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Effects of dapagliflozin compared with glimepiride on body composition in Asian patients with type 2 diabetes inadequately controlled with metformin: The BEYOND study

Diabetes Obes Metab. 2023 Jun 20. doi: 10.1111/dom.15164. Online ahead of print.

ABSTRACT

AIMS: To evaluate the effect of dapagliflozin on body composition such as total body fat (BF) mass, abdominal visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT) areas compared with glimepiride in Korean patients with type 2 diabetes.

MATERIALS AND METHODS: This was a 52-week, multicentre, randomized, parallel-group, open-label, Phase IV (NCT02564926) study. Patients with inadequate glycaemic control (glycated haemoglobin ≥7.0% and <10.0%) on metformin monotherapy (≥1000 mg/day) were randomized 1:1 to receive dapagliflozin 10 mg/day or glimepiride 1-2 mg/day for 12 months as an add-on to metformin. Baseline and end of study body composition evaluations included dual-energy X-ray absorptiometry and abdominal computed tomography scans.

RESULTS: Of 124 enrolled patients from 14 centres, 121 received study treatment (dapagliflozin: 60; glimepiride: 61) and 106 (85.5%) completed the study. Over 52 weeks, the dapagliflozin group showed the following differences versus the glimepiride group: -2.59 kg BF mass, -1.94% BF%, -17.55 cm2 VAT area, -18.39 cm2 SAT area, -0.46% glycated haemoglobin, -18.25 mg/dl fasting blood glucose, -3.7 kg weight, -2.21 cm waist circumference, -1.37 kg/m2 body mass index, -6.81 mmHg systolic blood pressure and +657.71 ng/ml in adiponectin; all were statistically significant. Both groups had similar incidences of adverse events; however, hypoglycaemic events were mainly (12 of 15) reported in the glimepiride group.

CONCLUSION: Dapagliflozin reduced total BF mass, abdominal VAT and SAT areas, and showed better glycaemic control than glimepiride. Being safe and well-tolerated, dapagliflozin appears to be a more favourable alternative to sulphonylureas as add-on therapy after metformin monotherapy failure in Korean patients with type 2 diabetes.

PMID:37337747 | DOI:10.1111/dom.15164

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Results of semaglutide in patients older than 70 years, a real-world study of efficacy and safety

Minerva Endocrinol (Torino). 2023 Jun 20. doi: 10.23736/S2724-6507.23.03985-4. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of this study is to investigate the use of once-weekly semaglutide in a real population of patients with type 2 diabetes mellitus (T2DM) over 70 years in two Spanish hospitals.

METHODS: An observational, retrospective, and multicenter clinical study was designed. It included 60 patients with T2DM, with a mean age of 76.5 years, 63.3% women, and a mean of 15.5 years of evolution of T2DM, all managed in the outpatient clinical setting. The primary endpoint was the change in HbA<inf>1c</inf> from baseline to the end of the study. The secondary endpoints included changes in body weight and the proportion of patients achieving HbA<inf>1c</inf> <7.0% and body weight loss >5%.

RESULTS: After 12 months of follow-up, the reductions in HbA<inf>1c</inf> were -0.61±0.9% (P<0.0001) in the total cohort. Body weight reductions were -8.2±5.3 kg (P<0.0001). Overall, 67% reached the objective of an HbA<inf>1c</inf> level of <7%, and 73% achieved a weight loss of ≥5%.

CONCLUSIONS: In routine clinical practice in Spain, the use of semaglutide once a week was associated with statistically significant and clinically relevant improvements in HbA<inf>1c</inf> and body weight in adults aged over 70 years with T2DM, without notable adverse effects, which supports real-world use.

PMID:37337740 | DOI:10.23736/S2724-6507.23.03985-4

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Comparison of COVID-19 Preprint and Peer-Reviewed Versions of Studies on Therapies for Critically Ill Patients

J Intensive Care Med. 2023 Jun 20:8850666231182563. doi: 10.1177/08850666231182563. Online ahead of print.

ABSTRACT

PURPOSE: Significant increases in the volume of preprint articles due to the COVID-19 pandemic, we examined the reliability of preprint articles compared to their peer-reviewed publications.

MATERIALS AND METHODS: Preprint articles evaluating experimental studies of select treatment options (anticoagulation, dexamethasone, hydroxychloroquine, remdesivir, and tocilizumab) for COVID-19 in the critically ill, available in a peer-reviewed publication were screened for inclusion within Altmetric (n = 2040). A total of 40 articles met inclusion criteria, with 21 being randomly selected for evaluation. The primary outcome of this evaluation was a change in a study’s reported primary outcome or statistical significance between preprint and peer-reviewed articles. Secondary outcomes included changes in primary/secondary outcome effect size and change in study conclusion.

RESULTS: One article (4.8%, 95% CI 0.12%-23.8%) had a change in the primary outcome. Seven articles (33.3%, 95% CI 14.6%-57.0%) had a change in the primary outcome’s effect measure. Five studies (23.8%, 95% CI 8.2%-47.2%) had changes in statistical significance of at least one secondary outcome. Four studies (19.0%, 95% CI 5.4%-41.9%) had a change in study conclusion.

CONCLUSIONS: In preprint articles of COVID-19 treatments, the provided primary outcome is generally reliable, while interpretation of secondary outcomes should be made with caution, while awaiting completion of the peer-review process.

PMID:37337731 | DOI:10.1177/08850666231182563

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Retraction

Arthritis Rheumatol. 2023 Jun 20. doi: 10.1002/art.42546. Online ahead of print.

ABSTRACT

Retraction: Pavelka, K., Trč, T., Karpaš, K., Vítek, P., Sedláčková, M., Vlasáková, V., Böhmová, J. and Rovenský, J. (2007), The efficacy and safety of diacerein in the treatment of painful osteoarthritis of the knee: A randomized, multicenter, double-blind, placebo-controlled study with primary end points at two months after the end of a three-month treatment period. Arthritis & Rheumatism, 56: 4055-4064. https://doi.org/10.1002/art.23056. The above article, published online on November 29, 2007 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the journal’s Editor-in-Chief, Dr. Daniel H. Solomon, the American College of Rheumatology, and Wiley Periodicals LLC. The retraction has been agreed following a post-hoc analysis by the research’s funder, TRB Chemedica International SA, that identified a discrepancy between the preliminary results of the post-hoc analysis and the results of the published article. The statistical analysis performed using the original database is deemed no longer reliable and the conclusions of the original study regarding the efficacy of diacerein versus placebo are not supported by robust data. As a result, the editors and funder are issuing this retraction.

PMID:37337725 | DOI:10.1002/art.42546

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Critical evaluation of strategies to achieve direct real-time PCR detection of swine pathogens in oral fluids

J Vet Diagn Invest. 2023 Jun 20:10406387231182102. doi: 10.1177/10406387231182102. Online ahead of print.

ABSTRACT

Based on publications reporting improvements in real-time PCR (rtPCR) performance, we compared protocols based on heat treatment or dilution followed by direct rtPCR to standard extraction and amplification methods for the detection of porcine reproductive and respiratory syndrome virus (PRRSV), influenza A virus (IAV), porcine epidemic diarrhea virus (PEDV), or Mycoplasma hyopneumoniae (MHP) in swine oral fluids (OFs). In part A, we subjected aliquots of positive OF samples to 1 of 4 protocols: protocol 1: heat (95°C × 30 min) followed by direct rtPCR; protocol 2: heat and cool (25°C × 20 min) followed by direct rtPCR; protocol 3: heat, cool, extraction, and rtPCR; protocol 4 (control): extraction and then rtPCR. In part B, positive OF samples were split into 3, diluted (D1 = 1:2 with Tris-borate-EDTA (TBE); D2 = 1:2 with negative OF; D3 = not diluted), and then tested by rtPCR using the best-performing protocol from part A (protocol 4). In part A, with occasional exceptions, heat treatment resulted in marked reduction in the detection of target and internal sample control (ISC) nucleic acids. In part B, sample dilution with TBE or OF produced no improvement in the detection of targets and ISCs. Thus, standard extraction and amplification methods provided superior detection of PRRSV, IAV, PEDV, and MHP nucleic acids in OFs.

PMID:37337714 | DOI:10.1177/10406387231182102

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Value of Dynamic 18F-FDG PET/CT in Predicting the Success of Neoadjuvant Chemotherapy in Patients with Locally Advanced Breast Cancer: A Prospective Study

Mol Imaging Radionucl Ther. 2023 Jun 20;32(2):94-102. doi: 10.4274/mirt.galenos.2022.97658.

ABSTRACT

OBJECTIVES: This prospective study was planned to compare the predictive value of dynamic 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) in locally advanced breast cancer patients (LABC) receiving neoadjuvant chemotherapy (NAC).

METHODS: Twenty seven patients with LABC [median age: 47, (26-66)] underwent a dynamic 18F-FDG PET study at baseline, and after 2-3 cycles of (NAC) were included (interim). Maximum standardized uptake value (SUVmax) values and SUV ratios for the 2nd, 5th, 10th, and 30th minutes and dynamic curve slope (SL) values and SL ratios were measured using 18F-FDG dynamic data. In addition, the values of SUVmean (2minSUVmean), SULpeak (2minSULpeak), metabolic volume (2minVol), and total lesion glycolysis (2minTLG) were measured for the first 2 min. Percent changes between baseline and interim studies were calculated and compared with the pathological results as the pathological complete response (PCR) or the pathological non-complete response (non-PCR). Receiver operating characteristic curves were obtained to calculate the area under the curve to predict PCR. Optimal threshold values were calculated to discriminate between PCR and non-PCR groups.

RESULTS: Baseline study SUV 30 (p=0.044), SUV 30/2 (p=0.041), SUV 30/5 (p=0.049), SUV 30/10 (p=0.021), SL 30/2 (p=0.029) and SL 30/5 (p=0.027) values were statistically significant different between PCR and non-PCR groups. The percentage changes of 2minVol between PCR and non-PCR groups were statistically significant. For the threshold value of -67.6% change in 2minVol, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 87.2%, 77.8%, 63.6%, 93.3%, and 80.7%, respectively (area under the curve: 0.826, p=0.009).

CONCLUSION: Semiquantitative parameters for dynamic 18F-FDG PET can predict PCR. % changes in 2minVol can identify non-responding patients better than other parameters.

PMID:37337702 | DOI:10.4274/mirt.galenos.2022.97658

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Role of PERK-mediated pathway in the effect of mild hypothermia after cerebral ischaemia/reperfusion

Eur J Clin Invest. 2023 Jun 19:e14040. doi: 10.1111/eci.14040. Online ahead of print.

ABSTRACT

BACKGROUND: Hypothermia is an effective method of reducing brain injury caused by a variety of neurological insults. It is aimed to elucidate whether a change in the expression of PERK-mediated pathway proteins is an indicator of the neuroprotective effect of mild hypothermia after cerebral ischaemia/reperfusion.

METHODS: One hundred and ninety-two male C57BL/6 mice were randomly divided into three groups: a sham group, a cerebral normothermic ischaemia/reperfusion (I/R) group and a cerebral hypothermic I/R group. A cerebral ischaemia model was established by ligating the bilateral common carotid artery for 15 min. Mice in the hypothermia group stayed in a cage that was set at 33°C, sprayed with a spray of 70% ethanol, and blown with two high-speed fans. The state of neurons was assessed on micropreparations stained with haematoxylin-eosin and TUNEL. The expressions of GRP78, p-perk, p-eif2α, ATF4 and CHOP were measured by western blot analysis 6, 12, 24 and 72 h after reperfusion.

RESULTS: The number of surviving cells was significantly higher in the hypothermia group than in the group without hypothermia (p < .05). The GRP78 expression in the hypothermia group was statistically higher (p < .05) than in the ischaemia/reperfusion group. Optical densities of p-perk, p-eif2α and ATF4 in hippocampus CA1 neurons ischaemia were statistically significantly lower in the hypothermia group than in the ischaemia/reperfusion group (p < .05). The CHOP expression in the hypothermia group was statistically lower (p < .05) than in the ischaemia/reperfusion group.

CONCLUSION: Mild hypothermia for 6 h promoted moderate neuroprotection by mediating the expression of GRP78, p-PERK, p-eIF2α, ATF4 and CHOP.

PMID:37337313 | DOI:10.1111/eci.14040

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Tick communities of cattle in smallholder rural livestock production systems in sub-Saharan Africa

Parasit Vectors. 2023 Jun 19;16(1):206. doi: 10.1186/s13071-023-05801-5.

ABSTRACT

BACKGROUND: The majority of the African population lives in rural areas and depends on agriculture for their livelihoods. To increase the productivity and sustainability of their farms, they need access to affordable yield-enhancing inputs of which parasite control is of paramount importance. We therefore determined the status of current tick species with the highest economic impact on cattle by sampling representative numbers of animals in each of seven sub-Saharan countries.

METHODS: Data included tick species’ half-body counts from approximately 120 cattle at each of two districts per country, collected four times in approximately 1 year (to include seasonality). Study sites were chosen in each country to include high cattle density and tick burden.

RESULTS: East Africa (Ethiopia, Uganda and Tanzania) showed overall a higher diversity and prevalence in tick infestations compared to West African countries (Benin, Burkina Faso, Ghana and Nigeria). In East Africa, Amblyomma variegatum (vector of Ehrlichia ruminantium), Rhipicephalus microplus (Babesia bovis, B. bigemina, Anaplasma marginale), R. evertsi evertsi (A. marginale) and R. appendiculatus (Theileria parva) were the most prevalent tick species of economic importance. While the latter species was absent in West Africa, here both A. variegatum and R. microplus occurred in high numbers. Rhipicephalus microplus had spread to Uganda, infesting half of the cattle sampled. Rhipicephalus appendiculatus is known for its invasive behaviour and displacement of other blue tick species, as observed in other East and West African countries. Individual cattle with higher body weights, as well as males, were more likely to be infested. For six tick species, we found reduced infestation levels when hosts were treated with anti-parasiticides.

CONCLUSIONS: These baseline data allow the determination of possible changes in presence and prevalence of ticks in each of the countries targeted, which is of importance in the light of human-caused climate and habitat alterations or anthropogenic activities. As many of the ticks in this study are vectors of important pathogens, but also, as cattle may act as end hosts for ticks of importance to human health, our study will help a wide range of stakeholders to provide recommendations for tick infestation surveillance and prevention.

PMID:37337296 | DOI:10.1186/s13071-023-05801-5

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Effect of the preoperative assessment of the anteroposterior diameters of the spinal canal and dural area on the efficacy of oblique lumbar interbody fusion in patients with lumbar spinal stenosis

J Orthop Surg Res. 2023 Jun 19;18(1):440. doi: 10.1186/s13018-023-03913-3.

ABSTRACT

OBJECTIVE: The purpose of this study was to quantify the degree of lumbar spinal stenosis by assessing the anterior and posterior vertebral canal diameter and dural area, determine the sensitivity of the anterior and posterior spinal canal diameter, dural area and dural occupying rate in predicting the postoperative efficacy of oblique lumbar interbody fusion (OLIF) for patients with single-stage lumbar spinal stenosis, and identify the corresponding indicators suggesting that OLIF surgery should not be performed.

METHODS: In a retrospective analysis of patients who had previously undergone OLIF surgery in our hospital, we included a total of 104 patients with lumbar spinal stenosis who had previously undergone single-stage surgery in our hospital. Three independent observers were employed to measure the anterior and posterior diameter of the spinal canal (AD, mm), dural area (CSA, mm2), the spinal canal area (SCA, mm2), and the ratio of the dural area to the spinal canal area (DM, %) at the disc level with the most severe stenosis on MRI. According to the values of AD and CSA in preoperative MRI, patients were divided into three groups: A, B, and C (Group A: AD > 12 and 100 < CSA ≤ 130, group B: Except A and C, group C: AD ≤ 10 and CSA ≤ 75). Preoperative and postoperative clinical outcome scores (Japanese Orthopaedic Association [JOA] score, VAS score, modified Macnab standard) of 104 patients were statistically.

RESULTS: There were significant differences in the preoperative and postoperative clinical correlation scores among the mild, moderate and severe lumbar spinal stenosis groups. The improvement rate of the post treatment JOA score, the difference between the preoperative and postoperative VAS score, and the modified Macnab standard were compared pairwise. There was no statistical significance in the improvement rate of the post treatment JOA score, the difference between the preoperative and postoperative VAS score, and the modified Macnab standard between Group A and Group B (P = 0.125, P = 0.620, P = 0.803). There were statistically significant differences between Group A and Group C and between Group B and Group C in the improvement rate of the JOA score, the difference in the pre- and postoperative VAS score, and the modified Macnab standard. The anterior and posterior vertebral canal diameter and dural area are sensitive predictors of the postoperative efficacy of OLIF surgery for single-stage lumbar spinal stenosis. Moreover, when the anterior and posterior vertebral canal diameter was less than 6.545 mm and the dural area was less than 34.43 mm2, the postoperative effect of OLIF surgery was poor.

CONCLUSIONS: All the patients with mild, moderate, and severe lumbar spinal stenosis achieved curative effects after OLIF surgery. Patients with mild and moderate lumbar spinal stenosis had better curative effects, and there was no significant difference between them, while patients with severe lumbar spinal stenosis had poor curative effects. Both the anteroposterior diameter of the spinal canal and the dural area of the spinal canal were sensitive in predicting the curative effect of OLIF surgery for single-stage lumbar spinal stenosis. When the anterior and posterior vertebral canal diameter was less than 6.545 mm and the dural area was less than 34.43 mm2, the postoperative effect of OLIF surgery was poor.

PMID:37337281 | DOI:10.1186/s13018-023-03913-3

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Comparison of serum acylcarnitine levels in patients with myalgic encephalomyelitis/chronic fatigue syndrome and healthy controls: a systematic review and meta-analysis

J Transl Med. 2023 Jun 19;21(1):398. doi: 10.1186/s12967-023-04226-z.

ABSTRACT

BACKGROUND: Myalgic encephalomyelitis/chronic fatigue syndrome/systemic exertion intolerance disease (ME/CFS/SEID) is a condition diagnosed primarily based on clinical symptoms, including prolonged fatigue and post-exertional malaise; however, there is no specific test for the disease. Additionally, diagnosis can be challenging since healthcare professionals may lack sufficient knowledge about the disease. Prior studies have shown that patients with ME/CFS/SEID have low serum acylcarnitine levels, which may serve as a surrogate test for patients suspected of having this disease. This systematic review and meta-analysis aimed to investigate the differences in serum acylcarnitine levels between patients with ME/CFS/SEID and healthy controls.

METHODS: This systematic review was conducted using PubMed and Ichushi-Web databases. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, we included all studies from the databases’ inception until February 17, 2023, that evaluated blood tests in both patients with ME/CFS/SEID and healthy control groups. The primary endpoint was the difference in serum acylcarnitine levels between the two groups.

RESULTS: The electronic search identified 276 studies. Among them, seven met the eligibility criteria. The serum acylcarnitine levels were analyzed in 403 patients with ME/CFS/SEID. The patient group had significantly lower serum acylcarnitine levels when compared with the control group, and the statistical heterogeneity was high.

CONCLUSION: The patient group had significantly lower serum acylcarnitine levels when compared with the control group. In the future, the measurement of serum acylcarnitine levels, in addition to clinical symptoms, may prove to be a valuable diagnostic tool for this condition.

PMID:37337273 | DOI:10.1186/s12967-023-04226-z