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Medscape
3 hours ago
- Medscape
Adherence to Male Hypogonadism Treatment Guidelines Is Low
SAN FRANCISCO — Adherence to diagnostic and treatment guidelines for male hypogonadism is quite low, with significant differences among medical specialists, a new study found. Off-label use of testosterone replacement therapy (TRT) has risen in recent years, corresponding with the advent of direct-to-consumer (DTC) advertising for TRT and the emergence of 'low T' clinics, Petra Pederson, MD, PhD, chief resident in internal medicine at Scripps Clinic/Green Hospital, San Diego, said at the ENDO 2025: The Endocrine Society Annual Meeting. 'This led to our hypothesis that [DTC] advertising in the presence of online clinics creates patient expectations that make it challenging for clinicians to practice evidence- and guideline-based care,' she said. Pederson and colleagues conducted a two-part study of adherence to TRT prescribing guidelines at their institution. The first part involved a retrospective chart review of 269 men who were prescribed TRT from January 1, 2019, through June 30, 2023, examining adherence to the 2018 Endocrine Society clinical practice guideline (CPG). Of the 269 TRT prescriptions, 67.3% were from primary care providers (54% internal medicine and 13% family medicine) and 32.7% from specialists (25% urology and 8% endocrinology). The majority of patients (72.1%) stayed on treatment for at least 1 year, with an average treatment duration of 25 months. Criteria for adherence was defined as: Confirmation of the diagnosis of hypogonadism with two separate low (< 264 ng/dL) early morning total testosterone levels. Determination of the etiology of hypogonadism by measuring luteinizing hormone (LH) and follicle-stimulating hormone (FSH) with appropriate laboratory or imaging follow-up based on the results. On-treatment therapeutic monitoring with total testosterone levels drawn at 3-6 months and 12 months. On-treatment safety monitoring, with hematocrit at baseline and at 3-6 months, with dose reduction if necessary and discontinuation if > 54%. Overall, the proportion of clinicians, primary care, and specialists combined who followed all four criteria was just 5.9%. The difference between primary care (3.3%) and specialists (11.4%) was statistically significant ( P = .009). By individual criteria, 17.8% overall had no low testosterone level prior to treatment, 21% among the primary care group vs 10.2% for the specialists. This difference was also significant ( P = .023). Follow-up total testosterone measurement at 3-6 months was performed for only 50% overall, 44.1% by primary care, and 62.5% by the specialists. Hematocrit testing at 3-6 months was measured at 54% overall, 48.0% by the primary care, and 65.3% by specialists. Both specialty differences were again significant ( P = .01 and P = .06, respectively). Between the two specialties, endocrinologists were more likely than urologists to follow all four criteria, 23.8% vs 7.5%, respectively ( P = .054), and were much more likely to have LH and FSH drawn (85.7% vs 16.4% for LH; P < .001). 'We postulate that these striking differences between endocrinology and urology could be related to the fact that urologists were seeing more patients who present with sexual dysfunction compared to endocrinologists, and perhaps they have more pressure to prescribe,' Pederson said. Barriers: DTC Advertising, Misinformation, Test Inaccuracy The second part of the study involved a survey to which 51 Scripps providers responded. Of those, 74% were primary care (41% internal medicine and 33% family medicine), 18% endocrinologists, and 8% urologists. All 51 reported having seen one or more patients in the last 6 months who requested TRT. The specialists were significantly more likely to report being comfortable with the guidelines than were the primary care providers and to prescribe TRT more often. A total of 74.5% overall felt that DTC advertising and testosterone 'clinics' were significant public health issues. A similar majority (76.5%) felt there was a need for more educational tools. Barriers to providing guideline-based care identified by the providers included misinformation through advertising or social media, for-profit 'low T' clinics that contradict evidence-based guidelines, patient dissatisfaction when guidelines don't align with their expectations, vague and subjective symptoms, and test inaccuracy and variability. 'We're planning to address this at our institution with a quality improvement initiative,' Pederson said. She acknowledged that the American Urological Association guidelines use a low testosterone cutoff of < 300 ng/dL, 'so we might underestimate guideline adherence with our criteria.' And she noted that a small number of primary care providers accounted for a disproportionate number of the prescriptions in their sample, which could limit generalizability. In response to a question from the audience about why the guideline adherence was so low even among specialists, Pederson responded, 'I think that they're experiencing some of the same challenges that PCPs are experiencing, which is the pressure from their patients, and also maybe issues related to tests and accuracy. And I just think the difficulty of getting patients to do all these follow-up tests when they're looking for a simple fix.' Improvements Are Underway, Patient Education Is Key Asked to comment, the Endocrine Society's CPG lead author Shalender Bhasin, MB, professor of medicine at Harvard Medical School and director of the Research Program in Men's Health: Aging and Metabolism at Brigham and Women's Hospital, Boston, told Medscape Medical News that these findings align with those of a study his group conducted a decade ago in the Veterans Administration (VA), but that the VA has since implemented system-wide improvements. 'I think it's gotten much better. In the VA, it was very low, and it has gotten substantially better because at the VA now there's one policy. Also, the assays have gotten better.' Bhasin also pointed out that the prescribing of testosterone has fluctuated over time, dropping in 2013 after an FDA advisory about cardiovascular risk but then rising again around 2017 following the TRAVERSE trial results showing cardiovascular safety. The subsequent rise has been slower, but, Bhasin noted, 'testosterone sales are growing, and at the same time, many men with testosterone deficiency remain undiagnosed, so it's both overuse and underuse.' Also asked to comment, session moderator Ismat Shafiq, MD, of the University of Rochester, Rochester, New York, told Medscape Medical News that patients will commonly have low total testosterone due to overweight or obesity and/or sleep apnea but will have normal free testosterone. 'If that's the case, we can properly educate our patients and work on managing their weight and sleep problems. That can reverse the hypogonadism and make them feel better, rather than giving them testosterone.' And if they have both low total and free testosterone, the cause could be something reversible, such as a prolactinoma or pituitary macroadenoma. 'If we check the prolactin level and we treat them, the hypogonadism will resolve. Primary hypothyroidism, too, if treated, can resolve the hypogonadism,' Shafiq said. 'Diagnosing the patient appropriately can identify causes that can be treatable and that can improve their quality of life and improve their testosterone level too, rather than jumping into giving them testosterone.' She also noted that many patients mistakenly believe that more testosterone is better. 'We need to educate them. In my experience, most of the patients listen and understand because nobody wants to take extra medicine all the time, unless it's really needed for them to improve their quality of life.' Pederson and Shafiq reported having no disclosures. Bhasin reported receiving research grant support from AbbVie and Metro International Biotech for investigator-initiated research, with the grants managed by Brigham and Women's Hospital. He has served as a consultant to Besins and Versanis and has an equity interest in XYone Therapeutics.
Yahoo
2 days ago
- Yahoo
Start your period before age 10 — or after 15? How it can impact your lifelong health, from obesity to heart issues
Your period could be crampin' your style — and your future health. Girls are reaching puberty faster than previous generations, a phenomenon perplexing researchers. The average age of the start of menstruation decreased slightly from around 12.5 years in the 1950s and 1960s to 11.9 years for those born between 2000 and 2005. Research indicates that approximately 2% of girls begin menstruating after 15 — even fewer experience it before the age of 9. That's good news, as a new study out of Brazil links early or late menstruation onset to health struggles later in life. 'We now have evidence from a large Brazilian population that confirms how both early and late puberty can have different long-term health impacts,' said study author Flávia Rezende Tinano of the University of Sao Paulo. 'Most women can remember when they had their first period, but they might not realize that it could signal future health risks.' Tinano's team analyzed data from over 7,600 women 35 to 74 years old. The women were divided into three categories based on the timing of their first period — 'early' (less than 10 years old), 'typical' (10 to 15) or 'late' (older than 15). The participants' health was assessed through interviews, physical measurements, lab tests and ultrasound imaging. The researchers determined that women who began menstruating before age 10 were more likely to develop obesity, high blood pressure, diabetes, heart problems and reproductive problems like preeclampsia over time. Women who got their first period after 15 were less likely to be obese but more likely to have irregular periods and certain heart conditions. 'Understanding these links can help women and their doctors be more proactive about preventing conditions like diabetes, high blood pressure and heart disease,' Tinano said. The study was presented this week at the Endocrine Society's annual meeting in San Francisco. Menstruation is the monthly shedding of uterine lining, signaling that the woman is not pregnant. Past research has suggested a link between late menarche and an increased risk of osteoporosis, fractures and Alzheimer's disease. Starting menstruation later means delayed exposure to estrogen, a key hormone that protects and builds bone density. On the other hand, starting menstruation earlier means higher lifetime exposure to estrogen, which stimulates breast tissue growth and development and may create a hormonal imbalance. Early menarche has been associated with elevated risks of heart problems, Type 2 diabetes, breast cancer, anxiety and depression. Researchers haven't pinpointed exactly why girls are going through puberty earlier than before. Some have pointed to increased rates of childhood obesity, greater exposure to endocrine-disrupting chemicals and higher stress levels. Solve the daily Crossword
Medscape
2 days ago
- Medscape
Does Romosozumab Deserve Its Black Box Warning?
Osteoporosis drug romosozumab showed no increased risk for the development of cardiovascular (CV) events compared with anabolic osteoporosis drugs, contrary to its black box warning, new research found. 'These findings suggest there is no heightened risk for major adverse cardiovascular events in patients with osteoporosis treated with romosozumab compared to the anabolic agents teriparatide or abaloparatide,' the authors reported at ENDO 2025: The Endocrine Society Annual Meeting. 'Further observational data is required to concur with such findings, which may lead to a discontinuation of the black box warning,' they said. Romosozumab, a monoclonal antibody targeting sclerostin, has a unique dual action of anabolic properties (increasing bone formation while reducing resorption and improving bone mineral density while reducing vertebral fracture risk). The drug is injected monthly for 12 months, after which time its anabolic effects decline and patients must transition to other antiresorptive therapies, such as bisphosphonates or denosumab, to maintain gains in bone density. Although the FDA approved romosozumab for osteoporosis management, it has given a black box warning after clinical trials (including the ARCH study) comparing romosozumab with alendronate suggested an increased risk for serious CV events, including myocardial infarction, stroke, and CV death. The drug is therefore contraindicated in patients with hypocalcemia and those who have had a myocardial infarction or stroke within the previous year. However, data on those risks has been highly inconsistent, first author Maxim John Levy Barnett, MD, of Jefferson-Einstein Hospital, Philadelphia, told Medscape Medical News . 'Most previous studies on this issue show a nonsignificant trend toward a higher risk but do not reach statistical significance,' he said. Even the ARCH trial 'showed a trend of higher incidence of adverse outcomes, but it was not statistically significant,' he noted. New Findings To further investigate the risks, Barnett and colleagues evaluated data on patients with osteoporosis in the TriNetX database, including 14,760 patients treated with romosozumab and 45,302 treated with either teriparatide or abaloparatide anabolic agents. For the propensity score analysis, patients in the two groups were matched for age, sex, race, glycated hemoglobin, hypertension, chronic kidney disease, ischemic heart disease, cerebrovascular disease, diabetes, and other factors. After matching, the romosozumab group had 14,288 patients compared with 14,362 in the anabolic agent group. Patients had a mean age at baseline of 70.5 years, 94% were women — as the drug is approved in the US for women only — and 71% were White. With a mean follow-up of 5 years (including the 1-year treatment with romosozumab), there was a nonsignificant trend toward a reduced risk for CV incidents among those treated with romosozumab (relative risk [RR], 0.601; P = .0692). The romosozumab group also had significantly lower ischemic heart disease rates than the anabolic agent group (RR, 0.848; P = .0017). In addition, those receiving romosozumab had a lower risk of acute myocardial infarction (RR, 0.654; P < .0001). Likewise, acute heart failure, either systolic or diastolic, was also significantly lower in the romosozumab group (RR, 0.664; P = .0029). 'After propensity-score matching, there was still a significant reduction [with romosozumab], which was a surprise,' Barnett said. 'Three out of the 4 outcomes actually showed a significant decrease in risk with romosozumab.' 'To the best of my knowledge, similar trends have not been noted in other studies,' he said, adding that there have been no significant changes to romosozumab's treatment regimen or other factors that might explain differences in risk since the issuance of the black box warning. 'It is important to note that this was not the primary objective of the noninferiority study, and it was not powered for this endpoint,' Barnett said. The findings nevertheless add to evidence from others showing results that call into question the concerns behind the black box warning. 'There is no substantial evidence for cardiovascular risk and this medication; nonetheless, the black box warning is present,' Barnett said. Commenting on the study, Tiffany Kim, MD, of the University of California, San Francisco, who co-moderated the session, agreed that 'these are definitely interesting findings that add to growing data that romosozumab may not be associated with increased cardiovascular risk.' She noted that, as intended, 'any black box warning has a big effect on how clinicians consider and talk to a patient about the risks of a medication.' 'From a medico-legal perspective, I always inform my patient so they aren't surprised if they read this later, and so that I can document that they accept the benefits outweigh the risk for their individual situation.' 'This study adds to the reassuring literature that romosozumab may not be associated with increased risk of cardiovascular disease,' Kim said. 'In my clinical practice, I only consider anabolic therapy for my patients with severe osteoporosis at high fracture risk who really need treatment, so having more data about the CV risk helps with my clinical decision-making and with discussions with my patients about the risks and benefits of this drug.' In terms of caveats, Kim noted that 'the study did a good job of matching for medical comorbidities, but there may be other factors that cause a clinician to prescribe the drugs that are associated with cardiovascular disease.' 'This study is a helpful addition to the literature, but it's hard to be definitive in an observational study,' she added.
