Megan Brooks

Progression-free survival (PFS) is now the dominant endpoint in cancer clinical trials, but simply prolonging time to progression without extending overall survival or quality of life does not justify additional therapy for many patients, new research indicates.
 

“The results of our study demonstrate that more than half of patients with advanced cancer would not want a treatment that delays time to progression on imaging without any improvement in survival or quality of life,” Christopher Booth, MD, an oncologist and professor at Queen’s University, Kingston, Ont., said in an interview.

Even with an overall survival benefit of 6 months, one in five patients said they would decline additional treatment, which indicates the limited value of extra months of life with better quality of life.

“This has very important implications for our field – how we design trials, how we write guidelines, and how we make treatment recommendations to our patients,” said Booth.

The findings highlight the importance of “making sure that we incorporate patient perspectives into what we do and the research around it,” agreed Richard Lee, MD, with City of Hope Comprehensive Cancer Center, Duarte, Calif., who wasn’t involved in the study.

“It’s easy for us to pick outcome measures that are important to us as researchers but really have very little value to the patient,” said Dr. Lee, associate editor (palliative care) for Cancer.Net, the American Society of Clinical Oncology patient information website.

The study was published online in the Journal of the National Cancer Institute.

Although PFS is often used as a primary endpoint in cancer drug trials, evidence indicates that PFS is typically a poor surrogate both for overall survival and quality of life. It’s also unclear how much patients value additional time with no progression, especially if it means extra toxicity with no overall survival or quality of life gains.

In the current study, Dr. Booth and colleagues wanted to better understand patients’ attitudes toward a treatment that offers PFS but does not improve overall survival.

The study involved 100 patients who had received at least 3 months of systemic therapy for incurable solid tumors. Nearly two-thirds of the patients were older than 60. They were asked about their preferences and goals for additional therapy. A variety of primary cancer sites were represented, most commonly gastrointestinal, breast, lung, genitourinary, and brain.

Among the patients interviewed, 80 were currently receiving palliative systemic treatment. Only one patient described the intent as curative; 45% described it as intending to prolong life, and 5% described it as intending to improve quality of life. The remainder had a combination of goals.

Overall, patients expressed a variety of preferences about additional treatment.

More than half (52%) said they would decline additional treatment that only offered PFS gains, while 26% said they would accept more treatment in the absence of an overall survival benefit if it meant delaying disease progression by 3-9 months.

About one in six patients (17%) said they would prefer additional treatment, even without any gain in PFS. These patients expressed “wanting to fight or hoping that they would defy the survival statistics” – an attitude that is “not irrational,” the researchers noted, but rather reflects the “more must be better” line of thinking.

Compared with the 26% of patients willing to undergo additional treatment for a PFS benefit but no overall survival benefit, 71% of patients said they would undergo more treatment for a 6-month gain in overall survival.
 

Weighing the benefits of more treatment

Overall, the findings suggest that while some patients are willing to undergo more toxic treatment regardless of PFS outcomes, most prefer to explicitly weigh the benefits of PFS, overall survival, and quality of life, Dr. Booth and colleagues said.

The findings also make clear the need to design randomized clinical trials that focus on endpoints and the gains that are of greatest value to patients.

“While there are a handful of circumstances in which PFS is a valid surrogate for overall survival, this is the exception and not the rule,” said Dr. Booth, who, along with colleagues, recently launched a global movement called Common Sense Oncology to help make cancer care and clinical trials more patient centered.

Drug companies like the PFS measure because it gives an answer quickly. “They don’t have to wait for the overall survival surrogate,” but in many cases, PFS is not a good primary endpoint, said Dr. Lee.

The exception, he noted, would be for some slow-growing cancers, such as low-grade prostate cancer, in which overall survival takes 10 years to gauge. “But outside of those few cancers, we need to stick to overall survival as the gold standard, and patients are basically telling us the same,” Dr. Lee explained.

What about a treatment that might not extend overall survival but could improve quality of life?

“It is easy to measure a year in life, but what about the life within a year,” Rachel Koven, MSc, author and patient advocate, Queen’s University Cancer Research Institute, said in an interview. “Beyond the potential for an extended number of days, what constitutes a ‘good’ day or a day well lived, and are the treatment decisions impacting that? While this may be different for each person, regardless of the definition used, it will still be of the utmost importance for all.”

Overall, Dr. Lee stressed, it’s important for oncologists to inform patients about what trial results show.

“We have to talk to patients and tell them a drug has shown progression-free improvement but not an overall survival benefit. That absolutely needs to be included in the discussion so that patients can give full, informed consent to what the treatment options are,” he said.

Ms. Koven agreed. “We must continuously strive to improve doctor-patient communication to ensure that patients facing incurable cancer can make evidence-based choices that match their unique goals, preferences, and needs,” she said.

“It is essential that care plans be created with outcomes that matter,” Ms. Koven said. “Treatments with small benefits lead to lost time for patients spent at the cancer center rather than with family and friends.”

The study was supported by the Canadian Institutes of Health Research. Dr. Booth, Ms. Koven, and Dr. Lee reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Progression-free survival (PFS) is now the dominant endpoint in cancer clinical trials, but simply prolonging time to progression without extending overall survival or quality of life does not justify additional therapy for many patients, new research indicates.
 

“The results of our study demonstrate that more than half of patients with advanced cancer would not want a treatment that delays time to progression on imaging without any improvement in survival or quality of life,” Christopher Booth, MD, an oncologist and professor at Queen’s University, Kingston, Ont., said in an interview.

Even with an overall survival benefit of 6 months, one in five patients said they would decline additional treatment, which indicates the limited value of extra months of life with better quality of life.

“This has very important implications for our field – how we design trials, how we write guidelines, and how we make treatment recommendations to our patients,” said Booth.

The findings highlight the importance of “making sure that we incorporate patient perspectives into what we do and the research around it,” agreed Richard Lee, MD, with City of Hope Comprehensive Cancer Center, Duarte, Calif., who wasn’t involved in the study.

“It’s easy for us to pick outcome measures that are important to us as researchers but really have very little value to the patient,” said Dr. Lee, associate editor (palliative care) for Cancer.Net, the American Society of Clinical Oncology patient information website.

The study was published online in the Journal of the National Cancer Institute.

Although PFS is often used as a primary endpoint in cancer drug trials, evidence indicates that PFS is typically a poor surrogate both for overall survival and quality of life. It’s also unclear how much patients value additional time with no progression, especially if it means extra toxicity with no overall survival or quality of life gains.

In the current study, Dr. Booth and colleagues wanted to better understand patients’ attitudes toward a treatment that offers PFS but does not improve overall survival.

The study involved 100 patients who had received at least 3 months of systemic therapy for incurable solid tumors. Nearly two-thirds of the patients were older than 60. They were asked about their preferences and goals for additional therapy. A variety of primary cancer sites were represented, most commonly gastrointestinal, breast, lung, genitourinary, and brain.

Among the patients interviewed, 80 were currently receiving palliative systemic treatment. Only one patient described the intent as curative; 45% described it as intending to prolong life, and 5% described it as intending to improve quality of life. The remainder had a combination of goals.

Overall, patients expressed a variety of preferences about additional treatment.

More than half (52%) said they would decline additional treatment that only offered PFS gains, while 26% said they would accept more treatment in the absence of an overall survival benefit if it meant delaying disease progression by 3-9 months.

About one in six patients (17%) said they would prefer additional treatment, even without any gain in PFS. These patients expressed “wanting to fight or hoping that they would defy the survival statistics” – an attitude that is “not irrational,” the researchers noted, but rather reflects the “more must be better” line of thinking.

Compared with the 26% of patients willing to undergo additional treatment for a PFS benefit but no overall survival benefit, 71% of patients said they would undergo more treatment for a 6-month gain in overall survival.
 

Weighing the benefits of more treatment

Overall, the findings suggest that while some patients are willing to undergo more toxic treatment regardless of PFS outcomes, most prefer to explicitly weigh the benefits of PFS, overall survival, and quality of life, Dr. Booth and colleagues said.

The findings also make clear the need to design randomized clinical trials that focus on endpoints and the gains that are of greatest value to patients.

“While there are a handful of circumstances in which PFS is a valid surrogate for overall survival, this is the exception and not the rule,” said Dr. Booth, who, along with colleagues, recently launched a global movement called Common Sense Oncology to help make cancer care and clinical trials more patient centered.

Drug companies like the PFS measure because it gives an answer quickly. “They don’t have to wait for the overall survival surrogate,” but in many cases, PFS is not a good primary endpoint, said Dr. Lee.

The exception, he noted, would be for some slow-growing cancers, such as low-grade prostate cancer, in which overall survival takes 10 years to gauge. “But outside of those few cancers, we need to stick to overall survival as the gold standard, and patients are basically telling us the same,” Dr. Lee explained.

What about a treatment that might not extend overall survival but could improve quality of life?

“It is easy to measure a year in life, but what about the life within a year,” Rachel Koven, MSc, author and patient advocate, Queen’s University Cancer Research Institute, said in an interview. “Beyond the potential for an extended number of days, what constitutes a ‘good’ day or a day well lived, and are the treatment decisions impacting that? While this may be different for each person, regardless of the definition used, it will still be of the utmost importance for all.”

Overall, Dr. Lee stressed, it’s important for oncologists to inform patients about what trial results show.

“We have to talk to patients and tell them a drug has shown progression-free improvement but not an overall survival benefit. That absolutely needs to be included in the discussion so that patients can give full, informed consent to what the treatment options are,” he said.

Ms. Koven agreed. “We must continuously strive to improve doctor-patient communication to ensure that patients facing incurable cancer can make evidence-based choices that match their unique goals, preferences, and needs,” she said.

“It is essential that care plans be created with outcomes that matter,” Ms. Koven said. “Treatments with small benefits lead to lost time for patients spent at the cancer center rather than with family and friends.”

The study was supported by the Canadian Institutes of Health Research. Dr. Booth, Ms. Koven, and Dr. Lee reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Progression-free survival (PFS) is now the dominant endpoint in cancer clinical trials, but simply prolonging time to progression without extending overall survival or quality of life does not justify additional therapy for many patients, new research indicates.
 

“The results of our study demonstrate that more than half of patients with advanced cancer would not want a treatment that delays time to progression on imaging without any improvement in survival or quality of life,” Christopher Booth, MD, an oncologist and professor at Queen’s University, Kingston, Ont., said in an interview.

Even with an overall survival benefit of 6 months, one in five patients said they would decline additional treatment, which indicates the limited value of extra months of life with better quality of life.

“This has very important implications for our field – how we design trials, how we write guidelines, and how we make treatment recommendations to our patients,” said Booth.

The findings highlight the importance of “making sure that we incorporate patient perspectives into what we do and the research around it,” agreed Richard Lee, MD, with City of Hope Comprehensive Cancer Center, Duarte, Calif., who wasn’t involved in the study.

“It’s easy for us to pick outcome measures that are important to us as researchers but really have very little value to the patient,” said Dr. Lee, associate editor (palliative care) for Cancer.Net, the American Society of Clinical Oncology patient information website.

The study was published online in the Journal of the National Cancer Institute.

Although PFS is often used as a primary endpoint in cancer drug trials, evidence indicates that PFS is typically a poor surrogate both for overall survival and quality of life. It’s also unclear how much patients value additional time with no progression, especially if it means extra toxicity with no overall survival or quality of life gains.

In the current study, Dr. Booth and colleagues wanted to better understand patients’ attitudes toward a treatment that offers PFS but does not improve overall survival.

The study involved 100 patients who had received at least 3 months of systemic therapy for incurable solid tumors. Nearly two-thirds of the patients were older than 60. They were asked about their preferences and goals for additional therapy. A variety of primary cancer sites were represented, most commonly gastrointestinal, breast, lung, genitourinary, and brain.

Among the patients interviewed, 80 were currently receiving palliative systemic treatment. Only one patient described the intent as curative; 45% described it as intending to prolong life, and 5% described it as intending to improve quality of life. The remainder had a combination of goals.

Overall, patients expressed a variety of preferences about additional treatment.

More than half (52%) said they would decline additional treatment that only offered PFS gains, while 26% said they would accept more treatment in the absence of an overall survival benefit if it meant delaying disease progression by 3-9 months.

About one in six patients (17%) said they would prefer additional treatment, even without any gain in PFS. These patients expressed “wanting to fight or hoping that they would defy the survival statistics” – an attitude that is “not irrational,” the researchers noted, but rather reflects the “more must be better” line of thinking.

Compared with the 26% of patients willing to undergo additional treatment for a PFS benefit but no overall survival benefit, 71% of patients said they would undergo more treatment for a 6-month gain in overall survival.
 

Weighing the benefits of more treatment

Overall, the findings suggest that while some patients are willing to undergo more toxic treatment regardless of PFS outcomes, most prefer to explicitly weigh the benefits of PFS, overall survival, and quality of life, Dr. Booth and colleagues said.

The findings also make clear the need to design randomized clinical trials that focus on endpoints and the gains that are of greatest value to patients.

“While there are a handful of circumstances in which PFS is a valid surrogate for overall survival, this is the exception and not the rule,” said Dr. Booth, who, along with colleagues, recently launched a global movement called Common Sense Oncology to help make cancer care and clinical trials more patient centered.

Drug companies like the PFS measure because it gives an answer quickly. “They don’t have to wait for the overall survival surrogate,” but in many cases, PFS is not a good primary endpoint, said Dr. Lee.

The exception, he noted, would be for some slow-growing cancers, such as low-grade prostate cancer, in which overall survival takes 10 years to gauge. “But outside of those few cancers, we need to stick to overall survival as the gold standard, and patients are basically telling us the same,” Dr. Lee explained.

What about a treatment that might not extend overall survival but could improve quality of life?

“It is easy to measure a year in life, but what about the life within a year,” Rachel Koven, MSc, author and patient advocate, Queen’s University Cancer Research Institute, said in an interview. “Beyond the potential for an extended number of days, what constitutes a ‘good’ day or a day well lived, and are the treatment decisions impacting that? While this may be different for each person, regardless of the definition used, it will still be of the utmost importance for all.”

Overall, Dr. Lee stressed, it’s important for oncologists to inform patients about what trial results show.

“We have to talk to patients and tell them a drug has shown progression-free improvement but not an overall survival benefit. That absolutely needs to be included in the discussion so that patients can give full, informed consent to what the treatment options are,” he said.

Ms. Koven agreed. “We must continuously strive to improve doctor-patient communication to ensure that patients facing incurable cancer can make evidence-based choices that match their unique goals, preferences, and needs,” she said.

“It is essential that care plans be created with outcomes that matter,” Ms. Koven said. “Treatments with small benefits lead to lost time for patients spent at the cancer center rather than with family and friends.”

The study was supported by the Canadian Institutes of Health Research. Dr. Booth, Ms. Koven, and Dr. Lee reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

The artificial intelligence chatbot ChatGPT can potentially be used as source of information for patients, as well as an aid to clinicians managing gastroesophageal reflux disease (GERD), investigators have found.

The researchers say the tool’s conversational format could improve clinical efficiency and reduce the volume of patient messages and calls, potentially diminishing clinician burnout.

However, inconsistencies and content errors observed require a certain level of clinical oversight, caution the researchers, led by Jacqueline Henson, MD, with the division of gastroenterology, Duke University, Durham, N.C.

The study was published online in the American Journal of Gastroenterology.
 

Putting ChatGPT to the GERD test

Affecting nearly 30% of U.S. adults, GERD is a common and increasingly complex condition to manage. AI technologies like ChatGPT (Open AI/Microsoft) have demonstrated an increasing role in medicine, although the ability of ChatGPT to provide guidance for GERD management is uncertain.

Dr. Henson and colleagues assessed ChatGPT’s ability to provide accurate and specific responses to questions regarding GERD care.

They generated 23 GERD management prompts based on published clinical guidelines and expert consensus recommendations. Five questions were about diagnosis, eleven on treatment, and seven on both diagnosis and treatment.

Each prompt was submitted to ChatGPT 3.5 (version 3/14/2023) three times on separate occasions without feedback to assess the consistency of the answer. Responses were rated by three board-certified gastroenterologists for appropriateness and specificity.

ChatGPT returned appropriate responses to 63 of 69 (91.3%) queries, with 29% considered completely appropriate and 62.3% mostly appropriate.

However, responses to the same prompt were often inconsistent, with 16 of 23 (70%) prompts yielding varying appropriateness, including three (13%) with both inappropriate and appropriate responses.

Prompts regarding treatment received the highest proportion of completely appropriate responses (39.4%), while prompts for diagnosis and management had the highest proportion of mostly inappropriate responses (14.3%).

For example, the chatbot failed to recommend consideration of Roux-en-Y gastric bypass for ongoing GERD symptoms with pathologic acid exposure in the setting of obesity, and some potential risks associated with proton pump inhibitor therapy were stated as fact.

However, the majority (78.3%) of responses contained at least some specific guidance, especially for prompts assessing diagnosis (93.3%). In all responses, ChatGPT suggested contacting a health care professional for further advice.

Eight patients from a range of educational backgrounds who provided feedback on the responses generally felt that the ChatGPT responses were both understandable and useful.

Overall, ChatGPT “provided largely appropriate and at least some specific guidance for GERD management, highlighting the potential for this technology to serve as a source of information for patients, as well as an aid for clinicians,” Dr. Henson and colleagues write.

However, “the presence of inappropriate responses with inconsistencies to the same prompt largely preclude its application within health care in its present state, at least for GERD,” they add.

The study had no commercial funding. Dr. Henson has served as a consultant for Medtronic.

A version of this article first appeared on Medscape.com.

The artificial intelligence chatbot ChatGPT can potentially be used as source of information for patients, as well as an aid to clinicians managing gastroesophageal reflux disease (GERD), investigators have found.

The researchers say the tool’s conversational format could improve clinical efficiency and reduce the volume of patient messages and calls, potentially diminishing clinician burnout.

However, inconsistencies and content errors observed require a certain level of clinical oversight, caution the researchers, led by Jacqueline Henson, MD, with the division of gastroenterology, Duke University, Durham, N.C.

The study was published online in the American Journal of Gastroenterology.
 

Putting ChatGPT to the GERD test

Affecting nearly 30% of U.S. adults, GERD is a common and increasingly complex condition to manage. AI technologies like ChatGPT (Open AI/Microsoft) have demonstrated an increasing role in medicine, although the ability of ChatGPT to provide guidance for GERD management is uncertain.

Dr. Henson and colleagues assessed ChatGPT’s ability to provide accurate and specific responses to questions regarding GERD care.

They generated 23 GERD management prompts based on published clinical guidelines and expert consensus recommendations. Five questions were about diagnosis, eleven on treatment, and seven on both diagnosis and treatment.

Each prompt was submitted to ChatGPT 3.5 (version 3/14/2023) three times on separate occasions without feedback to assess the consistency of the answer. Responses were rated by three board-certified gastroenterologists for appropriateness and specificity.

ChatGPT returned appropriate responses to 63 of 69 (91.3%) queries, with 29% considered completely appropriate and 62.3% mostly appropriate.

However, responses to the same prompt were often inconsistent, with 16 of 23 (70%) prompts yielding varying appropriateness, including three (13%) with both inappropriate and appropriate responses.

Prompts regarding treatment received the highest proportion of completely appropriate responses (39.4%), while prompts for diagnosis and management had the highest proportion of mostly inappropriate responses (14.3%).

For example, the chatbot failed to recommend consideration of Roux-en-Y gastric bypass for ongoing GERD symptoms with pathologic acid exposure in the setting of obesity, and some potential risks associated with proton pump inhibitor therapy were stated as fact.

However, the majority (78.3%) of responses contained at least some specific guidance, especially for prompts assessing diagnosis (93.3%). In all responses, ChatGPT suggested contacting a health care professional for further advice.

Eight patients from a range of educational backgrounds who provided feedback on the responses generally felt that the ChatGPT responses were both understandable and useful.

Overall, ChatGPT “provided largely appropriate and at least some specific guidance for GERD management, highlighting the potential for this technology to serve as a source of information for patients, as well as an aid for clinicians,” Dr. Henson and colleagues write.

However, “the presence of inappropriate responses with inconsistencies to the same prompt largely preclude its application within health care in its present state, at least for GERD,” they add.

The study had no commercial funding. Dr. Henson has served as a consultant for Medtronic.

A version of this article first appeared on Medscape.com.

The artificial intelligence chatbot ChatGPT can potentially be used as source of information for patients, as well as an aid to clinicians managing gastroesophageal reflux disease (GERD), investigators have found.

The researchers say the tool’s conversational format could improve clinical efficiency and reduce the volume of patient messages and calls, potentially diminishing clinician burnout.

However, inconsistencies and content errors observed require a certain level of clinical oversight, caution the researchers, led by Jacqueline Henson, MD, with the division of gastroenterology, Duke University, Durham, N.C.

The study was published online in the American Journal of Gastroenterology.
 

Putting ChatGPT to the GERD test

Affecting nearly 30% of U.S. adults, GERD is a common and increasingly complex condition to manage. AI technologies like ChatGPT (Open AI/Microsoft) have demonstrated an increasing role in medicine, although the ability of ChatGPT to provide guidance for GERD management is uncertain.

Dr. Henson and colleagues assessed ChatGPT’s ability to provide accurate and specific responses to questions regarding GERD care.

They generated 23 GERD management prompts based on published clinical guidelines and expert consensus recommendations. Five questions were about diagnosis, eleven on treatment, and seven on both diagnosis and treatment.

Each prompt was submitted to ChatGPT 3.5 (version 3/14/2023) three times on separate occasions without feedback to assess the consistency of the answer. Responses were rated by three board-certified gastroenterologists for appropriateness and specificity.

ChatGPT returned appropriate responses to 63 of 69 (91.3%) queries, with 29% considered completely appropriate and 62.3% mostly appropriate.

However, responses to the same prompt were often inconsistent, with 16 of 23 (70%) prompts yielding varying appropriateness, including three (13%) with both inappropriate and appropriate responses.

Prompts regarding treatment received the highest proportion of completely appropriate responses (39.4%), while prompts for diagnosis and management had the highest proportion of mostly inappropriate responses (14.3%).

For example, the chatbot failed to recommend consideration of Roux-en-Y gastric bypass for ongoing GERD symptoms with pathologic acid exposure in the setting of obesity, and some potential risks associated with proton pump inhibitor therapy were stated as fact.

However, the majority (78.3%) of responses contained at least some specific guidance, especially for prompts assessing diagnosis (93.3%). In all responses, ChatGPT suggested contacting a health care professional for further advice.

Eight patients from a range of educational backgrounds who provided feedback on the responses generally felt that the ChatGPT responses were both understandable and useful.

Overall, ChatGPT “provided largely appropriate and at least some specific guidance for GERD management, highlighting the potential for this technology to serve as a source of information for patients, as well as an aid for clinicians,” Dr. Henson and colleagues write.

However, “the presence of inappropriate responses with inconsistencies to the same prompt largely preclude its application within health care in its present state, at least for GERD,” they add.

The study had no commercial funding. Dr. Henson has served as a consultant for Medtronic.

A version of this article first appeared on Medscape.com.

Abiomed is recalling all Impella left-sided blood pumps in the United States over a potential safety issue when used in patients with a transcatheter aortic valve replacement (TAVR) stent – something that is not adequately addressed in the pumps’ current instructions for use (IFU).

This recall represents a “voluntary correction, not a product removal.” Impella heart pumps do not need to be returned, the U.S. Food and Drug Administration says.

Instead, the company will update the pump’s IFU to include guidance to clinicians on how to manage use of Impella in patients with TAVR.

Clinicians may continue to use the Impella devices, with the additional instructions for patients with TAVR in mind, the FDA says.

As explained in the recall notice, there is a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR, which may damage or destroy the motor’s impeller blades.

“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream,” the notice warns.

The recall covers 7895 devices distributed from May 1, 2021, to the present, including the following devices:

• Impella 5.0 Blood Pump, product number 005062
• Impella CP Blood Pump, product number 0048-0032
• Impella 2.5 Blood Pump, product number 005042
• Impella CP with SmartAssist Blood Pump, product numbers 0048-0024, 0048-0045, and 1000080
• Impella LD Blood Pump, product number 005082
• Impella 5.5 with SmartAssist Blood Pump, product numbers 0550-0008 and 1000100.

Abiomed reports 30 complaints, 26 injuries, and 4 deaths related to this issue, which has garnered a class I recall from the FDA, the most serious type.

In an urgent device correction letter sent to health care professionals in June, Abiomed says, “For a patient with TAVR who needs hemodynamic support, clinicians should factor this risk into the risk benefit analysis and are cautioned to position the Impella system carefully as directed in this notification.

“The risk of interaction is increased for oversized or under expanded frames with the distal ends not flush with the aortic wall, resulting in the distal stent structures oriented in such a way as to potentially enter the outflow window and allow contact of the end of the stent with the spinning impeller,” the letter states.

Clinicians are advised to avoid repositioning while the device is spinning and to turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity with the valve stent structures.

If low flow is observed in a patient implanted with a TAVR while on Impella heart pump support, clinicians should consider damage of the impeller and replace the Impella pump as soon as possible, the company says.

Questions about this recall can be addressed to Shashi Thoutam at 734-262-6255 and/or local clinical field staff.

Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

A version of this article first appeared on Medscape.com.

Abiomed is recalling all Impella left-sided blood pumps in the United States over a potential safety issue when used in patients with a transcatheter aortic valve replacement (TAVR) stent – something that is not adequately addressed in the pumps’ current instructions for use (IFU).

This recall represents a “voluntary correction, not a product removal.” Impella heart pumps do not need to be returned, the U.S. Food and Drug Administration says.

Instead, the company will update the pump’s IFU to include guidance to clinicians on how to manage use of Impella in patients with TAVR.

Clinicians may continue to use the Impella devices, with the additional instructions for patients with TAVR in mind, the FDA says.

As explained in the recall notice, there is a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR, which may damage or destroy the motor’s impeller blades.

“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream,” the notice warns.

The recall covers 7895 devices distributed from May 1, 2021, to the present, including the following devices:

• Impella 5.0 Blood Pump, product number 005062
• Impella CP Blood Pump, product number 0048-0032
• Impella 2.5 Blood Pump, product number 005042
• Impella CP with SmartAssist Blood Pump, product numbers 0048-0024, 0048-0045, and 1000080
• Impella LD Blood Pump, product number 005082
• Impella 5.5 with SmartAssist Blood Pump, product numbers 0550-0008 and 1000100.

Abiomed reports 30 complaints, 26 injuries, and 4 deaths related to this issue, which has garnered a class I recall from the FDA, the most serious type.

In an urgent device correction letter sent to health care professionals in June, Abiomed says, “For a patient with TAVR who needs hemodynamic support, clinicians should factor this risk into the risk benefit analysis and are cautioned to position the Impella system carefully as directed in this notification.

“The risk of interaction is increased for oversized or under expanded frames with the distal ends not flush with the aortic wall, resulting in the distal stent structures oriented in such a way as to potentially enter the outflow window and allow contact of the end of the stent with the spinning impeller,” the letter states.

Clinicians are advised to avoid repositioning while the device is spinning and to turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity with the valve stent structures.

If low flow is observed in a patient implanted with a TAVR while on Impella heart pump support, clinicians should consider damage of the impeller and replace the Impella pump as soon as possible, the company says.

Questions about this recall can be addressed to Shashi Thoutam at 734-262-6255 and/or local clinical field staff.

Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

A version of this article first appeared on Medscape.com.

Abiomed is recalling all Impella left-sided blood pumps in the United States over a potential safety issue when used in patients with a transcatheter aortic valve replacement (TAVR) stent – something that is not adequately addressed in the pumps’ current instructions for use (IFU).

This recall represents a “voluntary correction, not a product removal.” Impella heart pumps do not need to be returned, the U.S. Food and Drug Administration says.

Instead, the company will update the pump’s IFU to include guidance to clinicians on how to manage use of Impella in patients with TAVR.

Clinicians may continue to use the Impella devices, with the additional instructions for patients with TAVR in mind, the FDA says.

As explained in the recall notice, there is a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR, which may damage or destroy the motor’s impeller blades.

“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream,” the notice warns.

The recall covers 7895 devices distributed from May 1, 2021, to the present, including the following devices:

• Impella 5.0 Blood Pump, product number 005062
• Impella CP Blood Pump, product number 0048-0032
• Impella 2.5 Blood Pump, product number 005042
• Impella CP with SmartAssist Blood Pump, product numbers 0048-0024, 0048-0045, and 1000080
• Impella LD Blood Pump, product number 005082
• Impella 5.5 with SmartAssist Blood Pump, product numbers 0550-0008 and 1000100.

Abiomed reports 30 complaints, 26 injuries, and 4 deaths related to this issue, which has garnered a class I recall from the FDA, the most serious type.

In an urgent device correction letter sent to health care professionals in June, Abiomed says, “For a patient with TAVR who needs hemodynamic support, clinicians should factor this risk into the risk benefit analysis and are cautioned to position the Impella system carefully as directed in this notification.

“The risk of interaction is increased for oversized or under expanded frames with the distal ends not flush with the aortic wall, resulting in the distal stent structures oriented in such a way as to potentially enter the outflow window and allow contact of the end of the stent with the spinning impeller,” the letter states.

Clinicians are advised to avoid repositioning while the device is spinning and to turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity with the valve stent structures.

If low flow is observed in a patient implanted with a TAVR while on Impella heart pump support, clinicians should consider damage of the impeller and replace the Impella pump as soon as possible, the company says.

Questions about this recall can be addressed to Shashi Thoutam at 734-262-6255 and/or local clinical field staff.

Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

A version of this article first appeared on Medscape.com.

Recently published conclusions from the first interim analysis of overall survival in the IMpower010 trial of adjuvant atezolizumab for non–small cell lung cancer (NSCLC) have met with some pushback on Twitter.

Here’s why.

At a median follow-up of 45.3 months, 127 of 507 patients (25%) in the atezolizumab group and 124 of 498 (24.9%) in the best supportive care group had died.

Among all 882 patients with stage II-IIIA disease, the investigators found no significant improvement in overall survival with atezolizumab, compared with best supportive care (hazard ratio, 0.95; 95% confidence interval, 0.74-1.24).

The researchers, however, concluded that the trial showed a “positive” trend favoring atezolizumab in PD-L1 subgroup analyses.

In a subgroup of 476 patients with tumor PD-L1 expression ≥ 1%, patients who received atezolizumab exhibited a nonsignificant 29% improvement in overall survival (HR, 0.71; 95% CI, 0.49-1.03). The best results were in the subgroup of 229 patients with tumor PD-L1 expression ≥ 50% – these patients exhibited a 57% improvement in overall survival with atezolizumab (HR, 0.43; 95% CI, 0.24-0.78). Those with PD-L1 expression 1%-49%, however, demonstrated no improvement in overall survival (HR, 0.95).

In a Twitter post, H. Jack West, MD, City of Hope Comprehensive Cancer Center, Duarte, Calif., urged caution in interpreting the study data: “Let’s be clear: OS results are neg for OS benefit in PD-L1+ NSCLC. If we’re going to rely on smaller subgroups to highlight HR of 0.43 for those w/high PD-L1, we should also note HR for OS was 0.95 (i.e., NO trend for OS benefit) for those w/PD-L1 1-49%.”

The tweet continued: “With favorable results driven entirely by a 30% subgroup, it’s understandable that Roche would want to also promote benefit in broader population. But we shouldn’t perpetuate misinformation that there’s a benefit for broad group of PD-L1+, even if the effort is to market it this way.”

In an interview, Dr. West elaborated on his tweet, explaining that the way the overall survival data are presented in the paper is “disingenuous and misleading.”

The paper clearly highlights that the drug was significantly beneficial for the narrower population who had high PD-L1 expression. But the hazard ratio of 0.95 for the entire population is like “where’s Waldo in this paper. It’s almost impossible to find, but it should have been prominently included in the figure of results by subgroup,” Dr. West said.

“This is something that should have been objected to by the oncologists on the paper and by the reviews and the editors,” Dr. West said.

Two other oncologists agreed.

Joel Grossman, MD, tweeted: “Bingo. I’m not sure we need cancer ground shots or lengthy treatises on common sense, but I am damn sure we need honest interpretation of clinical trial data as Jack shows here. We can’t tolerate over-broad borderline deception that leads to poor and wasteful decision-making.”

Jeff Ryckman, MD, tweeted: “Problem is, this is a routine FDA #CarteBlanche approval regardless of no benefit in PD-L1 1%-49%. This will be Rx’d to everyone.”
 

Regulatory ‘gamesmanship’

The results of the IMpower010 analysis were published online in Annals of Oncology. The interim overall survival data were first reported last year at the World Conference on Lung Cancer.

IMpower010 was a global, randomized, open-label trial of 1,280 patients with completely resected stage IB (tumors ≥ 4 cm) through stage IIIA NSCLC for whom tissue samples were available for PD-L1 analysis.

All patients received four cycles of chemotherapy with cisplatin plus either pemetrexed, gemcitabine, docetaxel, or vinorelbine and were randomly assigned in a 1:1 ratio to receive either 16 cycles of atezolizumab or best supportive care.

Interim disease-free survival (DFS) results from IMpower010, presented at ASCO 2021, showed that patients with PD-L1 expression ≥ 1% experienced a 34% improvement in DFS, equating to a 21% improvement across all randomly assigned patients with stage II-IIIA disease.

On the basis of DFS findings, in 2021, the U.S. Food and Drug Administration granted atezolizumab a new indication – the adjuvant treatment following resection and platinum-based chemotherapy for patients with stage II-IIIA NSCLC whose tumors have PD-L1 expression ≥ 1%.

Looking at the big picture, Dr. West noted that regulatory approval for a drug allows for a certain amount of “gamesmanship.”

“It behooves a company to work with FDA to get approval for a broader population than it should be, relative to where the true clinical benefit lies,” he explained.

To this end, Dr. West noted that progression-free survival is increasingly being used as a primary endpoint in trials, but long-term data indicate that this surrogate endpoint is often not tethered to an overall survival benefit. However, drugs are often being approved now on the basis of a progression-free survival benefit.

“Unfortunately, that’s the system we live in today, with a bias toward, ‘If it could plausibly be interpreted as beneficial, we’ll wave it through for the broadest population possible,” Dr. West said.

The IMpower010 study and Annals of Oncology manuscript were funded by F. Hoffmann-La Roche. Several authors have disclosed relationships with the company. Dr. West has a regular column on Medscape.com and reported personal fees from AstraZeneca, Genentech/Roche, Merck, and Regeneron.

A version of this article appeared on Medscape.com.

Recently published conclusions from the first interim analysis of overall survival in the IMpower010 trial of adjuvant atezolizumab for non–small cell lung cancer (NSCLC) have met with some pushback on Twitter.

Here’s why.

At a median follow-up of 45.3 months, 127 of 507 patients (25%) in the atezolizumab group and 124 of 498 (24.9%) in the best supportive care group had died.

Among all 882 patients with stage II-IIIA disease, the investigators found no significant improvement in overall survival with atezolizumab, compared with best supportive care (hazard ratio, 0.95; 95% confidence interval, 0.74-1.24).

The researchers, however, concluded that the trial showed a “positive” trend favoring atezolizumab in PD-L1 subgroup analyses.

In a subgroup of 476 patients with tumor PD-L1 expression ≥ 1%, patients who received atezolizumab exhibited a nonsignificant 29% improvement in overall survival (HR, 0.71; 95% CI, 0.49-1.03). The best results were in the subgroup of 229 patients with tumor PD-L1 expression ≥ 50% – these patients exhibited a 57% improvement in overall survival with atezolizumab (HR, 0.43; 95% CI, 0.24-0.78). Those with PD-L1 expression 1%-49%, however, demonstrated no improvement in overall survival (HR, 0.95).

In a Twitter post, H. Jack West, MD, City of Hope Comprehensive Cancer Center, Duarte, Calif., urged caution in interpreting the study data: “Let’s be clear: OS results are neg for OS benefit in PD-L1+ NSCLC. If we’re going to rely on smaller subgroups to highlight HR of 0.43 for those w/high PD-L1, we should also note HR for OS was 0.95 (i.e., NO trend for OS benefit) for those w/PD-L1 1-49%.”

The tweet continued: “With favorable results driven entirely by a 30% subgroup, it’s understandable that Roche would want to also promote benefit in broader population. But we shouldn’t perpetuate misinformation that there’s a benefit for broad group of PD-L1+, even if the effort is to market it this way.”

In an interview, Dr. West elaborated on his tweet, explaining that the way the overall survival data are presented in the paper is “disingenuous and misleading.”

The paper clearly highlights that the drug was significantly beneficial for the narrower population who had high PD-L1 expression. But the hazard ratio of 0.95 for the entire population is like “where’s Waldo in this paper. It’s almost impossible to find, but it should have been prominently included in the figure of results by subgroup,” Dr. West said.

“This is something that should have been objected to by the oncologists on the paper and by the reviews and the editors,” Dr. West said.

Two other oncologists agreed.

Joel Grossman, MD, tweeted: “Bingo. I’m not sure we need cancer ground shots or lengthy treatises on common sense, but I am damn sure we need honest interpretation of clinical trial data as Jack shows here. We can’t tolerate over-broad borderline deception that leads to poor and wasteful decision-making.”

Jeff Ryckman, MD, tweeted: “Problem is, this is a routine FDA #CarteBlanche approval regardless of no benefit in PD-L1 1%-49%. This will be Rx’d to everyone.”
 

Regulatory ‘gamesmanship’

The results of the IMpower010 analysis were published online in Annals of Oncology. The interim overall survival data were first reported last year at the World Conference on Lung Cancer.

IMpower010 was a global, randomized, open-label trial of 1,280 patients with completely resected stage IB (tumors ≥ 4 cm) through stage IIIA NSCLC for whom tissue samples were available for PD-L1 analysis.

All patients received four cycles of chemotherapy with cisplatin plus either pemetrexed, gemcitabine, docetaxel, or vinorelbine and were randomly assigned in a 1:1 ratio to receive either 16 cycles of atezolizumab or best supportive care.

Interim disease-free survival (DFS) results from IMpower010, presented at ASCO 2021, showed that patients with PD-L1 expression ≥ 1% experienced a 34% improvement in DFS, equating to a 21% improvement across all randomly assigned patients with stage II-IIIA disease.

On the basis of DFS findings, in 2021, the U.S. Food and Drug Administration granted atezolizumab a new indication – the adjuvant treatment following resection and platinum-based chemotherapy for patients with stage II-IIIA NSCLC whose tumors have PD-L1 expression ≥ 1%.

Looking at the big picture, Dr. West noted that regulatory approval for a drug allows for a certain amount of “gamesmanship.”

“It behooves a company to work with FDA to get approval for a broader population than it should be, relative to where the true clinical benefit lies,” he explained.

To this end, Dr. West noted that progression-free survival is increasingly being used as a primary endpoint in trials, but long-term data indicate that this surrogate endpoint is often not tethered to an overall survival benefit. However, drugs are often being approved now on the basis of a progression-free survival benefit.

“Unfortunately, that’s the system we live in today, with a bias toward, ‘If it could plausibly be interpreted as beneficial, we’ll wave it through for the broadest population possible,” Dr. West said.

The IMpower010 study and Annals of Oncology manuscript were funded by F. Hoffmann-La Roche. Several authors have disclosed relationships with the company. Dr. West has a regular column on Medscape.com and reported personal fees from AstraZeneca, Genentech/Roche, Merck, and Regeneron.

A version of this article appeared on Medscape.com.

Recently published conclusions from the first interim analysis of overall survival in the IMpower010 trial of adjuvant atezolizumab for non–small cell lung cancer (NSCLC) have met with some pushback on Twitter.

Here’s why.

At a median follow-up of 45.3 months, 127 of 507 patients (25%) in the atezolizumab group and 124 of 498 (24.9%) in the best supportive care group had died.

Among all 882 patients with stage II-IIIA disease, the investigators found no significant improvement in overall survival with atezolizumab, compared with best supportive care (hazard ratio, 0.95; 95% confidence interval, 0.74-1.24).

The researchers, however, concluded that the trial showed a “positive” trend favoring atezolizumab in PD-L1 subgroup analyses.

In a subgroup of 476 patients with tumor PD-L1 expression ≥ 1%, patients who received atezolizumab exhibited a nonsignificant 29% improvement in overall survival (HR, 0.71; 95% CI, 0.49-1.03). The best results were in the subgroup of 229 patients with tumor PD-L1 expression ≥ 50% – these patients exhibited a 57% improvement in overall survival with atezolizumab (HR, 0.43; 95% CI, 0.24-0.78). Those with PD-L1 expression 1%-49%, however, demonstrated no improvement in overall survival (HR, 0.95).

In a Twitter post, H. Jack West, MD, City of Hope Comprehensive Cancer Center, Duarte, Calif., urged caution in interpreting the study data: “Let’s be clear: OS results are neg for OS benefit in PD-L1+ NSCLC. If we’re going to rely on smaller subgroups to highlight HR of 0.43 for those w/high PD-L1, we should also note HR for OS was 0.95 (i.e., NO trend for OS benefit) for those w/PD-L1 1-49%.”

The tweet continued: “With favorable results driven entirely by a 30% subgroup, it’s understandable that Roche would want to also promote benefit in broader population. But we shouldn’t perpetuate misinformation that there’s a benefit for broad group of PD-L1+, even if the effort is to market it this way.”

In an interview, Dr. West elaborated on his tweet, explaining that the way the overall survival data are presented in the paper is “disingenuous and misleading.”

The paper clearly highlights that the drug was significantly beneficial for the narrower population who had high PD-L1 expression. But the hazard ratio of 0.95 for the entire population is like “where’s Waldo in this paper. It’s almost impossible to find, but it should have been prominently included in the figure of results by subgroup,” Dr. West said.

“This is something that should have been objected to by the oncologists on the paper and by the reviews and the editors,” Dr. West said.

Two other oncologists agreed.

Joel Grossman, MD, tweeted: “Bingo. I’m not sure we need cancer ground shots or lengthy treatises on common sense, but I am damn sure we need honest interpretation of clinical trial data as Jack shows here. We can’t tolerate over-broad borderline deception that leads to poor and wasteful decision-making.”

Jeff Ryckman, MD, tweeted: “Problem is, this is a routine FDA #CarteBlanche approval regardless of no benefit in PD-L1 1%-49%. This will be Rx’d to everyone.”
 

Regulatory ‘gamesmanship’

The results of the IMpower010 analysis were published online in Annals of Oncology. The interim overall survival data were first reported last year at the World Conference on Lung Cancer.

IMpower010 was a global, randomized, open-label trial of 1,280 patients with completely resected stage IB (tumors ≥ 4 cm) through stage IIIA NSCLC for whom tissue samples were available for PD-L1 analysis.

All patients received four cycles of chemotherapy with cisplatin plus either pemetrexed, gemcitabine, docetaxel, or vinorelbine and were randomly assigned in a 1:1 ratio to receive either 16 cycles of atezolizumab or best supportive care.

Interim disease-free survival (DFS) results from IMpower010, presented at ASCO 2021, showed that patients with PD-L1 expression ≥ 1% experienced a 34% improvement in DFS, equating to a 21% improvement across all randomly assigned patients with stage II-IIIA disease.

On the basis of DFS findings, in 2021, the U.S. Food and Drug Administration granted atezolizumab a new indication – the adjuvant treatment following resection and platinum-based chemotherapy for patients with stage II-IIIA NSCLC whose tumors have PD-L1 expression ≥ 1%.

Looking at the big picture, Dr. West noted that regulatory approval for a drug allows for a certain amount of “gamesmanship.”

“It behooves a company to work with FDA to get approval for a broader population than it should be, relative to where the true clinical benefit lies,” he explained.

To this end, Dr. West noted that progression-free survival is increasingly being used as a primary endpoint in trials, but long-term data indicate that this surrogate endpoint is often not tethered to an overall survival benefit. However, drugs are often being approved now on the basis of a progression-free survival benefit.

“Unfortunately, that’s the system we live in today, with a bias toward, ‘If it could plausibly be interpreted as beneficial, we’ll wave it through for the broadest population possible,” Dr. West said.

The IMpower010 study and Annals of Oncology manuscript were funded by F. Hoffmann-La Roche. Several authors have disclosed relationships with the company. Dr. West has a regular column on Medscape.com and reported personal fees from AstraZeneca, Genentech/Roche, Merck, and Regeneron.

A version of this article appeared on Medscape.com.

TOPLINE:

Chronic pancreatitis raises the risk for pregnancy complications, including gestational diabetes, gestational hypertensive complications, and preterm labor, according to a large study.

METHODOLOGY:

• A retrospective analysis of hospital discharge records from the National Inpatient Sample database between 2009 and 2019 was conducted.
• The sample included 3,094 pregnancies with chronic pancreatitis and roughly 40.8 million pregnancies without this condition.
• The study focused on primary maternal outcomes and primary perinatal outcomes in pregnancies affected by chronic pancreatitis after accounting for relevant covariates.

TAKEAWAY:

• Chronic pancreatitis pregnancies had elevated rates of gestational diabetes (adjusted odds ratio, 1.63), gestational hypertensive complications (aOR, 2.48), preterm labor (aOR, 3.10), and small size for gestational age (aOR, 2.40).
• Women with chronic pancreatitis and a history of renal failure were more prone to gestational hypertensive complications (aOR, 20.09).
• Women with alcohol-induced chronic pancreatitis had a 17-fold higher risk for fetal death (aOR, 17.15).
• Pregnancies with chronic pancreatitis were associated with longer hospital stays and higher hospital costs.

IN PRACTICE:

“Our study provides novel insights into the impact of chronic pancreatitis on maternal and fetal health. The implications of our findings are critical for health care professionals, particularly those involved in preconception counseling. Pregnant women with chronic pancreatitis should be under the care of a multidisciplinary team of health care providers,” the authors advise.

SOURCE:

The study was led by Chengu Niu, MD, with Rochester General Hospital, Rochester, N.Y. It was published online July 18 in Digestive and Liver Disease. The study had no specific funding.

LIMITATIONS:

The authors note potential inaccuracies because of coding in the National Inpatient Sample database, a lack of detailed information regarding medication use, and a lack of follow-up clinical information. The findings are specific to the United States and may not be applicable to other countries.

DISCLOSURES:

The authors have no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Chronic pancreatitis raises the risk for pregnancy complications, including gestational diabetes, gestational hypertensive complications, and preterm labor, according to a large study.

METHODOLOGY:

• A retrospective analysis of hospital discharge records from the National Inpatient Sample database between 2009 and 2019 was conducted.
• The sample included 3,094 pregnancies with chronic pancreatitis and roughly 40.8 million pregnancies without this condition.
• The study focused on primary maternal outcomes and primary perinatal outcomes in pregnancies affected by chronic pancreatitis after accounting for relevant covariates.

TAKEAWAY:

• Chronic pancreatitis pregnancies had elevated rates of gestational diabetes (adjusted odds ratio, 1.63), gestational hypertensive complications (aOR, 2.48), preterm labor (aOR, 3.10), and small size for gestational age (aOR, 2.40).
• Women with chronic pancreatitis and a history of renal failure were more prone to gestational hypertensive complications (aOR, 20.09).
• Women with alcohol-induced chronic pancreatitis had a 17-fold higher risk for fetal death (aOR, 17.15).
• Pregnancies with chronic pancreatitis were associated with longer hospital stays and higher hospital costs.

IN PRACTICE:

“Our study provides novel insights into the impact of chronic pancreatitis on maternal and fetal health. The implications of our findings are critical for health care professionals, particularly those involved in preconception counseling. Pregnant women with chronic pancreatitis should be under the care of a multidisciplinary team of health care providers,” the authors advise.

SOURCE:

The study was led by Chengu Niu, MD, with Rochester General Hospital, Rochester, N.Y. It was published online July 18 in Digestive and Liver Disease. The study had no specific funding.

LIMITATIONS:

The authors note potential inaccuracies because of coding in the National Inpatient Sample database, a lack of detailed information regarding medication use, and a lack of follow-up clinical information. The findings are specific to the United States and may not be applicable to other countries.

DISCLOSURES:

The authors have no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Chronic pancreatitis raises the risk for pregnancy complications, including gestational diabetes, gestational hypertensive complications, and preterm labor, according to a large study.

METHODOLOGY:

• A retrospective analysis of hospital discharge records from the National Inpatient Sample database between 2009 and 2019 was conducted.
• The sample included 3,094 pregnancies with chronic pancreatitis and roughly 40.8 million pregnancies without this condition.
• The study focused on primary maternal outcomes and primary perinatal outcomes in pregnancies affected by chronic pancreatitis after accounting for relevant covariates.

TAKEAWAY:

• Chronic pancreatitis pregnancies had elevated rates of gestational diabetes (adjusted odds ratio, 1.63), gestational hypertensive complications (aOR, 2.48), preterm labor (aOR, 3.10), and small size for gestational age (aOR, 2.40).
• Women with chronic pancreatitis and a history of renal failure were more prone to gestational hypertensive complications (aOR, 20.09).
• Women with alcohol-induced chronic pancreatitis had a 17-fold higher risk for fetal death (aOR, 17.15).
• Pregnancies with chronic pancreatitis were associated with longer hospital stays and higher hospital costs.

IN PRACTICE:

“Our study provides novel insights into the impact of chronic pancreatitis on maternal and fetal health. The implications of our findings are critical for health care professionals, particularly those involved in preconception counseling. Pregnant women with chronic pancreatitis should be under the care of a multidisciplinary team of health care providers,” the authors advise.

SOURCE:

The study was led by Chengu Niu, MD, with Rochester General Hospital, Rochester, N.Y. It was published online July 18 in Digestive and Liver Disease. The study had no specific funding.

LIMITATIONS:

The authors note potential inaccuracies because of coding in the National Inpatient Sample database, a lack of detailed information regarding medication use, and a lack of follow-up clinical information. The findings are specific to the United States and may not be applicable to other countries.

DISCLOSURES:

The authors have no relevant disclosures.

A version of this article appeared on Medscape.com.

Abbott is recalling the Amplatzer steerable delivery sheath, used to deliver the Amplatzer Amulet left atrial appendage occluder during cardiac catheterization, because of an increased risk of air embolism, the Food and Drug Administration has announced.

Air embolism can lead to injuries such as acute reduction in blood flow to the heart (indicated by ST elevation), tachycardia, bradycardia, hypotension, and oxygen desaturation, as well as stroke and death, the FDA said in a recall notice.

Because of the potential for serious injury or death, the agency has identified this as a class I recall, the most serious type.

To date, Abbott has reported 26 incidents, 16 injuries, and no deaths related to this issue.

According to the recall notice, the overall reported incidence rate of observed or potential cases of air embolism during procedures in which the product was used is 0.77%.

The recall includes 672 devices (model: ASDS-14F-075) that were distributed from Oct. 4, 2022, to Feb. 22, 2023.

Abbott sent a medical device recall notice to customers in June asking them to return any remaining unused Amplatzer steerable delivery sheaths to Abbott and to complete an enclosed acknowledgment form.

The company advises use of the fixed curve TorqVue 45° x 45° delivery system for future Amplatzer Amulet left atrial appendage occluder implants.

Customers with questions about this recall should contact their local Abbott representative or Abbott support at 1-800-544-1664 (option 2).

A version of this article appeared on Medscape.com.

Abbott is recalling the Amplatzer steerable delivery sheath, used to deliver the Amplatzer Amulet left atrial appendage occluder during cardiac catheterization, because of an increased risk of air embolism, the Food and Drug Administration has announced.

Air embolism can lead to injuries such as acute reduction in blood flow to the heart (indicated by ST elevation), tachycardia, bradycardia, hypotension, and oxygen desaturation, as well as stroke and death, the FDA said in a recall notice.

Because of the potential for serious injury or death, the agency has identified this as a class I recall, the most serious type.

To date, Abbott has reported 26 incidents, 16 injuries, and no deaths related to this issue.

According to the recall notice, the overall reported incidence rate of observed or potential cases of air embolism during procedures in which the product was used is 0.77%.

The recall includes 672 devices (model: ASDS-14F-075) that were distributed from Oct. 4, 2022, to Feb. 22, 2023.

Abbott sent a medical device recall notice to customers in June asking them to return any remaining unused Amplatzer steerable delivery sheaths to Abbott and to complete an enclosed acknowledgment form.

The company advises use of the fixed curve TorqVue 45° x 45° delivery system for future Amplatzer Amulet left atrial appendage occluder implants.

Customers with questions about this recall should contact their local Abbott representative or Abbott support at 1-800-544-1664 (option 2).

A version of this article appeared on Medscape.com.

Abbott is recalling the Amplatzer steerable delivery sheath, used to deliver the Amplatzer Amulet left atrial appendage occluder during cardiac catheterization, because of an increased risk of air embolism, the Food and Drug Administration has announced.

Air embolism can lead to injuries such as acute reduction in blood flow to the heart (indicated by ST elevation), tachycardia, bradycardia, hypotension, and oxygen desaturation, as well as stroke and death, the FDA said in a recall notice.

Because of the potential for serious injury or death, the agency has identified this as a class I recall, the most serious type.

To date, Abbott has reported 26 incidents, 16 injuries, and no deaths related to this issue.

According to the recall notice, the overall reported incidence rate of observed or potential cases of air embolism during procedures in which the product was used is 0.77%.

The recall includes 672 devices (model: ASDS-14F-075) that were distributed from Oct. 4, 2022, to Feb. 22, 2023.

Abbott sent a medical device recall notice to customers in June asking them to return any remaining unused Amplatzer steerable delivery sheaths to Abbott and to complete an enclosed acknowledgment form.

The company advises use of the fixed curve TorqVue 45° x 45° delivery system for future Amplatzer Amulet left atrial appendage occluder implants.

Customers with questions about this recall should contact their local Abbott representative or Abbott support at 1-800-544-1664 (option 2).

A version of this article appeared on Medscape.com.

TOPLINE:

Registry data show a lower incidence of postcolonoscopy colorectal cancer (PCCRC) among endoscopists with higher sessile serrated lesion detection rates, validating the SSLDR as a clinically relevant quality measure.

METHODOLOGY:

• An analysis of the association between PCCRC and SSLDR was conducted using data from the New Hampshire Colonoscopy Registry.
• The cohort included patients who had either a colonoscopy or a diagnosis of CRC.
• The outcome was PCCRC (that is, CRC diagnosed at least 6 months after index colonoscopy).
• The exposure of interest was endoscopist-specific SSLDR.

TAKEAWAY:

• Of 26,901 patients, 162 were diagnosed with PCCRC.
• Endoscopists with a higher SSLDR had lower unadjusted risks for PCCRC (0.3% among those with an SSLDR of at least 6.0% (hazard ratio, 0.29).
• There was a significant 14% reduction in PCCRC for each 1% increase in SSLDR (HR, 0.86).
• Roughly one-third of endoscopists had an adequate adenoma detection rate yet had an SSLDR that was less than the most protective SSLDR of 6%.

IN PRACTICE:

“Endoscopists should strive to achieve the highest SSLDR rate, perhaps with the use of artificial intelligence,” the authors wrote. “Our data linking low SSLDR to increased PCCRC support development of recommendations to measure SDR [serrated detection rates] in clinical practice, and development of educational platforms, techniques and devices to improve low SDR.”

SOURCE:

The study was led by Joseph C. Anderson, MD, with the Geisel School of Medicine at Dartmouth, Hanover, N.H. It was published online in the American Journal of Gastroenterology. The study had no commercial funding.

LIMITATIONS:

The study population came from New Hampshire, which lacks racial diversity. There may be differences in serrated polyp detection in other populations with more high-risk groups, such as smokers. There may be significant variation in SSLDR because of variation in pathological interpretation.

DISCLOSURES:

The authors reported no relevant financial conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Registry data show a lower incidence of postcolonoscopy colorectal cancer (PCCRC) among endoscopists with higher sessile serrated lesion detection rates, validating the SSLDR as a clinically relevant quality measure.

METHODOLOGY:

• An analysis of the association between PCCRC and SSLDR was conducted using data from the New Hampshire Colonoscopy Registry.
• The cohort included patients who had either a colonoscopy or a diagnosis of CRC.
• The outcome was PCCRC (that is, CRC diagnosed at least 6 months after index colonoscopy).
• The exposure of interest was endoscopist-specific SSLDR.

TAKEAWAY:

• Of 26,901 patients, 162 were diagnosed with PCCRC.
• Endoscopists with a higher SSLDR had lower unadjusted risks for PCCRC (0.3% among those with an SSLDR of at least 6.0% (hazard ratio, 0.29).
• There was a significant 14% reduction in PCCRC for each 1% increase in SSLDR (HR, 0.86).
• Roughly one-third of endoscopists had an adequate adenoma detection rate yet had an SSLDR that was less than the most protective SSLDR of 6%.

IN PRACTICE:

“Endoscopists should strive to achieve the highest SSLDR rate, perhaps with the use of artificial intelligence,” the authors wrote. “Our data linking low SSLDR to increased PCCRC support development of recommendations to measure SDR [serrated detection rates] in clinical practice, and development of educational platforms, techniques and devices to improve low SDR.”

SOURCE:

The study was led by Joseph C. Anderson, MD, with the Geisel School of Medicine at Dartmouth, Hanover, N.H. It was published online in the American Journal of Gastroenterology. The study had no commercial funding.

LIMITATIONS:

The study population came from New Hampshire, which lacks racial diversity. There may be differences in serrated polyp detection in other populations with more high-risk groups, such as smokers. There may be significant variation in SSLDR because of variation in pathological interpretation.

DISCLOSURES:

The authors reported no relevant financial conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

Registry data show a lower incidence of postcolonoscopy colorectal cancer (PCCRC) among endoscopists with higher sessile serrated lesion detection rates, validating the SSLDR as a clinically relevant quality measure.

METHODOLOGY:

• An analysis of the association between PCCRC and SSLDR was conducted using data from the New Hampshire Colonoscopy Registry.
• The cohort included patients who had either a colonoscopy or a diagnosis of CRC.
• The outcome was PCCRC (that is, CRC diagnosed at least 6 months after index colonoscopy).
• The exposure of interest was endoscopist-specific SSLDR.

TAKEAWAY:

• Of 26,901 patients, 162 were diagnosed with PCCRC.
• Endoscopists with a higher SSLDR had lower unadjusted risks for PCCRC (0.3% among those with an SSLDR of at least 6.0% (hazard ratio, 0.29).
• There was a significant 14% reduction in PCCRC for each 1% increase in SSLDR (HR, 0.86).
• Roughly one-third of endoscopists had an adequate adenoma detection rate yet had an SSLDR that was less than the most protective SSLDR of 6%.

IN PRACTICE:

“Endoscopists should strive to achieve the highest SSLDR rate, perhaps with the use of artificial intelligence,” the authors wrote. “Our data linking low SSLDR to increased PCCRC support development of recommendations to measure SDR [serrated detection rates] in clinical practice, and development of educational platforms, techniques and devices to improve low SDR.”

SOURCE:

The study was led by Joseph C. Anderson, MD, with the Geisel School of Medicine at Dartmouth, Hanover, N.H. It was published online in the American Journal of Gastroenterology. The study had no commercial funding.

LIMITATIONS:

The study population came from New Hampshire, which lacks racial diversity. There may be differences in serrated polyp detection in other populations with more high-risk groups, such as smokers. There may be significant variation in SSLDR because of variation in pathological interpretation.

DISCLOSURES:

The authors reported no relevant financial conflicts of interest.

A version of this article first appeared on Medscape.com.

Treatment with an experimental oral tau aggregation inhibitor, hydromethylthionine mesylate (HMTM), led to a statistically significant reduction in an established biomarker of neurodegeneration in Alzheimer’s disease (AD) in the LUCIDITY phase 3 trial.
 

Blood concentrations of neurofilament light chain (NfL) showed a 93% reduction in change over 12 months in participants receiving HMTM at the target dose of 16 mg/day relative to the control group, which correlated significantly with a tau biomarker (p-tau 181) in blood and changes in cognitive test scores.

“This is the first tau aggregation inhibitor to reach the phase 3 stage of development and to produce results like this,” Claude Wischik, PhD, executive chairman of TauRx Therapeutics, which is developing the drug, noted in an interview.

“NfL is one of the best studied biomarkers in the business because it goes off the rails in a range of neurodegenerative disorders. In AD, it correlates with disease severity, and it tracks ongoing damage to neurons,” Dr. Wischik explained.

Oral HMTM was designed to reduce tau pathology in AD, and the noted changes in NfL concentration by HMTM indicate a “direct impact on disease pathology,” Dr. Wischik said.

The findings, from a prespecified blood biomarker analysis of the LUCIDITY phase 3 trial, were presented at the annual Alzheimer’s Association International Conference.
 

Support for tau inhibitor

Topline results from the LUCIDITY trial showed improvement in cognition over 18 months in participants with mild cognitive impairment (MCI) caused by AD who were treated with a 16-mg/day dose of HMTM.

However, in an odd twist, participants in the control group who received a low dose of methylthioninium chloride (MTC) also showed cognitive improvement.

As a result, HMTM 16 mg/day failed to reach its two primary endpoints – change from baseline on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog11) and the Alzheimer’s Disease Cooperative Study/Activities of Daily Living Inventory (ADCS-ADL23) – relative to the MTC control group.

That’s likely because treatment with MTC, which is a variant of HMTM, unexpectedly achieved blood levels of active drug above the threshold needed to produce a clinical effect.

For the prespecified biomarker analysis reported at AAIC 2023, baseline and 12-month NfL plasma levels were available in 161 of 185 participants receiving HMTM 16 mg/day, 38 of 48 receiving HMTM 8 mg/day and 136 of 185 receiving MTC 8 mg/week.

Blood concentrations of NfL showed a statistically significant 93% reduction in change over 12 months in participants receiving HMTM at a dose of 16 mg/day relative to the control group (P = .0278), Dr. Wischik reported.

In addition, the p-tau 181 increase over 12 months “reduced to zero” with HMTM 16 mg/day and there was significant correlation between change in NfL and p-tau 181 concentration, he noted.

NfL reductions were significantly correlated with change in ADAS-Cog11 (P = .0038) and whole brain volume (P = .0359) over 24 months.
 

‘Exciting’ biomarker data

Commenting on the new data in an interview, Christopher Weber, PhD, director of global science initiatives at the Alzheimer’s Association, said the phase 3 LUCIDITY results “suggest that HMTM could be a potential therapeutic for slowing down neurodegenerative processes in Alzheimer’s disease.”

“Plasma NfL is an interesting biomarker which is used more and more in clinical trials because it’s noninvasive, accessible, and can assist in diagnosing and monitoring the disease in the early stages. Elevated NfL levels suggest that neurons are being affected in the brain, which could indicate the presence or progression of Alzheimer’s disease,” Dr. Weber said in an interview.

He said the biomarker data from the LUCIDITY study are “exciting.”

“However, due to the relatively small sample size, we look forward to seeing additional research on HMTM in larger, and even more diverse cohorts to better understand the performance of this treatment and the role of NfL in Alzheimer’s disease,” Dr. Weber said.

Also providing outside perspective, Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, noted that currently “there is a lot of effort in trying to address the abnormal tau that occurs in Alzheimer’s disease.”

The biomarker data from LUCIDITY show that HMTM “seems to markedly decrease the amount of NfL in plasma and there is some correlation with cognitive scores. The obvious unknown is whether these changes in plasma NfL will predict clinical benefit,” Dr. Fillit said in an interview.

“This is an oral drug that has a good safety profile, and the mechanism of action makes sense, but we need to see the clinical data,” Dr. Fillit said.

Final 2-year data from the LUCIDITY trial are expected to be released later in 2023.

In the United Kingdom, TauRx has entered an accelerated approval process for the drug, and the company said it plans to seek regulatory approval in the United States and Canada in 2023.

The study was funded by TauRx Therapeutics. Dr. Wischik is an employee of the University of Aberdeen (Scotland), and TauRx Therapeutics. Dr. Weber and Dr. Fillit reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Treatment with an experimental oral tau aggregation inhibitor, hydromethylthionine mesylate (HMTM), led to a statistically significant reduction in an established biomarker of neurodegeneration in Alzheimer’s disease (AD) in the LUCIDITY phase 3 trial.
 

Blood concentrations of neurofilament light chain (NfL) showed a 93% reduction in change over 12 months in participants receiving HMTM at the target dose of 16 mg/day relative to the control group, which correlated significantly with a tau biomarker (p-tau 181) in blood and changes in cognitive test scores.

“This is the first tau aggregation inhibitor to reach the phase 3 stage of development and to produce results like this,” Claude Wischik, PhD, executive chairman of TauRx Therapeutics, which is developing the drug, noted in an interview.

“NfL is one of the best studied biomarkers in the business because it goes off the rails in a range of neurodegenerative disorders. In AD, it correlates with disease severity, and it tracks ongoing damage to neurons,” Dr. Wischik explained.

Oral HMTM was designed to reduce tau pathology in AD, and the noted changes in NfL concentration by HMTM indicate a “direct impact on disease pathology,” Dr. Wischik said.

The findings, from a prespecified blood biomarker analysis of the LUCIDITY phase 3 trial, were presented at the annual Alzheimer’s Association International Conference.
 

Support for tau inhibitor

Topline results from the LUCIDITY trial showed improvement in cognition over 18 months in participants with mild cognitive impairment (MCI) caused by AD who were treated with a 16-mg/day dose of HMTM.

However, in an odd twist, participants in the control group who received a low dose of methylthioninium chloride (MTC) also showed cognitive improvement.

As a result, HMTM 16 mg/day failed to reach its two primary endpoints – change from baseline on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog11) and the Alzheimer’s Disease Cooperative Study/Activities of Daily Living Inventory (ADCS-ADL23) – relative to the MTC control group.

That’s likely because treatment with MTC, which is a variant of HMTM, unexpectedly achieved blood levels of active drug above the threshold needed to produce a clinical effect.

For the prespecified biomarker analysis reported at AAIC 2023, baseline and 12-month NfL plasma levels were available in 161 of 185 participants receiving HMTM 16 mg/day, 38 of 48 receiving HMTM 8 mg/day and 136 of 185 receiving MTC 8 mg/week.

Blood concentrations of NfL showed a statistically significant 93% reduction in change over 12 months in participants receiving HMTM at a dose of 16 mg/day relative to the control group (P = .0278), Dr. Wischik reported.

In addition, the p-tau 181 increase over 12 months “reduced to zero” with HMTM 16 mg/day and there was significant correlation between change in NfL and p-tau 181 concentration, he noted.

NfL reductions were significantly correlated with change in ADAS-Cog11 (P = .0038) and whole brain volume (P = .0359) over 24 months.
 

‘Exciting’ biomarker data

Commenting on the new data in an interview, Christopher Weber, PhD, director of global science initiatives at the Alzheimer’s Association, said the phase 3 LUCIDITY results “suggest that HMTM could be a potential therapeutic for slowing down neurodegenerative processes in Alzheimer’s disease.”

“Plasma NfL is an interesting biomarker which is used more and more in clinical trials because it’s noninvasive, accessible, and can assist in diagnosing and monitoring the disease in the early stages. Elevated NfL levels suggest that neurons are being affected in the brain, which could indicate the presence or progression of Alzheimer’s disease,” Dr. Weber said in an interview.

He said the biomarker data from the LUCIDITY study are “exciting.”

“However, due to the relatively small sample size, we look forward to seeing additional research on HMTM in larger, and even more diverse cohorts to better understand the performance of this treatment and the role of NfL in Alzheimer’s disease,” Dr. Weber said.

Also providing outside perspective, Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, noted that currently “there is a lot of effort in trying to address the abnormal tau that occurs in Alzheimer’s disease.”

The biomarker data from LUCIDITY show that HMTM “seems to markedly decrease the amount of NfL in plasma and there is some correlation with cognitive scores. The obvious unknown is whether these changes in plasma NfL will predict clinical benefit,” Dr. Fillit said in an interview.

“This is an oral drug that has a good safety profile, and the mechanism of action makes sense, but we need to see the clinical data,” Dr. Fillit said.

Final 2-year data from the LUCIDITY trial are expected to be released later in 2023.

In the United Kingdom, TauRx has entered an accelerated approval process for the drug, and the company said it plans to seek regulatory approval in the United States and Canada in 2023.

The study was funded by TauRx Therapeutics. Dr. Wischik is an employee of the University of Aberdeen (Scotland), and TauRx Therapeutics. Dr. Weber and Dr. Fillit reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Treatment with an experimental oral tau aggregation inhibitor, hydromethylthionine mesylate (HMTM), led to a statistically significant reduction in an established biomarker of neurodegeneration in Alzheimer’s disease (AD) in the LUCIDITY phase 3 trial.
 

Blood concentrations of neurofilament light chain (NfL) showed a 93% reduction in change over 12 months in participants receiving HMTM at the target dose of 16 mg/day relative to the control group, which correlated significantly with a tau biomarker (p-tau 181) in blood and changes in cognitive test scores.

“This is the first tau aggregation inhibitor to reach the phase 3 stage of development and to produce results like this,” Claude Wischik, PhD, executive chairman of TauRx Therapeutics, which is developing the drug, noted in an interview.

“NfL is one of the best studied biomarkers in the business because it goes off the rails in a range of neurodegenerative disorders. In AD, it correlates with disease severity, and it tracks ongoing damage to neurons,” Dr. Wischik explained.

Oral HMTM was designed to reduce tau pathology in AD, and the noted changes in NfL concentration by HMTM indicate a “direct impact on disease pathology,” Dr. Wischik said.

The findings, from a prespecified blood biomarker analysis of the LUCIDITY phase 3 trial, were presented at the annual Alzheimer’s Association International Conference.
 

Support for tau inhibitor

Topline results from the LUCIDITY trial showed improvement in cognition over 18 months in participants with mild cognitive impairment (MCI) caused by AD who were treated with a 16-mg/day dose of HMTM.

However, in an odd twist, participants in the control group who received a low dose of methylthioninium chloride (MTC) also showed cognitive improvement.

As a result, HMTM 16 mg/day failed to reach its two primary endpoints – change from baseline on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog11) and the Alzheimer’s Disease Cooperative Study/Activities of Daily Living Inventory (ADCS-ADL23) – relative to the MTC control group.

That’s likely because treatment with MTC, which is a variant of HMTM, unexpectedly achieved blood levels of active drug above the threshold needed to produce a clinical effect.

For the prespecified biomarker analysis reported at AAIC 2023, baseline and 12-month NfL plasma levels were available in 161 of 185 participants receiving HMTM 16 mg/day, 38 of 48 receiving HMTM 8 mg/day and 136 of 185 receiving MTC 8 mg/week.

Blood concentrations of NfL showed a statistically significant 93% reduction in change over 12 months in participants receiving HMTM at a dose of 16 mg/day relative to the control group (P = .0278), Dr. Wischik reported.

In addition, the p-tau 181 increase over 12 months “reduced to zero” with HMTM 16 mg/day and there was significant correlation between change in NfL and p-tau 181 concentration, he noted.

NfL reductions were significantly correlated with change in ADAS-Cog11 (P = .0038) and whole brain volume (P = .0359) over 24 months.
 

‘Exciting’ biomarker data

Commenting on the new data in an interview, Christopher Weber, PhD, director of global science initiatives at the Alzheimer’s Association, said the phase 3 LUCIDITY results “suggest that HMTM could be a potential therapeutic for slowing down neurodegenerative processes in Alzheimer’s disease.”

“Plasma NfL is an interesting biomarker which is used more and more in clinical trials because it’s noninvasive, accessible, and can assist in diagnosing and monitoring the disease in the early stages. Elevated NfL levels suggest that neurons are being affected in the brain, which could indicate the presence or progression of Alzheimer’s disease,” Dr. Weber said in an interview.

He said the biomarker data from the LUCIDITY study are “exciting.”

“However, due to the relatively small sample size, we look forward to seeing additional research on HMTM in larger, and even more diverse cohorts to better understand the performance of this treatment and the role of NfL in Alzheimer’s disease,” Dr. Weber said.

Also providing outside perspective, Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, noted that currently “there is a lot of effort in trying to address the abnormal tau that occurs in Alzheimer’s disease.”

The biomarker data from LUCIDITY show that HMTM “seems to markedly decrease the amount of NfL in plasma and there is some correlation with cognitive scores. The obvious unknown is whether these changes in plasma NfL will predict clinical benefit,” Dr. Fillit said in an interview.

“This is an oral drug that has a good safety profile, and the mechanism of action makes sense, but we need to see the clinical data,” Dr. Fillit said.

Final 2-year data from the LUCIDITY trial are expected to be released later in 2023.

In the United Kingdom, TauRx has entered an accelerated approval process for the drug, and the company said it plans to seek regulatory approval in the United States and Canada in 2023.

The study was funded by TauRx Therapeutics. Dr. Wischik is an employee of the University of Aberdeen (Scotland), and TauRx Therapeutics. Dr. Weber and Dr. Fillit reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Twice-weekly subcutaneous ketamine injections are safe and highly effective for treatment-resistant depression (TRD), results of a randomized controlled phase 3 trial show.
 

University of New South Wales

“In this severely treatment-resistant population, of which 24% had failed to respond to treatment with electroconvulsive therapy, adequately dosed racemic ketamine produced benefits that were large, being both clinically and statistically superior to midazolam,” report the researchers, led by Colleen Loo, MD, MBBS, with Black Dog Institute, University of New South Wales, Sydney.

The study was published online in the British Journal of Psychiatry.


 

Individualized dosing

“Previously, most studies of racemic ketamine [administered] it by intravenous infusion over half an hour to several hours, which is a much more medically complex and expensive procedure,” Dr. Loo said in an interview.

The fact that subcutaneously administered ketamine was “highly effective” given by this practical and feasible route is a “major contribution to the field,” said Dr. Loo.

The Ketamine for Adult Depression trial assessed the acute efficacy and safety of a 4-week course of twice-weekly subcutaneous injections of racemic ketamine or midazolam (active control) in 174 adults with TRD.

Initially, the trial tested a fixed dose of 0.5 mg/kg ketamine vs. 0.025 mg/kg midazolam (cohort 1; 68 patients). Dosing was subsequently revised, after the data safety monitoring board recommended flexible-dose ketamine (0.5-0.9 mg/kg) or midazolam (0.025-0.045 mg/kg) with response-guided dosing increments (cohort 2; 106 patients).

The primary outcome was remission defined as Montgomery-Åsberg Rating Scale for Depression (MADRS) score ≤ 10 at week 4.

On this outcome, in the fixed-dose cohort, there was no statistically significant difference in remission rates between ketamine and midazolam (6.3% and 8.8%; odds ratio, 1.34; 95% CI, 0.22-8.21; P = .76).

However, there was a significant difference in remission in the flexible-dose cohort, with remission rates 19.6% for ketamine vs. just 2% for midazolam (OR, 12.11; 95% CI, 2.12-69.17; P = .005).

“The study showed that individualized dose adjustment, based on clinical response, was very important in optimizing the benefit of ketamine,” said Dr. Loo.

“It meant that one, you are more likely to respond as you receive a higher dose if needed, and two, you don’t receive a higher dose than needed, given that side effects are also dose-related,” she said.

Results also favored flexible-dose ketamine over midazolam for the secondary outcomes of response (≥ 50% reduction in MADRS: 29% vs. 4%; P = .001) and remission defined by a less rigid definition (MADRS ≤ 12: 22% vs. 4%; P = .007).

The results also confirm that the antidepressant effects of ketamine are not sustained when treatment stops.

“The study included careful follow-up for 4 weeks after the end of treatment. This is an important contribution to the literature, as it shows that ongoing treatment beyond the 4 weeks will be necessary for most people to maintain the benefits of ketamine treatment if you respond to the treatment. This study provided clear evidence of this, for racemic ketamine,” said Dr. Loo.

Overall, ketamine was well-tolerated, with the well-established acute effects of ketamine observed in both cohorts. The acute effects resolved or returned to pretreatment levels within the 2-hour observation period. No one required medical intervention, and there was no evidence of cognitive impairment.
 

Rigorous research, compelling data

Reached for comment, Roger S. McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, said the data are “compelling with respect to efficacy and safety of subcutaneous ketamine in adults with major depression.”

Dr. McIntyre said the data are “highly relevant” for several reasons. “First, it is the most rigorous study conducted to date with subcutaneous administration of ketamine for adults living with treatment-resistant depression.”

Second, it “demonstrates the efficacy and safety of this route of delivery, which until now has not been studied with this level of rigor and which is a more scalable and accessible approach to administer ketamine to suitable candidates,” Dr. McIntyre said.

The study was funded by a competitive research grant from the Australian National Health and Medical Research Council. Dr. Loo has disclosed relationships with Douglas Pharmaceuticals and Janssen Cilag and is the medical director of neurostimulation and interventional psychiatry at Ramsay Health Care. Dr. McIntyre has received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, and Atai Life Sciences. Dr. McIntyre is a CEO of Braxia Scientific Corp.

A version of this article first appeared on Medscape.com.

Twice-weekly subcutaneous ketamine injections are safe and highly effective for treatment-resistant depression (TRD), results of a randomized controlled phase 3 trial show.
 

University of New South Wales

“In this severely treatment-resistant population, of which 24% had failed to respond to treatment with electroconvulsive therapy, adequately dosed racemic ketamine produced benefits that were large, being both clinically and statistically superior to midazolam,” report the researchers, led by Colleen Loo, MD, MBBS, with Black Dog Institute, University of New South Wales, Sydney.

The study was published online in the British Journal of Psychiatry.


 

Individualized dosing

“Previously, most studies of racemic ketamine [administered] it by intravenous infusion over half an hour to several hours, which is a much more medically complex and expensive procedure,” Dr. Loo said in an interview.

The fact that subcutaneously administered ketamine was “highly effective” given by this practical and feasible route is a “major contribution to the field,” said Dr. Loo.

The Ketamine for Adult Depression trial assessed the acute efficacy and safety of a 4-week course of twice-weekly subcutaneous injections of racemic ketamine or midazolam (active control) in 174 adults with TRD.

Initially, the trial tested a fixed dose of 0.5 mg/kg ketamine vs. 0.025 mg/kg midazolam (cohort 1; 68 patients). Dosing was subsequently revised, after the data safety monitoring board recommended flexible-dose ketamine (0.5-0.9 mg/kg) or midazolam (0.025-0.045 mg/kg) with response-guided dosing increments (cohort 2; 106 patients).

The primary outcome was remission defined as Montgomery-Åsberg Rating Scale for Depression (MADRS) score ≤ 10 at week 4.

On this outcome, in the fixed-dose cohort, there was no statistically significant difference in remission rates between ketamine and midazolam (6.3% and 8.8%; odds ratio, 1.34; 95% CI, 0.22-8.21; P = .76).

However, there was a significant difference in remission in the flexible-dose cohort, with remission rates 19.6% for ketamine vs. just 2% for midazolam (OR, 12.11; 95% CI, 2.12-69.17; P = .005).

“The study showed that individualized dose adjustment, based on clinical response, was very important in optimizing the benefit of ketamine,” said Dr. Loo.

“It meant that one, you are more likely to respond as you receive a higher dose if needed, and two, you don’t receive a higher dose than needed, given that side effects are also dose-related,” she said.

Results also favored flexible-dose ketamine over midazolam for the secondary outcomes of response (≥ 50% reduction in MADRS: 29% vs. 4%; P = .001) and remission defined by a less rigid definition (MADRS ≤ 12: 22% vs. 4%; P = .007).

The results also confirm that the antidepressant effects of ketamine are not sustained when treatment stops.

“The study included careful follow-up for 4 weeks after the end of treatment. This is an important contribution to the literature, as it shows that ongoing treatment beyond the 4 weeks will be necessary for most people to maintain the benefits of ketamine treatment if you respond to the treatment. This study provided clear evidence of this, for racemic ketamine,” said Dr. Loo.

Overall, ketamine was well-tolerated, with the well-established acute effects of ketamine observed in both cohorts. The acute effects resolved or returned to pretreatment levels within the 2-hour observation period. No one required medical intervention, and there was no evidence of cognitive impairment.
 

Rigorous research, compelling data

Reached for comment, Roger S. McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, said the data are “compelling with respect to efficacy and safety of subcutaneous ketamine in adults with major depression.”

Dr. McIntyre said the data are “highly relevant” for several reasons. “First, it is the most rigorous study conducted to date with subcutaneous administration of ketamine for adults living with treatment-resistant depression.”

Second, it “demonstrates the efficacy and safety of this route of delivery, which until now has not been studied with this level of rigor and which is a more scalable and accessible approach to administer ketamine to suitable candidates,” Dr. McIntyre said.

The study was funded by a competitive research grant from the Australian National Health and Medical Research Council. Dr. Loo has disclosed relationships with Douglas Pharmaceuticals and Janssen Cilag and is the medical director of neurostimulation and interventional psychiatry at Ramsay Health Care. Dr. McIntyre has received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, and Atai Life Sciences. Dr. McIntyre is a CEO of Braxia Scientific Corp.

A version of this article first appeared on Medscape.com.

Twice-weekly subcutaneous ketamine injections are safe and highly effective for treatment-resistant depression (TRD), results of a randomized controlled phase 3 trial show.
 

University of New South Wales

“In this severely treatment-resistant population, of which 24% had failed to respond to treatment with electroconvulsive therapy, adequately dosed racemic ketamine produced benefits that were large, being both clinically and statistically superior to midazolam,” report the researchers, led by Colleen Loo, MD, MBBS, with Black Dog Institute, University of New South Wales, Sydney.

The study was published online in the British Journal of Psychiatry.


 

Individualized dosing

“Previously, most studies of racemic ketamine [administered] it by intravenous infusion over half an hour to several hours, which is a much more medically complex and expensive procedure,” Dr. Loo said in an interview.

The fact that subcutaneously administered ketamine was “highly effective” given by this practical and feasible route is a “major contribution to the field,” said Dr. Loo.

The Ketamine for Adult Depression trial assessed the acute efficacy and safety of a 4-week course of twice-weekly subcutaneous injections of racemic ketamine or midazolam (active control) in 174 adults with TRD.

Initially, the trial tested a fixed dose of 0.5 mg/kg ketamine vs. 0.025 mg/kg midazolam (cohort 1; 68 patients). Dosing was subsequently revised, after the data safety monitoring board recommended flexible-dose ketamine (0.5-0.9 mg/kg) or midazolam (0.025-0.045 mg/kg) with response-guided dosing increments (cohort 2; 106 patients).

The primary outcome was remission defined as Montgomery-Åsberg Rating Scale for Depression (MADRS) score ≤ 10 at week 4.

On this outcome, in the fixed-dose cohort, there was no statistically significant difference in remission rates between ketamine and midazolam (6.3% and 8.8%; odds ratio, 1.34; 95% CI, 0.22-8.21; P = .76).

However, there was a significant difference in remission in the flexible-dose cohort, with remission rates 19.6% for ketamine vs. just 2% for midazolam (OR, 12.11; 95% CI, 2.12-69.17; P = .005).

“The study showed that individualized dose adjustment, based on clinical response, was very important in optimizing the benefit of ketamine,” said Dr. Loo.

“It meant that one, you are more likely to respond as you receive a higher dose if needed, and two, you don’t receive a higher dose than needed, given that side effects are also dose-related,” she said.

Results also favored flexible-dose ketamine over midazolam for the secondary outcomes of response (≥ 50% reduction in MADRS: 29% vs. 4%; P = .001) and remission defined by a less rigid definition (MADRS ≤ 12: 22% vs. 4%; P = .007).

The results also confirm that the antidepressant effects of ketamine are not sustained when treatment stops.

“The study included careful follow-up for 4 weeks after the end of treatment. This is an important contribution to the literature, as it shows that ongoing treatment beyond the 4 weeks will be necessary for most people to maintain the benefits of ketamine treatment if you respond to the treatment. This study provided clear evidence of this, for racemic ketamine,” said Dr. Loo.

Overall, ketamine was well-tolerated, with the well-established acute effects of ketamine observed in both cohorts. The acute effects resolved or returned to pretreatment levels within the 2-hour observation period. No one required medical intervention, and there was no evidence of cognitive impairment.
 

Rigorous research, compelling data

Reached for comment, Roger S. McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, said the data are “compelling with respect to efficacy and safety of subcutaneous ketamine in adults with major depression.”

Dr. McIntyre said the data are “highly relevant” for several reasons. “First, it is the most rigorous study conducted to date with subcutaneous administration of ketamine for adults living with treatment-resistant depression.”

Second, it “demonstrates the efficacy and safety of this route of delivery, which until now has not been studied with this level of rigor and which is a more scalable and accessible approach to administer ketamine to suitable candidates,” Dr. McIntyre said.

The study was funded by a competitive research grant from the Australian National Health and Medical Research Council. Dr. Loo has disclosed relationships with Douglas Pharmaceuticals and Janssen Cilag and is the medical director of neurostimulation and interventional psychiatry at Ramsay Health Care. Dr. McIntyre has received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, and Atai Life Sciences. Dr. McIntyre is a CEO of Braxia Scientific Corp.

A version of this article first appeared on Medscape.com.

A novel type of talk therapy that pays as much attention to building positive mood as it does to reducing depressed mood may work as well, if not better, than cognitive-behavioral therapy (CBT) for anhedonic depression, results of a pilot trial suggest.
 

While the trial was not adequately powered to test if augmented depression therapy (ADepT) is superior to CBT, “results nevertheless were encouraging,” lead author Barnaby Dunn, PhD, professor of clinical psychology, University of Exeter (England), said in an interview.

The trial showed that ADepT is feasible, acceptable, and “not worse than CBT,” also showing the “potential to be better than CBT in clinical outcomes,” Dr. Dunn said.

“By building positive mood, ADepT may help individuals stay well for longer in the future,” he noted.

The early results were published online in eClinicalMedicine. 
 

Dual approach

“There are two sides to the depression coin – heightened negative mood and reduced positive mood. Classic CBT focuses mainly on repairing negative mood and pays less attention to building positive mood,” Dr. Dunn explained.

He said when he speaks to clients about what is key to recovery from depression, they often mention the importance of reconnecting to the positive.

“ADepT pays equal attention to building the positives as it does reducing the negatives, giving clients new skills to ‘act opposite’ to old ways of thinking and feeling that can stop them making the most of opportunities and being able to experience well-being,” Dr. Dunn said.

ADepT is an individual therapy delivered over 15 acute and 5 booster sessions, which is similar in “dose” to classic CBT, Dr. Dunn said.

The primary focus of ADepT is building well-being (capacity to experience pleasure, meaning, and social connection in life) and functional recovery, with depression conceptualized as patterns of thinking, feeling, and behaving that serve as barriers to achieving this goal.

Patients work with trained therapists to overcome barriers to being resilient (managing challenges to reduce negative affect) and thriving (taking opportunities to maximize positive affect).

A total of 82 adults with a moderate to severe current major depressive episode with features of anhedonia took part in the pilot trial. They were randomly allocated 1:1 to either 20 individual sessions of ADepT or CBT, delivered in the University of Exeter Accessing Evidence Based Psychological Therapies outpatient clinic.

Researcher-blinded assessments were completed at intake and after 6, 12, and 18 months. Coprimary outcomes were depression, measured via the Patient Health Questionnaire and well-being, gauged with the Warwick Edinburgh Mental Wellbeing Scale at 6 months.

Within-group analyses showed that both ADepT and CBT led to clinically meaningful improvements in depression, well-being, and all other secondary outcomes, including measures of anhedonia, Dr. Dunn said.

Between-group effects favored ADepT over CBT for depression and well-being. “For example, about 80% of clients no longer met diagnostic criteria for depression after ADepT, compared to around 56% of clients in CBT,” Dr. Dunn said.

“There were also numerically bigger gains in well-being and reductions in anhedonia in ADepT relative to CBT. A greater number of clients who recovered at the end of therapy stayed well over the longer term in ADepT relative to CBT,” he noted.

ADepT costs the same amount to deliver as CBT “but resulted in greater gains in quality of life, meaning it showed a high probability of being cost effective,” Dr. Dunn said.

ADepT has also been designed so that trained CBT therapists will be able to deliver it with minimal additional training.

“The next step,” said Dr. Dunn, “is a bigger definitive trial, which will formally test if ADepT is clinically superior to and better value for money than CBT when delivering ADepT in more routine care settings [U.K. NHS clinics rather than specialist university mood disorder center].”

The trial was funded by a Career Development Fellowship awarded to Dr. Dunn by the National Institute for Health and Care Research. Dr. Dunn has a book contract with Guilford Press to write the ADepT treatment manual and receives occasional payment or honoraria (including support for attending meetings) for delivering workshops and talks on ADepT.

A version of this article first appeared on Medscape.com.

A novel type of talk therapy that pays as much attention to building positive mood as it does to reducing depressed mood may work as well, if not better, than cognitive-behavioral therapy (CBT) for anhedonic depression, results of a pilot trial suggest.
 

While the trial was not adequately powered to test if augmented depression therapy (ADepT) is superior to CBT, “results nevertheless were encouraging,” lead author Barnaby Dunn, PhD, professor of clinical psychology, University of Exeter (England), said in an interview.

The trial showed that ADepT is feasible, acceptable, and “not worse than CBT,” also showing the “potential to be better than CBT in clinical outcomes,” Dr. Dunn said.

“By building positive mood, ADepT may help individuals stay well for longer in the future,” he noted.

The early results were published online in eClinicalMedicine. 
 

Dual approach

“There are two sides to the depression coin – heightened negative mood and reduced positive mood. Classic CBT focuses mainly on repairing negative mood and pays less attention to building positive mood,” Dr. Dunn explained.

He said when he speaks to clients about what is key to recovery from depression, they often mention the importance of reconnecting to the positive.

“ADepT pays equal attention to building the positives as it does reducing the negatives, giving clients new skills to ‘act opposite’ to old ways of thinking and feeling that can stop them making the most of opportunities and being able to experience well-being,” Dr. Dunn said.

ADepT is an individual therapy delivered over 15 acute and 5 booster sessions, which is similar in “dose” to classic CBT, Dr. Dunn said.

The primary focus of ADepT is building well-being (capacity to experience pleasure, meaning, and social connection in life) and functional recovery, with depression conceptualized as patterns of thinking, feeling, and behaving that serve as barriers to achieving this goal.

Patients work with trained therapists to overcome barriers to being resilient (managing challenges to reduce negative affect) and thriving (taking opportunities to maximize positive affect).

A total of 82 adults with a moderate to severe current major depressive episode with features of anhedonia took part in the pilot trial. They were randomly allocated 1:1 to either 20 individual sessions of ADepT or CBT, delivered in the University of Exeter Accessing Evidence Based Psychological Therapies outpatient clinic.

Researcher-blinded assessments were completed at intake and after 6, 12, and 18 months. Coprimary outcomes were depression, measured via the Patient Health Questionnaire and well-being, gauged with the Warwick Edinburgh Mental Wellbeing Scale at 6 months.

Within-group analyses showed that both ADepT and CBT led to clinically meaningful improvements in depression, well-being, and all other secondary outcomes, including measures of anhedonia, Dr. Dunn said.

Between-group effects favored ADepT over CBT for depression and well-being. “For example, about 80% of clients no longer met diagnostic criteria for depression after ADepT, compared to around 56% of clients in CBT,” Dr. Dunn said.

“There were also numerically bigger gains in well-being and reductions in anhedonia in ADepT relative to CBT. A greater number of clients who recovered at the end of therapy stayed well over the longer term in ADepT relative to CBT,” he noted.

ADepT costs the same amount to deliver as CBT “but resulted in greater gains in quality of life, meaning it showed a high probability of being cost effective,” Dr. Dunn said.

ADepT has also been designed so that trained CBT therapists will be able to deliver it with minimal additional training.

“The next step,” said Dr. Dunn, “is a bigger definitive trial, which will formally test if ADepT is clinically superior to and better value for money than CBT when delivering ADepT in more routine care settings [U.K. NHS clinics rather than specialist university mood disorder center].”

The trial was funded by a Career Development Fellowship awarded to Dr. Dunn by the National Institute for Health and Care Research. Dr. Dunn has a book contract with Guilford Press to write the ADepT treatment manual and receives occasional payment or honoraria (including support for attending meetings) for delivering workshops and talks on ADepT.

A version of this article first appeared on Medscape.com.

A novel type of talk therapy that pays as much attention to building positive mood as it does to reducing depressed mood may work as well, if not better, than cognitive-behavioral therapy (CBT) for anhedonic depression, results of a pilot trial suggest.
 

While the trial was not adequately powered to test if augmented depression therapy (ADepT) is superior to CBT, “results nevertheless were encouraging,” lead author Barnaby Dunn, PhD, professor of clinical psychology, University of Exeter (England), said in an interview.

The trial showed that ADepT is feasible, acceptable, and “not worse than CBT,” also showing the “potential to be better than CBT in clinical outcomes,” Dr. Dunn said.

“By building positive mood, ADepT may help individuals stay well for longer in the future,” he noted.

The early results were published online in eClinicalMedicine. 
 

Dual approach

“There are two sides to the depression coin – heightened negative mood and reduced positive mood. Classic CBT focuses mainly on repairing negative mood and pays less attention to building positive mood,” Dr. Dunn explained.

He said when he speaks to clients about what is key to recovery from depression, they often mention the importance of reconnecting to the positive.

“ADepT pays equal attention to building the positives as it does reducing the negatives, giving clients new skills to ‘act opposite’ to old ways of thinking and feeling that can stop them making the most of opportunities and being able to experience well-being,” Dr. Dunn said.

ADepT is an individual therapy delivered over 15 acute and 5 booster sessions, which is similar in “dose” to classic CBT, Dr. Dunn said.

The primary focus of ADepT is building well-being (capacity to experience pleasure, meaning, and social connection in life) and functional recovery, with depression conceptualized as patterns of thinking, feeling, and behaving that serve as barriers to achieving this goal.

Patients work with trained therapists to overcome barriers to being resilient (managing challenges to reduce negative affect) and thriving (taking opportunities to maximize positive affect).

A total of 82 adults with a moderate to severe current major depressive episode with features of anhedonia took part in the pilot trial. They were randomly allocated 1:1 to either 20 individual sessions of ADepT or CBT, delivered in the University of Exeter Accessing Evidence Based Psychological Therapies outpatient clinic.

Researcher-blinded assessments were completed at intake and after 6, 12, and 18 months. Coprimary outcomes were depression, measured via the Patient Health Questionnaire and well-being, gauged with the Warwick Edinburgh Mental Wellbeing Scale at 6 months.

Within-group analyses showed that both ADepT and CBT led to clinically meaningful improvements in depression, well-being, and all other secondary outcomes, including measures of anhedonia, Dr. Dunn said.

Between-group effects favored ADepT over CBT for depression and well-being. “For example, about 80% of clients no longer met diagnostic criteria for depression after ADepT, compared to around 56% of clients in CBT,” Dr. Dunn said.

“There were also numerically bigger gains in well-being and reductions in anhedonia in ADepT relative to CBT. A greater number of clients who recovered at the end of therapy stayed well over the longer term in ADepT relative to CBT,” he noted.

ADepT costs the same amount to deliver as CBT “but resulted in greater gains in quality of life, meaning it showed a high probability of being cost effective,” Dr. Dunn said.

ADepT has also been designed so that trained CBT therapists will be able to deliver it with minimal additional training.

“The next step,” said Dr. Dunn, “is a bigger definitive trial, which will formally test if ADepT is clinically superior to and better value for money than CBT when delivering ADepT in more routine care settings [U.K. NHS clinics rather than specialist university mood disorder center].”

The trial was funded by a Career Development Fellowship awarded to Dr. Dunn by the National Institute for Health and Care Research. Dr. Dunn has a book contract with Guilford Press to write the ADepT treatment manual and receives occasional payment or honoraria (including support for attending meetings) for delivering workshops and talks on ADepT.

A version of this article first appeared on Medscape.com.