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Nonsteroidal Anti-Inflammatory Drug Injections versus Steroid Injections in the Management of Upper and Lower Extremity Orthopedic Conditions: A Systematic Review with Meta-Analysis.
Rhim, HC, Ruiz, J, Taseh, A, Afunugo, W, Crockett, Z, Schon, J, Pan, X, Shin, J, Schowalter, S, Jang, KM, et al
Journal of clinical medicine. 2024;(4)
Abstract
BACKGROUND Although corticosteroid injections are an effective treatment for musculoskeletal pathologies, they may not be suitable for all patients. The purpose of this systematic review was to compare clinical outcomes between patients who received NSAID and corticosteroid injections for various orthopedic conditions. METHODS Medline, Embase, Web of Science, and Cochrane Central Register of Controlled Trials were searched, and meta-analyses were performed using a random-effects model for outcomes presented in three or more studies. Other studies were qualitatively analyzed. RESULTS A total of 28 articles with 2113 patients were included. A meta-analysis of five studies in patients with shoulder impingement syndrome demonstrated that there was no significant difference in the pain visual analogue scale (VAS) between subacromial NSAID injections and corticosteroid injections at 1 month [weighted mean difference (WMD) -0.244; 95% CI, -1.232 to 0.745; I2, 94.5%]. For patients with knee osteoarthritis, a meta-analysis of three studies demonstrated that there was no significant difference between intraarticular NSAID injections and corticosteroid injections in pain VAS at 1 month (WMD 0.754; 95% CI, -0.413 to 1.921; I2, 90.2%) and 3 months (WMD-0.089; 95% CI, -0.345 to 0.166; I2, 0%). A review of the studies assessing pain outcomes for hip osteoarthritis, adhesive capsulitis, and plantar fasciitis showed no significant differences between the NSAID and corticosteroid groups. CONCLUSION NSAID injections may be safe and effective alternatives to steroid injections, especially in shoulder impingement syndrome and knee osteoarthritis.
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Efficacy and safety of combination therapy with telmisartan, rosuvastatin, and ezetimibe in patients with dyslipidemia and hypertension: A randomized, double-blind, multicenter, therapeutic confirmatory, phase III clinical trial.
Lee, CJ, Kang, WC, Ihm, SH, Sohn, IS, Woo, JS, Kim, JW, Hong, SJ, Choi, JH, Suh, JW, Seo, JB, et al
Journal of clinical hypertension (Greenwich, Conn.). 2024;(3):262-273
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Abstract
This study aimed to compare and evaluate the efficacy of the blood pressure (BP) control and cholesterol-lowering effects and safety of combination therapy with telmisartan, rosuvastatin, and ezetimibe versus rosuvastatin and ezetimibe double therapy or telmisartan single therapy in dyslipidemia patients with hypertension. After a wash-out/therapeutic lifestyle change period of ≥4 weeks, a total of 100 eligible patients were randomized and received one of three treatments for 8 weeks: (1) telmisartan 80 mg/rosuvastatin 20 mg/ezetimibe 10 mg (TRE), (2) rosuvastatin 20 mg/ezetimibe 10 mg (RE), or (3) telmisartan 80 mg (T). The primary endpoint was the efficacy evaluation of TRE by comparing changes in mean sitting systolic blood pressure (msSBP) and mean percentage change in low-density lipoprotein-C (LDL-C) from baseline after 8 weeks of treatment. The least square (LS) mean (SE) changes in msSBP at 8 weeks compared with baseline were -23.02 (3.04) versus -7.18 (3.09) mmHg in the TRE and RE groups, respectively (p < .0001), and -25.80 (2.74) versus -14.92 (2.65) mmHg in the TRE and T groups, respectively (p = .0005). The percentage changes in the mean (SD) LDL-C at 8 weeks compared with baseline were -54.97% (3.49%) versus -0.17% (3.23%) in the TRE and T groups, respectively (p < .0001). No serious adverse events occurred, and no statistically significant differences in the incidence of overall AEs and adverse drug reactions occurred among the three groups. TRE therapy significantly decreased msSBP and LDL-C compared to RE or T therapy with comparable safety and tolerability profiles.
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Compositional and temporal division of labor modulates mixed sugar fermentation by an engineered yeast consortium.
Shin, J, Liao, S, Kuanyshev, N, Xin, Y, Kim, C, Lu, T, Jin, YS
Nature communications. 2024;(1):781
Abstract
Synthetic microbial communities have emerged as an attractive route for chemical bioprocessing. They are argued to be superior to single strains through microbial division of labor (DOL), but the exact mechanism by which DOL confers advantages remains unclear. Here, we utilize a synthetic Saccharomyces cerevisiae consortium along with mathematical modeling to achieve tunable mixed sugar fermentation to overcome the limitations of single-strain fermentation. The consortium involves two strains with each specializing in glucose or xylose utilization for ethanol production. By controlling initial community composition, DOL allows fine tuning of fermentation dynamics and product generation. By altering inoculation delay, DOL provides additional programmability to parallelly regulate fermentation characteristics and product yield. Mathematical models capture observed experimental findings and further offer guidance for subsequent fermentation optimization. This study demonstrates the functional potential of DOL in bioprocessing and provides insight into the rational design of engineered ecosystems for various applications.
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Safety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes.
Pihoker, C, Shulman, DI, Forlenza, GP, Kaiserman, KB, Sherr, JL, Thrasher, JR, Buckingham, BA, Kipnes, MS, Bode, BW, Carlson, AL, et al
Diabetes technology & therapeutics. 2023;(11):755-764
Abstract
Background: During MiniMed™ advanced hybrid closed-loop (AHCL) use by adolescents and adults in the pivotal trial, glycated hemoglobin (A1C) was significantly reduced, time spent in range (TIR) was significantly increased, and there were no episodes of severe hypoglycemia or diabetic ketoacidosis (DKA). The present study investigated the same primary safety and effectiveness endpoints during AHCL use by a younger cohort with type 1 diabetes (T1D). Methods: An intention-to-treat population (N = 160, aged 7-17 years) with T1D was enrolled in a single-arm study at 13 investigational centers. There was a run-in period (∼25 days) using HCL or sensor-augmented pump with/without predictive low-glucose management, followed by a 3-month study period with AHCL activated at two glucose targets (GTs; 100 and 120 mg/dL) for ∼45 days each. The mean ± standard deviation values of A1C, TIR, mean sensor glucose (SG), coefficient of variation (CV) of SG, time at SG ranges, and insulin delivered between run-in and study were analyzed (Wilcoxon signed-rank test or t-test). Results: Compared with baseline, AHCL use was associated with reduced A1C from 7.9 ± 0.9% (N = 160) to 7.4 ± 0.7% (N = 136) (P < 0.001) and overall TIR increased from the run-in 59.4 ± 11.8% to 70.3 ± 6.5% by end of study (P < 0.001), without change in CV, time spent below range (TBR) <70 mg/dL, or TBR <54 mg/dL. Relative to longer active insulin time (AIT) settings (N = 52), an AIT of 2 h (N = 19) with the 100 mg/dL GT increased mean TIR to 73.4%, reduced TBR <70 mg/dL from 3.5% to 2.2%, and reduced time spent above range (TAR) >180 mg/dL from 28.7% to 24.4%. During AHCL use, there was no severe hypoglycemia or DKA. Conclusions: In children and adolescents with T1D, MiniMed AHCL system use was safe, A1C was lower, and TIR was increased. The lowest GT and shortest AIT were associated with the highest TIR and lowest TBR and TAR, all of which met consensus-recommended glycemic targets. ClinicalTrials.gov ID: NCT03959423.
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Factors Associated with Long-Term Dietary Supplement Use among Korean Breast Cancer Survivors: A Cross-Sectional Study.
Kim, S, Yeo, Y, Shin, J, Shin, DW, Cho, B, Song, YM
Nutrients. 2023;(18)
Abstract
PURPOSE The factors associated with the dietary supplement (DS) use of Asian breast cancer survivors in consideration of the duration of use and types of DS have not been well established. METHODS We recruited 693 Korean female breast cancer survivors at two university-affiliated hospitals and collected study data through a self-administered questionnaire and a review of medical records. A multiple logistic regression analysis was conducted to evaluate the multivariable-adjusted association between DS use and study variables. RESULTS The prevalence of any (≥2 weeks) and long-term (≥6 months) DS use among study participants was 48.2% and 12.0%, respectively. Education level, alcohol use, adequate physical activity (≥150 min/week), and time lapse after cancer diagnosis were positively associated with any DS use. Among DS users, as compared with short-term (≥2 weeks and <6 months) users, long-term users were more likely to have a higher cancer stage, more diverse cancer treatment modalities, a shorter time since cancer diagnosis, and lower fear of cancer recurrence. When we repeated the analysis for each DS type, time lapse after cancer diagnosis showed a consistently inverse association with long-term use of the most frequently consumed DS (multivitamins, followed by vitamin D/calcium, vitamin C, and omega-3). The number of cancer treatment modalities was positively associated with the long-term use of multivitamins and vitamin D/calcium. Alcohol consumption and low bone mineral density were positively associated with long-term vitamin D/calcium use. CONCLUSIONS The factors associated with DS use differed by the duration of DS use and specific DS type. Long-term DS use was more frequently associated with cancer-related factors.
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Improved Glycemia with Hybrid Closed-Loop Versus Continuous Subcutaneous Insulin Infusion Therapy: Results from a Randomized Controlled Trial.
Garg, SK, Grunberger, G, Weinstock, R, Lawson, ML, Hirsch, IB, DiMeglio, LA, Pop-Busui, R, Philis-Tsimikas, A, Kipnes, M, Liljenquist, DR, et al
Diabetes technology & therapeutics. 2023;(1):1-12
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Objective: To evaluate safety and effectiveness of MiniMed™ 670G hybrid closed loop (HCL) in comparison with continuous subcutaneous insulin infusion (CSII) therapy for 6 months in persons with type 1 diabetes (T1D). Methods: Adults (aged 18-80 years), adolescents, and children (aged 2-17 years) with T1D who were using CSII therapy were enrolled and randomized (1:1) to 6 months of HCL intervention (n = 151, mean age of 39.9 ± 19.8 years) or CSII without continuous glucose monitoring (n = 151, 35.7 ± 18.4 years). Primary effectiveness endpoints included change in A1C for Group 1 (baseline A1C >8.0%), from baseline to the end of study, and difference in the end of study percentage of time spent below 70 mg/dL (%TBR <70 mg/dL) for Group 2 (baseline A1C ≤8.0%), to show superiority of HCL intervention versus control. Secondary effectiveness endpoints were change in A1C and %TBR <70 mg/dL for Group 2 and Group 1, respectively, to show noninferiority of HCL intervention versus control. Primary safety endpoints were rates of severe hypoglycemia and diabetic ketoacidosis (DKA). Results: Change in A1C and difference in %TBR <70 mg/dL for the overall group were significantly improved, in favor of HCL intervention. In addition, a significant mean (95% confidence interval) change in A1C was observed for both Group 1 (-0.8% [-1.1% to -0.4%], P < 0.0001) and Group 2 (-0.3% [-0.5% to -0.1%], P < 0.0001), in favor of HCL intervention. The same was observed for difference in %TBR <70 mg/dL for Group 1 (-2.2% [-3.6% to -0.9%]) and Group 2 (-4.9% [-6.3% to -3.6%]) (P < 0.0001 for both). There was one DKA event during run-in and six severe hypoglycemic events: two during run-in and four during study (HCL: n = 0 and CSII n = 4 [6.08 per 100 patient-years]). Conclusions: This RCT demonstrates that the MiniMed 670G HCL safely and significantly improved A1C and %TBR <70 mg/dL compared with CSII control in persons with T1D, irrespective of baseline A1C level.
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Comparison of efficacy and safety between third-dose triple and third-dose dual antihypertensive combination therapies in patients with hypertension.
Sung, KC, Hong, SJ, Rhee, MY, Jeong, MH, Kim, DH, Lim, SW, Park, K, Lee, JB, Kim, SY, Cho, JM, et al
Journal of clinical hypertension (Greenwich, Conn.). 2023;(5):429-439
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We compared the efficacy and safety of third-standard-dose triple and third-standard-dose dual antihypertensive combination therapies in patients with mild to moderate hypertension. This was a phase II multicenter, randomized, double-blind, parallel-group trial. After a 4-week placebo run-in period, 245 participants were randomized to the third-dose triple combination (ALC group; amlodipine 1.67 mg + losartan potassium 16.67 mg + chlorthalidone 4.17 mg) or third-dose dual combination (AL group; amlodipine 1.67 mg + losartan potassium 16.67 mg, LC group; losartan potassium 16.67 mg + chlorthalidone 4.17 mg, AC group; amlodipine 1.67 mg + chlorthalidone 4.17 mg) therapy groups and followed up for 8 weeks. The mean systolic blood pressure (BP) reduction was -18.3 ± 13.2, -13.0 ± 13.3, -16.3 ± 12.4, and -13.8 ± 13.2 mmHg in the ALC, AL, LC, and AC groups, respectively. The ALC group showed significant systolic BP reduction compared to the AL and AC groups at weeks 4 (P = .010 and P = .018, respectively) and 8 (P = .017 and P = .036, respectively). At week 4, the proportion of systolic BP responders was significantly higher in the ALC group (42.6%) than in the AL (22.0%), LC (23.3%), and AC (27.1%) groups (P = .013, P = .021, and P = .045, respectively). At week 8, the proportion of systolic and diastolic BP responders was significantly higher in the ALC group (59.7%) than in the AL (39.3%) and AC (42.4%) groups (P = .022 and P = .049, respectively) at week 8. Third-standard-dose triple antihypertensive combination therapy demonstrated early effective BP control compared to third-standard-dose dual combination therapies, without increasing adverse drug reactions in patients with mild-to-moderate hypertension.
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Resistant hypertension: consensus document from the Korean society of hypertension.
Park, S, Shin, J, Ihm, SH, Kim, KI, Kim, HL, Kim, HC, Lee, EM, Lee, JH, Ahn, SY, Cho, EJ, et al
Clinical hypertension. 2023;(1):30
Abstract
Although reports vary, the prevalence of true resistant hypertension and apparent treatment-resistant hypertension (aTRH) has been reported to be 10.3% and 14.7%, respectively. As there is a rapid increase in the prevalence of obesity, chronic kidney disease, and diabetes mellitus, factors that are associated with resistant hypertension, the prevalence of resistant hypertension is expected to rise as well. Frequently, patients with aTRH have pseudoresistant hypertension [aTRH due to white-coat uncontrolled hypertension (WUCH), drug underdosing, poor adherence, and inaccurate office blood pressure (BP) measurements]. As the prevalence of WUCH is high among patients with aTRH, the use of out-of-office BP measurements, both ambulatory blood pressure monitoring (ABPM) and home blood pressure monitoring (HBPM), is essential to exclude WUCH. Non-adherence is especially problematic, and methods to assess adherence remain limited and often not clinically feasible. Therefore, the use of HBPM and higher utilization of single-pill fixed-dose combination treatments should be emphasized to improve drug adherence. In addition, primary aldosteronism and symptomatic obstructive sleep apnea are quite common in patients with hypertension and more so in patients with resistant hypertension. Screening for these diseases is essential, as the treatment of these secondary causes may help control BP in patients who are otherwise difficult to treat. Finally, a proper drug regimen combined with lifestyle modifications is essential to control BP in these patients.
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Determinants of Self-Care and Home-Based Management of Hypertension: An Integrative Review.
Konlan, KD, Shin, J
Global heart. 2023;(1):16
Abstract
INTRODUCTION Patients with hypertension should perform diverse self-care activities that incorporate medication adherence and lifestyle modification, such as no smoking or alcohol, weight reduction, a low-salt diet, increased physical activity, increased self-monitoring, and stress reduction, for effective management at home. AIM: This systematic review assessed and synthesized the factors that are associated with self-care and home-based management of hypertension. METHODS The search of the articles incorporated the population, intervention, comparison, and outcome (PICO) framework. The literature was searched in four databases (PubMed, the Cumulative Index to Nursing and Allied Health Literature [CINAHL], Embase, and Web of Science) until 2022. The articles retrieved and searched from the reference list (531) were transported to EndNote version 20, and duplicates (19) were identified and removed to produce 512 titles. Following the eventual title, abstracts, and full-text screening, 13 articles were appropriate for this study. The narrative and thematic data analysis were used to analyze and integrate the data. RESULTS The analysis showed five themes were associated with home-based self-care and blood pressure (BP) control among patients diagnosed with hypertension. These themes that emerged were (1) the prevalence of control of BP, (2) sociodemographic factors, (3) treatment-related factors, (4) knowledge of management, and (5) knowledge of the prevention of risk factors of hypertension. The demographic factors influencing home-based self-care for hypertension were gender, age, and socioeconomic status. In contrast, the treatment factors were duration of hypertension treatment, medication burden, and medication adherence. Other factors that influenced self-care were inadequate knowledge of BP management, follow-up care, and risk factors of hypertension. CONCLUSION Hypertension self-care interventions must incorporate individual, societal, and cultural perspectives in increasing knowledge and improving home-based hypertension management. Therefore, well-designed clinical and community-dwelling interventions should integrate personal, social, and cultural perspectives to improve behavior in the home management of hypertension by increasing knowledge and self-efficacy.
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Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring.
van den Heuvel, T, Kolassa, R, Keuthage, W, Kroeger, J, Ré, R, de Portu, S, Vorrink, L, Shin, J, Castañeda, J, Vigersky, R, et al
Journal of diabetes science and technology. 2023;:19322968231161320
Abstract
BACKGROUND This analysis reports the findings from a predefined exploratory cohort (cohort B) from the ADAPT (ADvanced Hybrid Closed Loop Study in Adult Population with Type 1 Diabetes) study. Adults with type 1 diabetes (T1D) with suboptimal glucose control were randomly allocated to an advanced hybrid closed-loop (AHCL) system or multiple daily injections of insulin (MDI) plus real-time continuous glucose monitoring (RT-CGM). METHODS In this prospective, multicenter, exploratory, open-label, randomized controlled trial, 13 participants using MDI + RT-CGM and with HbA1c ≥8.0% were randomized to switch to AHCL (n = 8) or continue with MDI + RT-CGM (n = 5) for six months. Prespecified endpoints included the between-group difference in mean change from baseline in HbA1c, CGM-derived measures of glycemic control, and safety. RESULTS The mean HbA1c level decreased by 1.70 percentage points in the AHCL group versus a 0.60 percentage point decrease in the MDI + RT-CGM group, with a model-based treatment effect of -1.08 percentage points (95% confidence interval [CI] = -2.17 to 0.00 percentage points; P = .0508) in favor of AHCL. The percentage of time spent with sensor glucose levels between 70 and 180 mg/dL in the study phase was 73.6% in the AHCL group and 46.4% in the MDI + RT-CGM group; model-based between-group difference of 28.8 percentage points (95% CI = 12.3 to 45.3 percentage points; P = .0035). No diabetic ketoacidosis or severe hypoglycemia occurred in either group. CONCLUSIONS In people with T1D with HbA1c ≥8.0%, the use of AHCL resulted in improved glycemic control relative to MDI + RT-CGM. The scale of improvement suggests that AHCL should be considered as an option for people not achieving good glycemic control on MDI + RT-CGM.