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Sotatercept tied to disease modification in pulmonary arterial hypertension
MILAN – Sotatercept, a first-in-class activin signaling inhibitor, is currently under scrutiny as a potential game-changer in the treatment of pulmonary arterial hypertension (PAH). Data unveiled at the annual congress of the European Respiratory Society, held in Milan, suggest that sotatercept treatment has the capacity to deliver significant clinical benefits and could reshape the trajectory of this challenging disease. Experts are cautiously optimistic that this drug may soon find a place within the PAH treatment algorithm.
The STELLAR trial: A milestone in PAH research
PAH is intricately linked to the dysregulation of members within the TGF-beta superfamily, including activin receptor type IIA (ActRIIA) and its ligands activin A and activin B. This signaling pathway is believed to be a driving force behind the pulmonary vascular remodeling observed in PAH patients. Sotatercept, a fusion protein acting as a ligand trap for selected TGF-beta superfamily members, has been proposed to recalibrate pulmonary vascular homeostasis by promoting growth-inhibiting and pro-apoptotic signaling.
Sotatercept was tested first in a phase 2 trial (PULSAR) and later in a phase 3 trial (STELLAR). The STELLAR clinical trial, funded by Acceleron Pharma (now a subsidiary of Merck), was the subject of two presentations given by Marius M. Hoeper, MD, director of the department of respiratory medicine at Hannover Medical School, Hannover, Germany.
Dr. Hoeper commented on results published in the New England Journal of Medicine during a session titled, “Disease modification in pulmonary arterial hypertension.” Later, during the “From the Editor’s Desk” session, he presented new results recently published in the European Respiratory Journal about the effects of sotatercept on hemodynamics and right heart function.
Disease modification in PAH
In his initial address, Dr. Hoeper expounded on the concept of reverse remodeling as a therapeutic avenue for PAH. “PAH is not a disease of pulmonary vasoconstriction,” he clarified, “but a disease of proliferation. Endothelial cells and pulmonary vascular muscle cells proliferate and obliterate the lumen. It has been hypothesized that when we target this system successfully, we may not only stop disease progression, but we may have a chance to have at least some reverse remodeling, because, if these cells go into apoptosis, there may be a partial reopening of the vessels.”
“Sotatercept is probably going to be a game changer in our field,” Dr. Hoeper continued. “Is sotatercept a disease-modifying agent? It certainly induces disease improvement; in a few patients, although not in the majority, we see a normalization of hemodynamics. We target the underlying pathophysiology; this is clearly distinct from symptomatic treatment.” Dr. Hoeper went through the list of characteristics that a disease-modifying agent should have.
“To be able to say that a drug endures sustained clinical benefit, according to the FDA, you need to withdraw the drug, and this is something we do not know. We know that we can interrupt the treatment once or twice, but long-term I do not believe that,” he said, while acknowledging the need for more extended-term safety and efficacy data.
Unmasking hemodynamic impact
Dr. Hoeper’s second presentation focused on a post hoc analysis of the STELLAR trial never presented before. He analyzed right heart catheterization (RHC) and echocardiography (ECHO) data. With sotatercept treatment at week 24, the researchers observed:
- A small increase in systemic blood pressure and systemic vascular resistance.
- No changes in systolic and diastolic volumes of the left ventricle (lv).
- A small but significant reduction in lv ejection fraction.
- A great reduction in the mean pulmonary artery pressure (mPAP).
- No change in cardiac output.
- An improvement in pulmonary artery compliance.
- A reduction in the right ventricle work and in right atrial pressure.
- An improvement of echocardiographic parameters, including a significant decrease in tricuspid regurgitation.
“A drop of roughly 14 mm Hg in mPAP is something that we have never seen in PAH with any other add-on medication. This was entirely driven by improvement in the sotatercept group, not by deterioration in the placebo group,” Dr. Hoeper pointed out. Of note, change in mPAP correlated with changes in NT-proNBP and with changes in 6-minute walk distance (6MWD), the primary endpoint of the STELLAR trial. “We effectively unload the right ventricle by lowing the artery pressure. What we observe is exactly what we want to achieve in patients with PAH, because the heart is what really matters,” he concluded.
A new course in PAH treatment?
Olivier Sitbon, MD, PhD, professor of respiratory medicine at Université Paris-Saclay and consultant at the French Referral Center for Pulmonary Hypertension, echoed Dr. Hoeper’s enthusiasm. ,” he told this news organization.
Dr. Sitbon highlighted ongoing studies with sotatercept, including the ZENITH trial, focused on high-risk PAH patients, and the HYPERION trial, aimed at patients diagnosed within the first year of their PAH journey. He acknowledged that experts currently lack consensus on the ideal position for sotatercept within the PAH treatment algorithm. However, he anticipates a lively debate and expects sotatercept to find its place as a second-line treatment for intermediate low-risk or intermediate high-risk patients, with potential consideration for high-risk patients.
“There are two more studies ongoing with sotatercept: the ZENITH trial, dedicated to PAH patients at high risk, whose primary endpoint is mortality/need for lung transplant, and the HYPERION trial, dedicated to patients diagnosed less than 1 year (not really newly diagnosed but quite incident, while patients included in previous trial were very prevalent), whose primary endpoint is time to clinical worsening,” Dr. Sitbon noted, pointing out that there is currently no consensus among the experts about where to place sotatercept in the PAH treatment algorithm.
Further insights into sotatercept
The ERS Congress also unveiled two additional studies that provided fresh perspectives on sotatercept’s potential. Ioana R. Preston, MD, from Tufts Medical Center in Boston, presented the first interim analysis of SOTERIA, a long-term follow-up study involving 409 patients with a median exposure duration of 462 days to sotatercept. Treatment-emergent adverse events (TEAEs) were reported by 80% of patients, with 20% reporting a serious TEAE. Overall, four serious TEAEs (1% of patients) led to death, but only five patients (1.2%) discontinued sotatercept because of TEAE.
Notably, improvements in clinical efficacy measures persisted after 1 year. During SOTERIA, roughly 3% of patients on any prostacyclin discontinued it. “Results of SOTERIA support the long-term durable clinical benefit and safety of sotatercept for the treatment of PAH. Of note, patients were offered home self-administration therapy, so they do not need to come back to the office,” Dr. Preston said.
A second late-breaking abstract presented by Vallerie McLaughlin, MD, University of Michigan, Ann Arbor, described the possible long-term impact of sotatercept on morbidity and mortality. STELLAR trial data were analyzed to see how the risk profile of patients changed in the 24 weeks of study. Real-world registry data from the COMPERA registry were then used to extrapolate mortality and transplant need over 30 years based on risk transition. According to the simulation model, adding sotatercept to background therapy is expected to increase life expectancy by threefold, while avoiding nearly 700 hospitalizations and four lung/heart-lung transplantations per 1,000 patients. “Real-world data are needed to confirm these findings,” cautioned Dr. McLaughlin.
Dr. Hoeper disclosed speaking and consulting fees from Acceleron, Actelion, Altavant, AOP Health, Bayer, Ferrer, Janssen, Keros, and MSD. Dr. Sitbon disclosed speaking and consulting fees from Acceleron Pharmaceuticals, Altavant Sciences, AOP Orphan, Bayer, Ferrer, Gossamer Bio, Janssen, MSD, and United Therapeutics, and grant/research support from Acceleron Pharmaceuticals, AOP Orphan, Bayer, Janssen, and MSD. Dr. Preston disclosed speaking and consulting fees from Janssen and United Therapeutics, and grant/research support from Janssen and Respira Therapeutics. She has participated in scientific advisory boards for Aereovate, Altavant, and Gossamer Bio, and was in the Steering Committee of Acceleron, Liquidia, and United Therapeutics. Dr. McLaughlin has received speaking and consulting fees from Aerami, Aereovate, Caremark, Corvista, Enzyvant, Gossamer Bio, Janssen, Merck, United Therapeutics, and Vertex, and grant/research support from Aerovate, Enzyvant, Gossamer Bio, Janssen, Merck, and Sonovia. She is a member of the Board of Directors of Clene.
A version of this article first appeared on Medscape.com.
MILAN – Sotatercept, a first-in-class activin signaling inhibitor, is currently under scrutiny as a potential game-changer in the treatment of pulmonary arterial hypertension (PAH). Data unveiled at the annual congress of the European Respiratory Society, held in Milan, suggest that sotatercept treatment has the capacity to deliver significant clinical benefits and could reshape the trajectory of this challenging disease. Experts are cautiously optimistic that this drug may soon find a place within the PAH treatment algorithm.
The STELLAR trial: A milestone in PAH research
PAH is intricately linked to the dysregulation of members within the TGF-beta superfamily, including activin receptor type IIA (ActRIIA) and its ligands activin A and activin B. This signaling pathway is believed to be a driving force behind the pulmonary vascular remodeling observed in PAH patients. Sotatercept, a fusion protein acting as a ligand trap for selected TGF-beta superfamily members, has been proposed to recalibrate pulmonary vascular homeostasis by promoting growth-inhibiting and pro-apoptotic signaling.
Sotatercept was tested first in a phase 2 trial (PULSAR) and later in a phase 3 trial (STELLAR). The STELLAR clinical trial, funded by Acceleron Pharma (now a subsidiary of Merck), was the subject of two presentations given by Marius M. Hoeper, MD, director of the department of respiratory medicine at Hannover Medical School, Hannover, Germany.
Dr. Hoeper commented on results published in the New England Journal of Medicine during a session titled, “Disease modification in pulmonary arterial hypertension.” Later, during the “From the Editor’s Desk” session, he presented new results recently published in the European Respiratory Journal about the effects of sotatercept on hemodynamics and right heart function.
Disease modification in PAH
In his initial address, Dr. Hoeper expounded on the concept of reverse remodeling as a therapeutic avenue for PAH. “PAH is not a disease of pulmonary vasoconstriction,” he clarified, “but a disease of proliferation. Endothelial cells and pulmonary vascular muscle cells proliferate and obliterate the lumen. It has been hypothesized that when we target this system successfully, we may not only stop disease progression, but we may have a chance to have at least some reverse remodeling, because, if these cells go into apoptosis, there may be a partial reopening of the vessels.”
“Sotatercept is probably going to be a game changer in our field,” Dr. Hoeper continued. “Is sotatercept a disease-modifying agent? It certainly induces disease improvement; in a few patients, although not in the majority, we see a normalization of hemodynamics. We target the underlying pathophysiology; this is clearly distinct from symptomatic treatment.” Dr. Hoeper went through the list of characteristics that a disease-modifying agent should have.
“To be able to say that a drug endures sustained clinical benefit, according to the FDA, you need to withdraw the drug, and this is something we do not know. We know that we can interrupt the treatment once or twice, but long-term I do not believe that,” he said, while acknowledging the need for more extended-term safety and efficacy data.
Unmasking hemodynamic impact
Dr. Hoeper’s second presentation focused on a post hoc analysis of the STELLAR trial never presented before. He analyzed right heart catheterization (RHC) and echocardiography (ECHO) data. With sotatercept treatment at week 24, the researchers observed:
- A small increase in systemic blood pressure and systemic vascular resistance.
- No changes in systolic and diastolic volumes of the left ventricle (lv).
- A small but significant reduction in lv ejection fraction.
- A great reduction in the mean pulmonary artery pressure (mPAP).
- No change in cardiac output.
- An improvement in pulmonary artery compliance.
- A reduction in the right ventricle work and in right atrial pressure.
- An improvement of echocardiographic parameters, including a significant decrease in tricuspid regurgitation.
“A drop of roughly 14 mm Hg in mPAP is something that we have never seen in PAH with any other add-on medication. This was entirely driven by improvement in the sotatercept group, not by deterioration in the placebo group,” Dr. Hoeper pointed out. Of note, change in mPAP correlated with changes in NT-proNBP and with changes in 6-minute walk distance (6MWD), the primary endpoint of the STELLAR trial. “We effectively unload the right ventricle by lowing the artery pressure. What we observe is exactly what we want to achieve in patients with PAH, because the heart is what really matters,” he concluded.
A new course in PAH treatment?
Olivier Sitbon, MD, PhD, professor of respiratory medicine at Université Paris-Saclay and consultant at the French Referral Center for Pulmonary Hypertension, echoed Dr. Hoeper’s enthusiasm. ,” he told this news organization.
Dr. Sitbon highlighted ongoing studies with sotatercept, including the ZENITH trial, focused on high-risk PAH patients, and the HYPERION trial, aimed at patients diagnosed within the first year of their PAH journey. He acknowledged that experts currently lack consensus on the ideal position for sotatercept within the PAH treatment algorithm. However, he anticipates a lively debate and expects sotatercept to find its place as a second-line treatment for intermediate low-risk or intermediate high-risk patients, with potential consideration for high-risk patients.
“There are two more studies ongoing with sotatercept: the ZENITH trial, dedicated to PAH patients at high risk, whose primary endpoint is mortality/need for lung transplant, and the HYPERION trial, dedicated to patients diagnosed less than 1 year (not really newly diagnosed but quite incident, while patients included in previous trial were very prevalent), whose primary endpoint is time to clinical worsening,” Dr. Sitbon noted, pointing out that there is currently no consensus among the experts about where to place sotatercept in the PAH treatment algorithm.
Further insights into sotatercept
The ERS Congress also unveiled two additional studies that provided fresh perspectives on sotatercept’s potential. Ioana R. Preston, MD, from Tufts Medical Center in Boston, presented the first interim analysis of SOTERIA, a long-term follow-up study involving 409 patients with a median exposure duration of 462 days to sotatercept. Treatment-emergent adverse events (TEAEs) were reported by 80% of patients, with 20% reporting a serious TEAE. Overall, four serious TEAEs (1% of patients) led to death, but only five patients (1.2%) discontinued sotatercept because of TEAE.
Notably, improvements in clinical efficacy measures persisted after 1 year. During SOTERIA, roughly 3% of patients on any prostacyclin discontinued it. “Results of SOTERIA support the long-term durable clinical benefit and safety of sotatercept for the treatment of PAH. Of note, patients were offered home self-administration therapy, so they do not need to come back to the office,” Dr. Preston said.
A second late-breaking abstract presented by Vallerie McLaughlin, MD, University of Michigan, Ann Arbor, described the possible long-term impact of sotatercept on morbidity and mortality. STELLAR trial data were analyzed to see how the risk profile of patients changed in the 24 weeks of study. Real-world registry data from the COMPERA registry were then used to extrapolate mortality and transplant need over 30 years based on risk transition. According to the simulation model, adding sotatercept to background therapy is expected to increase life expectancy by threefold, while avoiding nearly 700 hospitalizations and four lung/heart-lung transplantations per 1,000 patients. “Real-world data are needed to confirm these findings,” cautioned Dr. McLaughlin.
Dr. Hoeper disclosed speaking and consulting fees from Acceleron, Actelion, Altavant, AOP Health, Bayer, Ferrer, Janssen, Keros, and MSD. Dr. Sitbon disclosed speaking and consulting fees from Acceleron Pharmaceuticals, Altavant Sciences, AOP Orphan, Bayer, Ferrer, Gossamer Bio, Janssen, MSD, and United Therapeutics, and grant/research support from Acceleron Pharmaceuticals, AOP Orphan, Bayer, Janssen, and MSD. Dr. Preston disclosed speaking and consulting fees from Janssen and United Therapeutics, and grant/research support from Janssen and Respira Therapeutics. She has participated in scientific advisory boards for Aereovate, Altavant, and Gossamer Bio, and was in the Steering Committee of Acceleron, Liquidia, and United Therapeutics. Dr. McLaughlin has received speaking and consulting fees from Aerami, Aereovate, Caremark, Corvista, Enzyvant, Gossamer Bio, Janssen, Merck, United Therapeutics, and Vertex, and grant/research support from Aerovate, Enzyvant, Gossamer Bio, Janssen, Merck, and Sonovia. She is a member of the Board of Directors of Clene.
A version of this article first appeared on Medscape.com.
MILAN – Sotatercept, a first-in-class activin signaling inhibitor, is currently under scrutiny as a potential game-changer in the treatment of pulmonary arterial hypertension (PAH). Data unveiled at the annual congress of the European Respiratory Society, held in Milan, suggest that sotatercept treatment has the capacity to deliver significant clinical benefits and could reshape the trajectory of this challenging disease. Experts are cautiously optimistic that this drug may soon find a place within the PAH treatment algorithm.
The STELLAR trial: A milestone in PAH research
PAH is intricately linked to the dysregulation of members within the TGF-beta superfamily, including activin receptor type IIA (ActRIIA) and its ligands activin A and activin B. This signaling pathway is believed to be a driving force behind the pulmonary vascular remodeling observed in PAH patients. Sotatercept, a fusion protein acting as a ligand trap for selected TGF-beta superfamily members, has been proposed to recalibrate pulmonary vascular homeostasis by promoting growth-inhibiting and pro-apoptotic signaling.
Sotatercept was tested first in a phase 2 trial (PULSAR) and later in a phase 3 trial (STELLAR). The STELLAR clinical trial, funded by Acceleron Pharma (now a subsidiary of Merck), was the subject of two presentations given by Marius M. Hoeper, MD, director of the department of respiratory medicine at Hannover Medical School, Hannover, Germany.
Dr. Hoeper commented on results published in the New England Journal of Medicine during a session titled, “Disease modification in pulmonary arterial hypertension.” Later, during the “From the Editor’s Desk” session, he presented new results recently published in the European Respiratory Journal about the effects of sotatercept on hemodynamics and right heart function.
Disease modification in PAH
In his initial address, Dr. Hoeper expounded on the concept of reverse remodeling as a therapeutic avenue for PAH. “PAH is not a disease of pulmonary vasoconstriction,” he clarified, “but a disease of proliferation. Endothelial cells and pulmonary vascular muscle cells proliferate and obliterate the lumen. It has been hypothesized that when we target this system successfully, we may not only stop disease progression, but we may have a chance to have at least some reverse remodeling, because, if these cells go into apoptosis, there may be a partial reopening of the vessels.”
“Sotatercept is probably going to be a game changer in our field,” Dr. Hoeper continued. “Is sotatercept a disease-modifying agent? It certainly induces disease improvement; in a few patients, although not in the majority, we see a normalization of hemodynamics. We target the underlying pathophysiology; this is clearly distinct from symptomatic treatment.” Dr. Hoeper went through the list of characteristics that a disease-modifying agent should have.
“To be able to say that a drug endures sustained clinical benefit, according to the FDA, you need to withdraw the drug, and this is something we do not know. We know that we can interrupt the treatment once or twice, but long-term I do not believe that,” he said, while acknowledging the need for more extended-term safety and efficacy data.
Unmasking hemodynamic impact
Dr. Hoeper’s second presentation focused on a post hoc analysis of the STELLAR trial never presented before. He analyzed right heart catheterization (RHC) and echocardiography (ECHO) data. With sotatercept treatment at week 24, the researchers observed:
- A small increase in systemic blood pressure and systemic vascular resistance.
- No changes in systolic and diastolic volumes of the left ventricle (lv).
- A small but significant reduction in lv ejection fraction.
- A great reduction in the mean pulmonary artery pressure (mPAP).
- No change in cardiac output.
- An improvement in pulmonary artery compliance.
- A reduction in the right ventricle work and in right atrial pressure.
- An improvement of echocardiographic parameters, including a significant decrease in tricuspid regurgitation.
“A drop of roughly 14 mm Hg in mPAP is something that we have never seen in PAH with any other add-on medication. This was entirely driven by improvement in the sotatercept group, not by deterioration in the placebo group,” Dr. Hoeper pointed out. Of note, change in mPAP correlated with changes in NT-proNBP and with changes in 6-minute walk distance (6MWD), the primary endpoint of the STELLAR trial. “We effectively unload the right ventricle by lowing the artery pressure. What we observe is exactly what we want to achieve in patients with PAH, because the heart is what really matters,” he concluded.
A new course in PAH treatment?
Olivier Sitbon, MD, PhD, professor of respiratory medicine at Université Paris-Saclay and consultant at the French Referral Center for Pulmonary Hypertension, echoed Dr. Hoeper’s enthusiasm. ,” he told this news organization.
Dr. Sitbon highlighted ongoing studies with sotatercept, including the ZENITH trial, focused on high-risk PAH patients, and the HYPERION trial, aimed at patients diagnosed within the first year of their PAH journey. He acknowledged that experts currently lack consensus on the ideal position for sotatercept within the PAH treatment algorithm. However, he anticipates a lively debate and expects sotatercept to find its place as a second-line treatment for intermediate low-risk or intermediate high-risk patients, with potential consideration for high-risk patients.
“There are two more studies ongoing with sotatercept: the ZENITH trial, dedicated to PAH patients at high risk, whose primary endpoint is mortality/need for lung transplant, and the HYPERION trial, dedicated to patients diagnosed less than 1 year (not really newly diagnosed but quite incident, while patients included in previous trial were very prevalent), whose primary endpoint is time to clinical worsening,” Dr. Sitbon noted, pointing out that there is currently no consensus among the experts about where to place sotatercept in the PAH treatment algorithm.
Further insights into sotatercept
The ERS Congress also unveiled two additional studies that provided fresh perspectives on sotatercept’s potential. Ioana R. Preston, MD, from Tufts Medical Center in Boston, presented the first interim analysis of SOTERIA, a long-term follow-up study involving 409 patients with a median exposure duration of 462 days to sotatercept. Treatment-emergent adverse events (TEAEs) were reported by 80% of patients, with 20% reporting a serious TEAE. Overall, four serious TEAEs (1% of patients) led to death, but only five patients (1.2%) discontinued sotatercept because of TEAE.
Notably, improvements in clinical efficacy measures persisted after 1 year. During SOTERIA, roughly 3% of patients on any prostacyclin discontinued it. “Results of SOTERIA support the long-term durable clinical benefit and safety of sotatercept for the treatment of PAH. Of note, patients were offered home self-administration therapy, so they do not need to come back to the office,” Dr. Preston said.
A second late-breaking abstract presented by Vallerie McLaughlin, MD, University of Michigan, Ann Arbor, described the possible long-term impact of sotatercept on morbidity and mortality. STELLAR trial data were analyzed to see how the risk profile of patients changed in the 24 weeks of study. Real-world registry data from the COMPERA registry were then used to extrapolate mortality and transplant need over 30 years based on risk transition. According to the simulation model, adding sotatercept to background therapy is expected to increase life expectancy by threefold, while avoiding nearly 700 hospitalizations and four lung/heart-lung transplantations per 1,000 patients. “Real-world data are needed to confirm these findings,” cautioned Dr. McLaughlin.
Dr. Hoeper disclosed speaking and consulting fees from Acceleron, Actelion, Altavant, AOP Health, Bayer, Ferrer, Janssen, Keros, and MSD. Dr. Sitbon disclosed speaking and consulting fees from Acceleron Pharmaceuticals, Altavant Sciences, AOP Orphan, Bayer, Ferrer, Gossamer Bio, Janssen, MSD, and United Therapeutics, and grant/research support from Acceleron Pharmaceuticals, AOP Orphan, Bayer, Janssen, and MSD. Dr. Preston disclosed speaking and consulting fees from Janssen and United Therapeutics, and grant/research support from Janssen and Respira Therapeutics. She has participated in scientific advisory boards for Aereovate, Altavant, and Gossamer Bio, and was in the Steering Committee of Acceleron, Liquidia, and United Therapeutics. Dr. McLaughlin has received speaking and consulting fees from Aerami, Aereovate, Caremark, Corvista, Enzyvant, Gossamer Bio, Janssen, Merck, United Therapeutics, and Vertex, and grant/research support from Aerovate, Enzyvant, Gossamer Bio, Janssen, Merck, and Sonovia. She is a member of the Board of Directors of Clene.
A version of this article first appeared on Medscape.com.
AT ERS 2023
Sleep apnea diagnosis: Awareness and tools
Obstructive sleep apnea (OSA) remains a significantly underdiagnosed condition, despite its high prevalence. Primary care physicians play a pivotal role in identifying patients afflicted by this condition. To effectively diagnose OSA in primary care, increasing awareness and enhancing communication are imperative. Fortunately, several straightforward diagnostic tools are readily available, and even more sophisticated ones, driven by artificial intelligence, are on the horizon.
Recognize the problem
At the annual congress of the European Respiratory Society, Cláudia Sofia De Almeida Vicente Ferreira, MD, a family physician from Coimbra, Portugal, and coordinator of the Respiratory Diseases Interest Group of the Portuguese Association of General and Family Medicine, highlighted the challenges of diagnosing OSA.
People do not come to the doctor and complain about it. Sometimes you catch it in the middle of other things,” she said in an interview.
Moreover, physicians’ busy schedules and limited appointment times often lead to a focus on the symptoms reported by patients, and insufficient attention is paid to the quality of sleep. This may be compounded by a tendency among medical professionals to underestimate the risks associated with OSA, as it is not directly linked to mortality, despite its clear connection to cardiovascular risks.
Identifying and recognizing risk factors can facilitate OSA suspicion during patient evaluations. These factors encompass both structural (for example, craniofacial and upper airway anomalies) and nonstructural elements (for example, smoking, alcohol use, or sedative consumption). While men are at higher risk, postmenopausal women who are not receiving hormone replacement therapy face similar risks. Certain medical conditions, such as hypothyroidism, acromegaly, amyloidosis, Cushing syndrome, and Down syndrome, have also been associated with OSA. A comprehensive physical examination can provide additional clues. Factors might include obesity, neck circumference, Mallampati score, and nasal and pharyngeal problems.
Inquire actively
Once the possibility of OSA is considered, the next step is to ask patients about their symptoms. Questionnaires are simple yet valuable tools for this purpose. The STOP questionnaire comprises four key questions:
- Do you SNORE loudly (louder than talking or loud enough to be heard through closed doors)?
- Do you often feel TIRED, fatigued, or sleepy during daytime?
- Has anyone OBSERVED you stop breathing during your sleep?
- Do you have or are you being treated for high blood PRESSURE?
The STOP-BANG questionnaire adds four clinical attributes: obesity (body mass index > 35 kg/m2), age (> 50 years), neck size (> 40 cm, or 16 inches), and sex.
Patients are classified as being at low, intermediate, or high risk for OSA.
The Epworth Sleepiness Scale, which is self-administered, is also useful: patients rate the likelihood of falling asleep in various daytime contexts. These questionnaires can be seamlessly integrated into routine patient appointments.
Comorbidities and occupation
Primary care physicians should carefully assess comorbidities, especially those linked to cardiovascular risk. Patients with resistant hypertension, pulmonary hypertension, and recurrent atrial fibrillation following cardioversion/ablation should be prioritized for diagnostic testing for OSA. Patients with other conditions, such as coronary artery disease or cerebrovascular disease, should also be referred to a sleep center if OSA is suspected on the basis of comprehensive sleep assessment. OSA has also been associated with type 2 diabetes, metabolic syndrome, and asthma.
Gaining access to sleep study services and subsequent therapy, such as continuous positive airway pressure (CPAP), can be challenging. Primary care physicians should prioritize patients on the basis of their risk levels. Occupation plays a significant role in this prioritization, as sleep fragmentation and daytime sleepiness can lead to workplace and vehicular accidents.
“You should include the occupation in the patient’s profile. What is he doing? Is he sitting at a desk, or is he working at height, driving, or operating machines? These workers are high-risk patients,” continued Dr. De Almeida Vicente Ferreira.
“I think that the family physician has a key role in the follow-up. Nobody else will look for CPAP compliance and will verify if CPAP is working or not. If the patient is not using it or if it is not effective, still there is someone paying for the machine (the national health care system or an insurance company). More importantly, if CPAP is not working, we are not improving our patient’s life in terms of reducing cardiovascular risk and ameliorating the quality of life.”
Is home testing a viable option?
Diagnosing OSA typically relies on overnight polysomnography in specialized sleep clinics, which is often associated with long waiting lists. Researchers are actively working on innovative sensors and digital solutions for home-based sleep testing, but according to Dr. De Almeida Vicente Ferreira, they are not yet ready for prime time: “Home-based studies with fewer evaluation parameters (such as pulse and oxygen levels) are not so secure or sensitive to establish a correct and complete diagnosis. Actually, the architecture of sleep is very complex. The test must be performed and read by a specialized team.”
Still, according to Renaud Tamisier, MD, PhD, professor of clinical physiology at the Université Grenoble Alpes in La Tronche, France, simplified sleep testing could be very useful. “There are many patients that still are not diagnosed despite having severe sleep apnea, with symptoms and comorbidities. These patients usually are not aware of their disease but complain about changes in their quality of life with excessive tiredness and sleepiness. Also, they are not connected to the healthcare system, for different reasons, including no time for consulting a sleep physician and performing a polysomnography, health cost, negligence. Therefore, providing through primary care a simple diagnostic approach deserves efforts and research,” he said in an interview.
New technologies could enable diagnostic sleep tests to be conducted at home, with the added benefit of multiple-night recordings to overcome the challenges of night-to-night variability in the apnea-hypopnea index. These novel testing methods should be cost effective, easy to install, and user friendly. Dr. Tamisier continued: “The issue about sleep diagnosis is that up to now, there was no such devices available. Many physicians use type III sleep recording that are dedicated to highly trained sleep scorers, but they use automatic analysis which in many cases is unsuccessful. For a trained sleep physician, it is easy to see that the result is inaccurate. New devices are being built for automatic analysis using artificial intelligence algorithms. Because by design they are automatic, the rate of success is very high, and if used with the right purpose, they could be highly effective and quick.”
In conclusion, the diagnosis of sleep apnea in primary care is becoming more feasible with advancements in diagnostic tools and technology. However, it is crucial for primary care physicians to exercise caution in cases in which the clinical presentation is not straightforward or when OSA is associated with comorbidities. Care management and clear boundaries are vital to ensure effective treatment and improve patient outcomes.
Dr. De Almeida Vicente Ferreira and Dr. Tamisier disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Obstructive sleep apnea (OSA) remains a significantly underdiagnosed condition, despite its high prevalence. Primary care physicians play a pivotal role in identifying patients afflicted by this condition. To effectively diagnose OSA in primary care, increasing awareness and enhancing communication are imperative. Fortunately, several straightforward diagnostic tools are readily available, and even more sophisticated ones, driven by artificial intelligence, are on the horizon.
Recognize the problem
At the annual congress of the European Respiratory Society, Cláudia Sofia De Almeida Vicente Ferreira, MD, a family physician from Coimbra, Portugal, and coordinator of the Respiratory Diseases Interest Group of the Portuguese Association of General and Family Medicine, highlighted the challenges of diagnosing OSA.
People do not come to the doctor and complain about it. Sometimes you catch it in the middle of other things,” she said in an interview.
Moreover, physicians’ busy schedules and limited appointment times often lead to a focus on the symptoms reported by patients, and insufficient attention is paid to the quality of sleep. This may be compounded by a tendency among medical professionals to underestimate the risks associated with OSA, as it is not directly linked to mortality, despite its clear connection to cardiovascular risks.
Identifying and recognizing risk factors can facilitate OSA suspicion during patient evaluations. These factors encompass both structural (for example, craniofacial and upper airway anomalies) and nonstructural elements (for example, smoking, alcohol use, or sedative consumption). While men are at higher risk, postmenopausal women who are not receiving hormone replacement therapy face similar risks. Certain medical conditions, such as hypothyroidism, acromegaly, amyloidosis, Cushing syndrome, and Down syndrome, have also been associated with OSA. A comprehensive physical examination can provide additional clues. Factors might include obesity, neck circumference, Mallampati score, and nasal and pharyngeal problems.
Inquire actively
Once the possibility of OSA is considered, the next step is to ask patients about their symptoms. Questionnaires are simple yet valuable tools for this purpose. The STOP questionnaire comprises four key questions:
- Do you SNORE loudly (louder than talking or loud enough to be heard through closed doors)?
- Do you often feel TIRED, fatigued, or sleepy during daytime?
- Has anyone OBSERVED you stop breathing during your sleep?
- Do you have or are you being treated for high blood PRESSURE?
The STOP-BANG questionnaire adds four clinical attributes: obesity (body mass index > 35 kg/m2), age (> 50 years), neck size (> 40 cm, or 16 inches), and sex.
Patients are classified as being at low, intermediate, or high risk for OSA.
The Epworth Sleepiness Scale, which is self-administered, is also useful: patients rate the likelihood of falling asleep in various daytime contexts. These questionnaires can be seamlessly integrated into routine patient appointments.
Comorbidities and occupation
Primary care physicians should carefully assess comorbidities, especially those linked to cardiovascular risk. Patients with resistant hypertension, pulmonary hypertension, and recurrent atrial fibrillation following cardioversion/ablation should be prioritized for diagnostic testing for OSA. Patients with other conditions, such as coronary artery disease or cerebrovascular disease, should also be referred to a sleep center if OSA is suspected on the basis of comprehensive sleep assessment. OSA has also been associated with type 2 diabetes, metabolic syndrome, and asthma.
Gaining access to sleep study services and subsequent therapy, such as continuous positive airway pressure (CPAP), can be challenging. Primary care physicians should prioritize patients on the basis of their risk levels. Occupation plays a significant role in this prioritization, as sleep fragmentation and daytime sleepiness can lead to workplace and vehicular accidents.
“You should include the occupation in the patient’s profile. What is he doing? Is he sitting at a desk, or is he working at height, driving, or operating machines? These workers are high-risk patients,” continued Dr. De Almeida Vicente Ferreira.
“I think that the family physician has a key role in the follow-up. Nobody else will look for CPAP compliance and will verify if CPAP is working or not. If the patient is not using it or if it is not effective, still there is someone paying for the machine (the national health care system or an insurance company). More importantly, if CPAP is not working, we are not improving our patient’s life in terms of reducing cardiovascular risk and ameliorating the quality of life.”
Is home testing a viable option?
Diagnosing OSA typically relies on overnight polysomnography in specialized sleep clinics, which is often associated with long waiting lists. Researchers are actively working on innovative sensors and digital solutions for home-based sleep testing, but according to Dr. De Almeida Vicente Ferreira, they are not yet ready for prime time: “Home-based studies with fewer evaluation parameters (such as pulse and oxygen levels) are not so secure or sensitive to establish a correct and complete diagnosis. Actually, the architecture of sleep is very complex. The test must be performed and read by a specialized team.”
Still, according to Renaud Tamisier, MD, PhD, professor of clinical physiology at the Université Grenoble Alpes in La Tronche, France, simplified sleep testing could be very useful. “There are many patients that still are not diagnosed despite having severe sleep apnea, with symptoms and comorbidities. These patients usually are not aware of their disease but complain about changes in their quality of life with excessive tiredness and sleepiness. Also, they are not connected to the healthcare system, for different reasons, including no time for consulting a sleep physician and performing a polysomnography, health cost, negligence. Therefore, providing through primary care a simple diagnostic approach deserves efforts and research,” he said in an interview.
New technologies could enable diagnostic sleep tests to be conducted at home, with the added benefit of multiple-night recordings to overcome the challenges of night-to-night variability in the apnea-hypopnea index. These novel testing methods should be cost effective, easy to install, and user friendly. Dr. Tamisier continued: “The issue about sleep diagnosis is that up to now, there was no such devices available. Many physicians use type III sleep recording that are dedicated to highly trained sleep scorers, but they use automatic analysis which in many cases is unsuccessful. For a trained sleep physician, it is easy to see that the result is inaccurate. New devices are being built for automatic analysis using artificial intelligence algorithms. Because by design they are automatic, the rate of success is very high, and if used with the right purpose, they could be highly effective and quick.”
In conclusion, the diagnosis of sleep apnea in primary care is becoming more feasible with advancements in diagnostic tools and technology. However, it is crucial for primary care physicians to exercise caution in cases in which the clinical presentation is not straightforward or when OSA is associated with comorbidities. Care management and clear boundaries are vital to ensure effective treatment and improve patient outcomes.
Dr. De Almeida Vicente Ferreira and Dr. Tamisier disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Obstructive sleep apnea (OSA) remains a significantly underdiagnosed condition, despite its high prevalence. Primary care physicians play a pivotal role in identifying patients afflicted by this condition. To effectively diagnose OSA in primary care, increasing awareness and enhancing communication are imperative. Fortunately, several straightforward diagnostic tools are readily available, and even more sophisticated ones, driven by artificial intelligence, are on the horizon.
Recognize the problem
At the annual congress of the European Respiratory Society, Cláudia Sofia De Almeida Vicente Ferreira, MD, a family physician from Coimbra, Portugal, and coordinator of the Respiratory Diseases Interest Group of the Portuguese Association of General and Family Medicine, highlighted the challenges of diagnosing OSA.
People do not come to the doctor and complain about it. Sometimes you catch it in the middle of other things,” she said in an interview.
Moreover, physicians’ busy schedules and limited appointment times often lead to a focus on the symptoms reported by patients, and insufficient attention is paid to the quality of sleep. This may be compounded by a tendency among medical professionals to underestimate the risks associated with OSA, as it is not directly linked to mortality, despite its clear connection to cardiovascular risks.
Identifying and recognizing risk factors can facilitate OSA suspicion during patient evaluations. These factors encompass both structural (for example, craniofacial and upper airway anomalies) and nonstructural elements (for example, smoking, alcohol use, or sedative consumption). While men are at higher risk, postmenopausal women who are not receiving hormone replacement therapy face similar risks. Certain medical conditions, such as hypothyroidism, acromegaly, amyloidosis, Cushing syndrome, and Down syndrome, have also been associated with OSA. A comprehensive physical examination can provide additional clues. Factors might include obesity, neck circumference, Mallampati score, and nasal and pharyngeal problems.
Inquire actively
Once the possibility of OSA is considered, the next step is to ask patients about their symptoms. Questionnaires are simple yet valuable tools for this purpose. The STOP questionnaire comprises four key questions:
- Do you SNORE loudly (louder than talking or loud enough to be heard through closed doors)?
- Do you often feel TIRED, fatigued, or sleepy during daytime?
- Has anyone OBSERVED you stop breathing during your sleep?
- Do you have or are you being treated for high blood PRESSURE?
The STOP-BANG questionnaire adds four clinical attributes: obesity (body mass index > 35 kg/m2), age (> 50 years), neck size (> 40 cm, or 16 inches), and sex.
Patients are classified as being at low, intermediate, or high risk for OSA.
The Epworth Sleepiness Scale, which is self-administered, is also useful: patients rate the likelihood of falling asleep in various daytime contexts. These questionnaires can be seamlessly integrated into routine patient appointments.
Comorbidities and occupation
Primary care physicians should carefully assess comorbidities, especially those linked to cardiovascular risk. Patients with resistant hypertension, pulmonary hypertension, and recurrent atrial fibrillation following cardioversion/ablation should be prioritized for diagnostic testing for OSA. Patients with other conditions, such as coronary artery disease or cerebrovascular disease, should also be referred to a sleep center if OSA is suspected on the basis of comprehensive sleep assessment. OSA has also been associated with type 2 diabetes, metabolic syndrome, and asthma.
Gaining access to sleep study services and subsequent therapy, such as continuous positive airway pressure (CPAP), can be challenging. Primary care physicians should prioritize patients on the basis of their risk levels. Occupation plays a significant role in this prioritization, as sleep fragmentation and daytime sleepiness can lead to workplace and vehicular accidents.
“You should include the occupation in the patient’s profile. What is he doing? Is he sitting at a desk, or is he working at height, driving, or operating machines? These workers are high-risk patients,” continued Dr. De Almeida Vicente Ferreira.
“I think that the family physician has a key role in the follow-up. Nobody else will look for CPAP compliance and will verify if CPAP is working or not. If the patient is not using it or if it is not effective, still there is someone paying for the machine (the national health care system or an insurance company). More importantly, if CPAP is not working, we are not improving our patient’s life in terms of reducing cardiovascular risk and ameliorating the quality of life.”
Is home testing a viable option?
Diagnosing OSA typically relies on overnight polysomnography in specialized sleep clinics, which is often associated with long waiting lists. Researchers are actively working on innovative sensors and digital solutions for home-based sleep testing, but according to Dr. De Almeida Vicente Ferreira, they are not yet ready for prime time: “Home-based studies with fewer evaluation parameters (such as pulse and oxygen levels) are not so secure or sensitive to establish a correct and complete diagnosis. Actually, the architecture of sleep is very complex. The test must be performed and read by a specialized team.”
Still, according to Renaud Tamisier, MD, PhD, professor of clinical physiology at the Université Grenoble Alpes in La Tronche, France, simplified sleep testing could be very useful. “There are many patients that still are not diagnosed despite having severe sleep apnea, with symptoms and comorbidities. These patients usually are not aware of their disease but complain about changes in their quality of life with excessive tiredness and sleepiness. Also, they are not connected to the healthcare system, for different reasons, including no time for consulting a sleep physician and performing a polysomnography, health cost, negligence. Therefore, providing through primary care a simple diagnostic approach deserves efforts and research,” he said in an interview.
New technologies could enable diagnostic sleep tests to be conducted at home, with the added benefit of multiple-night recordings to overcome the challenges of night-to-night variability in the apnea-hypopnea index. These novel testing methods should be cost effective, easy to install, and user friendly. Dr. Tamisier continued: “The issue about sleep diagnosis is that up to now, there was no such devices available. Many physicians use type III sleep recording that are dedicated to highly trained sleep scorers, but they use automatic analysis which in many cases is unsuccessful. For a trained sleep physician, it is easy to see that the result is inaccurate. New devices are being built for automatic analysis using artificial intelligence algorithms. Because by design they are automatic, the rate of success is very high, and if used with the right purpose, they could be highly effective and quick.”
In conclusion, the diagnosis of sleep apnea in primary care is becoming more feasible with advancements in diagnostic tools and technology. However, it is crucial for primary care physicians to exercise caution in cases in which the clinical presentation is not straightforward or when OSA is associated with comorbidities. Care management and clear boundaries are vital to ensure effective treatment and improve patient outcomes.
Dr. De Almeida Vicente Ferreira and Dr. Tamisier disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ERS 2023