, and yet 39% of these were not receiving antihypertensive medication. 4 The goal of treatment in pediatric hypertension is to reduce BP below the 95th percentile for age, gender, and height or below the 90th percentile for those patients with comorbidity. 1 Lifestyle modifications, including a lowsodium diet, increased exercise, and ...
Abstract-We evaluated the efficacy, safety, and dose-response relationship of fosinopril in children aged 6 to 16 years with hypertension or high-normal blood pressure with an associated medical condition requiring treatment. The study was a prospective, double-blind, placebo-controlled trial conducted in 78 clinical sites in the United States, Russia, and Israel. There were 4 phases: a screening phase of 10 days maximum, a 4-week dose-response phase, a placebo withdrawal phase of 2 weeks maximum, and a 52-week open-label safety phase. The primary objective of the dose-response phase was to determine whether low (0.1 mg/kg), medium (0.3 mg/kg), or high (0.6 mg/kg) doses of fosinopril based on established adult dosing affect trough seated systolic blood pressure. During the dose-response phase, all 3 doses were equally effective in lowering systolic blood pressure. During the placebo withdrawal phase, there was an adjusted mean systolic blood pressure increase of 5.2 mm Hg for the placebo group and 1.5 mm Hg for the fosinopril group, a net withdrawal effect of 3.7 mm Hg (Pϭ0.013). Fosinopril was well tolerated; serious adverse events occurred infrequently and were generally not attributed to fosinopril. Because children appear to be more sensitive to lower doses of fosinopril than adults, starting doses for children should be Յ0.1 mg/kg.
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