More cancers may be treated with personalized therapies before surgery, suggests study

Breast, bladder, and pancreatic cancers are increasingly being treated with a broad range of therapies before a patient undergoes surgery, and cancer stage at diagnosis continues to be a leading factor in determining a person’s survival rate for all types of cancer, according to the first-ever annual cancer report from the National Cancer Database (NCDB) of the American College of Surgeons (ACS) Cancer Programs.

The findings were published this weekin the Journal of the American College of Surgeons (JACS).

The NCDB, a clinical oncology database jointly operated by the ACS and the American Cancer Society, captures hospital-based data on approximately 74% of all cancers diagnosed in the U.S. and is one of the most comprehensive cancer research databases.

“This report is our approach to making NCDB data more broadly available to others who may benefit from understanding this large source of cancer data and what it’s telling us about the current state of cancer diagnoses and treatments in the United States,” said first author Elizabeth B. Habermann, MPH, PhD, chair of the ACS Cancer Data Modeling Committee and a professor of health services research at Mayo Clinic in Rochester, Minnesota.

The report summarizes new observations and recent trends in cancer diagnoses, and includes many details not usually included in other cancer reports, the authors said. Some unique metrics tracked in NCDB data include length of stay, hospital readmission rates, and hospital type (such as a community or academic institution). These metrics help hospitals assess quality of care and inform treatment options for the growing number of cancer patients nationwide, the authors added.

The report focuses on 2021, the most recently available data from the NCDB at the time, and overall trends in cancer from 2004-2021.

Main Findings

  • More cancers are being treated with targeted medical therapies before surgery: The use of neoadjuvant systemic therapy, which is usually given to patients before surgery or other primary cancer treatment, has increased for breast, urinary bladder, and pancreatic cancers, though it remains low for other cancers. Systemic therapies encompass a broad range of treatment options, including hormone therapy, immunotherapy, and chemotherapy, designed to reach cells throughout the body to hopefully shrink an existing tumor and prevent further spread. According to the report, the use of neoadjuvant systemic therapy, particularly hormone therapy, for breast cancer increased from 11% in 2010 to 18% in 2021 at Commission on Cancer (CoC) accredited sites. Substantial increases for neoadjuvant systematic therapy were also noted for pancreatic (224% increase) and urinary bladder (102% increase) cancers since 2010.Although there was a slight decrease in the use of systemic neoadjuvant therapy in 2021 in some cancers due to the pandemic, the authors said these trends show a sustained increase in the use of neoadjuvant systemic therapy for certain cancers.“One of the goals of neoadjuvant systemic therapy is to treat the cancer beforehand to hopefully decrease the size of the tumor and/or the lymph node involvement so that a less extensive surgery can be performed,” said Judy C. Boughey, MD, FACS, senior author of the JACS study and chair of the ACS Cancer Research Program.Dr. Boughey, who also serves as division chair of breast and melanoma surgical oncology at Mayo Clinic in Rochester, Minnesota, added that neoadjuvant systemic therapy may also inform recommendations regarding other cancer therapies after surgery based on how a patient’s tumor responds to the treatment received.
  • Catching cancer earlier saves lives: Across all cancers, patients with earlier-stage (pre-cancers or stage I-II) cancers had the best outcomes and 5-year survival rate. Although not a new finding, the authors said this finding confirms that screening and early diagnosis continue to be essential factors for patients who are diagnosed with cancer.
  • Women fare better than men: Overall five-year survival rate for all types of cancer in 2021 was 64%. When stratified by sex, women had a markedly better 5-year overall survival rate (68%) compared to men (59%) across all types of cancer analyzed in the report.

The report also describes in-depth data on three specific cancers-breast, colorectal, and pancreatic. The team selected these cancers due to their unique characteristics: colorectal and breast cancers are commonly diagnosed and treated with different kinds of surgery; pancreatic cancer is also treated with surgery but is rarer and has a very low survival rate.

  • Early-stage breast cancer is on the rise: From 2004-2021, about 21% more women were diagnosed with early-stage (stage I) breast cancer, while rates of advanced-stage diagnoses (stage IV) declined overall by about 28%. Most patients who had breast surgery underwent lumpectomy (66%), and the majority of these women (81%) were also treated with radiation therapy. The use of hormone therapy treatment more than doubled from 3.3% in 2018 to 7.7% in 2020.Breast cancer, which was one of the most common cancers diagnosed at CoC sites, also had one of the highest survival rates compared to other cancers, especially for women diagnosed with earlier-stage breast cancer, according to the report. Women diagnosed with stage I breast cancer have about a 93% 5-year survival rate.
  • Colon cancer is most commonly diagnosed at later stages: Nationwide, rates of colorectal cancer are rising among younger populations. The NCDB report found that colon cancer is one of the most common solid organ cancers diagnosed in both men and women, who were diagnosed at a median age of 68. Most commonly, patients were diagnosed with stage II or stage III colon cancer. About 81% of patients diagnosed with colon cancer underwent a colectomy, a surgery that involves removing all or part of the colon. The stage of diagnosis continues to be the most important determinant of long-term overall survival, with patients with stage IV colon cancer having about a 19% 5-year survival rate, according to the NCDB report, compared to about 82% for stage I or 72% for stage II colon cancers.
  • Pancreatic cancer is often found too late: Pancreatic cancer continues to be diagnosed at later stages when outcomes are worse for patients; nearly half of patients had stage IV disease when diagnosed, though the NCDB report found a steady increase in patients diagnosed with stage I pancreatic cancer over the last two decades (from about 10% in 2004 to about 28% in 2021). There currently are no uniform guidelines on screening for pancreatic cancer, and symptoms do not often appear until the cancer has spread, making it more difficult to treat. Patients with pancreatic cancer tend to be older (median age 70) and the disease is slightly more common in men. However, the NCDB report also noted some encouraging trends in treatment options for pancreatic cancer: More patients with pancreatic cancer are being treated with chemotherapy and other therapies before having surgery, with the use of neoadjuvant systemic therapy increasing by more than 200% from 2010 to 2021.

The ACS Cancer Data Modeling Committee plans to release annual cancer reports, with a focus on broad cancer trends as well as in-depth data on three different cancers selected based on volume and/or mortality rate.

“The CoC is dedicated to improving care for all cancer patients. The CoC standards and quality metrics have been developed by multi-disciplinary experts in each cancer type and are based on evidence-based research,” said Ronald J. Weigel, MD, PhD, MBA, FACS, medical director of the ACS Cancer Programs and co-author of the JACS study. “Comprehensive datasets such as the National Cancer Database are imperative to better inform research and help us advance cancer treatment.”

Reference:

Habermann, Elizabeth B PhD, MPH1; Day, Courtney N MS2; Palis, Bryan E MA3; Plichta, Jennifer K MD FACS4; Wasif, Nabil MD, FACS5; Weigel, Ronald J MD, FACS, PhD, MBA6; Boughey, Judy C MD, FACS7. American College of Surgeons Cancer Programs Annual Report from 2021 Participant User File. Journal of the American College of Surgeons ():10.1097/XCS.0000000000001214, December 03, 2024. | DOI: 10.1097/XCS.0000000000001214

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Pentoxifylline with tamsulosin significantly improves lower urinary symptoms in BPH patients, finds study

A recent research published in the journal of Lower Urinary Tract Symptoms found that adding Pentoxifylline to tamsulosin improved the lower urinary symptoms of individuals with benign prostatic hyperplasia (BPH). This medicine combo is well tolerated and has showed better treatment results than tamsulosin alone. 

A disorder known as benign prostatic hyperplasia is brought on by an enlarged prostate gland, which may impede or obstruct the flow of urine. BPH is a male-only condition that affects about 8% of males between the ages of 31 and 40. Over 80% of males over 80 suffer from BPH. Many BPH-afflicted males do not exhibit any symptoms. The most typical symptoms in males include leakage or dribbling of urine, a weak urine stream, and the urge to pee often (during the day and night). Lower urinary tract symptoms (LUTS) are the term for these symptoms. Men with unpleasant symptoms who have not responded to lifestyle modifications might be treated with one or more medications or have surgery.

Bladder outlet obstruction (BOO) is common in older persons, and it is largely caused by benign prostatic hyperplasia. These lower urinary tract problems can be addressed surgically or medically. Pentoxifylline, a phosphodiesterase inhibitor, may assist BOO patients more than tamsulosin because of its effects on microcirculatory blood flow and ischemic tissue oxygenation. Thereby, Mehdi Shirazi and colleagues undertook this experiment to investigate the effectiveness of Pentoxifylline in combination with Tamsulosin in treating BOO patients.

In 2022, this randomized, double-blind clinical trial included 60 individuals with BPH from a single site. The eligible patients were randomly assigned to the intervention (Pentoxifylline + tamsulosin) or control (placebo + tamsulosin) groups. At the start of the trial and after the 12th week, the patients were assessed for their international prostate symptom score (IPSS), quality of life (QoL), maximal urine flow rate (Qmax) by uroflowmetry, and post-void residual volume (PVR) by abdominal sonography.

The patients who received the combined medication showed considerable improvement in prostate symptoms and quality of life (IPSS: -36.6%, QoL: -45.3%) when compared to the patients who got tamsulosin alone (IPSS: -21.2%, QoL: -27.7%) (p <.001). This study found that combination treatment improves maximal urine flow rate and residual volume more considerably (Qmax: +42.5%, PVR: -42.6%) than monotherapy (Qmax: +25.1%, PVR: -26.1%) (p <.001). Overall, pentoxifylline, when taken with tamsulosin, has been shown to considerably relieve lower urinary symptoms of the BPH patients. It is well tolerated, and patients who take both Pentoxifylline and Tamsulosin have better treatment results than those who receive only Tamsulosin.

Reference:

Shirazi, M., Dehghanmanshadi, A., Sadr, S., & Jahanabadi, Z. (2024). Comparison between combination of tamsulosin and Pentoxifylline versus tamsulosin alone in the treatment of lower urinary tract symptoms due to benign prostate hyperplasia: A preliminary study. In LUTS: Lower Urinary Tract Symptoms (Vol. 16, Issue 1). Wiley. https://doi.org/10.1111/luts.12509

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Smoking and periodontitis relevant risk indicators of peri-implantits, finds study

Smoking and periodontitis are relevant risk indicators of peri-implants, finds a study published in the Clinical Oral Implants Research.

The primary aim of this study was to investigate the prevalence of peri-implant diseases in a randomly selected Norwegian population. The secondary aims were to explore risk indicators for peri-implant diseases and to validate self-reported outcome measures from a survey with clinical parameters. Patients (n = 3083) rehabilitated with dental implants in 2014 were mailed a questionnaire and invited to a clinical examination. A randomly selected subset of responders underwent a clinical examination (n = 242). Full mouth clinical and radiographic examinations were conducted. Multiple logistic regression was used to assess patient-related risk indicators for peri-implantitis. Self-reported data were compared with data from the clinical examination using Spearman correlation and binary logistic regression. Results: The prevalence of peri-implantitis was 17.0% at patient level and 8.6% at implant level, according to the 2018 classification. Risk indicators for peri-implantitis included smoking and periodontitis in the adjusted model. The correlation was strong (r = 0.91, p < 0.001) between number of self-reported implants and clinical counts, whereas self-reported peri-implant inflammation was associated with peri-implantitis (OR 6.4 [95% CI 3.0, 13.7]). Smoking and periodontitis were identified as key risk indicators for peri-implantitis. Questionnaire data rendered clinically valid estimates of implant number, and self-reported peri-implant inflammation was associated with clinical peri-implantitis.

Reference:

Mauland, E., Sørensen, K., Aarbu, N., Verket, A., Ellingsen, S., Bull, V., Gaarden, R., Lie, S. and Bunæs, D. (2024), A Cross-Sectional Study of Peri-Implant Diseases in a Random Norwegian Population: Prevalence, Risk Indicators, and Clinical Validation of Patient-Reported Outcomes. Clin Oral Impl Res. https://doi.org/10.1111/clr.14371

Keywords:

Smoking, periodontitis, relevant, risk, indicators, peri-implantits, finds, study, Mauland, E., Sørensen, K., Aarbu, N., Verket, A., Ellingsen, S., Bull, V., Gaarden, R., Lie, S. and Bunæs, D.

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Circadian syndrome associated with prevalence of gallstones in non smokers: BMC Study

A new study published in the journal of BMC Gastroenterology showed that the occurrence of gallstones was strongly correlated with circadian syndrome, especially in those who did not smoke. About 10% to 20% of individuals worldwide suffer from gallstone disease (GSD) that is one of the most frequent digestive problems in the general population. Symptoms of GSD include nausea, vomiting, loss of appetite, and discomfort in the stomach and abdomen.

Higher incidence and mortality rates from common chronic illnesses such diabetes, hypertension, cardiovascular disease, and gastrointestinal malignancies have been associated with gallstones. The internal circadian clock generates circadian rhythms which control important bodily physiological processes including metabolism, are produced by transcription factors and gene expression. Chronic conditions including kidney stones, overactive bladder, and stroke are associated with the circadian syndrome. However, nothing is known about the connection between gallstones and circadian disorders. This population-based study by Fenping Liang and colleagues was set to determine if circadian syndrome is linked to gallstones.

This cross-sectional study including a total of 2913 people used data from the National Health and Nutrition Examination Survey (NHANES) database covering the years 2017 to 2020. The relationship between the prevalence of gallstones and circadian syndrome was investigated using univariate and two adjusted multivariate regression models. The nonlinear connection was described by fitting smoothed curves with the generalized additive model (GAM). To look at possible differences in the association between the risk of gallstones and circadian syndrome, subgroup analyses were also conducted.

The results showed that gallstones and circadian syndrome were positively correlated, with model 2 demonstrating a 117% increase in risk. The frequency of gallstones increased by 76% in model 3. Gallstone risk, however, did not significantly correlate with the number of circadian syndrome components.

Further evidence of linear associations between CircS and gallstone risk was provided by smooth curve fitting based on the GAM. Also, subgroup analysis showed statistically significant correlations between the frequency of gallstones among non-smokers and circadian syndrome. Overall, the results show that among US adults, particularly the people who do not smoke, CircS is positively correlated with an increased incidence of gallstones.

Source:

Liang, F., Qin, T., Hao, Z., Zheng, Y., & Zhou, Y. (2024). Association between circadian syndrome and gallstones in US adult: a cross-sectional study of NHANES 2017–2020. In BMC Gastroenterology (Vol. 24, Issue 1). Springer Science and Business Media LLC. https://doi.org/10.1186/s12876-024-03504-4

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Chronic musculoskeletal pain independently linked to incidence of Parkinson’s disease: Study

A new study published in the journal of Movement Disorders showed that Parkinson’s disease (PD) was found to be independently linked to chronic musculoskeletal pain, indicating that chronic pain may be a useful indicator of PD risk. An estimated 40% to 83% of people with Parkinson’s disease experience pain, which is a significant non-motor symptom. Any stage of Parkinson’s disease (PD), including before a clinical diagnosis, can cause pain, which has a negative impact on the patients’ quality of life (QoL).

For 40% to 90% of PD patients, musculoskeletal discomfort is the source of their pain. Few studies have looked at the clinical traits and other elements linked to MSP. Thus, Fatemeh Vazirian and colleagues carried out this study to examine the relationships between incident risk of 3 neurodegenerative parkinsonian categories as PD, multiple system atrophy, and progressive supranuclear palsy (PSP) and chronic pain.

This study comprised a total of 355,890 adults from a population-based cohort who did not have parkinsonism at baseline (mean [standard deviation] age, 56.51 [8.07] years, 48.40% male). Hip, back, neck/shoulder, knee, or “all over the body” musculoskeletal discomfort was evaluated. If pain persisted for more than 3 months, it was considered chronic.

4 groups of participants were created where the ones who did not have chronic pain, the ones who had pain at 1 or 2, 3 or 4 places, and the ones who had pain “all over the body.” Hospital data, mortality registries, and self-reports were utilized to diagnose PD, MSA, and PSP. For the analysis, multivariable-adjusted Cox regression was used.

A total of 2044 patients acquired PD, 77 people got MSA, and 126 persons developed PSP after a median follow-up of 13.0 years. The total number of chronic pain areas and incident risk of Parkinson’s disease (PD) showed a dose-response association in multivariable analysis.

Individuals who had one or two pain sites were 11% more likely to acquire Parkinson’s disease (PD), whereas those who experienced 3 or 4 pain sites were 49% more likely to do so. Chronic pain did not correlate with either MSA or PSP.

Overall, 13-year follow-up research revealed an independent link between chronic musculoskeletal pain and Parkinson’s disease. In participants with one or two pain sites, the incidence of Parkinson’s disease increased by 11%, rising to 49% in the ones with 3 or 4 pain sites.

Source:

Vazirian, F., Tian, J., Jane Alty, Aitken, D., Callisaya, M. L., Cicuttini, F., Jones, G., & Pan, F. (2024). Chronic Musculoskeletal Pain and Risk of Incident Parkinson’s Disease: A 13‐Year Longitudinal Study. In Movement Disorders. Wiley. https://doi.org/10.1002/mds.30046

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Fiber diet may delay a type of blood cancer, reveals research

Today researchers at Memorial Sloan Kettering Cancer Center (MSK) reported results from the first ever clinical trial to show that a high fiber plant based dietary intervention may delay progression to multiple myeloma, a type of rare, incurable blood cancer affecting the bone marrow. The study enrolled 20 participants with a precancerous blood disorder and an elevated body mass index (BMI) at risk for developing multiple myeloma. They received 12 weeks of high fiber plant-based meals and 24 weeks of coaching. Two participants with progressing disease prior to study showed a significant improvement of their disease progression trajectory. Additionally, at one year after enrollment, none of the participants had progressed to multiple myeloma. MSK myeloma specialist and NUTRIVENTION study lead, Urvi Shah, MD, presented these findings at the 2024 American Society of Hematology (ASH) annual meeting in San Diego, California.

“This study showcases the power of nutrition-specifically a high fiber plant-based diet-and unlocks a better understanding of how it can lead to improvements in the microbiome and metabolism to build a stronger immune system,” said Dr. Shah. “These findings further support how we as physicians can empower patients, especially those with precancerous conditions, with knowledge on reducing their cancer risk through dietary changes.”

Multiple myeloma is the second most common blood cancer and typically arises from precursor conditions called monoclonal gammopathy of undetermined significance (MGUS) and smoldering (symptomless) myeloma. Recent studies have shown an increased risk of multiple myeloma in individuals with poor diet quality and reduced intake of plant foods. Additionally, individuals with these conditions and an elevated body mass index (BMI) are twice as likely to progress to multiple myeloma as people with these conditions and a normal BMI. With this information, researchers have been looking for ways to intervene before these conditions can progress to cancer.

During the study, participants were encouraged to eat as much as they wanted if it was whole plant-based foods such as fruits, vegetables, nuts, seeds, whole grains, and legumes. With these dietary changes there were significant improvements in quality of life, insulin resistance, gut microbiome health and inflammation. On average, participants lost eight percent of their body weight after 12 weeks. Following these positive results, Dr. Shah is currently enrolling for a larger, multi-center study with 150 participants called NUTRIVENTION-3.

These findings were confirmed in a smoldering myeloma mouse model where 44% of mice fed the high fiber diet did not progress to myeloma compared to the standard diet where all mice progressed to myeloma.

Reference:

New study reveals a fiber diet may delay a type of blood cancer, Memorial Sloan Kettering Cancer Center, Meeting: 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

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Oral Infigratinib Promising in Children with Achondroplasia, Increasing Growth with Mild Side Effects: NEJM

Australia: A recent study published in the New England Journal of Medicine highlighted the potential benefits of oral infigratinib therapy for children with achondroplasia, the most common form of dwarfism.

Phase 2 data showed that once-daily oral administration of the fibroblast growth factor receptor (FGFR) 1–3 selective tyrosine kinase inhibitor infigratinib results in a sustained increase in annualized height velocity in children with achondroplasia, with generally mild side effects.

“Infigratinib targets the root cause of achondroplasia by inhibiting FGFR phosphorylation, thereby reducing the activity of the two primary downstream signaling pathways involved in the condition. This mechanism offers a potential therapeutic approach to address FGFR3 hyperactivity,” explains Ravi Savarirayan (University of Melbourne, Victoria, Australia) and co-authors.

Achondroplasia is a genetic skeletal disorder characterized by disproportionate short stature and associated medical complications throughout an individual’s life. Infigratinib, an orally available FGFR1–3 selective tyrosine kinase inhibitor, is currently being developed as a potential treatment for achondroplasia.

Against the above background, Dr. Savarirayan and colleagues initiated the PROPEL2 dose-finding study to assess the safety and efficacy of oral infigratinib in children aged 3 to 11 years with achondroplasia.

A total of 72 children were enrolled across five sequential cohorts to receive daily infigratinib at varying doses: 0.016 mg/kg (cohort 1), 0.032 mg/kg (cohort 2), 0.064 mg/kg (cohort 3), 0.128 mg/kg (cohort 4), and 0.25 mg/kg (cohort 5) for 6 months. Following this, participants continued with 12 months of extended treatment, with the option for dose escalation in cohorts 1 and 2 at months 6 and 12. The primary safety outcome focused on the rate of adverse events leading to dose reduction or study discontinuation, while the primary efficacy outcome measured changes in annualized height velocity from baseline.

Key Findings:

  • All children experienced at least one adverse event during treatment, though most were mild or moderate in severity, and none led to treatment discontinuation.
  • In cohort 5, an increased annualized height velocity was observed, which continued throughout the study, with a mean change from baseline at 18 months of 2.50 cm per year.
  • The mean change from baseline in height z score at 18 months was 0.54 compared to an untreated achondroplasia reference population.
  • The mean change from baseline in the upper-to-lower body segment ratio was −0.12.

The study showed that oral infigratinib administration showed no major safety concerns and led to an increased annualized height velocity and height z score, along with a reduced upper-to-lower body segment ratio at 18 months of treatment in cohort 5.

Based on the current findings, Savarirayan and his team have initiated a pivotal phase 3 trial to assess infigratinib at a dose of 0.25 mg/kg per day in 110 children aged 3 to 17 years with achondroplasia who are still in the growth phase. Additionally, children who participated in the PROPEL2 study are continuing to receive infigratinib through an open-label extension study, which is monitoring long-term safety and efficacy outcomes.

Reference: N Engl J Med 2024; doi:10.1056/NEJMoa2411790

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Prophylactic NIV and HFNO Reduce Postextubation Respiratory Failure in High-Risk Non-COPD Patients, Study Finds

France: In non-COPD patients at high risk of extubation failure, prophylactic noninvasive ventilation (NIV) alternating with high-flow nasal oxygen (HFNO) was significantly more effective in reducing post-extubation respiratory failure (PRF) compared to conventional oxygen therapy, the WIN IN WEAN multicenter randomized controlled trial has shown.

“However, it did not result in lower reintubation rates or mortality. Although the intervention required more resources, it proved as effective as rescue NIV in managing PRF,” the researchers wrote. The findings were published online in Critical Care Journal on 26 November 2024.

Extubation is a critical step for ICU discharge, but 25% of high-risk patients experience post-extubation respiratory failure, with half requiring reintubation. Prophylactic NIV with high-flow nasal oxygen reduces PRF but does not lower reintubation rates. Lung ultrasound can predict PRF risk, helping to tailor extubation strategies.

Considering this, In the WIN IN WEAN randomized controlled trial, Jean-Jacques Rouby, Sorbonne University, GRC 29, DMU DREAM, Paris, France, and colleagues aimed to evaluate whether prophylactic NIV alternating with HFNO, compared to conventional oxygen, could reduce the incidence of PRF in non-COPD patients identified as high risk by a lung ultrasound score (LUS) ≥ 14 after a successful spontaneous breathing trial (SBT).

For this purpose, the researchers included ventilated patients without chronic obstructive pulmonary disease (COPD) and at high risk for PRF, defined by a LUS ≥ 14 during the spontaneous breathing trial, in a French-Chinese randomized controlled trial. PRF was characterized by two or more signs: SpO2 < 90%, respiratory rate > 30/min, hypercapnia, or hemodynamic and/or neurological disturbances of respiratory origin. The intervention group received prophylactic NIV alternating with HFNO for 48 hours after extubation, while the control group received conventional oxygen.

Clinicians were informed of the LUS in the intervention group, while those in the control group remained blinded. The primary outcome was the incidence of PRF 48 hours after extubation, with secondary outcomes including PRF and reintubation rates at day 7, number of ventilator-free days at day 28, length of ICU stay, and mortality at days 28 and 90.

The following were the key findings of the study:

  • 240 patients were randomized, with 227 analyzed (128 in the intervention group and 99 in the control group).
  • PRF at 48 hours was significantly reduced in the intervention group compared to the control group, with a relative risk of 0.52.
  • The benefit of reduced PRF persisted at day 7, with a relative risk of 0.62.
  • Weaning failure requiring reconnection to mechanical ventilation was not reduced.
  • Among patients who developed PRF and received rescue NIV, reintubation was avoided in 44% of control and 12% of intervention patients.
  • Other secondary outcomes showed no significant differences between the groups.
  • Prophylactic NIV alternating with HFNO was more resource-intensive and costly compared to conventional oxygen with rescue NIV while achieving the same clinical outcomes.

“The findings showed that prophylactic NIV alternating with HFNO significantly reduced postextubation respiratory failure compared to conventional oxygenation in high-risk, non-COPD patients, but did not lower reintubation rates or mortality. This approach proved as effective as rescue NIV in treating postextubation respiratory failure,” the researchers concluded.

Reference:

Rouby, JJ., Perbet, S., Quenot, JP. et al. Weaning of non COPD patients at high-risk of extubation failure assessed by lung ultrasound: the WIN IN WEAN multicentre randomised controlled trial. Crit Care 28, 391 (2024). https://doi.org/10.1186/s13054-024-05166-w

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Once Daily extended release Nifedipine Effective for Blood Pressure Management in Pregnancy, finds study

A recent retrospective analysis of hypertension management during and after pregnancy revealed that extended-release nifedipine dosed at 60mg once daily (QD) is as effective as the 30mg twice daily (BID) regimen for managing blood pressure (BP) in pregnant and postpartum patients with hypertensive disorders.. The study spanned over 6 years, from January 2015 to April 2021, and the findings of this study were published in the American Journal of Perinatology.

The primary goal was to assess whether the single daily dose could match the effectiveness of the twice-daily regimen in controlling blood pressure (BP) during the antepartum and postpartum periods. The research sought to determine if either group required additional dose adjustments or supplementary anti-hypertensive medications.

The participants were short-listed from Mount Sinai Health System based on specific criteria, excluding the women with preexisting renal conditions or prior use of oral anti-hypertensives. Of the 237 women included, 139 (59%) were treated with the 30 mg BID regimen, while 98 (41%) received 60 mg QD.

The findings revealed no statistically significant difference between the two groups in terms of the need to increase nifedipine doses or introduce additional medications. The up-titration rates were nearly identical, with 33.8% in the BID group and 35.7% in the QD group. Adjusted odds ratio (aOR) calculations further confirmed this parity (aOR: 0.90; 95% CI: 0.50-1.60; p=0.71).

Also, there was no notable difference in the need for emergency hypertension treatment after reaching the study doses (p=0.19) or in rates of readmission for BP control (p > 0.99). These findings hold practical implications for the management of hypertensive disorders in pregnancy. The results suggest that a once-daily dosing regimen is as effective as the twice-daily regimen in controlling BP without necessitating further interventions.

This provides a compelling argument for preferring the once-daily regimen, given its convenience and potential to improve patient compliance, especially during the demanding phases of pregnancy and postpartum recovery. Overall, this study adds to the growing body of evidence to support simplified treatment strategies in obstetric care and could potentially influence future guidelines for managing hypertensive disorders of pregnancy.

Source:

Peterson, J. A., Band, I. C., Wang, K., & Bianco, A. T. (2024). Daily versus Twice Daily Nifedipine for Blood Pressure Control in Pregnancy and Postpartum. In American Journal of Perinatology. Georg Thieme Verlag KG. https://doi.org/10.1055/a-2486-8840

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Liberal vs. Restrictive Blood Transfusion Strategies Show Similar Outcomes in Subarachnoid Hemorrhage Patients: JAMA

Researchers have demonstrated that implementation of a liberal blood transfusion policy does not offer cognitive-neurological benefit as compared to a restrictive policy in the situation of patients with aneurysmal subarachnoid hemorrhage and anemia. The SAHARA trial showed that both methods gave identical neurological outcomes after 12 months so that no one was clearly better than the other. The study was conducted by Shane W. and colleagues which was published in The New England Journal of Medicine.

In this study, a liberal transfusion strategy considered compulsory transfusion at a hemoglobin cutoff of ≤10 g/dL, while a restrictive strategy allowed optional transfusion at a hemoglobin level of ≤8 g/dl. At 12 months, unfavorable neurological outcomes, as defined by a modified Rankin scale score of ≥4, were found in 33.5% of the liberal group and 37.7% of the restrictive group (relative risk [RR]=0.88, 95% confidence interval [CI] 0.72-1.09).

Blood transfusion thresholds and guidelines seem contentious in different situations among critically ill patients, with guidelines presenting rather vague recommendations. Liberal transfusions offer the promise of improved oxygen delivery, which would leave behind a poorly perfused, hypoxic brain tissue, but carry additional risks for complications and mortality. Cumulative previous studies, including HEMOTION and TRAIN trials, yielded conflicting results on appropriate transfusion thresholds in critically ill people. The SAHARA trial was designed to confront this ignorance by focusing on patients with acute aneurysmal subarachnoid hemorrhage and anemia.

SAHARA trial by 23 centers in Canada, Australia, and the US recruited a total of 742 critically ill adults, almost 82% of whom are women, with a mean age of 59.4 years. The major findings are:

  • Neurological outcomes: Unfavorable outcomes occurred in 33.5% of the liberal group and 37.7% of the restrictive group (RR 0.88, 95% CI 0.72-1.09). Mortality rates: Similar between groups at 27.2% for the liberal group and 27.1% for the restrictive group (RR 0.99, 95% CI 0.77-1.28).

  • Functional independence: Functional Independence Measure scores were 82.8 points in the liberal group versus 79.8 points in the restrictive group.

  • Quality of life (QoL): EuroQol utility index scores were 0.5 in both groups, and visual analog scale scores were 52.1 against 50 points, respectively.

  • Transfusion specifics: Median red cell units transfused as 2 in liberal group and 0 in the restrictive group, with median pretransfusion hemoglobin levels of 9.6 g/dL and 7.6 g/dl, respectively.

The findings indicate that neither the liberal transfusion strategy nor the restrictive transfusion strategy offers a clear neurological benefit to patients with aneurysmal subarachnoid hemorrhage with anemia.

Reference:

English SW, Delaney A, Fergusson DA, Chassé M, Turgeon AF, Lauzier F, Tuttle A, Sadan O, Griesdale DE, Redekop G, Chapman M, Hannouche M, Kramer A, Seppelt I, Udy A, Kutsogiannis DJ, Zarychanski R, D’Aragon F, Boyd JG, Salt G, Bellapart J, Wood G, Cava L, Pickett G, Koffman L, Watpool I, Bass F, Hammond N, Ramsay T, Mallick R, Scales DC, Andersen CR, Fitzgerald E, Talbot P, Dowlatshahi D, Sinclair J, Acker J, Marshall SC, McIntyre L; SAHARA Trial Investigators on behalf of the Canadian Critical Care Trials Group. Liberal or Restrictive Transfusion Strategy in Aneurysmal Subarachnoid Hemorrhage. N Engl J Med. 2024 Dec 9. doi: 10.1056/NEJMoa2410962. Epub ahead of print. PMID: 39655786.

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