Category: Cardiovascular Disease

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Regular Sleep Schedule May Improve Recovery from Heart Failure Hospitalisation

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People recovering from heart failure should consider improving the regularity of their sleep, a study led by Oregon Health & Science University suggests. The research team found that even moderately irregular sleep doubles the risk of having another clinical event within six months, according to a study published in the journal JACC Advances. A clinical event could be another visit to the emergency room, hospitalisation or even death.

“Going to bed and waking up at consistent times is important for overall health,” said lead author Brooke Shafer, PhD, a research assistant professor in the Sleep, Chronobiology and Health Laboratory in the OHSU School of Nursing. “Our study suggests that consistency in sleep timing may be especially important for adults with heart failure.”

Researchers enrolled 32 patients who had been hospitalised for acutely decompensated heart failure at OHSU Hospital and Hillsboro Medical Center from September 2022 through October 2023. For one week following hospital discharge, participants used sleep diaries to record the time they fell asleep at night, woke up in the morning and the timing of naps they took during the day.

The participants were then categorised as regular sleepers or moderately irregular sleepers, based on their sleep patterns.

The study found:

  • Following discharge from the hospital, 21 participants experienced a clinical event over the course of six months.
  • Of that group, 13 were classified as moderately irregular sleepers compared with eight classified as having a regular sleep schedule.
  • Statistically, the irregular sleepers had more than double the risk of an event across the six-month time span.

The increased risk of a clinical event for moderately irregular sleepers remained even when accounting for possible contributing factors like sleep disorders and other underlying medical conditions. The research team says the study is among the first to examine the impact of sleep regularity in the context of heart failure, and the findings add to a growing body of evidence suggesting the importance of maintaining a regular sleep schedule.

“Improving sleep regularity may be a low-cost therapeutic approach to mitigate adverse events in adults with heart failure,” the authors conclude.

Shafer said the results strengthen the connection between sleep regularity and cardiovascular health.

“When we’re asleep and in a resting state, our blood pressure and heart rate decrease compared with daytime levels,” she said. “But variability in sleep timing may disrupt mechanisms involved in the regulation of the cardiovascular system. Irregular sleep may contribute to adverse outcomes, especially for people already affected by heart failure.”

The next step would be to scale up the research to a larger cohort of participants and see whether improving sleep regularity lowers the risk of another clinical event, she said.

Source: Oregon Health & Science University

Categories : Cardiovascular DiseaseTags :

Why Common Blood Pressure Readings May Be Misleading – and How to Fix Them

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Researchers have found why common cuff-based blood pressure readings are inaccurate and how they might be improved, which could improve health outcomes for patients.

Photo by CDC on Unsplash

High blood pressure, or hypertension, is the top risk factor for premature death, associated with heart disease, strokes and heart attacks. However, inaccuracies in the most common form of blood pressure measurement mean that as many as 30% of cases of high blood pressure could be missed.

The researchers, from the University of Cambridge, built an experimental model that explained the physics behind these inaccuracies and provided a better understanding of the mechanics of cuff-based blood pressure readings.

The researchers say that some straightforward changes, which don’t necessarily involve replacing standard cuff-based measurement, could lead to more accurate blood pressure readings and better results for patients. Their results are reported in the journal PNAS Nexus.

Anyone who has ever had their blood pressure taken will be familiar with the cuff-based method. This type of measurement, also known as the auscultatory method, relies on inflating a cuff around the upper arm to the point where it cuts off blood flow to the lower arm, and then a clinician listens for tapping sounds in the arm through a stethoscope while the cuff is slowly deflated.

Blood pressure is inferred from readings taken from a pressure gauge attached to the deflating cuff. Blood pressure is given as two separate numbers: a maximum (systolic) and a minimum (diastolic) pressure. A blood pressure reading of 120/80 is considered ‘ideal’.

“The auscultatory method is the gold standard, but it overestimates diastolic pressure, while systolic pressure is underestimated,” said co-author Kate Bassil from Cambridge’s Department of Engineering. “We have a good understanding of why diastolic pressure is overestimated, but why systolic pressure is underestimated has been a bit of a mystery.”

“Pretty much every clinician knows blood pressure readings are sometimes wrong, but no one could explain why they are being underestimated — there’s a real gap in understanding,” said co-author Professor Anurag Agarwal, also from Cambridge’s Department of Engineering.

Previous non-clinical studies into measurement inaccuracy used rubber tubes that did not fully replicate how arteries collapse under cuff pressure, which masked the underestimation effect.

The researchers built a simplified physical model to isolate and study the effects of downstream blood pressure — the blood pressure in the part of the arm below the cuff. When the cuff is inflated and blood flow to the lower arm is cut off, it creates a very low downstream pressure. By reproducing this condition in their experimental rig, they determined this pressure difference causes the artery to stay closed for longer while the cuff deflates, delaying the reopening and leading to an underestimation of blood pressure.

This physical mechanism — the delayed reopening due to low downstream pressure — is the likely cause of underestimation, a previously unidentified factor. “We are currently not adjusting for this error when diagnosing or prescribing treatments, which has been estimated to lead to as many as 30% of cases of systolic hypertension being missed,” said Bassil.

Instead of the rubber tubes used in earlier physical models of arteries, the Cambridge researchers used tubes that lay flat when deflated and fully close when the cuff pressure is inflated, the key condition for reproducing the low downstream pressure observed in the body.

The researchers say that there are a range of potential solutions to this underestimation, which include raising the arm in advance of measurement, potentially producing a predictable downstream pressure and therefore predictable underestimation. This change doesn’t require new devices, just a modified protocol.

“You might not even need new devices, just changing how the measurement is done could make it more accurate,” said Agarwal.

However, if new devices for monitoring blood pressure are developed, they might ask for additional inputs which correlate with downstream pressure, to adjust what the ‘ideal’ readings might be for each individual. These may include age, BMI, or tissue characteristics.

The researchers hope to secure funding for clinical trials to test their findings in patients, and are looking for industrial or research partners to help refine their calibration models and validate the effect in diverse populations. Collaboration with clinicians will also be essential to implement changes to clinical practice.

The research was supported by the Engineering and Physical Sciences Research Council (EPSRC), part of UK Research and Innovation (UKRI). Anurag Agarwal is a Fellow of Emmanuel College, Cambridge. 

Reference:
Kate Bassil and Anurag Agarwal. ‘Underestimation of systolic pressure in cuff-based blood pressure measurement.’ PNAS Nexus (2025). DOI: 10.1093/pnasnexus/pgaf222.

Republished from University of Cambridge under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Read the original article.

Categories : Cardiovascular Disease Metabolic DisordersTags :

Study Finds Higher Cardiovascular Risk for One Particular Sulfonylurea

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New research from investigators at Mass General Brigham suggests that a commonly used type 2 diabetes medication is linked to a higher rate of heart-related conditions compared to medications that hit other targets. The study examined nationwide data from nearly 50,000 patients treated with different sulfonylureas and found that glipizide – the most widely used drug in the US within this category, but not available in South Africa – was linked to higher incidence of heart failure, related hospitalisation and death compared to dipeptidyl peptidase-4 (DPP-4) inhibitors. Results are published in JAMA Network Open.

“Patients with type 2 diabetes are at heightened risk of adverse cardiovascular incidents such as stroke and cardiac arrest,” said corresponding author Alexander Turchin, MD, MS, of the Division of Endocrinology at Brigham and Women’s Hospital (BWH), a founding member of the Mass General Brigham healthcare system. “While sulfonylureas are popular and affordable diabetes medications, there is a lack of long-term clinical data on how they affect cardiac health in comparison to more neutral alternatives like dipeptidyl peptidase 4 inhibitors.”

Turchin and co-authors emulated a target trial by analysing electronic health records and insurance claims data from the BESTMED consortium. The cohort included 48 165 patients with type 2 diabetes and moderate cardiovascular risk who received care at 10 different study sites across the country, including BWH, as well as those covered by two different national health insurance plans.

The researchers studied the five-year risk of major adverse cardiovascular events in patients treated with different sulfonylureas (glimepiride, glipizide or glyburide) or DPP4i in addition to metformin, a primary diabetes medication. They found that glipizide was associated with a 13% increase in cardiovascular risk when compared to DPP4i, while glimepiride and glyburide led to relatively smaller and less clear effects, respectively. The authors propose that further research is needed to uncover the underlying mechanisms.

“Our study underscores the importance of evaluating each drug in a particular pharmacological class on its own merits,” said Turchin. 

Source: Mass General Brigham

Categories : Cardiovascular Disease Diet and NutritionTags :

Beetroot Juice Lowers Blood Pressure in Older People by Changing Oral Microbiome

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Pic by Jim Wileman – University of Exeter images

The blood pressure lowering effect of nitrate-rich beetroot juice in older people may be due to specific changes in their oral microbiome, according to the largest study of its kind.

Researchers at the University of Exeter conducted the study, published in the journal Free Radical Biology and Medicine, comparing responses between a group of older adults to that of younger adults. Previous research has shown that a high nitrate diet can reduce blood pressure, which can help reduce risk of heart disease.

Nitrate is crucial to the body and is consumed as a natural part of a vegetable-rich diet.  When the older adults drank a concentrated beetroot juice ‘shot’ twice a day for two weeks*, their blood pressure decreased – an effect not seen in the younger group.

The new study, funded by a BBSRC Industrial Partnership Award, provides evidence that this outcome was likely caused by the suppression of potentially harmful bacteria in the mouth.  An imbalance between beneficial and harmful oral bacteria can decrease the conversion of nitrate (abundant in vegetable-rich diets) to nitric oxide. Nitric oxide is key to healthy functioning of the blood vessels, and therefore the regulation of blood pressure.

Study author Professor Anni Vanhatalo, of the University of Exeter, said: “We know that a nitrate-rich diet has health benefits, and older people produce less of their own nitric oxide as they age. They also tend to have higher blood pressure, which can be linked to cardiovascular complications like heart attack and stroke. Encouraging older adults to consume more nitrate-rich vegetables could have significant long term health benefits. The good news is that if you don’t like beetroot, there are many nitrate-rich alternatives like spinach, rocket, fennel, celery and kale.”

The study recruited 39 adults aged under 30, and 36 adults in their 60s and 70s through the NIHR Exeter Clinical Research Facility. The trial was supported by the Exeter Clinical Trials Unit. Each group spent two weeks taking regular doses of nitrate-rich beetroot juice and two weeks on a placebo version of the juice with nitrate stripped out. Each condition had a two week “wash out” period in between to reset. The team then used a bacterial gene sequencing method to analyse which bacteria were present in the mouth before and after each condition.

In both groups, the make-up of the oral microbiome changed significantly after drinking the nitrate-rich beetroot juice, but these changes differed between the younger and older age groups.

The older age group experienced a notable decrease in the mouth bacteria Prevotella after drinking the nitrate rich juice, and an increase in the growth of bacteria known to benefit health such as Neisseria. The older group had higher average blood pressure at the start of the study, which fell after taking the nitrate-rich beetroot juice, but not after taking the placebo supplement.

Co-author Professor Andy Jones, of the University of Exeter, said: “This study shows that nitrate-rich foods alter the oral microbiome in a way that could result in less inflammation, as well as a lowering of blood pressure in older people. This paves the way for larger studies to explore the influence of lifestyle factors and biological sex in how people respond to dietary nitrate supplementation.”

Dr Lee Beniston FRSB, Associate Director for Industry Partnerships and Collaborative Research and Development at BBSRC, said: “This research is a great example of how bioscience can help us better understand the complex links between diet, the microbiome and healthy ageing. By uncovering how dietary nitrate affects oral bacteria and blood pressure in older adults, the study opens up new opportunities for improving vascular health through nutrition. BBSRC is proud to have supported this innovative partnership between academic researchers and industry to advance knowledge with real-world benefits.”

Source: University of Exeter

Categories : Cardiovascular Disease Diet and NutritionTags :

Common Sugar Substitute Shown to Impair Brain Cells, Boost Stroke Risk

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New University of Colorado Boulder research shows the popular sugar substitute erythritol comes with serious downsides, impacting brain cells in numerous ways that can boost the risk of stroke. The study was published in the Journal of Applied Physiology.

“Our study adds to the evidence suggesting that non-nutritive sweeteners that have generally been purported to be safe, may not come without negative health consequences,” said senior author Christopher DeSouza, professor of integrative physiology and director of the Integrative Vascular Biology Lab.

First approved by the Food and Drug Administration in 2001, erythritol is a sugar alcohol, often produced by fermenting corn, and found in hundreds of products made by various brands. It has almost no calories, is about 80% as sweet as table sugar, and has a negligible impact on insulin levels, making it a favourite for people trying to lose weight, keep their blood sugar in check or avoid carbohydrates.

But recent research has begun to shed light on its risks.

One recent Cleveland Clinic study involving 4000 people in the US and Europe found that men and women with higher circulating levels of erythritol were significantly more likely to have a heart attack or stroke within the next three years.

DeSouza and first author Auburn Berry, a graduate student in his lab, set out to understand what might be driving that increased risk.

To test impacts of erythritol on cells, researchers in the lab treated human cerebral microvascular endothelial cells (hCMECs)  for three hours with about the same amount of erythritol contained in a typical sugar-free beverage.

They observed that the treated cCMEVs were altered in numerous ways: 

They expressed significantly less nitric oxide, a molecule that relaxes and widens blood vessels, and more endothelin-1, a protein that constricts blood vessels. Meanwhile, when challenged with thrombin, cellular production of the natural clot-busting compound t-PA was “markedly blunted.” The erythritol-treated cells also produced more reactive oxygen species (ROS), aka “free radicals,” metabolic byproducts which can age and damage cells and inflame tissue.

Thrombophilia. Credit: Scientific Animations CC4.0.

Previous research has shown that as little as 30g of erythritol (about as much as you’d find in 600mL of sugar-free ice cream) can also cause platelets to clump together, potentially forming clots.

“Big picture, if your vessels are more constricted and your ability to break down blood clots is lowered, your risk of stroke goes up,” said Berry. “Our research demonstrates not only that, but how erythritol has the potential to increase stroke risk.”

DeSouza notes that their study used only a serving-size worth of the sugar substitute.
For those who consume multiple servings per day, the impact, presumably, could be worse.

The authors caution that their study was a laboratory study, conducted on cells, and larger studies in people are now needed.

That said, De Souza encourages consumers to read labels, looking for erythritol or “sugar alcohol” on the label.

“Given the epidemiological study that inspired our work, and now our cellular findings, we believe it would be prudent for people to monitor their consumption of non-nutrient-sweeteners such as this one,” he said.

Source: University of Colorado Boulder

Categories : Cardiovascular DiseaseTags :

P2Y12 Drugs Preferable to Aspirin for CVD Prevention in Coronary Artery Disease

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Findings support use of P2Y12 therapy instead of aspirin for long term prevention

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Giving a P2Y12 inhibitor anti-clotting drug to patients with coronary artery disease is associated with lower rates of cardiovascular death, heart attack and stroke compared with traditional aspirin, with no increased risk of major bleeding, finds a study published by The BMJ.

P2Y12 inhibitors are often given to patients alongside aspirin (“dual therapy”) after percutaneous coronary intervention (PCI) – a procedure to widen or unblock a coronary artery – to help prevent cardiovascular events including heart attack and stroke.

After several months, patients are usually switched from dual therapy to lifelong aspirin, but some trials have suggested that a P2Y12 inhibitor may be more effective for long term prevention than aspirin.

To explore this further, researchers analysed individual patient data from five randomised clinical trials involving 16 117 patients (average age 65; 24% women) who were assigned to a P2Y12 inhibitor (clopidogrel or ticagrelor) or aspirin after completing dual therapy following PCI.

After an average follow-up period of around 4 years, P2Y12 inhibitor therapy was associated with a 23% lower risk of an outcome that combined cardiovascular death, heart attack, or stroke, compared with aspirin, with no significant difference in major bleeding. This means that for every 46 patients taking a P2Y12 inhibitor instead of aspirin after dual therapy, one cardiovascular death, heart attack, or stroke would be prevented.

When considering outcomes individually, P2Y12 inhibitor therapy reduced heart attacks and stroke compared with aspirin. However, all-cause death, cardiovascular death, and stent thrombosis were similar between the treatments.

The researchers acknowledge that some changes in the original design of some trials were needed to create uniform data, and that certain characteristics of individual trial populations may reduce the generalisability of the findings.

But they say no significant difference in major bleeding between groups was seen, and results were consistent after further analyses accounting for factors such as age, sex, geographical region, smoking, previous heart attack or stroke, underlying conditions and medication history, suggesting they are robust.

“Overall, this study supports preferential P2Y12 inhibitor monotherapy prescription over aspirin due to reductions in major adverse cardiac and cerebrovascular events (MACCE) without increasing major bleeding in the medium term,” say researchers in a linked editorial.

However, they note that “medium term efficacy does not necessarily extend lifelong, which is the duration we advise patients to continue these medications.”

As such, they suggest that “a large-scale globally representative trial directly comparing different monotherapy strategies (including discontinuation) with extended follow-up would benefit our understanding of the long-term impact of P2Y12 inhibitor monotherapy across the treatment class for secondary prevention following PCI.”

Source: BMJ Group

Categories : Cardiovascular Disease Obstetrics & GynaecologyTags :

Premenstrual Symptoms Linked to Increased Risk of Cardiovascular Disease

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Women diagnosed with premenstrual symptoms have a slightly increased risk of developing cardiovascular disease later in life. This is shown by a new study from Karolinska Institutet published in Nature Cardiovascular Research.

Premenstrual symptoms include premenstrual syndrome (PMS) and the more severe form, premenstrual dysphoric disorder (PMDD). The symptoms, which appear a few days before menstruation and then subside, can be both psychological and physical.

The study included more than 99 000 women with premenstrual symptoms who were followed for up to 22 years. The researchers compared their health with women without these symptoms – both in the general population and by comparing them with their own sisters to take into account hereditary factors and upbringing.

The results show that women with premenstrual symptoms had about a ten per cent higher risk of developing cardiovascular disease. When the researchers also looked at different types of cardiovascular disease, they found that the link was particularly strong for heart rhythm disorders (arrhythmias), where the risk was 31 per cent higher, and for stroke caused by a blood clot, where the risk was 27 per cent higher. Even after the researchers took into account other factors such as smoking, BMI and mental health, the link between premenstrual symptoms and increased disease risk remained.

”The increased risk was particularly clear in women who were diagnosed before the age of 25 and in those who had also experienced postnatal depression, a condition that can also be caused by hormonal fluctuations,” says first author Yihui Yang, PhD student at the Institute of Environmental Medicine.

Research has not yet identified the cause of this link, but the researchers behind the study suggest three possible explanations. One is that women with premenstrual symptoms may have a disrupted regulation of the renin-angiotensin-aldosterone system (RAAS), which controls blood pressure and fluid balance in the body, among other things. The second is that these women have increased levels of inflammation in the body, which is a known risk factor for atherosclerosis and other heart problems. Finally, it may be because women with premenstrual symptoms may have metabolic abnormalities, which are linked to an increased risk of both stroke and heart attack.

”We hope that our findings will contribute to greater awareness that premenstrual disorders not only affect daily life but can also have consequences for long-term health,” says last author Donghao Lu, associate professor at the same department.

Source: Karolinska Institutet

Categories : Cardiovascular Disease NeurologyTags :

Study Finds that Cognitive Impairment is Common After Cardiogenic Shock

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Many survivors of cardiogenic shock showed evidence of new cognitive impairment after leaving the hospital, according to a study led by UT Southwestern Medical Center researchers. The findings, published in the Journal of the American College of Cardiology, highlight a need to screen survivors and provide referrals to neuropsychology experts, the authors said.

“Our study demonstrated that nearly two-thirds of cardiogenic shock survivors experienced cognitive impairment within three months of hospital discharge, underscoring a critical but overlooked aspect of recovery,” said senior investigator James de Lemos, MD, Professor of Internal Medicine and Chief of the Division of Cardiology at UT Southwestern. “The findings are important for developing interventions that focus not only on improving survival but also on preventing or mitigating the functional consequences of cardiogenic shock, including cognitive decline.”

Cardiogenic shock results from heart failure, heart attack, or complications following cardiac surgery, and is characterised by a sudden drop in heart pumping ability. It results in acute hypoperfusion and hypoxia of the organs and has historically resulted in high mortality.

With advances in treatment during the past two decades, up to 70% of patients suffering from cardiogenic shock can now survive. But there is limited understanding of survivors’ recovery and quality of life after they leave the hospital.

“Our study is the first to systematically examine the cognitive outcomes of cardiogenic shock survivors, evaluating how cognition impacts patients’ ability to return to daily activities,” said Eric Hall, M.D., a clinical fellow in the Division of Cardiology who was the study leader and first author. “We found that cardiogenic shock is associated with cognitive impairment, which is an under-recognized consequence strongly linked to patients’ overall quality of life.”

UTSW researchers conducted the study by enrolling 141 patients who had survived cardiogenic shock before being discharged. To establish a baseline, family members completed a questionnaire, the AD8 survey, about the patients’ cognitive function before hospitalisation.

Before discharge, each patient completed the Montreal Cognitive Assessment-Blind (bMoCA) to screen for signs of cognitive impairment. Three months after discharge, patients repeated the assessments, allowing researchers to track changes in thinking ability and daily functioning over time.

Among patients with no sign of cognitive impairment before admission, 65% were found to have new impairment at discharge, and 53% continued to show impairment at their three-month follow-up. UTSW researchers emphasized that these findings should inform the development of comprehensive survivorship programs including screening protocols to identify impairments patients face and rehabilitation programs to help them recover from those challenges.

“We hope to use this study as a foundation to develop targeted rehabilitation strategies that connect patients with neuropsychology experts and improve long-term recovery in cardiogenic shock survivors,” Dr de Lemos said.

Source: UT Southwestern Medical Center

Categories : Cardiovascular Disease NeurologyTags :

Early Anticoagulants Found to be Safe and Effective for AF Stroke Patients

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Ischaemic and haemorrhagic stroke. Credit: Scientific Animations CC4.0

Patients with atrial fibrillation who have experienced a stroke would benefit greatly from earlier treatment than is currently recommended in UK guidelines, finds a new study led by UCL researchers.

The results of the CATALYST study, published in The Lancet, included data from four randomised trials with a total of 5441 patients across the UK, Switzerland, Sweden and the United States, who had all experienced a recent stroke (between 2017-2024) due to a blocked artery and atrial fibrillation (irregular heartbeat).

Patients had either started medication early (within four days of their stroke) or later (after five days or more).

The researchers found that starting direct oral anticoagulants (DOACs, which thin the blood to prevent it from clotting as quickly) within four days of having a stroke was safe, with no increase in bleeding into the brain. Additionally, early initiation of treatment significantly reduced the risk of another stroke due to bleeding or artery blockage by 30% compared to those who started treatment later.

People with atrial fibrillation who have had a stroke have an increased risk of having another stroke, but this risk can be reduced by taking anticoagulants.

Anticoagulants come with the rare but dangerous side effect of bleeding into the brain, and there is a lack of evidence about when is best to start taking them after a stroke. Current UK guidelines are varied, suggesting that those who have had a moderate or severe stroke should wait at least five days before starting blood-thinning treatments.

To tackle this question, the researchers investigated the impact of early compared to delayed anticoagulant treatment.

Chief Investigator, Professor David Werring (UCL Queen Square Institute of Neurology) said: “Our new study supports the early initiation of DOACs in clinical practice, offering better protection against further strokes for a wide range of patients.”

The researchers now hope that their findings will influence clinical guidelines and improve outcomes for stroke patients worldwide.

First author and main statistician, Dr Hakim-Moulay Dehbi (UCL Comprehensive Clinical Trials Unit), said: “By systematically combining the data from four clinical trials, we have identified with increased confidence, compared to the individual trials, that early DOAC initiation is effective.”

The CATALYST study builds on findings from the British Heart Foundation funded OPTIMAS study – where the UCL-led research team analysed 3621 patients with atrial fibrillation who had had a stroke between 2019 and 2024, across 100 UK hospitals.

Half of the participants began anticoagulant treatment within four days of their stroke (early), and the other half started treatment seven to 14 days after having a stroke (delayed). Patients were followed up after 90 days to assess several outcomes including whether they went on to have another stroke and whether they experienced bleeding in the brain.

Both the early and late groups experienced a similar number of recurrent strokes. Early treatment was found to be effective and did not increase the risk of a bleed into the brain.

Professor Nick Freemantle, Senior Investigator and Director of the UCL Comprehensive Clinical Trials Unit (CCTU) that co-ordinated the OPTIMAS trial, said: “The benefits of early initiation of blood-thinning treatment are clear: patients receive the definitive and effective long-term stroke prevention therapy promptly, rather than waiting. This approach ensures that crucial treatments are not delayed or missed, particularly for patients who are discharged from the hospital.”

Study limitations

The timing for starting blood-thinning medication was based on previous trial designs (such as OPTIMAS), which may not cover all possible scenarios. Additionally, not all participants were randomised to the same timing groups, so some data was excluded. Lastly, the study didn’t include many patients with very severe strokes, so the findings might not apply to those cases.

Source: University College London

Categories : Cardiovascular DiseaseTags :

BMJ Finds Inaccuracies in Key Studies for AstraZeneca’s Blockbuster Heart Drug Ticagrelor

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Investigation finds evidence of serious misreporting, raising fresh doubts over the approval and decade long use of ticagrelor

Photo by National Cancer Institute on Unsplash

In a follow up investigation into the multibillion dollar drug ticagrelor, The BMJ has uncovered fresh concerns, this time in key platelet studies used in its FDA approval.

For more than a decade, ticagrelor (Brilinta in the US and Brilique in Europe) has been recommended for patients with acute coronary syndrome – a range of conditions related to sudden reduced blood flow to the heart.

Last December, an investigation by The BMJ found serious data integrity problems in the landmark clinical trial (PLATO) that was used to gain worldwide approval for ticagrelor, calling into question the drug’s advantage over cheaper rivals.

Now, as generic versions of the drug prepare to launch this year, The BMJ has expanded its investigation, looking at two key platelet studies that AstraZeneca claimed explained ticagrelor’s ability to treat acute coronary syndrome successfully.

It finds that the “primary endpoint” results (the trial’s key measurement) for both clinical trials were inaccurately reported in the leading cardiology journal Circulation, and reveals that more than 60 of 282 readings from platelet machines used in the trials were not present in US Food and Drug Administration (FDA) datasets.

What’s more, one active trial investigator never became a study author, while one author told The BMJ he was not involved in the trial, and most investigators, including the principal investigator, were unreachable or declined to be interviewed.

Victor Serebruany, an adjunct faculty member at Johns Hopkins University and ticagrelor’s most renowned critic, told The BMJ that “there are episodes of skyrocketing rebound and profound platelet inhibition after ticagrelor making patients prone to thrombosis or bleeding. If doctors had known what happened in these trials, they would never have started using ticagrelor.”

Circulation and AstraZeneca did not respond to a request for comment.

Serebruany added: “It’s been obvious for years that there is something wrong with the data. That the FDA’s leadership could look past all these problems—on top of the many problems their own reviewers identified and are now being discovered by The BMJ—is unconscionable. We all need to know how and why that happened.”

Source: BMJ