High Prevalence of Vitamin D Deficiency in Adults Aged 50 Years and Older in Gwangju,Korea: the Dong-gu Study

Vitamin D plays an important role in bone metabolism and maintaining bone health. Recently, new evidence has revealed that vitamin D affects chronic diseases such as autoimmune diseases, cardiovascular diseases and certain cancers. The aim of this study was to evaluate the vitamin D status and the prevalence of vitamin D deficiency in an urban Korean population. This study included 8,976 participants (3,587 men and 5,389 women) aged 50 yr and older. Serum 25(OH)D level was measured by chemiluminescent microparticle immunoassay. The prevalence of vitamin D deficiency [25(OH)D < 20 ng/mL] was 59.7% and 86.5% in men and women, respectively. The prevalence of vitamin D deficiency increased significantly with age in men, but not in women and it decreased from April to July, more prominently in men than in women. These results suggest that sun exposure, intake of vitamin D supplement, and regular physical activities is recommended in an urban Koreans, especially in women.     

Efficacy and Safety of Crofelemer for Noninfectious Diarrhea in HIV-Seropositive Individuals (ADVENT Trial): A Randomized,Double-Blind,Placebo-Controlled,Two-Stage Study

Abstract

Background: HIV-associated diarrhea remains a significant concern with limited treatment options. Objective: To determine the optimal dose, efficacy, and safety of crofelemer for noninfectious diarrhea. Methods: This randomized, double-blind, phase 3 trial used a 2-stage design. Both stages included 2-week screening, 4-week placebo-controlled treatment, and 20-week placebo-free (open-label) extension phases. In stage I, 196 HIV-seropositive patients with chronic diarrhea were randomized to crofelemer 125 mg, 250 mg, or 500 mg or placebo twice daily. Using a prospective analysis, the 125-mg twice-daily dose was selected for stage II. In stage II, 180 new patients were randomized to crofelemer 125 mg twice daily or placebo for 4 weeks. Primary efficacy analysis was the percentage of patients (stages I/II combined) who achieved clinical response (defined as ≤2 watery stools/week during ≥2 of 4 weeks). During the placebo-free extension phase, response (≤2 watery stools) was assessed weekly. Results: Significantly more patients receiving crofelemer 125 mg achieved clinical response versus placebo (17.6% vs 8.0%; one-sided, P = .01). Crofelemer 125 mg resulted in a greater change from baseline in number of daily watery bowel movements (P = .04) and daily stool consistency score (P = .02) versus placebo. During the placebo-free extension phase, percentages of weekly responders ranged from 40% to 56% at weeks 11 to 24. Crofelemer was minimally absorbed, well tolerated, did not negatively impact clinical immune parameters, and had a safety profile comparable to placebo. Conclusions: In HIV-seropositive patients taking stable antiretroviral therapy, crofelemer provided significant improvement in diarrhea with a favorable safety profile.     

Randomized Controlled Trial of Once-Daily Tenofovir,Lamivudine, and Lopinavir/Ritonavir Versus Remaining on the Same Regimen in Virologically Suppressed HIV-Infected Patients on Their First PI-Containing HAART Regimen

Abstract

Purpose: To assess the effects of switching to once-daily (QD) lopinavir/ritonavir (LPV/r)-based combination therapy in HIV-infected patients who are virologically suppressed (HIV viral load <50 copies/mL) on their first protease inhibitor (PI)-containing regimen. Method: In this 48-week, prospective, open-label, randomized study, patients were either switched to once-daily LPV/r, tenofovir (TDF), and lamivudine (3TC) (QD arm) or remained on their existing regimen (control arm). The primary endpoint of the study was the proportion of patients maintaining virologic suppression following 48 weeks of treatment. Results: Fifty and 22 patients were randomized to the QD and control arms, respectively. At week 48, there was no significant difference in virological suppression between the QD and control arms using intent-to-treat (missing = failure) analysis (p = .44). There was no significant difference in discontinuation rates between the two arms (p = .66). Significantly more patients randomized to the QD arm reported gastrointestinal adverse events compared with the control arm (p = .009). There were no study drug-related serious adverse events. Conclusion: For patients who are already virologically suppressed on their first PI-containing regimen, switching to a QD regimen of TDF+3TC+LPV/r resulted in similar rates of virologic suppression when compared with staying on existing therapy.     

Association between Objectively Measured Sleep Quality and Obesity in Community-dwelling Adults Aged 80 Years or Older: A Cross-sectional Study

The purpose of this study was to examine the association between objective measures of sleep quality and obesity in older community-dwelling people. This cross-sectional study included 189 community-dwelling adults aged ≥ 80 yr (83.4 ± 2.5 yr [age range, 80-95 yr]). Participants wore an accelerometer (ActiGraph GT3X+) on their non-dominant wrist 24 hr per day for 7 consecutive nights. Sleep parameters measured included total sleep time, sleep efficiency, and wake after sleep onset (WASO) during the night. Associations between sleep parameters and obesity were investigated by using multivariate logistic regression analysis. In multivariate models, those with sleep efficiency lower than 85% had a 2.85-fold increased odds of obesity, compared with those with sleep efficiency of 85% or higher. Similarly, those with WASO of ≥ 60 min (compared with < 60 min) had a 3.13-fold increased odds of obesity. However, there were no significant associations between total sleep time or self-reported napping duration and obesity. We found that poor sleep quality was an independent risk factor for obesity in community-dwelling Japanese adults aged ≥ 80 yr, even after controlling for potential confounding factors, including daily physical activity.     

A Pilot,Prospective, Open-Label Simplification Study to Evaluate the Safety,Efficacy, and Pharmacokinetics of Once-Daily Lopinavir-Ritonavir Monotherapy in HIV-HCV Coinfected Patients: The MONOCO Study

Abstract

Background: A safe, effective, easy-to-dose antiretroviral therapy that minimizes hepatic complication risk is essential in optimizing HIV-HCV treatment. Nucleoside-sparing boosted protease inhibitor monotherapy may achieve this goal. Methods: A prospective, open-label pilot simplification study of once-daily lopina-vir/ritonavir (LPV/r) monotherapy in HIV-HCV coinfected patients was conducted in patients on HAART with undetectable HIV RNA for ≥6 months. The primary outcome was maintenance of HIV RNA <50 copies/mL through week 48. HIV RNA, immune measures, metabolic markers, and pharmacokinetics were assessed. Results: Twenty participants received once-daily LPV/r monotherapy. Mean baseline age was 46.9 years and CD4 467 cells/L. By per protocol analysis, 71.4% (95% CI, 45.4-88.3) remained on once-daily LPV/r monotherapy with virologic suppression at week 48. Virologic breakthrough (HIV RNA >50 copies/mL on 2 consecutive measures) occurred in 7 patients (mean standard error [SE] time to breakthrough, 38.3 [4.8] weeks). Resuppression occurred with improved adherence in 2 partici-pants and improved adherence plus addition of nucleosides in 2 others. LPV C ^min was <1 mg/L in 8 patients and was associated with virologic breakthrough in 2 cases but with no development of resistance. No clinically significant changes in CD4, lipids, or glucose were noted. Three participants developed transient ≥5-fold liver enzyme elevations. None of 9 severe adverse events were LPV/r- or liver-related. Six discontinued participation for withdrawal of consent (n=1), poor adherence (n=3), or drug intolerance (n=2). Conclusions: Once-daily LPV/r monotherapy in HIV-HCV coinfected individuals offers a safe and effective approach to the management of the HIV infection, with a predictable pharmacokinetic profile.     

New Reference Data on Bone Mineral Density and the Prevalence of Osteoporosis in Korean Adults Aged 50 Years or Older: The Korea National Health and Nutrition Examination Survey 2008-2010

This cross-sectional study was performed to investigate the reference values for bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) and the prevalence of osteoporosis in the Korean population by applying domestic reference data. In total, 25,043 Korean adults ≥20 yr of age (11,792 men and 13,251 women) participated in the study. The BMDs of the total hip, femoral neck, and lumbar spine were measured by DXA (Discovery-W, Hologic Inc.), and subjects with a BMD - 2.5 standard deviations or lower than the mean BMD for young adults (20-29 yr old) were considered to have osteoporosis. When applying the new reference values determined in this study from Korean subjects, the overall prevalence of osteoporosis increased in men aged ≥50 yr compared with that provided by the DXA manufacturer from Japanese subjects (12.2% vs. 7.8%, P<0.001) and decreased in postmenopausal women aged ≥50 yr (32.9% vs. 38.7%, P<0.001). According to the findings of this study, use of the reference values provided by the DXA manufacturer has resulted in the underdiagnosis of osteoporosis in Korean men and the overdiagnosis of osteoporosis in Korean women. Our data will serve as valuable reference standards for the diagnosis and management for osteoporosis in the Korean population.

Graphical Abstract

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Infection with Retroviruses Other Than HIV-1 in Spain: A Retrospective Analysis for HIV-2, HTLV-I,and/or HTLV-II

Abstract

HIV-2, human T-cell lymphotropic virus (HTLV)-I, and HTLV-II infections are currently circulating in Spain with no evidence of an increase in the number of reported cases over time. Up to June 2002, a total of 106, 53, and 460 cases of HIV-2, HTLV-I, and HTLV-II infection, respectively, have been identified in Spain. Most HIV-2-infected and HTLV-I-infected individuals are immigrants who come from endemic areas or are Spaniards with a past history of travel to or sexual contacts with persons originating in those areas. In contrast, HTLV-II infection is mainly limited to native intravenous drug users who are frequently coinfected with HIV-1.     

Why HIV Positive Patients on Antiretroviral Treatment and/or Cotrimoxazole Prophylaxis Use Traditional Medicine: Perceptions of Health Workers,Traditional Healers and Patients: A Study in Two Provinces of South Africa

The study explored the perceptions, knowledge and attitudes of patients, health workers and traditional healers about the use of traditional medicine and Anti Retroviral Therapy (ART). The study explored the perceptions, knowledge and attitudes of patients, health workers and traditional healers about the use of traditional medicine and Anti Retroviral Therapy (ART), using an exploratory qualitative design in two provinces of South Africa: an urban township health facility in the Western Cape, and a rural district hospital in KwaZulu-Natal (KZN) with antennal HIV rate of 32% and 28%''respectively. In-depth interviews were conducted with 14 participants: six HIV patients on ART and using Traditional Medicine(TM), two doctors, two nurses and four traditional healers. Two focus group discussions -one at each site - were held with community health workers who work with HIV-positive patients (Western Cape [5] and in KZN [4]). Patient said to have used Traditional Healing Practices (THP) before they were diagnosed with HIV, and some who have been diagnosed with HIV continue using TM in conjunction with ART and/or Cotrimoxazole prophylaxis. Patients preferred not to disclose THP to health professionals because of lack of support and understanding. Patients utilize THP because of family expectations, privacy and confidentiality, especially when they have not disclosed their HIV status. Healthcare professionals had strong negative opinions about THP, especially for HIV-positive patients. Traditional healers supported the patient''s rationale for THP use. This study revealed a need to better understand factors involved in patients'' choosing to use THP concurrently with ART.     

Multicenter Biologic Assignment Trial Comparing Reduced-Intensity Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients Aged 50 to 75 with Intermediate-2 and High-Risk Myelodysplastic Syndrome: Blood and Marrow Transplant Clinical Trials Network #1102 Study Rationale,Design, and Methods

The introduction of reduced-intensity conditioning (RIC) regimens made it possible to offer allogeneic hematopoietic cell transplantation (alloHCT) to older patients with myelodysplastic syndromes (MDS). However, the relative risks and benefits of alloHCT compared with novel nontransplant therapies continue to be the source of considerable uncertainty. We will perform a prospective biologic assignment trial to compare RIC alloHCT with nontransplant therapies based on donor availability. Primary outcome is 3-year overall survival. Secondary outcomes include leukemia-free survival, quality of life, and cost-effectiveness. Four hundred patients will be enrolled over roughly 3 years. Planned subgroup analyses will evaluate key biologic questions, such as the impact of age and response to hypomethylating agents on treatment effects. Findings from this study potentially may set a new standard of care for older MDS patients who are considered candidates for alloHCT.     

A Phase I/II,Open-Label,Prospective, Multicenter Study to Evaluate the Efficacy and Safety of Lower Doses of Bortezomib Plus Busulfan and Melphalan as a Conditioning Regimen in Patients with Multiple Myeloma Undergoing Autologous Peripheral Blood Stem Cell Transplantation: The KMM103 Study

A phase I/II trial was conducted to explore the safety and activity of the addition of bortezomib on days -6, -3, and +1 relative to the day of autologous stem cell transplantation (ASCT) to a conditioning regimen with busulfan and melphalan (BuMel; 3.2 mg/kg/day busulfan on days -5 to -3 and 140 mg/m²/day melphalan on day -2) in patients with multiple myeloma (MM) following bortezomib-based induction chemotherapy. In phase I, doses of bortezomib (.7, 1.0, and 1.3 mg/m²) with BuMel were administered to groups of 3 patients each. No dose-limiting toxicities were observed. The maximum tolerated dose of bortezomib was 1.3 mg/m²/day. A subsequent cohort with 41 patients was analyzed in a phase II trial to identify safety and efficacy. The phase II trial showed a 75% response rate, including very good partial response (VGPR) or better, and a 55% rate of complete response (CR) at 3 months; For post-transplantation best response, an 83% rate of VGPR or better (68% CR) was observed. With a median follow-up of 31.4 months, the median progression-free survival (PFS) was 26.8 months. The probability of 2 year-PFS was 56.5%, and median overall survival (OS) could not calculated. Specifically, high-risk cytogenetics were associated with adverse survival outcomes compared with standard-risk cytogenetics (median PFS, 12.2 months versus 35.7 months, P = .039; median OS, 26.7 months versus 73.3 months; P = .086). With a median of 11 days to neutrophil engraftment and 10 days for platelet engraftment, no graft failure or delayed engrafting were observed. The most common grade 3 or severe nonhematologic adverse events included neutropenic fever (73.2%) and stomatitis (14.6%). Except for 3 patients with transplantation-related mortality due to sepsis, other adverse events were manageable. These findings demonstrate that bortezomib is safe and has a potential role in conditioning regimens in combination with BuMel for patients with transplantation-eligible MM.