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A new fixed-dose combination (FDC) formulation of raloxifene 60 mg and cholecalciferol 800 IU was developed to improve the medication compliance and overall efficacy of raloxifene treatment in postmenopausal osteoporosis patients. The aim of this study was to compare the pharmacokinetics between two tablets of FDC formulation of raloxifene/cholecalciferol and the two products administered concomitantly at respective doses. This randomized, open-label, single-dose, two-treatment, two-way crossover study included 46 volunteers. During each treatment period, subjects received the test formulation (FDC formulation containing raloxifene and cholecalciferol) or the reference formulation (co-administration of raloxifene and cholecalciferol), with a 14-d washout period. Serial blood samples were collected periodically over 96 hours after drug intake. In total, 46 subjects completed the study. The geometric mean ratios and its 90% confidence intervals of the FDC to the single agents for the area under the concentration-time curve from zero to the last quantifiable time point and the maximum plasma concentration met the regulatory criteria for bioequivalence: 1.1364 (1.0584–1.2201) and 1.1010 (0.9945–1.2188) for raloxifene and 1.0266 (0.9591–1.0989) and 1.0354 (0.9816–1.0921) for baseline-corrected cholecalciferol, respectively. Both formulations were well tolerated. No significant differences was observed in the incidence of adverse events between the two treatments. It was concluded that two tablets of the newly developed FDC formulation of raloxifene and cholecalciferol and the corresponding two agents administered concomitantly at respective doses were bioequivalent.
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Objectives@#Along with the exponentially-growing data produced and accumulated every day through mobile platforms, social networking services, the Internet, and other media, information is becoming increasingly important as a strategic resource. This report presents specific and clear directions and suggests empirical project plans regarding innovations in regional health information systems to promote the utilization of medical information. @*Methods@#We reviewed and examined documents about global trends and examples of regional health information systems. The problems and solutions of health information utilization and regional health information systems in Korea were analyzed. @*Results@#This study presented examples of the establishment of health information systems, problems in the use of local healthcare information, and an empirical project for improvement. @*Conclusions@#The results of this study imply the need for long-term and systematic approaches for the use of medical information and the establishment of a local healthcare information system, along with implementation plans. As a first step, it is imperative to clarify the goal of building a medical information system, the information that must be provided to build the system, and the data that should be collected to provide such information, while moving away from the mentality of focusing on technology-oriented medical information services. In addition, it is necessary to consider information governance, data-based service development, and the medical innovation framework, which are ways to efficiently manage, utilize, and systemize the data to be collected.
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Objectives@#Along with the exponentially-growing data produced and accumulated every day through mobile platforms, social networking services, the Internet, and other media, information is becoming increasingly important as a strategic resource. This report presents specific and clear directions and suggests empirical project plans regarding innovations in regional health information systems to promote the utilization of medical information. @*Methods@#We reviewed and examined documents about global trends and examples of regional health information systems. The problems and solutions of health information utilization and regional health information systems in Korea were analyzed. @*Results@#This study presented examples of the establishment of health information systems, problems in the use of local healthcare information, and an empirical project for improvement. @*Conclusions@#The results of this study imply the need for long-term and systematic approaches for the use of medical information and the establishment of a local healthcare information system, along with implementation plans. As a first step, it is imperative to clarify the goal of building a medical information system, the information that must be provided to build the system, and the data that should be collected to provide such information, while moving away from the mentality of focusing on technology-oriented medical information services. In addition, it is necessary to consider information governance, data-based service development, and the medical innovation framework, which are ways to efficiently manage, utilize, and systemize the data to be collected.
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This study compared the pharmacokinetics of a fixed-dose combination (FDC) of candesartan (16 mg) and amlodipine (10 mg) versus coadministration of individual formulations to clarify the bioequivalence of the FDC. In this randomized, open-label, single-dose, 2-treatment, 2-way crossover study, healthy Korean volunteers received a single dose of candesartan (16 mg) with amlodipine (10 mg) as either an FDC or single agents concomitantly administered, with a 2-week washout period. Serial blood samples were collected up to 72 hours after dosing for each treatment period, and plasma concentrations of candesartan and amlodipine were measured using a validated liquid chromatography-tandem mass spectrometry method. A total of 39 subjects completed the study. The geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for the area under the plasma concentration-time curve from time 0 to the last measurement (AUC0-t) and the peak plasma concentration (Cmax) for candesartan were 1.0182 (0.9562–1.0841) and 0.9492 (0.8726–1.0324), respectively. The GMR and 90% CI for the AUC0-t and Cmax for amlodipine were 1.0552 (1.0255–1.0857) and 1.0668 (1.0259–1.1094), respectively. In conclusion, the new FDC formulation of candesartan (16 mg) and amlodipine (10 mg) was bioequivalent to the concomitant administration of single agents. A single dose of candesartan/amlodipine as the FDC or as single agents was well tolerated.
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Background@#Sleep is an important physiological process that is required to perform daily functions. Sleep duration is reported to be correlated withobesity. This study investigated the association between sleep duration and abdominal obesity in Korean adult male. @*Methods@#We used data from the seventh Korean National Health and Nutrition Examination Survey conducted during 2016–2017. In total, 3,997 maleaged >20 years were included. The frequency and weighting percentage of sleep duration were calculated. Chi-square test was performed withRao–Scott calibration. Logistic regression was performed to evaluate the association of sleep duration with abdominal obesity. @*Results@#The overall effect of abdominal obesity on sleep duration was significant. The probability of developing abdominal obesity when the averagesleep duration was below than 5 hours was 1.495 times higher than that when it was 7 hours. @*Conclusion@#Sleep duration was related to abdominal obesity in Korean adult male.
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BACKGROUND: The purpose of this study was to analyze the socioeconomic factors that affect atherosclerotic cardiovascular disease risk.METHODS: We used data from 3,704 individuals between 40 and 79 years of age, who participated in the Korean National Health Examination and Nutrition Survey in 2016. Socioeconomic groups were categorized by income and education level. We analyzed the odds ratios and 95% confidence intervals (CIs) from logistic regression for the atherosclerotic cardiovascular disease risk in each group.RESULTS: Using logistic regression analysis, the odds ratios and 95% CIs of atherosclerotic cardiovascular disease risk based on high, middle, and low socioeconomic factors were 1.0, 1.597 (95% CI, 1.279–1.993), and 5.689 (95% CI, 4.030–8.032), respectively. The results after adjusting for covariates (age, gender, obesity, alcohol consumption) also showed statistical significance.CONCLUSION: We conclude that socioeconomic factors such as income and education level are correlated with increased atherosclerotic cardiovascular disease risk.
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Doenças Cardiovasculares , Educação , Coreia (Geográfico) , Modelos Logísticos , Inquéritos Nutricionais , Obesidade , Razão de Chances , Fatores SocioeconômicosRESUMO
BACKGROUND: Olmesartan medoxomil is an angiotensin II receptor blocker commonly used in hypertension. First objective of this study was to evaluate the bioequivalence of two olmesartan formulations, Olmesartan 20 mg and 40 mg tablet (Yuhan, Pharmaceutical Corp. Seoul, Korea) as test drugs and Olmetec(R) 20 mg and 40 mg tablet (Daewoong, Pharmaceutical Corp. Seoul, Korea) as reference drugs. Second objective of this study was to evaluate the dose-proportionality of two formulations. METHODS: Two studies (20 mg, 40 mg) were conducted as a randomized, open-label, 2-period, crossover design. Each subject received one 20 mg or 40 mg tablet of the reference or test formulation of olmesartan medoxomil in each study. Blood samples were obtained during the 48-hour period after the dose in each treatment period. Wash-out period was 1 week in each study. Concentrations of olmesartan medoxomil in plasma were analyzed using a liquid chromatography system with tandem mass-spectrometric detection (LC/MS/MS). The primary pharmacokinetic parameters were Cmax (maximum concentration) and AUCt (area under the concentration-time curve from time 0 to the last sampling time). RESULTS: A total number of 40 healthy male volunteers participated in the study and 37 volunteers completed both treatment periods in 20 mg trial. All 40 participants completed both treatment periods in 40 mg trial. The 90 % CIs for the geometric mean ratios of the pharmacokinetic parameters (test:reference drug) were 0.93 ~ 1.04 for AUCt and 0.97 ~ 1.08 for Cmax in 20 mg trial. The 90 CIs were 0.94 ~ 1.02 for AUCt and 1.00 ~ 1.11 for Cmax in 40 mg trial. All parameters of two studies satisfy the range of bioequivalence criterion. CONCLUSION: The obtained results indicated that pharmacokinetic exposure to Olmesartan 20 mg and 40 mg tablet was bioequivalent to that of Olmetec(R) 20 mg and 40 mg tablet, respectively.
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Humanos , Masculino , Cromatografia Líquida , Estudos Cross-Over , Hipertensão , Imidazóis , Plasma , Receptores de Angiotensina , Tetrazóis , Equivalência TerapêuticaRESUMO
PURPOSE: A simple, rapid, and highly sensitive analytical method for Gb3 in plasma was developed without labor-extensive pre-treatment by electrospray ionization MS/MS (ESI-MS/MS). Measurement of globotriaosylceramide (Gb3, ceramide trihexoside) in plasma has clinical importance for monitoring after enzyme replacement therapy in Fabry disease patients. The disease is an X-linked lipid storage disorder that results from a deficiency of the enzyme ??-galactosidase A (alpha-Gal A). The lack of alpha-Gal A causes an intracellular accumulation of glycosphingolipids, mainly Gb3. METHODS: Only simple 50-fold dilution of plasma is necessary for the extraction and isolation of Gb3 in plasma. Gb3 in diluted plasma was dissolved in dioxane containing C17:0 Gb3 as an internal standard. After centrifugation it was directly injected and analyzed through guard column by in combination with multiple reaction monitoring mode of ESI-MS/MS. RESULTS: Eight isoforms of Gb3 were completely resolved from plasma matrix. C16:0 Gb3 occupied 50% of total Gb3 as a major component in plasma. Linear relationship for Gb3 isoforms was found in the range of 0.001-1.0 microgram/mL. The limit of detection (S/N=3) was 0.001 microgram/mL and limit of quantification was 0.01 microgram/mL for C16:0 Gb3 with acceptable precision and accuracy. Correlation coefficient of calibration curves for 8 Gb3 isoforms ranged from 0.9678 to 0.9982. CONCLUSION: This quantitative method developed could be useful for rapid and sensitive 1st line Fabry disease screening, monitoring and/or diagnostic tool for Fabry disease.