Patient navigators improve colonoscopy rates after abnormal stool tests, study shows

 A University of Arizona Health Sciences-led study found that patients are more likely to get colonoscopies following abnormal stool test results if patient navigators assist them through the process.

The paper, published in the Annals of Internal Medicine, showed that 55% of patients who were assigned to a patient navigator received follow-up colonoscopies within a year compared with 42.5% of patients who received usual care without a navigator.

“It is important for patients with abnormal stool test results to get a colonoscopy as soon as possible to prevent an increased risk of colorectal cancer and later-stage cancer detection,” said first author Gloria Coronado, PhD, the U of A Cancer Center’s associate director of population science and a professor at the U of A Mel and Enid Zuckerman College of Public Health. “We found that using patient navigators improved rates of colonoscopy follow-up and reduced time to follow-up among patients who had an abnormal fecal immunochemical test, or FIT test. This guidance through the process can improve patient survival rates through earlier cancer detection.”

Patients ranging in age from 50 to 75 who had abnormal fecal test results in the prior month were enrolled in PRECISE, which stands for Predicting and Addressing Coloscopy Non-Adherence in Community Settings. All of the patients were seen at Sea Mar Community Health Centers, a federally qualified health center that operates 32 clinics in western Washington.

A total of 970 patients with abnormal FIT results were enrolled, and 479 were randomly selected and assigned to a patient navigator on staff at Sea Mar. Patients not assigned to a navigator received usual care consisting of up to two phone calls and a letter to schedule a colonoscopy appointment.

Patient navigators sent introductory letters, made phone calls and delivered text messages to patients addressing six topic areas at scheduled times: introduction and barrier assessment, barrier resolution, bowel preparation instructions, bowel preparation reminder, colonoscopy check-in and a final checkup following the completed procedure. Navigators made up to six attempts for each scheduled call, and patients not initially reached were called up to 12 more times and sent a follow-up letter.

Patient navigation resulted in a 12% improvement in one-year follow-up colonoscopy completion rates over usual care. Additionally, patients allocated to navigation obtained a colonoscopy in an average of 229 days, which was 27 days shorter than usual care patients.

Coronado said the colorectal cancer mortality rate could be substantially reduced if patients with abnormal stool test results received timely follow-up colonoscopies, as patients who delay are seven times more likely to die from colorectal cancer.

In the future, Coronado said her team hopes clinics will use navigators for patients who receive an abnormal stool test result.

“By standardizing navigation, clinics can establish procedures that include notifying patients of their results and assisting them in understanding the importance of a colonoscopy,” Coronado said.

According to the American Cancer Society, colorectal cancer is the third-leading cause of cancer-related deaths in U.S. men and the fourth-leading cause in U.S. women, but it’s the second most common cause of cancer deaths when numbers for men and women are combined.

Reference:

Gloria D. Coronado, Amanda F. Petrik, Jamie H. Thompson, et al. Patient Navigation to Improve Colonoscopy Completion After an Abnormal Stool Test Result: A Randomized Controlled Trial. Ann Intern Med. [Epub 1 April 2025]. doi:10.7326/ANNALS-24-01885

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Spironolactone Use among Young Women for acne treatment Growing despite Safety Concerns: JAMA

Researchers have found in a new study that use of spironolactone among young women and girls has increased since 2000, primarily for acne and androgen-related conditions. While the drug is well-established for cardiovascular issues, its safety for relatively healthy individuals using it off-label remains unproven. The FDA warns of potential risks, including hyperkalemia, hypotension, worsening renal function, electrolyte imbalances, metabolic abnormalities, and gynecomastia.

Spironolactone is FDA-approved for cardiovascular disease but is widely prescribed off-label for androgen-related conditions such as acne in young women and girls, often at higher doses (100-200 mg/d) than cardiovascular uses (25 mg/d). While clinical trials have primarily focused on older adults with heart failure, safety concerns related to androgen deprivation, including vulvar pain, have emerged in case reports. However, large-scale safety evaluations in younger populations remain limited. Given spironolactone’s increasing use for acne, particularly among adolescents, understanding prescribing trends can inform the need for further safety studies.This cohort study analyzed prescribing trends from 2000 to 2020 among 38 million insured females aged 12 to 40 years using deidentified claims data. Among 451,234 new spironolactone users (1.2% of the cohort), 11.5% were aged 12 to 18 years at initiation. Acne was the most common diagnosis (55.5%), followed by hirsutism (8.3%) and polycystic ovary syndrome (8.1%). Cardiovascular conditions were rare, with hypertension (4.0%) and congestive heart failure (0.8%). Notably, 29.4% of users lacked a recorded diagnosis for these conditions, possibly indicating alternative uses such as cancer-related edema management. New prescriptions increased from 17 per 100,000 covered individuals in 2000 to 88 per 100,000 in 2020, with the highest growth among those aged 19 to 25 years. Despite potential misclassification of indications due to insurance reimbursement factors, the study found a significant rise in spironolactone use among young women and girls, with most users requiring doses higher than those evaluated in cardiovascular trials. Given its widespread use and the potential for safety concerns, particularly regarding androgen deprivation effects, further targeted safety studies may be necessary to assess risks in this population.

Reference:

Soppe SE, Robinson WR, Lachiewicz MP, Wood ME. Trends in the Proportion of Young Women and Girls Prescribed Spironolactone. JAMA Netw Open. 2025;8(3):e250842. doi:10.1001/jamanetworkopen.2025.0842

Keywords:

Spironolactone, Use, among, Young, Women, acne, treatment, Growing, despite, Safety, Concern, JAMA, Soppe SE, Robinson WR, Lachiewicz MP, Wood ME

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Study shows how new antibody therapy works against ovarian cancer: Study

Research has shed light on how a new type of antibody treatment reactivates patients’ immune cells to fight ovarian cancer.

The research, from the group of Professor Sophia Karagiannis at King’s College London, could help to better understand the responses of patients who receive this type of therapy.

Antibody treatments are a type of immunotherapy, which work by helping the body’s immune system to recognise and kill cancer cells. Almost all antibodies currently used in cancer treatment are made from a type of antibody called IgG, however, IgGs have not been effective against ovarian cancer.

Researchers at King’s are the first in the world to develop a treatment from a different type of antibody, called IgE. IgE has important roles in triggering the immune response during an allergic reaction or by stimulating immune cells to fight parasite infections. Unlike IgG antibodies, which activate immune cells circulating in the blood, IgE antibodies bind very tightly to immune cells found in tissues. The team has been working to harness these immune-boosting activities of IgE against solid cancers.

The team investigated an IgE antibody called MOv18, exploring its ability to activate immune cells from patients with ovarian cancer and its influence on the tumour’s environment.

The research showed that MOv18 IgE works in a unique way, by reversing the suppression of the immune system imposed by the tumour, through activation of different groups of immune cells against the cancer.

MOv18 IgE treatment has already shown promising results in a phase Ia clinical trial designed and run by the King’s researchers in the National Institute for Health and Care Research (NIHR) Guy’s and St Thomas’ Clinical Research Facility and in collaboration with Cancer Research UK’s Centre for Drug Development. At low doses, MOv18 IgE shrank the tumour of a patient with ovarian cancer who had not responded to conventional therapy. In a new study, the team set out to understand exactly how the antibody works in the immune environment conditions of ovarian cancer.

The findings were published today in Nature Communications and the work was supported by Cancer Research UK, the Medical Research Council and Breast Cancer Now.

Understanding the biology

In the multidisciplinary study, conducted at King’s in collaboration with colleagues at Guy’s and St Thomas’ NHS Foundation Trust, the Medical University of Vienna, Fondazione IRCCS Instituto Nazionale dei Tumori, Milan, and SeromYx Systems, Inc, the team looked at how MOv18 IgE interacts with different groups of immune cells in ovarian cancer patients. They principally investigated macrophages, an immune cell which normally fights infection and kills microorganisms. However, cancer can corrupt macrophages – suppressing their ability to trigger an immune response and re-programming them to support tumour growth instead.

Previous research in animal models suggested that MOv18 IgE activates these corrupted macrophages to drive them towards fighting the cancer. To investigate this in the human context of ovarian cancer, the team first collected macrophages from healthy donors and then exposed them to cancerous fluid samples from the peritoneal cavity (the main site of ovarian cancer spread) of patients with ovarian cancer. The team then isolated macrophages directly from these patient-derived cancerous fluid samples. All patient samples were collected from Guy’s and St Thomas’ NHS Foundation Trust.

In both cases, they found that ovarian cancer suppressed the immune activity of macrophages. However, they discovered that MOv18 IgE could bind and activate these suppressed macrophages to kill ovarian cancer cells. Additionally, through this activation, MOv18 IgE reversed the suppressive effect of ovarian cancer macrophages on other immune cells called T cells, which are known to be key in maintaining long-term immune responses against cancer in patients.

Dr Gabriel Osborn, who conducted the research when he was a PhD student at King’s College London, said: “We found that in patients, ovarian cancer re-programmed macrophages away from normal immune activation. Instead, they formed an immunosuppressive web in association with T cells, that could restrict anti-cancer immunity in patients. MOv18 IgE however induced patient macrophages to kill cancer cells and undergo a highly inflammatory activation, which reversed their suppressive effects on T cells. This study adds important patient-level information to support what we previously observed for MOv18 IgE in the laboratory and reveals, for the first time, that IgE-driven macrophage stimulation can activate the wider tumour immune system.”

After seeing these results in the lab, the team looked at tumour biopsies from two patients who took part in the phase Ia clinical trial. They analysed one biopsy from each patient that had been collected before treatment with MOv18, and a second biopsy that was collected after treatment. They saw increased numbers of macrophages and T cells present in the post-treatment samples, indicating these two groups of immune cells play a key role in the anti-tumour activity of MOv18 IgE.

“Understanding the biology of how a treatment works is essential for bringing treatments closer to patients,” says Professor Sophia Karagiannis, Professor of Translational Cancer Immunology and Immunotherapy at King’s College London and senior author of the study. “We found that immune cells which are otherwise inhibited in the ‘microenvironment’ of the tumour, are directed by IgE to target the cancer cells. While we are still progressing with clinical testing in patients, it is imperative that we continue in our quest towards understanding how MOv18 IgE, and a wider panel of IgE-based antibodies we are studying, harness the immune system in different groups of patients and cancer types.”

Dr Debra Josephs, consultant medical oncologist at Guy’s and St Thomas’ NHS Foundation Trust and co-author of the study who developed pre-clinical research studies that guided MOv18 IgE to clinical testing said: “Our focus is to deepen our understanding of the immune system and its interaction with cancer, with the goal of discovering better treatments for patients. During the preclinical development of MOv18 IgE we demonstrated the important role of activation and migration of tumour-associated macrophages into cancer lesions for this antibody treatment to be effective. This research marks an important next step in the development of MOv18 IgE by advancing our understanding of macrophage-mediated mechanisms, thus supporting the therapeutic potential of this novel antibody.”

Professor James Spicer, Professor of Experimental Cancer Medicine at King’s College London, consultant in medical oncology at Guy’s and St Thomas’ NHS Foundation Trust and Chief Clinical Investigator of the MOv18 IgE Phase Ia trial, who is co-author of the study said: “We need to achieve better outcomes for our patients. Clear progress is being made by studying the immune system and the environment in which the cancer grows. In our ongoing research we are striving to understand how we can capitalise on the power of IgE to develop novel effective treatments, which will complement established IgG antibody drugs used in the clinic.”

Reference:

Osborn, G., López-Abente, J., Adams, R. et al. Hyperinflammatory repolarisation of ovarian cancer patient macrophages by anti-tumour IgE antibody, MOv18, restricts an immunosuppressive macrophage:Treg cell interaction. Nat Commun 16, 2903 (2025). https://doi.org/10.1038/s41467-025-57870-y

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Adrenalectomy Linked to Lower Risk of Vertebral Fractures in patients with mild autonomous cortisol secretion: Study

Two studies published in the Journal of Clinical Endocrinology & Metabolism have found that adrenalectomy significantly reduces the risk of vertebral fractures in patients with adrenal incidentalomas and mild autonomous cortisol secretion.

Mild autonomous cortisol secretion (MACS) is associated with increased risk of vertebral fractures (VFx). The impact of recovery from MACS on bone health remains unclear. Retrospective intervention Study (Study1): 53 patients with MACS were followed for 35.2±18.6 months; 31 patients underwent surgery (Study1-GroupA, 74.2% women, age 63 years [57-67]), while 22 patients received conservative treatment (Study1-GroupB, 45.5% women, age 64 years [61-72]). Fifty-one outpatients with MACS were randomly assigned to either adrenalectomy (Study2-GroupA, 21 patients, 67% women, age 63 [56.5-72.5]) or conservative approach (Study2-GroupB, 28 patients, 78% women, age 69 [61-73]) and were followed for 24 months. MACS was diagnosed in patients with adrenal incidentalomas (AI)>1 cm and cortisol after 1-mg dexamethasone suppression test (F-1mgDST) ≥1.8 µg/dL (50 nmol/L). At baseline and at the end of follow-up we assessed: calcium-phosphorus metabolism, bone mineral density (BMD) at the lumbar spine (LS), total hip (TH) and femoral neck (FN) using Dual-energy X-ray Absorptiometry, and the presence of VFx. Results

Study 1: At the end of the follow-up, Study1-GroupB showed an increased incidence of VFx (n=11, 50%) than Study1-GroupA (n=3, 9.7%, p<0.005). In both groups BMD at LS, FN and TH was comparable between baseline and the end of follow-up. Study 2: After 24 months in Study2-GroupA, but not in Study2-GroupB, calcium and phosphorus levels increased compared to baseline (p=0.03 and p=0.04, respectively). At the end of follow up, BMD remained stable across both groups, but Study2-GroupB showed a significantly higher incidence of VFx (n=7, 25%) compared to Study2-GroupA (n=1, 4.8%, p=0.04). In patients with AI and MACS, adrenalectomy significantly reduces the risk of VFx

Reference:

Valentina Morelli, Vittoria Favero, Sofia Frigerio, Carmen Aresta, Flavia Pugliese, Antonio Stefano Salcuni, Alessandro Risio, Cristina Eller-Vainicher, Serena Palmieri, Elisa Cairoli, Sabrina Corbetta, Giovanna Mantovani, Alfredo Scillitani, Iacopo Chiodini, Adrenalectomy reduces the risk of vertebral fractures in patients with mild autonomous cortisol secretion, The Journal of Clinical Endocrinology & Metabolism, 2025;, dgaf227, https://doi.org/10.1210/clinem/dgaf227

Keywords:

Adrenalectomy, Linked, Lower Risk, Vertebral, Fractures, patients, mild autonomous, cortisol, secretion, Study, The Journal of Clinical Endocrinology & Metabolism, mild autonomous cortisol secretion, bone mineral density, vertebral fracture, Valentina Morelli, Vittoria Favero, Sofia Frigerio, Carmen Aresta, Flavia Pugliese, Antonio Stefano Salcuni, Alessandro Risio, Cristina Eller-Vainicher, Serena Palmieri, Elisa Cairoli, Sabrina Corbetta, Giovanna Mantovani, Alfredo Scillitani, Iacopo Chiodini, Adrenalectomy

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Microultrasonography-Guided Biopsy Viable Alternative to MRI-Guided Biopsy for prostate cancer detection: JAMA

Researchers have found in a new study that microultrasonography-guided biopsy is noninferior to MRI fusion-guided biopsy for detecting prostate cancer. This suggests that microultrasonography could serve as an alternative to MRI for image-guided prostate biopsies, potentially offering a more accessible and cost-effective diagnostic option.

Biopsies guided by high resolution ultrasound are as effective as those using MRI in diagnosing prostate cancer, an international clinical trial has shown.

The technology, called micro-ultrasound, is cheaper and easier to use than MRI. It could significantly speed up diagnosis, reduce the need for multiple hospital visits and free up MRI for other uses, researchers say.

The results of the OPTIMUM trial are presented today [Sunday 23 March 2025] at the European Association of Urology Congress in Madrid and published in JAMA.

OPTIMUM is the first randomised trial to compare micro-ultrasound (microUS) guided biopsy with MRI-guided biopsy for prostate cancer. It involves 677 men who underwent biopsy at 19 hospitals across Canada, the USA and Europe. Of these, half underwent MRI-guided biopsy, a third received microUS-guided biopsy followed by MRI-guided biopsy and the remainder received microUS-guided biopsy alone.

MicroUS was able to identify prostate cancer as effectively as MRI-guided biopsy, with very similar rates of detection across all three arms of the trial. There was little difference even in the group who received both types of biopsies, with the microUS detecting the majority of significant cancers.

Around a million prostate cancer biopsies are carried out each year in Europe, a similar number in the USA and around 100,000 in Canada. The majority of biopsies are conducted using MRI images fused onto conventional ultrasound, as this enables urologists to target potential tumours directly, leading to more effective diagnosis. MRI-guided biopsy requires a two-step process (the MRI scan, followed by the ultrasound-guided biopsy), requiring multiple hospital visits and specialist radiological expertise to interpret the MRI images and fuse them onto the ultrasound.

Micro-ultrasound has higher frequency than conventional ultrasound, resulting in three times greater resolution images that can capture similar detail to MRI scans for targeted biopsies. Clinicians such as urologists and oncologists can be easily trained to use the technique and interpret the images, especially if they have experience in conventional ultrasound. MicroUS is cheaper to buy and run compared to MRI, and could enable imaging and biopsy to be carried out during one appointment, even outside a hospital setting.

The results of the OPTIMUM trial could have a similar impact to the first introduction of MRI, according to lead researcher on the trial, Laurence Klotz, Professor of Surgery at the University of Toronto’s Temerty Faculty of Medicine and the Sunnybrook Chair of Prostate Cancer Research.

“When MRI first emerged and you could image prostate cancer accurately for the first time to do targeted biopsies, that was a gamechanger,” he recalls. “But MRI isn’t perfect. It’s expensive. It can be challenging to get access to it quickly. It requires a lot of experience to interpret properly. And it uses gadolinium which has some toxicity. Not all patients can have MRI, if they have replacement hips or pacemakers for example.

“But we now know that microUS can give as good a diagnostic accuracy as MRI and that is also game changing. It means you can offer a one stop shop, where patients are scanned, then biopsied immediately if required. There’s no toxicity. There are no exclusions. It’s much cheaper and more accessible. And it frees up MRIs for hips and knees and all the other things they’re needed for.”

Professor Jochen Walz, from the Institut Paoli-Calmettes Cancer Center, Marseille/France, is a leading expert in the field of urological imaging and a member of the EAU Scientific Congress Office. He said: “This is a well conducted and exciting study which adds a very important tool to the diagnosis of prostate cancer. Using micro-ultrasound is a more straightforward and simpler process. This also makes it safer, by avoiding the potential errors that can creep in during the transfer of MRI to ultrasound for a fusion biopsy.

“It does require training to spot the patterns and interpret micro-ultrasound images correctly. But once that’s been mastered, then it could enable prostate cancer diagnosis and biopsy to happen at the same appointment. It could also make targeted biopsies more available in less developed healthcare systems where MRI is a very precious resource.

“The ease and cost of micro-ultrasound means it could be an important tool for screening programmes as well, but further research would be needed to understand its potential role in that setting.”

Reference:

Kinnaird A, Luger F, Cash H, et al. Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis: The OPTIMUM Randomized Clinical Trial. JAMA. Published online March 23, 2025. doi:10.1001/jama.2025.3579.

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Jubilant Chairman Cleared of Charges in Sexual Assault Case

New Delhi: Jubilant Pharmova Limited has officially announced that the allegations made against its Chairman, Shyam S Bhartia have been found to be “baseless and false,” as per a closure report submitted by the police and accepted by the court.

The update was communicated to the stock exchanges, BSE and NSE, on April 20, 2025, under Regulation 30(11) of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015​.

The development follows a disclosure made by the company on February 25, 2025, regarding certain media reports on the registration of a First Information Report (FIR) concerning allegations against Bhartia. The company had previously clarified that the case did not have any material impact on its business operations.

Also Read: Jubilant Pharmova Arm Salisbury Facility Gets USFDA EIR

In its recent update, the company stated, “The Police officials have filed a Closure Report as the allegations against him have been found to be baseless and false. The Hon’ble Court after examining the Closure Report and the statements given by the Complainant has passed an Order accepting the said Closure Report. Therefore, there is no case against Mr. Shyam S. Bhartia.”

As per a media report in The Indian Express, allegations of rape and money fraud were levelled against Bhartia and one of his associates by a Bollywood actress.

Lately, the latest order effectively clears Bhartia of all charges. The company also reiterated that Bhartia, in his personal capacity, had earlier denied all allegations, terming them as, “Baseless, false and disparaging.”

The company emphasized that these proceedings had no material impact on Jubilant Pharmova’s operations.

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As Ozempic, Wegovy Take Priority, Novo Nordisk Winds Down Insulin Portfolio In India

New Delhi: Danish pharmaceutical giant Novo Nordisk has announced plans to phase out Human Mixtard, India’s top-selling insulin brand. This decision is part of the company’s global strategy to prioritize newer, patented therapies such as Ozempic and Wegovy.

Human Mixtard, despite being under price control, generates approximately Rs 800 crore annually for Novo Nordisk in India. The discontinuation will also affect other products in the Rs 5,000 crore insulin market like Actrapid, Insulatard, Insulin Detemir, Levemir, and Xultophy, primarily available in pre-filled disposable pens and cartridges (Penfill and FlexPen).​

According to a recent media report in The Times of India, Novo Nordisk has informed its marketing partner, Abbott India, that these products will be discontinued once current stocks are depleted, a process expected to take about six months. ​

Also Read: Union Health Ministry Notifies 300 Drug Brands Under Schedule H2, Details

The company will continue to offer Human Mixtard, Actrapid, and Insulatard in vial form, which requires administration via syringes. However, TOI reports that this shift may limit access for patients who prefer pen devices due to their convenience and ease of use. ​

The Economic Times reports that this move aligns with Novo Nordisk’s focus on introducing its newer therapies, Ozempic and Wegovy, to the Indian market later this year. These drugs have shown significant promise in managing diabetes and aiding weight loss.​

The discontinuation of these insulin products marks a significant shift in India’s diabetes care landscape, prompting healthcare providers and patients to adapt to the evolving treatment options.

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Single-dose psychedelic boosts brain flexibility for weeks, study finds

University of Michigan researchers have discovered that a single dose of a psychedelic compound can enhance cognitive flexibility—the brain’s ability to adapt to changing circumstances—for weeks after administration, potentially revolutionizing treatments for depression, PTSD, and neurodegenerative diseases.

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Medication-induced sterol disruption: A silent threat to brain development and public health

An editorial published in Brain Medicine raises the alarm about a previously overlooked threat to brain development and public health: the disruption of sterol biosynthesis by common prescription medications.

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