Eli Lilly Inluriyo gets USFDA nod for adults with advanced breast cancer

Indianapolis: Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET).

In the Phase 3 EMBER-3 trial, Inluriyo reduced the risk of progression or death by 38% versus ET. Among patients with ESR1-mutated MBC, Inluriyo significantly improved progression-free survival (PFS) versus fulvestrant or exemestane, with a median PFS of 5.5 months vs 3.8 months (HR=0.62 [95% CI: 0.46-0.82]); p-value=0.0008.

Inluriyo is a treatment for ER+, HER2–, ESR1-mutated MBC. Some breast cancers develop ESR1 mutations that can cause estrogen receptors to become overactive and drive cancer growth. Inluriyo binds, blocks, and facilitates the degradation of these receptors, helping to slow disease progression. Its once-daily dosing provides patients with an oral treatment option.

“This therapy reflects our commitment to developing treatments that improve outcomes for people with breast cancer and represents an important step toward advancing innovative, all-oral treatment approaches,” said Jacob Van Naarden, executive vice president and president of Lilly Oncology. “We are deeply grateful to the patients, investigators, Lilly team members and clinical care teams who made this advancement possible. This therapy has the potential to make the treatment journey more manageable for those living with breast cancer.”

The Inluriyo label contains a warning and precaution for embryo-fetal toxicity. 

The FDA approval is based on the results of the EMBER-3 trial in the patient population harboring ESR1-mutated MBC (n=256). Patients received Inluriyo or ET as first-line treatment for MBC following recurrence on adjuvant aromatase inhibitor (AI), +/- prior CDK4/6 inhibitor (21%), or as second-line treatment for MBC following progression on AI, +/- prior CDK4/6 inhibitor (79%).

“This represents an important advancement for patients with ESR1-mutated MBC, a mutation found in nearly half of patients who have taken hormone therapies, often contributing to treatment resistance,” said Komal Jhaveri, M.D., FACP, FASCO, section head of Endocrine Therapy Research and clinical director of Early Drug Development at Memorial Sloan Kettering Cancer Center, and a principal investigator of EMBER-3. “With its demonstrated efficacy, tolerability profile and oral administration, this therapy provides a meaningful alternative treatment option for this patient population.”

“The approval of Inluriyo expands the metastatic breast cancer treatment landscape for patients who test positive for the ESR1 mutation,” said Jean Sachs, CEO, Living Beyond Breast Cancer. “Eligible patients will now have access to an additional treatment option, offering them the potential for flexibility in their daily lives and disease management, and—above all—renewed hope for the future.”

Inluriyo is also being studied in the ongoing Phase 3 EMBER-4 trial in the adjuvant setting for people with ER+, HER2– early breast cancer (EBC) at increased risk of recurrence, which is enrolling approximately 8,000 patients worldwide.

Inluriyo is expected to be available in the United States in the coming weeks.

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Gynaecologist faces bribery allegations at Shujalpur Govt Hospital

Shujalpur: In a shocking case of bribery, a gynaecologist from Shujalpur has been accused of demanding and accepting a bribe from the family of a pregnant woman, despite conducting the delivery at the Shujalpur Government Hospital. 

According to the complainant, his daughter had been under the doctor’s care throughout her pregnancy. He alleged that from the beginning, the doctor hinted that the delivery would require extra money and suggested shifting the procedure to her private clinic instead of the government hospital. 

On September 18, the woman underwent a cesarean delivery at the government hospital. However, the complainant alleged that before proceeding with the surgery, the doctor demanded Rs 12,000. Unable to arrange the full amount immediately, he first paid Rs 8,000, but the doctor allegedly insisted that the remaining Rs 4,000 must be cleared quickly.

Also read- Retired Gynaecologist sentenced to 5 years in jail for bribery

After the surgery, the woman’s father claimed that the doctor refused to remove his daughter’s stitches until the pending money was paid. He said he was left humiliated and helpless, worrying not only about his daughter’s health but also about the safety of the newborn.

Speaking to Dainik Bhaskar, the father said, “I had already given Rs 8,000, but when I couldn’t arrange the balance, the doctor threatened not to cut my daughter’s stitches. What kind of system is this, where even in government hospitals you are forced to pay bribes?”

On September 23, the father claimed that he went to the doctor’s private clinic to make the payment. He said that he had to borrow the money from someone else. At the clinic, he first gave Rs 5,000 to the doctor’s assistant, and then another Rs 3,000 after about 20 minutes.

However, the woman’s father was clever; he recorded the money exchange scene with the assistant. The footage showed him handing over money while the assistant can be heard saying that the remaining amount would be settled during the stitch removal.

When asked about the allegations, the doctor denied all charges, calling them false and politically motivated. She said, “The accusations are false. I have never demanded any money. These claims are fabricated to tarnish my reputation.”

So far, no case has been registered by the police as the woman’s family has not yet filed any complaint against the doctor.

Also read- FIR against Haryana Health Director, 2 others for bribery and forgery allegations

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Dr Reddy’s Labs appoints Gayatri Prabhu as Head Digital Marketing (Emerging Markets)

Hyderabad: Dr Reddy’s Labs has appointed Gayatri Prabhu as Head Digital Marketing (Emerging Markets).

Gayatri is a result-driven Digital Professional with 20 plus years of experience in driving Innovation, Digital Transformation and Business growth across Banking, Insurance and Pharma industry. She specialises in the areas of Transforming Offline Business to Digital, with key focus on New Customer Acquisition, Retention and Loyalty of Existing Customers, Customer Experience Management on Web, Mobile, Bots, Social Media, CRM, Marketing Automation and Analytics. She hold a master’s degree specializing in Marketing Management from NMIMS and a certification in ‘Leadership in Artificial Intelligence’ from ISB.

Prior to joining Dr Reddy’s Labs, Gayatri served as Head of Omnichannel & Digital Transformation at Sanofi. Her earlier roles include positions at Mahindra Insurance Brokers Limited, SBI General Insurance, HDFC ERGO General Insurance, and ICICI Bank.

Read also: Dr Reddy’s Labs receives positive EMA Committee opinion for proposed biosimilar of Prolia, Xgeva

Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr Reddy’s Labs major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.

Read also: Dr Reddy’s Secures CDSCO Panel Approval to Import, Market Olutasidenib for AML

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All India Institute of Ayurveda Goa launches integrative cancer centre

Panaji: The All India Institute of Ayurveda in Goa on Wednesday launched a joint Integrative Oncology Research and Care Centre. The initiative combines modern oncology with AYUSH systems of medicine to improve the quality of life of cancer patients, an official said.

According to the PTI report, the inaugural clinic was conducted at the newly inaugurated Integrative Oncology Research and Care Centre of AIIA in Dhargal of North Goa, the senior official said. 

He said four complex cancer cases were presented before a multi-disciplinary panel comprising oncologists, AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy) experts, and senior researchers.

Also Read:Ministry of Ayush celebrates 10th Ayurveda Day

Patients and their relatives were present during the deliberations and had their queries addressed in detail.

“Each case was evaluated from diverse clinical perspectives, and after comprehensive discussion, the panel reached a consensus on therapeutic and adjuvant treatment options. The initiative aims to offer patients an evidence-based integrative approach to improve treatment outcomes and quality of life,” the official said.

“This is the first-of-its-kind collaboration in India, and it is significant that Goa has taken the lead,” said Dr Shekhar Salkar, senior oncosurgeon at Manipal Hospital, Goa, and member of an empowered committee.

He added that such clinics will now be held every month, with prior appointments required at the AIIA centre.

The clinic brought together experts from various institutions, including Tata Memorial Centre and its Navi Mumbai-based R&D wing ACTREC.

According to organisers, the effort represents a shared vision of modern and traditional medicine experts to provide holistic cancer care. Patients attending the first session reported being “immensely benefited” from the exercise, officials said.

Medical Dialogues had earlier reported that Patients visiting the South Goa District Hospital will no longer have to undergo treatment on wheelchairs or stretchers, as the hospital has finally been upgraded to its full 500-bed capacity.

Also Read:AIIA holds bike rally under the theme Ayurveda for People and Planet

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Once-Weekly Semaglutide bests Sitagliptin for blood sugar, Weight, and Lipid Profile control in T2DM: Study

Hungary: Researchers have found in a new study that once-weekly semaglutide significantly reduces weight and HbA1c while favorably modifying atherogenic lipoprotein subfractions in type 2 diabetes patients. After 52 weeks, semaglutide lowered LDL and non-HDL cholesterol, reduced small dense LDL, and increased large, cardioprotective HDL particles. In contrast, sitagliptin showed only modest glycemic and weight-lowering benefits with minimal impact on lipid or inflammatory markers.

The findings, published in the International Journal of Molecular Sciences, are the result of a 52-week randomized clinical trial led by László Imre Tóth and colleagues from the Division of Metabolism, Department of Internal Medicine, University of Debrecen, Hungary. The study compared the effects of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), with sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, in individuals with type 2 diabetes mellitus (T2DM).

A total of 34 obese adults with T2DM were enrolled and randomized to receive either once-weekly subcutaneous semaglutide (n=18) or once-daily oral sitagliptin (n=16). An additional 31 age- and weight-matched non-diabetic individuals were included as controls. The study primarily assessed changes in glycemic control, anthropometric measurements, and detailed lipoprotein subfractions using Lipoprint gel electrophoresis.

The study revealed the following findings:

  • Participants who received semaglutide showed significant reductions in body mass index (BMI), waist circumference, and HbA1c levels, indicating effective control over both weight and blood sugar.
  • Semaglutide induced favorable changes in lipid profiles, including notable reductions in low-density lipoprotein (LDL) and non-high-density lipoprotein (non-HDL) cholesterol.
  • The treatment also led to a selective decrease in small, dense LDL particles, which are known to be highly atherogenic and associated with increased cardiovascular risk.
  • Semaglutide was found to increase the proportion of larger HDL particles, which are considered protective against heart disease, thereby contributing to a more cardioprotective lipid profile.
  • These combined effects suggest that semaglutide promotes a comprehensive shift in lipid metabolism, favoring a profile associated with reduced cardiovascular risk in patients with type 2 diabetes.
  • Individuals treated with sitagliptin experienced only modest improvements in blood sugar control and weight, without significant impact on lipid subfractions or inflammatory markers.
  • This stark difference highlights the broader metabolic and cardioprotective advantages of semaglutide over DPP-4 inhibitors like sitagliptin.
  • Multivariate regression analysis revealed that changes in lipoprotein subfractions following semaglutide treatment were not correlated with changes in BMI or HbA1c.
  • This finding suggests that semaglutide may have direct, independent effects on lipid remodeling processes, beyond its influence on weight and glucose control.

The authors emphasize that semaglutide may play a critical role in managing not just glycemic control, but also broader cardiometabolic risks associated with type 2 diabetes. By promoting a healthier lipid profile, it may contribute to lowering cardiovascular disease risk in this population.

“These findings highlight the therapeutic potential of semaglutide in addressing multiple facets of T2DM and support further research into its long-term cardiovascular benefits across diverse patient populations,” the authors concluded.

Reference:

Tóth, L. I., Harsányi, A., Csiha, S., Molnár, Á., Lőrincz, H., Nagy, A. C., Paragh, G., Harangi, M., & Sztanek, F. (2024). Semaglutide Improves Lipid Subfraction Profiles in Type 2 Diabetes: Insights from a One-Year Follow-Up Study. International Journal of Molecular Sciences, 26(13), 5951. https://doi.org/10.3390/ijms26135951

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C-reactive Protein–Triglyceride Glucose Index Independently Predicts Stroke Risk in Cardiovascular-Kidney-Metabolic Syndrome: Study

Researchers have identified in a new study that the C-reactive protein–triglyceride glucose index (CTI) is linearly and positively correlated with stroke risk among subjects with cardiovascular-kidney-metabolic (CKM) syndrome. The study concluded that CTI not only better predicts stroke risk compared to the well-established triglyceride–glucose index (TyG), but also represents a useful risk marker among patients with CKM stage 2 and 3, where the risk of stroke events is notably high. The study was published in BMC Cardiovascular Disorders by Yinsong Xu and fellow researchers.

The data from 5767 subjects with stages 0–3 CKM syndrome participating in the China Health and Retirement Longitudinal Study (CHARLS) were examined in this study. The participants were tracked from 2011 to 2020 to examine the development of incident stroke, as diagnosed by self-reported questionnaires.

The CTI was derived from the formula:

CTI = 0.412 × ln[hs-CRP (mg/L)] + ln[(triglyceride (mg/dL) × fasting glucose (mg/dL)) / 2]

More advanced statistical techniques such as Cox proportional hazards models, restricted cubic spline (RCS) analysis, and subgroup analyses were utilized to compare associations of CTI with risk of stroke. Predictive accuracy was compared with TyG and metabolic score for insulin resistance (METS-IR) using time-dependent ROC analysis. Multiple testing correction was achieved through the false discovery rate approach to provide robustness.

Results

  • After controlling for possible confounders, higher levels of CTI were significantly linked to increased risk of stroke (Hazard Ratio [HR] 1.33, 95% CI 1.18–1.51).

  • RCS analysis revealed a linear relationship, without any suggestion of nonlinearity (P for nonlinearity = 0.182).

Subgroup analysis showed stage-specific effects:

  • CKM Stage 2: HR 1.27, 95% CI 1.04–1.56 (P = 0.019; adjusted P = 0.023)

  • CKM Stage 3: HR 1.25, 95% CI 1.04–1.50 (P = 0.022; adjusted P = 0.025)

  • CKM Stages 0–1: No significant association seen

  • Predictive performance analysis also revealed that CTI outperformed TyG at both year 5 and year 7 in stroke prediction consistently, with DeLong’s test adjusted P = 0.028 for both contrasts.

The present nationwide cohort study supplies strong evidence that the CTI is independently and linearly related to stroke risk in CKM syndrome patients, especially at stages 2 and 3. In addition, CTI always presents higher predictive accuracy than TyG and thus has the potential to serve as an excellent clinical tool for risk stratification and early intervention in high-risk individuals.

Reference:

Xu Y, Chen S, Zhu J, et al. C-reactive protein-triglyceride glucose index and stroke risk in early cardiovascular-kidney-metabolic syndrome: a National cohort study. BMC Cardiovasc Disord. 2025;25(1):634. Published 2025 Aug 26. doi:10.1186/s12872-025-05143-3

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Single-Dose Clesrovimab Safely Lowers RSV Infections and Hospitalizations in Infants: NEJM

Researchers have found in a new clinical trial that a single dose of clesrovimab, a long-acting investigational monoclonal antibody targeting site IV of the respiratory syncytial virus (RSV) fusion protein, significantly reduced the risk of RSV-associated illness in healthy infants. The study, published in The New England Journal of Medicine, evaluated the safety and efficacy of clesrovimab in both preterm and full-term infants during their first RSV season, a period marked by heightened vulnerability to severe lower respiratory tract infections. Infants were randomly assigned to receive either one intramuscular injection of clesrovimab or placebo, and outcomes were monitored for 150 days following administration. Findings showed that clesrovimab markedly lowered the incidence of medically attended lower respiratory tract infections due to RSV compared with placebo, and also substantially reduced RSV-related hospitalizations, underscoring its potential as a preventive strategy for this common and sometimes life-threatening infection. Importantly, the safety profile of clesrovimab was comparable to placebo, with no signal of increased adverse events, further supporting its potential suitability for widespread use. RSV is a leading cause of infant hospitalization worldwide, and while supportive care remains the mainstay of treatment, there is a recognized need for effective preventive measures beyond maternal vaccination and existing monoclonal antibodies. The results of this large, randomized, placebo-controlled trial suggest that clesrovimab could fill an important gap in infant RSV prevention strategies by providing durable protection with a single dose, potentially easing the burden on healthcare systems and reducing parental anxiety during RSV season. The authors noted that longer follow-up and real-world studies will be essential to confirm durability of protection, cost-effectiveness, and feasibility of integration into national immunization programs, but the current evidence positions clesrovimab as a promising candidate for future inclusion in RSV prevention protocols for infants.

Keywords: Clesrovimab, RSV, monoclonal antibody, infants, prevention, respiratory infection, hospitalization, immunization

Reference: Zar HJ, Simões EAF, Madhi SA, Ramilo O, Senders SD, Shepard JS, Laoprasopwattana K, et al; CLEVER (MK-1654-004) Study Group. Clesrovimab for Prevention of RSV Disease in Healthy Infants. N Engl J Med. 2025; DOI: 10.1056/NEJMoa2502984.

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Crisaborole Boosts Effectiveness of Amorolfine in Keratinized Tinea Foot: Study

Researchers have found in a new study that adding two percent crisaborole ointment to amorolfine hydrochloride cream significantly enhances therapeutic outcomes in the management of keratinized tinea foot. Tinea foot, a common superficial fungal infection caused by dermatophytes, often presents in a chronic keratinized form where thickened skin and scaling limit the penetration and efficacy of topical antifungal treatments. Amorolfine hydrochloride, a well-established antifungal agent, is effective against dermatophytes but faces challenges in achieving optimal results in heavily keratinized lesions due to poor drug penetration. The study explored whether the phosphodiesterase-4 (PDE4) inhibitor crisaborole, known for its anti-inflammatory and skin barrier–modulating properties, could improve outcomes when combined with amorolfine. The combination therapy demonstrated superior antifungal activity, greater improvement in lesion clearance, and better patient-reported symptom relief compared with amorolfine monotherapy. The enhanced effectiveness is thought to stem from crisaborole’s ability to reduce inflammation, soften hyperkeratotic tissue, and improve drug absorption, thereby allowing amorolfine to penetrate more effectively into the infected areas. Importantly, the combination was well tolerated, with no significant increase in adverse effects, supporting its safety for clinical use. These findings suggest that dual therapy with crisaborole and amorolfine may provide a more effective option for patients with keratinized tinea foot, a condition that is often resistant to standard topical treatments and requires prolonged therapy. The results also open avenues for exploring similar combination approaches in other keratinized fungal infections where topical antifungal penetration is limited. Clinicians may consider the combined regimen as part of personalized treatment strategies, particularly for patients with chronic or recurrent infections. However, the researchers emphasized the need for larger randomized controlled trials to validate these results, assess long-term efficacy, and determine whether the combination can reduce recurrence rates.

Keywords: Crisaborole, amorolfine, keratinized tinea foot, dermatophyte infection, topical antifungal therapy, combination treatment, PDE4 inhibitor, skin barrier, hyperkeratosis, clinical effectiveness

Reference:
Li, X., Zhang, Y., Chen, L., et al. Combination of crisaborole ointment with amorolfine cream improves therapeutic efficacy in keratinized tinea pedis. Mycoses. 2025. https://doi.org/10.1111/myc.78945

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Albuminuria, Not Kidney Function, Predicts Future Cancer Risk, reveals study

Researchers have determined in a new study that albuminuria, and not diminished kidney function, is independently associated with a greater risk of cancer development. The research, involving more than 1.3 million participants in 54 global cohorts, showed albuminuria levels to be associated consistently with site-specific and overall cancer risk, while eGFR had no apparent correlation with the majority of cancers. The study was published in the British Journal of Cancer by Yejin M. and colleagues.

Chronic kidney disease (CKD) is prevalent all over the world and generally evaluated with two significant markers: eGFR, which is a measure of kidney function, and albuminuria, which is a measure of kidney damage. Because both CKD and cancer have common risk factors of age, hypertension, diabetes, and inflammation, it is necessary to determine if markers of CKD independently are predictive of cancer.

This participant-level data meta-analysis involved 54 cohorts with full data on albuminuria (defined as urine albumin-to-creatinine ratio [ACR]) and eGFR and on cancer incidence. A total of 1,319,308 participants were included, all aged 18 years or more, with no history of cancer or end-stage kidney disease at baseline. Both overall and site-specific cancer outcomes were examined after adjustment for established cancer risk factors.

Statistical analyses included adjusted hazard ratios (HRs) for cancer incidence related to ACR and eGFR changes, in addition to 1-year landmark analysis to control for early detection bias.

Results

  • Incidence of overall cancer during follow-up was 17.3 per 1000 person-years.

  • Albuminuria: Increased ACR was significantly associated with increased cancer risk. Namely, with each 8-fold rise in ACR, the HR for cancer adjusted was 1.08 (95% CI 1.06–1.10). This correlation remained across various cancers.

  • eGFR: There was no significant correlation between decreased eGFR and cancer risk overall. Reduced eGFR was associated, however, with urological cancers and multiple myeloma increased risk.

  • Site-specific associations: Increased ACR correlated with increased risk for various cancers, such as kidney, head and neck, colorectal, liver, pancreas, bile duct, stomach, larynx, lung, hemolymphatic cancers, leukemia, and multiple myeloma.

  • Robustness check: Results were replicated in 1-year landmark analysis, reducing the risk of reverse causality.

Patients with increased urine albumin had a higher risk of developing a broad variety of cancers, highlighting albuminuria as an essential biomarker for cancer prediction. These results necessitate further studies into pathways between albuminuria and cancer and indicate that monitoring albuminuria routinely can have implications greater than kidney disease control.

Reference:

Mok, Y., Surapaneni, A., Sang, Y. et al. Chronic kidney disease and incident cancer risk: an individual participant data meta-analysis. Br J Cancer (2025). https://doi.org/10.1038/s41416-025-03140-z

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Midlife Hypertension Increased Vascular Dementia Risk: Study

A new study published in the journal of Alzheimer’s & Dementia found that high blood pressure during midlife is strongly associated with an increased risk of dementia later in life, particularly vascular dementia, while hypertension during pregnancy appears to have little impact on long-term cognitive health.

This study examined health data from 1,363,457 women with a mean age of 57 and tracked them over an average of 21 years to investigate the relationship between hypertension and subsequent dementia. The participants were asked about current treatment for high blood pressure and any history of pregnancy-related hypertension. Dementia cases were identified via hospital records, and sophisticated statistical models adjusted for socioeconomic status, lifestyle factors, and metabolic health to isolate the effects of hypertension.

Over the course of the study, a total of 84,729 women developed dementia. The results showed that women with midlife hypertension had a 17% higher risk of developing dementia of any type compared to the individuals without high blood pressure (hazard ratio [HR] 1.17, 95% confidence interval [CI] 1.15 to 1.19). The link was even stronger for vascular dementia, with affected women showing a 50% increased risk (HR 1.50, 95% CI 1.45 to 1.56), whereas the risk for Alzheimer’s disease appeared minimal (HR 1.01, 95% CI 0.98 to 1.04).

These findings highlight midlife hypertension as a modifiable risk factor for dementia, particularly vascular dementia, reinforcing the importance of early detection and management of high blood pressure.

Also, hypertension during pregnancy did not demonstrate a significant effect on dementia risk later in life. Women who experienced high blood pressure while pregnant had only a very slight increase in risk (HR 1.04, 95% CI 1.01 to 1.06), suggesting that the long-term cognitive impact of pregnancy-related hypertension is minimal.

While Alzheimer’s disease was largely unaffected by midlife blood pressure, vascular dementia was strongly linked to earlier hypertension. This distinction highlights the complex relationship between cardiovascular health and cognitive decline.

These results could have major public health implications, emphasizing that midlife hypertension is not only a concern for heart disease and stroke but also for long-term brain health. Controlling blood pressure through lifestyle changes and medical management in midlife could help reduce the incidence of vascular dementia in aging populations.

Overall, these findings reinforces that keeping blood pressure in check during midlife is an useful strategy for protecting the brain, while pregnancy-related hypertension appears to play a negligible role in later-life dementia risk.

Source:

Floud, S., Hermon, C., Whiteley, W., Fitzpatrick, K. E., & Reeves, G. K. (2025). Hypertension in pregnancy and in midlife and the risk of dementia: prospective study of 1.3 million UK women. Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, 21(9), e70595. https://doi.org/10.1002/alz.70595

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