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Yahoo
12-05-2025
- Business
- Yahoo
Mineralys Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
– Pivotal Advance-HTN and Launch-HTN trials successfully achieved statistical significance in primary efficacy endpoints and demonstrated a favorable safety and tolerability profile – – Anticipate Explore-CKD Phase 2 trial to deliver topline data in Q2 2025 – – Initiated Explore-OSA Phase 2 Trial in Q1 2025 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the first quarter ended March 31, 2025, and provided a corporate update. 'We are pleased to have recently announced positive topline results from our pivotal trials, Launch-HTN and Advance-HTN, that evaluated lorundrostat's efficacy and safety as a potential treatment for patients with uncontrolled or resistant hypertension. The Advance-HTN late-breaking presentation at the American College of Cardiology meeting and the recent publication in the New England Journal of Medicine underscore the strength of our clinical data and the potentially transformative nature of lorundrostat. With the success of our two pivotal trials, we are working toward submitting our new drug application with a pre-NDA meeting with the FDA anticipated in the fourth quarter of 2025,' stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. 'We are excited to announce the appointment of Eric Warren as our Chief Commercial Officer. Eric's proven leadership skills, extensive cardiovascular experience and track record of success, will be invaluable to Mineralys as we solidify our commercial and partnering strategy.' Recent Clinical Highlights and Upcoming Milestones Pivotal Launch-HTN Phase 3 Trial – The trial met its primary endpoint in evaluating the efficacy and safety of lorundrostat for the treatment of subjects with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) as add-on therapy, who fail to achieve blood pressure control on their existing medications. The trial reported that the lorundrostat 50 mg dose achieved a 16.9 mmHg reduction in systolic blood pressure, and a 9.1 mmHg placebo-adjusted reduction (p-value < 0.0001), as assessed by automated office blood pressure at week six. This benefit was sustained with potential further reduction through week 12, with a 19.0 mmHg reduction in automated office systolic blood pressure and an 11.7 mmHg placebo-adjusted reduction (p-value <0.0001). The clinical safety results, including adrenocorticotropic hormone (ACTH)-stimulated and serum cortisol, change in serum potassium, serum sodium, and estimated glomerular filtration rate (eGFR), as well as incidence of hypotension, from the trial support a favorable benefit-risk profile in a 'real world' setting. The incidence of hyperkalemia (serum potassium >6.0 mmol/L) at the scheduled study visit was 1.1% and 1.5% in the 50 mg and 50 to 100 mg arms, respectively. After exclusion of factitious test results, the incidence of confirmed hyperkalemia was 0.6% and 1.1%, respectively. The Launch-HTN trial has been accepted as a late-breaking presentation at the 2025 European Society of Hypertension Meeting on Hypertension and Cardiovascular Protection, which is being held in Milan, Italy on May 23-26, 2025. Pivotal Advance-HTN Trial – Detailed results from the Advance-HTN trial were recently presented in a late-breaking presentation at the American College of Cardiology's ACC.25 meeting and published on May 8th in the New England Journal of Medicine. The trial met its primary endpoints in evaluating the efficacy and safety of lorundrostat for the treatment of confirmed uHTN or rHTN. The trial reported that the lorundrostat 50 mg dose cohort achieved a 15.4 mmHg absolute reduction in systolic blood pressure and a 7.9 mmHg placebo-adjusted reduction (p-value = 0.001), as assessed by 24-hour ambulatory blood pressure monitoring at 12 weeks. Lorundrostat demonstrated a favorable safety and tolerability profile, with modest changes in serum potassium, serum sodium and eGFR, and a low discontinuation rate. The incidence of hyperkalemia (serum potassium >6.0 mmol/L) at the scheduled study visit was 5.3% and 7.4% in the 50 mg and 50 to 100 mg arms, respectively. After exclusion of factitious test results, the incidence of confirmed hyperkalemia was 2.1% and 3.2%, respectively. These results reinforce lorundrostat's favorable benefit-risk profile in a high-risk population that would typically be treated by specialists rather than general practitioners. Transform-HTN Open-Label Extension Trial – The Company's ongoing open-label extension trial allows subjects to continue to receive lorundrostat and the Company to obtain additional safety and efficacy data. Explore-CKD Phase 2 Trial – Enrollment has been completed and topline data are anticipated in the second quarter of 2025. The trial is designed to evaluate the safety and efficacy of lorundrostat when added to background treatment with an ACE inhibitor or ARB and a SGLT2 inhibitor for the treatment of hypertension in subjects with Stage 2 to 3b CKD (eGFR greater than or equal to 30 mL/min/1.73m2 ) and albuminuria. Explore-OSA Phase 2 Trial – The Company initiated the trial in the first quarter of 2025, which will evaluate the safety and efficacy of lorundrostat in the treatment of overweight and obese subjects with moderate-to-severe OSA and hypertension. Expanded Management Team – Appointed Eric Warren as Chief Commercial Officer. Mr. Warren brings more than three decades of commercial leadership experience across multiple healthcare segments with a heavy emphasis on cardiovascular disease. Mr. Warren will lead the Company's commercial strategy and support future partnering opportunities. Strengthened Balance Sheet – On March 18, 2025, the Company completed a public equity financing for gross proceeds of approximately $201.2 million, before deducting fees and expenses. The Company reported a total of $343.0 million of cash, cash equivalents and investments as of March 31, 2025. First Quarter 2025 Financial Highlights Cash, cash equivalents and investments were $343.0 million as of March 31, 2025, compared to $198.2 million as of December 31, 2024. The Company believes that its current cash, cash equivalents and investments will be sufficient to fund its planned clinical trials and regulatory activities, as well as support corporate operations, into 2027. Research and Development (R&D) expenses for the quarter ended March 31, 2025 were $37.9 million, compared to $30.8 million for the quarter ended March 31, 2024. The increase in R&D expenses was primarily due to increases of $4.8 million in preclinical and clinical costs and $2.8 million in compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation, partially offset by $0.5 million in lower clinical supply, manufacturing and regulatory costs. General and Administrative (G&A) expenses were $6.6 million for the quarter ended March 31, 2025, compared to $4.6 million for the quarter ended March 31, 2024. The increase in G&A expenses was primarily due to $1.2 million in higher compensation expense resulting from additions to headcount, increases in salaries and accrued bonuses and increased stock-based compensation, and $0.7 million in higher professional fees. Total other income, net was $2.2 million for the quarter ended March 31, 2025, compared to $3.9 million for the quarter ended March 31, 2024. The decrease was primarily attributable to decreased interest earned on our investments in money market funds and U.S. treasuries. Net loss was $42.2 million for the quarter ended March 31, 2025, compared to $31.5 million for the quarter ended March 31, 2024. The increase was primarily attributable to the factors impacting the Company's expenses described above. Conference Call The Company's management team will host a conference call at 4:30 p.m. ET on Monday, May 12, 2025. To access the call, please dial 1-800-717-1738 in the United States or 1-646-307-1865 outside the United States. A live webcast of the conference call may be found here. A replay of the call will be available on the 'News & Events' page in the Investor Relations section of the Mineralys Therapeutics website (click here). About Hypertension Having sustained, elevated blood pressure (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an average annual economic burden of about $219 billion in the United States in 2019. Less than 50% of hypertension patients achieve their blood pressure goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About CKD CKD, which is characterized by the gradual loss of kidney function, is estimated to affect more than 10% of the global population and is one of the leading causes of mortality worldwide. According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 1-in-7 (15%) of U.S. adults have CKD. Diabetes and hypertension are responsible for approximately two-thirds of CKD cases. Early detection and treatment can often keep CKD from getting worse. When CKD progresses, it may eventually lead to kidney failure, which requires dialysis or a kidney transplant to maintain life. About OSA OSA is characterized by repetitive overnight hypoxic episodes and subsequent sleep fragmentation due to a complete or partial collapse of the upper airway. Moderate OSA is defined as having between 15 and 30 breathing pauses (apnea or hypopnea events) per hour of sleep, while severe OSA indicates more than 30 breathing pauses per hour. OSA impacts almost one billion people globally, including 425 million moderate-to-severe cases. Around 80% of adults with OSA are undiagnosed. As of 2015, undiagnosed OSA is estimated to cost the United States approximately $149.6 billion annually from comorbid disease, workplace accidents, motor vehicle accidents and loss of workplace productivity. Between 30-50% of adults with hypertension have OSA, and this number increases to between 70-80% in adults with rHTN. Additionally, untreated moderate-to-severe OSA increases the risk of rHTN. Along with hypertension, OSA is a major risk factor of cardiovascular disease, type-2 diabetes mellitus and stroke. About Lorundrostat Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uHTN or rHTN, as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive subjects. In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated statistically significant and clinically meaningful systolic blood pressure reduction in both automated office systolic blood pressure measurement and 24-hour ambulatory systolic blood pressure monitoring. Adverse events observed were a modest increase in serum potassium, decrease in eGFR, urinary tract infection and hypertension, with one serious adverse event possibly related to study drug being hyponatremia. About Mineralys Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit Follow Mineralys on LinkedIn and Twitter. Forward-Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company's expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company's expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in any submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the Company's ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of patients in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading 'Risk Factors' in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Investor Relationsinvestorrelations@ Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@ Mineralys Therapeutics, Inc. Condensed Statements of Operations (in thousands, except share and per share data) (unaudited) Three Months Ended March 31, 2025 2024 Operating expenses: Research and development $ 37,879 $ 30,754 General and administrative 6,568 4,608 Total operating expenses 44,447 35,362 Loss from operations (44,447 ) (35,362 ) Interest income, net 2,239 3,853 Other income (expense) (3 ) 1 Total other income, net 2,236 3,854 Net loss $ (42,211 ) $ (31,508 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.79 ) $ (0.70 ) Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted 53,163,551 44,900,755 Mineralys Therapeutics, Inc. Selected Financial Information Condensed Balance Sheet Data (amounts in thousands) (unaudited) March 31, December 31, 2025 2024 Cash, cash equivalents and investments $ 343,026 $ 198,187 Total assets $ 354,941 $ 205,903 Total liabilities $ 13,386 $ 14,646 Total stockholders' equity $ 341,555 $ 191,257
Yahoo
08-05-2025
- Health
- Yahoo
Study blames pollution, unhealthy diets for regional heart disease spikes across Asia
May 8 (UPI) -- Rapidly rising rates of heart disease across Southeast Asia, East Asia and Oceania are being driven by differing, localized consequences of industrialization and rapid economic growth, according to research released Thursday. In a study unveiled at the American College of Cardiology Asia 2025 scientific meeting in Singapore, researchers from India's Gujarat Adani Institute of Medical Sciences reported their data analysis shows that although ischemic heart disease soared across all three regions from 1990 to 2021, the factors driving the increases aren't the same everywhere. These "region-specific, modifiable risk factors" include toxic air pollution in East Asia and ultra-processed dietary dependence in Oceania, according to the authors. ischemic heart disease, or IHD, is a condition in which the heart is starved of oxygen due to a reduced blood supply, most commonly caused by a build-up of fatty plaque in the wall of one of the arteries supplying blood to the heart. As the plaque enlarges, it gradually obstructs the flow of blood, which deprives the heart of oxygen and nutrients, often resulting in strokes and heart attacks. IHD usually doesn't cause signs or symptoms until it severely narrows or totally blocks an artery. It is now the leading cause of premature death in 146 countries for men and 98 countries for women, according to the World Heart Federation. While previous research has shown that with rapid industrialization and resulting lifestyle changes, cardiovascular disease across Asia and Oceania has become a major concern, but the latest research shines a spotlight how the phenomenon differs from place to place. "Our study uncovers a critical and underreported dimension of the global cardiovascular crisis: the rapidly rising and regionally distinct burden of ischemic heart disease across Southeast Asia, East Asia, and Oceania -- regions that together represent over 2 billion people," said lead author Hardik Dineshbhai Desai, an independent researcher at the Gujarat Adani Institute. His analysis tapped data from the landmark Global Burden of Disease 2021 standardized methodology to assess the changing incidence and prevalence of IHD, along with rates of mortality and disability due to IHD, across the three regions. Among the nations included in the study were China, North Korea, Taiwan, the Philippines, Sri Lanka, Thailand and American Samoa. The study revealed that during the 31 years from 1990 to 2021, the annual percentage change for total prevalence of ischemic heart disease across all three regions rose by 3.79%, while ISD-related deaths rose by 4.12%. Disability-adjusted life years, or DALYs -- representing the total years of life lost due to premature mortality and the time lived with a disability -- went up by 3.24%. Regionally, East Asia experienced the highest burden over the last three decades. Those younger than age 70 showed a "significant increase" in heart disease incidences and DALYs, while those 70 or older saw a rise in deaths during the same period. East Asian deaths from heart disease attributable to modifiable risk factors such as high blood pressure, unhealthy diets and air pollution rose by 2.4%, while DALYs rose by 1.71% from 1990 to 2021, the authors estimated. Meanwhile, the highest age-standardized IHD mortality rate was found in the nations of Oceania, including American Samoa, Papua New Guinea, Fiji, Guam, Tuvalu and Vanuatu. Those countries posted a rate of 170.9 deaths per 100,000 people in 2021, mainly attributable to the rise in heavily processed foods in local diets, according to Desai. "The rise of IHD in Oceania -- and increasingly in parts of Southeast Asia and East Asia -- is strongly tied to the proliferation of ultra-processed foods, a byproduct of globalized food systems," he told UPI in emailed comments. "These foods, often high in trans fats, refined sugars and sodium and low in fiber or essential nutrients, are aggressively marketed, widely accessible and economically attractive, especially in low- and middle-income settings." In Oceania, particularly among Pacific Island nations, "traditional diets rich in root crops, fruits and fish have been steadily replaced by imported, calorie-dense packaged products such as processed meats, sugary beverages, instant noodles and refined snacks," he added. "This dietary shift is not simply a matter of personal choice, but reflects deeper structural issues -- including food import dependence, limited local food production, urbanization and economic constraints. "The epidemiological outcome is a dramatic rise in obesity, type 2 diabetes, hypertension and dyslipidemia -- key metabolic risk factors driving IHD." Across all of Asia, the rising levels of heart disease are evidence of what Desai called an "economic paradox" in which "the very forces driving economic growth -- urbanization, industrialization, and globalized food systems -- are simultaneously accelerating the burden of ischemic heart disease." In parts of Southeast and East Asia, he said, "modern food environments and sedentary urban lifestyles are rapidly displacing traditional, balanced diets. What makes this particularly concerning is that the metabolic consequences emerge earlier and progress more aggressively in these populations, often without adequate health system capacity to respond." The study's findings "demonstrate an alarming rise of ischemic heart disease across Southeast Asia and East Asia," said Dr. Kevin Shah, a cardiologist with the MemorialCare Heart & Vascular Institute at Long Beach Medical Center in California. Shah, who has conducted research focused on heart disease in the South Asian community, was not connected to the Indian study. He told UPI its results "underscore how globalized changing dietary patterns have converged with traditional risk factors to create a 'perfect storm' for cardiovascular disease in a region representing nearly a third of global economic activity." The study, he said, is "particularly valuable" due to its detailed mapping of regional disparities and the identification of metabolic risk factors as the fastest-growing contributors to mortality. "As we confront the reality that ischemic heart disease now accounts for nearly 15% of all deaths in this region, this study provides an further support for developing targeted interventions that can address both the socioeconomic determinants and clinical management of heart disease across diverse Asian populations," Shah said. Desai, the study's chief author, agreed that it could provide a roadmap for Asian policymakers to move from "reactive to preventive" cardiovascular strategies and to concentrate on localized approaches, such as controlling air pollution control in East Asia and lipid and blood pressure screening in Southeast Asia. "One-size-fits-all approaches have failed in the past because they overlook local context; our findings offer a data-driven roadmap for precision public health," he said. And more broadly, the findings can serve a guide for implementing "bold, localized policy" across multiple sectors of governments, including not only health ministries but those covering agriculture, trade, urban planning and education. "For example, governments can implement front-of-pack food labeling, regulate trans fats and added sugars, subsidize healthier local produce, and limit the marketing of ultra-processed foods, especially to children," Desai said. "Investments in primary care infrastructure for early detection of hypertension and metabolic risks can also be scaled in high-burden areas." Dr. Annabelle Santos Volgman, a cardiologist, researcher and professor at Rush College of Medicine in Chicago, said the study's findings are all too familiar. "We have been seeing a trend in these regions of the world for the increasing mortality from cardiovascular disease versus communicable disease," she told UPI. "The reasons for this increase have been explained by the authors, but the challenge is that social determinants of health are a major barrier to decreasing cardiovascular mortality in many nations."
Time of India
03-05-2025
- Health
- Time of India
Coffee addicts, beware: Your daily fix may raise stroke risk
Coffee is the most favoured drink in India. Who doesn't like coffee ?!! In most countries around the world, more than fifty per cent of people consume coffee or tea. According to a report by the Coffee Board, Indians consumed 91,000 tonnes of coffee in 2023 !! The value of the coffee market in India is not less. Tired of too many ads? go ad free now In 2024, there were $ 51 billion worth coffee. Coffee for South Indians is a nector. Studies have shown many benefits in drinking two cups of coffee every day. According to a study published in the American College of Cardiology magazine in 2022, there was a reduction in heart attack, diabetes and Alzheimer's disease in persons who consumed two cups of coffee. Anything taken in excess amount always comes with hazards. According to a study published in one of the prestigious magazines of the World Stroke Organization, people consuming more than four cups of coffee per day has increased risk of stroke . One of the largest studies on stroke in the world, the "INTERSTROKE", was conducted from 2007 to 2015. In this study, treatments and results were analyzed by various types of stroke in 26,950 patients across 32 countries in 5 continents. Based on the results of this study, investigators of the InterStroke study concluded that high caffeine consumption of more than four cups per day was associated with higher risk of ischemic stroke. The problem of clotting in the brain blood vessels was 37 percent higher in patients who consumed more than four cups of coffee per day compared to those who consumed in moderation. However we have a good news here. Stroke risk was lesser in patients who consumed tea regularly. Tired of too many ads? go ad free now They had 19% reduced risk of ischemic stroke compared to those patients who didn't consume tea. Brain bleeding risk didn't change significantly in all the subgroups. However, coffee addicts had higher BMI (obesity), poor diet and exercise compared to controls. Coffee addiction is harmful and may lead to increased risk of ischemic stroke. Tea consumption in various forms as green tea, lemon tea or milk tea is associated with reduced risk of stroke. However coffee consumption in moderation (2cups or less per day) is associated with reduced risk of heart attack, Alzheimer's disease and diabetes. Prevention is better than cure. Control your habits and lead a healthy lifestyle so that you can stay away from life threatening illnesses such as stroke. Dr. Suryanarayana Sharma P.M. Senior Neurologist and stroke specialist, Apollo Hospital Bannerghatta Road Bangalore Secretary, Karnataka Stroke Foundation, Bangalore.
Scientific American
29-04-2025
- Health
- Scientific American
HPV Infection May Increase the Risk of Heart Disease. Could Vaccination Lower It?
Human papillomavirus (HPV) causes nearly 38,000 cancers a year, including most cervical and throat cancers. Now recent research suggests HPV infection also increases the risk of heart disease. An analysis of seven studies with a total of nearly 250,000 participants found that those who tested positive for HPV were 33 percent more likely than those who tested negative to develop cardiovascular disease. Now Stephen Akinfenwa, an internal medicine resident at the University of Connecticut School of Medicine and one of the lead authors of the analysis, says he would like to study whether the HPV vaccine, which can prevent 90 percent of cervical cancers, also reduces the risk of heart disease. The vaccine, which has been recommended for adolescents since 2006, protects against infection with nine strains of HPV, including high-risk types that are the most likely to cause cervical cancer, as well as strains that cause genital warts. The Centers for Disease Control and Prevention recommends that boys and girls receive a series of two HPV shots at ages 11 or 12 as part of their routine childhood vaccinations—and that people receive three shots if their first dose is instead administered between the ages of 15 and 26. The vaccine is most protective when given before people become sexually active. On supporting science journalism If you're enjoying this article, consider supporting our award-winning journalism by subscribing. By purchasing a subscription you are helping to ensure the future of impactful stories about the discoveries and ideas shaping our world today. The HPV vaccine has been strikingly effective. Cervical cancer deaths in women under age 25—the first generation eligible to receive the vaccine— fell by 65 percent from 2012 to 2019. Learning that heart disease may be related to HPV is exciting because HPV infection is preventable, Akinfenwa explains. 'It feels like good news,' he says. 'We're hoping that [the vaccine] will be a powerful tool for prevention.' Akinfenwa and his colleagues presented a condensed version of their analysis in March at the annual meeting of the American College of Cardiology. It has not yet been published as a peer-reviewed study. The analysis included studies published between 2011 and 2024 that followed women for three to 17 years. The largest study included in the analysis was published by researchers in South Korea in 2024 and followed apparently healthy women who were tested for 13 strains of high-risk HPV as part of a routine screening for cervical cancer. The women returned for health checks every year or two for an average of 8.6 years. Although heart disease and death were rare among these women, who had an average age of 40, those who tested positive for high-risk HPV were nearly four times as likely as those who tested negative to develop blocked arteries or die from heart disease, the study found. Women aren't the only ones at risk, Akinfenwa says. In one paper included in the analysis, a 2017 study of people undergoing radiation therapy for head and neck cancer, 75 percent of patients were men. (Head and neck cancers are more than twice as common in men as they are in women, according to the National Cancer Institute.) The 2017 study found that people who tested positive for HPV were more likely to have strokes compared with those who tested negative. HPV is ubiquitous and the most common sexually transmitted infection in the U.S. Among sexually active people, more than 90 percent of men and more than 80 percent of women are infected with HPV during their lifetime. About half of HPV infections involve high-risk strains that cause the bulk of cancers of the cervix, throat, vagina, vulva, anus and penis. Vaccine hesitancy and lack of awareness about HPV has kept many parents from vaccinating their children against the infection, research shows. Some parents are reluctant to vaccinate their kids against HPV because they don't think their children will have sex as teenagers. Only 61 percent of adolescents are up to date on all HPV vaccines. Even without a study that has specifically analyzed the effect of HPV vaccination on heart disease, the link between HPV and heart disease suggests that 'vaccination is a good idea, and our study definitely supports that,' Akinfenwa says. Given what scientists know about HPV, it's likely that the vaccine could prevent cases of heart disease related to the virus or at least the nine strains of the virus that are included in the shot, says Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, who studies emerging infectious diseases and was not involved in the new analysis. Other experts aren't so sure about the link between HPV and heart disease. Mark Einstein, chair of obstetrics and gynecology and women's health at Montefiore Einstein, who also was not involved in the analysis, says researchers have a long way to go before they can confidently say that the virus causes heart disease. 'This sort of association has come up a number of times over the years,' Einstein says. 'When you have a common disease—heart disease—and a common infection—HPV—it's easy to use statistical nuance to show a correlation,' he says. But 'association is different than causality.' A Source of Chronic Inflammation Scientists don't know exactly how HPV may increase the risk of heart disease, but it's unlikely that the virus directly infects the heart or blood vessels, says C. Noel Bairey Merz, director of the Barbra Streisand Women's Heart Center at the Cedars-Sinai Smidt Heart Institute in Los Angeles, who was not involved in the new research. HPV causes cancer in parts of the body that come into direct contact with the virus through sexual activity, says Kevin Ault, a professor of obstetrics and gynecology at the Western Michigan University Homer Stryker M.D. School of Medicine. The virus is not thought to travel to distant organs and cause lung or liver cancer, for example. 'We usually don't think of human papillomavirus as going all around the body,' Ault says. 'It's going to infect mostly skin' or mucous membranes. Instead, Merz says, HPV probably increases the risk of heart disease by causing inflammation, which occurs as the immune system attempts to control the virus. Chronic inflammation has been shown to irritate blood vessels and can lead to the hardening of fatty plaques in the lining of the arteries, which reduces blood flow to the heart. Inflammation can also cause those plaques to burst and form blood clots, which can lead to a heart attack or stroke. Although the immune system naturally controls most HPV infections within a year or two, a small number of infections become chronic, a problem that increases the risk of cervical cancer, says Rebecca Perkins, obstetrician and gynecologist at the Woman, Mother and Baby Research Institute at Tufts Medical Center. Even after HPV is controlled, the virus doesn't disappear from the body. Like the virus that causes chicken pox (varicella-zoster), HPV can lie dormant in the body for decades. And just as the varicella-zoster virus can reactivate decades after a childhood infection and cause shingles, HPV can wake up and cause women to test positive during cervical cancer screenings, Perkins says. The studies included in the new analysis typically cited the result of a single test for HPV, Akinfenwa says. HPV tests are now included in most routine cervical cancer screenings, either alone or in combination with a Pap smear. So a positive test result cannot distinguish among a recent exposure, a reactivation of the virus and a chronic infection, Akinfenwa says. How Infections Can Damage the Heart Many pathogens can cause heart disease, Adalja says. A wide variety of viruses, bacteria, parasites and fungi can trigger myocarditis, an inflammation of the heart muscle, which can make the heart too weak to pump blood efficiently. Those include the viruses that cause influenza and COVID. And untreated strep throat and scarlet fever, caused by Streptococcus bacteria, can lead to rheumatic fever, which can damage heart valves and cause heart failure. 'Many infectious diseases set off inflammatory cascades that can prompt cardiovascular and neurological events like heart attacks, blood clots and strokes,' Adalja says. 'By staving off infection, [vaccinating] against these agents—such as influenza, varicella-zoster virus and, presumably, HPV—these events will be prevented or become less likely.' Doctors have frequently been surprised by unexpected or off-target benefits from vaccines, Adalja says. A growing number of studies suggest that the shingles vaccine also reduces the risk of dementia —possibly by preventing the inflammation that contributes to the disease, Adalja says. The bacillus Calmette-Guérin (BCG) vaccine against tuberculosis also has been found to reduce risk of other diseases in which the immune system goes awry, including type 1 diabetes, cancer, multiple sclerosis and Alzheimer's disease. And an analysis published in 2024 found that meningitis vaccines reduced the incidence of gonorrhea by 30 to 59 percent. Such cross-protective immunity can occur when two bacteria are from similar families. The bacterium that causes gonorrhea is related to the meningococcus bacterium, which causes most cases of meningitis, an inflammation of the protective membranes around the brain, Adalja says. To better understand how HPV damages the heart and whether the HPV vaccine might offer protection, Merz says, researchers could compare rates of chronic inflammation in adolescents who were vaccinated with rates in those who weren't vaccinated. 'It's logical to think preventing the HPV infection itself via vaccination will reduce the risk of cardiovascular disease,' Akinfenwa says. 'Having said that, it needs to be tested.'
Edinburgh Live
27-04-2025
- Health
- Edinburgh Live
One glass a day 'significantly' increases heart disease risk, study warns
Our community members are treated to special offers, promotions and adverts from us and our partners. You can check out at any time. More info A study has warned that women who consume as little as a daily glass of wine and two at weekends are at a "significantly higher" risk of developing heart disease. American researchers found that women who consume more than eight alcoholic drinks a week were nearly 50 per cent more likely to develop the potentially fatal condition. Binge drinkers of both sexes were also discovered to be at a much higher risk of heart disease. The 2024 study from the American College of Cardiology (ACC) - one of the largest ever conducted on the link between alcohol and coronary heart disease - cautioned that heavy-drinking young and middle-aged women were particularly at risk, regardless of their age. Heart attacks and other forms of heart disease are currently increasing among younger generations in both the US and the UK. Coronary heart disease happens when the arteries supplying blood to the heart become narrowed, restricting blood flow. READ MORE - The unlikely royal who has run the London Marathon - and even set a world record READ MORE - How much London Marathon 2025 winners and record breakers receive in iconic race This condition can lead to chest pain and acute events such as heart attacks. Alcohol use and episodic drinking - or binge drinking - have also increased amongst female populations in recent decades. Dr Jamal Rana, a cardiologist and lead author of the study, explained: "When it comes to binge drinking, both men and women with excess alcohol consumption had a higher risk of heart disease,", reports Surrey Live. "For women, we find consistently higher risk even without binge drinking. I wasn't expecting these results among women in this lower age group because we usually see increased risk for heart disease among older women. It was definitely surprising." Data from over 430,000 individuals who received care in the Kaiser Permanente Northern California integrated health organisation were utilised by researchers. Almost 243,000 men and 189,000 women, with an average age of 44 and free from heart disease at the start, formed the cohort under study. During primary care consultations, information regarding alcohol consumption was gathered using the standard 'Alcohol as a Vital Sign' screening initiative of the health organisation, which employs visual reference charts to assist patients in gauging their alcohol quantity intakes in line with standard measurements. The team examined the link between the alcohol intake levels the patients reported during routine assessments in 2014 and 2015 and the occurrence of coronary heart disease over the next four years. Participants' overall alcohol consumption was determined on the basis of self-reported assessments, classifying it as low (one to two drinks per week for both genders), moderate (three to 14 for men and three to seven for women weekly), or high (15 or more for men and eight or more weekly for women). Each participant was categorised separately based on whether they engaged in binge drinking - defined as consuming more than four drinks for men or more than three drinks for women in a single day over the past three months. Those who reported no alcohol use were excluded from the study, and the data was adjusted to account for age, physical activity, smoking and other known cardiovascular risk factors. During the four-year follow-up period, 3,108 patients were diagnosed with coronary heart disease. The researchers discovered that the incidence of coronary heart disease rose with higher levels of alcohol consumption. Among women, those who reported high alcohol intake had a 45 per cent higher risk of heart disease compared to those reporting low intake, and a 29 per cent higher risk compared to those reporting moderate intake. However, the most significant difference was found among individuals categorised as binge drinkers - with women in this category being a staggering two-thirds (68 per cent) more likely to develop heart disease compared to those with a moderate alcohol intake. Men with high overall intake were also a third (33 per cent) more likely to develop heart disease compared with men who reported a moderate intake. The results showed no significant difference in risk between people who reported moderate versus low alcohol intake, regardless of whether they were also categorised as binge drinkers. "Women feel they're protected against heart disease until they're older, but this study shows that even when you're young or middle-aged, if you are a heavy alcohol user or binge drink, you are at risk for coronary heart disease," Dr Rana explained. Alcohol's effects can raise blood pressure and result in metabolic changes linked to inflammation and obesity, and as women metabolise alcohol differently than men, Dr Rana and his team have emphasised the health dangers of alcohol use and the need to factor it into heart disease risk assessments and prevention strategies. "When it comes to heart disease, the number one thing that comes to mind is smoking, and we do not think about alcohol as one of the vital signs," Dr Rana remarked. "I think a lot more awareness is needed, and alcohol should be part of routine health assessments moving forward." A key caveat of the study, which Dr Rana presented at the ACC's Annual Scientific Session in Atlanta, Georgia, on 6 April last year - is the common belief that patients downplay their alcohol consumption. Consequently, the researchers suggest that their findings regarding alcohol-linked heart disease risk may be 'conservative'.
