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Jun 27 2025 This Week in Cardiology
Please note that the text below is not a full transcript and has not been copyedited. For more insight and commentary on these stories, subscribe to the This Week in Cardiology podcast , download the Medscape app or subscribe on Apple Podcasts, Spotify, or your preferred podcast provider. This podcast is intended for healthcare professionals only. In This Week's Podcast For the week ending June 27, 2025, John Mandrola, MD, comments on the following topics: FDA approves triple-drug polypill, a change of opinion, a deep dive into invasive pulmonary embolism therapies, heart disease trends, and diabetes care is on fire. I learned this week that fellow medical conservative, Andrew Flapan, MD, of Edinburgh, died suddenly. Andrew invited me twice to speak at the Royal College meeting. I enjoyed my time with him immensely. He was a force of nature, and a 'doctor's doctor.' To my colleagues in Edinburgh, I offer my condolences. FDA News in Hypertension The FDA this week approved the three-component polypill for hypertension. It's going to be called Widaplik, which is a silly name. It includes the angiotensin receptor blocker (ARB) telmisartan, the calcium-channel blocker amlodipine and the diuretic indapamide. There will be a polypill with standard doses of the three drugs, but also one with two lower doses. My feelings have changed about the polypill. I used to be dead set against it. I thought it was dumb, and it would be far better to just titrate does of selected drugs. But now I am more open to the whole simplicity thing. As I age, I grow more interested in minimally disruptive care — a concept began by Mayo Clinic endocrinologist Victor Montori, MD. The idea is that life is for living, not for being a patient. Getting prescriptions filled is a huge pain in the butt these days. So the idea of taking one pill that has a better chance of controlling blood pressure (BP) is absolutely minimally disruptive compared to titrating two or three pills, each requiring a prescription. The evidence for polypill efficacy is quite decent. The Lancet published an RCT comparing the triple polypill to three different two-drug combinations. And it fared well — the triple-drug polypill lowered the systolic blood pressure statistically more than any of the other combinations. It was a small efficacy trial but there were no significant differences in hypotension, though more patients in the triple therapy arm had out-of-range sodium or potassium values, but 'very few clinically significant electrolyte abnormalities occurred in any groups.' Also in 2024, JACC published an RCT of about 300 patients with mild to moderate hypertension. This trial randomized patients in a 2:2:1 ratio to polypill quarter-dose (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg), polypill half-dose (telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg), or placebo. The BP reductions delta vs placebo was about 7-8 mm Hg. At Week 4, clinic BP control (<140/90 mm Hg) was 37% for placebo, 65% for quarter-dose and 70% for half-dose. Both doses had highly significant P-values. Adverse effects were similar. In 2023, JAMA Cardiology published a meta-analysis of seven trials with 1900 patients looking at 3- and 4-component polypills vs monotherapy or placebo. Again, the polypills were more effective BP-lowering drugs and there were very little adverse effect differences. A word of caution: These trials enrolled 59-year-old patients. They had run-in periods. And in trials, patients are motivated, clinicians are motivated, there are research nurses. IOW the trial environment is seriously protective. The practice of evidence-based medicine (EBM) requires us, the practitioners, to be mindful of the external validity of trials. Giving three drugs in a single pill is not for frail, elderly patients with serious comorbidity. Patients on these drugs should get follow-up. But, again, I stress, the sole point of preventive therapies, like treating hypertension in middle-aged people is so they become old-aged. When patients successfully make it to old age, there is reason for caution. Benefits are less and side effects come more frequently. The thing about the polypill is that it offers a single best chance of getting control of BP. Simple is better not only because it is less work for the patient, but in my experience, early success is more likely to lead to adherence and confidence in the clinician. I don't know how much this drug will cost. The three components are not at all costly but putting them together could be. That would be sad. I am upbeat about polypills. I have changed my mind. We need to talk about a new kid on the block — interventional pulmonary embolism (PE) care. Our two EP labs bookend the three cath labs. I visit our cath labs as a curious person and journalist. I often see the doctors treating PE. The pictures are impressive when a doctor literally sucks a clot out of the pulmonary artery. My former partner for decades, Tom Tu, MD, became the chief medical officer of Inari. I loved working with Tom. Our cubicles in clinic were close. (By the way in private practice, you only get a cubby. My diplomas are not on the way, they're in boxes.). Tom pushed me on evidence. And I once debated him in front of the entire medical staff about percutaneous coronary intervention (PCI) for stable coronary artery disease (CAD). I had all the data; Tom had the stories. And I got crushed. Anyway, I liken endovascular clot aspiration in PE to clot aspiration in myocardial infarction (MI) and embolic protection devices in transcatheter aortic valve replacement (TAVR). Seeing a clot that was once in the body has huge persuasive properties. But scary pictures of clot are not evidence. The European Heart Journal Open has published an eye-opening review on the endovascular treatment of intermediate-risk PE. Now I know what you are thinking: review articles are terrible to read. And I would agree in most cases, but this review however by Arman Shahriar, MD, is superb. Sharp, short sentences; lots of subdivisions. I will link to it, and there are two reasons to read it: (1) if you are interested in PE care, which is increasingly common in cardiology practice; and (2) this is a shining example of the failure of evidence-based practice to determine best therapies. Advocates of EBM should read it for the many lessons. Here is a brief review: PE is obviously a leading cause of CV mortality and morbidity. But the hard part of PE treatment is that PE is not one thing. It's a bit like atrial fibrillation (AF) in that way. PE can be mild, even incidentally discovered on a CT done for other reasons, and it can be severe and devastating, causing shock and collapse. The extremes make for easy decisions. But most people with PE present with 'intermediate' levels of risk. Endovascular procedures have increasingly been used in the past decade. Interesting is that the increased use parallels almost exactly the rise of PE Response Teams (or PERT). Since so few patients present with extremely high-risk PE or extremely low risk, most endovascular therapies are deployed in intermediate risk patients. The problem is that there is little evidence for use of these procedures in intermediate risk. In fact, no guideline gives interventional therapy a Class 1 recommendation because there is not Class-1-level data. A word on risk stratification and basic management: Everyone agrees the first step in PE care is to risk-stratify using clinical, lab, and imaging parameters. The European Society of Cardiology (ESC) defines high-risk PE by hemodynamic instability, which is associated with a 30-day mortality risk exceeding 15%. These patients require immediate adjunctive intervention directed at reperfusion (medical, endovascular, or surgical) to prevent death. By contrast, low-risk PE — characterized by normal BP, low clinical severity, and no evidence of cardiac dysfunction — carries a low early-mortality risk of < 1% and can generally be safely managed with anticoagulation alone in the outpatient setting. Intermediate-risk patients, which encompass 25%-60% of hospitalized PE cases, have stable vital signs but other concerning features, such as cardiac dysfunction. Short-term mortality rates in intermediate-risk PE range from 1%–3% in clinical trials; and 3%–5% in observational studies. According to the ESC, patients with both imaging and laboratory evidence of cardiac dysfunction are deemed intermediate-to- high risk. This is where controversy and uncertainty come in — because of the limited data. The rationale for endovascular therapy of PE stems from a seminal trial called PEITHO in 2014. NEJM published the RCT of systemic lytics + heparin vs heparin alone in 1000 patients with intermediate-risk PE. The study found a small benefit in its primary efficacy endpoint (composite of 7-day mortality and hemodynamic decompensation; 2.6% vs. 5.6%, P = .02) that was outweighed by risks of major extracranial (6.3% vs. 1.2%, P ≤ .001) and intracranial (2.4% vs. 0.2%, P = .003) hemorrhage. Thus, the rationale for endovascular therapies were born. Because systemic lytics worked but were far too dangerous. Lax FDA likely leads to dubious evidence: Five endovascular devices hold indications for PE in the US. In 2014, the EKOS ultrasound-assisted thrombolysis catheter (Boston Scientific) became the first FDA-authorized endovascular therapy in acute PE. This catheter was initially studied in one RCT of 59 intermediate-risk patients (ULTIMA) and a prospective cohort of 150 intermediate and high-risk patients (SEATTLE II), with both studies demonstrating short-term improvements in the right ventricular/left ventricular (RV/LV) ratio. Thereafter, four 'analogous' devices have passed muster in the FDA's 510k pathway, where a device only has to be shown similar to a previous device. These include clot extraction devices of one sort of another. The authors of the review paper in EHJ Open then discuss four important and yet unanswered clinical questions: One question is surrogate validity. Measures of right ventricular (RV) dysfunction, such as RV size > LV size were adopted in earlier studies because it is associated with early mortality. But experts, including the AHA guideline writers, acknowledge uncertainty as to whether rapid improvements in RV dysfunction is a reliable surrogate for outcomes. I would add that RV size is like LDL. No one cares about their echo image. They care about being alive and breathing well. Remaining question number 2 asks whether interventional therapy plus anticoagulation beats simple anticoagulation alone in the short and long term. Only three small trials have addressed this question and the results are mixed. Less than 200 patients have been studied in RCTs with these devices. I know; it's crazy. And again, I remind you FDA allowed these devices based on similarity to others — not evidence of benefit. Remaining question number 3 is whether endovascular therapy added to anticoagulation improves clinical outcomes for patients, including mortality, hemodynamic deterioration, symptom resolution, and sequalae that contribute to long-term mortality such as chronic thromboembolic pulmonary hypertension (CTEPH), post-PE impairment (PPEI), or recurrence of disease. For instance, in intermediate-high risk PE, short-term mortality ranges from 1%–3% and CTEPH develops in 2%–3% of patients, and PPEI in 10%–30%. Despite the rise in endovascular therapy, there have been no RCTs. The good news is that there are now at least three ongoing trials. My hospital participates in one of them and the problem is extremely strict entry criteria, which will limit external validity. The fourth remaining question is the safety of endovascular therapy. While all the devices limit systemic thrombolysis, some involved large-bore catheters. The authors cite a large, real-world, non-industry supported observational study published in the Journal of the Society for Cardiovascular Angiography & Interventions that found much higher rates of major bleeding with endovascular therapy than previously described (10%–15%). The authors devote another section to explaining the popularity of these devices in the absence of evidence. This is quite interesting. One cause is the rise of PERT teams — who are led by interventional-minded doctors. Another, and perhaps stronger, tailwind is reimbursement changes. I did not know this, but following an FDA 510k market approval, insurers independently determine if they will cover a device. The Centers for Medicare & Medicaid Services (CMS) is the largest insurer and its decision influence private insurers. But in 2021, CMS controversially ended its non-coverage policy for PE devices, which allowed local Medicare contractors to decide. This decision accelerated coverage and in turn accelerated use. CMS, the authors wrote, could have required ongoing evidence generation within its CED mechanism — that is, coverage with evidence development . But, alas, they did not. (By the way, a sidebar here, I feel like coverage with evidence—for everything new—could be the most important policy ever employed.) The third reason for rising popularity of these treatments is marketing of observational research. Industry sponsors registries, which of course are voluntary, and produce favorable results, and these get made into ads. Companies than spend money paying doctors to speak and travel. Here is a direct quote from the paper: Until its recent acquisition by Stryker, Inari Medical was a relatively young company that derived two-thirds of its revenue from FlowTriever sales. Since its initial public offering in 2020, the company had rapidly increased its volume and magnitude of general physician payments. In 2020, it made 3500 general payments to physicians amounting to nearly a million dollars. Over the next three calendar years (2021, 2022, and 2023), these figures increased to $2.49 million, $4.86 million, and $6.74 million, respectively, representing 0.9%, 1.2%, and 1.4% of top-line revenues. And it wasn't just physicians. Hospitals too benefited financially via higher diagnosis-related group (DRG) reimbursement rates. Get this: hospitals get paid on severity. Using a device bumps severity. So it's self-fulfilling. Here's another quote from the authors: ' Between 2021 and 2022, for example, the reimbursement for endovascular therapy for PE with major comorbidity or complications (MS-DRG 166) nearly tripled from $9040 to $24,550. Accordingly, an interventional PE service line can generate high revenues for a hospital system .' BOOM—there you go. PERT teams make money. I don't mean to beat up the PE treatment people. I highlight this topic because of its EBM lessons. In the heyday of cardiology, we were leaders in the generation of evidence. Post-MI care, HF care, and in arrhythmias we had CAST and AFFIRM. So, it's weird that that same evidence-generating ethos did not infect the PE world. Which of these devices, if any, is better is a knowable question. But it won't come from observational studies. It has to be via RCTs. And I realize PE patients come in different varieties, but nonetheless, these studies could have been done. And then we would know. And you might say, John, there are ongoing trials now. My counter is that it's largely too late. Equipoise has been injured. When you return from a clot-extracting course on a beach resort, do you think you are going to be energized to randomize a PE patient in a trial or do clot extraction? When reimbursement is favorable, do you think doctors will be keen to randomize or do the procedure? I have already sent multiple notes to my friend Vinay Prasad encouraging him and Marty Makary at the FDA to do something to tighten device regulation. I am not against approving early generation devices, but there must be strong post-marketing requirements for evidence. There currently is not. But, in truth, as professionals and scientists, we should not need FDA to help us. We should want evidence; we should require evidence before exposing our patients to unproven therapy. Sadly, though, the recent experiences with left atrial appendage occlusion, PE, and now tricuspid interventions don't shine a favorable light on the scientific aspects of our profession. The Journal of the American Heart Association published an interesting paper on trends in heart disease mortality. It makes you think. A Stanford-led team used the national vital statistics at the CDC to present data on heart disease mortality over the past 52 years — from 1970 to 2022. The findings: Some good news: Heart disease deaths are decreasing. In 1970, heart disease accounted for 41% of deaths; that has declined to 24% of all deaths. And life expectancy went from 71 years in 1970 to 77.5 in 2022. The proportions of types of heart disease deaths have changed dramatically. Over the past 50 years, overall age‐adjusted heart disease mortality decreased by 66% from 1970 to 2022 (from 761 to 258 per 100,000). In 1970, more than 90% of heart disease deaths were ischemic. Ischemic causes of cardiovascular (CV) death declined to 53% in 2022. One of the reasons may be this statistic: Since 1970, age-adjusted mortality from acute myocardial infarction (AMI) decreased by 89%, from 354 to 40 per 100,000. Since 1970, age-adjusted mortality from any ischemic disease decreased by 81%. But, conversely, since 1970, age-adjusted mortality from other heart disease subtypes increased by 81% with the greatest increases in HF (146%), hypertensive (106%) and arrhythmia (450%). For instance, in 1970, these other subtypes (HF, hypertensive, and arrhythmia) accounted for just 9% of heart disease deaths; now it is 47% of heart disease deaths. First is that the authors rightly acknowledge limitations in the use of coding. For instance, disease names have shifted somewhat. Arrhythmia-related deaths may in fact be related to underlying ischemic heart disease. But limitations aside, it's worth thinking about this data. The fall in deaths from AMI and ischemic heart disease represents a shining example of excellence in both cardiology and public health. The reduction in smoking stands out as a huge success in public policy. Surely this has enhanced the lives of millions of people. I would also laud my interventional colleagues. I spend a great deal of time criticizing the overuse of intervention in stable CAD, but the acute treatment of MI has been one of the most important medical achievements of a generation. Young people cannot appreciate where we were when I began medical school in 1985. MIs then were largely treated with morphine and Swan-Ganz catheters. Now, people come in with an anterior MI and leave with band-aid on their wrist and a normal ejection fraction. So impressive has been the trend in AMI care that it is hard to find an ischemic cardiomyopathy patient who qualifies for a primary prevention implantable cardioverter-defibrillator (ICD). Keep in mind too that this marked reduction in MI deaths bears on screening for heart disease. Namely, the better we get at treating a condition, the less value there is in finding it early. We don't screen for appendicitis or gallbladder disease or pneumonia because we can simply treat those problems when they occur. AMI isn't quite there but it's approaching that. By the way, if you are young and looking for a job that has meaning, I can't think of a better job than interventional cardiology. Nearly every day, you are saving or enhancing a life. The problem of course is that it is hard because like delivering babies, MIs happen at all hours. Another factor in the reduction of death from ischemic heart disease could be statins. Statin use has gone from none to up to 45% of adults over the time frame. Since we know that statins consistently reduce CV events by about 25%, not having an MI in the first place is a good way to not die of ischemic heart disease. I for one think statins play a consequential role in lower ischemic heart disease deaths but smoking and MI care are much larger causal factors. My final comment is the alarming language (both in the paper and online) regarding the rise in other forms of heart disease. Yes, the rise in obesity, which has led to more hypertension and more AF and more heart failure with preserved ejection fraction (HFpEF) is a big concern. I don't want to downplay it. Obesity is a public health crisis, and largely a public health failure. But on the other hand, it's important for doctors to understand that all people die. If you reduce MI deaths, and increase life expectancy, what do you think happens: people die of other diseases, such as heart failure, atrial fibrillation, dementia, cancer, and falls. It's normal. It's still a good thing to extend life, and enhance life, but it's also important to recognize that reducing ischemic heart disease deaths does not magically reduce healthcare costs, because eventually, aging people develop some sort of disease, and if is treated, money is spent. The reason to improve treatment of heart disease is not to save money — it is to extend quality of life. If our therapies do that, then it is worth the money spent. American Diabetes Association (ADA) 85th Scientific Sessions I won't get into specifics, but at the recent American Diabetes Association meeting in Chicago a trove of studies came out that should be on our radar. For instance, a study showed early data on once-weekly insulin. Think about that if you have type 1 diabetes: once-weekly insulin. There were early studies on other GLP-1 drugs as well as combinations of drugs. I think semaglutide and tirzepatide may become the simvastatin of GLP-1's soon. There was even some encouraging data on recombinant gene therapy for type 1 diabetes. The diabetes world is advancing fast. And I think it's only a matter of a short time that cardiologists will be prescribing GLP-1 drugs like we did for SGLT2 drugs. And finally, before I close, I'll say that there's been another BMJ investigation as reported on more potential — emphasis, potential — troubles in the ticagrelor evidence base. I will look into that and have a report on the next TWIC podcast.
Medscape
a day ago
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Sclerosing Mesenteritis: Update on Rare GI Disease
The American Gastroenterological Association (AGA) has issued an updated pragmatic review on sclerosing mesenteritis (SM). Published in Clinical Gastroenterology and Hepatology, the update evaluates available evidence for diagnosis and treatment and examines opportunities for future research in SM, previously known by such names as misty mesentery, mesenteric panniculitis, and inflammatory pseudotumor. Led by Mark T. Worthington, MD, a professor of medicine in the Division of Gastroenterology and Hepatology at the University of Virginia in Charlottesville, Virginia, an expert AGA panel described SM as an uncommon benign idiopathic autoimmune disease of the mesenteric fat. Although of poorly understood etiology, gastroenterologists need to be prepared to diagnose it. 'CT radiologists increasingly are reporting SM and related lesions, such as misty mesentery,' Worthington told Medscape Medical News . 'We are also seeing new SM cases caused by immune checkpoint inhibitors in cancer treatment, and the oncologists ask us to manage this because it interferes with the treatment of the underlying malignancy. Those are often readily treated because we catch them so early.' Metabolic syndrome and associated conditions increase the risk for SM, as does aging. The recent changes are intended to help clinicians predict disease activity and the need for other testing or treatment. 'For instance, most cases are indolent and do not require aggressive treatment — often no treatment at all — but for those that are aggressive, we want the clinician to be able to identify those and make sure the treatment is appropriate. The aggressive cases may warrant tertiary referral,' Worthington said. 'A secondary cancer is a possibility in this condition, so drawing from the SM radiology studies, we try to help the clinician decide who needs other testing, such as PET-CT or biopsy, and who can be monitored.' As many as 60% of cases are asymptomatic, requiring no treatment. Abdominal pain is the most frequent symptom and its location on clinical examination should correspond to the SM lesion on imaging. Treatment involves anti-inflammatory medications tailored to disease severity and clinical response. No biopsy is not necessary if the lesion meets three of the five CT criteria reported by B. Coulier and has no features of more aggressive disease or malignancy. Although some have suggested that SM may be a paraneoplastic syndrome, current evidence does not support this. SM needs to be differentiated from other diagnoses such as non-Hodgkin's lymphoma, peritoneal carcinomatosis, and mesenteric fibromatosis. 'There are now CT guidelines for who actually has SM, who needs a biopsy or a PET-CT to rule-out malignancy, and who doesn't,' said Worthington. 'Radiologists do not always use the Coulier criteria for diagnosis, but often they will with encouragement. From this review, a GI clinician should be able to identify SM on CT.' Epidemiologically, retrospective CT studies have reported a frequency of 0.6%-1.1%, the panelists noted. And while demographic data are limited, a large early case series reported that SM patients had a mean age of 55 years and more likely to be men and of White race. Patients with SM do not have a higher prevalence of autoimmunity in general, but may have increased rates of metabolic syndrome, obesity, coronary artery disease, and urolithiasis, the panelists noted. The update allows room for differences in clinical judgment. 'For instance, a longer or more frequent CT surveillance interval can be justified depending on the patient's findings, and no one should feel locked in by these recommendations,' Worthington said. Medical Therapy Although there is no surgical cure, pharmacologic options are many. These include prednisone, tamoxifen, colchicine, azathioprine, thalidomide, cyclophosphamide, and methotrexate, as well as the biologics rituximab, infliximab and ustekinumab. Current corticosteroid-based therapies often require months to achieve a clinical response, however. Bowel obstruction is managed nonoperatively when feasible, but medically refractory disease may require surgical bypass. Offering his perspective on the guidance but not involved in its formulation, Gastroenterologist Stephen B. Hanauer, MD, a professor of medicine at Northwestern Medicine in Chicago, said, 'The most useful component of the practical review is the algorithm for diagnosis and determination when biopsy or follow-up imaging is reasonable in the absence of evidence.' He stressed that the recommendations are pragmatic rather than evidence-based 'as there are no controlled trials and the presentation is heterogeneous.' Hanauer added that none of the recommended treatments have been shown to impact reduction on imaging. 'Hence, all of the treatments are empiric without biological or imaging endpoints.' In his experience, patients with inflammatory features are the best candidates for immune-directed therapies as reduction in inflammatory markers is a potential endpoint, although no therapies have demonstrated an effect on imaging or progression. 'As an IBD doctor, I favor steroids and azathioprine or anti-TNF directed therapy, but again, there is no evidence beyond reports of symptomatic improvement.' Worthington and colleagues agreed that treatment protocols have developed empirically. 'Future investigation for symptomatic SM should focus on the nature of the inflammatory response, including causative cytokines and other proinflammatory mediators, the goal being targeted therapy with fewer side effects and a more rapid clinical response,' they wrote. Currently, said Worthington, the biggest gaps remain in treatment. 'Even the best studies are small and anecdotal, and we do not know the cytokine or other proinflammatory mediators.' In other comments, Gastroenterologist Eli D. Ehrenpreis, MD, research director, Internal Medicine Residency, at Advocate Lutheran General Hospital in Park Ridge, Illinois, and not involved in the update, found it fell short in several ways, including nomenclature. 'The appropriate term for this condition is mesenteric panniculitis, meaning inflammation of the mesenteric fat, seen histologically on biopsy. The term sclerosing mesenteritis introduces the idea of fibrosis, which is seen in a smaller number of patients, not all,' he told Medscape Medical News . Ehrenpreis also took issue with the inclusion of the cancer drug tamoxifen as the most common treatment used. 'Mesenteric panniculitis, when it does not represent a malignancy, is a benign disease,' he said. 'However, many patients on tamoxifen will experience hormone-related adverse effects such as breast tenderness and hot flashes.' He noted the drug has an FDA Black Box warning for uterine malignancies, pulmonary embolism, and other thromboembolic events, including stroke. Another significant gap, in his view, is the lack of recognition of the psychological effects on patients of the diagnosis. According to Ehrenpreis, more prospective analyses of treatments are needed with objective measures of success including symptom scoring and laboratory testing with erythrocyte sedimentation rate and C-reactive protein. 'And as with many rare diseases, a better understanding of the psychological effects of having a poorly understood disease and management of this challenge is vital to the comprehensive care of the patient with mesenteric panniculitis.' This guidance was supported by the AGA. Worthington reported renumeration from TriCity Surgery Center, Prescott, Ariz. The coauthor Wolf has received renumeration from AbbVie, Align Technology, Alnylam Pharmaceuticals, CVS Health ORP, Dexcom, Exact Sciences, HCA Healthcare, Johnson & Johnson, Eli Lilly, McKesson, Moderna, Regeneron Pharmaceuticals, Sarepta Therapeutics, Seagen, Stryker, and Thermo Fisher Scientific. Crockett has served as a consultant for IngenioRx. Pardi has served as a consultant for Boehringer Ingelheim and received research support from Atlantic, ExeGI Pharma, Rise Therapeutics, Janssen, Pfizer, Seres, Applied Molecular Transport, Takeda Pharmaceuticals, and Vedanta Biosciences. Hanauer and Ehrenpreis had no conflicts of interest relevant to their comments.
Medscape
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Canadian Physicians Report Happiness, Acknowledge Challenges
Canadian physicians reported a high rate of happiness at work and in their home life in a new physician wellness survey conducted by Medscape Medical News . At the same time, many physicians acknowledged experiencing work-related burnout and depression. The national survey included information submitted by 744 respondents (66% specialists, 34% general practitioners [GPs]). Most respondents lived in Manitoba (42%), followed by Alberta (17%), Prince Edward Island (13%), and Newfoundland/Labrador (12%). Smaller proportions came from Ontario and Quebec, the country's most populated provinces. While 37% of respondents reported working in hospitals, 24% were based in GP groups or private practice settings, 19% were based in clinics, 15% were based in other settings (including virtually, working from home, and long-term care), and 5% were in academic settings. More than half (57%) of respondents identified as men and 41% as women. The majority (91%) were aged 45 years or older, including 24% who were aged 70 years or older. Widespread Happiness While most respondents reported being very or somewhat happy with their work life (68%) and personal life (74%), 24% reported experiencing burnout, 3% reported depression, and 11% reported both. The remaining 62% reported experiencing neither condition. Burnout was more commonly reported by respondents younger than 45 years (about 40%) compared with older respondents (23%). Women reported a higher rate of burnout than men (35% vs 17%), and respondents based in an office practice were more likely to report burnout than those working in a hospital setting (33% vs 23%). While 57% of physicians who reported burnout or depression attributed some of it to personal life, 73% attributed all or most of it to work. About 69% said that work burnout had negatively affected their personal relationships. This effect on personal relationships was most evident in respondents younger than 45 years (90%), compared with those aged 45 years or older (65%). Health and wellness were a priority or somewhat of a priority for 91% of respondents, with exercise being a commonly reported activity to achieve them (72%). Exercise was a daily activity for 17% of respondents. About 30% reported engaging in it two or three times a week, and 26% reported exercising four to five times weekly. Slightly more respondents (73%) reported spending time with family and friends and pursuing hobbies as their way to stay well. Healthy eating was reported by 64%, and 58% reported getting enough sleep. Yearly vacation time totals of 3-4 weeks were common (36%), and many respondents (42%) had more weeks of vacation than that. Almost half (48%) of respondents said that they would take a salary reduction to achieve better work-life balance, while 27% said that they would not, and 25% said that they were not sure. Respondents younger than 45 years were more likely to endorse this option than older respondents (61% vs 47%). A desire to spend less personal time online was reported by 49% of respondents, with 56% reporting spending 2-4 hours a day online for personal reasons, including social media, texting, movies, news, and other interests. Poor Self-Assessment? Commenting on the survey results for Medscape Medical News , Catherine Pound, MD, director of Physician Support and Wellness at the Canadian Medical Protective Association (CMPA), said the rate of burnout and depression in the survey is likely an underestimate. The CMPA recently launched the Physician Well-Being Index, a validated tool that has found higher rates of physician depression and burnout, said Pound. 'The level of distress we are seeing is about two thirds of physicians who are struggling or in distress, and that level was a bit lower in the Medscape survey. 'What was super interesting to me is that the Medscape survey asked people to self-assess, as opposed to the Well-Being Index, which gives you a result of well-being based on the questions they ask,' Pound added. Physicians are not good at assessing their own mental states, she said. 'If I ask a physician if they're distressed, they may say no, but if I give them a validated tool, the result may be different.' The Well-Being Index has thus far collected almost 4000 responses from 117,000 CMPA members. While those responses might reflect a self-selection bias of respondents who are feeling higher than average levels of distress, Pound said that the findings dovetail with the results of the Medscape survey. 'All across Canada, there's a human resource crisis. We know that physicians are working really hard. They're working long hours, and we know that there's a lot of emotional distress and burnout. Physician wellness is a pillar of the healthcare system. If you don't have physician well-being, then we know there's an increased risk of patient dissatisfaction, there's an increased risk of patient safety events, and there's an increased risk of burnout, and the more physicians who leave the system because they're burnt out. It's a vicious cycle.' Small Numbers Margot Burnell, MD, president of the Canadian Medical Association, said the Medscape survey provides more information on this area and is consistent with research underway by her organization, but it includes a relatively small sample size. 'We will be releasing our national physician health survey results in the fall, so seeing something a little more robust will be good to add to all of these data points on this important topic,' she told Medscape Medical News. Burnell identified four main opportunities to alleviate physician burnout and improve well-being, including facilitating physician autonomy, easing administrative burden, streamlining team-based care models, and improving access to patient health data through electronic medical health records. 'There were several bills that died when government was prorogued, and one was on connected care and data interoperability,' she explained. 'There is an imperative to get that back onto the legislative table. We will be working with all parties to identify solutions that we can move through with our stakeholders — federal, provincial, and territorial medical societies and governments — to keep healthcare at the forefront.' Pound and Burnell reported having no relevant financial relationships.
Medscape
a day ago
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- Medscape
AAD Updates AD Guidelines With Four New Treatment Picks
The American Academy of Dermatology (AAD) recently issued a focused update to its guidelines on the management of atopic dermatitis (AD) in adults, strongly recommending four recently approved therapies: tapinarof cream, roflumilast cream, lebrikizumab, and nemolizumab (in combination with topical therapy). These additions reflect high-certainty evidence supporting both efficacy and safety, according to the workgroup's systematic review published in the Journal of the American Academy of Dermatology . Robert Sidbury, MD Asked to comment on the updates, one of the authors, Robert Sidbury, MD, cochair of the guideline committee and chief of dermatology at Seattle Children's Hospital, Seattle, called the rapid need for a guideline update 'a reflection of the extraordinary progress in AD care that is ongoing and is indeed revolutionizing care.' Having 'two new nonsteroidal topical therapies is quite significant,' he added in an interview with Medscape Dermatology . 'Patients have long been dissatisfied with topical options, which have been shackled by safety concerns, some real, some not, and intolerance, such as application site stinging.' The update comes just over a year after the release of AAD's 2023-2024 adult AD guidelines on treatment with topical and systemic therapies, underscoring the rapid pace of therapeutic development for AD. The update was initiated following the FDA approval of multiple new therapies and newly published high-certainty evidence supporting their use, prompting the AAD to incorporate this data into its existing guidance, according to the authors. Strong Recommendations for Four New Agents The guideline workgroup applied the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) framework to assess new data and formulate treatment recommendations. According to the authors, all four therapies received 'strong' recommendations based on high-certainty evidence: Tapinarof cream 1% : A nonsteroidal aryl hydrocarbon receptor agonist approved in 2024 for moderate to severe AD. In four trials (n = 1169), once-daily use over 8-12 weeks resulted in statistically and clinically significant improvements in investigator's global assessment (IGA), eczema area and severity index (EASI)-75, and itch scores. : A nonsteroidal aryl hydrocarbon receptor agonist approved in 2024 for moderate to severe AD. In four trials (n = 1169), once-daily use over 8-12 weeks resulted in statistically and clinically significant improvements in investigator's global assessment (IGA), eczema area and severity index (EASI)-75, and itch scores. Roflumilast cream 0.15% : A phosphodiesterase-4 inhibitor approved in 2024 for mild to moderate AD. Clinical trials (n = 1427) demonstrated significant improvements in IGA and EASI-75 after 4 weeks. : A phosphodiesterase-4 inhibitor approved in 2024 for mild to moderate AD. Clinical trials (n = 1427) demonstrated significant improvements in IGA and EASI-75 after 4 weeks. Lebrikizumab : An interleukin (IL)-13-targeting monoclonal antibody approved in 2024 for moderate to severe AD. In over 1700 patients, treatment with or without topical corticosteroids led to marked improvements in clinical and patient-reported outcomes. : An interleukin (IL)-13-targeting monoclonal antibody approved in 2024 for moderate to severe AD. In over 1700 patients, treatment with or without topical corticosteroids led to marked improvements in clinical and patient-reported outcomes. Nemolizumab (with topical therapy): An IL-31 receptor inhibitor approved in 2024 for patients aged 12 years or older inadequately controlled with topical therapies. In three trials (n = 1256), nemolizumab plus topical corticosteroids (with or without topical calcineurin inhibitor) led to significant reductions in itch and improvements in EASI-75 and Dermatology Life Quality Index. Updated Treatment Algorithm The guideline includes an updated treatment algorithm to help clinicians integrate these agents into clinical practice. It emphasizes: All four newly recommended therapies are indicated with strong recommendation symbols in the updated algorithm figure. Real-World Considerations Sidbury emphasized that having multiple high-certainty options creates new opportunities but also new challenges in decision-making. 'Such choice is a lovely problem to have,' he said, but he urged clinicians to look beyond efficacy. For example, 'a patient with baseline ocular difficulties would want to be aware that IL-4/13 or IL-13 biologics can cause or exacerbate conjunctivitis,' he explained. 'Nemolizumab or a JAK inhibitor, neither of which carries ocular risk, might be a good choice. Similarly, patients with cardiovascular risk may want to avoid JAK inhibitors due to their boxed warning.' Treatment selection, he said, should be rooted in shared decision-making: 'It's important to weigh evidence alongside a patient's comorbidities, preferences, and tolerability history.' Remaining Gaps and Considerations Despite the promising data, the authors acknowledged important limitations. Most trials were short-term (≤ 24 weeks), and the long-term safety, durability of response, and comparative effectiveness of these agents remain unknown. Cost is another factor. The authors noted, 'costs for the considered therapies may be prohibitive without adequate insurance coverage.' As such, they stressed the importance of a shared decision-making process that weighs efficacy, safety, and affordability. Clinical Impact and Future Directions The update is expected to have an immediate impact in clinical settings. 'Atopic dermatitis care has long been an 'off-label' affair,' Sidbury said. 'Prior to 2017, the only FDA-approved systemic therapy for AD was systemic steroids. Since then, we've seen numerous novel topical and systemic therapies approved with many more on the way. Better evidence plus more choices equals improved outcomes.' Still, more research is needed. Sidbury pointed to the importance of identifying which therapies may work best for specific patient subtypes — by age, race, gender, or AD phenotype. 'We don't know yet, but the answer is likely yes. This gets at personalized medicine — and that's where we're headed,' he said, noting that future treatment may be guided by inflammatory signatures or genotyping. While this focused update offers valuable clarity on incorporating new treatment options for adult AD, further research is needed, according to the authors. The workgroup called for real-world data, head-to-head trials, and longer-term outcome studies. The authors also noted pediatric guideline updates are expected in a future publication. This study was funded in total by internal funds from the American Academy of Dermatology. Sidbury disclosed he serves as an advisory board member for Pfizer, receiving honoraria; as a principal investigator for Regeneron, receiving grants and research funding; as an investigator for Brickell Biotech, and Galderma USA, receiving grants and research funding; and as a consultant for Galderma Global and Microes, receiving fees or no compensation. Other authors reported having financial disclosures with many pharmaceutical companies. : Biologics, JAK inhibitors, and immunosuppressants remain key choices for refractory disease.
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