Elevated serum androgen levels in patients with PCOS associated with multiple metabolic abnormalities: Study

Elevated serum androgen levels in patients with PCOS associated with multiple metabolic abnormalities suggest a study published in the Gynecological Endocrinology.

This study aimed to investigate the impact of serum androgen levels on metabolic profiles in patients with polycystic ovary syndrome (PCOS). They included 216 patients with PCOS and 216 healthy individuals selected as the control group. According to the measured serum androgen levels, patients with PCOS were divided into the hyperandrogenism group and non-hyperandrogenism group. Clinical metabolic indicators were assessed and compared between the two groups. Additionally, they assessed the correlation between androgen levels and clinical metabolic indicators.

Results: The body mass index, waist-to-hip ratio, mF-G score, and acne score, as well as T, LH, LSH/FSH, FPG, Cr, UA, TG, TC, and LDL-C levels were significantly higher in the PCOS group than in the control group. The incidence of hyperandrogenism and clinical hyperandrogenism in the PCOS group was significantly higher than that in the control group. Regarding clinical hyperandrogenism, hirsutism, acne, and acanthosis nigricans were significantly more common in the PCOS group than in the control group. Serum androgen levels were significantly correlated with the mF-G score, acne score, FSH, glucose concentration at 30 min, glucose concentration at 60 min, glucose concentration at 120 min, FINS, N120, HOMA-IR, HbA1c, AUCG, UA, TG, and hHDL-Clevels. Elevated serum androgen levels are commonly observed in patients with PCOS and are associated with multiple metabolic abnormalities. Therefore, it is recommended to regularly monitor glucose and lipid metabolism-related indicators in patients with PCOS who have elevated androgen levels.

Reference:

Ting Z, Xinghua T, Xiao X, Lingchuan L, Xiaomei W, Tao Y. The impact of androgen levels on serum metabolic profiles in patients with polycystic ovary syndrome. Gynecol Endocrinol. 2024 Dec;40(1):2352136. doi: 10.1080/09513590.2024.2352136. Epub 2024 May 11. PMID: 38733359.

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Electronic nicotine delivery systems linked to earlier onset of asthma in adults: JAMA

USA: A recent study has shed light on a concerning correlation between the use of electronic nicotine delivery systems (ENDS) and the age of asthma onset among both adults and youths in the United States. Published in JAMA Network Open, the research adds to growing concerns about the potential health implications of vaping, particularly concerning respiratory conditions.

This cohort study comprised 7766 adults and 17 023 youths from the Population Assessment of Tobacco and Health Study (2013-2021). It revealed that adults who used ENDS in the past 30 days had an increased risk for asthma incidence at earlier ages versus adults who did not use ENDS in the past 30 days. This finding did not apply to youths.

“These findings suggest the need for tobacco regulations, intervention campaigns, prevention, and cessation programs to prevent early age of asthma onset among adults using ENDS, to protect public health, and to help improve asthma screening guidelines,” the researchers wrote.

The association of the use of electronic nicotine delivery systems with the age of asthma onset is unknown. To fill this knowledge gap, Adriana Pérez, The University of Texas Health Science Center at Houston, School of Public Health, Austin, and colleagues explored the association of past 30-day ENDS use with the age of asthma onset in youths and adults who did not have chronic obstructive pulmonary disease (COPD) or asthma and never used cigarettes.

For this purpose, the researchers conducted a secondary analysis of waves 1 to 6 of the US study. Eligible participants included (≥18 years) and youths (12-17 years) who did not have COPD or asthma at the first wave of participation.

The exposure was past 30-day ENDS use at the first wave of participation in the study preceding the asthma onset.

Upper and lower age limits were estimated using the age reported at the first wave of participation and the number of weeks between follow-up waves until asthma was first reported or censored. Weighted interval-censoring Cox regression was used to estimate the association of past 30-day ENDS use with the age of asthma onset. Interval-censoring survival analysis estimated the cumulative hazard function for the age of asthma onset.

The researchers reported the following findings:

  • 24, 789 participants were included, with 7766 adults (3305 male [weighted percentage, 40.89%] and 4461 female [weighted percentage, 59.11%]), representing 80.0 million adults, and 17 023 youths (8496 male [weighted percentage 49.32%] and 8514 female [weighted percentage, 50.60%]), representing 33.9 million youths. By age 27, 6.2 per 1000 adults reported asthma incidence (hazard ratio [HR], 0.62%).
  • While controlling for covariates, there was a 252% increased risk of the onset of asthma at earlier ages for adults who used ENDS in the past 30 days versus adults who did not (adjusted HR, 3.52).
  • For youths, there was no association of ENDS use in the past 30 days with the age of asthma onset (adjusted HR, 1.79), which could be due to a lack of statistical power.

“Modifying screening asthma guidelines to incorporate the P30 ENDS use may lead to early asthma detection leading to better symptom control, fewer adverse effects, lower doses of medication, and improved treatment outcomes,” the researchers wrote.

“Cessation and prevention programs directed at ENDS use are needed to alleviate its impact on the age of asthma onset,” they concluded.

Reference:

Pérez A, Valencia S, Jani PP, Harrell MB. Use of Electronic Nicotine Delivery Systems and Age of Asthma Onset Among US Adults and Youths. JAMA Netw Open. 2024;7(5):e2410740. doi:10.1001/jamanetworkopen.2024.10740

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Bariatric surgery may slow cognitive decline for people with obesity: Study

Within the next 10 years, it’s projected that up to 50% of United States adults will be affected by obesity, which is associated with cognitive impairment and dementia.

Investigators at Michigan Medicine found that people with obesity who underwent bariatric surgery had stable cognition two years later.

Researchers say it suggests that bariatric surgery may mitigate the natural history of cognitive decline expected in people with obesity.

The results are published in the Journal of Nutrition, Health & Aging.

“Since individuals with obesity experience more rapid cognitive decline than those without, stable cognition two years after bariatric surgery may be considered a success against historical trends, yet future controlled trials are needed to test this,” said first author Evan Reynolds, Ph.D., lead statistician for the NeuroNetwork for Emerging Therapies at Michigan Medicine.

Using a collection of memory and language tests developed by the National Institutes of Health, as well as the Rey Auditory Verbal Learning Test, the research team assessed over 85 bariatric surgery patients at two-year follow up.

They found that NIH Cognitive Battery test scores remained stable, with secondary executive function tests showing improvement.

One of the memory assessments, however, declined following surgery.

While this current study is the largest to assess changes two years after bariatric surgery, researchers say, the results conflict with previous studies which found improved memory and executive functioning among similar patients.

“That study was primarily made up of patients who received gastric bypass, while our study was made up primarily of individuals that completed a sleeve gastrectomy,” Reynolds said.

“To provide the best evidence on the effectiveness of bariatric surgery on cognition and potential differences between surgery types, we must conduct larger observational studies or randomized, controlled trials.”

After bariatric surgery, improvements in diabetes complications, such as peripheral neuropathy, chronic kidney disease and retinopathy, were not associated with improved cognition.

“Metabolic factors, including diabetes and obesity, are associated with cognitive decline, but we still need to better understand how best to treat these factors to improve patients’ cognitive outcomes,” said senior author Brian Callaghan, M.D., a neurologist at University of Michigan Health and the Eva L. Feldman., M.D, Ph.D., professor of neurology at U-M Medical School.

Reference:

Reynolds, E.L., Votruba, K.L., Watanabe, M. et al. The Effect of Surgical Weight Loss on Cognition in Individuals with Class II/III Obesity. J Nutr Health Aging 27, 1153–1161 (2023). https://doi.org/10.1007/s12603-023-2047-1.

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Study reveals Perioperative Risk Factors for ICU Admission After Craniotomy

Recently published study evaluates the relationship between perioperative risk factors and postoperative neurological complications requiring ICU admission following elective craniotomy for intracranial neoplasm, as well as the validation of the Cranio Score. The primary objective was to assess the relationship between perioperative risk factors and the incidence of early postoperative complications, while the secondary outcomes studied were 30-day postoperative morbidity/mortality and the association with patient-related risk factors.

Findings and Risk Factors

The study included 119 patients scheduled for elective craniotomy and tumor excision, and found that 37.82% of the patients required postoperative ICU care with a mean ICU stay of 1.92 ± 4.91 days. Several perioperative risk factors were associated with a higher incidence of ICU care, including tumor location, preoperative deglutition disorder, Glasgow Coma Scale (GCS) less than 15, motor deficit, cerebellar deficit, midline shift >3 mm, mass effect, tumor size, use of blood products, lateral position, inotropic support, elevated systolic/mean arterial pressures, and duration of anesthesia/surgery. Maximum and minimum systolic arterial pressures were identified as the only independent risk factors. The Cranio Score was found to be an accurate predictor of complications at a cut-off point of >10.52%, and the preoperative motor deficit was the only independent risk factor associated with 30-day morbidity.

Conclusion and Recommendations

The authors concluded that perioperative hemodynamic effects are an independent predictor of postoperative ICU requirement, and the Cranio Score was shown to be a good scoring system for postoperative complications. The study suggested that aggressive control of systolic arterial pressures may minimize the expansion of hemorrhagic strokes. The findings also highlighted the importance of perioperative vigilance and optimization of preoperative hypertension in neurosurgical patients. The study acknowledged certain limitations, such as being single-centric with a smaller sample size and short follow-up period, and recommended including a retrospective cohort for correlation to enhance statistical accuracy.

In summary, the study identified several perioperative risk factors associated with postoperative neurological complications requiring ICU care, with a focus on hemodynamic effects and the effectiveness of the Cranio Score as a predictor of postoperative complications. The detailed analysis of the findings provides valuable insights for clinical practice and highlights the significance of careful perioperative management in patients undergoing elective craniotomy for intracranial neoplasms.

Key Points

– The study aimed to assess the relationship between perioperative risk factors and postoperative neurological complications requiring ICU admission following elective craniotomy for intracranial neoplasm. It also sought to validate the Cranio Score and its effectiveness in predicting postoperative complications. The primary objective was to evaluate the relationship between perioperative risk factors and the incidence of early postoperative complications, with the secondary outcomes including 30-day postoperative morbidity/mortality and the association with patient-related risk factors.

– The authors concluded that perioperative hemodynamic effects are an independent predictor of postoperative ICU requirement and that the Cranio Score is a valuable scoring system for predicting postoperative complications. The study recommended aggressive control of systolic arterial pressures to minimize the expansion of hemorrhagic strokes, emphasized the importance of perioperative vigilance, and highlighted the significance of careful perioperative management in patients undergoing elective craniotomy for intracranial neoplasms. The study acknowledged limitations, such as its single-centric nature, smaller sample size, and short follow-up period, and recommended including a retrospective cohort for correlation to enhance statistical accuracy.

Reference-

Biswas K, Agrawal S, Gupta P, Arora R. Evaluation of risk factors for postoperative neurologic intensive care admission after brain tumor craniotomy: A single center longitudinal study. J Anaesthesiol Clin Pharmacol 2024;40:217-27.

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New guideline: Barrett’s esophagus can precede esophageal cancer, but not all patients need a procedure to remove abnormal cells

The American Gastroenterological Association’s (AGA) new evidence-based Clinical Practice Guideline on Endoscopic Eradication Therapy of Barrett’s Esophagus and Related Neoplasia, published today in Gastroenterology, establishes updated guidance for Barrett’s esophagus patients.

A precursor to esophageal cancer, Barrett’s esophagus is a condition in which the cells in the esophagus have been replaced with non-cancerous abnormal cells. These cells can progress to a condition called dysplasia, which may in turn become cancer. Dysplasia is considered low-grade or high-grade, depending on the degree of cellular change.

“While the benefit is clear for patients with high-grade dysplasia, we suggest considering endoscopic eradication therapy for patients with low-grade dysplasia after clearly discussing the risks and benefits of endoscopic therapy,” said guideline author Dr. Tarek Sawas, assistant professor in the department of internal medicine at UT Southwestern. “A patient-centered approach ensures that treatment decision is made collaboratively, taking into account both the medical evidence and the patient’s preferences and values. Surveillance is a reasonable option for patients who place a higher value on harms and a lower value on the uncertain benefits regarding reduction of esophageal cancer mortality”

Endoscopic eradication therapy consists of minimally invasive procedures such as endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), followed by ablation (burning or freezing) techniques.

Key guideline takeaways:

• For patients with low-grade dysplasia, it may be appropriate to either remove or monitor the cells. This is a decision doctors and patients should make together after discussing the risks and benefits of treatment.

• For patients with high-grade dysplasia, AGA recommends endoscopic therapy to remove the abnormal pre-cancerous cells.

• Most patients undergoing endoscopic eradication can be safely treated with EMR, which has a lower risk of adverse events. Patients who undergo ESD can face an increased risk of strictures and perforation. AGA recommends reserving ESD primarily for lesions suspected of harboring cancers invading more deeply into the wall of the esophagus or those who have failed EMR.

• Patients with Barrett’s esophagus (dysplasia or early cancer) should be treated and monitored by expert endoscopists and pathologists who have experience in Barrett’s neoplasia.

“We need to have a conversation with patients in clinic prior to when they show up in the endoscopy unit on a gurney. Patients need to be fully aware of the risks and benefits, both in the short term but also in the long run, to decide which treatment approach is best for them. This decision often comes down to personal factors and values,” added guideline author Dr. Joel Rubenstein who is the director of the Barrett’s Esophagus Program at the University of Michigan.

The guideline provides the following general implementation considerations:

• Tobacco use and obesity are risk factors for esophageal adenocarcinoma, so counseling patients to abstain from tobacco use and to lose weight can help improve outcomes.

• In patients with Barrett’s esophagus, reflux control should be optimized with both medication and lifestyle modifications.

Reference:

Joel H. Rubenstein, Tarek Sawas, Sachin Wani, Siddharth Singh, David Katzka, Perica Davitkov, AGA Clinical Practice Guideline on Endoscopic Eradication Therapy of Barrett’s Esophagus and Related Neoplasia, Gastroenterology, https://doi.org/10.1053/j.gastro.2024.03.019.

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Treatment with IV acetaminophen may not improve organ dysfunction in critically ill patients with sepsis: ASTER trial

USA: In a groundbreaking development in critical care medicine, the ASTER randomized clinical trial (RCT) has shed light on the potential of acetaminophen in preventing and treating organ dysfunction among critically ill patients battling sepsis. The findings of this trial, conducted across multiple medical centers, bring hope for more effective management of sepsis, a leading cause of mortality in intensive care units worldwide.

The study, published in the Journal of the American Medical Association (JAMA), revealed that intravenous (IV) acetaminophen is safe but failed to significantly improve days alive and free of organ support in critically ill patients with sepsis.

“In the RCT of 447 adults, acetaminophen was safe, but there was no meaningful difference in the number of days alive and free of organ support in the acetaminophen arm (20.2 days) versus the placebo arm (19.6 days),” the researchers reported. There was no significant interaction between cell-free hemoglobin levels and acetaminophen.

Sepsis, a life-threatening condition triggered by the body’s extreme response to an infection, often leads to organ dysfunction and failure. Despite advances in critical care, treatment options for sepsis have remained limited, prompting researchers to explore alternative therapies. Acetaminophen (paracetamol), a widely available over-the-counter medication known for its antipyretic and analgesic properties, emerged as a potential candidate for mitigating the devastating effects of sepsis on organ function.

Acetaminophen has many pharmacological effects that may benefit sepsis, including inhibition of cell-free hemoglobin-induced oxidation of lipids and other substrates. Considering this, Lorraine B. Ware, Vanderbilt University Medical Center, Nashville, Tennessee, and colleagues aimed to investigate if acetaminophen increases days alive and free of organ dysfunction in sepsis compared with placebo.

For this purpose, the researchers conducted a phase 2b randomized, double-blind, clinical trial from 2021 to 2023 with 90-day follow-up. It enrolled adults with sepsis and circulatory or respiratory organ dysfunction in the intensive care unit or emergency department of 40 US academic hospitals within 36 hours of presentation.

Patients were randomized to 1 g of IV acetaminophen every 6 hours or placebo for five days.

The primary endpoint was days alive and free of organ support (vasopressors, mechanical ventilation, and kidney replacement therapy) to day 28. Treatment effect modification was assessed for acetaminophen by pre-randomization plasma cell-free hemoglobin level higher than 10 mg/dL.

The study led to the following findings:

  • Of 447 patients enrolled (mean age, 64 years, 51% female, mean Sequential Organ Failure Assessment [SOFA] score, 5.4), 227 were randomized to acetaminophen and 220 to placebo.
  • Acetaminophen was safe with no difference in liver enzymes, hypotension, or fluid balance between treatment arms.
  • Days alive and free of organ support to day 28 were not meaningfully different for acetaminophen (20.2 days) versus placebo (19.6 days).
  • Among 15 secondary outcomes, total, respiratory, and coagulation SOFA scores were significantly lower on days 2 through 4 in the acetaminophen arm, so was the rate of development of acute respiratory distress syndrome within seven days (2.2% versus 8.5% acetaminophen vs placebo).
  • There was no significant interaction between cell-free hemoglobin levels and acetaminophen.

The findings showed that treatment of critically ill patients with sepsis with either circulatory or respiratory organ dysfunction with 1 g of IV acetaminophen every 6 hours for five days was safe but did not significantly improve the primary outcome of days alive and free of organ support to day 28, including vasopressors, mechanical ventilation, and kidney replacement therapy.

Reference:

Ware LB, Files DC, Fowler A, et al. Acetaminophen for Prevention and Treatment of Organ Dysfunction in Critically Ill Patients With Sepsis: The ASTER Randomized Clinical Trial. JAMA. Published online May 19, 2024. doi:10.1001/jama.2024.8772

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Air pollution promotes inflammation in brain, accelerates cognitive decline and increases risk of dementia: Study

Results from new study suggests that long-term exposure to air pollution leads to increased risk in dementia in Denmark.

“We also find association with noise, but this seems to be explained by air pollution primarily. Our study is in line with growing international knowledge on this topic.” says Professor at Section of Environmental Health Zorana Jovanovic Andersen.

This is an important finding which adds that air pollution, beyond well-known effects on respiratory and cardiovascular system, also has major impacts on our brain, promoting inflammation in the brain, accelerating cognitive decline, and increasing risk of dementia.

“This is the first study in Denmark showing a link between air pollution and dementia. Although air pollution levels in Denmark have been declining and are relatively low, compared of the rest of Europe and world, this study shows that there are still significant and concerning health effects that demand more action and policies towards reduction of air pollution. As we are going to live longer, and more and more people will be diagnosed with dementia, this finding is important as it offer an opportunity to prevent new dementia cases, and ensure more healthy aging, by cleaning up the air we breathe,” says Zorana Jovanovic Andersen.

An internationally unique study

The study followed a cohort of nurses for 27 years, from 1993 until 2020.

“This is internationally unique and necessary in regards of the development of dementia which can take many years. Second, the air pollution was estimated for each participant for a total of 41 years (from 1979 until 2020), which is also incredible. Third, we had extensive details about participant’s lifestyle and socio-economics and all our result take them in consideration. The novelty of this study is the very detailed and accurate data that we used,” says Research Assistant from Section of Environmental Health Stéphane Tuffier.

“Nurses with higher physical activity had a lower risk of dementia when exposed to air pollution compared to nurses with less physical activity. This indicates that physical activity might mitigate the adverse effects of air pollution on cognitive decline and risk of dementia,” Tuffier says.

Reference:

Stéphane Tuffier, Jiawei Zhang, Marie Bergmann, Rina So, George Maria Napolitano, Thomas Cole-Hunter, Matija Maric, Sonja Antic, Jørgen Brandt, Matthias Ketzel, Steffen Loft, Youn-Hee Lim, Zorana Jovanovic Andersen, Long-term exposure to air pollution and road traffic noise and incidence of dementia in the Danish Nurse Cohort, Alzheimer s & Dementia, https://doi.org/10.1002/alz.13814.

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Both water jet flossing and interdental flossing reduce plaque accumulation and gingival bleeding among orthodontic patients: Study

In a head-to-head battle for oral hygiene supremacy among orthodontic patients, a recent study compared water jet flossing to traditional interdental flossing. With both methods significantly reducing plaque buildup and gingival bleeding after two weeks, the water jet flossing group showed a slight edge in plaque removal and bleeding reduction, although not statistically significant.

Orthodontic treatment presents challenges with plaque accumulation around brackets, archwires, and elastics, leading to retained plaque and gingival inflammation. Conventional toothbrushing may not be enough, requiring additional oral hygiene aids like interproximal brushes, dental flosses, and water flossers. Limited research exists on comparing water flossing and interdental flossing in orthodontic patients. Therefore, this study aims to assess their effectiveness in maintaining oral hygiene during active orthodontic treatment.

A single-blind, randomized, parallel clinical study recruited orthodontic patients with full-mouth brackets and archwires. Thirty participants were randomly assigned to either water jet flossing or interdental flossing groups. All participants were instructed to brush twice daily with a provided toothbrush and toothpaste and use the assigned intervention once daily at night. Clinical measures, including the Gingival Bleeding Index (BI), Plaque Index (PI), and Gingival Index (GI), were recorded at baseline and day 14. Descriptive statistics and statistical tests were performed using SPSS software. Results: The water jet flossing group demonstrated a slightly higher, albeit non-significant, benefit in plaque removal (median difference of 6.79%%, P = 0.279) and bleeding reduction (median difference of 5.21%%, P = 0.172) compared to the interdental flossing group after two weeks. Both groups showed significant reductions in gingival bleeding index and plaque index from baseline to the 2-week follow-up. The interdental flossing group had median mean percentage differences of 16.13%% (plaque index) and 23.57% (gingival bleeding index), while the water jet flossing group had median percentage differences of 21.87% (plaque index) and 32.29% (gingival bleeding index). No significant changes in gingival index grades were observed in either group. Both water jet flossing and interdental flossing were effective in reducing plaque accumulation and gingival bleeding among orthodontic patients. While no significant differences were found between the two methods, water jet flossing showed a potential advantage. Further research is needed to validate its effectiveness, assess long-term impact, and understand its benefits for orthodontic patients.

Reference:

AlMoharib, H.S., Alqasem, A., Almusfer, G. et al. The effectiveness of water jet flossing and interdental flossing for oral hygiene in orthodontic patients with fixed appliances: a randomized clinical trial. BMC Oral Health 24, 498 (2024). https://doi.org/10.1186/s12903-024-04166-0

Keywords:

AlMoharib, H.S., Alqasem, A., Almusfer, G, effectiveness, water, jet flossing, interdental, flossing, oral hygiene, orthodontic patients, fixed appliances, randomized, clinical trial, BMC Oral Health, Water jet, Dental floss, Orthodontic treatment, Plaque index, Gingivitis

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Ziltivekimab targets IL-6 to effectively treat anemia patients with CKD stage 3-5, finds study

Anemia affects about 15% of CKD patients and is linked to increased morbidity, mortality, and reduced quality of life. In 30-50% of dialysis patients with kidney failure, high biomarkers of inflammation such as IL-6 and hsCRP are present. Elevated hsCRP (high-sensitivity C-reactive protein) levels are also associated with anemia onset in early CKD stages. Reducing inflammation (indicated by hsCRP decline) may improve CKD patient outcomes.

Pablo E Pergola et al. and colleagues, in a recent study published in the Journal of the American Society of Nephrology, said that Anti-inflammatory therapy with ziltivekimab improved anaemia and iron homeostasis markers in stage 3-5 CKD patients with systemic inflammation, suggesting a possible role in anaemia management.

In the phase 2 RESCUE trial, ziltivekimab reduced inflammation biomarkers compared to placebo in CKD patients with systemic inflammation (hs-CRP ≥2 mg/L). This subanalysis assessed ziltivekimab’s effect on Hb and iron homeostasis in these patients.

This study analyzed exploratory endpoints from the RESCUE trial, which included 264 adults with CKD stages 3-5 and high-sensitivity C-reactive protein ≥2 mg/L. Participants were randomized to receive a placebo or subcutaneous ziltivekimab (7.5, 15, or 30 mg) once every four weeks for up to 24 weeks.

  • There was a significant increase in Hb levels with ziltivekimab 7.5, 15, and 30 mg (treatment differences versus placebo: +0.57 g/dl, +1.05 g/dl, and +0.99 g/dl), respectively.
  • From baseline to week 12, Ziltivekimab was associated with increased serum iron levels, total iron-binding capacity, and transferrin saturation.
  • There were no major safety concerns reported.
  • Anemia, sustained thrombocytopenia, sustained neutropenia, and iron deficiency anemia cases were infrequent and similar across all groups.

Due to COVID-19, the trial was terminated early, and 12-week data is presented in the study.

The levels of biomarkers related to iron metabolism increased with ziltivekimab compared to placebo, suggesting that anti-inflammatory therapy may be beneficial for treating anemia in CKD.

The decrease in hepcidin levels may have been physiologically meaningful, as it could explain the observed effects on iron metabolism and, ultimately, on Hb levels, they added.

Novo Nordisk A/S funded the study.

Reference:

Pergola PE et al. Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3-5: An Analysis of a Randomized Trial (RESCUE). J Am Soc Nephrol. 2023 Dec 13.

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Postoperative PRP Injection may Not Enhance ACL Reconstruction Outcomes: Study

Researchers in a recent study have found that postoperative intra-articular platelet-rich plasma (PRP) injection does not lead to superior improvement in knee symptoms and function compared to no injection after anterior cruciate ligament reconstruction (ACLR). This study was published in JAMA Network Open by Zipeng Ye and colleagues.

Anterior cruciate ligament (ACL) injuries are common in athletes and individuals engaging in physical activities, often requiring surgical intervention for reconstruction. Platelet-rich plasma (PRP) therapy has emerged as a potential adjunctive treatment for musculoskeletal injuries due to its purported ability to enhance tissue healing and regeneration. However, its efficacy in ACL reconstruction outcomes remains uncertain, with conflicting evidence from previous studies.

To compare subjective outcomes and graft maturity in patients undergoing ACL reconstruction with and without postoperative PRP injection. This randomized clinical trial included 120 patients aged 16 to 45 undergoing ACL reconstruction at a national medical center in China. Patients were randomized to receive either postoperative PRP injection (n=60) or no injection (n=60). Follow-up occurred for 12 months. Patients in the PRP group received 3 doses of intra-articular PRP injection at monthly intervals postoperatively, while the control group did not receive PRP injection. Both groups underwent the same rehabilitation protocol and follow-up schedule.

The key findings of the study were:

  • Among the 120 participants, 114 were available for primary outcome analysis.

  • At 12 months postoperatively, the mean Knee Injury and Osteoarthritis Outcome Score (KOOS4) was 78.3 in the PRP group and 76.8 in the control group, with no statistically significant difference between groups (adjusted mean difference, 2.0; 95% CI, -2.3 to 6.3; P = .36).

  • Secondary outcomes, including patient-reported outcomes, graft maturity on magnetic resonance imaging, and physical examinations, did not significantly differ between groups, except for sports and recreation level and graft maturity at 6 months.

  • Adverse events associated with PRP injection included pain at the injection site and knee swelling post-injection.

In this randomized clinical trial, the addition of postoperative intra-articular PRP injection did not result in superior improvement of knee symptoms and function at 12 months compared to no injection in patients undergoing ACL reconstruction. These findings suggest that PRP injection may not provide added benefit in the context of ACL reconstruction and highlight the need for further research to determine its appropriate indications and efficacy in musculoskeletal disorders.

Reference:

Ye, Z., Chen, H., Qiao, Y., Wu, C., Cho, E., Wu, X., Li, Z., Wu, J., Lu, S., Xie, G., Dong, S., Xu, J., & Zhao, J. (2024). Intra-articular platelet-rich plasma injection after anterior cruciate ligament reconstruction: A randomized clinical trial. JAMA Network Open, 7(5), e2410134. https://doi.org/10.1001/jamanetworkopen.2024.10134

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