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  1. Choi Y, Chang Y, Ryu S, Cho J, Rampal S, Zhang Y, et al.
    Heart, 2015 May;101(9):686-91.
    PMID: 25732752 DOI: 10.1136/heartjnl-2014-306663
    To investigate the association between regular coffee consumption and the prevalence of coronary artery calcium (CAC) in a large sample of young and middle-aged asymptomatic men and women.
  2. Zhao D, Kim MH, Pastor-Barriuso R, Chang Y, Ryu S, Zhang Y, et al.
    PLoS One, 2016;11(1):e0146057.
    PMID: 26731527 DOI: 10.1371/journal.pone.0146057
    IMPORTANCE: Intraocular pressure (IOP) reduction or stabilization is the only proven method for glaucoma management. Identifying risk factors for IOP is crucial to understand the pathophysiology of glaucoma.

    OBJECTIVE: To examine the associations of change in body mass index (BMI), waist circumference, and percent fat mass with change in intraocular pressure (IOP) in a large sample of Korean adults.

    DESIGN, SETTING AND PARTICIPANTS: Cohort study of 274,064 young and middle age Korean adults with normal fundoscopic findings who attended annual or biennial health exams from January 1, 2002 to Feb 28, 2010 (577,981 screening visits).

    EXPOSURES: BMI, waist circumference, and percent fat mass.

    MAIN OUTCOME MEASURE(S): At each visit, IOP was measured in both eyes with automated noncontact tonometers.

    RESULTS: In multivariable-adjusted models, the average increase in IOP (95% confidence intervals) over time per interquartile increase in BMI (1.26 kg/m2), waist circumference (6.20 cm), and percent fat mass (3.40%) were 0.18 mmHg (0.17 to 0.19), 0.27 mmHg (0.26 to 0.29), and 0.10 mmHg (0.09 to 0.11), respectively (all P < 0.001). The association was stronger in men compared to women (P < 0.001) and it was only slightly attenuated after including diabetes and hypertension as potential mediators in the model.

    CONCLUSIONS AND RELEVANCE: Increases in adiposity were significantly associated with an increase in IOP in a large cohort of Korean adults attending health screening visits, an association that was stronger for central obesity. Further research is needed to understand better the underlying mechanisms of this association, and to establish the role of weight gain in increasing IOP and the risk of glaucoma and its complications.

  3. Zhao D, Kim MH, Pastor-Barriuso R, Chang Y, Ryu S, Zhang Y, et al.
    Invest Ophthalmol Vis Sci, 2014 Oct;55(10):6244-50.
    PMID: 25183763 DOI: 10.1167/iovs.14-14151
    To examine the longitudinal association between age and intraocular pressure (IOP) in a large sample of Korean men and women.
  4. Zhang Y, Chang Y, Ryu S, Cho J, Lee WY, Rhee EJ, et al.
    J Clin Endocrinol Metab, 2014 Jul;99(7):2467-76.
    PMID: 24708095 DOI: 10.1210/jc.2013-3832
    CONTEXT: Hyperthyroidism and hypothyroidism, both overt and subclinical, are associated with all-cause and cardiovascular mortality. The association between thyroid hormones and mortality in euthyroid individuals, however, is unclear.
    OBJECTIVE: To examine the prospective association between thyroid hormones levels within normal ranges and mortality endpoints.
    SETTING AND DESIGN: A prospective cohort study of 212 456 middle-aged South Korean men and women who had normal thyroid hormone levels and no history of thyroid disease at baseline from January 1, 2002 to December 31, 2009. Free T4 (FT4), free T3 (FT3), and TSH levels were measured by RIA. Vital status and cause of death ascertainment were based on linkage to the National Death Index death certificate records.
    RESULTS: After a median follow-up of 4.3 years, 730 participants died (335 deaths from cancer and 112 cardiovascular-related deaths). FT4 was inversely associated with all-cause mortality (HR = 0.77, 95% confidence interval 0.63-0.95, comparing the highest vs lowest quartile of FT4; P for linear trend = .01), and FT3 was inversely associated cancer mortality (HR = 0.62, 95% confidence interval 0.45-0.85; P for linear trend = .001). TSH was not associated with mortality endpoints.
    CONCLUSIONS: In a large cohort of euthyroid men and women, FT4 and FT3 levels within the normal range were inversely associated with the risk of all-cause mortality and cancer mortality, particularly liver cancer mortality.
  5. Chang Y, Kim BK, Yun KE, Cho J, Zhang Y, Rampal S, et al.
    J Am Coll Cardiol, 2014 Jun 24;63(24):2679-86.
    PMID: 24794119 DOI: 10.1016/j.jacc.2014.03.042
    The purpose of this study was to compare the coronary artery calcium (CAC) scores of metabolically-healthy obese (MHO) and metabolically healthy normal-weight individuals in a large sample of apparently healthy men and women.
  6. Cainzos-Achirica M, Rampal S, Chang Y, Ryu S, Zhang Y, Zhao D, et al.
    Atherosclerosis, 2015 Aug;241(2):350-6.
    PMID: 26071657 DOI: 10.1016/j.atherosclerosis.2015.05.031
    OBJECTIVE: To evaluate the association between brachial-ankle pulse wave velocity (baPWV), a convenient, non-radiating, readily available measurement of arterial stiffness, and coronary artery calcium (CAC), a reliable marker of coronary atherosclerosis, in a large sample of young and middle-aged asymptomatic adults; and to assess the incremental value of baPWV for detecting prevalent CAC beyond traditional risk factors.
    METHODS: Cross-sectional study of 15,185 asymptomatic Korean adults who voluntarily underwent a comprehensive health screening program including measurement of baPWV and CAC. BaPWV was measured using an oscillometric method with cuffs placed on both arms and ankles. CAC burden was assessed using a multi-detector CT scan and scored following Agatston's method.
    RESULTS: The prevalence of CAC > 0 and CAC > 100 increased across baPWV quintiles. The multivariable-adjusted odds ratios (95% CI) for CAC > 0 comparing baPWV quintiles 2-5 versus quintile 1 were 1.06 (0.87-1.30), 1.24 (1.02-1.50), 1.39 (1.15-1.69) and 1.60 (1.31-1.96), respectively (P trend < 0.001). Similarly, the relative prevalence ratios for CAC > 100 were 1.30 (0.74-2.26), 1.59 (0.93-2.71), 1.74 (1.03-2.94) and 2.59 (1.54-4.36), respectively (P trend < 0.001). For CAC > 100, the area under the ROC curve for baPWV alone was 0.71 (0.68-0.74), and the addition of baPWV to traditional risk factors significantly improved the discrimination and calibration of models for detecting prevalent CAC > 0 and CAC > 100.
    CONCLUSIONS: BaPWV was independently associated with the presence and severity of CAC in a large sample of young and middle-aged asymptomatic adults. BaPWV may be a valuable tool for identifying apparently low-risk individuals with increased burden of coronary atherosclerosis.
    KEYWORDS: Arterial stiffness; Atherosclerosis; Coronary artery calcium; Pulse wave velocity; Subclinical disease
  7. Choi Y, Chang Y, Lee JE, Chun S, Cho J, Sung E, et al.
    Atherosclerosis, 2015 Aug;241(2):305-12.
    PMID: 26062990 DOI: 10.1016/j.atherosclerosis.2015.05.036
    OBJECTIVE:
    The association of egg consumption with subclinical coronary atherosclerosis remains unknown. Our aim was to examine the association between egg consumption and prevalence of coronary artery calcium (CAC).
    METHODS:
    Cross-sectional study of 23,417 asymptomatic adult men and women without a history of cardiovascular disease (CVD) or hypercholesterolemia, who underwent a health screening examination including cardiac computed tomography for CAC scoring and completed a validated food frequency questionnaire at the Kangbuk Samsung Hospital Total Healthcare Centers, South Korea (March 2011-April 2013).
    RESULTS:
    The prevalence of detectable CAC (CAC score > 0) was 11.2%. In multivariable-adjusted models, CAC score ratio (95% confidence interval [CI]) comparing participants eating ≥ 7 eggs/wk to those eating < 1 egg/wk was 1.80 (1.14-2.83; P for trend = 0.003). The multivariable CAC score ratio (95% CI) associated with an increase in consumption of 1 egg/day was 1.54 (1.11-2.14). The positive association seemed to be more pronounced among participants with low vegetable intake (P for interaction = 0.02) and those with high BMI (P for interaction = 0.05). The association was attenuated and no longer significant after further adjustment for dietary cholesterol.
    CONCLUSION:
    Egg consumption was associated with an increased prevalence of subclinical coronary atherosclerosis and with a greater degree of coronary calcification in asymptomatic Korean adults, which may be mediated by dietary cholesterol. The association was particularly pronounced among individuals with low vegetable intake and those with high BMI.
    KEYWORDS:
    Coronary artery calcium score; Coronary artery disease; Egg consumption
  8. Zhang Y, Kim BK, Chang Y, Ryu S, Cho J, Lee WY, et al.
    Arterioscler Thromb Vasc Biol, 2014 Sep;34(9):2128-34.
    PMID: 25060795 DOI: 10.1161/ATVBAHA.114.303889
    OBJECTIVE: Overt and subclinical hypothyroidism are risk factors for atherosclerosis. It is unclear whether thyroid hormone levels within the normal range are also associated with atherosclerosis measured by coronary artery calcium (CAC).
    APPROACH AND RESULTS: We conducted a cross-sectional study of 41 403 apparently healthy young and middle-aged men and women with normal thyroid hormone levels. Free thyroxin, free triiodothyronine, and thyroid-stimulating hormone levels were measured by electrochemiluminescent immunoassay. CAC score was measured by multidetector computed tomography. The multivariable adjusted CAC ratios comparing the highest versus the lowest quartile of thyroid hormones were 0.74 (95% confidence interval, 0.60-0.91; P for trend <0.001) for free thyroxin, 0.81 (0.66-1.00; P for trend=0.05) for free triiodothyronine, and 0.78 (0.64-0.95; P for trend=0.01) for thyroid-stimulating hormone. Similarly, the odds ratios for detectable CAC (CAC >0) comparing the highest versus the lowest quartiles of thyroid hormones were 0.87 (0.79-0.96; P for linear trend <0.001) for free thyroxin, 0.90 (0.82-0.99; P for linear trend=0.02) for free triiodothyronine, and 0.91 (0.83-1.00; P for linear trend=0.03) for thyroid-stimulating hormone.
    CONCLUSIONS: In a large cohort of apparently healthy young and middle-aged euthyroid men and women, low-normal free thyroxin and thyroid-stimulating hormone were associated with a higher prevalence of subclinical coronary artery disease and with a greater degree of coronary calcification.
    KEYWORDS: thyroid hormones; thyrotropin; thyroxine; triiodothyronine
  9. Yun KE, Chang Y, Rampal S, Zhang Y, Cho J, Jung HS, et al.
    J Clin Gastroenterol, 2018 07;52(6):508-514.
    PMID: 28471937 DOI: 10.1097/MCG.0000000000000824
    GOALS: Because of shared risk factors between clinically manifest cardiovascular disease and colorectal cancer, we hypothesized the coexistence of subclinical atherosclerosis measured by coronary artery calcium (CAC) and colorectal adenoma (CRA) and that these 2 processes would also share common risk factors.

    BACKGROUND: No study has directly compared the risk factors associated with subclinical coronary atherosclerosis and CRA.

    STUDY: This was a cross-sectional study using multinomial logistic regression analysis of 4859 adults who participated in a health screening examination (2010 to 2011; analysis 2014 to 2015). CAC scores were categorized as 0, 1 to 100, or >100. Colonoscopy results were categorized as absent, low-risk, or high-risk CRA.

    RESULTS: The prevalence of CAC>0, CAC 1 to 100 and >100 was 13.0%, 11.0%, and 2.0%, respectively. The prevalence of any CRA, low-risk CRA, and high-risk CRA was 15.1%, 13.0%, and 2.1%, respectively. The adjusted odds ratios (95% confidence interval) for CAC>0 comparing participants with low-risk and high-risk CRA with those without any CRA were 1.35 (1.06-1.71) and 2.09 (1.29-3.39), respectively. Similarly, the adjusted odds ratios (95% confidence interval) for any CRA comparing participants with CAC 1 to 100 and CAC>100 with those with no CAC were 1.26 (1.00-1.6) and 2.07 (1.31-3.26), respectively. Age, smoking, diabetes, and family history of CRC were significantly associated with both conditions.

    CONCLUSIONS: We observed a graded association between CAC and CRA in apparently healthy individuals. The coexistence of both conditions further emphasizes the need for more evidence of comprehensive approaches to screening and the need to consider the impact of the high risk of coexisting disease in individuals with CAC or CRA, instead of piecemeal approaches restricted to the detection of each disease independently.

  10. Hong YS, Chang Y, Ryu S, Cainzos-Achirica M, Kwon MJ, Zhang Y, et al.
    Sci Rep, 2017 07 04;7(1):4606.
    PMID: 28676706 DOI: 10.1038/s41598-017-04206-6
    The role of hepatitis virus infection in glucose homeostasis is uncertain. We examined the associations between hepatitis B virus (HBV) or hepatitis C virus (HCV) infection and the development of diabetes in a cohort (N = 439,708) of asymptomatic participants in health screening examinations. In cross-sectional analyses, the multivariable-adjusted odds ratio for prevalent diabetes comparing hepatitis B surface antigen (HBsAg) (+) to HBsAg (-) participants was 1.17 (95% CI 1.06-1.31; P = 0.003). The corresponding odds ratio comparing hepatitis C antibodies (HCV Ab) (+) to HCV Ab (-) participants was 1.43 (95% CI 1.01-2.02, P = 0.043). In prospective analyses, the multivariable-adjusted hazard ratio for incident diabetes comparing HBsAg (+) to HbsAg (-) participants was 1.23 (95% CI 1.08-1.41; P = 0.007). The number of incident cases of diabetes among HCV Ab (+) participants (10 cases) was too small to reliably estimate the prospective association between HCV infection and diabetes. In this large population at low risk of diabetes, HBV and HCV infections were associated with diabetes prevalence and HBV infection with the risk of incident diabetes. Our studies add evidence suggesting that diabetes is an additional metabolic complication of HBV and HCV infection.
  11. Hong YS, Jung KU, Rampal S, Zhao D, Guallar E, Ryu S, et al.
    Sci Rep, 2022 01 07;12(1):129.
    PMID: 34996957 DOI: 10.1038/s41598-021-03838-z
    Hemorrhoidal disease is a highly prevalent anorectal condition causing substantial discomfort, disability, and decreased quality of life. Evidence on preventable risk factors for hemorrhoidal disease is limited. We conducted a cross-sectional study of 194,620 healthy men and women who completed a health screening exam including colonoscopy in 2011-2017. We evaluated potential risk factors of hemorrhoidal disease, including lifestyle factors, medical history, birth history, gastrointestinal symptoms, and anthropometric measurements. The prevalence of hemorrhoidal disease was 16.6%, and it was higher in females than in males (17.2 vs. 16.3%; P 
  12. Chun S, Choi Y, Chang Y, Cho J, Zhang Y, Rampal S, et al.
    Am Heart J, 2016 07;177:17-24.
    PMID: 27297845 DOI: 10.1016/j.ahj.2016.03.018
    BACKGROUND: Sugar-sweetened carbonated beverage consumption has been linked to obesity, metabolic syndrome, type 2 diabetes, and clinically manifest coronary heart disease, but its association with subclinical coronary heart disease remains unclear. We investigated the relationship between sugar-sweetened carbonated beverage consumption and coronary artery calcium (CAC) in a large study of asymptomatic men and women.

    METHODS: This was a cross-sectional study of 22,210 adult men and women who underwent a comprehensive health screening examination between 2011 and 2013 (median age 40 years). Sugar-sweetened carbonated beverage consumption was assessed using a validated food frequency questionnaire, and CAC was measured by cardiac computed tomography. Multivariable-adjusted CAC score ratios and 95% CIs were estimated from robust Tobit regression models for the natural logarithm (CAC score +1).

    RESULTS: The prevalence of detectable CAC (CAC score >0) was 11.7% (n = 2,604). After adjustment for age; sex; center; year of screening examination; education level; physical activity; smoking; alcohol intake; family history of cardiovascular disease; history of hypertension; history of hypercholesterolemia; and intake of total energy, fruits, vegetables, and red and processed meats, only the highest category of sugar-sweetened carbonated beverage consumption was associated with an increased CAC score compared with the lowest consumption category. The multivariable-adjusted CAC ratio comparing participants who consumed ≥5 sugar-sweetened carbonated beverages per week with nondrinkers was 1.70 (95% CI, 1.03-2.81). This association did not differ by clinical subgroup, including participants at low cardiovascular risk.

    CONCLUSION: Our findings suggest that high levels of sugar-sweetened carbonated beverage consumption are associated with a higher prevalence and degree of CAC in asymptomatic adults without a history of cardiovascular disease, cancer, or diabetes.

  13. Choi Y, Chang Y, Ryu S, Cho J, Kim MK, Ahn Y, et al.
    Am J Cardiol, 2015 Aug 15;116(4):520-6.
    PMID: 26073677 DOI: 10.1016/j.amjcard.2015.05.005
    The relation between glycemic index, glycemic load, and subclinical coronary atherosclerosis is unknown. The aim of the study was to evaluate the associations between energy-adjusted glycemic index, glycemic load, and coronary artery calcium (CAC). This study was cross-sectional analysis of 28,429 asymptomatic Korean men and women (mean age 41.4 years) without a history of diabetes or cardiovascular disease. All participants underwent a health screening examination between March 2011 and April 2013, and dietary intake over the preceding year was estimated using a validated food frequency questionnaire. Cardiac computed tomography was used for CAC scoring. The prevalence of detectable CAC (CAC score >0) was 12.4%. In multivariable-adjusted models, the CAC score ratios (95% confidence intervals) comparing the highest to the lowest quintile of glycemic index and glycemic load were 1.74 (1.08 to 2.81; p trend = 0.03) and 3.04 (1.43 to 6.46; p trend = 0.005), respectively. These associations did not differ by clinical subgroups, including the participants at low cardiovascular risk. In conclusion, these findings suggest that high dietary glycemic index and glycemic load were associated with a greater prevalence and degree of CAC, with glycemic load having a stronger association.
  14. Kim CW, Chang Y, Zhao D, Cainzos-Achirica M, Ryu S, Jung HS, et al.
    Arterioscler Thromb Vasc Biol, 2015 Oct;35(10):2238-45.
    PMID: 26359509 DOI: 10.1161/ATVBAHA.115.306110
    OBJECTIVE: Short and long sleep duration are associated with increased risk of clinical cardiovascular events, but the association between sleep duration and subclinical cardiovascular disease is not well established. We examined the association between sleep duration and sleep quality with coronary artery calcification (CAC) and with brachial-ankle pulse wave velocity (PWV) in a large sample of young and middle-aged asymptomatic adults.
    APPROACH AND RESULTS: We conducted a cross-sectional study of adult men and women who underwent a health checkup examination, including assessment of sleep duration and quality and coupled with either CAC (n=29 203) or brachial-ankle PWV (n=18 106). The multivariate-adjusted CAC score ratios (95% confidence interval) comparing sleep durations of ≤5, 6, 8, and ≥9 hours with 7 hours of sleep were 1.50 (1.17-1.93), 1.34 (1.10-1.63), 1.37 (0.99-1.89), and 1.72 (0.90-3.28), respectively (P for quadratic trend=0.002). The corresponding average differences in brachial-ankle PWV were 6.7 (0.75-12.6), 2.9 (-1.7 to 7.4), 10.5 (4.5-16.5), and 9.6 (-0.7 to 19.8) cm/s, respectively (P for quadratic trend=0.019). Poor subjective sleep quality was associated with CAC in women but not in men, whereas the association between poor subjective sleep quality and brachial-ankle PWV was stronger in men than in women.
    CONCLUSIONS: In this large study of apparently healthy men and women, extreme sleep duration and poor subjective sleep quality were associated with increased prevalence of CAC and higher PWV. Our results underscore the importance of an adequate quantity and quality of sleep to maintain cardiovascular health.
    KEYWORDS: coronary calcification; pulse wave velocity; sleep duration; sleep quality; subclinical atherosclerosis
  15. Gaffney D, Small B, Kitchener H, Young Ryu S, Viswanathan A, Trimble T, et al.
    Int. J. Gynecol. Cancer, 2016 Nov;26(9):1690-1693.
    PMID: 30814204 DOI: 10.1097/IGC.0000000000000823
    Eighty-seven percent of cervix cancer occurs in less-developed regions of the world, and there is up to an 18-fold difference in mortality rate for cervix cancer depending on the region of the world. The Cervix Cancer Research Network (CCRN) was founded through the Gynecologic Cancer InterGroup with the aim of improving access to clinical trials in cervix cancer worldwide, and in so doing improving standards of care. The CCRN recently held its first international educational symposium in Bangkok. Sixty-two participants attended from 16 different countries including Pakistan, India, Bangladesh, Thailand, Malaysia, Singapore, Philippines, Taiwan, China, Vietnam, Korea, Japan, Columbia, Brazil, Canada, and the United States. The focus of this symposium was to evaluate progress, to promote new clinical trials for the CCRN, and to provide education regarding the role of brachytherapy in the treatment of cervical cancer.
  16. Gaffney D, Small B, Kitchener H, Young Ryu S, Viswanathan A, Trimble T, et al.
    Int. J. Gynecol. Cancer, 2016 11;26(9):1690-1693.
    PMID: 27779548
    Eighty-seven percent of cervix cancer occurs in less-developed regions of the world, and there is up to an 18-fold difference in mortality rate for cervix cancer depending on the region of the world. The Cervix Cancer Research Network (CCRN) was founded through the Gynecologic Cancer InterGroup with the aim of improving access to clinical trials in cervix cancer worldwide, and in so doing improving standards of care. The CCRN recently held its first international educational symposium in Bangkok. Sixty-two participants attended from 16 different countries including Pakistan, India, Bangladesh, Thailand, Malaysia, Singapore, Philippines, Taiwan, China, Vietnam, Korea, Japan, Columbia, Brazil, Canada, and the United States. The focus of this symposium was to evaluate progress, to promote new clinical trials for the CCRN, and to provide education regarding the role of brachytherapy in the treatment of cervical cancer.
  17. Chang Y, Jung HS, Cho J, Zhang Y, Yun KE, Lazo M, et al.
    Am J Gastroenterol, 2016 08;111(8):1133-40.
    PMID: 27185080 DOI: 10.1038/ajg.2016.178
    OBJECTIVES: The risk of nonalcoholic fatty liver disease (NAFLD) among obese individuals without obesity-related metabolic abnormalities, a condition referred to as metabolically healthy obese (MHO), is largely unexplored. Therefore, we examined the association between body mass index (BMI) categories and the development of NAFLD in a large cohort of metabolically healthy men and women.

    METHODS: A cohort study was conducted in 77,425 men and women free of NAFLD and metabolic abnormalities at baseline, who were followed-up annually or biennially for an average of 4.5 years. Being metabolically healthy was defined as not having any metabolic syndrome component and having a homeostasis model assessment of insulin resistance <2.5. The presence of fatty liver was determined using ultrasound.

    RESULTS: During 348,193.5 person-years of follow-up, 10,340 participants developed NAFLD (incidence rate, 29.7 per 1,000 person-years). The multivariable adjusted hazard ratios (95% confidence intervals) for incident NAFLD comparing overweight and obese with normal-weight participants were 2.15 (2.06-2.26) and 3.55 (3.37-3.74), respectively. In detailed dose-response analyses, increasing baseline BMI showed a strong and approximately linear relationship with the incidence of NAFLD, with no threshold at no risk. This association was present in both men and women, although it was stronger in women (P for interaction <0.001), and it was evident in all clinically relevant subgroups evaluated, including participants with low inflammation status.

    CONCLUSIONS: In a large cohort of strictly defined metabolically healthy men and women, overweight and obesity were strongly and progressively associated with an increased incidence of NAFLD, suggesting that the obese phenotype per se, regardless of metabolic abnormalities, can increase the risk of NAFLD.

  18. Cho Y, Chang Y, Choi HR, Kang J, Kwon R, Lim GY, et al.
    Nutrients, 2022 Jul 08;14(14).
    PMID: 35889762 DOI: 10.3390/nu14142805
    The role of nonalcoholic fatty liver disease (NAFLD) in vasomotor symptom (VMS) risk in premenopausal women is unknown. We examined the prevalence of early-onset VMSs according to NAFLD status in lean and overweight premenopausal women. This cross-sectional study included 4242 premenopausal Korean women (mean age 45.4 years). VMSs (hot flashes and night sweats) were assessed using the Korean version of the Menopause-Specific Quality of Life questionnaire. Hepatic steatosis was determined using liver ultrasound; lean was defined as a body mass index of <23 kg/m2. Participants were categorized into four groups: NAFLD-free lean (reference), NAFLD-free overweight, lean NAFLD, and overweight NAFLD. Compared with the reference, the multivariable-adjusted prevalence ratios (PRs) (95% confidence intervals (CIs)) for VMSs in NAFLD-free overweight, lean NAFLD, and overweight NAFLD were 1.22 (1.06−1.41), 1.38 (1.06−1.79), and 1.49 (1.28−1.73), respectively. For moderate-to-severe VMSs, the multivariable-adjusted PRs (95% CIs) comparing NAFLD-free overweight, lean NAFLD, and overweight NAFLD to the reference were 1.38 (1.10−1.74), 1.73 (1.16−2.57), and 1.74 (1.37−2.21), respectively. NAFLD, even lean NAFLD, was significantly associated with an increased risk of prevalent early-onset VMSs and their severe forms among premenopausal women. Further studies are needed to determine the longitudinal association between NAFLD and VMS risk.
  19. Wadhwa M, Kang HN, Jivapaisarnpong T, WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Andalucia LR, Blades CDRZ, et al.
    Biologicals, 2020 May;65:50-59.
    PMID: 31959504 DOI: 10.1016/j.biologicals.2019.12.008
    The first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adopted by the WHO Expert Committee in 2018 was held in June 2019. The workshop participants recognized that the principles based on sound science and the potential for risk, as described in the WHO Guidelines on post-approval changes, which constitute the global standard for product life-cycle management are providing clarity and helping national regulatory authorities in establishing guidance while improving time-lines for an efficient regulation of products. Consequently, the regulatory situation for post-approval changes and guideline implementation is changing but there is a disparity between different countries. While the guidelines are gradually being implemented in some countries and also being considered in other countries, the need for regional workshops and further training on post-approval changes was a common theme reiterated by many participants. Given the complexities relating to post-approval changes in different regions/countries, there was a clear understanding among all participants that an efficient approach for product life-cycle management at a national level is needed to ensure faster availability of high standard, safe and efficacious medicines to patients as per the World Health Assembly Resolution 67.21.
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