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Treatment with the oral Bruton tyrosine kinase (BTK) inhibitor acalabrutinib in combination with venetoclax was associated with improved progression-free survival, compared with standard-of-care chemoimmunotherapy in frontline treatment of chronic lymphocytic leukemia (CLL), according to a prespecified interim analysis of the AMPLIFY trial.

In fit, adult patients without del(17p) or TP53 mutations, the acalabrutinib-venetoclax combination, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with a combination of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab, reported principal investigator Jennifer R. Brown, MD, PhD,who presented the results at the American Society of Hematology (ASH) 2024 Annual Meeting.

Patients with CLL have several frontline treatment options, which include chemoimmunotherapy for low-risk disease as well as venetoclax plus the first-generation BTK inhibitor ibrutinib.

While fixed-duration venetoclax plus ibrutinib can result in deep, durable responses, cardiac toxicity remains a concern, particularly in older patients, explained Brown, director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts, during a press conference.

Acalabrutinib is a highly selective second-generation BTK inhibitor with improved safety and tolerability, compared with ibrutinib. Brown and colleagues wanted to see whether this second-generation BTK inhibitor alongside venetoclax provided a clinical benefit and fewer cardiac toxicities as a frontline option in this patient population.

“AMPLIFY provides the first phase 3 evidence of fixed-duration therapy with a combination of venetoclax and a second-generation BTK inhibitor in patients with treatment-naive CLL,” Brown said. And these results “show the promise of a new all-oral fixed-duration therapy approach, which would allow patients to take breaks from treatment, reducing the risk of long-term adverse events and drug resistance,” Brown, also from Harvard Medical School, Boston, added in a press release.

 

Study Details

AMPLIFY randomized 867 patients (median age, 61 years) to three treatment arms: Acalabrutinib in combination with venetoclax alone (n = 291), acalabrutinib and venetoclax with obinutuzumab (n = 286), or the investigator’s choice of chemoimmunotherapy — a combination of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab (n = 290). The median follow-up was 41 months.

Compared with 66.5% in the chemoimmunotherapy arm, 83.1% of patients in the acalabrutinib-venetoclax arm and 76.5% of the acalabrutinib-venetoclax-obinutuzumab arm reached the primary endpoint of 36-month progression-free survival (hazard ratios [HRs] of 0.65 and 0.42, respectively). Median progression-free survival was not reached in the two acalabrutinib arms, compared with 47.6 months in the chemotherapy arm.

More than half of all participants (58.6%) had unmutated immunoglobulin heavy-chain variable region gene (IGHV) status. In a subgroup analysis, patients on either acalabrutinib regimen experienced a significant improvement in progression-free survival compared with those on chemoimmunotherapy, regardless of IGHV status.

It was “particularly noticeable” in the acalabrutinib-venetoclax-obinutuzumab arm (HR, 0.35) that patients with unmutated IGHV were doing as well as those with mutated IGHV, “suggesting that the addition of obinutuzumab may overcome the adverse impact of unmutated IGHV,” Brown said.

Patients also demonstrated a robust response in both investigational arms with an overall response rate of 92.8% for acalabrutinib-venetoclax and 92.7% for acalabrutinib-venetoclax-obinutuzumab, compared with 75.2% for chemoimmunotherapy (P < .0001 for both).

In addition, compared with chemoimmunotherapy, acalabrutinib-venetoclax was associated with a significant improvement in overall survival (HR, 0.33; 95% CI, 0.18-0.56). Acalabrutinib-venetoclax-obinutuzumab was associated with better overall survival (HR, 0.78), but the findings were not statistically significant.

When considering COVID-19 deaths, overall survival findings were significant for both acalabrutinib regimens, Brown reported.

COVID-19 deaths were observed in 10 patients in the acalabrutinib-venetoclax arm, 25 in the acalabrutinib-venetoclax-obinutuzumab arm, and 21 in the chemoimmunotherapy arm.

In terms of safety, both acalabrutinib treatment regimens demonstrated “tolerable safety profiles with a low incidence of cardiac adverse events typically associated with BTK inhibitors, including atrial fibrillation or hypertension,” she reported.

Any serious adverse events were observed in 24.7% of the acalabrutinib-venetoclax patients, 38.4% of those receiving acalabrutinib-venetoclax-obinutuzumab, and 27.4% on chemoimmunotherapy. Serious adverse events leading to death occurred in 3.4%, 6.0%, and 3.5% of patients in the three groups, respectively, and adverse events leading to death occurred in about 8%, 20%, and 10.8%, respectively, of patients.

The most common adverse event was neutropenia, with grade 3 or higher neutropenia occurring in 32.3% of patients in the acalabrutinib-venetoclax arm and 46.1% in the acalabrutinib-venetoclax-obinutuzumab group, compared with 43.2% of patients with chemoimmunotherapy.

As for cardiac events, 9.3% of patients in the acalabrutinib-venetoclax group experienced an event of any grade compared with 12% in the acalabrutinib-venetoclax-obinutuzumab group and 3.5% in the chemoimmunotherapy group.

 

To Add or Not to Add Obinutuzumab

Asked how clinicians might decide between the two acalabrutinib regimens, Brown said, “if you add the obinutuzumab, it does add more work for the patient,” and it adds more toxicity.

But, she noted, it might optimize progression-free survival.

“I think when physicians are considering whether to use the two- or the three-drug regimen, they have to take account of the patient in front of them,” Brown said. “The acalabrutinib-venetoclax regimen is a very well-tolerated oral regimen, which is really going to be suitable for anyone, and I think, easy to use in the community.”

The fact that there were more COVID-19 deaths in the obinutuzumab arm, compared with the acalabrutinib-venetoclax arm, suggests more immunosuppression in the three-drug regimen, said session moderator Deborah M. Stephens, DO, associate professor of medicine and director of the Chronic Lymphocytic Leukemia and Richter’s Program at the University of North Carolina School of Medicine in Chapel Hill.

This finding could “call into question whether acalabrutinib-venetoclax may have a better risk/benefit ratio when compared to acalabrutinib-venetoclax-obinutuzumab,” she wrote in an email.

Overall, “AMPLIFY is an important trial, and these data will likely be submitted to the US FDA and regulatory bodies of other involved countries to gain approval of the acalabrutinib + venetoclax +/− obinutuzumab regimen,” Stephens added.

“Notably, this is another in a string of phase 3 trials showing that survival is prolonged with targeted agents compared to chemoimmunotherapy,” indicating that standard chemoimmunotherapy “should be considered obsolete as a control arm for phase 3 studies in the frontline treatment of CLL,” said Stephens.

Alexey Danilov, MD, PhD, another CLL specialist from City of Hope, Duarte, California, who was also presenting at the press conference, said, “I don’t see a full justification to use the acalabrutinib-venetoclax-obinutuzumab regimen across the board in all patients, even though progression-free is better. I do think that, unfortunately, this benefit is offset by increased frequency of adverse events.”

Although it looks like “the majority of patients will be very good candidates for acalabrutinib-venetoclax, with impressive progression-free survival, I think we will still have to define who these patients are,” he added.

However, overall, he was enthusiastic. “This is anticipated to get approval as the first oral doublet front line therapy of CLL, and I think many patients do — in my clinic at least — prefer the idea of finite duration therapy to continuous BTK inhibitors.”

The study was funded by AstraZeneca. Brown disclosed consulting with Acerta/AstraZeneca, Genentech/Roche, AbbVie, and multiple other companies. Danilov disclosed consulting with AstraZeneca, Genentech, AbbVie, among others. Stephens had no relevant disclosures.

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

Treatment with the oral Bruton tyrosine kinase (BTK) inhibitor acalabrutinib in combination with venetoclax was associated with improved progression-free survival, compared with standard-of-care chemoimmunotherapy in frontline treatment of chronic lymphocytic leukemia (CLL), according to a prespecified interim analysis of the AMPLIFY trial.

In fit, adult patients without del(17p) or TP53 mutations, the acalabrutinib-venetoclax combination, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with a combination of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab, reported principal investigator Jennifer R. Brown, MD, PhD,who presented the results at the American Society of Hematology (ASH) 2024 Annual Meeting.

Patients with CLL have several frontline treatment options, which include chemoimmunotherapy for low-risk disease as well as venetoclax plus the first-generation BTK inhibitor ibrutinib.

While fixed-duration venetoclax plus ibrutinib can result in deep, durable responses, cardiac toxicity remains a concern, particularly in older patients, explained Brown, director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts, during a press conference.

Acalabrutinib is a highly selective second-generation BTK inhibitor with improved safety and tolerability, compared with ibrutinib. Brown and colleagues wanted to see whether this second-generation BTK inhibitor alongside venetoclax provided a clinical benefit and fewer cardiac toxicities as a frontline option in this patient population.

“AMPLIFY provides the first phase 3 evidence of fixed-duration therapy with a combination of venetoclax and a second-generation BTK inhibitor in patients with treatment-naive CLL,” Brown said. And these results “show the promise of a new all-oral fixed-duration therapy approach, which would allow patients to take breaks from treatment, reducing the risk of long-term adverse events and drug resistance,” Brown, also from Harvard Medical School, Boston, added in a press release.

 

Study Details

AMPLIFY randomized 867 patients (median age, 61 years) to three treatment arms: Acalabrutinib in combination with venetoclax alone (n = 291), acalabrutinib and venetoclax with obinutuzumab (n = 286), or the investigator’s choice of chemoimmunotherapy — a combination of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab (n = 290). The median follow-up was 41 months.

Compared with 66.5% in the chemoimmunotherapy arm, 83.1% of patients in the acalabrutinib-venetoclax arm and 76.5% of the acalabrutinib-venetoclax-obinutuzumab arm reached the primary endpoint of 36-month progression-free survival (hazard ratios [HRs] of 0.65 and 0.42, respectively). Median progression-free survival was not reached in the two acalabrutinib arms, compared with 47.6 months in the chemotherapy arm.

More than half of all participants (58.6%) had unmutated immunoglobulin heavy-chain variable region gene (IGHV) status. In a subgroup analysis, patients on either acalabrutinib regimen experienced a significant improvement in progression-free survival compared with those on chemoimmunotherapy, regardless of IGHV status.

It was “particularly noticeable” in the acalabrutinib-venetoclax-obinutuzumab arm (HR, 0.35) that patients with unmutated IGHV were doing as well as those with mutated IGHV, “suggesting that the addition of obinutuzumab may overcome the adverse impact of unmutated IGHV,” Brown said.

Patients also demonstrated a robust response in both investigational arms with an overall response rate of 92.8% for acalabrutinib-venetoclax and 92.7% for acalabrutinib-venetoclax-obinutuzumab, compared with 75.2% for chemoimmunotherapy (P < .0001 for both).

In addition, compared with chemoimmunotherapy, acalabrutinib-venetoclax was associated with a significant improvement in overall survival (HR, 0.33; 95% CI, 0.18-0.56). Acalabrutinib-venetoclax-obinutuzumab was associated with better overall survival (HR, 0.78), but the findings were not statistically significant.

When considering COVID-19 deaths, overall survival findings were significant for both acalabrutinib regimens, Brown reported.

COVID-19 deaths were observed in 10 patients in the acalabrutinib-venetoclax arm, 25 in the acalabrutinib-venetoclax-obinutuzumab arm, and 21 in the chemoimmunotherapy arm.

In terms of safety, both acalabrutinib treatment regimens demonstrated “tolerable safety profiles with a low incidence of cardiac adverse events typically associated with BTK inhibitors, including atrial fibrillation or hypertension,” she reported.

Any serious adverse events were observed in 24.7% of the acalabrutinib-venetoclax patients, 38.4% of those receiving acalabrutinib-venetoclax-obinutuzumab, and 27.4% on chemoimmunotherapy. Serious adverse events leading to death occurred in 3.4%, 6.0%, and 3.5% of patients in the three groups, respectively, and adverse events leading to death occurred in about 8%, 20%, and 10.8%, respectively, of patients.

The most common adverse event was neutropenia, with grade 3 or higher neutropenia occurring in 32.3% of patients in the acalabrutinib-venetoclax arm and 46.1% in the acalabrutinib-venetoclax-obinutuzumab group, compared with 43.2% of patients with chemoimmunotherapy.

As for cardiac events, 9.3% of patients in the acalabrutinib-venetoclax group experienced an event of any grade compared with 12% in the acalabrutinib-venetoclax-obinutuzumab group and 3.5% in the chemoimmunotherapy group.

 

To Add or Not to Add Obinutuzumab

Asked how clinicians might decide between the two acalabrutinib regimens, Brown said, “if you add the obinutuzumab, it does add more work for the patient,” and it adds more toxicity.

But, she noted, it might optimize progression-free survival.

“I think when physicians are considering whether to use the two- or the three-drug regimen, they have to take account of the patient in front of them,” Brown said. “The acalabrutinib-venetoclax regimen is a very well-tolerated oral regimen, which is really going to be suitable for anyone, and I think, easy to use in the community.”

The fact that there were more COVID-19 deaths in the obinutuzumab arm, compared with the acalabrutinib-venetoclax arm, suggests more immunosuppression in the three-drug regimen, said session moderator Deborah M. Stephens, DO, associate professor of medicine and director of the Chronic Lymphocytic Leukemia and Richter’s Program at the University of North Carolina School of Medicine in Chapel Hill.

This finding could “call into question whether acalabrutinib-venetoclax may have a better risk/benefit ratio when compared to acalabrutinib-venetoclax-obinutuzumab,” she wrote in an email.

Overall, “AMPLIFY is an important trial, and these data will likely be submitted to the US FDA and regulatory bodies of other involved countries to gain approval of the acalabrutinib + venetoclax +/− obinutuzumab regimen,” Stephens added.

“Notably, this is another in a string of phase 3 trials showing that survival is prolonged with targeted agents compared to chemoimmunotherapy,” indicating that standard chemoimmunotherapy “should be considered obsolete as a control arm for phase 3 studies in the frontline treatment of CLL,” said Stephens.

Alexey Danilov, MD, PhD, another CLL specialist from City of Hope, Duarte, California, who was also presenting at the press conference, said, “I don’t see a full justification to use the acalabrutinib-venetoclax-obinutuzumab regimen across the board in all patients, even though progression-free is better. I do think that, unfortunately, this benefit is offset by increased frequency of adverse events.”

Although it looks like “the majority of patients will be very good candidates for acalabrutinib-venetoclax, with impressive progression-free survival, I think we will still have to define who these patients are,” he added.

However, overall, he was enthusiastic. “This is anticipated to get approval as the first oral doublet front line therapy of CLL, and I think many patients do — in my clinic at least — prefer the idea of finite duration therapy to continuous BTK inhibitors.”

The study was funded by AstraZeneca. Brown disclosed consulting with Acerta/AstraZeneca, Genentech/Roche, AbbVie, and multiple other companies. Danilov disclosed consulting with AstraZeneca, Genentech, AbbVie, among others. Stephens had no relevant disclosures.

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

Treatment with the oral Bruton tyrosine kinase (BTK) inhibitor acalabrutinib in combination with venetoclax was associated with improved progression-free survival, compared with standard-of-care chemoimmunotherapy in frontline treatment of chronic lymphocytic leukemia (CLL), according to a prespecified interim analysis of the AMPLIFY trial.

In fit, adult patients without del(17p) or TP53 mutations, the acalabrutinib-venetoclax combination, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with a combination of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab, reported principal investigator Jennifer R. Brown, MD, PhD,who presented the results at the American Society of Hematology (ASH) 2024 Annual Meeting.

Patients with CLL have several frontline treatment options, which include chemoimmunotherapy for low-risk disease as well as venetoclax plus the first-generation BTK inhibitor ibrutinib.

While fixed-duration venetoclax plus ibrutinib can result in deep, durable responses, cardiac toxicity remains a concern, particularly in older patients, explained Brown, director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts, during a press conference.

Acalabrutinib is a highly selective second-generation BTK inhibitor with improved safety and tolerability, compared with ibrutinib. Brown and colleagues wanted to see whether this second-generation BTK inhibitor alongside venetoclax provided a clinical benefit and fewer cardiac toxicities as a frontline option in this patient population.

“AMPLIFY provides the first phase 3 evidence of fixed-duration therapy with a combination of venetoclax and a second-generation BTK inhibitor in patients with treatment-naive CLL,” Brown said. And these results “show the promise of a new all-oral fixed-duration therapy approach, which would allow patients to take breaks from treatment, reducing the risk of long-term adverse events and drug resistance,” Brown, also from Harvard Medical School, Boston, added in a press release.

 

Study Details

AMPLIFY randomized 867 patients (median age, 61 years) to three treatment arms: Acalabrutinib in combination with venetoclax alone (n = 291), acalabrutinib and venetoclax with obinutuzumab (n = 286), or the investigator’s choice of chemoimmunotherapy — a combination of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab (n = 290). The median follow-up was 41 months.

Compared with 66.5% in the chemoimmunotherapy arm, 83.1% of patients in the acalabrutinib-venetoclax arm and 76.5% of the acalabrutinib-venetoclax-obinutuzumab arm reached the primary endpoint of 36-month progression-free survival (hazard ratios [HRs] of 0.65 and 0.42, respectively). Median progression-free survival was not reached in the two acalabrutinib arms, compared with 47.6 months in the chemotherapy arm.

More than half of all participants (58.6%) had unmutated immunoglobulin heavy-chain variable region gene (IGHV) status. In a subgroup analysis, patients on either acalabrutinib regimen experienced a significant improvement in progression-free survival compared with those on chemoimmunotherapy, regardless of IGHV status.

It was “particularly noticeable” in the acalabrutinib-venetoclax-obinutuzumab arm (HR, 0.35) that patients with unmutated IGHV were doing as well as those with mutated IGHV, “suggesting that the addition of obinutuzumab may overcome the adverse impact of unmutated IGHV,” Brown said.

Patients also demonstrated a robust response in both investigational arms with an overall response rate of 92.8% for acalabrutinib-venetoclax and 92.7% for acalabrutinib-venetoclax-obinutuzumab, compared with 75.2% for chemoimmunotherapy (P < .0001 for both).

In addition, compared with chemoimmunotherapy, acalabrutinib-venetoclax was associated with a significant improvement in overall survival (HR, 0.33; 95% CI, 0.18-0.56). Acalabrutinib-venetoclax-obinutuzumab was associated with better overall survival (HR, 0.78), but the findings were not statistically significant.

When considering COVID-19 deaths, overall survival findings were significant for both acalabrutinib regimens, Brown reported.

COVID-19 deaths were observed in 10 patients in the acalabrutinib-venetoclax arm, 25 in the acalabrutinib-venetoclax-obinutuzumab arm, and 21 in the chemoimmunotherapy arm.

In terms of safety, both acalabrutinib treatment regimens demonstrated “tolerable safety profiles with a low incidence of cardiac adverse events typically associated with BTK inhibitors, including atrial fibrillation or hypertension,” she reported.

Any serious adverse events were observed in 24.7% of the acalabrutinib-venetoclax patients, 38.4% of those receiving acalabrutinib-venetoclax-obinutuzumab, and 27.4% on chemoimmunotherapy. Serious adverse events leading to death occurred in 3.4%, 6.0%, and 3.5% of patients in the three groups, respectively, and adverse events leading to death occurred in about 8%, 20%, and 10.8%, respectively, of patients.

The most common adverse event was neutropenia, with grade 3 or higher neutropenia occurring in 32.3% of patients in the acalabrutinib-venetoclax arm and 46.1% in the acalabrutinib-venetoclax-obinutuzumab group, compared with 43.2% of patients with chemoimmunotherapy.

As for cardiac events, 9.3% of patients in the acalabrutinib-venetoclax group experienced an event of any grade compared with 12% in the acalabrutinib-venetoclax-obinutuzumab group and 3.5% in the chemoimmunotherapy group.

 

To Add or Not to Add Obinutuzumab

Asked how clinicians might decide between the two acalabrutinib regimens, Brown said, “if you add the obinutuzumab, it does add more work for the patient,” and it adds more toxicity.

But, she noted, it might optimize progression-free survival.

“I think when physicians are considering whether to use the two- or the three-drug regimen, they have to take account of the patient in front of them,” Brown said. “The acalabrutinib-venetoclax regimen is a very well-tolerated oral regimen, which is really going to be suitable for anyone, and I think, easy to use in the community.”

The fact that there were more COVID-19 deaths in the obinutuzumab arm, compared with the acalabrutinib-venetoclax arm, suggests more immunosuppression in the three-drug regimen, said session moderator Deborah M. Stephens, DO, associate professor of medicine and director of the Chronic Lymphocytic Leukemia and Richter’s Program at the University of North Carolina School of Medicine in Chapel Hill.

This finding could “call into question whether acalabrutinib-venetoclax may have a better risk/benefit ratio when compared to acalabrutinib-venetoclax-obinutuzumab,” she wrote in an email.

Overall, “AMPLIFY is an important trial, and these data will likely be submitted to the US FDA and regulatory bodies of other involved countries to gain approval of the acalabrutinib + venetoclax +/− obinutuzumab regimen,” Stephens added.

“Notably, this is another in a string of phase 3 trials showing that survival is prolonged with targeted agents compared to chemoimmunotherapy,” indicating that standard chemoimmunotherapy “should be considered obsolete as a control arm for phase 3 studies in the frontline treatment of CLL,” said Stephens.

Alexey Danilov, MD, PhD, another CLL specialist from City of Hope, Duarte, California, who was also presenting at the press conference, said, “I don’t see a full justification to use the acalabrutinib-venetoclax-obinutuzumab regimen across the board in all patients, even though progression-free is better. I do think that, unfortunately, this benefit is offset by increased frequency of adverse events.”

Although it looks like “the majority of patients will be very good candidates for acalabrutinib-venetoclax, with impressive progression-free survival, I think we will still have to define who these patients are,” he added.

However, overall, he was enthusiastic. “This is anticipated to get approval as the first oral doublet front line therapy of CLL, and I think many patients do — in my clinic at least — prefer the idea of finite duration therapy to continuous BTK inhibitors.”

The study was funded by AstraZeneca. Brown disclosed consulting with Acerta/AstraZeneca, Genentech/Roche, AbbVie, and multiple other companies. Danilov disclosed consulting with AstraZeneca, Genentech, AbbVie, among others. Stephens had no relevant disclosures.

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

TOPLINE:

The use of active surveillance or watchful waiting increased by more than twofold overall between 2010 and 2020 among patients with intermediate-risk prostate cancer.

METHODOLOGY:

• Current guidelines support active surveillance or watchful waiting for select patients with intermediate-risk prostate cancer. These observation strategies may help reduce the adverse effects associated with immediate radical treatment.
• To understand the trends over time in the use of active surveillance and watchful waiting, researchers looked at data of 147,205 individuals with intermediate-risk prostate cancer from the Surveillance, Epidemiology, and End Results prostate cancer database between 2010 and 2020 in the United States.
• Criteria for intermediate-risk included Gleason grade group 2 or 3, prostate-specific antigen (PSA) levels of 10-20 ng/mL, or stage cT2b of the disease. Researchers also included trends for patients with Gleason grade group 1, as a reference group.
• Researchers assessed the temporal trends and factors associated with the selection of active surveillance and watchful waiting in this population.

TAKEAWAY:

• Overall, the rate of active surveillance and watchful waiting more than doubled among intermediate-risk patients from 5% to 12.3% between 2010 and 2020.
• Between 2010 and 2020, the use of active surveillance and watchful waiting increased significantly among patients in Gleason grade group 1 (13.2% to 53.8%) and Gleason grade group 2 (4.0% to 11.6%) but remained stable for those in Gleason grade group 3 (2.5% to 2.8%; P = .85). For those with PSA levels < 10 ng/mL, adoption increased from 3.4% in 2010 to 9.2% in 2020 and more than doubled (9.3% to 20.7%) for those with PSA levels of 10-20 ng/mL.
• Higher Gleason grade groups had a significantly lower likelihood of adopting active surveillance or watchful waiting (Gleason grade group 2 vs 1: odds ratio [OR], 0.83; Gleason grade group 3 vs 1: OR, 0.79).
• Hispanic or Latino individuals (OR, 0.98) and non-Hispanic Black individuals (OR, 0.99) were slightly less likely to adopt these strategies than non-Hispanic White individuals.

IN PRACTICE:

“This study found a significant increase in initial active surveillance and watchful waiting for intermediate-risk prostate cancer between 2010 and 2020,” the authors wrote. “Research priorities should include reducing upfront overdiagnosis and better defining criteria for starting and stopping active surveillance and watchful waiting beyond conventional clinical measures such as GGs [Gleason grade groups] or PSA levels alone.”

SOURCE:

This study, led by Ismail Ajjawi, Yale School of Medicine, New Haven, Connecticut, was published online in JAMA.

LIMITATIONS:

This study relied on observational data and therefore could not capture various factors influencing clinical decision-making processes. Additionally, the absence of information on patient outcomes restricted the ability to assess the long-term implications of different management strategies.

DISCLOSURES:

This study received financial support from the Urological Research Foundation. Several authors reported having various ties with various sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The use of active surveillance or watchful waiting increased by more than twofold overall between 2010 and 2020 among patients with intermediate-risk prostate cancer.

METHODOLOGY:

• Current guidelines support active surveillance or watchful waiting for select patients with intermediate-risk prostate cancer. These observation strategies may help reduce the adverse effects associated with immediate radical treatment.
• To understand the trends over time in the use of active surveillance and watchful waiting, researchers looked at data of 147,205 individuals with intermediate-risk prostate cancer from the Surveillance, Epidemiology, and End Results prostate cancer database between 2010 and 2020 in the United States.
• Criteria for intermediate-risk included Gleason grade group 2 or 3, prostate-specific antigen (PSA) levels of 10-20 ng/mL, or stage cT2b of the disease. Researchers also included trends for patients with Gleason grade group 1, as a reference group.
• Researchers assessed the temporal trends and factors associated with the selection of active surveillance and watchful waiting in this population.

TAKEAWAY:

• Overall, the rate of active surveillance and watchful waiting more than doubled among intermediate-risk patients from 5% to 12.3% between 2010 and 2020.
• Between 2010 and 2020, the use of active surveillance and watchful waiting increased significantly among patients in Gleason grade group 1 (13.2% to 53.8%) and Gleason grade group 2 (4.0% to 11.6%) but remained stable for those in Gleason grade group 3 (2.5% to 2.8%; P = .85). For those with PSA levels < 10 ng/mL, adoption increased from 3.4% in 2010 to 9.2% in 2020 and more than doubled (9.3% to 20.7%) for those with PSA levels of 10-20 ng/mL.
• Higher Gleason grade groups had a significantly lower likelihood of adopting active surveillance or watchful waiting (Gleason grade group 2 vs 1: odds ratio [OR], 0.83; Gleason grade group 3 vs 1: OR, 0.79).
• Hispanic or Latino individuals (OR, 0.98) and non-Hispanic Black individuals (OR, 0.99) were slightly less likely to adopt these strategies than non-Hispanic White individuals.

IN PRACTICE:

“This study found a significant increase in initial active surveillance and watchful waiting for intermediate-risk prostate cancer between 2010 and 2020,” the authors wrote. “Research priorities should include reducing upfront overdiagnosis and better defining criteria for starting and stopping active surveillance and watchful waiting beyond conventional clinical measures such as GGs [Gleason grade groups] or PSA levels alone.”

SOURCE:

This study, led by Ismail Ajjawi, Yale School of Medicine, New Haven, Connecticut, was published online in JAMA.

LIMITATIONS:

This study relied on observational data and therefore could not capture various factors influencing clinical decision-making processes. Additionally, the absence of information on patient outcomes restricted the ability to assess the long-term implications of different management strategies.

DISCLOSURES:

This study received financial support from the Urological Research Foundation. Several authors reported having various ties with various sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The use of active surveillance or watchful waiting increased by more than twofold overall between 2010 and 2020 among patients with intermediate-risk prostate cancer.

METHODOLOGY:

• Current guidelines support active surveillance or watchful waiting for select patients with intermediate-risk prostate cancer. These observation strategies may help reduce the adverse effects associated with immediate radical treatment.
• To understand the trends over time in the use of active surveillance and watchful waiting, researchers looked at data of 147,205 individuals with intermediate-risk prostate cancer from the Surveillance, Epidemiology, and End Results prostate cancer database between 2010 and 2020 in the United States.
• Criteria for intermediate-risk included Gleason grade group 2 or 3, prostate-specific antigen (PSA) levels of 10-20 ng/mL, or stage cT2b of the disease. Researchers also included trends for patients with Gleason grade group 1, as a reference group.
• Researchers assessed the temporal trends and factors associated with the selection of active surveillance and watchful waiting in this population.

TAKEAWAY:

• Overall, the rate of active surveillance and watchful waiting more than doubled among intermediate-risk patients from 5% to 12.3% between 2010 and 2020.
• Between 2010 and 2020, the use of active surveillance and watchful waiting increased significantly among patients in Gleason grade group 1 (13.2% to 53.8%) and Gleason grade group 2 (4.0% to 11.6%) but remained stable for those in Gleason grade group 3 (2.5% to 2.8%; P = .85). For those with PSA levels < 10 ng/mL, adoption increased from 3.4% in 2010 to 9.2% in 2020 and more than doubled (9.3% to 20.7%) for those with PSA levels of 10-20 ng/mL.
• Higher Gleason grade groups had a significantly lower likelihood of adopting active surveillance or watchful waiting (Gleason grade group 2 vs 1: odds ratio [OR], 0.83; Gleason grade group 3 vs 1: OR, 0.79).
• Hispanic or Latino individuals (OR, 0.98) and non-Hispanic Black individuals (OR, 0.99) were slightly less likely to adopt these strategies than non-Hispanic White individuals.

IN PRACTICE:

“This study found a significant increase in initial active surveillance and watchful waiting for intermediate-risk prostate cancer between 2010 and 2020,” the authors wrote. “Research priorities should include reducing upfront overdiagnosis and better defining criteria for starting and stopping active surveillance and watchful waiting beyond conventional clinical measures such as GGs [Gleason grade groups] or PSA levels alone.”

SOURCE:

This study, led by Ismail Ajjawi, Yale School of Medicine, New Haven, Connecticut, was published online in JAMA.

LIMITATIONS:

This study relied on observational data and therefore could not capture various factors influencing clinical decision-making processes. Additionally, the absence of information on patient outcomes restricted the ability to assess the long-term implications of different management strategies.

DISCLOSURES:

This study received financial support from the Urological Research Foundation. Several authors reported having various ties with various sources.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

National Organization for Rare Disorders: Strengthening Rare Cancer Advocacy
By Alli Ward
NORD's Rare Cancer Coalition has transformed advocacy and awareness efforts, offering education and fostering research to address the challenges of rare cancers.

Treatment of Glioblastoma: A Potential Shift in Paradigm
By Jeffrey N. Bruce, MD
Immunotherapies and molecular profiling are paving the way for more targeted approaches in treating glioblastoma.

Emerging Insights and Therapeutic Strategies for Large Cell Neuroendocrine Carcinoma of the Lung
By Robert A. Ramirez, DO, FACP, and Aman Chauhan, MD 
New diagnostic tools and precision medicine approaches are addressing the unique challenges of this aggressive neuroendocrine cancer.

Advancements in the Treatment of Malignant PEComas with mTOR Inhibitors
By Richard F. Riedel, MD
The use of mTOR inhibitors marks significant progress in managing advanced malignant PEComas, offering new hope for patients.

Cutaneous T-Cell Lymphomas Update: Benefits of a Multidisciplinary Care Approach
By Jina Chung, MD, and Eric Mou, MD
A multidisciplinary care model ensures optimal outcomes for patients with cutaneous T-cell lymphomas, addressing both medical and emotional needs.

Optimizing Myelofibrosis Care in the Age of JAK Inhibitors
By Douglas Tremblay, MD
JAK inhibitors are central to myelofibrosis management, with personalized strategies helping to navigate resistance and improve quality of life.

Current Management and Future Directions in the Treatment of Gallbladder Cancer
By Ghassan K. Abou-Alfa, MD, MBA, JD, FASCO
Molecular profiling and immunotherapy are reshaping the treatment paradigm for gallbladder cancer, improving survival outcomes.

Improving Prognosis in Hepatoblastoma: Evolving Risk Stratification and Treatment Strategies
By Greg M. Tiao, MD
Risk stratification and individualized therapies are driving progress in treating hepatoblastoma, with promising advancements on the horizon.

National Organization for Rare Disorders: Strengthening Rare Cancer Advocacy
By Alli Ward
NORD's Rare Cancer Coalition has transformed advocacy and awareness efforts, offering education and fostering research to address the challenges of rare cancers.

Treatment of Glioblastoma: A Potential Shift in Paradigm
By Jeffrey N. Bruce, MD
Immunotherapies and molecular profiling are paving the way for more targeted approaches in treating glioblastoma.

Emerging Insights and Therapeutic Strategies for Large Cell Neuroendocrine Carcinoma of the Lung
By Robert A. Ramirez, DO, FACP, and Aman Chauhan, MD 
New diagnostic tools and precision medicine approaches are addressing the unique challenges of this aggressive neuroendocrine cancer.

Advancements in the Treatment of Malignant PEComas with mTOR Inhibitors
By Richard F. Riedel, MD
The use of mTOR inhibitors marks significant progress in managing advanced malignant PEComas, offering new hope for patients.

Cutaneous T-Cell Lymphomas Update: Benefits of a Multidisciplinary Care Approach
By Jina Chung, MD, and Eric Mou, MD
A multidisciplinary care model ensures optimal outcomes for patients with cutaneous T-cell lymphomas, addressing both medical and emotional needs.

Optimizing Myelofibrosis Care in the Age of JAK Inhibitors
By Douglas Tremblay, MD
JAK inhibitors are central to myelofibrosis management, with personalized strategies helping to navigate resistance and improve quality of life.

Current Management and Future Directions in the Treatment of Gallbladder Cancer
By Ghassan K. Abou-Alfa, MD, MBA, JD, FASCO
Molecular profiling and immunotherapy are reshaping the treatment paradigm for gallbladder cancer, improving survival outcomes.

Improving Prognosis in Hepatoblastoma: Evolving Risk Stratification and Treatment Strategies
By Greg M. Tiao, MD
Risk stratification and individualized therapies are driving progress in treating hepatoblastoma, with promising advancements on the horizon.

National Organization for Rare Disorders: Strengthening Rare Cancer Advocacy
By Alli Ward
NORD's Rare Cancer Coalition has transformed advocacy and awareness efforts, offering education and fostering research to address the challenges of rare cancers.

Treatment of Glioblastoma: A Potential Shift in Paradigm
By Jeffrey N. Bruce, MD
Immunotherapies and molecular profiling are paving the way for more targeted approaches in treating glioblastoma.

Emerging Insights and Therapeutic Strategies for Large Cell Neuroendocrine Carcinoma of the Lung
By Robert A. Ramirez, DO, FACP, and Aman Chauhan, MD 
New diagnostic tools and precision medicine approaches are addressing the unique challenges of this aggressive neuroendocrine cancer.

Advancements in the Treatment of Malignant PEComas with mTOR Inhibitors
By Richard F. Riedel, MD
The use of mTOR inhibitors marks significant progress in managing advanced malignant PEComas, offering new hope for patients.

Cutaneous T-Cell Lymphomas Update: Benefits of a Multidisciplinary Care Approach
By Jina Chung, MD, and Eric Mou, MD
A multidisciplinary care model ensures optimal outcomes for patients with cutaneous T-cell lymphomas, addressing both medical and emotional needs.

Optimizing Myelofibrosis Care in the Age of JAK Inhibitors
By Douglas Tremblay, MD
JAK inhibitors are central to myelofibrosis management, with personalized strategies helping to navigate resistance and improve quality of life.

Current Management and Future Directions in the Treatment of Gallbladder Cancer
By Ghassan K. Abou-Alfa, MD, MBA, JD, FASCO
Molecular profiling and immunotherapy are reshaping the treatment paradigm for gallbladder cancer, improving survival outcomes.

Improving Prognosis in Hepatoblastoma: Evolving Risk Stratification and Treatment Strategies
By Greg M. Tiao, MD
Risk stratification and individualized therapies are driving progress in treating hepatoblastoma, with promising advancements on the horizon.

TOPLINE:

The beneficial effect of clopidogrel monotherapy over aspirin monotherapy in patients who underwent percutaneous coronary intervention (PCI) and remained event free for 6-18 months on dual antiplatelet therapy (DAPT) is consistent, regardless of bleeding risk or PCI complexity, according to a post hoc analysis of the HOST-EXAM trial.

METHODOLOGY:

• The HOST-EXAM Extended study conducted across 37 sites in South Korea included patients who underwent PCI with drug-eluting stents and remained free of clinical events for 6-18 months post-PCI, while receiving DAPT.
• This post hoc analysis of the HOST-EXAM Extended study compared the effectiveness of long-term daily clopidogrel (75 mg) with that of aspirin monotherapy (100 mg) after PCI, according to bleeding risk and procedural complexity in 3974 patients (mean age, 63 years; 75% men) who were followed for up to 5.9 years.
• High bleeding risk was reported in 866 patients, and 849 patients underwent complex PCI.
• Patients were classified into four distinct risk groups: No bleeding risk and noncomplex PCI, no bleeding risk and complex PCI, high bleeding risk and noncomplex PCI, and high bleeding risk and complex PCI.
• The co-primary endpoints were thrombotic composite events (cardiovascular death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and definite/probable stent thrombosis) and any bleeding event.

TAKEAWAY:

• Thrombotic composite events (hazard ratio [HR], 2.15; P < .001) and any bleeding event (HR, 3.64; P < .001) were more frequent in patients with a high bleeding risk than in those without.
• However, there was no difference in the risk for thrombotic composite events or any bleeding event by PCI complexity.
• The long-term benefits of clopidogrel monotherapy over aspirin monotherapy were seen in all patients, regardless of bleeding risks (P for interaction = .38 for thrombotic composite events and P for interaction = .20 for any bleeding event) or PCI complexity (P for interaction = .12 for thrombotic composite events and P for interaction = .62 for any bleeding event).
• The greatest risk reduction in thrombotic composite events with clopidogrel monotherapy occurred in patients with a high bleeding risk who underwent complex PCI (HR, 0.46; P = .03).

IN PRACTICE:

“[In this study], no significant interaction was found between treatment arms and risk groups, denoting that the beneficial impact of clopidogrel monotherapy was consistent regardless of HBR [high bleeding risk] or PCI complexity,” the authors wrote.

SOURCE:

This study was led by Jeehoon Kang, MD, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea. It was published online on November 27, 2024, in JAMA Cardiology.

LIMITATIONS:

As this study is a post hoc analysis, the findings should be considered primarily hypothesis generating. This study was conducted exclusively in an East Asian population and may not be generalizable to other ethnic groups. The definitions of high bleeding risk and complex PCI used in this analysis were not prespecified in the study protocol of the HOST-EXAM trial. Certain criteria defining high bleeding risk were not analyzed as they fell under the exclusion criteria of the HOST-EXAM trial or were not recorded in the study case report form.

DISCLOSURES:

This study was supported by grants from the Patient-Centered Clinical Research Coordinating Center and Seoul National University Hospital. One author reported receiving grants and personal fees from various pharmaceutical companies outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The beneficial effect of clopidogrel monotherapy over aspirin monotherapy in patients who underwent percutaneous coronary intervention (PCI) and remained event free for 6-18 months on dual antiplatelet therapy (DAPT) is consistent, regardless of bleeding risk or PCI complexity, according to a post hoc analysis of the HOST-EXAM trial.

METHODOLOGY:

• The HOST-EXAM Extended study conducted across 37 sites in South Korea included patients who underwent PCI with drug-eluting stents and remained free of clinical events for 6-18 months post-PCI, while receiving DAPT.
• This post hoc analysis of the HOST-EXAM Extended study compared the effectiveness of long-term daily clopidogrel (75 mg) with that of aspirin monotherapy (100 mg) after PCI, according to bleeding risk and procedural complexity in 3974 patients (mean age, 63 years; 75% men) who were followed for up to 5.9 years.
• High bleeding risk was reported in 866 patients, and 849 patients underwent complex PCI.
• Patients were classified into four distinct risk groups: No bleeding risk and noncomplex PCI, no bleeding risk and complex PCI, high bleeding risk and noncomplex PCI, and high bleeding risk and complex PCI.
• The co-primary endpoints were thrombotic composite events (cardiovascular death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and definite/probable stent thrombosis) and any bleeding event.

TAKEAWAY:

• Thrombotic composite events (hazard ratio [HR], 2.15; P < .001) and any bleeding event (HR, 3.64; P < .001) were more frequent in patients with a high bleeding risk than in those without.
• However, there was no difference in the risk for thrombotic composite events or any bleeding event by PCI complexity.
• The long-term benefits of clopidogrel monotherapy over aspirin monotherapy were seen in all patients, regardless of bleeding risks (P for interaction = .38 for thrombotic composite events and P for interaction = .20 for any bleeding event) or PCI complexity (P for interaction = .12 for thrombotic composite events and P for interaction = .62 for any bleeding event).
• The greatest risk reduction in thrombotic composite events with clopidogrel monotherapy occurred in patients with a high bleeding risk who underwent complex PCI (HR, 0.46; P = .03).

IN PRACTICE:

“[In this study], no significant interaction was found between treatment arms and risk groups, denoting that the beneficial impact of clopidogrel monotherapy was consistent regardless of HBR [high bleeding risk] or PCI complexity,” the authors wrote.

SOURCE:

This study was led by Jeehoon Kang, MD, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea. It was published online on November 27, 2024, in JAMA Cardiology.

LIMITATIONS:

As this study is a post hoc analysis, the findings should be considered primarily hypothesis generating. This study was conducted exclusively in an East Asian population and may not be generalizable to other ethnic groups. The definitions of high bleeding risk and complex PCI used in this analysis were not prespecified in the study protocol of the HOST-EXAM trial. Certain criteria defining high bleeding risk were not analyzed as they fell under the exclusion criteria of the HOST-EXAM trial or were not recorded in the study case report form.

DISCLOSURES:

This study was supported by grants from the Patient-Centered Clinical Research Coordinating Center and Seoul National University Hospital. One author reported receiving grants and personal fees from various pharmaceutical companies outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The beneficial effect of clopidogrel monotherapy over aspirin monotherapy in patients who underwent percutaneous coronary intervention (PCI) and remained event free for 6-18 months on dual antiplatelet therapy (DAPT) is consistent, regardless of bleeding risk or PCI complexity, according to a post hoc analysis of the HOST-EXAM trial.

METHODOLOGY:

• The HOST-EXAM Extended study conducted across 37 sites in South Korea included patients who underwent PCI with drug-eluting stents and remained free of clinical events for 6-18 months post-PCI, while receiving DAPT.
• This post hoc analysis of the HOST-EXAM Extended study compared the effectiveness of long-term daily clopidogrel (75 mg) with that of aspirin monotherapy (100 mg) after PCI, according to bleeding risk and procedural complexity in 3974 patients (mean age, 63 years; 75% men) who were followed for up to 5.9 years.
• High bleeding risk was reported in 866 patients, and 849 patients underwent complex PCI.
• Patients were classified into four distinct risk groups: No bleeding risk and noncomplex PCI, no bleeding risk and complex PCI, high bleeding risk and noncomplex PCI, and high bleeding risk and complex PCI.
• The co-primary endpoints were thrombotic composite events (cardiovascular death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and definite/probable stent thrombosis) and any bleeding event.

TAKEAWAY:

• Thrombotic composite events (hazard ratio [HR], 2.15; P < .001) and any bleeding event (HR, 3.64; P < .001) were more frequent in patients with a high bleeding risk than in those without.
• However, there was no difference in the risk for thrombotic composite events or any bleeding event by PCI complexity.
• The long-term benefits of clopidogrel monotherapy over aspirin monotherapy were seen in all patients, regardless of bleeding risks (P for interaction = .38 for thrombotic composite events and P for interaction = .20 for any bleeding event) or PCI complexity (P for interaction = .12 for thrombotic composite events and P for interaction = .62 for any bleeding event).
• The greatest risk reduction in thrombotic composite events with clopidogrel monotherapy occurred in patients with a high bleeding risk who underwent complex PCI (HR, 0.46; P = .03).

IN PRACTICE:

“[In this study], no significant interaction was found between treatment arms and risk groups, denoting that the beneficial impact of clopidogrel monotherapy was consistent regardless of HBR [high bleeding risk] or PCI complexity,” the authors wrote.

SOURCE:

This study was led by Jeehoon Kang, MD, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea. It was published online on November 27, 2024, in JAMA Cardiology.

LIMITATIONS:

As this study is a post hoc analysis, the findings should be considered primarily hypothesis generating. This study was conducted exclusively in an East Asian population and may not be generalizable to other ethnic groups. The definitions of high bleeding risk and complex PCI used in this analysis were not prespecified in the study protocol of the HOST-EXAM trial. Certain criteria defining high bleeding risk were not analyzed as they fell under the exclusion criteria of the HOST-EXAM trial or were not recorded in the study case report form.

DISCLOSURES:

This study was supported by grants from the Patient-Centered Clinical Research Coordinating Center and Seoul National University Hospital. One author reported receiving grants and personal fees from various pharmaceutical companies outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Patients receiving > 200 mL/kg of fluid resuscitation for burn injuries show higher rates of worsening neurologic findings on imaging, with follow-up scans showing deterioration in high-volume recipients compared with low-volume recipients.

METHODOLOGY:

• Researchers conducted a single-center review of 5176 patients with burn injuries who were admitted to a verified American Burn Association center (2003-2017); 622 of them underwent head CT within 96 hours of admission, and 83 showed intracranial abnormalities.
• Of 42 patients (mean age, 49.7 years; 80.5% men) who were admitted within 24 hours of burn, 30 patients received < 200 mL/kg and 11 received > 200 mL/kg of total resuscitation fluids, with a median total body surface area (TBSA) of 20.0.
• The primary outcome assessed was the worsening of neurologic findings on imaging related to the volume of the resuscitation fluid administered; the secondary outcomes were the incidence of new or worsening intracranial abnormalities, including hemorrhage, edema, ischemia, or infarction.

TAKEAWAY:

• Neurologic findings worsened in 47.6% patients receiving < 200 mL/kg of fluid resuscitation and 85.7% of those receiving > 200 mL/kg (P =.064).
• Repeat imaging was performed in 21 (70.0%) patients receiving < 200 mL/kg and 7 (63.6%) patients receiving > 200 mL/kg of resuscitation who underwent follow-up imaging.
• The median TBSA was 16.5 in the < 200 mL/kg group and 53.2 in the > 200 mL/kg group (P <.001).
• Intracranial abnormalities were found in 31.3% patients with hemorrhage, 18.8% with worsening edema, and 43.8% with ischemia or infarction.

IN PRACTICE:

“Patients who received over 200 mL/kg of resuscitation had an increased progression of intracranial abnormalities when compared with patients receiving less volume resuscitation,” the authors wrote. “Neurologic changes prompting imaging in burn patients may be undetectable, and our study further highlights the need for routine evaluation with neurologic imaging when undergoing large-volume resuscitations.”

SOURCE:

The study was led by Connor L. Kenney, MD, Brooke Army Medical Center, San Antonio, and was published online on November 07, 2024, in the Journal of Surgical Research.

LIMITATIONS:

Study limitations included a small patient sample and unclear guidelines for obtaining head CT scans, making it difficult to distinguish between trauma-related brain changes and disease progression. Additionally, the study lacked data on hypotensive episodes and long-term neurologic outcomes.

DISCLOSURES:

This study did not receive any specific funding. The authors declared no conflicts of interest.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Patients receiving > 200 mL/kg of fluid resuscitation for burn injuries show higher rates of worsening neurologic findings on imaging, with follow-up scans showing deterioration in high-volume recipients compared with low-volume recipients.

METHODOLOGY:

• Researchers conducted a single-center review of 5176 patients with burn injuries who were admitted to a verified American Burn Association center (2003-2017); 622 of them underwent head CT within 96 hours of admission, and 83 showed intracranial abnormalities.
• Of 42 patients (mean age, 49.7 years; 80.5% men) who were admitted within 24 hours of burn, 30 patients received < 200 mL/kg and 11 received > 200 mL/kg of total resuscitation fluids, with a median total body surface area (TBSA) of 20.0.
• The primary outcome assessed was the worsening of neurologic findings on imaging related to the volume of the resuscitation fluid administered; the secondary outcomes were the incidence of new or worsening intracranial abnormalities, including hemorrhage, edema, ischemia, or infarction.

TAKEAWAY:

• Neurologic findings worsened in 47.6% patients receiving < 200 mL/kg of fluid resuscitation and 85.7% of those receiving > 200 mL/kg (P =.064).
• Repeat imaging was performed in 21 (70.0%) patients receiving < 200 mL/kg and 7 (63.6%) patients receiving > 200 mL/kg of resuscitation who underwent follow-up imaging.
• The median TBSA was 16.5 in the < 200 mL/kg group and 53.2 in the > 200 mL/kg group (P <.001).
• Intracranial abnormalities were found in 31.3% patients with hemorrhage, 18.8% with worsening edema, and 43.8% with ischemia or infarction.

IN PRACTICE:

“Patients who received over 200 mL/kg of resuscitation had an increased progression of intracranial abnormalities when compared with patients receiving less volume resuscitation,” the authors wrote. “Neurologic changes prompting imaging in burn patients may be undetectable, and our study further highlights the need for routine evaluation with neurologic imaging when undergoing large-volume resuscitations.”

SOURCE:

The study was led by Connor L. Kenney, MD, Brooke Army Medical Center, San Antonio, and was published online on November 07, 2024, in the Journal of Surgical Research.

LIMITATIONS:

Study limitations included a small patient sample and unclear guidelines for obtaining head CT scans, making it difficult to distinguish between trauma-related brain changes and disease progression. Additionally, the study lacked data on hypotensive episodes and long-term neurologic outcomes.

DISCLOSURES:

This study did not receive any specific funding. The authors declared no conflicts of interest.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Patients receiving > 200 mL/kg of fluid resuscitation for burn injuries show higher rates of worsening neurologic findings on imaging, with follow-up scans showing deterioration in high-volume recipients compared with low-volume recipients.

METHODOLOGY:

• Researchers conducted a single-center review of 5176 patients with burn injuries who were admitted to a verified American Burn Association center (2003-2017); 622 of them underwent head CT within 96 hours of admission, and 83 showed intracranial abnormalities.
• Of 42 patients (mean age, 49.7 years; 80.5% men) who were admitted within 24 hours of burn, 30 patients received < 200 mL/kg and 11 received > 200 mL/kg of total resuscitation fluids, with a median total body surface area (TBSA) of 20.0.
• The primary outcome assessed was the worsening of neurologic findings on imaging related to the volume of the resuscitation fluid administered; the secondary outcomes were the incidence of new or worsening intracranial abnormalities, including hemorrhage, edema, ischemia, or infarction.

TAKEAWAY:

• Neurologic findings worsened in 47.6% patients receiving < 200 mL/kg of fluid resuscitation and 85.7% of those receiving > 200 mL/kg (P =.064).
• Repeat imaging was performed in 21 (70.0%) patients receiving < 200 mL/kg and 7 (63.6%) patients receiving > 200 mL/kg of resuscitation who underwent follow-up imaging.
• The median TBSA was 16.5 in the < 200 mL/kg group and 53.2 in the > 200 mL/kg group (P <.001).
• Intracranial abnormalities were found in 31.3% patients with hemorrhage, 18.8% with worsening edema, and 43.8% with ischemia or infarction.

IN PRACTICE:

“Patients who received over 200 mL/kg of resuscitation had an increased progression of intracranial abnormalities when compared with patients receiving less volume resuscitation,” the authors wrote. “Neurologic changes prompting imaging in burn patients may be undetectable, and our study further highlights the need for routine evaluation with neurologic imaging when undergoing large-volume resuscitations.”

SOURCE:

The study was led by Connor L. Kenney, MD, Brooke Army Medical Center, San Antonio, and was published online on November 07, 2024, in the Journal of Surgical Research.

LIMITATIONS:

Study limitations included a small patient sample and unclear guidelines for obtaining head CT scans, making it difficult to distinguish between trauma-related brain changes and disease progression. Additionally, the study lacked data on hypotensive episodes and long-term neurologic outcomes.

DISCLOSURES:

This study did not receive any specific funding. The authors declared no conflicts of interest.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The risk for melanoma-related death was higher in individuals with tumors with a Breslow thickness of 0.8-1.0 mm than in individuals with tumors smaller than 0.8 mm, in an Australian study that used registry data.

METHODOLOGY:

• The study analyzed 144,447 individuals (median age, 56 years, 54% men) diagnosed with thin (T1) primary invasive melanomas (Breslow thickness, ≤ 1.0 mm) between 1982 and 2014 from all eight Australian state and territory population-based cancer registries.
• The researchers evaluated the associations between Breslow thickness (< 0.8 mm vs 0.8-1.0 mm) and incidences of melanoma-related and nonmelanoma-related deaths.
• The primary endpoint was time to death attributable to a melanoma-related cause, with death by a nonmelanoma-related cause as a competing event.

TAKEAWAY:

• The 20-year cumulative incidence of melanoma-related deaths was 6.3% for the whole cohort. The incidence was higher for tumors with a thickness of 0.8-1.0 mm (11%) than for those with a thickness < 0.8 mm (5.6%).
• The overall 20-year melanoma-specific survival rate was 95.9%, with rates of 94.2% for tumors < 0.8 mm and 87.8% for tumors measuring 0.8-1.0 mm in thickness. Each 0.1-mm increase in Breslow thickness was associated with worse prognosis.
• A multivariable analysis revealed that a tumor thickness of 0.8-1.0 mm was associated with both a greater absolute risk for melanoma-related deaths (subdistribution hazard ratio, 2.92) and a higher rate of melanoma-related deaths (hazard ratio, 2.98) than a tumor thickness < 0.8 mm.
• The 20-year incidence of death from nonmelanoma-related causes was 23.4%, but the risk for death from these causes showed no significant association with Breslow thickness categories.

IN PRACTICE:

“The findings of this large-scale population–based analysis suggest the separation of risk for patients with melanomas with a Breslow thickness above and below 0.8 mm,” the authors wrote, adding: “These results suggest that a change of the T1 threshold from 1.0 mm to 0.8 mm should be considered when the AJCC [American Joint Committee on Cancer] staging system is next reviewed.”

SOURCE:

The study was led by Serigne N. Lo, PhD, Melanoma Institute Australia, the University of Sydney. It was published online on December 11, 2024, in JAMA Dermatology.

LIMITATIONS:

The study was registry-based and did not capture details such as tumor characteristics and treatment modalities. Inaccuracies in reporting the cause of death may have led to an underestimation of melanoma-specific mortality risks across all thickness groups and an overestimation of nonmelanoma mortality risks.

DISCLOSURES:

The study received funding support from Melanoma Institute Australia and two grants from the Australian National Health and Medical Research Council (NHMRC). Several authors reported receiving grants or personal fees from or having ties with various sources, including NHMRC.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The risk for melanoma-related death was higher in individuals with tumors with a Breslow thickness of 0.8-1.0 mm than in individuals with tumors smaller than 0.8 mm, in an Australian study that used registry data.

METHODOLOGY:

• The study analyzed 144,447 individuals (median age, 56 years, 54% men) diagnosed with thin (T1) primary invasive melanomas (Breslow thickness, ≤ 1.0 mm) between 1982 and 2014 from all eight Australian state and territory population-based cancer registries.
• The researchers evaluated the associations between Breslow thickness (< 0.8 mm vs 0.8-1.0 mm) and incidences of melanoma-related and nonmelanoma-related deaths.
• The primary endpoint was time to death attributable to a melanoma-related cause, with death by a nonmelanoma-related cause as a competing event.

TAKEAWAY:

• The 20-year cumulative incidence of melanoma-related deaths was 6.3% for the whole cohort. The incidence was higher for tumors with a thickness of 0.8-1.0 mm (11%) than for those with a thickness < 0.8 mm (5.6%).
• The overall 20-year melanoma-specific survival rate was 95.9%, with rates of 94.2% for tumors < 0.8 mm and 87.8% for tumors measuring 0.8-1.0 mm in thickness. Each 0.1-mm increase in Breslow thickness was associated with worse prognosis.
• A multivariable analysis revealed that a tumor thickness of 0.8-1.0 mm was associated with both a greater absolute risk for melanoma-related deaths (subdistribution hazard ratio, 2.92) and a higher rate of melanoma-related deaths (hazard ratio, 2.98) than a tumor thickness < 0.8 mm.
• The 20-year incidence of death from nonmelanoma-related causes was 23.4%, but the risk for death from these causes showed no significant association with Breslow thickness categories.

IN PRACTICE:

“The findings of this large-scale population–based analysis suggest the separation of risk for patients with melanomas with a Breslow thickness above and below 0.8 mm,” the authors wrote, adding: “These results suggest that a change of the T1 threshold from 1.0 mm to 0.8 mm should be considered when the AJCC [American Joint Committee on Cancer] staging system is next reviewed.”

SOURCE:

The study was led by Serigne N. Lo, PhD, Melanoma Institute Australia, the University of Sydney. It was published online on December 11, 2024, in JAMA Dermatology.

LIMITATIONS:

The study was registry-based and did not capture details such as tumor characteristics and treatment modalities. Inaccuracies in reporting the cause of death may have led to an underestimation of melanoma-specific mortality risks across all thickness groups and an overestimation of nonmelanoma mortality risks.

DISCLOSURES:

The study received funding support from Melanoma Institute Australia and two grants from the Australian National Health and Medical Research Council (NHMRC). Several authors reported receiving grants or personal fees from or having ties with various sources, including NHMRC.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The risk for melanoma-related death was higher in individuals with tumors with a Breslow thickness of 0.8-1.0 mm than in individuals with tumors smaller than 0.8 mm, in an Australian study that used registry data.

METHODOLOGY:

• The study analyzed 144,447 individuals (median age, 56 years, 54% men) diagnosed with thin (T1) primary invasive melanomas (Breslow thickness, ≤ 1.0 mm) between 1982 and 2014 from all eight Australian state and territory population-based cancer registries.
• The researchers evaluated the associations between Breslow thickness (< 0.8 mm vs 0.8-1.0 mm) and incidences of melanoma-related and nonmelanoma-related deaths.
• The primary endpoint was time to death attributable to a melanoma-related cause, with death by a nonmelanoma-related cause as a competing event.

TAKEAWAY:

• The 20-year cumulative incidence of melanoma-related deaths was 6.3% for the whole cohort. The incidence was higher for tumors with a thickness of 0.8-1.0 mm (11%) than for those with a thickness < 0.8 mm (5.6%).
• The overall 20-year melanoma-specific survival rate was 95.9%, with rates of 94.2% for tumors < 0.8 mm and 87.8% for tumors measuring 0.8-1.0 mm in thickness. Each 0.1-mm increase in Breslow thickness was associated with worse prognosis.
• A multivariable analysis revealed that a tumor thickness of 0.8-1.0 mm was associated with both a greater absolute risk for melanoma-related deaths (subdistribution hazard ratio, 2.92) and a higher rate of melanoma-related deaths (hazard ratio, 2.98) than a tumor thickness < 0.8 mm.
• The 20-year incidence of death from nonmelanoma-related causes was 23.4%, but the risk for death from these causes showed no significant association with Breslow thickness categories.

IN PRACTICE:

“The findings of this large-scale population–based analysis suggest the separation of risk for patients with melanomas with a Breslow thickness above and below 0.8 mm,” the authors wrote, adding: “These results suggest that a change of the T1 threshold from 1.0 mm to 0.8 mm should be considered when the AJCC [American Joint Committee on Cancer] staging system is next reviewed.”

SOURCE:

The study was led by Serigne N. Lo, PhD, Melanoma Institute Australia, the University of Sydney. It was published online on December 11, 2024, in JAMA Dermatology.

LIMITATIONS:

The study was registry-based and did not capture details such as tumor characteristics and treatment modalities. Inaccuracies in reporting the cause of death may have led to an underestimation of melanoma-specific mortality risks across all thickness groups and an overestimation of nonmelanoma mortality risks.

DISCLOSURES:

The study received funding support from Melanoma Institute Australia and two grants from the Australian National Health and Medical Research Council (NHMRC). Several authors reported receiving grants or personal fees from or having ties with various sources, including NHMRC.

This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Glucagon-like peptide 1 (GLP-1) receptor agonists led to a significant reduction in the risk for venous thromboembolism (VTE) among individuals with type 2 diabetes, compared with dipeptidyl peptidase 4 (DPP-4) inhibitors, a recent analysis indicated.

Overall, GLP-1 agonist use was associated with a 20% reduction in VTE, compared with DPP-4 inhibitor use, in those with type 2 diabetes, and this benefit held regardless of people’s obesity status, said study investigator Cho-Han Chiang, MD, a medical resident at Mount Auburn Hospital, Cambridge, Massachusetts, who presented the findings at the American Society of Hematology (ASH) 2024 Annual Meeting.

The incidence of VTE has increased by 20% over the past 10 years, and obesity is a risk factor for VTE, Chiang explained. A growing body of evidence demonstrated that GLP-1s provide a variety of cardiovascular benefits in people with type 2 diabetes, but data on VTE benefits remain more limited.

In the retrospective study, the researchers combed electronic health records from the TriNetX global database, which includes more than 250 million patients, and identified adults with type 2 diabetes who were taking a GLP-1 agonist or a DPP-4 inhibitor.

After excluding anyone with prior VTE or atrial fibrillation as well as those treated with both drugs or with oral anticoagulants, patients on GLP-1s were matched with those on DPP-4 inhibitors based on predetermined variables, including age, sex, race, body mass index (BMI), hemoglobin A1c, use of other antidiabetic agents, and underlying comorbidities. VTE was a composite of pulmonary embolism and deep vein thrombosis.

The researchers also performed a subgroup analysis that stratified patients by obesity status, defined as a BMI ≥ 30.

Within 1 year of GLP-1 or DPP-4 prescription, VTE occurred at a rate of 6.5 cases/1000 person-years in the GLP-1 group vs 7.9 cases/1000 person years in the DPP-4 inhibitor group (hazard ratio [HR], 0.80; P < .001).

The 20% risk reduction in VTE held across various subgroups of BMI, including among those with obesity, Chiang reported.

Among patients with the highest BMI (≥ 40), VTE occurred at a rate of 7.2 cases/1000 person years in the GLP-1 group vs 9.6 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.74). Among patients with the next highest BMI (30-34.9), VTE occurred at a rate of 4.8 cases/1000 person years in the GLP-1 group vs 7.9 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.60). Among those with the lowest BMI (18.5-24.9), VTE occurred significantly less frequently among those in the GLP-1 group — 4.7 cases/1000 person years vs 7.4 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.61).

The lower risk for VTE associated with GLP-1s also held across the individual components of the composite VTE. Pulmonary embolism occurred at a rate of 3.1 cases/1000 person years in the GLP-1 group vs 3.9 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.78), and deep vein thrombosis occurred in 4.2 cases/1000 person years in the GLP-1 group vs 5.0 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.82).

Interestingly, the GLP-1 and DPP-4 curves started diverging within the first 30 days of the index prescription date, said Chiang.

Session moderator Ghadeer Dawwas, PhD, said in an interview that patients with type 2 diabetes are increasingly using GLP-1 agonists because of the cardiovascular benefits associated with the agents, which include lower risks for stroke and heart failure, but the antithrombotic benefits are still debated.

“The current study indicates that GLP-1 agonists may help lower the risk of VTE in patients with type 2 diabetes, irrespective of their baseline body weight,” said Dawwas, a pharmacoepidemiologist and assistant professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee. “However, given the current landscape of evidence and the existence of conflicting data on VTE risk, clinicians should proceed with caution and await further studies to validate these findings before making clinical decisions.”

This study was funded by the National Blood Clot Alliance and Conquer Cancer Foundation. Chiang and Dawwas had no disclosures.

A version of this article appeared on Medscape.com.

Glucagon-like peptide 1 (GLP-1) receptor agonists led to a significant reduction in the risk for venous thromboembolism (VTE) among individuals with type 2 diabetes, compared with dipeptidyl peptidase 4 (DPP-4) inhibitors, a recent analysis indicated.

Overall, GLP-1 agonist use was associated with a 20% reduction in VTE, compared with DPP-4 inhibitor use, in those with type 2 diabetes, and this benefit held regardless of people’s obesity status, said study investigator Cho-Han Chiang, MD, a medical resident at Mount Auburn Hospital, Cambridge, Massachusetts, who presented the findings at the American Society of Hematology (ASH) 2024 Annual Meeting.

The incidence of VTE has increased by 20% over the past 10 years, and obesity is a risk factor for VTE, Chiang explained. A growing body of evidence demonstrated that GLP-1s provide a variety of cardiovascular benefits in people with type 2 diabetes, but data on VTE benefits remain more limited.

In the retrospective study, the researchers combed electronic health records from the TriNetX global database, which includes more than 250 million patients, and identified adults with type 2 diabetes who were taking a GLP-1 agonist or a DPP-4 inhibitor.

After excluding anyone with prior VTE or atrial fibrillation as well as those treated with both drugs or with oral anticoagulants, patients on GLP-1s were matched with those on DPP-4 inhibitors based on predetermined variables, including age, sex, race, body mass index (BMI), hemoglobin A1c, use of other antidiabetic agents, and underlying comorbidities. VTE was a composite of pulmonary embolism and deep vein thrombosis.

The researchers also performed a subgroup analysis that stratified patients by obesity status, defined as a BMI ≥ 30.

Within 1 year of GLP-1 or DPP-4 prescription, VTE occurred at a rate of 6.5 cases/1000 person-years in the GLP-1 group vs 7.9 cases/1000 person years in the DPP-4 inhibitor group (hazard ratio [HR], 0.80; P < .001).

The 20% risk reduction in VTE held across various subgroups of BMI, including among those with obesity, Chiang reported.

Among patients with the highest BMI (≥ 40), VTE occurred at a rate of 7.2 cases/1000 person years in the GLP-1 group vs 9.6 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.74). Among patients with the next highest BMI (30-34.9), VTE occurred at a rate of 4.8 cases/1000 person years in the GLP-1 group vs 7.9 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.60). Among those with the lowest BMI (18.5-24.9), VTE occurred significantly less frequently among those in the GLP-1 group — 4.7 cases/1000 person years vs 7.4 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.61).

The lower risk for VTE associated with GLP-1s also held across the individual components of the composite VTE. Pulmonary embolism occurred at a rate of 3.1 cases/1000 person years in the GLP-1 group vs 3.9 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.78), and deep vein thrombosis occurred in 4.2 cases/1000 person years in the GLP-1 group vs 5.0 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.82).

Interestingly, the GLP-1 and DPP-4 curves started diverging within the first 30 days of the index prescription date, said Chiang.

Session moderator Ghadeer Dawwas, PhD, said in an interview that patients with type 2 diabetes are increasingly using GLP-1 agonists because of the cardiovascular benefits associated with the agents, which include lower risks for stroke and heart failure, but the antithrombotic benefits are still debated.

“The current study indicates that GLP-1 agonists may help lower the risk of VTE in patients with type 2 diabetes, irrespective of their baseline body weight,” said Dawwas, a pharmacoepidemiologist and assistant professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee. “However, given the current landscape of evidence and the existence of conflicting data on VTE risk, clinicians should proceed with caution and await further studies to validate these findings before making clinical decisions.”

This study was funded by the National Blood Clot Alliance and Conquer Cancer Foundation. Chiang and Dawwas had no disclosures.

A version of this article appeared on Medscape.com.

Glucagon-like peptide 1 (GLP-1) receptor agonists led to a significant reduction in the risk for venous thromboembolism (VTE) among individuals with type 2 diabetes, compared with dipeptidyl peptidase 4 (DPP-4) inhibitors, a recent analysis indicated.

Overall, GLP-1 agonist use was associated with a 20% reduction in VTE, compared with DPP-4 inhibitor use, in those with type 2 diabetes, and this benefit held regardless of people’s obesity status, said study investigator Cho-Han Chiang, MD, a medical resident at Mount Auburn Hospital, Cambridge, Massachusetts, who presented the findings at the American Society of Hematology (ASH) 2024 Annual Meeting.

The incidence of VTE has increased by 20% over the past 10 years, and obesity is a risk factor for VTE, Chiang explained. A growing body of evidence demonstrated that GLP-1s provide a variety of cardiovascular benefits in people with type 2 diabetes, but data on VTE benefits remain more limited.

In the retrospective study, the researchers combed electronic health records from the TriNetX global database, which includes more than 250 million patients, and identified adults with type 2 diabetes who were taking a GLP-1 agonist or a DPP-4 inhibitor.

After excluding anyone with prior VTE or atrial fibrillation as well as those treated with both drugs or with oral anticoagulants, patients on GLP-1s were matched with those on DPP-4 inhibitors based on predetermined variables, including age, sex, race, body mass index (BMI), hemoglobin A1c, use of other antidiabetic agents, and underlying comorbidities. VTE was a composite of pulmonary embolism and deep vein thrombosis.

The researchers also performed a subgroup analysis that stratified patients by obesity status, defined as a BMI ≥ 30.

Within 1 year of GLP-1 or DPP-4 prescription, VTE occurred at a rate of 6.5 cases/1000 person-years in the GLP-1 group vs 7.9 cases/1000 person years in the DPP-4 inhibitor group (hazard ratio [HR], 0.80; P < .001).

The 20% risk reduction in VTE held across various subgroups of BMI, including among those with obesity, Chiang reported.

Among patients with the highest BMI (≥ 40), VTE occurred at a rate of 7.2 cases/1000 person years in the GLP-1 group vs 9.6 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.74). Among patients with the next highest BMI (30-34.9), VTE occurred at a rate of 4.8 cases/1000 person years in the GLP-1 group vs 7.9 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.60). Among those with the lowest BMI (18.5-24.9), VTE occurred significantly less frequently among those in the GLP-1 group — 4.7 cases/1000 person years vs 7.4 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.61).

The lower risk for VTE associated with GLP-1s also held across the individual components of the composite VTE. Pulmonary embolism occurred at a rate of 3.1 cases/1000 person years in the GLP-1 group vs 3.9 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.78), and deep vein thrombosis occurred in 4.2 cases/1000 person years in the GLP-1 group vs 5.0 cases/1000 person years in the DPP-4 inhibitor group (HR, 0.82).

Interestingly, the GLP-1 and DPP-4 curves started diverging within the first 30 days of the index prescription date, said Chiang.

Session moderator Ghadeer Dawwas, PhD, said in an interview that patients with type 2 diabetes are increasingly using GLP-1 agonists because of the cardiovascular benefits associated with the agents, which include lower risks for stroke and heart failure, but the antithrombotic benefits are still debated.

“The current study indicates that GLP-1 agonists may help lower the risk of VTE in patients with type 2 diabetes, irrespective of their baseline body weight,” said Dawwas, a pharmacoepidemiologist and assistant professor of medicine at Vanderbilt University Medical Center in Nashville, Tennessee. “However, given the current landscape of evidence and the existence of conflicting data on VTE risk, clinicians should proceed with caution and await further studies to validate these findings before making clinical decisions.”

This study was funded by the National Blood Clot Alliance and Conquer Cancer Foundation. Chiang and Dawwas had no disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO — Incidentally discovered vertebral fractures are common on scans in the general population, while the absolute risk for multiple myeloma (MM) in those with such fractures is “quite modest,” according to findings in a Danish cohort of more than 9000 patients.

The findings suggest that evaluation for underlying MM — as recommended in some clinical guidelines — may be unwarranted in the absence of symptoms or other clinical findings leading to suspicion of underlying MM, Rasmus Rønnemoes, MD, reported during a poster session at the annual American Society of Hematology conference.

“Some guidelines say to evaluate patients with vertebral fractures, including measuring serum M-protein and free light chains, and others say to evaluate only if there is an indication — but without specifying what an indication is,” Rønnemoes, of the Danish Red Blood Cell Center, Copenhagen University Hospital — Rigshospitalet, Denmark, said in an interview. 

To assess the association between vertebral fractures and MM, he and his colleagues studied 9065 individuals from the Danish general population, aged 33-94 years (median, 62 years) who were part of the Copenhagen General Population Study and who had attended a health examination and underwent a CT scan as part of the study. Overall, 1574 (17.4%) had one or more incidentally discovered vertebral fracture on the CT scan, and of those, 875 (9.7%) had a grade 1 fracture as the highest grade and 699 (7.7%) had grade 2-3 fractures.

During a median prospective follow-up of 5.5 years after the scan, 13 were diagnosed with myeloma.

“We did find an increased relative risk of myeloma in these patients, which we thought was quite interesting, but the absolute risk was quite modest,” Rønnemoes said.

The absolute 5-year risk for MM was 0.07% and 0.10% in women and men without vertebral fractures, respectively, and the risk for those with fractures was 0.17% and 0.24% in women and men with grade 1 fractures, respectively, and 0.43% and 0.63% in women and men with grade 2-3 fractures, respectively.

A case-cohort study based on more than 56,000 individuals from the UK Biobank cohort who had undergone a dual-energy x-ray absorptiometry scan as part of that study validated the findings in the Danish population: At median follow-up of 4 years, 49 patients in the validation cohort were diagnosed with myeloma, and the absolute 5-year risk for myeloma was 0.06% and 0.12% in women and men with grade 1 fractures, respectively, and 0.14% and 0.26% in women and men with grade 2-3 fractures, respectively.

Given the apparently modest absolute risk for MM in patients with incidentally discovered fractures in the absence of strong indications or risk, treatment guidelines should consider the potential harms associated with additional work up and a monoclonal gammopathy of undetermined significance diagnosis, Rønnemoes said. 

Such a diagnosis can lead to psychological distress in individuals who may never develop malignant disease, he noted.

“We just hope to bring more value to the guidelines by identifying who should be evaluated,” he said, adding that additional study — perhaps looking more closely at whether only the more severe fractures should prompt additional evaluation — is warranted.

Rønnemoes reported no disclosures.

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

SAN DIEGO — Incidentally discovered vertebral fractures are common on scans in the general population, while the absolute risk for multiple myeloma (MM) in those with such fractures is “quite modest,” according to findings in a Danish cohort of more than 9000 patients.

The findings suggest that evaluation for underlying MM — as recommended in some clinical guidelines — may be unwarranted in the absence of symptoms or other clinical findings leading to suspicion of underlying MM, Rasmus Rønnemoes, MD, reported during a poster session at the annual American Society of Hematology conference.

“Some guidelines say to evaluate patients with vertebral fractures, including measuring serum M-protein and free light chains, and others say to evaluate only if there is an indication — but without specifying what an indication is,” Rønnemoes, of the Danish Red Blood Cell Center, Copenhagen University Hospital — Rigshospitalet, Denmark, said in an interview. 

To assess the association between vertebral fractures and MM, he and his colleagues studied 9065 individuals from the Danish general population, aged 33-94 years (median, 62 years) who were part of the Copenhagen General Population Study and who had attended a health examination and underwent a CT scan as part of the study. Overall, 1574 (17.4%) had one or more incidentally discovered vertebral fracture on the CT scan, and of those, 875 (9.7%) had a grade 1 fracture as the highest grade and 699 (7.7%) had grade 2-3 fractures.

During a median prospective follow-up of 5.5 years after the scan, 13 were diagnosed with myeloma.

“We did find an increased relative risk of myeloma in these patients, which we thought was quite interesting, but the absolute risk was quite modest,” Rønnemoes said.

The absolute 5-year risk for MM was 0.07% and 0.10% in women and men without vertebral fractures, respectively, and the risk for those with fractures was 0.17% and 0.24% in women and men with grade 1 fractures, respectively, and 0.43% and 0.63% in women and men with grade 2-3 fractures, respectively.

A case-cohort study based on more than 56,000 individuals from the UK Biobank cohort who had undergone a dual-energy x-ray absorptiometry scan as part of that study validated the findings in the Danish population: At median follow-up of 4 years, 49 patients in the validation cohort were diagnosed with myeloma, and the absolute 5-year risk for myeloma was 0.06% and 0.12% in women and men with grade 1 fractures, respectively, and 0.14% and 0.26% in women and men with grade 2-3 fractures, respectively.

Given the apparently modest absolute risk for MM in patients with incidentally discovered fractures in the absence of strong indications or risk, treatment guidelines should consider the potential harms associated with additional work up and a monoclonal gammopathy of undetermined significance diagnosis, Rønnemoes said. 

Such a diagnosis can lead to psychological distress in individuals who may never develop malignant disease, he noted.

“We just hope to bring more value to the guidelines by identifying who should be evaluated,” he said, adding that additional study — perhaps looking more closely at whether only the more severe fractures should prompt additional evaluation — is warranted.

Rønnemoes reported no disclosures.

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

SAN DIEGO — Incidentally discovered vertebral fractures are common on scans in the general population, while the absolute risk for multiple myeloma (MM) in those with such fractures is “quite modest,” according to findings in a Danish cohort of more than 9000 patients.

The findings suggest that evaluation for underlying MM — as recommended in some clinical guidelines — may be unwarranted in the absence of symptoms or other clinical findings leading to suspicion of underlying MM, Rasmus Rønnemoes, MD, reported during a poster session at the annual American Society of Hematology conference.

“Some guidelines say to evaluate patients with vertebral fractures, including measuring serum M-protein and free light chains, and others say to evaluate only if there is an indication — but without specifying what an indication is,” Rønnemoes, of the Danish Red Blood Cell Center, Copenhagen University Hospital — Rigshospitalet, Denmark, said in an interview. 

To assess the association between vertebral fractures and MM, he and his colleagues studied 9065 individuals from the Danish general population, aged 33-94 years (median, 62 years) who were part of the Copenhagen General Population Study and who had attended a health examination and underwent a CT scan as part of the study. Overall, 1574 (17.4%) had one or more incidentally discovered vertebral fracture on the CT scan, and of those, 875 (9.7%) had a grade 1 fracture as the highest grade and 699 (7.7%) had grade 2-3 fractures.

During a median prospective follow-up of 5.5 years after the scan, 13 were diagnosed with myeloma.

“We did find an increased relative risk of myeloma in these patients, which we thought was quite interesting, but the absolute risk was quite modest,” Rønnemoes said.

The absolute 5-year risk for MM was 0.07% and 0.10% in women and men without vertebral fractures, respectively, and the risk for those with fractures was 0.17% and 0.24% in women and men with grade 1 fractures, respectively, and 0.43% and 0.63% in women and men with grade 2-3 fractures, respectively.

A case-cohort study based on more than 56,000 individuals from the UK Biobank cohort who had undergone a dual-energy x-ray absorptiometry scan as part of that study validated the findings in the Danish population: At median follow-up of 4 years, 49 patients in the validation cohort were diagnosed with myeloma, and the absolute 5-year risk for myeloma was 0.06% and 0.12% in women and men with grade 1 fractures, respectively, and 0.14% and 0.26% in women and men with grade 2-3 fractures, respectively.

Given the apparently modest absolute risk for MM in patients with incidentally discovered fractures in the absence of strong indications or risk, treatment guidelines should consider the potential harms associated with additional work up and a monoclonal gammopathy of undetermined significance diagnosis, Rønnemoes said. 

Such a diagnosis can lead to psychological distress in individuals who may never develop malignant disease, he noted.

“We just hope to bring more value to the guidelines by identifying who should be evaluated,” he said, adding that additional study — perhaps looking more closely at whether only the more severe fractures should prompt additional evaluation — is warranted.

Rønnemoes reported no disclosures.

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

The American Diabetes Association (ADA)’s Standards of Care — 2025 offer new guidance on broader use of continuous glucose monitoring (CGM), use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) beyond weight loss, management of metabolic dysfunction-associated liver disease (MAFLD), plus a strong endorsement for drinking water and much more. 

The Standards of Care — 2025 were published December 9 as a supplement to Diabetes Care. The standards “incorporate the latest information from clinical trial data and knowledge of diabetes management into a comprehensive guidelines document that will assist physicians in managing patients with diabetes in their practices,” said Mandeep Bajaj, MBBS, ADA’s President, Medicine & Science.

In an interview, Bajaj highlighted some of the most important of the clinical updates in 2024, including the following: 

• Consideration of the use of continuous glucose monitoring devices in adults with type 2 diabetes (T2D) who don’t use insulin. Medicare and many other payers currently only cover CGM for people who use insulin or are otherwise at risk for hypoglycemia. However, some CGMs are now available over the counter, Bajaj pointed out.
• Actions to be taken in the event of medication shortages. The ADA published guidance for this in the case of GLP-1 RAs on December 2. Essentially ADA advised substituting a different GLP-1 RA if possible. Nonapproved products aren’t recommended, but guidance is provided for people who choose to use them.
• Use of GLP-1 RAs for heart and kidney health. Recommendations were revised to explicitly advise on choice of pharmacotherapy for individuals with T2D, based on new data on those with established or high risk for atherosclerotic cardiovascular disease, heart failure with preserved ejection fraction, and chronic kidney disease.
• Treatment of MAFLD with moderate or advanced liver fibrosis. A new recommendation for use of a thyroid hormone receptor–beta agonist is based on trial data for resmetirom. Moreover, Bajaj noted, “we’ve adopted the new nomenclature, which was previously NAFLD and NASH, and now is MAFLD and MASH [metabolic-associated steatohepatitis].”
• Advice to continue weight management therapy beyond achieving weight loss goals. This is based on a large amount of evidence that “stopping these therapies are associated with weight regain and increased cardiovascular risk,” Bajaj said, adding that this recommendation was made in collaboration with the Obesity Society.
• Antibody-based screening for presymptomatic T1D in family members of people with T2D and others who may be at risk. “Individuals who test autoantibody positive should be provided with or referred for counseling about the risk of developing diabetes, diabetes symptoms, and [diabetic ketoacidosis] prevention and should be given consideration for referral to a specialized center for further evaluation and/or consideration of a clinical trial or approved therapy to potentially delay development of clinical diabetes,” the document says.
• Screen for psychosocial issues. People with diabetes should be screened for concerns including diabetes distress, depression, anxiety, fear of hypoglycemia, and disordered eating behaviors. “People on insulin or sulfonylureas may have fear of hypoglycemia, but diabetes distress can happen to anyone with diabetes,” Bajaj pointed out. Caregivers and family members should be screened as well, the document advises.
• Drink water, not soda. In the nutrition section, a new recommendation strongly advises drinking water instead of nutritive or nonnutritive sweetened beverages. “This is an important recommendation. So, when patients ask what’s the best thing to drink, our answer is drink water rather than Coca Cola or Diet Coke,” Bajaj said. But, what about people with diabetes who can’t quit their diet soda habit? “We’ve said that the nonnutritive sweetener is preferred over sugar sweetener, provided it’s in moderation and short term ... but the best is water.”

Bajaj has received grant support from ADA. He had no further disclosures.

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

The American Diabetes Association (ADA)’s Standards of Care — 2025 offer new guidance on broader use of continuous glucose monitoring (CGM), use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) beyond weight loss, management of metabolic dysfunction-associated liver disease (MAFLD), plus a strong endorsement for drinking water and much more. 

The Standards of Care — 2025 were published December 9 as a supplement to Diabetes Care. The standards “incorporate the latest information from clinical trial data and knowledge of diabetes management into a comprehensive guidelines document that will assist physicians in managing patients with diabetes in their practices,” said Mandeep Bajaj, MBBS, ADA’s President, Medicine & Science.

In an interview, Bajaj highlighted some of the most important of the clinical updates in 2024, including the following: 

• Consideration of the use of continuous glucose monitoring devices in adults with type 2 diabetes (T2D) who don’t use insulin. Medicare and many other payers currently only cover CGM for people who use insulin or are otherwise at risk for hypoglycemia. However, some CGMs are now available over the counter, Bajaj pointed out.
• Actions to be taken in the event of medication shortages. The ADA published guidance for this in the case of GLP-1 RAs on December 2. Essentially ADA advised substituting a different GLP-1 RA if possible. Nonapproved products aren’t recommended, but guidance is provided for people who choose to use them.
• Use of GLP-1 RAs for heart and kidney health. Recommendations were revised to explicitly advise on choice of pharmacotherapy for individuals with T2D, based on new data on those with established or high risk for atherosclerotic cardiovascular disease, heart failure with preserved ejection fraction, and chronic kidney disease.
• Treatment of MAFLD with moderate or advanced liver fibrosis. A new recommendation for use of a thyroid hormone receptor–beta agonist is based on trial data for resmetirom. Moreover, Bajaj noted, “we’ve adopted the new nomenclature, which was previously NAFLD and NASH, and now is MAFLD and MASH [metabolic-associated steatohepatitis].”
• Advice to continue weight management therapy beyond achieving weight loss goals. This is based on a large amount of evidence that “stopping these therapies are associated with weight regain and increased cardiovascular risk,” Bajaj said, adding that this recommendation was made in collaboration with the Obesity Society.
• Antibody-based screening for presymptomatic T1D in family members of people with T2D and others who may be at risk. “Individuals who test autoantibody positive should be provided with or referred for counseling about the risk of developing diabetes, diabetes symptoms, and [diabetic ketoacidosis] prevention and should be given consideration for referral to a specialized center for further evaluation and/or consideration of a clinical trial or approved therapy to potentially delay development of clinical diabetes,” the document says.
• Screen for psychosocial issues. People with diabetes should be screened for concerns including diabetes distress, depression, anxiety, fear of hypoglycemia, and disordered eating behaviors. “People on insulin or sulfonylureas may have fear of hypoglycemia, but diabetes distress can happen to anyone with diabetes,” Bajaj pointed out. Caregivers and family members should be screened as well, the document advises.
• Drink water, not soda. In the nutrition section, a new recommendation strongly advises drinking water instead of nutritive or nonnutritive sweetened beverages. “This is an important recommendation. So, when patients ask what’s the best thing to drink, our answer is drink water rather than Coca Cola or Diet Coke,” Bajaj said. But, what about people with diabetes who can’t quit their diet soda habit? “We’ve said that the nonnutritive sweetener is preferred over sugar sweetener, provided it’s in moderation and short term ... but the best is water.”

Bajaj has received grant support from ADA. He had no further disclosures.

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

The American Diabetes Association (ADA)’s Standards of Care — 2025 offer new guidance on broader use of continuous glucose monitoring (CGM), use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) beyond weight loss, management of metabolic dysfunction-associated liver disease (MAFLD), plus a strong endorsement for drinking water and much more. 

The Standards of Care — 2025 were published December 9 as a supplement to Diabetes Care. The standards “incorporate the latest information from clinical trial data and knowledge of diabetes management into a comprehensive guidelines document that will assist physicians in managing patients with diabetes in their practices,” said Mandeep Bajaj, MBBS, ADA’s President, Medicine & Science.

In an interview, Bajaj highlighted some of the most important of the clinical updates in 2024, including the following: 

• Consideration of the use of continuous glucose monitoring devices in adults with type 2 diabetes (T2D) who don’t use insulin. Medicare and many other payers currently only cover CGM for people who use insulin or are otherwise at risk for hypoglycemia. However, some CGMs are now available over the counter, Bajaj pointed out.
• Actions to be taken in the event of medication shortages. The ADA published guidance for this in the case of GLP-1 RAs on December 2. Essentially ADA advised substituting a different GLP-1 RA if possible. Nonapproved products aren’t recommended, but guidance is provided for people who choose to use them.
• Use of GLP-1 RAs for heart and kidney health. Recommendations were revised to explicitly advise on choice of pharmacotherapy for individuals with T2D, based on new data on those with established or high risk for atherosclerotic cardiovascular disease, heart failure with preserved ejection fraction, and chronic kidney disease.
• Treatment of MAFLD with moderate or advanced liver fibrosis. A new recommendation for use of a thyroid hormone receptor–beta agonist is based on trial data for resmetirom. Moreover, Bajaj noted, “we’ve adopted the new nomenclature, which was previously NAFLD and NASH, and now is MAFLD and MASH [metabolic-associated steatohepatitis].”
• Advice to continue weight management therapy beyond achieving weight loss goals. This is based on a large amount of evidence that “stopping these therapies are associated with weight regain and increased cardiovascular risk,” Bajaj said, adding that this recommendation was made in collaboration with the Obesity Society.
• Antibody-based screening for presymptomatic T1D in family members of people with T2D and others who may be at risk. “Individuals who test autoantibody positive should be provided with or referred for counseling about the risk of developing diabetes, diabetes symptoms, and [diabetic ketoacidosis] prevention and should be given consideration for referral to a specialized center for further evaluation and/or consideration of a clinical trial or approved therapy to potentially delay development of clinical diabetes,” the document says.
• Screen for psychosocial issues. People with diabetes should be screened for concerns including diabetes distress, depression, anxiety, fear of hypoglycemia, and disordered eating behaviors. “People on insulin or sulfonylureas may have fear of hypoglycemia, but diabetes distress can happen to anyone with diabetes,” Bajaj pointed out. Caregivers and family members should be screened as well, the document advises.
• Drink water, not soda. In the nutrition section, a new recommendation strongly advises drinking water instead of nutritive or nonnutritive sweetened beverages. “This is an important recommendation. So, when patients ask what’s the best thing to drink, our answer is drink water rather than Coca Cola or Diet Coke,” Bajaj said. But, what about people with diabetes who can’t quit their diet soda habit? “We’ve said that the nonnutritive sweetener is preferred over sugar sweetener, provided it’s in moderation and short term ... but the best is water.”

Bajaj has received grant support from ADA. He had no further disclosures.

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

TOPLINE:

Self-care preparedness is positively associated with improved health-related quality of life (HRQOL) in patients with chronic conditions over 36 months, and patients who enhance their self-care preparedness experience better QOL outcomes.

METHODOLOGY:

• A secondary analysis of a randomized controlled trial conducted in Finland from 2017 to 2021 aimed to analyze the longitudinal associations between self-care preparedness and HRQOL over a 36-month follow-up period.
• A total of 256 adults with hypertension, diabetes, or coronary artery disease who participated in a patient care planning process in primary healthcare and completed the self-care intervention were included.
• The intervention comprised individualized care plans with a self-care form, including the self-care preparedness index (SCPI), which was initially mailed to the participants; the form explained self-care concepts and included assessments of health behaviors and willingness to change.
• Self-care preparedness was measured using SCPI scores, which were divided into tertiles: Low (−5 to 0), moderate (1-3), and high (4-5) preparedness.
• Outcome measures assessed at baseline and at 12 and 36 months included changes in the SCPI; HRQOL, assessed using 15D, which is a 15-dimensional measure; depressive symptoms; self-rated health; life satisfaction; and physical activity. The associations were analyzed using regression models.

TAKEAWAY:

• At baseline, participants with a higher SCPI score showed higher physical activity, life satisfaction, self-rated health, and management of their overall health; however, body mass index and the presence of depressive symptoms had a negative relationship with SCPI.
• Various dimensions of 15D, particularly usual activities, discomfort and symptoms, distress, depression, vitality, and sexual activity, showed a positive linear relationship with SCPI at baseline.
• A lower SCPI score at baseline was associated with greater improvements in the measures of HRQOL.
• A significant positive longitudinal association was observed between changes in SCPI and 15D from baseline to 36 months (beta coefficient, +0.19; P = .002), showing that QOL can improve if patients manage to improve their SCPI.

IN PRACTICE:

“SCPI could be used as an indicative index, keeping in mind that participants with lower SCPI have the potential to benefit and change their health behavior the most. The patient and the healthcare provider should consider which areas of self-care the patient needs support,” the authors wrote. “This study provides further knowledge of this tool for the purpose of aiding healthcare professionals in screening self-care preparedness in primary healthcare,” they added.

SOURCE:

The study was led by Ulla Mikkonen, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland. It was published online in Family Practice.

LIMITATIONS:

The relatively small sample size limited to a local area in Finland may have affected the generalizability of the findings. Additionally, variations in the implementation of the intervention in real-life settings could have influenced the results. The data on whether general practitioners used the SCPI to formulate care plans were lacking.

DISCLOSURES:

The study received funding from the Primary Health Care Unit of the Northern Savo Hospital District and Siilinjärvi Health Center. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Self-care preparedness is positively associated with improved health-related quality of life (HRQOL) in patients with chronic conditions over 36 months, and patients who enhance their self-care preparedness experience better QOL outcomes.

METHODOLOGY:

• A secondary analysis of a randomized controlled trial conducted in Finland from 2017 to 2021 aimed to analyze the longitudinal associations between self-care preparedness and HRQOL over a 36-month follow-up period.
• A total of 256 adults with hypertension, diabetes, or coronary artery disease who participated in a patient care planning process in primary healthcare and completed the self-care intervention were included.
• The intervention comprised individualized care plans with a self-care form, including the self-care preparedness index (SCPI), which was initially mailed to the participants; the form explained self-care concepts and included assessments of health behaviors and willingness to change.
• Self-care preparedness was measured using SCPI scores, which were divided into tertiles: Low (−5 to 0), moderate (1-3), and high (4-5) preparedness.
• Outcome measures assessed at baseline and at 12 and 36 months included changes in the SCPI; HRQOL, assessed using 15D, which is a 15-dimensional measure; depressive symptoms; self-rated health; life satisfaction; and physical activity. The associations were analyzed using regression models.

TAKEAWAY:

• At baseline, participants with a higher SCPI score showed higher physical activity, life satisfaction, self-rated health, and management of their overall health; however, body mass index and the presence of depressive symptoms had a negative relationship with SCPI.
• Various dimensions of 15D, particularly usual activities, discomfort and symptoms, distress, depression, vitality, and sexual activity, showed a positive linear relationship with SCPI at baseline.
• A lower SCPI score at baseline was associated with greater improvements in the measures of HRQOL.
• A significant positive longitudinal association was observed between changes in SCPI and 15D from baseline to 36 months (beta coefficient, +0.19; P = .002), showing that QOL can improve if patients manage to improve their SCPI.

IN PRACTICE:

“SCPI could be used as an indicative index, keeping in mind that participants with lower SCPI have the potential to benefit and change their health behavior the most. The patient and the healthcare provider should consider which areas of self-care the patient needs support,” the authors wrote. “This study provides further knowledge of this tool for the purpose of aiding healthcare professionals in screening self-care preparedness in primary healthcare,” they added.

SOURCE:

The study was led by Ulla Mikkonen, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland. It was published online in Family Practice.

LIMITATIONS:

The relatively small sample size limited to a local area in Finland may have affected the generalizability of the findings. Additionally, variations in the implementation of the intervention in real-life settings could have influenced the results. The data on whether general practitioners used the SCPI to formulate care plans were lacking.

DISCLOSURES:

The study received funding from the Primary Health Care Unit of the Northern Savo Hospital District and Siilinjärvi Health Center. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Self-care preparedness is positively associated with improved health-related quality of life (HRQOL) in patients with chronic conditions over 36 months, and patients who enhance their self-care preparedness experience better QOL outcomes.

METHODOLOGY:

• A secondary analysis of a randomized controlled trial conducted in Finland from 2017 to 2021 aimed to analyze the longitudinal associations between self-care preparedness and HRQOL over a 36-month follow-up period.
• A total of 256 adults with hypertension, diabetes, or coronary artery disease who participated in a patient care planning process in primary healthcare and completed the self-care intervention were included.
• The intervention comprised individualized care plans with a self-care form, including the self-care preparedness index (SCPI), which was initially mailed to the participants; the form explained self-care concepts and included assessments of health behaviors and willingness to change.
• Self-care preparedness was measured using SCPI scores, which were divided into tertiles: Low (−5 to 0), moderate (1-3), and high (4-5) preparedness.
• Outcome measures assessed at baseline and at 12 and 36 months included changes in the SCPI; HRQOL, assessed using 15D, which is a 15-dimensional measure; depressive symptoms; self-rated health; life satisfaction; and physical activity. The associations were analyzed using regression models.

TAKEAWAY:

• At baseline, participants with a higher SCPI score showed higher physical activity, life satisfaction, self-rated health, and management of their overall health; however, body mass index and the presence of depressive symptoms had a negative relationship with SCPI.
• Various dimensions of 15D, particularly usual activities, discomfort and symptoms, distress, depression, vitality, and sexual activity, showed a positive linear relationship with SCPI at baseline.
• A lower SCPI score at baseline was associated with greater improvements in the measures of HRQOL.
• A significant positive longitudinal association was observed between changes in SCPI and 15D from baseline to 36 months (beta coefficient, +0.19; P = .002), showing that QOL can improve if patients manage to improve their SCPI.

IN PRACTICE:

“SCPI could be used as an indicative index, keeping in mind that participants with lower SCPI have the potential to benefit and change their health behavior the most. The patient and the healthcare provider should consider which areas of self-care the patient needs support,” the authors wrote. “This study provides further knowledge of this tool for the purpose of aiding healthcare professionals in screening self-care preparedness in primary healthcare,” they added.

SOURCE:

The study was led by Ulla Mikkonen, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland. It was published online in Family Practice.

LIMITATIONS:

The relatively small sample size limited to a local area in Finland may have affected the generalizability of the findings. Additionally, variations in the implementation of the intervention in real-life settings could have influenced the results. The data on whether general practitioners used the SCPI to formulate care plans were lacking.

DISCLOSURES:

The study received funding from the Primary Health Care Unit of the Northern Savo Hospital District and Siilinjärvi Health Center. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.