UP Government Revises Nursing Designations, Recruitment Criteria

Lucknow: Uttar Pradesh Deputy Chief Minister and Health Minister Brajesh Pathak on Monday announced significant changes in the designation and recruitment criteria for nursing staff within the state’s health department. The changes align with the central government’s health department norms and aim to upgrade the status and recognition of nurses. 

Speaking to Hindustan Times, Pathak said, “Also, the nursing sister or nursing ward master will be called senior nursing officer.” This change comes following a memorandum submitted by the Rajkiya Nurses’ Sangh. However, the designations of assistant nursing superintendent, deputy nursing superintendent, nursing superintendent, and chief nursing officer remain unchanged.

Pathak also outlined the revised eligibility criteria for appointment as nursing officers. Candidates must hold a BSc (Honours) degree, have six months of relevant experience, and have a two-and-a-half-year diploma course experience from a hospital with at least 50 beds.

Also Read: AYUSH Ministry hosts 3-day Yoga Maha Kumbh in Delhi

Deputy Chief Minister Brajesh Pathak also highlighted Uttar Pradesh’s outstanding participation in International Yoga Day celebrations. With 8.27 lakh people practising yoga, Uttar Pradesh topped the list among Indian states.

As per the recent media reports by Hindustan Times, “The Yoga Day was celebrated at 16,063 Arogya Mandirs in the state. According to statistics shared by the government of India, Andhra Pradesh was in second position, Rajasthan third, Tamil Nadu fourth, while Karnataka was in fifth place,” said Pathak.

According to the statistics, Uttar Pradesh recorded the highest number of Yoga practitioners at 8,27,313, followed by Andhra Pradesh with 7,24,179 and Rajasthan with 6,15,118.

Also Read: Incorporate Yoga into Daily Life to Build a Healthier Society: CM Yogi

Medical Dialogues had previously reported that Uttar Pradesh Chief Minister Yogi Adityanath extended heartfelt congratulations on the occasion of the 11th International Day of Yoga (IDY), urging citizens to incorporate yoga into their daily lives to build a healthier and more harmonious society. Observed globally every year on June 21, the International Day of Yoga was first proposed by Prime Minister Narendra Modi in 2014 and swiftly adopted by the United Nations, garnering support from 177 countries. Since then, the day has become a global celebration of India’s ancient wellness tradition.

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Add on Cagrilintide to Semaglutide tied to Significant Weight Loss in diabetics and non diabetics in Obesity Trials

Researchers have found in phase IIIa REDEFINE 1 trial that Addition of investigational cagrilintide to GLP-1 agonist semaglutide led to 20.4% body weight loss in adults with obesity with or without type 2 diabete . The findings of the trial were presented at the American Diabetes Association annual meeting.

Semaglutide at a dose of 2.4 mg has established weight-loss and cardiovascular benefits, and cagrilintide at a dose of 2.4 mg has shown promising results in early-phase trials; the efficacy of the combination (known as CagriSema) on weight loss in persons with either overweight and coexisting conditions or obesity is unknown.

In a phase 3a, 68-week, multicenter, double-blind, placebo-controlled and active-controlled trial, we enrolled adults without diabetes who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher or a BMI of 27 or higher with at least one obesity-related complication. Participants were randomly assigned in a ratio of 21:3:3:7 to receive the combination of semaglutide at a dose of 2.4 mg and cagrilintide at a dose of 2.4 mg, semaglutide alone at a dose of 2.4 mg, cagrilintide alone at a dose of 2.4 mg, or placebo, plus lifestyle interventions for all groups. The coprimary end points were the relative change in body weight and a reduction of 5% or more in body weight from baseline to week 68 with cagrilintide–semaglutide as compared with placebo. Body-weight reductions of 20% or more, 25% or more, and 30% or more were assessed as confirmatory secondary end points. Effect estimates were assessed with the treatment-policy estimand (consistent with the intention-to-treat principle). Safety was assessed.

Results: A total of 3417 participants underwent randomization, with 2108 assigned to receive cagrilintide–semaglutide, 302 to receive semaglutide, 302 to receive cagrilintide, and 705 to receive placebo. The estimated mean percent change in body weight from baseline to week 68 was –20.4% with cagrilintide–semaglutide as compared with –3.0% with placebo (estimated difference, –17.3 percentage points; 95% confidence interval, –18.1 to –16.6; P<0.001). Participants receiving cagrilintide–semaglutide were more likely than those receiving placebo to reach weight-loss targets of 5% or more, 20% or more, 25% or more, and 30% or more (P<0.001 for all comparisons). Gastrointestinal adverse events (affecting 79.6% in the cagrilintide–semaglutide group and 39.9% in the placebo group), including nausea, vomiting, diarrhea, constipation, or abdominal pain, were mainly transient and mild-to-moderate in severity. Cagrilintide–semaglutide provided significant and clinically relevant body-weight reductions in adults with overweight or obesity, as compared with placebo.

Reference:

Melanie J. Davies,Harpreet S. Bajaj,Christa Broholm,Astrid Eliasen,W. Timothy Garvey,Carel W. le Roux,Ildiko Lingvay,Christian Bøge Lyndgaard,Julio Rosenstock,Sue D. Pedersen,Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes, New England Journal of Medicine, 0, 0, (undefined).

/doi/full/10.1056/NEJMoa2502082

Keywords:

Cagrilintide, Semaglutide, Significant, Weight Loss, diabetics, non diabetics, Obesity Trials, The New England Journal of Medicine, Melanie J. Davies,Harpreet S. Bajaj,Christa Broholm,Astrid Eliasen,W. Timothy Garvey,Carel W. le Roux,Ildiko Lingvay,Christian Bøge Lyndgaard,Julio Rosenstock,Sue D.

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Olorofim Shows Promise for Difficult-to-Treat Invasive Fungal Infections: Lancet

Researchers have found in a phase IIb study that investigational antifungal olorofim demonstrated efficacy in 29% of patients with invasive fungal disease lacking other treatment options. When including stable disease in the success definition, 75% achieved a global response. The drug was well-tolerated, with elevated liver enzymes being the most common side effect.

Only a small number of antifungal therapies for invasive fungal disease (IFD) are currently available, and many pathogens are resistant to one or more of these therapies. Olorofim, the first orotomide antifungal agent to be developed, is active against fungi that are resistant to registered therapies. It impairs fungal pyrimidine biosynthesis, leading to cell death. We sought initial data on the efficacy and safety of olorofim as a therapy for IFD.

In this single-arm, open-label, phase 2b study, patients aged 16 years or older with few or no treatment options for proven IFD or probable invasive pulmonary aspergillosis were recruited from 22 centres in 11 countries. The first 58 patients received a weight-based loading dose of oral olorofim 180–300 mg in two to three divided doses on day 1 followed by 120–240 mg daily in two to three divided doses from day 2 onwards. On the basis of pharmacokinetic data from the first 25 patients, dosing was simplified from patient 59 onwards to a loading dose of 150 mg twice on day 1 followed by a fixed maintenance dose of 90 mg twice a day up to day 84 (main treatment phase) with extended therapy as needed. The primary endpoint was global response rate (based on a composite of clinical, radiological, and mycological responses) at day 42, determined as success (complete or partial improvement in all three components) or failure (stable disease or progression on any one component or death from any cause) by a data review committee (DRC). Secondary efficacy endpoints included global response rate at day 84 and all-cause mortality at day 42 and day 84. Global response rate with stable disease classified as success and response rate in the clinical component of the global response at day 42 and day 84 were also assessed. Efficacy was analysed for all patients who were confirmed by the DRC to have an IFD and who received at least one dose of olorofim (the modified intention-to-treat population). Safety was analysed in all patients who received at least one dose of olorofim (the safety population). This trial is registered with ClinicalTrials.gov, NCT03583164, and is completed.

Findings

Between June 6, 2018, and Sept 8, 2022, 204 patients were enrolled. Of these, 203 were treated with olorofim and 202 (124 male, 78 female) had DRC-adjudicated IFD. Causative pathogens were Aspergillus spp (n=101, including 22 azole-resistant strains), Lomentospora prolificans (n=26), Scedosporium spp (n=22), Coccidioides spp (n=41), and other fungi (n=12). Successful global response was confirmed in 58 of 202 patients (28·7%, 95% CI 22·6–35·5) at day 42 and in 55 patients (27·2%, 21·2–33·9) at day 84. Successful global response with stable disease included in the definition of success was seen in 152 patients (75·2%, 68·7–81·0) at day 42 and in 128 patients (63·4%, 56·3–70·0) at day 84. A successful clinical response was seen in 121 patients (59·9%, 52·8–66·7) at day 42 and in 109 patients (54·0%, 46·8–61·0) at day 84. All-cause mortality was documented in 24 patients (11·9%, 7·8–17·2) at day 42 and in 33 patients (16·3%, 11·5–22·2) at day 84. Mean dosing duration was 73 days (SD 25) for the 203 patients in the main treatment phase (median 84 days [range 2–99, IQR 78–87]) and 361 days (SD 220) for the 114 patients who received extended treatment after the main phase (median 309 days [38–988, 180–502]). Medically significant liver enzyme elevations adjudicated to be at least possibly due to olorofim occurred in 20 (10%) of 203 patients and were managed to resolution by dose modification in 14 (7%) patients or by discontinuation of treatment in six (3%). Gastrointestinal intolerance, which occurred in 20 (10%) patients, was predominantly reported as mild or moderate and self-limiting. There were no treatment-related deaths.

Olorofim showed efficacy and good tolerability in patients with IFD with few or no treatment options. Further studies will be needed to fully delineate the role of this new antifungal agent.

Reference:

Olorofim for the treatment of invasive fungal diseases in patients with few or no therapeutic options: a single-arm, open-label, phase 2b study

Maertens, Johan A et al. The Lancet Infectious Diseases, Volume 0, Issue 0

Keywords:

Olorofim, Shows , Promise, Difficult-to-Treat, Invasive, Fungal , Infections, Lancet, Maertens, Johan, The Lancet Infectious Diseases,

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Among Older ACS Patients early invasive therapy fails to reduce mortality vs conservative treatment: JAMA

A new meta-analysis published in the Journal of American Medical Association found an early invasive strategy did not reduce all-cause mortality compared to conservative treatment in acute coronary syndrome (ACS). However, it did lower the risk of recurrent myocardial infarction (MI) and need for repeated coronary revascularization, though it also increased the risk of major bleeding. These competing outcomes highlight the need for shared decision-making when choosing treatment strategies in older ACS patients.

This systematic review drew from MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials through October 2024. It included only randomized controlled trials comparing early invasive versus conservative strategies in patients aged 70 or older presenting with ACS. The trials involved both ST-elevation and non-ST-elevation ACS were considered. The mean age of participants was 82.6 years, and nearly half were women.

The analysis revealed no statistically significant difference in all-cause mortality between the two approaches (relative risk [RR], 1.05; 95% CI, 0.98–1.11), a finding consistent across various subgroups and with zero heterogeneity across studies (I² = 0%). This suggests that an invasive strategy does not improve survival in elderly patients with ACS.

The patients receiving early invasive treatment had a 22% lower risk of experiencing another myocardial infarction (RR, 0.78; 95% CI, 0.67–0.91). Also, the risk of needing repeated coronary revascularization was cut by more than half (RR, 0.43; 95% CI, 0.30–0.60). These results suggest that invasive strategies can provide meaningful reductions in recurrent cardiac events.

This invasive strategy was associated with a 60% increased risk of major bleeding (RR, 1.60; 95% CI, 1.01–2.53). Though bleeding events varied by trial, this finding reinforces concerns about the vulnerability of older patients to procedure-related complications. Other secondary endpoints, including stroke, cardiovascular death, heart failure hospitalization, and major adverse cardiovascular or cerebrovascular events, showed no significant differences between the two strategies.

The outcomes in patients with non–ST-elevation ACS mirrored the overall results, which suggested the findings are broadly applicable across ACS subtypes in the elderly. While early invasive therapy for older ACS patients can reduce heart attacks and the need for repeat procedures, these advantages must be carefully weighed against a significantly higher bleeding risk and no apparent survival benefit. Overall, the findings highlight the importance of individualized, shared decision-making between clinicians and elderly patients, factoring in comorbidities, frailty, and patient preferences.

Reference:

Reddy, R. K., Koeckerling, D., Eichhorn, C., Jamil, Y., Ardissino, M., Braun, V., Abu Sharar, H., Frey, N., Howard, J. P., & Ahmad, Y. (2025). Early invasive or conservative strategies for older patients with acute coronary syndromes: A meta-analysis. JAMA Internal Medicine. https://doi.org/10.1001/jamainternmed.2025.2058

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FDA Approves At-Home Belimumab Injection for Children with Lupus Nephritis

The FDA has approved a 200 mg/mL autoinjector of belimumab (Benlysta) for at-home subcutaneous use in children aged 5 years and older with active lupus nephritis receiving standard therapy-marking the first treatment of its kind for pediatric patients.

Lupus nephritis is one of the most serious complications of lupus and occurs when the immune system mistakenly attacks the kidneys, leading to inflammation and possibly to organ damage. About 30-50% of children with lupus develop LN, typically within one to two years after their initial lupus diagnosis.1,2

Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America said: “In children, lupus tends to be more aggressive and severe than it is in adults. The symptoms can be more intense, and the disease can have long-term effects on a child’s growth and quality of life.1,2 Having the Benlysta autoinjector provides a much-needed option that can help reduce the burden of frequent clinic visits for treatment and add greater flexibility for children and their families when considering continuity of care and routines of daily life.”

Court Horncastle, Senior Vice President, and Head of US Specialty, GSK said: “For children and parents of children with lupus nephritis, this approval represents a choice in their care. Providing this at-home treatment option with the efficacy and safety of Benlysta is a testament to our ongoing commitment to the lupus community. GSK is driven by the belief that our therapeutic solutions should always prioritize improving patients’ well-being and easing their treatment journey, including for younger patients.”

Caregivers of children who are currently using intravenous infusions of belimumab to manage their LN can work with their child’s healthcare provider to decide if at-home administration via autoinjector is appropriate. If so, the healthcare provider will administer treatment or the healthcare provider will provide instructions to the patients’ caregiver that will allow them to administer the medicine at home via an autoinjector. The 200 mg/mL autoinjector of belimumab will be available for pediatric patients and their caregivers immediately.

About systemic lupus erythematosus (SLE) and lupus nephritis (LN)

Systemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. LN is a complication of SLE and occurs when the immune system mistakenly attacks the kidneys and leads to inflammation and potential organ damage. This inflammation can harm the kidney’s ability to remove waste from the blood.1

LN can lead to end-stage kidney disease, which requires kidney dialysis or a transplant. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis for people living with lupus.3,4 Manifestations of LN include proteinuria, elevations in serum creatinine and the presence of red and white blood cells in the urine.

About Benlysta

Benlysta (belimumab) is a B-lymphocyte stimulator (BLyS) specific inhibitor that binds to soluble BLyS. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Benlysta does not bind B cells directly. The US FDA first approved Benlysta for the treatment of active SLE; it is the first and only approved biologic for both SLE and LN in more than 50 years, including for the pediatric population.

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New Ultrasound-Driven Model Boosts Accuracy in Diagnosing Endometrial Malignancy: Study Shows

China: A new study published on April 21 in the Journal of Radiation Research and Applied Sciences has shown that combining clinical parameters with ultrasound imaging significantly improves the detection of endometrial malignancy in postmenopausal women.

The research, led by Dr. Xiu Yun Dong and her team at the Jinan Maternal and Child Health Hospital Affiliated with Shandong First Medical University, emphasizes a more personalized approach to evaluating endometrial thickening. The study aims to evaluate the diagnostic effectiveness of transvaginal ultrasound (TVUS) and to develop a multivariable risk stratification model for identifying endometrial malignancy and precursor lesions in postmenopausal women presenting with asymptomatic endometrial thickening.

For this purpose, the researchers analyzed retrospective data from 587 postmenopausal women who had asymptomatic endometrial thickening detected during routine transvaginal ultrasound examinations. Participants were categorized based on histopathological results—221 women were found to have malignant or precursor lesions, while 366 had benign outcomes.

By developing a multivariable risk stratification model, the researchers aimed to better distinguish which women were more likely to have underlying malignancies. The model incorporated ultrasound findings—such as endometrial thickness, border irregularities, and heterogeneous texture—alongside clinical data like age, BMI, and diabetes status.

The key findings of the study were as follows:

  • Women with malignant or pre-malignant findings had a significantly thicker endometrium (average 14.2 mm) than those with benign lesions (10.1 mm).
  • Ultrasound abnormalities were more commonly observed among women in the positive group.
  • Independent predictors of malignancy included increased endometrial thickness (OR 2.94), abnormal ultrasound features (OR 4.12), presence of diabetes (OR 1.98), and obesity with a BMI ≥ 30 kg/m² (OR 1.82).
  • The predictive model showed strong diagnostic performance, achieving an area under the curve (AUC) of 0.81, reflecting good accuracy in identifying high-risk cases.

According to the researchers, incorporating clinical and imaging data enables a more holistic understanding of a patient’s risk profile. “This model provides a practical method for identifying high-risk postmenopausal women,” the authors noted, highlighting the potential to reduce unnecessary invasive tests while ensuring timely intervention for those who need it.

They also stressed the importance of future research to validate this model across broader populations and explore new imaging techniques that may further refine diagnostic capabilities.

By aligning with personalized medicine principles, the study marks a step forward in enhancing care pathways for postmenopausal women with endometrial abnormalities.

Reference:

Qiu, S., Wu, S., Song, Y., Wang, B., & Dong, X. Y. (2025). Endometrial thickness and its diagnostic utility in postmenopausal women: A retrospective analysis of ultrasound and histopathological findings. Journal of Radiation Research and Applied Sciences, 18(2), 101509. https://doi.org/10.1016/j.jrras.2025.101509

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Iron Deficiency Linked to Altered Brain Development in Adolescents, Even in Anemia Absence: JAMA

USA: Researchers have found in a new study that even in the absence of anemia, iron deficiency (ID) during adolescence is associated with changes in brain development. Early screening for ID in at-risk adolescents may help improve neuropsychiatric outcomes.

The study, conducted by Dr. Dimitri Fiani and colleagues from Baylor College of Medicine in Houston, Texas, and published in JAMA Network Open, explored how iron deficiency (ID) without anemia affects brain iron levels and related cognitive and psychiatric outcomes in adolescents.

Although iron is crucial for processes such as neurogenesis, myelination, and neurotransmitter production, ID is typically diagnosed using blood-based measures of anemia. This research focused instead on how ID—without the presence of anemia—might influence brain iron content, particularly in the basal ganglia, a region critical to motor control and cognitive function.

In this cross-sectional analysis, 209 otherwise healthy, unmedicated adolescents aged 10 to 17 years were enrolled between December 2020 and April 2024 through a network of pediatric clinics. The group included both adolescents with depressive or anxiety disorders and those without psychopathology. Participants with anemia or acute inflammation were excluded, and ID without anemia was defined by serum ferritin levels below 15 ng/mL, in line with WHO guidelines.

Participants underwent brain MRI scans to measure basal ganglia susceptibility—a marker of iron content—as well as clinical assessments of psychiatric symptoms and neuropsychological performance.

The study revealed the following findings:

  • 30% of the adolescent participants had iron deficiency (ID) without anemia.
  • These adolescents showed significantly lower iron content in the caudate and putamen regions of the brain.
  • The reduction in brain iron content was more pronounced in females.
  • The differences in brain iron levels appeared to increase with age, indicating a possible dose-dependent effect.
  • In females, the interaction between age and ID status led to progressively larger differences in brain iron content over time.
  • Lower basal ganglia iron content was associated with structural brain changes.
  • Reduced iron levels were also linked to more severe psychiatric symptoms.
  • Poorer cognitive performance was observed in adolescents with lower brain iron content, with stronger associations in females.

The authors note that this is one of the first studies to demonstrate that iron deficiency, even in the absence of anemia, can influence brain development during adolescence, a critical period for neurodevelopment.

However, the study’s cross-sectional design means the researchers could not determine when ID without anemia first developed in these individuals. They also call for future longitudinal studies to clarify how early-life ID might have lasting effects, to include more male participants, and to explore additional biomarkers beyond ferritin for better detection.

Given that certain racial and ethnic groups are more prone to ID, these findings highlight an urgent need to update clinical screening guidelines and proactively identify adolescents at risk, potentially preventing long-term neuropsychiatric consequences.

Reference:

Fiani D, Kim J, Hu M, et al. Iron Deficiency Without Anemia and Reduced Basal Ganglia Iron Content in Youths. JAMA Netw Open. 2025;8(6):e2516687. doi:10.1001/jamanetworkopen.2025.16687

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Maternal Smoking during pregnancy and Secondhand Smoke Exposure tied to Increased Stroke Risk: Study

Researchers have discovered in a new study that both maternal smoking and secondhand smoke (SHS) exposure were independently and jointly associated with a higher risk of stroke. Therefore there was an urgent need for stronger tobacco control policies to reduce these harmful exposures and their public health consequences.

A study was done to evaluate the independent and combined associations of secondhand smoke (SHS) exposure and maternal smoking during pregnancy with the risk of total stroke and its subtypes, including ischemic and hemorrhagic stroke, among nonsmokers. A study was done to investigate the independent and combined associations of SHS exposure and maternal smoking during pregnancy with stroke risk in nonsmokers. A prospective analysis was conducted using 336,640 nonsmoking participants from a nationwide cohort, free from pre-existing cardiovascular disease. SHS exposure was categorized based on hours per week (0, >0–4, >4), and maternal smoking was assessed via participant recall. Outcomes included total stroke, ischemic stroke, and hemorrhagic stroke, identified through hospital records. Cox regression models adjusted for demographic, behavioral, and clinical covariates were used to estimate hazard ratios (HRs) and 95 % confidence intervals (CIs). Results: Over a median follow-up of 11.8 years, 5,051 participants experienced strokes. SHS exposure >4 hours/week was associated with increased incident stroke risk (HR 1.34, 95 % CI 1.18–1.52) compared to no exposure. Maternal smoking was associated with a 7 % increase in total stroke risk (HR 1.07, 95 % CI 1.02–1.14). Combined exposure to SHS >4 hours/week and maternal smoking conferred the highest stroke risk (HR 1.57, 95 % CI 1.29–1.90). Subgroup and sensitivity analyses confirmed these findings. SHS exposure and maternal smoking was independently and jointly associated with higher stroke risk, underscoring the need for robust tobacco control policies to mitigate these exposures and their public health impact.

Reference:

Association between secondhand smoke exposure, maternal smoking during pregnancy, and stroke incidence in nonsmokers. Huang, Yi-Ping et al. Journal of Stroke and Cerebrovascular Diseases, Volume 34, Issue 8, 108379

Keywords:

Maternal, Smoking, during, pregnancy, Secondhand, Smoke, Exposure, tied, Increased Stroke Risk, Study , Secondhand smoke, Maternal smoking, Stroke, Ischemic stroke, Hemorrhagic stroke, Uk Biobank, ournal of Stroke and Cerebrovascular Diseases

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New clinical practice guideline for surgical management of chronic rhinosinusitis in adults

The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) published the new Clinical Practice Guideline (CPG): Surgical Management of Chronic Rhinosinusitis today in Otolaryngology-Head and Neck Surgery.

Chronic rhinosinusitis (CRS) affects 11.6% of adults and prompts 4.1 million annual ambulatory visits.

“Chronic rhinosinusitis doesn’t just affect the nose—it can influence a person’s general life. Patients can struggle with poor sleep, brain fog, depression, anxiety, and reduced productivity that ripples through their relationships and work or school performance,” said Jennifer J. Shin, MD, SM, Chair of the CPG Guideline Development Group.

“Many people don’t realize that chronic rhinosinusitis can affect patients as much as diseases that have traditionally been viewed as life-threatening or more serious. Patients with CRS face daily challenges that deserve our full attention and comprehensive care. This CPG provides the guidance for developing the needed care pathways for patients who may undergo surgery for CRS, based on current best evidence, such as systematic reviews, meta-analyses, and randomized control trials, as well as observational studies when these were more apt for specific clinical research questions.”

CRS is diagnosed when a patient has two or more symptoms or signs of CRS for 12 weeks or longer, and inflammation is documented by one or more findings. The symptoms and signs include:

Thick and/or discolored drainage (from the front of the nose, down the back of the nose, or both),

Nasal obstruction (congestion),

Facial pain, pressure, and fullness, or

Decreased sense of smell

Some people with chronic sinus problems need surgery when medications alone don’t provide enough relief. For certain types of sinus disease, having surgery sooner can help prevent worsening symptoms and reduce pain. Surgery works especially well for people who have fungal infections or nasal polyps (small growths), since these conditions often don’t respond well to medication alone. Surgery may also help people whose sinus problems cause frequent infections, ongoing symptoms, or make other conditions like asthma worse.

This CPG provides proven, research-based recommendations for the best ways to treat chronic sinus problems. Specifically, through 11 evidence-based key action statements, it covers the main surgery and additional treatments that might be needed, as well as follow-up procedures when necessary. The goal is to ensure patients receive excellent care before, during, and after their sinus surgery, while making sure doctors clearly explain treatment options and involve patients in making informed decisions about their care.

The guideline development group consisted of 18 panel members representing experts in specialties/subspecialities encompassing rhinology, comprehensive otolaryngology, otolaryngic allergy, otorhinolaryngological advanced practice provision, as well as a consumer representative.

Members of the media who wish to request an interview or obtain a copy of the guideline should contact newsroom@entnet.org.

References: Betty S. Tsai Do MD, Matthew L. Bush MD, PhD, MBA, Heather M. Weinreich MD, MPH, Seth R. Schwartz MD, MPH, Samantha Anne MD, MS, Oliver F. Adunka MD, MBA, Kaye Bender PhD, RN, Kristen M. Bold MPAS, PA-C, Michael J. Brenner MD, Ardeshir Z. Hashmi MD, Teresa A. Keenan PhD, Ana H. Kim MD, Denée J. Moore MD, Carrie L. Nieman MD, MPH, Catherine V. Palmer PhD, Erin J. Ross DNP, APRN, Kristen K. Steenerson MD, Kevin Y. Zhan MD, Joe Reyes MS, Nui Dhepyasuwan MEd First published: 30 April 2024 https://doi.org/10.1002/ohn.750

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Weekly Oral Risperidone Found Effective and Safe for Schizophrenia in Phase III Trial

Researchers have found in a Phase III Trial that patients with schizophrenia who were treated with the investigational long-acting oral weekly risperidone formulation (LYN 005) remained clinically stable without any unexpected safety issues. The findings of the trial have been published in Lancet Psychiatry. The new drug formulation may assist in solving one of schizophrenia treatment’s greatest challenges: adherence to medication. This phase 3 trial reinforced that once-weekly LYN-005 offers extended drug release and achieves pre-specified pharmacokinetic equivalence requirements, with potential as a long-acting oral drug for those with difficulty maintaining daily dosing regimens. The study was conducted by Citrome and colleagues.

Schizophrenia medication non-adherence is an epidemic problem that results in a common relapse, hospitalization, and deterioration of disease course. While long-acting injectable antipsychotics have improved adherence in some patients, a non-invasive, oral, long-acting formulation might prove more acceptable and feasible. LYN-005, a long-acting oral formulation of risperidone for weekly dosing, was developed to fill this gap. The purpose of this study was to determine if LYN-005 was able to produce stable therapeutic levels equivalent to once-daily risperidone without raising new safety issues.

This non-randomized, open-label, phase 3 trial recruited 83 clinically stable subjects with schizophrenia or schizoaffective disorder at five inpatient sites in the USA between April 13 and December 1, 2023. Participants (mean age: 49.3 years, SD 11.5) were 75% male (n=62) and 81% Black or African American (n=67). After 7 days of run-in with daily immediate-release risperidone (2 mg or 6 mg), the participants were administered five weekly doses of LYN-005 (15 mg or 45 mg, respectively) and a half-dose supplement of daily risperidone for the first week in order to taper off the transition.

The trial assessed principal pharmacokinetic parameters—minimum concentration (Cmin), peak concentration (Cmax), and mean concentration (Cavg)—at weeks 1 and 5. Predefined acceptance criteria were on geometric mean ratios of LYN-005 versus immediate-release risperidone.

Findings

  • 47 subjects completed the study, and 44 subjects were included in the analysis for pharmacokinetics.

  • At week 1, Cmin for LYN-005 was 1.02 (90% CI: 0.93–1.12) versus immediate-release risperidone.

At week 5, the ratios were:

  • Cmin: 1.04 (90% CI: 0.87–1.23)

  • Cmax: 0.84 (90% CI: 0.77–0.92)

  • Cavg: 1.03 (90% CI: 0.93–1.13)

All results were within or near the pre-established ranges of acceptance, confirming pharmacokinetic equivalence.

  • Gastrointestinal treatment-emergent adverse events occurred in 66% (n=44) of 67 patients treated with LYN-005, and these were predominantly mild.

  • A single serious adverse event was reported, with no safety signals outside expectations.

  • Patients were clinically stable during the study, reaffirming the efficacy of the formulation.

This phase 3 trial concludes that oral LYN-005 weekly administers steady therapeutic risperidone levels with equal bioavailability compared to daily risperidone. The preparation was tolerable, with no emerging safety issues, and achieved clinical stability among subjects. These findings attest to the promise of LYN-005 as an alternative long-acting oral agent for schizophrenia and schizoaffective disorder management, with the potential to enhance adherence and long-term outcomes.

Reference:

Citrome, L., Nagaraj, N., Traverso, G., Dumas, T., & Scranton, R. (2025). Long-acting oral weekly risperidone (LYN-005) for schizophrenia in the USA (STARLYNG-1): a multicentre, open-label, non-randomised phase 3 trial. The Lancet. Psychiatry, 12(7), 504–512. https://doi.org/10.1016/s2215-0366(25)00135-x

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