Relugolix Rapidly Achieves Sustained Castration in Prostate Cancer Patients Undergoing Radiotherapy: Study

Prostate cancer remains one of the most prevalent cancers in men worldwide, often requiring a multimodal treatment approach for optimal management. Among the treatment modalities, combination androgen deprivation therapy (ADT) with radiotherapy has been a cornerstone in both localized and advanced disease settings. However, the effectiveness and tolerability of traditional ADT regimens have been a subject of ongoing investigation, leading to the exploration of novel therapeutic options such as relugolix. A recent study was published in JAMA Oncology. The study was conducted by Daniel E. and colleagues.

In this post hoc analysis, researchers evaluated the efficacy and safety of relugolix in combination with radiotherapy for the treatment of prostate cancer. The analysis incorporated data from two randomized clinical trials, including a subset from the phase 3 HERO trial comparing relugolix with leuprolide acetate and a phase 2 trial comparing relugolix with degarelix. A total of 260 patients with localized and advanced prostate cancer undergoing radiotherapy were included in the analysis, with 164 patients receiving relugolix.

The key findings of the study were as follows:

  • The analysis revealed compelling findings regarding the efficacy of relugolix in achieving sustained castration in prostate cancer patients undergoing radiotherapy.

  • Relugolix demonstrated high castration rates, with 95% among patients receiving short-term ADT and 97% among those receiving longer-term ADT.

  • Asignificant proportion of patients achieved testosterone levels comparable to baseline or higher within 12 weeks post–short-term relugolix treatment, indicating rapid hormonal recovery following therapy cessation. In addition to its efficacy, relugolix exhibited a favorable safety profile in conjunction with radiotherapy.

  • Adverse events of grade 3 or greater, such as headache, hypertension, and atrial fibrillation, were uncommon, affecting less than 5% of patients.

  • These findings underscore the potential of relugolix as a well-tolerated treatment option for prostate cancer patients, offering a promising alternative to traditional ADT regimens.

The results of this analysis support the use of relugolix in combination with radiotherapy for the management of prostate cancer. The therapy’s ability to rapidly achieve sustained castration, coupled with its favorable safety profile, positions it as a valuable addition to the treatment armamentarium for prostate cancer. Further research and long-term follow-up studies are warranted to validate these findings and explore the full potential of relugolix in improving outcomes for prostate cancer patients undergoing radiotherapy.

Reference:

Spratt, D. E., George, D. J., Shore, N. D., Cookson, M. S., Saltzstein, D. R., Tutrone, R., Bossi, A., Brown, B. A., Lu, S., Fallick, M., Hanson, S., & Tombal, B. F. (2024). Efficacy and safety of radiotherapy plus relugolix in men with localized or advanced prostate cancer. JAMA Oncology. https://doi.org/10.1001/jamaoncol.2023.7279

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FDA approves iloperidone for acute treatment of bipolar disorder

The US Food and Drug Administration (FDA) has granted approval to iloperidone (Fanapt) for acute treatment of bipolar I disorder.

Fanapt is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009.

“Manic or mixed episodes associated with bipolar I disorder are highly complex conditions, which require a host of trusted options to meet individual patient needs. With over 100,000 patient years of experience, Fanapt is a familiar therapeutic agent that offers flexible dosing with a well-known safety profile. This FDA approval gives patients and service providers a new treatment option for managing bipolar I disorder,” said Mihael H. Polymeropoulos M.D., Vanda’s President, CEO and Chairman of the Board.

Bipolar disorder is a serious, highly prevalent psychiatric chronic condition affecting approximately 2.8% of the U.S. adult population, with 83% of them classified as severe1. Bipolar disorder is a group of disorders that are characterized by periods of elevated mood alternating with periods of depressed mood. For the diagnosis of bipolar I disorder, people must have experienced one or more episodes of mania and most would have episodes of both mania and depression. Patients with bipolar I disorder with manic or mixed episodes are a subset of those approximately 10 million Americans with bipolar disorder1. The marketing approval of Fanapt in bipolar I disorder with manic and mixed episodes significantly increases the commercial opportunity for Fanapt.

Stephen Stahl, MD, PhD, Professor of Psychiatry at the University of California San Diego, said, “Many patients today are still unable to find suitable treatment options for effectively managing bipolar disorder. Tailoring the right treatment for the right patient is critical for effective care, and the approval of Fanapt represents an important milestone. Fanapt possesses a well-studied safety profile, and its approval will provide patients with a new and effective option for treating a highly complex disorder.”

The approval of Fanapt for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder was based on a pivotal study randomizing approximately 400 patients. The primary endpoint measured in Week 4 of treatment was assessed by the Young Mania Rating Scale (YMRS), a rating scale of clinical severity in the core symptoms of mania. At the end of the study (Week 4), Fanapt treated patients showed a larger improvement than placebo treated patients, and this difference was highly statistically significant (p=0.000008). YMRS was assessed at the end of Weeks 1, 2, 3 and 4. Statistically significant benefit in the Fanapt treated group over placebo was observed as early as the Week 2 assessment. The safety profile of Fanapt in this study was similar to that seen in Fanapt studies previously conducted for the treatment of schizophrenia in adults.

Dr. Polymeropoulos continued, “Today’s announcement marks a significant step forward for one of Vanda’s leading franchises and underscores the effectiveness of our strategy in pursuing innovative therapies that address high unmet medical needs to improve the lives of patients. With this as our foundation, we have established a resilient business, with a diverse product pipeline, a history of revenue growth and strong financial position. We remain focused on providing critical medicines to patients across the world while creating sustainable, long-term value.”

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Role of SGLT2 inhibitors beyond diabetes care to metabolic care: Indian Perspective

India: A recent article published in the Indian Journal of Endocrinology and Metabolism has presented an Indian perspective on the paradigm shift of SGLT2 inhibitors from diabetes care to metabolic care.

The study revealed that sodium-glucose co-transporter 2 (SGLT2) inhibitors, with their several pleiotropic benefits, have received considerable attention recently as a novel class of antihyperglycaemic agents (AHAs) for diabetes management.

“SGLT2 inhibitors play an important role in the transition from glycemic control to metabolic care, specifically in the context of cardiovascular disease, obesity, and renal disease,” Preet Lakhani, Medical Affairs, Johnson & Johnson Private Limited, Mumbai, Maharashtra, India, and colleagues wrote in their study. “In addition to improving glycemic control, SGLT2 inhibitors have been shown to reduce blood pressure, promote weight loss, and improve lipid profiles, which are key components of metabolic health.”

SGLT2 inhibitors have demonstrated renal protective effects, including a slower decline in the estimated glomerular filtration rate (eGFR) and a reduction in albuminuria, suggesting a potential role in managing renal dysfunction.

There is a rise in the burden and prevalence of diabetes in India, making it ‘the diabetes capital of the world’. Comorbidities such as chronic kidney disease (CKD), cardiovascular (CV) complications, non-alcoholic fatty liver disease (NAFLD), neurodegenerative diseases, and obesity are common in patients with diabetes.

Recent breakthroughs in continuous glucose monitoring and diabetes medications have resulted in a paradigm shift in diabetes care. Hence, a review is warranted in the Indian context.

The review focuses on the evidence (gathered through a systematic literature search using online databases) on the cardio-renoprotective, metabolic, and hepatoprotective effects of SGLT2 inhibition, particularly in the Indian setting.

In conclusion, the transition from diabetes care to metabolic care represents a paradigm shift the metabolic disorders management. By taking a comprehensive approach that targets the underlying pathophysiology and addressing the multiple metabolic abnormalities associated with these disorders, metabolic care has the potential to improve outcomes and reduce the risk of complications.

The study further adds, “By addressing not only diabetes but also other comorbidities such as NAFLD, obesity, CVD, hypertension, and DKD, metabolic care aims to improve patient outcomes and reduce CVD risk. Implementing personalized and evidence-based interventions, including pharmacotherapy and lifestyle modifications, can help achieve optimal metabolic control and prevent the development of complications.”

“This shift requires a more patient-centered approach focusing on individualized care, emphasizes lifestyle modifications, and utilizes a multidisciplinary team-based approach. By embracing this transition, healthcare providers can better address the interconnected and complex nature of metabolic disorders and provide more effective and personalized care to their patients.”

“Patients with type 2 diabetes requiring additional benefits for the management of multiple comorbidities along with glycaemic control may find SGLT inhibitors a promising therapy, particularly considering obesity, diabetes burden, and associated CV and other comorbidities in the Indian population,” the researchers concluded.

Reference:

Kumar, K M Prasanna; Unnikrishnan, A G1; Jariwala, Pankaj2; Mehta, Ashwani3; Chaturvedi, Richa4; Panchal, Sagar5; Lakhani, Preet5; Acharya, Rachana5; Dixit, Jitendra6. SGLT2 Inhibitors: Paradigm Shift from Diabetes Care to Metabolic Care—An Indian Perspective. Indian Journal of Endocrinology and Metabolism 28(1):p 11-18, Jan–Feb 2024. | DOI: 10.4103/ijem.ijem_377_23

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Chatbot outperformed physicians in clinical reasoning in head-to-head study: JAMA

ChatGPT-4, an artificial intelligence program designed to understand and generate human-like text, outperformed internal medicine residents and attending physicians at two academic medical centers at processing medical data and demonstrating clinical reasoning. In a research letter published in JAMA Internal Medicine, physician-scientists at Beth Israel Deaconess Medical Center (BIDMC) compared a large language model’s (LLM) reasoning abilities directly against human performance using standards developed to assess physicians.

“It became clear very early on that LLMs can make diagnoses, but anybody who practices medicine knows there’s a lot more to medicine than that,” said Adam Rodman MD, an internal medicine physician and investigator in the department of medicine at BIDMC. “There are multiple steps behind a diagnosis, so we wanted to evaluate whether LLMs are as good as physicians at doing that kind of clinical reasoning. It’s a surprising finding that these things are capable of showing the equivalent or better reasoning than people throughout the evolution of clinical case.”

Rodman and colleagues used a previously validated tool developed to assess physicians’ clinical reasoning called the revised-IDEA (r-IDEA) score. The investigators recruited 21 attending physicians and 18 residents who each worked through one of 20 selected clinical cases comprised of four sequential stages of diagnostic reasoning. The authors instructed physicians to write out and justify their differential diagnoses at each stage. The chatbot GPT-4 was given a prompt with identical instructions and ran all 20 clinical cases. Their answers were then scored for clinical reasoning (r-IDEA score) and several other measures of reasoning.

“The first stage is the triage data, when the patient tells you what’s bothering them and you obtain vital signs,” said lead author Stephanie Cabral, MD, a third-year internal medicine resident at BIDMC. “The second stage is the system review, when you obtain additional information from the patient. The third stage is the physical exam, and the fourth is diagnostic testing and imaging.”

Rodman, Cabral and their colleagues found that the chatbot earned the highest r-IDEA scores, with a median score of 10 out of 10 for the LLM, 9 for attending physicians and 8 for residents. It was more of a draw between the humans and the bot when it came to diagnostic accuracy—how high up the correct diagnosis was on the list of diagnosis they provided—and correct clinical reasoning. But the bots were also “just plain wrong” – had more instances of incorrect reasoning in their answers – significantly more often than residents, the researchers found. The finding underscores the notion that AI will likely be most useful as a tool to augment, not replace, the human reasoning process.

“Further studies are needed to determine how LLMs can best be integrated into clinical practice, but even now, they could be useful as a checkpoint, helping us make sure we don’t miss something,” Cabral said. “My ultimate hope is that AI will improve the patient-physician interaction by reducing some of the inefficiencies we currently have and allow us to focus more on the conversation we’re having with our patients.

“Early studies suggested AI could makes diagnoses, if all the information was handed to it,” Rodman said. “What our study shows is that AI demonstrates real reasoning-maybe better reasoning than people through multiple steps of the process. We have a unique chance to improve the quality and experience of healthcare for patients.”

Reference:

Stephanie Cabral, Daniel Restrepo, Zahir Kanjee, Philip Wilson, Byron Crowe, Raja-Elie Abdulnour, Adam Rodman. Clinical Reasoning of a Generative Artificial Intelligence Model Compared With Physicians. JAMA Internal Medicine, 2024; DOI: 10.1001/jamainternmed.2024.0295.

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Too much consumption of sodium associated with development of heart disease: Study

Researchers have found in a new study that high consumption of sodium was associated with increased risk of  cardiovascular disease.Therefore individuals with heart disease stand to gain the most from a low-sodium diet. Further the research revealed that majority of patients of heart disease on an average consumed over twice the recommended daily sodium intake.

The study is being presented at the American College of Cardiology’s Annual Scientific Session.

Sodium is an essential nutrient, but consuming too much can raise blood pressure, which damages blood vessels and forces the heart to work harder. Excess sodium can also cause the body to retain fluid, exacerbating conditions like heart failure. The current U.S. Dietary Guidelines put out by the U.S. Department of Agriculture recommends most adults limit their sodium intake to less than 2,300 mg/day, which is equivalent to about 1 teaspoon of table salt. For individuals with cardiovascular diseases, the limit is even lower at 1,500 mg/day, according to guideline recommendations from the ACC and the American Heart Association.

This new study found that among a sample of more than 3,100 people with heart disease, 89% consumed more than the recommended daily maximum of 1,500 mg of sodium and, on average, study participants consumed more than twice this amount. Limiting sodium intake is a fundamental lifestyle modification shown to reduce the likelihood of subsequent major adverse cardiovascular events, researchers said. Their findings underscore the challenges many people face in keeping within recommended sodium limits, regardless of other factors such as socioeconomic status.

“Estimating sodium quantities in a meal can be challenging,” said Elsie Kodjoe, MD, MPH, an internal medicine resident at Piedmont Athens Regional Hospital in Athens, Georgia and the study’s lead author. “Food labels aid in dietary sodium estimation by providing sodium quantities in packaged food. Yet, adhering to a low sodium diet remains challenging even for individuals with cardiovascular disease who have a strong incentive to adhere.”

The study used data from patients diagnosed with a heart attack, stroke, heart failure, coronary artery disease or angina who participated in the National Health and Nutrition Examination Survey (NHANES) between 2009–2018.

Researchers estimated sodium intake based on questionnaires in which participants were asked to report everything they had consumed in 24 hours. According to the results, study participants with cardiovascular disease consumed an average of 3,096 mg of sodium per day, which is slightly lower than the national average of 3,400 mg/day reported by the U.S. Centers for Disease Control and Prevention.

“The relatively small difference in sodium intake suggests that people with cardiovascular disease are not limiting their intake very much compared with the general population and are also consuming more than double what is recommended,” Kodjoe said. “To make it easier for patients to adhere to dietary guidelines, we need to find more practical ways for the general public to estimate dietary sodium levels or perhaps consider a reduction in the sodium content of the food we consume right from the source.”

The researchers also compared sodium intake among people in different socioeconomic groups, but they did not find any significant differences between wealthier and less affluent participants after accounting for age, sex, race and educational attainment.

Individuals can take proactive measures to lower their sodium intake, Kodjoe said. This includes preparing more meals at home where they have greater control over the sodium content and paying close attention to food labels, particularly targeting foods with sodium levels of 140 mg or less per serving. Researchers suggested that better education around the benefits of limiting sodium could also help motivate more people to follow the recommendations.

“Cardiovascular disease is real, and it is the number one cause of morbidity and mortality worldwide according to the World Health Organization,” Kodjoe said. “Adhering to sodium guidelines is one of the easier strategies individuals could readily adopt to reduce hospitalizations, health care costs, morbidity and mortality associated with cardiovascular disease.”

One limitation of the study is that sodium intake was estimated based on food recall questionnaires, rather than 24-hour urine sodium measurements, which is considered the gold standard method. NHANES has included 24-hour urine sodium measurements in its data gathering methods in recent survey cycles, so future studies using this data could provide a more accurate assessment of sodium intake among people with cardiovascular disease.  

Reference:

Majority of people with heart disease consume too much sodium, American College of Cardiology, Meeting: American College of Cardiology’s Annual Scientific Session.

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Incidence of cancer significantly higher in tuberculosis patients, finds study

South Korea: A recent study has shown an association between tuberculosis (TB) and cancer, with those with current or previous TB more likely to have a diagnosis of a variety of cancers, including blood, lung, colorectal, and gynecological cancers.

The findings from the population-wide observational study were presented at this year’s European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2024) in Barcelona, Spain (27-30 April). The study is by Dr Jiwon Kim, National Health Insurance Service, Ilsan Hospital, Goyang, South Korea, and Dr Jinnam Kim, Hanyang University College of Medicine, Seoul, South Korea, and colleagues.

Despite a successful cure of TB being possible, complications can occur at various anatomical sites due to structural or vascular damage, metabolic abnormalities and host inflammatory response. These complications may include an increased risk of cancer, which may be influenced by host tissue and DNA damage, and/or interruption of normal gene repair processes and growth factors present in the blood. In this study, the authors investigated the association between cancer incidence and TB compared with the general population.

They retrospectively reviewed data from the National Health Insurance Service-National Health Information Database of South Korea between 2010 and 2017. Patients with TB were defined as a those with a disease code for TB entered into the system, or treated with two or more TB drugs for more than 28 days. The control group from the general population was randomly selected in a 1:5 ratios and matched for sex, age, income level, residence, and index year. The authors analysed the incidence of newly diagnosed cancer patients after enrolment (post-TB diagnosis). The primary outcome was the incidence of cancer in patients diagnosed with TB infection in the period 2010-2017 compared with the matched cohort. The secondary outcomes were to investigate the risk factors for cancer incidence in TB patients.

The final analysis included total of 72,542 patients with TB and 72,542 matched controls. The mean follow-up duration was 67 months (around five-and-a-half years), and the mean age in patients with TB was 62 years.

Compared with the general population, the incidence of cancer was significantly higher in TB patients: 80% higher for all cancers combined; 3.6 times higher for lung cancer, 2.4 times higher for blood (haematological) cancers); 2.2 times higher for gynaecological cancer; 57% higher for colorectal cancer; 56% higher for thyroid cancer and 55% higher for oesophagus and stomach cancer.

After adjustment, current smoking (40% increased risk versus non-smokers), heavy alcohol consumption (15% increased risk versus regular alcohol consumption) chronic liver disease (42% increased risk versus no liver diseases) and chronic obstructive pulmonary disease (COPD) (8% increased risk) were also identified as independent risk factors for cancer in people with TB.

The authors say: “TB is an independent risk factor for cancer, not only lung cancer, but also various site-specific cancers, after adjusting for confounders. Screening and management for cancer should be warranted in patients with TB.”

Reference:

Study finds association between TB infection and increased risk of various cancers, European Society of Clinical Microbiology and Infectious Diseases, Meeting: The European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2024).

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Postoperative hypothermia tied to reduced length of stay after surgery in adult acute burn patients: Study

Australia: A recent study published in the journal Burns has revealed an association between postoperative hypothermia and a reduced length of hospital stay in adult acute burn survivors.

“These findings indicate possible benefit from mild hypothermia in burns surgery,” Fiona M. Wood, Fiona Wood Foundation, Perth, WA, Australia, and colleagues wrote in their study. “A review of body temperature maintenance strategies for acute burn is warranted.”

The findings challenge the established practice of targeting normothermia and avoiding even mild hypothermia in adult burn patients who need acute surgery. Postoperative mild hypothermia was associated independently with a reduced length of stay versus those who were normothermic.

In the study, the researchers revealed that there was no evidence for an association of perioperative hypothermia with in-hospital complications.

The hypermetabolic response following a burn predisposes patients to hypothermia due to impairment of thermoregulation. Traditionally, hypothermia is actively avoided in burn care due to reported complications linked with low body temperature. The likelihood of hypothermia with acute burn surgery is compounded by exposure to wound areas, general anesthesia, and prolonged operation times. However, not many studies have explored the effects of perioperative hypothermia on length of stay in the adult burn population.

Against the above background, Dr. Wood and the team aimed to investigate whether an association exists between postoperative hypothermia and hospital length of stay in adult burns patients.

For this purpose, they conducted a retrospective cohort study involving patients admitted to the State Adult Burn Unit in Western Australia between 2015 and 2021. The study included all adults who underwent surgery for acute burn and had postoperative recovery room body temperature recorded.

In the study, normothermia was defined as 36.5–37.5 °C and hypothermia as < 36.0 °C with mild, moderate, and severe hypothermia being 35.0–35.9 °C, 34.0–34.9 °C and < 34.0 °C, respectively. Hyperthermia patients were excluded. Multivariable general linear models determined the presence of an independent association between hypothermia and length of stay.

The study led to the following findings:

  • Among 1486 adult patients, 90% were normothermic postoperatively, with temperatures 36.0–37.5 °C.
  • There were 10% of patients with hypothermia (temperature <36.0 °C) postoperatively.
  • Most burns in the study population were minor: 96% had burns < 15% TBSA.
  • Data modeling demonstrated that hypothermia was associated with a shorter length of hospital stay (coefficient = −0.129).

“The study’s positive results indicate that a review of the core temperature targets with acute burn surgery and timing of burn patient cooling practices in general is warranted,” the researchers concluded.

Reference:

Mai, L., Boardman, G., Robinson, K., Edgar, D. W., & Wood, F. M. (2024). Postoperative hypothermia is associated with reduced length of stay in adult acute burn survivors. Burns. https://doi.org/10.1016/j.burns.2024.02.033

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New wavelength-dependent indicators improve efficacy of spot-on laser treatment for skin blemishes: Study

Japan: An Osaka Metropolitan University-led research group has developed an index of the threshold energy density, known as fluence, and the dependent wavelength for picosecond lasers. This will help improve efficacy and reduce complications in people bothered by skin blemishes who might turn to laser treatment. 

Picosecond lasers have in recent years been used to remove pigmented lesions.

These lasers deliver energy beams in pulses that last for about a trillionth of a second.

The lasers target melanosomes, which produce, store, and transport the melanin responsible for pigment.

Postdoctoral Fellow Yu Shimojo of OMU’s Graduate School of Medicine and Specially Appointed Professor Toshiyuki Ozawa and Professor Daisuke Tsuruta of the school’s Department of Dermatology were among the researchers who developed this first picosecond laser index for each of the wavelengths used in clinical practice in treating pigmented lesions. 

The key findings of the study were as follows:

  • The threshold fluences were determined to be
    0.95, 2.25, 2.75, and 6.50 J/cm² for 532-, 730-, 785-, and 1064-nm picosecond
    lasers, respectively.
  • The numerical results quantitatively revealed
    the relationship between irradiation wavelength, incident fluence, and spot
    size required to disrupt melanosomes distributed at different depths in the
    skin tissue.
  • The calculated irradiation parameters were
    consistent with clinical parameters that showed high efficacy with a low
    incidence of complications.

Comparing previously reported clinical studies, the researchers confirmed that clinical results showing low complication rates and high efficacy can be explained based on these wavelength-dependent indicators. 

“The use of this indicator is expected to play an important part in setting irradiation conditions in clinical practice,” Postdoc Fellow Shimojo said. “In addition, the implementation of picosecond laser therapy based on scientific evidence, rather than relying solely on physicians’ experience, is expected to improve the safety and effectiveness of the treatment.”

Reference:

Yu Shimojo, Takahiro Nishimura, Daisuke Tsuruta, Toshiyuki Ozawa, Henry Hin Lee Chan, Taro Kono. Wavelength‐dependent threshold fluences for melanosome disruption to evaluate the treatment of pigmented lesions with 532‐, 730‐, 755‐, 785‐, and 1064‐nm picosecond lasers. Lasers in Surgery and Medicine, 2024; DOI: 10.1002/lsm.23773.

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Men at higher risk of fracture from falls compared to women, Study finds

A recent study titled “A meta-analysis of previous falls and subsequent fracture risk in cohort studies” found links between self-reported falls and increased fracture risk and also that prior falls increased the risk for fracture slightly more in men than women.

Published in Osteoporosis International, this international meta-analysis of data pooled from 46 prospective cohorts comprising over 900,000 individuals also recommended that previous falls are a factor that should be included in patients’ histories used by fracture risk assessment tools like the FRAX (Fracture Risk Assessment) Tool to calculate a person’s likelihood of getting a fracture over the next decade. FRAX is the most commonly used assessment to predict fracture risk.

“FRAX was developed using longitudinal data from studies around the world. Although previous falls have long been recognized as a significant risk factor for fractures, until now, they have not been factored into the FRAX algorithm,” saidDouglas P. Kiel, M.D., MPH, director of the Musculoskeletal Research Center and senior scientist at the Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, a nonprofit, Harvard Medical School affiliated institution. “In this newly updated FRAX dataset, previous falls were included as a risk factor and were found to increase the risk for fracture. These findings underscore that falls are an important contributor to fracture in both men and women, but interestingly, slightly more in men.”

Key findings of the meta-analysis include:

  • Increased Fracture Risk: Individuals with a history of falls within the past year were found to have a significantly higher risk of any clinical fracture, osteoporotic fracture, major osteoporotic fracture, and hip fracture. One or more previous falls were significantly associated with an increased risk of death among women and men.
  • Sex Disparities: The association between previous falls and fracture risk was observed to vary by sex, with men exhibiting higher predictive values compared to women.
  • Independent Risk Factor: The increased fracture risk linked to previous falls was largely independent of bone mineral density, emphasizing the standalone significance of falls as a risk factor. A previous fall in the past year confers a significantly increased risk of any clinical fracture, osteoporotic fracture, and hip fracture with the increase in risk varying between 36% and 59% depending on the fracture outcome and sex.

These findings underscore the importance of incorporating previous falls into the FRAX algorithm,” Dr. Kiel added. Integrating this information into tools like FRAX can enhance their predictive accuracy and ultimately help health care providers to more accurately predict fracture risk and tailor preventive strategies accordingly to improve patient outcomes.

Reference:

Vandenput, L., Johansson, H., McCloskey, E.V. et al. A meta-analysis of previous falls and subsequent fracture risk in cohort studies. Osteoporos Int 35, 469–494 (2024). https://doi.org/10.1007/s00198-023-07012-1.

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Young adults with migraine, other nontraditional risk factors may have higher stroke risk: Study

Adults younger than 35- to 45-years old may have a higher risk of developing a stroke from nontraditional risk factors such as migraines than from traditional risks like high blood pressure. That’s according to new research published today in Circulation: Cardiovascular Quality and Outcomes, a peer-reviewed American Heart Association journal.

Most strokes are caused by traditional stroke risk factors,such as high blood pressure, high cholesterol, Type 2 diabetes, smoking, obesity, low physical activity, alcohol abuse or coronary heart disease. However, recent data showed an increased incidence of strokes even among young adults without these risk factors, according to the study.

“We wanted to understand which risk factors were the top contributors to stroke risk among young adults,” said study lead author Michelle Leppert, M.D., M.S., M.B.A., FAHA, an assistant professor of neurology at the University of Colorado School of Medicine in Aurora, Colorado.

Using an administrative database of health insurance claims reported in Colorado, researchers matched data of more than 2,600 people who had strokes to more than 7,800 people who did not to determine which risk factors may most often lead to strokes.

The analysis found that nontraditional stroke risk factors, such as migraines, blood clotting disorders, kidney failure, autoimmune diseases or malignancy, were significantly associated with the development of strokes in men and women 18- to 44-years old. The association between stroke and nontraditional stroke risk factors was stronger in adults younger than 35 years old.

Results also showed:

  • Among 18- to 34-year-olds, more strokes were associated with nontraditional risk factors (31% in men and about 43% in women) than traditional risk factors (about 25% in men and more than 33% in women).
  • Migraine was the most important nontraditional stroke risk factor among 18- to 34-year-olds, accounting for 20% of strokes in men and nearly 35% in women.
  • The contribution of traditional stroke risk factors peaked among adults aged 35-44 and were associated with nearly 33% of strokes in men and about 40% in women.
  • In the 45-55 age group, nontraditional risk factors accounted for more than 19% of strokes in men and nearly 28% in women.
  • High blood pressure was the most important traditional stroke risk factor among 45- to 55-year-olds, accounting for 28% of strokes in men and about 27% in women.
  • Each additional traditional and nontraditional risk factor was associated with increased risk of stroke in all sex and age groups.

“These findings are significant because most of our attention has been focused on traditional risk factors,” Leppert said. “We should not ignore nontraditional stroke risk factors and only focus on traditional risk factors; both are important to the development of strokes among young people.

“In fact, the younger they are at the time of stroke, the more likely their stroke is due to a nontraditional risk factor,” she said. “We need to better understand the underlying mechanisms of these nontraditional risk factors to develop targeted interventions.”

Researchers were surprised to find that non-traditional risk factors were equally important as traditional risk factors in the development of strokes in young men and women. Leppert added that the large contribution that migraine headaches had in the development of strokes was also unexpected.

“There have been many studies demonstrating the association between migraines and strokes, but to our knowledge, this study may be the first to demonstrate just how much stroke risk may be attributable to migraines,” Leppert said.

Study details, background and design:

  • Researchers collected data from 2012-2019 from the Colorado All Payer Claims Database, which mandates the submission of all commercial insurance, Medicaid and Medicare claims.
  • Among the study’s stroke cases selected from adults 18- to 55-years old, 52% were among women and more than 73% were ischemic (clot-caused) strokes, which occur when a vessel supplying blood to the brain is obstructed.
  • Individual race and ethnicity, based on insurance reporting, were missing for almost half of all participants.
  • Data for stroke cases and people who did have strokes were matched by sex, age, insurance type and pre-stroke period.
  • Cases were defined as someone admitted to a hospital with a primary diagnosis of ischemic stroke, hemorrhagic (bleeding) stroke or subarachnoid hemorrhage (bleeding in the space surrounding the brain).
  • Nontraditional stroke risk factors were defined as factors that are rarely the cause of stroke in older adults or unique to young adults and included: migraines, malignancy, HIV, hepatitis, thrombophilia (including history of deep vein thrombosis and pulmonary embolism), autoimmune disease, vasculitis, sickle cell disease, heart valve disease and renal failure. Hormonal risk factors, such as oral contraceptive use and pregnancy, were considered separately among women.
  • Traditional stroke risk factors were defined as well-established potential causes for stroke routinely considered for adults ages 65 and older and included: high blood pressure, Type 2 diabetes, high cholesterol, sleep apnea, peripheral artery disease, atrial fibrillation, coronary artery disease, alcohol abuse, substance abuse, tobacco use, obesity and congestive heart failure.

The study had several limitations including its reliance on an administrative database, which could impact how risk factors were noted, and because it lacked data about race and ethnicity for many participants. Also, the research was conducted in metro areas one mile or more above sea level, so altitude may create unique conditions that are not applicable to people living at other altitudes.

Reference:

Michelle H. Leppert, Sharon N. Poisson, Sharon Scarbro, Krithika Suresh, Lynda D. Lisabeth, Jukka Putaala, Lee H. Schwamm, Stacie L. Daugherty, Cathy J. Bradley, James F. Burke and P. Michael Ho, Association of Traditional and Nontraditional Risk Factors in the Development of Strokes Among Young Adults by Sex and Age Group: A Retrospective Case-Control Study, Circulation, DOI:10.1161/CIRCOUTCOMES.123.010307.

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