Frailty Significantly Increases Mortality and Complications in PCI Patients, NCDR Registry Study Finds

USA: Frailty is common among older patients undergoing percutaneous coronary intervention (PCI) in the United States, with greater frailty linked to significantly higher risks of in-hospital death and procedural complications, according to new findings from the American College of Cardiology’s CathPCI Registry. The study, led by Dr. Benjamin Peterson from the University of Kentucky School of Medicine, was published online in JACC ahead of its June 24, 2025, issue.

The analysis included over 1.3 million patients (mean age 74.6 years; 34% women) aged 65 years or older who underwent PCI between October 2018 and December 2021. Frailty was evaluated using the Canadian Study of Health and Aging Clinical Frailty Scale (CFS), which assesses the ability to perform both basic and instrumental activities of daily living. Patients were classified into four groups: non-frail (CFS 1-2), prefrail (CFS 3-4), frail (CFS 5-6), and severely frail (CFS 7-9).

The key findings were as follows:

  • Frailty was widespread among PCI patients, with 67.8% categorized as prefrail, 21.6% as frail, and 2.2% as severely frail.
  • The overall in-hospital mortality rate was 2.4%.
  • Mortality increased sharply with frailty: 0.5% in nonfrail patients, 1.1% in prefrail, 3.3% in frail, and 20.3% in severely frail patients.
  • More than half of all PCIs were performed in patients over 65 years, who account for nearly 80% of PCI-related mortality.
  • The study demonstrated a clear gradient of increasing risk tied to frailty status, independent of bedside mortality scores and across various clinical subgroups.
  • Among severely frail patients undergoing complex PCI scenarios, mortality rates were 44.2% following cardiac arrest, 51.0% with cardiogenic shock, 46.1% with mechanical circulatory support, 23.9% with chronic total occlusions, 29.6% for left main coronary interventions, and 22.4% with severe calcification.
  • The rates of complications, including bleeding, transfusion need, vascular issues, new dialysis initiation, and stroke, consistently rose with increasing frailty severity.

While the authors caution against using these findings to withhold PCI, especially in acute coronary syndromes, they emphasize the importance of incorporating frailty assessment into routine clinical evaluations. “Frailty status, even at the prefrail level, significantly affects procedural risk and should guide shared decision-making,” the authors noted.

In an accompanying editorial, Dr. John A. Dodson and Dr. Ashok Krishnaswami advocate for incorporating frailty screening into routine patient assessment, similar to vital signs, to enhance outcomes for older adults undergoing PCI.

“To meaningfully improve care for older adults, frailty assessment should become a routine part of clinical practice—integrated into every evaluation just as vital signs are,” they wrote.

Reference:

Peterson, B., Kochar, A., Young, R., Senman, B., Rymer, J., Wojdyla, D., … Bhatt, D. L. (2025). Effect of Frailty on In-Hospital Mortality and Complications of PCI: An NCDR Registry Report (Accepted). Journal of the American College of Cardiology, 85(24), 2416–2420. https://doi.org/10.1016/j.jacc.2025.04.027

Powered by WPeMatico

Combination Therapy Halts Progression of COVID-19 Associated sino-maxillary and mandibular mucormycosis, suggests study

Researchers have found in a new research that the combined use of oral posaconazole, adjunctive hyperbaric oxygen (HBO) therapy, and methylene blue effectively prevents further progression of COVID-19 associated sino-maxillary and mandibular mucormycosis.

The study aimed to assess the cumulative role of oral posaconazole, post-debridement Hyperbaric Oxygen (HBO) therapy, along with local application and steam inhalation with methylene blue as an adjunct to surgery to prevent further progression of COVID-19 associated sino-maxillary or mandibular mucormycosis.

A retrospective observational study was conducted on patients diagnosed with sino-maxillary or mandibular mucormycosis associated with COVID-19. A total of 38 patients underwent surgical debridement and received adjunctive treatment with posaconazole, hyperbaric oxygen therapy, and local application and steam inhalation of methylene blue. Medical records were analyzed for COVID-19-related hyperglycemia, prolonged hospitalization, immunosuppressive/steroid therapy, and the use of iron or zinc supplements, which may be linked to increased mucormycosis incidence. Outcomes were evaluated for association with any concurrent infection, complications, need for sequential debridement, and further progression of disease.

Results: A total of 38 patients (range: 23–68) were included, comprising 24 males and 14 females. Isolated sino-maxillary involvement was observed in 32 cases (84.21%), and mandibular involvement in 5 cases (13.15%). No further disease progression was noted during the 2-year follow-up, based on clinical evaluation and postoperative computed tomography (CT) scans. Actinomycosis co-infection was identified in 21.05% of cases.

Complications included wound dehiscence (39.47%), pus discharge (5.26%), reversible hearing impairment during HBO therapy (5.26%), and flap necrosis (2.63%). Four patients (10.52%) required sequential surgical debridement for sequestrum removal. It was concluded that concurrent use of oral posaconazole, adjunct HBO therapy and methylene blue prevents further progression of COVID-19 associated sino-maxillary and mandibular mucormycosis.

Reference:

Mohanty, S., Bansal, N., Verma, A. et al. Adjunctive use of posaconazole, hyperbaric oxygen therapy, and methylene blue for COVID-19-associated mucormycosis. Oral Maxillofac Surg 29, 126 (2025). https://doi.org/10.1007/s10006-025-01419-2

Powered by WPeMatico

Enlicitide Decanoate Promising as Oral PCSK9 Inhibitor in Hyperlipidemia in Phase 3 trials

Phase 3 trials have demonstrated that enlicitide decanoate significantly reduces LDL cholesterol, showing strong potential as an oral PCSK9 inhibitor for patients with hyperlipidemia and heterozygous familial hypercholesterolemia (HeFH).

The CORALreef HeFH and CORALreef AddOn trials successfully met their primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful greater reductions in low-density lipoprotein cholesterol (LDL-C) for enlicitide compared to placebo (CORALreef HeFH) and compared to other oral non-statin therapies (CORALreef AddOn). There were no clinically meaningful differences in incidences of adverse events (AE) and serious adverse events (SAE) in either trial.

Results from the three Phase 3 trials in the CORALreef clinical development program will be presented at a future scientific congress.

Key takeaways from CORALreef HeFH and CORALreef AddOn studies:

• CORALreef HeFH: statistically significant and clinically meaningful reductions in LDL-C for enlicitide versus placebo in adults with heterozygous familial hypercholesterolemia (HeFH) who have a history of or are at risk for atherosclerotic cardiovascular disease (ASCVD) and are treated with a statin.

• CORALreef AddOn: statistically significant and clinically meaningful reductions in LDL-C for enlicitide versus ezetimibe, versus bempedoic acid and versus ezetimibe and bempedoic acid in adults with hyperlipidemia who have a history of or are at risk for ASCVD and are treated with a statin.

“We are thrilled to bring forward the first Phase 3 results from our clinical development program evaluating enlicitide, which, if approved, would be the first marketed oral PCSK9 inhibitor in the U.S.,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “Enlicitide is a novel macrocyclic peptide that has the potential to deliver antibody-like efficacy and specificity for the validated PCSK9 mechanism in the form of a daily oral pill. We are working with urgency to make this oral therapy available to patients worldwide.”

“Atherosclerotic cardiovascular disease accounts for 85 percent of cardiovascular deaths. Despite available treatment options, cardiovascular-related deaths remain the leading cause of death worldwide and continue to rise,” said Dr. Christie M. Ballantyne, principal investigator of the CORALreef HeFH study and Professor of Medicine at Baylor College of Medicine. “LDL-C is a major modifiable risk driver for atherosclerosis and prioritization of LDL-C management should be a cornerstone of cardiovascular risk prevention. Early intervention and intensification of lipid treatment would allow more patients to achieve LDL-C goals.”

The efficacy and safety of enlicitide are being evaluated through the comprehensive CORALreef Phase 3 clinical development program, which aims to enroll approximately 17,000 patients across several trials, including two large ongoing trials, CORALreef Lipids and CORALreef Outcomes.

About CORALreef HeFH

CORALreef HeFH (NCT05952869) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the safety and efficacy of enlicitide compared to placebo in adults with HeFH who have a history of or were at risk for a major ASCVD event and are treated with a moderate or high intensity statin with or without other lipid-lowering therapies. The primary endpoints were mean percent change from baseline in LDL-C at week 24, number of participants with one or more adverse events (AEs), and number of participants who discontinued study drug due to an AE. Secondary endpoints included mean percent change from baseline in LDL-C at week 52, mean percent change from baseline in non-HDL-C, ApoB and percent change in Lp(a) at week 24.

About CORALreef AddOn

CORALreef AddOn (NCT06450366) is a Phase 3, randomized, double-blind, multicenter study designed to evaluate the efficacy and safety of enlicitide compared to ezetimibe, to bempedoic acid, and to ezetimibe and bempedoic acid, in patients with hypercholesterolemia who had a history of a major ASCVD event or were at risk for a major ASCVD event and are treated with a statin. The primary endpoint was the mean percent change from baseline in LDL-C at week 8. Secondary endpoints included mean percent change from baseline in non-HDL-C and ApoB.

About enlicitide and PCSK9

Enlicitide is an investigational, potentially first oral PCSK9 inhibitor designed to lower LDL-C via the same biological mechanism as currently approved monoclonal antibody injectable PCSK9 inhibitors but in a daily pill form. Enlicitide is a novel oral macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors.

PCSK9 plays a key role in cholesterol homeostasis by regulating levels of the LDL receptor, which is responsible for the uptake of cholesterol into cells. Inhibition of PCSK9 with enlicitide prevents the interaction of PCSK9 with LDL receptors. This results in greater numbers of LDL receptors available on the cell surface to remove LDL cholesterol from the blood.

About hyperlipidemia

Hyperlipidemia is a disorder characterized by an excess of lipids or fats in the blood, affecting approximately 86 million adults (aged 20 and older) in the U.S. Despite adjusting diet or other lifestyle factors, some individuals may not reach recommended lipid levels and will require medication to treat and manage hyperlipidemia. Hyperlipidemia is a major risk driver for the development of ASCVD events, such as heart attacks and strokes, which account for 85 percent of cardiovascular deaths.

Powered by WPeMatico

Zydus Gets CDSCO Panel Nod to Conduct Phase IV Trial for Indacaterol-Budesonide FDC Inhalation

New Delhi: In response to the proposal presented by Zydus Healthcare, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the drug maker to conduct the Phase IV clinical trial of the fixed dose combination (FDC) Indacaterol maleate plus Budesonide Powder for inhalation (capsules).

In addition, the committee recommended the firm to submit the Phase IV clinical trial report of the FDC Indacaterol maleate plus Budesonide Powder for inhalation.

This came after the firm presented the Phase IV clinical trial protocol before the committee.

Indacaterol is a long-acting β2-adrenoceptor agonist and bronchodilator with a rapid onset of action. It was developed by Novartis. It is used to relax bronchial smooth muscle and improve symptoms and airflow obstruction caused by Chronic Obstructive Pulmonary Disease (COPD) and moderate to severe asthma.

Budesonide is a glucocorticoid that acts as an anti-inflammatory and immunomodulator. Budesonide inhalation is a treatment for asthma and chronic obstructive pulmonary disease (COPD).

At the recent SEC meeting, the expert panel reviewed the Phase IV clinical trial protocol before the committee.

After detailed deliberation, the committee recommended for grant of permission to conduct of the Phase IV clinical trial. “Accordingly, the firm should submit the Phase IV clinical trial report to CDSCO for further review by the committee,” the Panel noted.

Also Read: CDSCO Panel Accepts Mylan’s Post-Marketing Surveillance Report for Liposomal Amphotericin B Injection

Powered by WPeMatico

Digital Inhalers Improve Asthma Control, May Lower Risk of Severe Exacerbations: Study Shows

Canada: A comprehensive meta-analysis has found that patient-facing digital inhalers may significantly improve asthma management, particularly among individuals who struggle with medication adherence or inhalation techniques. The findings, published in The Journal of Allergy and Clinical Immunology: In Practice, indicate that these devices likely enhance asthma control and could lower the risk of severe asthma exacerbations with minimal associated harm.

Digital inhalers have sensors that provide real-time feedback to patients regarding their medication usage and inhalation technique. These tools aim to address the long-standing issue of poor adherence, estimated to affect around 43% of asthma patients globally.

To better understand their clinical utility, Leonardo Ologundudu, from McMaster University in Ontario, Canada, and colleagues conducted a systematic review of 12 randomized controlled trials involving 2,483 children (ages 4–17) and adults. This work was undertaken in the context of developing new clinical guidelines for severe and difficult-to-control asthma by the American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma, and Immunology Joint Task Force.

Based on the study, the researchers reported the following findings:

  • Digital inhalers likely improve asthma symptom control, with 44.3% of users achieving at least a three-point increase in Asthma Control Test scores, compared to 39.8% in the control group.
  • The study suggests that digital inhalers may reduce the incidence of severe asthma exacerbations, particularly in patients at high risk, with an 11% relative reduction, though the certainty of this finding is low.
  • On average, digital inhalers may result in 45 fewer severe exacerbations per 1,000 patients.
  • The review found minimal harm associated with digital inhalers, with a median device failure rate of about 12%.
  • Technical issues, such as sensor synchronization with smartphones, were the primary cause of failure.
  • One trial reported a case of protected health information exposure, but overall, adverse outcomes were rare.

The authors emphasize considering the benefits of digital inhalers within a broader clinical context. Patients already demonstrating consistent adherence and proper technique may derive limited additional benefit, whereas those requiring ongoing support might find digital inhalers especially helpful.

However, limitations exist. Many studies lacked blinded outcome assessors, and few enrolled older adults above 60. Moreover, the combined effect of digital inhalers and remote clinician monitoring was commonly studied, making it difficult to isolate its standalone impact.

Still, the findings are expected to influence future clinical practice. “These results support the incorporation of digital inhalers into asthma management, particularly for select patient subgroups. Updated guidelines should reflect this evolving landscape,” the researchers concluded.

Reference:

Ologundudu L, Rayner DG, Oppenheimer J, Sumino K, Hoyte F, RiveraSpoljaric K, Perry TT, Nyenhuis SM, Chipps B, Israel E, Shade LE, Press VG, Rangel S, Guyatt GH, McCabe E, O’Byrne PM, Hall L, Orr H, Sue-Wah-Sing D, Melendez A, Winders T, Przywara K, Gardner DD, Rank MA, Bacharier LB, Mosnaim G, Chu DK, Patient-facing digital inhalers for asthma: a systematic review and meta-analysis, The Journal of Allergy and Clinical Immunology: In Practice (2025), doi: https://doi.org/10.1016/j.jaip.2025.04.039.

Powered by WPeMatico

Gepotidacin Offers Safe and Effective Oral Alternative for Urogenital Gonorrhoea: Lancet

A new study published in The Lancet journal showed that Gepotidacin was non-inferior to the standard treatment of ceftriaxone plus azithromycin for urogenital Neisseria gonorrhoeae, with no new safety concerns reported. This highlights gepotidacin as a promising novel oral treatment option for uncomplicated urogenital gonorrhoea.

It has been demonstrated that gepotidacin, a first-in-class, bactericidal, triazaacenaphthylene antibiotic that prevents bacterial DNA replication, is both effective and well-tolerated when used to treat simple UTIs. Thus, to assess the safety and effectiveness of gepotidacin for the treatment of uncomplicated urogenital gonorrhea, Jonathan Ross and colleagues carried out this investigation.

This trial compared conventional therapy for uncomplicated urogenital gonorrhea (500 mg IM ceftriaxone + 1 g oral azithromycin) with oral gepotidacin (two 3000 mg doses, 10–12 hours apart). The participants were randomized 1:1, stratified by age, sex, and sexual orientation, and had to be at least 12 years old, weigh more than 45 kg, and have a proven or suspected infection. Microbiological success, or the culture-confirmed eradication of Neisseria gonorrhoeae at days 4–8, was the main endpoint, with a non-inferiority margin of −10%.

All participants randomly assigned to a study treatment who acquired at least one dose of their study treatment and were found to have ceftriaxone-susceptible N. gonorrhoeae isolated from the baseline culture of their urogenital specimen were evaluated for the primary outcome in the microbiological intention-to-treat (micro-ITT) population.

A total of 628 participants were randomized evenly to either ceftriaxone plus azithromycin or gepotidacin from October 2019 to October 2023 and 39% of them were lost to follow-up. There were 406 individuals in the micro-ITT population (204 receiving conventional treatment and 202 receiving gepotidacin).

The majority (92%) were men, and MSM made up a larger percentage (71%) than MSW (20%). 74% were White, 15% were Black/African American, and 17% were Hispanic or Latino. Non-inferiority was demonstrated by the microbiological success rates at test-of-cure, which were 92.6% in the gepotidacin group and 91.2% in the ceftriaxone + azithromycin group.

In neither group did urogenital N. gonorrhoeae persist. Mild to moderate gastrointestinal problems were the most common drug-related side events in the gepotidacin group. Neither group experienced any severe or major adverse effects. Overall, with no new safety issues, gepotidacin showed no inferiority to ceftriaxone with azithromycin for urogenital N. gonorrhoeae, providing a new oral treatment option for simple urogenital gonorrhea.

Source:

Ross, J. D. C., Wilson, J., Workowski, K. A., Taylor, S. N., Lewis, D. A., Gatsi, S., Flight, W., Scangarella-Oman, N. E., Jakielaszek, C., Lythgoe, D., Powell, M., Janmohamed, S., Absalon, J., & Perry, C. (2025). Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. Lancet, 405(10489), 1608–1620. https://doi.org/10.1016/S0140-6736(25)00628-2

Powered by WPeMatico

Vitiligo Linked to Increased Risk of Heart, Autoimmune, and Mental Health Conditions: Study Shows

USA: In a recent case-control study utilizing data from the All of Us research program, researchers have uncovered a broad spectrum of comorbidities linked to vitiligo, extending well beyond its traditionally recognized autoimmune associations. The study, published in Clinical and Experimental Dermatology, was led by Austin J Piontkowski and colleagues from the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, New York.

“The All of Us study revealed that vitiligo patients face significantly higher risks of cardiovascular and autoimmune comorbidities. Notably, they showed increased odds of hyperlipidemia (OR 2.32), atherosclerotic disease (OR 1.78), and hypertension (OR 1.75),” the researchers reported The condition was also linked to bone and joint, endocrine, and psychiatric disorders, highlighting the importance of a comprehensive, multidisciplinary approach to patient care.

Vitiligo, a condition characterized by the loss of skin pigmentation, has long been associated with other autoimmune disorders. However, this new analysis suggests that individuals with vitiligo may also face heightened risks for several systemic health issues.

The researchers examined health data from 1,074 individuals with vitiligo and compared them with 4,296 matched controls. Using conditional logistic regression models, they assessed the odds of developing 29 pre-selected comorbid conditions. P-values were adjusted using the Benjamini-Hochberg method to account for multiple comparisons.

The key findings of the study were as follows:

  • Vitiligo patients showed significantly higher odds of hyperlipidemia (OR 2.32).
  • They had an increased risk of atherosclerotic disease (OR 1.78).
  • The likelihood of developing hypertension was also elevated (OR 1.75).
  • Vitiligo was linked to a higher burden of musculoskeletal conditions.
  • Endocrine disorders were more prevalent among individuals with vitiligo.
  • There was a notable association between vitiligo and autoimmune diseases.
  • Psychiatric conditions were also more common in vitiligo patients.
  • These findings suggest that vitiligo may involve broader systemic health impacts beyond skin depigmentation.

“These results point to the complex and multifaceted nature of vitiligo,” the authors noted, suggesting that systemic inflammation may be a common underlying factor contributing to these associations.

The findings carry important clinical implications. The authors emphasize the need for integrated care strategies with vitiligo patients facing elevated risks for a broad range of comorbidities. Instead of treating vitiligo in isolation, healthcare providers should consider comprehensive management approaches that address co-existing cardiovascular, autoimmune, endocrine, and mental health issues.

The study contributes to a growing body of evidence highlighting the systemic burden of vitiligo and calls for future research into therapeutic options that target both skin symptoms and underlying inflammatory processes.

The large-scale analysis from the All of Us database sheds new light on the health risks individuals face with vitiligo. The findings advocate for a more holistic treatment approach, emphasizing early identification and management of associated conditions to improve overall patient outcomes.

Reference:

Piontkowski, A. J., Dubin, C., Thakker, S., Orloff, J., Powers, C., Silver, C., Ungar, B., & Gulati, N. Vitiligo and associated comorbidities: A case-control study in the All of Us database. Clinical and Experimental Dermatology. https://doi.org/10.1093/ced/llaf228

Powered by WPeMatico

Tamsulosin Fails to prevent urinary retention After Inguinal Hernioplasty under spinal anesthesia, suggests study

Researchers have found in a new study that Prophylactic use of tamsulosin did not significantly lower the incidence of postoperative urinary retention (POUR) in patients undergoing inguinal hernioplasty under spinal anesthesia.

Inguinal hernioplasty is a common surgical procedure, often associated with complications such as post-operative urinary retention (POUR). Post-operative urinary retention, characterized by an inability to urinate despite a full bladder following a surgery that may need foley catheterization that on its own can lead to urinary tract infection, stricture, prolonged hospitalization, and increases cost of hospital care. Tamsulosin is a selective alpha-1 adrenergic blocker that can increase urine flow by relaxing the smooth muscle of urethra and prostate, thereby as a less invasive method may be effective in prevention of post-operative urinary retention. This randomized clinical trial involved 179 male participants over 50 undergoing unilateral hernioplasty under spinal anesthesia. Group A (87 subjects) received 0.4 mg Tamsulosin 8 hours before surgery, then 6 to 12 hours post-operatively. Group B (92 subjects) received a placebo on the same schedule. Both were monitored for post-operative urinary retention incidence within 24 hours post-surgery. Data were analyzed using SPSS software version 18 and the P < 0.05 was considered statistically significant. Results: The mean age of participants was 63.37±10.62 years. Post-operative urinary retention requiring catheterization occurred in 10.3% of Group A and 16.3% of Group B. However, the difference was not statistically significant (p=0.242). Logistic regression showed no significant prophylactic effect of Tamsulosin (p=0.171), hypertension (p=0.166), diabetes mellitus (p=0.196), or benign prostatic hyperplasia (p=0.273) on post-operative urinary retention incidence. Prophylactic Tamsulosin did not significantly reduce the incidence of post-operative urinary retention following inguinal hernioplasty under spinal anesthesia.

Reference:

prophylactic effect of Tamsulosin on postoperative urinary retention in Inguinal hernia repair under spinal anesthesia. Seyedinnavadeh, Seyedehatefe et al. The American Journal of Surgery, Volume 0, Issue 0, 116455

Keywords:

Tamsulosin, Fails, prevent, urinary, retention, After, Inguinal, Hernioplasty, under, spinal, anesthesia, suggests, study , Tamsulosin, urinary retention, inguinal hernia, post-operative, The American Journal of Surgery

Powered by WPeMatico

Vitamin D increases likelihood that breast cancer will disappear with chemotherapy: Study

A study conducted at the Botucatu School of Medicine at São Paulo State University (FMB-UNESP) in Brazil has shown that low-dose vitamin D supplementation can increase the effectiveness of chemotherapy treatment in women with breast cancer. The results suggest that the substance could be an alternative to hard-to-access drugs that also aim to increase the response to chemotherapy.

The research, supported by FAPESP, involved 80 women over the age of 45 who were about to start treatment at the oncology outpatient clinic of the general and teaching hospital (“Hospital das Clínicas”) at FMB-UNESP. They were separated into two groups: 40 of them took 2,000 IU (international units) of vitamin D a day, while the other 40 received placebo tablets.

After six months of cancer treatment and supplementation, 43% of participants using vitamin D saw their disease disappear with the use of chemotherapy, compared to 24% of the placebo group. All the participants in the study underwent so-called neoadjuvant chemotherapy, which is used to facilitate surgery to remove the tumor.

“Even with a small sample of participants, it was possible to observe a significant difference in the response to chemotherapy. In addition, the dosage used in the research [2,000 IU per day] is far below the target dose for correcting vitamin D deficiency, which is usually 50,000 IU per week,” says Eduardo Carvalho-Pessoa, president of the São Paulo Regional Brazilian Society of Mastology and one of the authors of the article published in the journal Nutrition and Cancer.

Immunity

Vitamin D is a hormone that aids in the absorption of calcium and phosphorus, which is essential for bone health. Recent studies have shown that it also plays an important role in the immune system by helping to fight infections and diseases, including cancer. However, most studies linking cancer and vitamin D supplementation have used high doses of the substance.

This hormone is obtained primarily through exposure to sunlight and food. The recommended daily intake is 600 IU for those who are not deficient in the vitamin, and 800 IU a day for older people. The American Academy of Pediatrics recommends 400 IU of vitamin D per day for babies. It is important to note that too much can be toxic and cause vomiting, weakness, bone pain, and kidney stones.

Most of the participants in the study had low levels of vitamin D, defined as less than 20 nanograms per milliliter (ng/mL) of blood. The Brazilian Society of Rheumatology recommends levels between 40 and 70 ng/mL. “With supplementation, levels increased throughout chemotherapy treatment, which reinforces a possible contribution to the patients’ recovery,” Carvalho-Pessoa told Agência FAPESP. “Vitamin D is an accessible and inexpensive option compared to other drugs used to improve the response to chemotherapy, some of which are not even included in the list of the Unified Health System [the Brazilian national public health network, known as the SUS, its acronym in Portuguese],” he adds.

For the researcher, the findings pave the way for further investigation into the auxiliary role of the substance in the response to cancer treatment. “These are encouraging results that justify a new round of studies with a larger number of participants. This will allow a greater understanding of the role of vitamin D in increasing the response to chemotherapy treatment and, consequently, in the greater likelihood of breast cancer remission,” he concludes.

Reference:

Omodei, M. S., Chimicoviaki, J., Buttros, D. A. B., Almeida-Filho, B. S., Carvalho-Pessoa, C. P., Carvalho-Pessoa, E., … Nahas, E. A. P. (2025). Vitamin D Supplementation Improves Pathological Complete Response in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy: A Randomized Clinical Trial. Nutrition and Cancer, 77(6), 648–657. https://doi.org/10.1080/01635581.2025.2480854

Powered by WPeMatico

FDA Approves Clesrovimab to Prevent RSV in Infants

The FDA has approved clesrovimab, marketed as Enflonsia, for the prevention of RSV lower respiratory tract disease in neonates and infants during their first RSV season.

ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same 105 mg dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year.

“RSV disease is the leading cause of infant hospitalization in the U.S. and can lead to serious respiratory conditions like bronchiolitis and pneumonia,” said Dr. Octavio Ramilo, chair of the Department of Infectious Diseases at St. Jude Children’s Research Hospital and investigator for the CLEVER (MK-1654-004) and SMART (MK-1654-007) trials. “ENFLONSIA combines dosing convenience with strong clinical data showing significant reductions in RSV disease incidence and hospitalizations, making it a promising new intervention to help protect infants from RSV.”

ENFLONSIA should not be administered to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA. See additional Selected Safety Information below.

The approval is based on results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004) evaluating a single dose of ENFLONSIA administered to preterm and full-term infants (birth to 1 year of age). The trial met its primary and key secondary endpoints, as outlined below.

• ENFLONSIA demonstrated a reduction in incidence of RSV-associated medically attended lower respiratory infections (MALRI) requiring ≥1 indicator of lower respiratory infection (LRI) or severity compared to placebo through 5 months (primary endpoint) by 60.5% (95% CI: 44.2, 72.0, p<0.001) (incidence rates: ENFLONSIA, 0.026; placebo, 0.065).

• ENFLONSIA demonstrated a reduction in RSV-associated hospitalizations through 5 months (key secondary endpoint) by 84.3% (95% CI: 66.7, 92.6, p<0.001) (incidence rates: ENFLONSIA, 0.004; placebo, 0.024), showing increasing efficacy with increasing disease severity.

The approval is also supported by results from the Phase 3 SMART trial (MK-1654-007) evaluating the safety and efficacy of ENFLONSIA versus palivizumab in infants at increased risk for severe RSV disease.

“ENFLONSIA provides an important new preventive option to help protect healthy and at-risk infants born during or entering their first RSV season with the same dose regardless of weight,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We are committed to ensuring availability of ENFLONSIA in the U.S. before the start of the upcoming RSV season to help reduce the significant burden of this widespread seasonal infection on families and health care systems.”

The U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of ENFLONSIA in infants. Ordering is anticipated to begin in July, with shipments delivered before the start of the 2025-2026 RSV season.

About ENFLONSIA™ (clesrovimab-cfor)

ENFLONSIA (clesrovimab-cfor) is Merck’s extended half-life monoclonal antibody (mAb) indicated for passive immunization for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. ENFLONSIA is administered using non-weight-based dosing and is designed to provide direct, rapid and durable protection through 5 months, a typical RSV season. For infants born during the RSV season, ENFLONSIA is to be administered starting from birth. For infants born outside of the RSV season, ENFLONSIA should be administered prior to the start of their first RSV season. For infants undergoing cardiac surgery with cardiopulmonary bypass during or entering their first RSV season, an additional 105 mg dose is recommended as soon as the infant is stable after surgery.

Powered by WPeMatico