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Context Conflicting predictions of malnutrition for the long-term prognosis of coronary artery disease (CAD) exist. Objective This study aimed to investigate the relationship between malnutrition and long-term prognosis of patients with CAD. Data Sources Four databases were searched for articles from February 11, 1936, to September 10, 2022. Data Extraction Cohort studies adjusting for multiple cardiovascular risk factors with data on CAD and malnutrition were included. Malnutrition was measured and defined by different nutritional evaluation tools. The hazard ratios (HRs) and confidence intervals (CIs) for all-cause mortality and major adverse cardiovascular events (MACEs) were synthesized. Subgroup analyses were performed based on study design, assessment tools, ethnicity/race, follow-up, sample size, and types of CAD. Meta-regression was used to compare whether the effect sizes of the 2 subgroups were statistically significant. Data Analysis A total of 30 cohort studies were included, totaling 81 361 participants with CAD. Nutritional evaluation tools, including the Geriatric Nutritional Risk Index (GNRI), Controlling Nutritional Status (CONUT), Nutritional Risk Screening 2002, Mini-Nutritional Assessment, and Prognostic Nutritional Index, were used. Malnutrition increased all-cause mortality (HR = 1.72; 95% CI: 1.53, 1.93) and MACEs (HR = 1.47; 95% CI: 1.35, 1.60) in patients with CAD. Subgroup analysis revealed the results were consistent across study design, ethnicity/race, follow-up, sample size, and types of CAD. Subgroup analyses and meta-regression revealed that malnutrition was associated with a higher risk of all-cause mortality (HR = 2.26; 95% CI: 1.91, 2.68) and MACEs (HR = 2.28; 95% CI: 1.69, 3.08) in patients with stable CAD than those with other types of CAD. Meta-regression revealed that the GNRI (HR = 2.20; 95% CI: 1.65, 2.93) was more effective than CONUT (HR = 1.47; 95% CI: 1.21, 1.78) in predicting all-cause mortality. Conclusion Malnutrition independently increased all-cause mortality by 72% and MACEs by 47% in patients with CAD, especially with stable CAD. The GNRI is a more effective nutritional evaluation tool than CONUT in predicting all-cause mortality. [ABSTRACT FROM AUTHOR]

Background: Studies have shown that the wet suction technique in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) generates better histological diagnostic accuracy and specimen quality than the dry suction technique. However, conclusions of wet suction on the diagnostic accuracy of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) are still controversial. Besides, the optimal number of passes for EUS-FNB has not been determined. We aimed to design a large multicenter randomized trial to compare the diagnostic accuracy of dry suction versus wet suction technique in solid pancreatic lesions (SPLs) using 22G Franseen needles and determine the optimal number of passes required for EUS-FNB. Methods: This is a multi-center open-label, randomized controlled non-inferiority trial with two parallel groups. Two hundred patients with SPLs will undergo EUS-FNB using 22G Franseen needles in 4 tertiary hospitals in China and will be randomly assigned to the dry suction group and wet suction group in a ratio of 1:1. The primary endpoint is diagnostic accuracy. Secondary endpoints include the optimal number of needle passes, sensitivity, specificity, specimen quality, cytological diagnoses, time of the procedure, and incidence of complications. Discussion: This study has been designed to determine (i) whether EUS-FNB using 22G Franseen needle with dry suction is non-inferior to wet suction in terms of diagnostic accuracy and (ii) the optimal number of passes during EUS-FNB of SPLs using 22G Franseen needle. Trial registration: ClinicalTrials.gov NCT05549856. Registered on September 22, 2022. [ABSTRACT FROM AUTHOR]

Aims: To present the results of an exploratory analysis of the BEYOND V study in which Chinese individuals with uncontrolled type 2 diabetes (T2D) received short‐term intensive insulin therapy (SIIT) during study run‐in (prior to randomization) using a basal‐first insulin titration method. Materials and methods: This was exclusively an exploratory analysis of the 7‐ to 10‐day run‐in period of BEYOND V. Participants were hospitalized and had oral therapies withdrawn (except metformin). They received SIIT with once‐daily insulin glargine and three‐times‐daily premeal insulin glulisine, titrated daily from a total starting dose of 0.4 to 0.5 units/kg/d, first adjusting insulin glargine to achieve fasting blood glucose (FBG) of 4.4 to 6.1 mmol/L (79 to 119 mg/dL), then insulin glulisine to achieve pre‐meal blood glucose of 4.4 to 6.1 mmol/L. Key outcomes were the proportions of participants achieving FBG and 2‐hour postprandial blood glucose (PBG) targets. Results: Overall, 397 entered the run‐in (mean 54.2 years, 235 males [59.2%]). At the end of SIIT, 374/396 participants (94.4%) had both FBG <7.0 mmol/L (<126 mg/dL) and 2‐hour PBG <10 mmol/L (<180 mg/dL) and 282/396 (71.2%) had both FBG <6.1 mmol/L (<100 mg/dL) and 2‐hour PBG <10 mmol/L. The mean first time taken to achieve FBG <7 mmol/L, 2‐hour PBG <10 mmol/L, and both, was 4.35, 3.88, and 5.04 days, respectively. Hypoglycaemia occurred in 99 participants (24.9%). There was no severe hypoglycaemia. Conclusions: Titrating basal insulin first is an effective and safe method of SIIT in individuals with T2D, rapidly achieving target glucose levels with a relatively low rate of hypoglycaemia. [ABSTRACT FROM AUTHOR]

The Fuzzy C means algorithm cannot effectively segment object pixels from a non-destructive testing ( NDT) image because of the great difference between the background and the object region. Therefore, a fast fuzzy C means algorithm for segmentation of NDT image was proposed in this study. In the process of clustering, local spatial information and gray information were introduced to improve the robustness of the algorithm. The condition value was used to represent the sample size to balance clusters of different sizes and solve the cluster-size sensitivity problem. Based on the new constraints, a new form of membership degree and cluster center representation could be obtained. The execution time of image segmentation was no longer determined by the size of the image, but by the gray level of the image. The computational complexity of the algorithm was greatly reduced. NDT images and synthetic images with a large difference in cluster size were used for testing. The segmentation accuracy ( SA), F-value, G-mean and the execution time of image segmentation were used to evaluate the performance of algorithms. The experimental results showed that when the original test image was polluted by Gaussian noise, salt and pepper noise, Rayleigh noise and multiplicative noise, the proposed algorithm had better robustness, SA is 97. 93%, F-value is 88. 50%, G-mean is 93. 83%, the execution time of image segmentation was less, about 14. 06 ms. The simulation tests could verify the effectiveness of the proposed algorithm. [ABSTRACT FROM AUTHOR]

Aim: To compare the efficacy and safety of basal insulin glargine 100 units/ml (Gla) + 2‐3 oral antihyperglycaemic drugs (OADs) with twice‐daily premixed insulin aspart 70/30 (Asp30) + metformin (MET) after short‐term intensive insulin therapy in adults with type 2 diabetes in China. Materials and Methods: This open‐label trial enrolled insulin‐naïve adults with type 2 diabetes and an HbA1c of 7.5%‐11.0% (58‐97 mmol/mol) despite treatment with 2‐3 OADs. All participants stopped previous OADs except MET, then received short‐term intensive insulin therapy during the run‐in period, when those with a fasting plasma glucose of less than 7.0 mmol/L and 2‐hour postprandial glucose of less than 10.0 mmol/L were randomized to Gla + MET + a dipeptidyl peptidase‐4 inhibitor or twice‐daily Asp30 + MET. If HbA1c was more than 7.0% (>53 mmol/mol) at week 12, participants in the Gla group were added repaglinide or acarbose, at the physician's discretion, and participants in the Asp30 group continued to titrate insulin dose. The change in HbA1c from baseline to week 24 was assessed in the per protocol (PP) population (primary endpoint). Results: There were 384 enrollees (192 each to Gla and Asp30); 367 were included in the PP analysis. The threshold for non‐inferiority of Gla + OADs versus Asp30 + MET was met, with a least squares mean change from baseline in HbA1c of –1.72% and –1.70% (–42.2 and –42.1 mmol/mol), respectively (estimated difference –0.01%; 95% CI –0.20%, 0.17% [–0.1 mmol/mol; 95% CI –2.2, 1.9]). Achievement of HbA1c less than 7.0% (<53 mmol/mol) was comparable between the groups (60% vs. 57%). The proportion of participants with any (24% vs. 38%; P =.003), symptomatic (19% vs. 31%; P =.007) or confirmed hypoglycaemia (18% vs. 33%; P <.001) was lower in the Gla + OADs group. Conclusions: Compared with Asp30 + MET, Gla + 2‐3 OADs showed similar efficacy but a lower hypoglycaemia risk in Chinese individuals with type 2 diabetes who had undergone short‐term intensive insulin therapy. [ABSTRACT FROM AUTHOR]

Introduction: BEYOND 7 demonstrated that a higher starting dose (0.3 U/kg) of insulin glargine 100 U/mL (Gla-100) is as safe as the standard starting dose (0.2 U/kg) in Chinese individuals with type 2 diabetes who had uncontrolled hyperglycaemia despite receiving oral antihyperglycaemic drugs. This post hoc analysis determined the effect of baseline characteristics on hypoglycaemia risk in these individuals. Methods: Participants from BEYOND 7 were assessed based on their age at baseline (< 60 vs. ≥ 60 years), duration of diabetes (< 10 vs. ≥ 10 years), glycated haemoglobin (HbA1c; < 9 vs. ≥ 9%) and fasting plasma glucose level (FPG; < 11 vs. ≥ 11 mmol/L). Endpoints included the proportion of participants with overall confirmed (≤ 3.9 mmol/L) and symptomatic hypoglycaemia, as well as the proportion of participants who achieved an HbA1c < 7% without hypoglycaemia, the time to first achievement of fasting blood glucose (FBG) < 7 mmol/L and the change in HbA1c from baseline between the two treatment arms in each of these subgroups. Results: The proportion of participants with overall confirmed (6.1–16.7%) or symptomatic hypoglycaemia (5.7–18.4%) or the proportion who achieved HbA1c < 7.0% without hypoglycaemia (23.6–47.4%) was similar between the two treatment arms in all subgroups, with the exception of participants with a baseline duration of diabetes ≥ 10 years who experienced more symptomatic hypoglycaemia if initiating Gla-100 at a dose of 0.3 versus 0.2 U/kg. Participants aged < 60 years with an HbA1c < 9% or ≥ 9% or a duration of diabetes of 2–10 years achieved an FBG < 7.0 mmol/L in a significantly shorter time with Gla-100 starting dose of 0.3 U/kg versus 0.2 U/kg (all p < 0.001). No significant differences were seen among the subgroups in terms of change from baseline in HbA1c. Conclusions: Baseline age, duration of diabetes, HbA1c level and FPG level do not affect the risk of hypoglycaemia with a higher starting dose of Gla-100 versus its standard starting dose. Trial registration: ClinicalTrials.gov: NCT02836704. [ABSTRACT FROM AUTHOR]

Aim: To determine the safety of a higher starting dose of basal insulin in overweight/obese patients with type 2 diabetes (T2D). Materials and methods: This 16‐week, randomized, multicentre, open‐label trial enrolled adults with T2D (body mass index 25–40 kg/m2) and suboptimal glycaemic control (glycated haemoglobin [HbA1c] 7.5–11.0% [58–97 mmol/mol] and fasting plasma glucose [FPG] >9.0 mmol/L) with two to three oral anti‐hyperglycaemic drugs at 51 centres in China. Patients were randomized (1:1) to a higher (0.3 U/kg) or standard (0.2 U/kg) starting dose of insulin glargine 100 U/mL, which was then titrated to achieve a self‐monitored fasting blood glucose (FBG) of 4.4 to 5.6 mmol/L. The primary endpoint was the percentage of patients with ≥1 episode of overall confirmed hypoglycaemia (≤3.9 mmol/L or severe). Results: At the end of study (n = 866), 11.0% patients treated with the 0.3 U/kg starting insulin dose experienced overall confirmed hypoglycaemia versus 8.6% of patients treated with 0.2 U/kg (estimated difference 2.1%, 95% confidence interval − 1.68, 5.89). The proportions of patients with symptomatic (9.8% vs 7.0%; P = 0.128) and nocturnal hypoglycaemia (2.7% vs 1.2%; P = 0.102) were similar in the two groups. There were no events of severe hypoglycaemia or FBG <3.0 mmol/L during the 16‐week treatment, and achievement of HbA1c <7.0% (53 mmol/mol) (37.1% vs 37.1%) or FPG <5.6 mmol/L (15.9% vs 16.3%), <6.1 mmol/L (27.6% vs 26.1%), or < 7.0 mmol/L (48.8% vs 48.3%) without hypoglycaemia were comparable in the two groups. Moreover, the mean time was shorter (4.53, 3.95 and 2.74 weeks vs 5.51, 5.21 and 3.64 weeks) and number of titrations was lower (3.5, 3.0 and 2.0 vs 4.3, 4.0 and 2.8) to achieve self‐monitored FBG targets of <5.6, <6.1 and <7.0 mmol/L in the higher versus the standard insulin dose group (all P < 0.01). Conclusions: Among overweight/obese patients with T2D, a higher insulin starting dose was as safe as the standard starting dose, and self‐monitored FBG targets were achieved earlier with the higher versus the standard dose. [ABSTRACT FROM AUTHOR]

Low-intensity ultrasound-microbubble (LIUS-MB) treatment is a promising antivascular therapy for tumors. We sought to determine whether LIUS-MB treatment with an appropriate ultrasound pressure could achieve substantial and persistent cessation of tumor perfusion without having significant effects on normal tissue. Further, we investigated the mechanisms underlying this treatment. Murine S-180 sarcomas, thigh muscles, and skin tissue from 60 tumor-bearing mice were subjected to sham therapy, an ultrasound application combined with microbubbles in four different ultrasound pressures (0.5, 1.5, 3.0, 5.0 MPa), or ultrasound at 5.0 MPa alone. Subsequently, contrast-enhanced ultrasonic imaging and histological studies were performed. Tumor microvessels, tumor cell necrosis, apoptosis, tumor growth, and survival were evaluated in 85 mice after treatment with the selected ultrasound pressure. We found that twenty-four hours after LIUS-MB treatment at 3.0 MPa, blood perfusion and microvessel density of the tumor had substantially decreased by 84 ± 8% and 84%, respectively ( p < 0.01). Similar reductions were not observed in the muscle or skin. Additionally, an extreme reduction in the number of immature vessels was observed in the tumor (reduced by 90%, p < 0.01), while the decrease in mature vessels was not significant. Further, LIUS-MB treatment at 3.0 MPa promoted tumor cell necrosis and apoptosis, delayed tumor growth, and increased the survival rate of tumor-bearing mice ( p < 0.01). These findings indicate that LIUS-MB treatment with an appropriate ultrasound pressure could selectively and persistently reduce tumor perfusion by depleting the neovasculature. Therefore, LIUS-MB treatment offers great promise for clinical applications in antivascular therapy for solid tumors. [ABSTRACT FROM AUTHOR]

Premixed insulin is the most commonly used insulin in China. This trial compared the efficacy and safety of once-daily insulin glargine 100 U/mL (Gla-100) + oral antihyperglycemic drugs (OADs) and twice-daily insulin aspart 70/30 (Asp 30) + OAD in T2D patients. Chinese adults with T2D receiving stable doses of metformin and 1-2 OADs with HbA1c 7.5%-11.0% were enrolled and entered a 7-10 day SIT period in which they were treated with basal-bolus to achieve a fasting blood glucose (FBG) <7 mmol/L and 2-hour postprandial glucose (2hPG) <10 mmol/L. Patients were then randomized 1:1 to receive Gla-100 + OADs (n=192) or Asp 30 + OAD (n=192) for 24 weeks. Baseline characteristics were balanced across groups. Mean (SD) age was 54.2 (8.8) years, BMI was 26.0 (3.1) kg/m2, and duration of diabetes was 6.8 (3.0) years. At week 24, the least square mean (SE) change from baseline in HbA1c was -1.72% (0.07) and -1.70% (0.07) in the Gla-100 and Asp 30 groups, respectively (Table); group difference (-0.01%; 95% CI -0.20, 0.17) met the pre-specified non-inferiority criteria (upper bound 95% CI <0.4%). All hypoglycemia events were significantly lower in the Gla-100 group. In conclusion, compared with Asp 30 + OAD, Gla-100 + OAD showed similar efficacy but lower hypoglycemia risk in Chinese T2D patients. Disclosure: Y. Mu: Speaker's Bureau; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi-Aventis. J. Liu: Employee; Self; Sanofi China. X. Zhang: None. N. Cui: Employee; Self; Sanofi China. H. Yin: None. L. Guo: Consultant; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., BD, Eli Lilly and Company, Merck & Co., Inc., Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk, Sanofi China. H. Wan: None. J. Wang: None. B. Xu: None. G. Wang: None. C. Jiang: None. L. Liang: None. W. Feng: Employee; Self; Sanofi China. Funding: Sanofi China (NCT03359837) [ABSTRACT FROM AUTHOR]

To titrate basal and bolus insulin sequentially or simultaneously during SIT remains controversial. Here we report an easy titration order verified in a 7-10 day SIT period. Insulin naïve Chinese T2D adults receiving stable doses of metformin and 1-2 oral antihyperglycemic drugs with HbA1c 7.5%-11.0% were treated with once-daily insulin glargine 100 U/mL (Gla-100) and thrice-daily insulin glulisine (Glu) for 7-10 days titrated to achieve a fasting blood glucose (FBG) <7 mmol/L and 2-hour postprandial glucose (2hPG) <10 mmol/L. Gla-100 was titrated first until FBG achieved 4.4-6.1 mmol/L, then Glu was titrated to achieve pre-meal blood glucose 4.4-6.1 mmol/L. Of 466 patients screened, 397 entered the SIT period; 391 (98.5%) completed. Baseline mean (SD) age was 54.2 (8.8) years, duration of disease was 6.8 (3.0) years, BMI was 26.0 (3.2) kg/m2, HbA1c was 9.1% (1.1), and FBG was 10.7 (2.5) mmol/L; 59.2% were male. Overall, 94.4% of patients achieved the predefined target at the end of the SIT period (Table). The mean time to first achieving 2hPG target was less than the time to first achieving FBG target, implying that titrating basal insulin first could minimize Glu dose increases and potential hypoglycemia risk. In conclusion, when starting basal-bolus regimen in SIT, basal-first titration order was effective, fast to target and well tolerated in Chinese T2D patients. Disclosure: L. Guo: Consultant; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., BD, Eli Lilly and Company, Merck & Co., Inc., Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk, Sanofi China. J. Liu: Employee; Self; Sanofi China. X. Zhang: None. N. Cui: Employee; Self; Sanofi China. H. Yin: None. Y. Mu: Speaker's Bureau; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi-Aventis. H. Wan: None. J. Wang: None. B. Xu: None. G. Wang: None. C. Jiang: None. L. Liang: None. W. Feng: Employee; Self; Sanofi China. Funding: Sanofi China (NCT03359837) [ABSTRACT FROM AUTHOR]

With type 2 diabetes (T2D) progression, patients require insulin, but insufficient titration often leads to poor glycemic control. A higher insulin starting dose may reduce the optimal dose deficit, but whether this procedure increases hypoglycemia risk is unknown. This open-label, multicenter trial (NCT02836704) evaluated safety and efficacy of a high (0.3 U/kg) vs. standard (0.2 U/kg) starting dose of glargine 100 U/ml (Gla-100) followed by titration over 16 weeks to achieve self-monitored FBG 4.4-5.6 mmol/L using the same algorithm in each group. Overall, 892 patients with overweight/obesity (BMI 25-40 kg/m2) and uncontrolled T2D (HbA1c 7.5-11.0%; lab FPG >9.0 mmol/L) on stable doses of 2-3 OADs were randomized to receive a high (n=444) or standard (n=448) starting dose of Gla-100. At week 16, 92% of patients completed the study and 866 were analyzed. The primary endpoint (percentage of patients with ≥1 confirmed hypoglycemia, BG <3.9 mmol/L) met the pre-specified threshold (upper bound 95% CI <10%) for non-inferiority of Gla-100 0.3 U/kg vs. 0.2 U/kg with 11.0% and 8.6% in the respective groups (log-binomial regression estimated difference 2.1%; 95% CI: −1.68%, 5.89%). At week 16, symptomatic (9.8% vs. 7.0%, p=0.13) and nocturnal hypoglycemia (2.7% vs. 1.2%, p=0.10), percentage of patients achieving HbA1c <7.0% without hypoglycemia (37.1% vs. 37.1%), and percentage of patients achieving lab FPG targets <5.6 mmol/L (15.9% vs. 16.3%), <6.1 mmol/L (27.6% vs. 26.1%), or <7.0 mmol/L (48.8% vs. 48.3%) were all similar in both groups. However, time to achieve first self-monitored FBG <5.6, <6.1, or <7 mmol/L was 6, 9, and 7 days shorter in the 0.3 U/kg group (all p<0.01). In conclusion, among patients with overweight/obesity and T2D, a higher Gla-100 starting dose was as safe as a standard Gla-100 starting dose and achieved FBG targets earlier during the course of therapy. Disclosure: L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck KGaA, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Roche Pharma, Sanofi. H. Wan: None. B. Wen: None. X. Wang: None. J. Wang: Research Support; Self; Sanofi. R. Bian: None. W. Pang: None. W. Feng: Employee; Self; Sanofi. X. Zhang: None. N. Cui: Employee; Self; Sanofi. Funding: Sanofi China [ABSTRACT FROM AUTHOR]