Low-value health care services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association said in a newly released scientific statement.

Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors noted. Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States.

The statement was published online Feb. 22, 2022, in Circulation: Cardiovascular Quality and Outcomes.
 

High burden with uncertain benefit

“Cardiovascular disease is common and can present suddenly, such as a heart attack or abnormal heart rhythm,” Vinay Kini, MD, chair of the statement writing group and assistant professor of medicine at Weill Cornell Medicine, New York, said in a news release.

“Our desire to be vigilant about treating and preventing cardiovascular disease may sometimes lead to use of tests and procedures where the benefits to patients may be uncertain,” Dr. Kini said. “This may impose burdens on patients, in the form of increased risk of physical harm from the low-value procedure or potential complications, as well as follow-up care and out-of-pocket financial costs.”

For example, studies have shown that up to one in five echocardiograms and up to half of all stress tests performed in the United States may be rated as rarely appropriate, based on established guidelines for their use.

In addition, up to 15% of percutaneous coronary interventions (PCIs) are classified as rarely appropriate, the writing group said.

Annually, among Medicare fee-for-service beneficiaries, low-value stress testing in patients with stable coronary artery disease is estimated to cost between $212 million and $2.1 billion, while costs of PCI for stable CAD range from $212 million to $2.8 billion, the writing group noted.

“At best, spending on low-value care potentially diverts resources from higher-value services that would benefit patients more effectively at the same or reduced cost. At worst, low-value care results in physical harm in the form of preventable morbidity and mortality,” they said.

“Thus, reducing low-value care is one of the few patient-centered solutions that directly address both the need to control health care spending and the societal imperative to devote its limited resources to beneficial health care services that improve health,” they added.

The group outlines several ways to reduce low-value cardiovascular care targeting patients, providers, and payers/policymakers.

For patients, education and shared decision-making may help reduce low-value care and dispel misconceptions about the intended purpose of test or treatment, they suggested.

For clinicians, a “layered” approach to reducing low-value care may be most effective, such as through education, audit and feedback, and behavioral science tools (“nudges”) to shift behaviors and practices, they said.

For payers and policy leaders, interventions to reduce low-value care include national insurance coverage determinations; prior authorization; alternative payment models that reward lower costs and higher-quality health care; value-based insurance designs that financially penalize low-value care; and medical liability reform to reduce defensive medical practices.

Low-value cardiovascular care is a complex problem, the writing group acknowledged, and achieving meaningful reductions in low-value cardiovascular care will require a multidisciplinary approach that includes continuous research, implementation, evaluation, and adjustment while ensuring equitable access to care.

“Each approach has benefits and drawbacks,” Dr. Kini said. “For example, prior authorization imposes a large burden on health care professionals to obtain insurance approval for tests and treatments. Prior authorization and some value-based payment models may unintentionally worsen existing racial and ethnic health care disparities.

“A one-size-fits-all approach to reducing low-value care is unlikely to succeed; rather, acting through multiple perspectives and frequently measuring impacts and potential unintended consequences is critical,” he concluded.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Quality of Care and Outcomes Research.

The research had no commercial funding. Dr. Kini disclosed no relevant financial relationships.

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

Low-value health care services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association said in a newly released scientific statement.

Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors noted. Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States.

The statement was published online Feb. 22, 2022, in Circulation: Cardiovascular Quality and Outcomes.
 

High burden with uncertain benefit

“Cardiovascular disease is common and can present suddenly, such as a heart attack or abnormal heart rhythm,” Vinay Kini, MD, chair of the statement writing group and assistant professor of medicine at Weill Cornell Medicine, New York, said in a news release.

“Our desire to be vigilant about treating and preventing cardiovascular disease may sometimes lead to use of tests and procedures where the benefits to patients may be uncertain,” Dr. Kini said. “This may impose burdens on patients, in the form of increased risk of physical harm from the low-value procedure or potential complications, as well as follow-up care and out-of-pocket financial costs.”

For example, studies have shown that up to one in five echocardiograms and up to half of all stress tests performed in the United States may be rated as rarely appropriate, based on established guidelines for their use.

In addition, up to 15% of percutaneous coronary interventions (PCIs) are classified as rarely appropriate, the writing group said.

Annually, among Medicare fee-for-service beneficiaries, low-value stress testing in patients with stable coronary artery disease is estimated to cost between $212 million and $2.1 billion, while costs of PCI for stable CAD range from $212 million to $2.8 billion, the writing group noted.

“At best, spending on low-value care potentially diverts resources from higher-value services that would benefit patients more effectively at the same or reduced cost. At worst, low-value care results in physical harm in the form of preventable morbidity and mortality,” they said.

“Thus, reducing low-value care is one of the few patient-centered solutions that directly address both the need to control health care spending and the societal imperative to devote its limited resources to beneficial health care services that improve health,” they added.

The group outlines several ways to reduce low-value cardiovascular care targeting patients, providers, and payers/policymakers.

For patients, education and shared decision-making may help reduce low-value care and dispel misconceptions about the intended purpose of test or treatment, they suggested.

For clinicians, a “layered” approach to reducing low-value care may be most effective, such as through education, audit and feedback, and behavioral science tools (“nudges”) to shift behaviors and practices, they said.

For payers and policy leaders, interventions to reduce low-value care include national insurance coverage determinations; prior authorization; alternative payment models that reward lower costs and higher-quality health care; value-based insurance designs that financially penalize low-value care; and medical liability reform to reduce defensive medical practices.

Low-value cardiovascular care is a complex problem, the writing group acknowledged, and achieving meaningful reductions in low-value cardiovascular care will require a multidisciplinary approach that includes continuous research, implementation, evaluation, and adjustment while ensuring equitable access to care.

“Each approach has benefits and drawbacks,” Dr. Kini said. “For example, prior authorization imposes a large burden on health care professionals to obtain insurance approval for tests and treatments. Prior authorization and some value-based payment models may unintentionally worsen existing racial and ethnic health care disparities.

“A one-size-fits-all approach to reducing low-value care is unlikely to succeed; rather, acting through multiple perspectives and frequently measuring impacts and potential unintended consequences is critical,” he concluded.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Quality of Care and Outcomes Research.

The research had no commercial funding. Dr. Kini disclosed no relevant financial relationships.

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

Low-value health care services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association said in a newly released scientific statement.

Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors noted. Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States.

The statement was published online Feb. 22, 2022, in Circulation: Cardiovascular Quality and Outcomes.
 

High burden with uncertain benefit

“Cardiovascular disease is common and can present suddenly, such as a heart attack or abnormal heart rhythm,” Vinay Kini, MD, chair of the statement writing group and assistant professor of medicine at Weill Cornell Medicine, New York, said in a news release.

“Our desire to be vigilant about treating and preventing cardiovascular disease may sometimes lead to use of tests and procedures where the benefits to patients may be uncertain,” Dr. Kini said. “This may impose burdens on patients, in the form of increased risk of physical harm from the low-value procedure or potential complications, as well as follow-up care and out-of-pocket financial costs.”

For example, studies have shown that up to one in five echocardiograms and up to half of all stress tests performed in the United States may be rated as rarely appropriate, based on established guidelines for their use.

In addition, up to 15% of percutaneous coronary interventions (PCIs) are classified as rarely appropriate, the writing group said.

Annually, among Medicare fee-for-service beneficiaries, low-value stress testing in patients with stable coronary artery disease is estimated to cost between $212 million and $2.1 billion, while costs of PCI for stable CAD range from $212 million to $2.8 billion, the writing group noted.

“At best, spending on low-value care potentially diverts resources from higher-value services that would benefit patients more effectively at the same or reduced cost. At worst, low-value care results in physical harm in the form of preventable morbidity and mortality,” they said.

“Thus, reducing low-value care is one of the few patient-centered solutions that directly address both the need to control health care spending and the societal imperative to devote its limited resources to beneficial health care services that improve health,” they added.

The group outlines several ways to reduce low-value cardiovascular care targeting patients, providers, and payers/policymakers.

For patients, education and shared decision-making may help reduce low-value care and dispel misconceptions about the intended purpose of test or treatment, they suggested.

For clinicians, a “layered” approach to reducing low-value care may be most effective, such as through education, audit and feedback, and behavioral science tools (“nudges”) to shift behaviors and practices, they said.

For payers and policy leaders, interventions to reduce low-value care include national insurance coverage determinations; prior authorization; alternative payment models that reward lower costs and higher-quality health care; value-based insurance designs that financially penalize low-value care; and medical liability reform to reduce defensive medical practices.

Low-value cardiovascular care is a complex problem, the writing group acknowledged, and achieving meaningful reductions in low-value cardiovascular care will require a multidisciplinary approach that includes continuous research, implementation, evaluation, and adjustment while ensuring equitable access to care.

“Each approach has benefits and drawbacks,” Dr. Kini said. “For example, prior authorization imposes a large burden on health care professionals to obtain insurance approval for tests and treatments. Prior authorization and some value-based payment models may unintentionally worsen existing racial and ethnic health care disparities.

“A one-size-fits-all approach to reducing low-value care is unlikely to succeed; rather, acting through multiple perspectives and frequently measuring impacts and potential unintended consequences is critical,” he concluded.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Quality of Care and Outcomes Research.

The research had no commercial funding. Dr. Kini disclosed no relevant financial relationships.

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

The predilection for brain metastases in human epidermal growth factor receptor 2 (HER2)-positive breast cancer has historically presented a therapeutic challenge, and agents with enhanced central nervous system (CNS) penetrance are certainly desired. Pyrotinib is a small molecule irreversible tyrosine kinase inhibitor against epidermal growth factor receptor (EGFR), HER2, and HER4. Yan et al investigated the activity and safety of pyrotinib + capecitabine in the single-arm, two-cohort, phase 2 PERMEATE study among 78 patients with HER2-positive metastatic breast cancer (MBC) with brain metastases. The intracranial objective response rate was 74.6% in radiotherapy-naive patients and 42.1% in those progressing after prior radiotherapy. The combination showed good tolerability with the most common grade 3 treatment-related adverse events of diarrhea and neutropenia. Additional studies have shown impressive CNS activity with other HER2-targeted therapies including tucatinib + capecitabine + trastuzumab combination, as well as trastuzumab deruxtecan (HER2CLIMB and DESTINY-Breast03 trials, respectively). The evolution of these agents in both the metastatic and early settings will continue to transform the treatment algorithm for HER2-positive breast cancer. A particularly interesting concept is whether earlier use of drugs with better CNS efficacy can reduce risk or prevent development of brain metastases.

Endocrine therapy in early-stage hormone receptor-positive (HR+) breast cancer leads to significant reductions in recurrence and breast cancer mortality. A meta-analysis was performed by Early Breast Cancer Trialists' Collaborative Group including four trials (ABCSG XII, SOFT, TEXT and HOBOE), 7030 premenopausal patients with early-stage ER+ breast cancer, who received an aromatase inhibitor or tamoxifen for 3-5 years with ovarian suppression. Rates of breast cancer recurrence were lower with an aromatase inhibitor vs tamoxifen, with the main benefit seen during years 0-4 (relative risk [RR] 0.68, P < .0001) and an absolute reduction in 5-year recurrence risk of 3.2% (6.9% vs 10.1%). Aromatase inhibitor use was associated with decreased distant recurrence risk (RR 0.83), but there was no significant difference for breast cancer or all-cause mortality. The favored endocrine therapy approach for an individual patient is often complex and based on overall risk, comorbidities and toxicity concerns, as well as patient preference. Longer follow-up of trials with endocrine therapy and ovarian suppression will provide further insight on mortality impact.

Aromatase inhibitor (AI)-associated musculoskeletal symptoms are not infrequent and can contribute to treatment discontinuation. Current management practices include use of non-steroidal anti-inflammatory drugs (NSAID), weight loss and exercise, trial of alternative AI or tamoxifen, use of serotonin and norepinephrine reuptake inhibitors (SNRI) (duloxetine) and acupuncture. Martinez et al reported on outcomes of the non-selective NSAID, sulindac (150mg twice daily for 12 months), in a phase 2 study among postmenopausal women with early HR+ breast cancer who were stable on AI therapy for at least 3 months. At 12 months, patients receiving sulindac (n = 43) reported improvements (decreases) in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index (-5.85, P = .003), pain (-5.40, P = .043), stiffness (-9.53, P < .001) and physical function (-5.61, P = .006); those in the observation group (n = 40) did not experience improvements in these variables. The most significant improvement with sulindac was seen in those with a higher degree of baseline symptoms and in overweight/obese patients. These findings support further investigation into abbreviated NSAID use and strategies focused on exercise and healthy body weight maintenance for breast cancer patients.

The treatment landscape for early-stage triple-negative breast cancer (TNBC) continues to evolve with integration of new drugs into our armamentarium, and use of pathologic complete response (pCR) as a surrogate for outcome and for tailoring adjuvant therapy. Geyer et al reported on event-free survival outcomes with a 4.5 year follow-up of the phase 3 BrighTNess trial, which included 634 patients with stage II-III TNBC. Significant improvement in event-free survival (EFS) was seen in the carboplatin + veliparib + paclitaxel arm vs. paclitaxel alone (HR 0.63, P = .02), but no difference in EFS in carboplatin + veliparib + paclitaxel vs. carboplatin + paclitaxel (HR 1.12, P = .62). The EFS rates at 4 years were 78% (carboplatin + veliparib + paclitaxel), 79% (carboplatin + paclitaxel) and 69% (paclitaxel alone). The phase 3 KEYNOTE-522 trial demonstrated improvement in EFS with the addition of neoadjuvant pembrolizumab to chemotherapy (carboplatin/paclitaxel followed by AC) followed by adjuvant pembrolizumab compared to chemotherapy alone in patients with stage II-III TNBC. The emergence of new therapies for early TNBC, including immunotherapy and  poly (ADP-ribose) polymerase (PARP) inhibitors (the latter for patients with germline BRCA mutations), has created more treatment options for patients along with questions regarding combinations and sequencing.  

Recommended Additional Reading:

Lin N et al. Updated results of tucatinib vs placebo added to trastuzumab and capecitabine for patients with previously treated HER2+ metastatic breast cancer with brain metastases (HER2CLIMB). Presented at: 2021 San Antonio Breast Cancer Symposium; December 7-10, 2021;Spotlight Poster Session, PD4-04 Abstract 858. https://www.abstractsonline.com/pp8/#!/10462/presentation/482

Hurvitz S et al. Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2+ metastatic breast cancer: subgroup analyses from the randomized phase 3 study DESTINY-Breast03. Presented at: 2021 San Antonio Breast Cancer Symposium; December 7-10, 2021;General Session, GS3-01. https://www.abstractsonline.com/pp8/#!/10462/presentation/649

Rosati MS, Di Seri M, Baciarello G, et al. Etoricoxib and anastrozole in adjuvant early breast cancer: ETAN trial (phase III). J Clin Oncol. 2011;29:suppl.533. https://ascopubs.org/doi/10.1200/jco.2011.29.15_suppl.533

Schmid P et al for the KEYNOTE-522 Investigators. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386(6):556-567. https://www.nejm.org/doi/full/10.1056/NEJMoa2112651

The predilection for brain metastases in human epidermal growth factor receptor 2 (HER2)-positive breast cancer has historically presented a therapeutic challenge, and agents with enhanced central nervous system (CNS) penetrance are certainly desired. Pyrotinib is a small molecule irreversible tyrosine kinase inhibitor against epidermal growth factor receptor (EGFR), HER2, and HER4. Yan et al investigated the activity and safety of pyrotinib + capecitabine in the single-arm, two-cohort, phase 2 PERMEATE study among 78 patients with HER2-positive metastatic breast cancer (MBC) with brain metastases. The intracranial objective response rate was 74.6% in radiotherapy-naive patients and 42.1% in those progressing after prior radiotherapy. The combination showed good tolerability with the most common grade 3 treatment-related adverse events of diarrhea and neutropenia. Additional studies have shown impressive CNS activity with other HER2-targeted therapies including tucatinib + capecitabine + trastuzumab combination, as well as trastuzumab deruxtecan (HER2CLIMB and DESTINY-Breast03 trials, respectively). The evolution of these agents in both the metastatic and early settings will continue to transform the treatment algorithm for HER2-positive breast cancer. A particularly interesting concept is whether earlier use of drugs with better CNS efficacy can reduce risk or prevent development of brain metastases.

Endocrine therapy in early-stage hormone receptor-positive (HR+) breast cancer leads to significant reductions in recurrence and breast cancer mortality. A meta-analysis was performed by Early Breast Cancer Trialists' Collaborative Group including four trials (ABCSG XII, SOFT, TEXT and HOBOE), 7030 premenopausal patients with early-stage ER+ breast cancer, who received an aromatase inhibitor or tamoxifen for 3-5 years with ovarian suppression. Rates of breast cancer recurrence were lower with an aromatase inhibitor vs tamoxifen, with the main benefit seen during years 0-4 (relative risk [RR] 0.68, P < .0001) and an absolute reduction in 5-year recurrence risk of 3.2% (6.9% vs 10.1%). Aromatase inhibitor use was associated with decreased distant recurrence risk (RR 0.83), but there was no significant difference for breast cancer or all-cause mortality. The favored endocrine therapy approach for an individual patient is often complex and based on overall risk, comorbidities and toxicity concerns, as well as patient preference. Longer follow-up of trials with endocrine therapy and ovarian suppression will provide further insight on mortality impact.

Aromatase inhibitor (AI)-associated musculoskeletal symptoms are not infrequent and can contribute to treatment discontinuation. Current management practices include use of non-steroidal anti-inflammatory drugs (NSAID), weight loss and exercise, trial of alternative AI or tamoxifen, use of serotonin and norepinephrine reuptake inhibitors (SNRI) (duloxetine) and acupuncture. Martinez et al reported on outcomes of the non-selective NSAID, sulindac (150mg twice daily for 12 months), in a phase 2 study among postmenopausal women with early HR+ breast cancer who were stable on AI therapy for at least 3 months. At 12 months, patients receiving sulindac (n = 43) reported improvements (decreases) in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index (-5.85, P = .003), pain (-5.40, P = .043), stiffness (-9.53, P < .001) and physical function (-5.61, P = .006); those in the observation group (n = 40) did not experience improvements in these variables. The most significant improvement with sulindac was seen in those with a higher degree of baseline symptoms and in overweight/obese patients. These findings support further investigation into abbreviated NSAID use and strategies focused on exercise and healthy body weight maintenance for breast cancer patients.

The treatment landscape for early-stage triple-negative breast cancer (TNBC) continues to evolve with integration of new drugs into our armamentarium, and use of pathologic complete response (pCR) as a surrogate for outcome and for tailoring adjuvant therapy. Geyer et al reported on event-free survival outcomes with a 4.5 year follow-up of the phase 3 BrighTNess trial, which included 634 patients with stage II-III TNBC. Significant improvement in event-free survival (EFS) was seen in the carboplatin + veliparib + paclitaxel arm vs. paclitaxel alone (HR 0.63, P = .02), but no difference in EFS in carboplatin + veliparib + paclitaxel vs. carboplatin + paclitaxel (HR 1.12, P = .62). The EFS rates at 4 years were 78% (carboplatin + veliparib + paclitaxel), 79% (carboplatin + paclitaxel) and 69% (paclitaxel alone). The phase 3 KEYNOTE-522 trial demonstrated improvement in EFS with the addition of neoadjuvant pembrolizumab to chemotherapy (carboplatin/paclitaxel followed by AC) followed by adjuvant pembrolizumab compared to chemotherapy alone in patients with stage II-III TNBC. The emergence of new therapies for early TNBC, including immunotherapy and  poly (ADP-ribose) polymerase (PARP) inhibitors (the latter for patients with germline BRCA mutations), has created more treatment options for patients along with questions regarding combinations and sequencing.  

Recommended Additional Reading:

Lin N et al. Updated results of tucatinib vs placebo added to trastuzumab and capecitabine for patients with previously treated HER2+ metastatic breast cancer with brain metastases (HER2CLIMB). Presented at: 2021 San Antonio Breast Cancer Symposium; December 7-10, 2021;Spotlight Poster Session, PD4-04 Abstract 858. https://www.abstractsonline.com/pp8/#!/10462/presentation/482

Hurvitz S et al. Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2+ metastatic breast cancer: subgroup analyses from the randomized phase 3 study DESTINY-Breast03. Presented at: 2021 San Antonio Breast Cancer Symposium; December 7-10, 2021;General Session, GS3-01. https://www.abstractsonline.com/pp8/#!/10462/presentation/649

Rosati MS, Di Seri M, Baciarello G, et al. Etoricoxib and anastrozole in adjuvant early breast cancer: ETAN trial (phase III). J Clin Oncol. 2011;29:suppl.533. https://ascopubs.org/doi/10.1200/jco.2011.29.15_suppl.533

Schmid P et al for the KEYNOTE-522 Investigators. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386(6):556-567. https://www.nejm.org/doi/full/10.1056/NEJMoa2112651

The predilection for brain metastases in human epidermal growth factor receptor 2 (HER2)-positive breast cancer has historically presented a therapeutic challenge, and agents with enhanced central nervous system (CNS) penetrance are certainly desired. Pyrotinib is a small molecule irreversible tyrosine kinase inhibitor against epidermal growth factor receptor (EGFR), HER2, and HER4. Yan et al investigated the activity and safety of pyrotinib + capecitabine in the single-arm, two-cohort, phase 2 PERMEATE study among 78 patients with HER2-positive metastatic breast cancer (MBC) with brain metastases. The intracranial objective response rate was 74.6% in radiotherapy-naive patients and 42.1% in those progressing after prior radiotherapy. The combination showed good tolerability with the most common grade 3 treatment-related adverse events of diarrhea and neutropenia. Additional studies have shown impressive CNS activity with other HER2-targeted therapies including tucatinib + capecitabine + trastuzumab combination, as well as trastuzumab deruxtecan (HER2CLIMB and DESTINY-Breast03 trials, respectively). The evolution of these agents in both the metastatic and early settings will continue to transform the treatment algorithm for HER2-positive breast cancer. A particularly interesting concept is whether earlier use of drugs with better CNS efficacy can reduce risk or prevent development of brain metastases.

Endocrine therapy in early-stage hormone receptor-positive (HR+) breast cancer leads to significant reductions in recurrence and breast cancer mortality. A meta-analysis was performed by Early Breast Cancer Trialists' Collaborative Group including four trials (ABCSG XII, SOFT, TEXT and HOBOE), 7030 premenopausal patients with early-stage ER+ breast cancer, who received an aromatase inhibitor or tamoxifen for 3-5 years with ovarian suppression. Rates of breast cancer recurrence were lower with an aromatase inhibitor vs tamoxifen, with the main benefit seen during years 0-4 (relative risk [RR] 0.68, P < .0001) and an absolute reduction in 5-year recurrence risk of 3.2% (6.9% vs 10.1%). Aromatase inhibitor use was associated with decreased distant recurrence risk (RR 0.83), but there was no significant difference for breast cancer or all-cause mortality. The favored endocrine therapy approach for an individual patient is often complex and based on overall risk, comorbidities and toxicity concerns, as well as patient preference. Longer follow-up of trials with endocrine therapy and ovarian suppression will provide further insight on mortality impact.

Aromatase inhibitor (AI)-associated musculoskeletal symptoms are not infrequent and can contribute to treatment discontinuation. Current management practices include use of non-steroidal anti-inflammatory drugs (NSAID), weight loss and exercise, trial of alternative AI or tamoxifen, use of serotonin and norepinephrine reuptake inhibitors (SNRI) (duloxetine) and acupuncture. Martinez et al reported on outcomes of the non-selective NSAID, sulindac (150mg twice daily for 12 months), in a phase 2 study among postmenopausal women with early HR+ breast cancer who were stable on AI therapy for at least 3 months. At 12 months, patients receiving sulindac (n = 43) reported improvements (decreases) in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index (-5.85, P = .003), pain (-5.40, P = .043), stiffness (-9.53, P < .001) and physical function (-5.61, P = .006); those in the observation group (n = 40) did not experience improvements in these variables. The most significant improvement with sulindac was seen in those with a higher degree of baseline symptoms and in overweight/obese patients. These findings support further investigation into abbreviated NSAID use and strategies focused on exercise and healthy body weight maintenance for breast cancer patients.

The treatment landscape for early-stage triple-negative breast cancer (TNBC) continues to evolve with integration of new drugs into our armamentarium, and use of pathologic complete response (pCR) as a surrogate for outcome and for tailoring adjuvant therapy. Geyer et al reported on event-free survival outcomes with a 4.5 year follow-up of the phase 3 BrighTNess trial, which included 634 patients with stage II-III TNBC. Significant improvement in event-free survival (EFS) was seen in the carboplatin + veliparib + paclitaxel arm vs. paclitaxel alone (HR 0.63, P = .02), but no difference in EFS in carboplatin + veliparib + paclitaxel vs. carboplatin + paclitaxel (HR 1.12, P = .62). The EFS rates at 4 years were 78% (carboplatin + veliparib + paclitaxel), 79% (carboplatin + paclitaxel) and 69% (paclitaxel alone). The phase 3 KEYNOTE-522 trial demonstrated improvement in EFS with the addition of neoadjuvant pembrolizumab to chemotherapy (carboplatin/paclitaxel followed by AC) followed by adjuvant pembrolizumab compared to chemotherapy alone in patients with stage II-III TNBC. The emergence of new therapies for early TNBC, including immunotherapy and  poly (ADP-ribose) polymerase (PARP) inhibitors (the latter for patients with germline BRCA mutations), has created more treatment options for patients along with questions regarding combinations and sequencing.  

Recommended Additional Reading:

Lin N et al. Updated results of tucatinib vs placebo added to trastuzumab and capecitabine for patients with previously treated HER2+ metastatic breast cancer with brain metastases (HER2CLIMB). Presented at: 2021 San Antonio Breast Cancer Symposium; December 7-10, 2021;Spotlight Poster Session, PD4-04 Abstract 858. https://www.abstractsonline.com/pp8/#!/10462/presentation/482

Hurvitz S et al. Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2+ metastatic breast cancer: subgroup analyses from the randomized phase 3 study DESTINY-Breast03. Presented at: 2021 San Antonio Breast Cancer Symposium; December 7-10, 2021;General Session, GS3-01. https://www.abstractsonline.com/pp8/#!/10462/presentation/649

Rosati MS, Di Seri M, Baciarello G, et al. Etoricoxib and anastrozole in adjuvant early breast cancer: ETAN trial (phase III). J Clin Oncol. 2011;29:suppl.533. https://ascopubs.org/doi/10.1200/jco.2011.29.15_suppl.533

Schmid P et al for the KEYNOTE-522 Investigators. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386(6):556-567. https://www.nejm.org/doi/full/10.1056/NEJMoa2112651

As the COVID-19 pandemic enters its third year, the death toll continues to rise and with it, the number of children who may be left without anyone to care for them.

By Oct. 31, 2021, more than 5 million people worldwide had died from COVID-19, and about 5.2 million children had lost a parent or caregiver, according to new research published in the Lancet Child and Adolescent Health.

Of particular note, wrote the authors, was how the number of affected children surged during the latter part of their study period. During the first 14 months of the pandemic (March 1, 2020, to April 30, 2021), 2,737,300 children were affected by COVID-19-related caregiver death. But that number jumped by 90% during the next 6 months, from April 30 to Oct. 31, 2021, to 5,209,000. Essentially, the number of children who were affected nearly doubled, compared with those observed during that first year.

To put these numbers into perspective, study author Charles Nelson, PhD, professor of pediatrics and neuroscience and professor of psychology in the department of psychiatry at Harvard Medical School, Boston, compared it to the HIV/AIDS pandemic. “The current worldwide estimate is now approaching 6 million,” he said. “For HIV, it took 10 years before the number of orphans hit 5 million but for COVID it took 2 years. This should provide some perspective.”

Dr. Nelson pointed out that there are many other differences between the two pandemics. “There was no vaccine for HIV/AIDS, in contrast to the last year or so for COVID, when illness and death could largely be prevented,” he explained. “The politics surrounding HIV-related deaths seemed ‘relatively’ apolitical compared to COVID.”

Another major difference is that children whose parents had HIV were allowed to visit their parents, but for COVID-19, isolation was in place so many children could not see their parents before they died.

There is also more misinformation versus lack of information about COVID-19, compared to HIV/AIDS. “As an example, one young girl who lost her father to COVID was told by her classmates that her father hadn’t really died, he just abandoned the family,” Dr. Nelson said.
 

Minority communities face heaviest loss

A “companion study” was conducted by the Centers for Disease Control and Prevention, which looked at parental/caregiver death just within the United States. During the period between April 1, 2020, through June 30, 2021, the researchers found that more than 140,000 children under the age of 18 years had lost a parent, custodial grandparent, or grandparent caregiver because of COVID-19. In addition, there were significant racial, ethnic, and geographic disparities in COVID-19–associated death of caregivers, and the highest burden of death was observed in the Southern states along the U.S.-Mexican border for Hispanic children, Southeastern states for Black children, and in states with tribal areas for American Indian/Alaska Native populations. Overall, almost two-thirds (65%) of the children who lost a primary caregiver belonged to a racial or ethnic minority.

But as with the international data, the number of affected children has continued to rise since the end of the original study period. “Seth Flaxman, at Imperial College London, has updated the figures as of end of December for the U.S.,” said Dr. Nelson. The 140,000 has increased to 222,718 who lost a primary or secondary caregiver.

In addition, 192,449 lost a primary caregiver, 175,151 lost a parent, and 30,269 lost a secondary caregiver.

The rate, unfortunately, remains disproportionate to minorities. These data do reflect the inequities that have been observed since the beginning of the pandemic, as COVID-19 unequally affected many racial and ethnic minority groups and put them at a higher risk of severe illness and death. “Native Americans are four times more likely than Whites to be orphaned, and Black and Hispanic children 2.5 times more likely,” said Dr. Nelson.

The COVID Collaborative, a diverse group of leading experts from a wide range of disciplines including health, education, and economics, is working to develop consensus recommendations on pandemic-related issues such as vaccination of children who have lost caregivers. In December 2021, they released Hidden Pain: Children Who Lost a Parent or Caretaker to COVID-19 and What the Nation Can Do to Help Them, a report providing estimates of the number of children who lost a caregiver and concrete recommendations to support them.

“The death of an adult caregiver is life-altering for any child regardless of the circumstances or cause,” said Dan Treglia, PhD, associate professor of practice at the University of Pennsylvania, Philadelphia, and a contributor to Hidden Pain. “Traumatic grief is more common in sudden deaths like accidents where support systems are unable to mobilize in anticipation of the death and COVID-19 patients who die are typically in the hospital for barely a week before they pass.”

This suggests that responses to COVID-19 deaths may be more typical of sudden deaths than those of chronic illness such as cancer, he noted, adding that the pandemic has hindered the systems that children and their caregivers would normally rely on for support.

“Social distancing, for example, has limited informal community relationships critical for emotional health and in the current National Emergency in Children’s Mental Health, as noted by the American Academy of Pediatrics, among others, formal community-based and clinical services are overwhelmed,” said Dr. Treglia.

The authors of Hidden Pain note that the children most likely to lose a parent or other caregiver are generally the most likely to have faced “significant previous adversities that hinder their ability to successfully adapt to new experiences of adversity or trauma.” Studies have now revealed the magnitude of COVID-19–associated parent and caregiver death, and Dr. Treglia pointed out that action is needed from federal, state, and local policymakers to help children who have lost a caregiver to COVID-19.
 

Solutions needed now

“Their whole world has collapsed around them, as they have lost a provider of love, affection, developmental support, and in many cases a provider of critical financial support,” he said. “The federal government has an unparalleled ability to direct resources and attention and shape policy at lower levels of government, and its leadership is critical if we want to ensure care for COVID-bereaved children in all corners of the country.”

At least one state thus far is moving toward legislation to help this population. In California, a state with a high number of children who have lost a caregiver, the Hope, Opportunity, Perseverance, and Empowerment (HOPE) for Children Act has been introduced into the state legislature. If passed into law, children who lost a parent or caregiver to COVID-19 and are in the state’s foster care system or a low-income household would be eligible for a state-funded trust fund.

But while this is a start, the consequences of caregiver loss go far beyond the economics, and can include depression, PTSD, substance use disorder, lower levels of educational attainment, and subsequent lower levels of employment. However, most children (90%-95%) will experience a normative course of grief, according to the COVID Collaboration, which can be managed through family and social support systems. Community-based interventions, such as grief camps, peer support groups, or a mentoring program can also be very helpful.

Camp Erin, for example, is a bereavement camp for children aged 6-17 years. It is run by Eluna, a national nonprofit that supports children and families impacted by grief or addiction. “Camp Erin is the largest national bereavement program for children who are grieving the loss of a family member or caregiver, or other significant person in their lives,” said Mary FitzGerald, CEO of Eluna. “Many families needed help with these new dynamics of loss due to COVID.”

Led by bereavement professionals and volunteers, Camp Erin is a weekend experience that combines grief education and emotional support with traditional and fun activities. “It’s a safe environment for children to explore grief, and be with other children who are also grieving,” said Ms. FitzGerald. “There are 33 locations and it’s free of charge.”

Dr. Treglia emphasized the necessity of providing immediate financial assistance through well-established funding streams. “For example, Temporary Assistance to Needy Families, Supplemental Nutritional Assistance Program, and Social Security Survivor’s Benefits are a good start to reinforce their economic stability and keep financial disaster from piling onto their personal tragedy,” he said. “We also need to buttress community-based organizations and schools to ensure they have the resources and grief competence to identify bereaved children and can either provide services directly or refer them to organizations that can.”

He added that the infrastructure and knowledge already exist and “it’s a matter of making strategic investments at the necessary scale.”

As the COVID-19 pandemic enters its third year, the death toll continues to rise and with it, the number of children who may be left without anyone to care for them.

By Oct. 31, 2021, more than 5 million people worldwide had died from COVID-19, and about 5.2 million children had lost a parent or caregiver, according to new research published in the Lancet Child and Adolescent Health.

Of particular note, wrote the authors, was how the number of affected children surged during the latter part of their study period. During the first 14 months of the pandemic (March 1, 2020, to April 30, 2021), 2,737,300 children were affected by COVID-19-related caregiver death. But that number jumped by 90% during the next 6 months, from April 30 to Oct. 31, 2021, to 5,209,000. Essentially, the number of children who were affected nearly doubled, compared with those observed during that first year.

To put these numbers into perspective, study author Charles Nelson, PhD, professor of pediatrics and neuroscience and professor of psychology in the department of psychiatry at Harvard Medical School, Boston, compared it to the HIV/AIDS pandemic. “The current worldwide estimate is now approaching 6 million,” he said. “For HIV, it took 10 years before the number of orphans hit 5 million but for COVID it took 2 years. This should provide some perspective.”

Dr. Nelson pointed out that there are many other differences between the two pandemics. “There was no vaccine for HIV/AIDS, in contrast to the last year or so for COVID, when illness and death could largely be prevented,” he explained. “The politics surrounding HIV-related deaths seemed ‘relatively’ apolitical compared to COVID.”

Another major difference is that children whose parents had HIV were allowed to visit their parents, but for COVID-19, isolation was in place so many children could not see their parents before they died.

There is also more misinformation versus lack of information about COVID-19, compared to HIV/AIDS. “As an example, one young girl who lost her father to COVID was told by her classmates that her father hadn’t really died, he just abandoned the family,” Dr. Nelson said.
 

Minority communities face heaviest loss

A “companion study” was conducted by the Centers for Disease Control and Prevention, which looked at parental/caregiver death just within the United States. During the period between April 1, 2020, through June 30, 2021, the researchers found that more than 140,000 children under the age of 18 years had lost a parent, custodial grandparent, or grandparent caregiver because of COVID-19. In addition, there were significant racial, ethnic, and geographic disparities in COVID-19–associated death of caregivers, and the highest burden of death was observed in the Southern states along the U.S.-Mexican border for Hispanic children, Southeastern states for Black children, and in states with tribal areas for American Indian/Alaska Native populations. Overall, almost two-thirds (65%) of the children who lost a primary caregiver belonged to a racial or ethnic minority.

But as with the international data, the number of affected children has continued to rise since the end of the original study period. “Seth Flaxman, at Imperial College London, has updated the figures as of end of December for the U.S.,” said Dr. Nelson. The 140,000 has increased to 222,718 who lost a primary or secondary caregiver.

In addition, 192,449 lost a primary caregiver, 175,151 lost a parent, and 30,269 lost a secondary caregiver.

The rate, unfortunately, remains disproportionate to minorities. These data do reflect the inequities that have been observed since the beginning of the pandemic, as COVID-19 unequally affected many racial and ethnic minority groups and put them at a higher risk of severe illness and death. “Native Americans are four times more likely than Whites to be orphaned, and Black and Hispanic children 2.5 times more likely,” said Dr. Nelson.

The COVID Collaborative, a diverse group of leading experts from a wide range of disciplines including health, education, and economics, is working to develop consensus recommendations on pandemic-related issues such as vaccination of children who have lost caregivers. In December 2021, they released Hidden Pain: Children Who Lost a Parent or Caretaker to COVID-19 and What the Nation Can Do to Help Them, a report providing estimates of the number of children who lost a caregiver and concrete recommendations to support them.

“The death of an adult caregiver is life-altering for any child regardless of the circumstances or cause,” said Dan Treglia, PhD, associate professor of practice at the University of Pennsylvania, Philadelphia, and a contributor to Hidden Pain. “Traumatic grief is more common in sudden deaths like accidents where support systems are unable to mobilize in anticipation of the death and COVID-19 patients who die are typically in the hospital for barely a week before they pass.”

This suggests that responses to COVID-19 deaths may be more typical of sudden deaths than those of chronic illness such as cancer, he noted, adding that the pandemic has hindered the systems that children and their caregivers would normally rely on for support.

“Social distancing, for example, has limited informal community relationships critical for emotional health and in the current National Emergency in Children’s Mental Health, as noted by the American Academy of Pediatrics, among others, formal community-based and clinical services are overwhelmed,” said Dr. Treglia.

The authors of Hidden Pain note that the children most likely to lose a parent or other caregiver are generally the most likely to have faced “significant previous adversities that hinder their ability to successfully adapt to new experiences of adversity or trauma.” Studies have now revealed the magnitude of COVID-19–associated parent and caregiver death, and Dr. Treglia pointed out that action is needed from federal, state, and local policymakers to help children who have lost a caregiver to COVID-19.
 

Solutions needed now

“Their whole world has collapsed around them, as they have lost a provider of love, affection, developmental support, and in many cases a provider of critical financial support,” he said. “The federal government has an unparalleled ability to direct resources and attention and shape policy at lower levels of government, and its leadership is critical if we want to ensure care for COVID-bereaved children in all corners of the country.”

At least one state thus far is moving toward legislation to help this population. In California, a state with a high number of children who have lost a caregiver, the Hope, Opportunity, Perseverance, and Empowerment (HOPE) for Children Act has been introduced into the state legislature. If passed into law, children who lost a parent or caregiver to COVID-19 and are in the state’s foster care system or a low-income household would be eligible for a state-funded trust fund.

But while this is a start, the consequences of caregiver loss go far beyond the economics, and can include depression, PTSD, substance use disorder, lower levels of educational attainment, and subsequent lower levels of employment. However, most children (90%-95%) will experience a normative course of grief, according to the COVID Collaboration, which can be managed through family and social support systems. Community-based interventions, such as grief camps, peer support groups, or a mentoring program can also be very helpful.

Camp Erin, for example, is a bereavement camp for children aged 6-17 years. It is run by Eluna, a national nonprofit that supports children and families impacted by grief or addiction. “Camp Erin is the largest national bereavement program for children who are grieving the loss of a family member or caregiver, or other significant person in their lives,” said Mary FitzGerald, CEO of Eluna. “Many families needed help with these new dynamics of loss due to COVID.”

Led by bereavement professionals and volunteers, Camp Erin is a weekend experience that combines grief education and emotional support with traditional and fun activities. “It’s a safe environment for children to explore grief, and be with other children who are also grieving,” said Ms. FitzGerald. “There are 33 locations and it’s free of charge.”

Dr. Treglia emphasized the necessity of providing immediate financial assistance through well-established funding streams. “For example, Temporary Assistance to Needy Families, Supplemental Nutritional Assistance Program, and Social Security Survivor’s Benefits are a good start to reinforce their economic stability and keep financial disaster from piling onto their personal tragedy,” he said. “We also need to buttress community-based organizations and schools to ensure they have the resources and grief competence to identify bereaved children and can either provide services directly or refer them to organizations that can.”

He added that the infrastructure and knowledge already exist and “it’s a matter of making strategic investments at the necessary scale.”

As the COVID-19 pandemic enters its third year, the death toll continues to rise and with it, the number of children who may be left without anyone to care for them.

By Oct. 31, 2021, more than 5 million people worldwide had died from COVID-19, and about 5.2 million children had lost a parent or caregiver, according to new research published in the Lancet Child and Adolescent Health.

Of particular note, wrote the authors, was how the number of affected children surged during the latter part of their study period. During the first 14 months of the pandemic (March 1, 2020, to April 30, 2021), 2,737,300 children were affected by COVID-19-related caregiver death. But that number jumped by 90% during the next 6 months, from April 30 to Oct. 31, 2021, to 5,209,000. Essentially, the number of children who were affected nearly doubled, compared with those observed during that first year.

To put these numbers into perspective, study author Charles Nelson, PhD, professor of pediatrics and neuroscience and professor of psychology in the department of psychiatry at Harvard Medical School, Boston, compared it to the HIV/AIDS pandemic. “The current worldwide estimate is now approaching 6 million,” he said. “For HIV, it took 10 years before the number of orphans hit 5 million but for COVID it took 2 years. This should provide some perspective.”

Dr. Nelson pointed out that there are many other differences between the two pandemics. “There was no vaccine for HIV/AIDS, in contrast to the last year or so for COVID, when illness and death could largely be prevented,” he explained. “The politics surrounding HIV-related deaths seemed ‘relatively’ apolitical compared to COVID.”

Another major difference is that children whose parents had HIV were allowed to visit their parents, but for COVID-19, isolation was in place so many children could not see their parents before they died.

There is also more misinformation versus lack of information about COVID-19, compared to HIV/AIDS. “As an example, one young girl who lost her father to COVID was told by her classmates that her father hadn’t really died, he just abandoned the family,” Dr. Nelson said.
 

Minority communities face heaviest loss

A “companion study” was conducted by the Centers for Disease Control and Prevention, which looked at parental/caregiver death just within the United States. During the period between April 1, 2020, through June 30, 2021, the researchers found that more than 140,000 children under the age of 18 years had lost a parent, custodial grandparent, or grandparent caregiver because of COVID-19. In addition, there were significant racial, ethnic, and geographic disparities in COVID-19–associated death of caregivers, and the highest burden of death was observed in the Southern states along the U.S.-Mexican border for Hispanic children, Southeastern states for Black children, and in states with tribal areas for American Indian/Alaska Native populations. Overall, almost two-thirds (65%) of the children who lost a primary caregiver belonged to a racial or ethnic minority.

But as with the international data, the number of affected children has continued to rise since the end of the original study period. “Seth Flaxman, at Imperial College London, has updated the figures as of end of December for the U.S.,” said Dr. Nelson. The 140,000 has increased to 222,718 who lost a primary or secondary caregiver.

In addition, 192,449 lost a primary caregiver, 175,151 lost a parent, and 30,269 lost a secondary caregiver.

The rate, unfortunately, remains disproportionate to minorities. These data do reflect the inequities that have been observed since the beginning of the pandemic, as COVID-19 unequally affected many racial and ethnic minority groups and put them at a higher risk of severe illness and death. “Native Americans are four times more likely than Whites to be orphaned, and Black and Hispanic children 2.5 times more likely,” said Dr. Nelson.

The COVID Collaborative, a diverse group of leading experts from a wide range of disciplines including health, education, and economics, is working to develop consensus recommendations on pandemic-related issues such as vaccination of children who have lost caregivers. In December 2021, they released Hidden Pain: Children Who Lost a Parent or Caretaker to COVID-19 and What the Nation Can Do to Help Them, a report providing estimates of the number of children who lost a caregiver and concrete recommendations to support them.

“The death of an adult caregiver is life-altering for any child regardless of the circumstances or cause,” said Dan Treglia, PhD, associate professor of practice at the University of Pennsylvania, Philadelphia, and a contributor to Hidden Pain. “Traumatic grief is more common in sudden deaths like accidents where support systems are unable to mobilize in anticipation of the death and COVID-19 patients who die are typically in the hospital for barely a week before they pass.”

This suggests that responses to COVID-19 deaths may be more typical of sudden deaths than those of chronic illness such as cancer, he noted, adding that the pandemic has hindered the systems that children and their caregivers would normally rely on for support.

“Social distancing, for example, has limited informal community relationships critical for emotional health and in the current National Emergency in Children’s Mental Health, as noted by the American Academy of Pediatrics, among others, formal community-based and clinical services are overwhelmed,” said Dr. Treglia.

The authors of Hidden Pain note that the children most likely to lose a parent or other caregiver are generally the most likely to have faced “significant previous adversities that hinder their ability to successfully adapt to new experiences of adversity or trauma.” Studies have now revealed the magnitude of COVID-19–associated parent and caregiver death, and Dr. Treglia pointed out that action is needed from federal, state, and local policymakers to help children who have lost a caregiver to COVID-19.
 

Solutions needed now

“Their whole world has collapsed around them, as they have lost a provider of love, affection, developmental support, and in many cases a provider of critical financial support,” he said. “The federal government has an unparalleled ability to direct resources and attention and shape policy at lower levels of government, and its leadership is critical if we want to ensure care for COVID-bereaved children in all corners of the country.”

At least one state thus far is moving toward legislation to help this population. In California, a state with a high number of children who have lost a caregiver, the Hope, Opportunity, Perseverance, and Empowerment (HOPE) for Children Act has been introduced into the state legislature. If passed into law, children who lost a parent or caregiver to COVID-19 and are in the state’s foster care system or a low-income household would be eligible for a state-funded trust fund.

But while this is a start, the consequences of caregiver loss go far beyond the economics, and can include depression, PTSD, substance use disorder, lower levels of educational attainment, and subsequent lower levels of employment. However, most children (90%-95%) will experience a normative course of grief, according to the COVID Collaboration, which can be managed through family and social support systems. Community-based interventions, such as grief camps, peer support groups, or a mentoring program can also be very helpful.

Camp Erin, for example, is a bereavement camp for children aged 6-17 years. It is run by Eluna, a national nonprofit that supports children and families impacted by grief or addiction. “Camp Erin is the largest national bereavement program for children who are grieving the loss of a family member or caregiver, or other significant person in their lives,” said Mary FitzGerald, CEO of Eluna. “Many families needed help with these new dynamics of loss due to COVID.”

Led by bereavement professionals and volunteers, Camp Erin is a weekend experience that combines grief education and emotional support with traditional and fun activities. “It’s a safe environment for children to explore grief, and be with other children who are also grieving,” said Ms. FitzGerald. “There are 33 locations and it’s free of charge.”

Dr. Treglia emphasized the necessity of providing immediate financial assistance through well-established funding streams. “For example, Temporary Assistance to Needy Families, Supplemental Nutritional Assistance Program, and Social Security Survivor’s Benefits are a good start to reinforce their economic stability and keep financial disaster from piling onto their personal tragedy,” he said. “We also need to buttress community-based organizations and schools to ensure they have the resources and grief competence to identify bereaved children and can either provide services directly or refer them to organizations that can.”

He added that the infrastructure and knowledge already exist and “it’s a matter of making strategic investments at the necessary scale.”

The Food and Drug Administration has approved an expanded heart failure indication for the sodium-glucose transporter 2 inhibitor empagliflozin (Jardiance) that now includes HF with mid-range or preserved left ventricular ejection fraction (LVEF), the agency announced on Feb. 24.

That means the SGLT2 inhibitor, once considered primarily an antidiabetic agent, is approved for use in patients with HF per se without regard to ventricular function. The drug received approval for HF with reduced LVEF in August 2021.

Olivier Le Moal/Getty Images

The expanded indication, specifically for reducing the risk of cardiovascular death and HF hospitalization in adults, was widely anticipated based on the landmark results from the EMPEROR-Preserved trial. The study saw a significant 21% relative reduction in that composite endpoint over about 2 years in patients with New York Heart Association class II-IV heart failure and an LVEF greater than 40% who received empagliflozin along with other standard care.

Interestingly, the drug’s expanded indication in HF resembles that approved for sacubitril/valsartan (Entresto) in February 2021 based mostly on the PARAGON-HF trial, which entered patients with HF and an LVEF at least 45%. The trial was “negative” in that it saw no significant advantage to the drug for its primary clinical outcome but did suggest benefit for some secondary endpoints.

The FDA had used more cautionary language in its expanded indication for sacubitril/valsartan, “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction below normal.”

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

The Food and Drug Administration has approved an expanded heart failure indication for the sodium-glucose transporter 2 inhibitor empagliflozin (Jardiance) that now includes HF with mid-range or preserved left ventricular ejection fraction (LVEF), the agency announced on Feb. 24.

That means the SGLT2 inhibitor, once considered primarily an antidiabetic agent, is approved for use in patients with HF per se without regard to ventricular function. The drug received approval for HF with reduced LVEF in August 2021.

Olivier Le Moal/Getty Images

The expanded indication, specifically for reducing the risk of cardiovascular death and HF hospitalization in adults, was widely anticipated based on the landmark results from the EMPEROR-Preserved trial. The study saw a significant 21% relative reduction in that composite endpoint over about 2 years in patients with New York Heart Association class II-IV heart failure and an LVEF greater than 40% who received empagliflozin along with other standard care.

Interestingly, the drug’s expanded indication in HF resembles that approved for sacubitril/valsartan (Entresto) in February 2021 based mostly on the PARAGON-HF trial, which entered patients with HF and an LVEF at least 45%. The trial was “negative” in that it saw no significant advantage to the drug for its primary clinical outcome but did suggest benefit for some secondary endpoints.

The FDA had used more cautionary language in its expanded indication for sacubitril/valsartan, “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction below normal.”

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

The Food and Drug Administration has approved an expanded heart failure indication for the sodium-glucose transporter 2 inhibitor empagliflozin (Jardiance) that now includes HF with mid-range or preserved left ventricular ejection fraction (LVEF), the agency announced on Feb. 24.

That means the SGLT2 inhibitor, once considered primarily an antidiabetic agent, is approved for use in patients with HF per se without regard to ventricular function. The drug received approval for HF with reduced LVEF in August 2021.

Olivier Le Moal/Getty Images

The expanded indication, specifically for reducing the risk of cardiovascular death and HF hospitalization in adults, was widely anticipated based on the landmark results from the EMPEROR-Preserved trial. The study saw a significant 21% relative reduction in that composite endpoint over about 2 years in patients with New York Heart Association class II-IV heart failure and an LVEF greater than 40% who received empagliflozin along with other standard care.

Interestingly, the drug’s expanded indication in HF resembles that approved for sacubitril/valsartan (Entresto) in February 2021 based mostly on the PARAGON-HF trial, which entered patients with HF and an LVEF at least 45%. The trial was “negative” in that it saw no significant advantage to the drug for its primary clinical outcome but did suggest benefit for some secondary endpoints.

The FDA had used more cautionary language in its expanded indication for sacubitril/valsartan, “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction below normal.”

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

While overall incidences of leukemia have decreased worldwide in recent decades, new data show that the rates of chronic lymphocytic leukemia (CLL) appear to have risen significantly from 1990 to 2019. However, increased testing and incidental findings are suspected as factors driving these trends.

Either way, “to our best knowledge, this study is the first study to provide a comprehensive description of the epidemiology and global burden of CLL worldwide,” the authors reported in BioMedical Engineering Online.

The findings are an evaluation of data from the 2019 Global Burden of Disease study, which includes epidemiological data on 369 diseases in 204 nations and territories around the world.

According to the analysis, the age-standardized incidence rate of CLL rose globally over the last 3 decades, from 0.76 per 100,000 persons in 1990 to 1.34 per 100,000 in 2019, for an estimated annual percentage change of 1.86%.

While increases were observed across all economic levels, the highest increases were observed in regions with the highest social determinant index. Notably, the fastest rise was observed in middle-income regions.

“What cannot be ignored is the rapid growth of the disease burden in middle [social determinant index] regions, which potentially indicated an underestimated incidence and mortality in underdeveloped countries,” write the authors, led by senior author Huafeng Wang, MD, of the department of hematology, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.

The highest annual age-standardized incidence rates in 2019 occurred in western Europe, high-income areas of North America and central Europe, while the fastest increase in the incidence of CLL occurred in east Asia, central Europe, and Andean Latin America, according to the study.
 

Mortality rates

The age-standardized death rate from CLL also increased globally, from 0.40 per 100,000 persons in 1990 to 0.58 per 100,000 in 2019, for an estimated annual percentage change of 1.17.

The increases in death rates were observed across all income regions over the study period, with the highest age-standardized death rate in 2019, consistent with incidence rates, occurring in the highest-income regions, specifically in central Europe, western Europe, and high-income North America.

The geographic trends were similar in terms of disability-adjusted life-years, which increased globally from 9.20 per 100,000 persons in 1990 to 12.26 per 100,000 in 2019, for an estimated annual percentage change of 0.92%.

The authors noted that the geographic variation of CLL is consistent with research suggesting that White ancestry is a risk factor for this leukemia. And while the incidence of CLL is generally low in the 22 nations of the Arab League, the burden of disease is high in Israel.
 

Age and gender

The study shows that, during the past 30 years in general, CLL was more common among males, with some regional differences. For instance, in contrast to global trends, females in low-income regions accounted for the majority of incidence and mortality.

The majority of CLL cases occurred in people over the age of 50, which is consistent with known patterns of CLL occurring in older patients. Of note, the majority of cases between the ages of 50 and 69 were in low-income regions, while more than half of the incidence cases in higher-income regions were among those over the age of 70.
 

Risk factors

Key risk factors that may to be linked to CLL-related mortality and disability include high body mass index, occupational exposure to benzene and formaldehyde, and smoking, which was the strongest risk factor, the authors reported.

Obesity has previously been linked with an increased risk of lymphohematopoietic cancers in general and with poorer responses to treatment and reduced progression-free survival in CLL, in particular.

While the database otherwise provided only limited insights into potential CLL risk factors, “among the factors [the database] provided, the risk of benzene and formaldehyde exposure should be paid attention to,” Dr. Wang said in an interview.

“Different from other risk factors, emerging evidence has clearly pointed out the close relationship between benzene and formaldehyde exposure and hematological malignancies,” he explained. “With globalization, a large number of factories moved to less developed regions. The problem of occupational toxic exposure needs to be addressed.”

In general, the trends in the current study are consistent with previous research showing that, while there was a significant global decrease in leukemia incidence between 1990 and 2017, the incidence rates of CLL as well as acute myeloid leukemia (AML) significantly increased in most countries during that period.

“The age-standardized incidence rate of AML has steadily increased over the past 30 years, but not as rapidly as CLL,” Dr. Wang said.

He added that an encouraging sign is the “significant decline” in the age-standardized rate of chronic myeloid leukemia seen with the advent of tyrosine kinase inhibitors (TKIs).

“Perhaps for CLL, the emergence of epoch-making therapies like TKIs will also contribute to the reduction of disease burden [with that disease],” he said.
 

Surveillance bias?

The authors note a key caveat that the lower rates observed in low-income regions could be related to underreporting and lower screening of cancers in those regions. However, commenting on the study, Robert Peter Gale, MD, PhD, suggested that, conversely, the trends may represent a surveillance bias, reflecting an increased detection of CLL.

In fact, “it is most unlikely the incidence of CLL is really increasing,” Dr. Gale, visiting professor of hematology at the Hematology Research Centre, department of immunology and inflammation, Imperial College London, said in an interview.

“More than one-half of people with CLL have no signs or symptoms, and the diagnosis is made when they have a blood test done for unrelated reasons,” such as in the process of qualifying for life or medical insurance or for a new job, he explained. “The more testing you do, the more cases you will detect.”

Dr. Gale pointed out that research his team has conducted in China also showed an increasing incidence of CLL. However, “on closer study, we found about two-thirds of cases were incidental, namely cases detected under circumstances [such as blood testing for a job].”

Shen-Miao Yang, MD, first author of that study, agreed and noted that improved treatment with drugs such as Bruton kinase inhibitors also can have the effect of increasing incidence – by extending lives.

“More patients are diagnosed, [and] receive the new agent, and their longer survival contributes to the increased burden of CLL,” Dr. Yang of People’s Hospital of Peking University, Peking University Institute of Hematology, Beijing, said in an interview.

Furthermore, “advanced techniques such as flow cytometry and fluorescence in situ hybridization are routinely used for the diagnosis and prognosis of CLL patients – that also increases the CLL burden.”

Dr. Yang had no disclosures to report. Dr. Gale disclosed that he is a consultant to BeiGene, Fusion Pharma, La Jolla NanoMedical, MingSight Pharmaceuticals, CStone Pharmaceuticals, NexImmune, and Prolacta Bioscience; an adviser to Antengene Biotech; medical director of FFF Enterprises; a partner of AZCA; member of the board of directors of the Russian Foundation for Cancer Research Support; and on the scientific advisory board of StemRad.

While overall incidences of leukemia have decreased worldwide in recent decades, new data show that the rates of chronic lymphocytic leukemia (CLL) appear to have risen significantly from 1990 to 2019. However, increased testing and incidental findings are suspected as factors driving these trends.

Either way, “to our best knowledge, this study is the first study to provide a comprehensive description of the epidemiology and global burden of CLL worldwide,” the authors reported in BioMedical Engineering Online.

The findings are an evaluation of data from the 2019 Global Burden of Disease study, which includes epidemiological data on 369 diseases in 204 nations and territories around the world.

According to the analysis, the age-standardized incidence rate of CLL rose globally over the last 3 decades, from 0.76 per 100,000 persons in 1990 to 1.34 per 100,000 in 2019, for an estimated annual percentage change of 1.86%.

While increases were observed across all economic levels, the highest increases were observed in regions with the highest social determinant index. Notably, the fastest rise was observed in middle-income regions.

“What cannot be ignored is the rapid growth of the disease burden in middle [social determinant index] regions, which potentially indicated an underestimated incidence and mortality in underdeveloped countries,” write the authors, led by senior author Huafeng Wang, MD, of the department of hematology, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.

The highest annual age-standardized incidence rates in 2019 occurred in western Europe, high-income areas of North America and central Europe, while the fastest increase in the incidence of CLL occurred in east Asia, central Europe, and Andean Latin America, according to the study.
 

Mortality rates

The age-standardized death rate from CLL also increased globally, from 0.40 per 100,000 persons in 1990 to 0.58 per 100,000 in 2019, for an estimated annual percentage change of 1.17.

The increases in death rates were observed across all income regions over the study period, with the highest age-standardized death rate in 2019, consistent with incidence rates, occurring in the highest-income regions, specifically in central Europe, western Europe, and high-income North America.

The geographic trends were similar in terms of disability-adjusted life-years, which increased globally from 9.20 per 100,000 persons in 1990 to 12.26 per 100,000 in 2019, for an estimated annual percentage change of 0.92%.

The authors noted that the geographic variation of CLL is consistent with research suggesting that White ancestry is a risk factor for this leukemia. And while the incidence of CLL is generally low in the 22 nations of the Arab League, the burden of disease is high in Israel.
 

Age and gender

The study shows that, during the past 30 years in general, CLL was more common among males, with some regional differences. For instance, in contrast to global trends, females in low-income regions accounted for the majority of incidence and mortality.

The majority of CLL cases occurred in people over the age of 50, which is consistent with known patterns of CLL occurring in older patients. Of note, the majority of cases between the ages of 50 and 69 were in low-income regions, while more than half of the incidence cases in higher-income regions were among those over the age of 70.
 

Risk factors

Key risk factors that may to be linked to CLL-related mortality and disability include high body mass index, occupational exposure to benzene and formaldehyde, and smoking, which was the strongest risk factor, the authors reported.

Obesity has previously been linked with an increased risk of lymphohematopoietic cancers in general and with poorer responses to treatment and reduced progression-free survival in CLL, in particular.

While the database otherwise provided only limited insights into potential CLL risk factors, “among the factors [the database] provided, the risk of benzene and formaldehyde exposure should be paid attention to,” Dr. Wang said in an interview.

“Different from other risk factors, emerging evidence has clearly pointed out the close relationship between benzene and formaldehyde exposure and hematological malignancies,” he explained. “With globalization, a large number of factories moved to less developed regions. The problem of occupational toxic exposure needs to be addressed.”

In general, the trends in the current study are consistent with previous research showing that, while there was a significant global decrease in leukemia incidence between 1990 and 2017, the incidence rates of CLL as well as acute myeloid leukemia (AML) significantly increased in most countries during that period.

“The age-standardized incidence rate of AML has steadily increased over the past 30 years, but not as rapidly as CLL,” Dr. Wang said.

He added that an encouraging sign is the “significant decline” in the age-standardized rate of chronic myeloid leukemia seen with the advent of tyrosine kinase inhibitors (TKIs).

“Perhaps for CLL, the emergence of epoch-making therapies like TKIs will also contribute to the reduction of disease burden [with that disease],” he said.
 

Surveillance bias?

The authors note a key caveat that the lower rates observed in low-income regions could be related to underreporting and lower screening of cancers in those regions. However, commenting on the study, Robert Peter Gale, MD, PhD, suggested that, conversely, the trends may represent a surveillance bias, reflecting an increased detection of CLL.

In fact, “it is most unlikely the incidence of CLL is really increasing,” Dr. Gale, visiting professor of hematology at the Hematology Research Centre, department of immunology and inflammation, Imperial College London, said in an interview.

“More than one-half of people with CLL have no signs or symptoms, and the diagnosis is made when they have a blood test done for unrelated reasons,” such as in the process of qualifying for life or medical insurance or for a new job, he explained. “The more testing you do, the more cases you will detect.”

Dr. Gale pointed out that research his team has conducted in China also showed an increasing incidence of CLL. However, “on closer study, we found about two-thirds of cases were incidental, namely cases detected under circumstances [such as blood testing for a job].”

Shen-Miao Yang, MD, first author of that study, agreed and noted that improved treatment with drugs such as Bruton kinase inhibitors also can have the effect of increasing incidence – by extending lives.

“More patients are diagnosed, [and] receive the new agent, and their longer survival contributes to the increased burden of CLL,” Dr. Yang of People’s Hospital of Peking University, Peking University Institute of Hematology, Beijing, said in an interview.

Furthermore, “advanced techniques such as flow cytometry and fluorescence in situ hybridization are routinely used for the diagnosis and prognosis of CLL patients – that also increases the CLL burden.”

Dr. Yang had no disclosures to report. Dr. Gale disclosed that he is a consultant to BeiGene, Fusion Pharma, La Jolla NanoMedical, MingSight Pharmaceuticals, CStone Pharmaceuticals, NexImmune, and Prolacta Bioscience; an adviser to Antengene Biotech; medical director of FFF Enterprises; a partner of AZCA; member of the board of directors of the Russian Foundation for Cancer Research Support; and on the scientific advisory board of StemRad.

While overall incidences of leukemia have decreased worldwide in recent decades, new data show that the rates of chronic lymphocytic leukemia (CLL) appear to have risen significantly from 1990 to 2019. However, increased testing and incidental findings are suspected as factors driving these trends.

Either way, “to our best knowledge, this study is the first study to provide a comprehensive description of the epidemiology and global burden of CLL worldwide,” the authors reported in BioMedical Engineering Online.

The findings are an evaluation of data from the 2019 Global Burden of Disease study, which includes epidemiological data on 369 diseases in 204 nations and territories around the world.

According to the analysis, the age-standardized incidence rate of CLL rose globally over the last 3 decades, from 0.76 per 100,000 persons in 1990 to 1.34 per 100,000 in 2019, for an estimated annual percentage change of 1.86%.

While increases were observed across all economic levels, the highest increases were observed in regions with the highest social determinant index. Notably, the fastest rise was observed in middle-income regions.

“What cannot be ignored is the rapid growth of the disease burden in middle [social determinant index] regions, which potentially indicated an underestimated incidence and mortality in underdeveloped countries,” write the authors, led by senior author Huafeng Wang, MD, of the department of hematology, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.

The highest annual age-standardized incidence rates in 2019 occurred in western Europe, high-income areas of North America and central Europe, while the fastest increase in the incidence of CLL occurred in east Asia, central Europe, and Andean Latin America, according to the study.
 

Mortality rates

The age-standardized death rate from CLL also increased globally, from 0.40 per 100,000 persons in 1990 to 0.58 per 100,000 in 2019, for an estimated annual percentage change of 1.17.

The increases in death rates were observed across all income regions over the study period, with the highest age-standardized death rate in 2019, consistent with incidence rates, occurring in the highest-income regions, specifically in central Europe, western Europe, and high-income North America.

The geographic trends were similar in terms of disability-adjusted life-years, which increased globally from 9.20 per 100,000 persons in 1990 to 12.26 per 100,000 in 2019, for an estimated annual percentage change of 0.92%.

The authors noted that the geographic variation of CLL is consistent with research suggesting that White ancestry is a risk factor for this leukemia. And while the incidence of CLL is generally low in the 22 nations of the Arab League, the burden of disease is high in Israel.
 

Age and gender

The study shows that, during the past 30 years in general, CLL was more common among males, with some regional differences. For instance, in contrast to global trends, females in low-income regions accounted for the majority of incidence and mortality.

The majority of CLL cases occurred in people over the age of 50, which is consistent with known patterns of CLL occurring in older patients. Of note, the majority of cases between the ages of 50 and 69 were in low-income regions, while more than half of the incidence cases in higher-income regions were among those over the age of 70.
 

Risk factors

Key risk factors that may to be linked to CLL-related mortality and disability include high body mass index, occupational exposure to benzene and formaldehyde, and smoking, which was the strongest risk factor, the authors reported.

Obesity has previously been linked with an increased risk of lymphohematopoietic cancers in general and with poorer responses to treatment and reduced progression-free survival in CLL, in particular.

While the database otherwise provided only limited insights into potential CLL risk factors, “among the factors [the database] provided, the risk of benzene and formaldehyde exposure should be paid attention to,” Dr. Wang said in an interview.

“Different from other risk factors, emerging evidence has clearly pointed out the close relationship between benzene and formaldehyde exposure and hematological malignancies,” he explained. “With globalization, a large number of factories moved to less developed regions. The problem of occupational toxic exposure needs to be addressed.”

In general, the trends in the current study are consistent with previous research showing that, while there was a significant global decrease in leukemia incidence between 1990 and 2017, the incidence rates of CLL as well as acute myeloid leukemia (AML) significantly increased in most countries during that period.

“The age-standardized incidence rate of AML has steadily increased over the past 30 years, but not as rapidly as CLL,” Dr. Wang said.

He added that an encouraging sign is the “significant decline” in the age-standardized rate of chronic myeloid leukemia seen with the advent of tyrosine kinase inhibitors (TKIs).

“Perhaps for CLL, the emergence of epoch-making therapies like TKIs will also contribute to the reduction of disease burden [with that disease],” he said.
 

Surveillance bias?

The authors note a key caveat that the lower rates observed in low-income regions could be related to underreporting and lower screening of cancers in those regions. However, commenting on the study, Robert Peter Gale, MD, PhD, suggested that, conversely, the trends may represent a surveillance bias, reflecting an increased detection of CLL.

In fact, “it is most unlikely the incidence of CLL is really increasing,” Dr. Gale, visiting professor of hematology at the Hematology Research Centre, department of immunology and inflammation, Imperial College London, said in an interview.

“More than one-half of people with CLL have no signs or symptoms, and the diagnosis is made when they have a blood test done for unrelated reasons,” such as in the process of qualifying for life or medical insurance or for a new job, he explained. “The more testing you do, the more cases you will detect.”

Dr. Gale pointed out that research his team has conducted in China also showed an increasing incidence of CLL. However, “on closer study, we found about two-thirds of cases were incidental, namely cases detected under circumstances [such as blood testing for a job].”

Shen-Miao Yang, MD, first author of that study, agreed and noted that improved treatment with drugs such as Bruton kinase inhibitors also can have the effect of increasing incidence – by extending lives.

“More patients are diagnosed, [and] receive the new agent, and their longer survival contributes to the increased burden of CLL,” Dr. Yang of People’s Hospital of Peking University, Peking University Institute of Hematology, Beijing, said in an interview.

Furthermore, “advanced techniques such as flow cytometry and fluorescence in situ hybridization are routinely used for the diagnosis and prognosis of CLL patients – that also increases the CLL burden.”

Dr. Yang had no disclosures to report. Dr. Gale disclosed that he is a consultant to BeiGene, Fusion Pharma, La Jolla NanoMedical, MingSight Pharmaceuticals, CStone Pharmaceuticals, NexImmune, and Prolacta Bioscience; an adviser to Antengene Biotech; medical director of FFF Enterprises; a partner of AZCA; member of the board of directors of the Russian Foundation for Cancer Research Support; and on the scientific advisory board of StemRad.

New recommendations from the European Alliance of Associations for Rheumatology provide both broad and detailed advice for cardiovascular risk management in various rheumatic and musculoskeletal diseases (RMDs), many of which can lead to an increased possibility of cardiovascular disease (CVD).

“The panel believes that these recommendations will enable health care providers and patients to mutually engage in a long-term care pathway tailored to patients’ needs and expectations for improving cardiovascular health in RMDs,” write George C. Drosos, National and Kapodistrian University of Athens, and colleagues. The recommendations were published in February in Annals of the Rheumatic Diseases).

EULAR assembled a task force to generate best practices for preventing CVD in patients with gout, vasculitis, systemic sclerosis (SSc), myositis, mixed connective tissue disease (MCTD), Sjögren syndrome (SS), systemic lupus erythematosus (SLE), and antiphospholipid syndrome (APS).

The cardiovascular risk management of patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis was covered in prior EULAR recommendations.

The task force included 20 members from 11 European countries, including 12 rheumatologists, 2 cardiologists, 1 metabolic medicine physician, 1 health care professional, 2 patient representatives, and 2 EMEUNET (Emerging EULAR Network) members. One group of task force members conducted a systematic literature review of 105 articles about gout, vasculitis, SSc, myositis, MCTD, and SS, and another group evaluated 75 articles about SLE and APS. Together, they decided on four overarching principles:

Clinicians need to be aware of increased cardiovascular risk in patients with RMDs, with disease reduction likely decreasing risk.

Rheumatologists – in tandem with other health care providers – are responsible for their patients’ cardiovascular risk assessment and management.

Screening for cardiovascular risk should be performed regularly in all patients with RMDs, with an emphasis on factors like smoking and blood pressure management.

Patient education and counseling on cardiovascular risk, including important lifestyle modifications, is key for RMD patients.

Specific recommendations from the gout, vasculitis, SSc, myositis, MCTD, and SS group include deploying existing cardiovascular prediction tools as they are used in the general population, with the European Vasculitis Society model suggesting to supplement the Framingham Risk Score for patients with antineutrophil cytoplasmic antibody–associated vasculitis. They also recommended avoiding diuretics in patients with gout and beta-blockers in patients with SSc, as well as following the same blood pressure and lipid management strategies that are used among the general population.

Recommendations from the SLE and APS group include thoroughly assessing traditional cardiovascular risk factors in all patients, following typical blood pressure management strategies in patients with APS, and setting a blood pressure target of less than 130/80 mm Hg in patients with SLE. They also recommended administering the lowest possible glucocorticoid dose in patients with SLE, along with treatment with hydroxychloroquine – unless contraindicated – and even common preventive strategies like low-dose aspirin if it suits their cardiovascular risk profile.

As for next steps, the task force noted several areas where additional focus is needed, such as identifying patient subgroups with increased cardiovascular risk. This could include patients with a longer disease duration or more flare-ups, older patients, and those with certain disease characteristics like antiphospholipid positivity in SLE.

Can EULAR’s recommendations be implemented in U.S. rheumatology practices?

“We have been hearing for years that patients with rheumatic diseases have an increased risk of cardiovascular disease,” Ali A. Duarte Garcia, MD, a rheumatologist at the Mayo Clinic in Rochester, Minn., told this news organization. “That has been consistently published for more than a decade now. But any further guidance about it has not been issued. I think there was a void there.”

“Certainly, cardiovascular disease risk in rheumatoid and psoriatic arthritis has been front of mind for the last decade or so,” Christie M. Bartels, MD, chief of the division of rheumatology at the University of Wisconsin, Madison, said when asked to comment on the recommendations. “But in some of these other conditions, it hasn’t been.”

When asked if rheumatologists would be ready and willing to implement these recommendations, Dr. Duarte Garcia acknowledged that it could be challenging for some.

“It’s a different workflow,” he said. “You’ve been trained traditionally to assess inflammation, to keep the disease under control, which is something they recommend, by the way. If you control the disease, patients do better. But I think lipid screening, for example, and testing for cholesterol, smoking cessation, those well-established programs are harder to bring to a rheumatology clinic. It’s doable, but it’s something that needs to be implemented within the current workflows and could take a few years to take hold.”

Dr. Bartels, however, noted that her group has done extensive work over the last 5 years incorporating certain interventions into practice, including sending patients with high blood pressure back to primary care.

“It’s a sustainable intervention in our clinic that basically our medical assistants and nurses do as a routine operation,” she said. “Our primary care providers are grateful to get these patients back. Our patients are grateful because otherwise when they come to the rheumatologist, get their blood pressure measured, and don’t get feedback, they assume they’re OK. So, we’re giving them a false signal.

“We have a similar intervention with smoking,” she added. “Often our patients aren’t even aware that they’re at increased risk of cardiovascular disease or that smoking might make their rheumatic disease and their cardiovascular outcomes worse. No one has had that conversation with them. They really welcome engaging in those discussions.

“Our tobacco intervention takes 90 seconds at point of care. Our blood pressure intervention at point of care, we’ve timed it, takes 3 minutes. There are ways that we can hardwire this into care.”

Along those lines, Dr. Duarte Garcia stated that the recommendations – although released by EULAR – are largely intuitive and should be very adaptable to an American health care context. He also recognized this moment as an opportunity for rheumatologists to consider patient outcomes beyond what they usually encounter firsthand.

“I don’t think we have many rheumatologists with patients who get a stroke or heart attack because if that happens, it’s in a hospital context or they go see a cardiologist,” he said. “You may see it once it happens if they survive and come and see you – or perhaps if you’re in a more integrated practice – but I don’t think it’s as apparent in our clinics because it is a predominantly outpatient practice and many times those are emergencies or inpatient complications.

“The bottom line,” he added, “is these are practical guidelines. It’s a push in the right direction, but there is still work to be done. And hopefully some of the recommendations, like measuring high blood pressure and addressing it just as in the general population, are something we can start to implement.”

Dr. Duarte Garcia reported receiving grant funding from the Rheumatology Research Foundation and the Centers for Disease Control and Prevention. Dr. Bartels reported that her group’s tobacco cessation work is funded by Pfizer’s Independent Grants for Learning and Change.

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

New recommendations from the European Alliance of Associations for Rheumatology provide both broad and detailed advice for cardiovascular risk management in various rheumatic and musculoskeletal diseases (RMDs), many of which can lead to an increased possibility of cardiovascular disease (CVD).

“The panel believes that these recommendations will enable health care providers and patients to mutually engage in a long-term care pathway tailored to patients’ needs and expectations for improving cardiovascular health in RMDs,” write George C. Drosos, National and Kapodistrian University of Athens, and colleagues. The recommendations were published in February in Annals of the Rheumatic Diseases).

EULAR assembled a task force to generate best practices for preventing CVD in patients with gout, vasculitis, systemic sclerosis (SSc), myositis, mixed connective tissue disease (MCTD), Sjögren syndrome (SS), systemic lupus erythematosus (SLE), and antiphospholipid syndrome (APS).

The cardiovascular risk management of patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis was covered in prior EULAR recommendations.

The task force included 20 members from 11 European countries, including 12 rheumatologists, 2 cardiologists, 1 metabolic medicine physician, 1 health care professional, 2 patient representatives, and 2 EMEUNET (Emerging EULAR Network) members. One group of task force members conducted a systematic literature review of 105 articles about gout, vasculitis, SSc, myositis, MCTD, and SS, and another group evaluated 75 articles about SLE and APS. Together, they decided on four overarching principles:

Clinicians need to be aware of increased cardiovascular risk in patients with RMDs, with disease reduction likely decreasing risk.

Rheumatologists – in tandem with other health care providers – are responsible for their patients’ cardiovascular risk assessment and management.

Screening for cardiovascular risk should be performed regularly in all patients with RMDs, with an emphasis on factors like smoking and blood pressure management.

Patient education and counseling on cardiovascular risk, including important lifestyle modifications, is key for RMD patients.

Specific recommendations from the gout, vasculitis, SSc, myositis, MCTD, and SS group include deploying existing cardiovascular prediction tools as they are used in the general population, with the European Vasculitis Society model suggesting to supplement the Framingham Risk Score for patients with antineutrophil cytoplasmic antibody–associated vasculitis. They also recommended avoiding diuretics in patients with gout and beta-blockers in patients with SSc, as well as following the same blood pressure and lipid management strategies that are used among the general population.

Recommendations from the SLE and APS group include thoroughly assessing traditional cardiovascular risk factors in all patients, following typical blood pressure management strategies in patients with APS, and setting a blood pressure target of less than 130/80 mm Hg in patients with SLE. They also recommended administering the lowest possible glucocorticoid dose in patients with SLE, along with treatment with hydroxychloroquine – unless contraindicated – and even common preventive strategies like low-dose aspirin if it suits their cardiovascular risk profile.

As for next steps, the task force noted several areas where additional focus is needed, such as identifying patient subgroups with increased cardiovascular risk. This could include patients with a longer disease duration or more flare-ups, older patients, and those with certain disease characteristics like antiphospholipid positivity in SLE.

Can EULAR’s recommendations be implemented in U.S. rheumatology practices?

“We have been hearing for years that patients with rheumatic diseases have an increased risk of cardiovascular disease,” Ali A. Duarte Garcia, MD, a rheumatologist at the Mayo Clinic in Rochester, Minn., told this news organization. “That has been consistently published for more than a decade now. But any further guidance about it has not been issued. I think there was a void there.”

“Certainly, cardiovascular disease risk in rheumatoid and psoriatic arthritis has been front of mind for the last decade or so,” Christie M. Bartels, MD, chief of the division of rheumatology at the University of Wisconsin, Madison, said when asked to comment on the recommendations. “But in some of these other conditions, it hasn’t been.”

When asked if rheumatologists would be ready and willing to implement these recommendations, Dr. Duarte Garcia acknowledged that it could be challenging for some.

“It’s a different workflow,” he said. “You’ve been trained traditionally to assess inflammation, to keep the disease under control, which is something they recommend, by the way. If you control the disease, patients do better. But I think lipid screening, for example, and testing for cholesterol, smoking cessation, those well-established programs are harder to bring to a rheumatology clinic. It’s doable, but it’s something that needs to be implemented within the current workflows and could take a few years to take hold.”

Dr. Bartels, however, noted that her group has done extensive work over the last 5 years incorporating certain interventions into practice, including sending patients with high blood pressure back to primary care.

“It’s a sustainable intervention in our clinic that basically our medical assistants and nurses do as a routine operation,” she said. “Our primary care providers are grateful to get these patients back. Our patients are grateful because otherwise when they come to the rheumatologist, get their blood pressure measured, and don’t get feedback, they assume they’re OK. So, we’re giving them a false signal.

“We have a similar intervention with smoking,” she added. “Often our patients aren’t even aware that they’re at increased risk of cardiovascular disease or that smoking might make their rheumatic disease and their cardiovascular outcomes worse. No one has had that conversation with them. They really welcome engaging in those discussions.

“Our tobacco intervention takes 90 seconds at point of care. Our blood pressure intervention at point of care, we’ve timed it, takes 3 minutes. There are ways that we can hardwire this into care.”

Along those lines, Dr. Duarte Garcia stated that the recommendations – although released by EULAR – are largely intuitive and should be very adaptable to an American health care context. He also recognized this moment as an opportunity for rheumatologists to consider patient outcomes beyond what they usually encounter firsthand.

“I don’t think we have many rheumatologists with patients who get a stroke or heart attack because if that happens, it’s in a hospital context or they go see a cardiologist,” he said. “You may see it once it happens if they survive and come and see you – or perhaps if you’re in a more integrated practice – but I don’t think it’s as apparent in our clinics because it is a predominantly outpatient practice and many times those are emergencies or inpatient complications.

“The bottom line,” he added, “is these are practical guidelines. It’s a push in the right direction, but there is still work to be done. And hopefully some of the recommendations, like measuring high blood pressure and addressing it just as in the general population, are something we can start to implement.”

Dr. Duarte Garcia reported receiving grant funding from the Rheumatology Research Foundation and the Centers for Disease Control and Prevention. Dr. Bartels reported that her group’s tobacco cessation work is funded by Pfizer’s Independent Grants for Learning and Change.

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

New recommendations from the European Alliance of Associations for Rheumatology provide both broad and detailed advice for cardiovascular risk management in various rheumatic and musculoskeletal diseases (RMDs), many of which can lead to an increased possibility of cardiovascular disease (CVD).

“The panel believes that these recommendations will enable health care providers and patients to mutually engage in a long-term care pathway tailored to patients’ needs and expectations for improving cardiovascular health in RMDs,” write George C. Drosos, National and Kapodistrian University of Athens, and colleagues. The recommendations were published in February in Annals of the Rheumatic Diseases).

EULAR assembled a task force to generate best practices for preventing CVD in patients with gout, vasculitis, systemic sclerosis (SSc), myositis, mixed connective tissue disease (MCTD), Sjögren syndrome (SS), systemic lupus erythematosus (SLE), and antiphospholipid syndrome (APS).

The cardiovascular risk management of patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis was covered in prior EULAR recommendations.

The task force included 20 members from 11 European countries, including 12 rheumatologists, 2 cardiologists, 1 metabolic medicine physician, 1 health care professional, 2 patient representatives, and 2 EMEUNET (Emerging EULAR Network) members. One group of task force members conducted a systematic literature review of 105 articles about gout, vasculitis, SSc, myositis, MCTD, and SS, and another group evaluated 75 articles about SLE and APS. Together, they decided on four overarching principles:

Clinicians need to be aware of increased cardiovascular risk in patients with RMDs, with disease reduction likely decreasing risk.

Rheumatologists – in tandem with other health care providers – are responsible for their patients’ cardiovascular risk assessment and management.

Screening for cardiovascular risk should be performed regularly in all patients with RMDs, with an emphasis on factors like smoking and blood pressure management.

Patient education and counseling on cardiovascular risk, including important lifestyle modifications, is key for RMD patients.

Specific recommendations from the gout, vasculitis, SSc, myositis, MCTD, and SS group include deploying existing cardiovascular prediction tools as they are used in the general population, with the European Vasculitis Society model suggesting to supplement the Framingham Risk Score for patients with antineutrophil cytoplasmic antibody–associated vasculitis. They also recommended avoiding diuretics in patients with gout and beta-blockers in patients with SSc, as well as following the same blood pressure and lipid management strategies that are used among the general population.

Recommendations from the SLE and APS group include thoroughly assessing traditional cardiovascular risk factors in all patients, following typical blood pressure management strategies in patients with APS, and setting a blood pressure target of less than 130/80 mm Hg in patients with SLE. They also recommended administering the lowest possible glucocorticoid dose in patients with SLE, along with treatment with hydroxychloroquine – unless contraindicated – and even common preventive strategies like low-dose aspirin if it suits their cardiovascular risk profile.

As for next steps, the task force noted several areas where additional focus is needed, such as identifying patient subgroups with increased cardiovascular risk. This could include patients with a longer disease duration or more flare-ups, older patients, and those with certain disease characteristics like antiphospholipid positivity in SLE.

Can EULAR’s recommendations be implemented in U.S. rheumatology practices?

“We have been hearing for years that patients with rheumatic diseases have an increased risk of cardiovascular disease,” Ali A. Duarte Garcia, MD, a rheumatologist at the Mayo Clinic in Rochester, Minn., told this news organization. “That has been consistently published for more than a decade now. But any further guidance about it has not been issued. I think there was a void there.”

“Certainly, cardiovascular disease risk in rheumatoid and psoriatic arthritis has been front of mind for the last decade or so,” Christie M. Bartels, MD, chief of the division of rheumatology at the University of Wisconsin, Madison, said when asked to comment on the recommendations. “But in some of these other conditions, it hasn’t been.”

When asked if rheumatologists would be ready and willing to implement these recommendations, Dr. Duarte Garcia acknowledged that it could be challenging for some.

“It’s a different workflow,” he said. “You’ve been trained traditionally to assess inflammation, to keep the disease under control, which is something they recommend, by the way. If you control the disease, patients do better. But I think lipid screening, for example, and testing for cholesterol, smoking cessation, those well-established programs are harder to bring to a rheumatology clinic. It’s doable, but it’s something that needs to be implemented within the current workflows and could take a few years to take hold.”

Dr. Bartels, however, noted that her group has done extensive work over the last 5 years incorporating certain interventions into practice, including sending patients with high blood pressure back to primary care.

“It’s a sustainable intervention in our clinic that basically our medical assistants and nurses do as a routine operation,” she said. “Our primary care providers are grateful to get these patients back. Our patients are grateful because otherwise when they come to the rheumatologist, get their blood pressure measured, and don’t get feedback, they assume they’re OK. So, we’re giving them a false signal.

“We have a similar intervention with smoking,” she added. “Often our patients aren’t even aware that they’re at increased risk of cardiovascular disease or that smoking might make their rheumatic disease and their cardiovascular outcomes worse. No one has had that conversation with them. They really welcome engaging in those discussions.

“Our tobacco intervention takes 90 seconds at point of care. Our blood pressure intervention at point of care, we’ve timed it, takes 3 minutes. There are ways that we can hardwire this into care.”

Along those lines, Dr. Duarte Garcia stated that the recommendations – although released by EULAR – are largely intuitive and should be very adaptable to an American health care context. He also recognized this moment as an opportunity for rheumatologists to consider patient outcomes beyond what they usually encounter firsthand.

“I don’t think we have many rheumatologists with patients who get a stroke or heart attack because if that happens, it’s in a hospital context or they go see a cardiologist,” he said. “You may see it once it happens if they survive and come and see you – or perhaps if you’re in a more integrated practice – but I don’t think it’s as apparent in our clinics because it is a predominantly outpatient practice and many times those are emergencies or inpatient complications.

“The bottom line,” he added, “is these are practical guidelines. It’s a push in the right direction, but there is still work to be done. And hopefully some of the recommendations, like measuring high blood pressure and addressing it just as in the general population, are something we can start to implement.”

Dr. Duarte Garcia reported receiving grant funding from the Rheumatology Research Foundation and the Centers for Disease Control and Prevention. Dr. Bartels reported that her group’s tobacco cessation work is funded by Pfizer’s Independent Grants for Learning and Change.

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

Key clinical point: Atogepant shows a favorable safety and efficacy profile in the prophylactic treatment of episodic migraine.

Major finding: Atogepant (10 mg, 30 mg, and 60 mg) vs. placebo caused a significant reduction in mean monthly migraine (P < .00001, P < .00001, and P = .007; respectively), headache (P < .00001, P < .00001, and P = .001; respectively), and medication use (all P < .00001) days; an increase in the ≥50% responder rate (P = .0008, P = .02, and P = .04; respectively); and a nonsignificant difference in the outcomes of adverse events (P = .57, P = .64, and P = .68; respectively).

Study details: Findings are from a meta-analysis of 3 randomized controlled trials including 2,466 adult patients with episodic migraine who received atogepant (10 mg, 30 mg, or 60 mg once daily) or placebo.

Disclosures: The study was supported by the Suzhou Health Talents Training Project. None of the authors declared any conflicts of interest.

Source: Tao X et al. J Headache Pain. 2022;23:19 (Jan 29). Doi: 10.1186/s10194-022-01391-2

Key clinical point: Atogepant shows a favorable safety and efficacy profile in the prophylactic treatment of episodic migraine.

Major finding: Atogepant (10 mg, 30 mg, and 60 mg) vs. placebo caused a significant reduction in mean monthly migraine (P < .00001, P < .00001, and P = .007; respectively), headache (P < .00001, P < .00001, and P = .001; respectively), and medication use (all P < .00001) days; an increase in the ≥50% responder rate (P = .0008, P = .02, and P = .04; respectively); and a nonsignificant difference in the outcomes of adverse events (P = .57, P = .64, and P = .68; respectively).

Study details: Findings are from a meta-analysis of 3 randomized controlled trials including 2,466 adult patients with episodic migraine who received atogepant (10 mg, 30 mg, or 60 mg once daily) or placebo.

Disclosures: The study was supported by the Suzhou Health Talents Training Project. None of the authors declared any conflicts of interest.

Source: Tao X et al. J Headache Pain. 2022;23:19 (Jan 29). Doi: 10.1186/s10194-022-01391-2

Key clinical point: Atogepant shows a favorable safety and efficacy profile in the prophylactic treatment of episodic migraine.

Major finding: Atogepant (10 mg, 30 mg, and 60 mg) vs. placebo caused a significant reduction in mean monthly migraine (P < .00001, P < .00001, and P = .007; respectively), headache (P < .00001, P < .00001, and P = .001; respectively), and medication use (all P < .00001) days; an increase in the ≥50% responder rate (P = .0008, P = .02, and P = .04; respectively); and a nonsignificant difference in the outcomes of adverse events (P = .57, P = .64, and P = .68; respectively).

Study details: Findings are from a meta-analysis of 3 randomized controlled trials including 2,466 adult patients with episodic migraine who received atogepant (10 mg, 30 mg, or 60 mg once daily) or placebo.

Disclosures: The study was supported by the Suzhou Health Talents Training Project. None of the authors declared any conflicts of interest.

Source: Tao X et al. J Headache Pain. 2022;23:19 (Jan 29). Doi: 10.1186/s10194-022-01391-2

Key clinical point: Discontinuation of anticalcitonin gene-related protein (CGRP) monoclonal antibodies (mAb) leads to a progressive increase in monthly migraine days (MMD) and analgesic use from the first month, which, on reinitiation, revert to values comparable with those in the last month of treatment.

Main finding: At months 2 and 3 after discontinuation, a significant increase in MMD (P = .003 and P < .001, respectively) and analgesic use (both P < .001) was observed compared with month 12 of treatment. In the reinitiation month, the MMD (P = .40), days with ≥1 analgesic used (P = .83), and number of analgesics used (P = .74) were similar to the treatment month 12 values.

Study details: Findings are from a single-center, prospective, observational study involving 44 patients >18 years of age with treatment-resistant chronic migraine who received erenumab or galcanezumab for 12 months before a 3-month treatment discontinuation phase and 1 month of reinitiation.

Disclosures: The study received no specific funding. Some authors reported receiving personal fees or grants from various sources.

Source: Iannone LF et al. Eur J Neurol. 2022 (Jan 31). Doi: 10.1111/ene.15260

Key clinical point: Discontinuation of anticalcitonin gene-related protein (CGRP) monoclonal antibodies (mAb) leads to a progressive increase in monthly migraine days (MMD) and analgesic use from the first month, which, on reinitiation, revert to values comparable with those in the last month of treatment.

Main finding: At months 2 and 3 after discontinuation, a significant increase in MMD (P = .003 and P < .001, respectively) and analgesic use (both P < .001) was observed compared with month 12 of treatment. In the reinitiation month, the MMD (P = .40), days with ≥1 analgesic used (P = .83), and number of analgesics used (P = .74) were similar to the treatment month 12 values.

Study details: Findings are from a single-center, prospective, observational study involving 44 patients >18 years of age with treatment-resistant chronic migraine who received erenumab or galcanezumab for 12 months before a 3-month treatment discontinuation phase and 1 month of reinitiation.

Disclosures: The study received no specific funding. Some authors reported receiving personal fees or grants from various sources.

Source: Iannone LF et al. Eur J Neurol. 2022 (Jan 31). Doi: 10.1111/ene.15260

Key clinical point: Discontinuation of anticalcitonin gene-related protein (CGRP) monoclonal antibodies (mAb) leads to a progressive increase in monthly migraine days (MMD) and analgesic use from the first month, which, on reinitiation, revert to values comparable with those in the last month of treatment.

Main finding: At months 2 and 3 after discontinuation, a significant increase in MMD (P = .003 and P < .001, respectively) and analgesic use (both P < .001) was observed compared with month 12 of treatment. In the reinitiation month, the MMD (P = .40), days with ≥1 analgesic used (P = .83), and number of analgesics used (P = .74) were similar to the treatment month 12 values.

Study details: Findings are from a single-center, prospective, observational study involving 44 patients >18 years of age with treatment-resistant chronic migraine who received erenumab or galcanezumab for 12 months before a 3-month treatment discontinuation phase and 1 month of reinitiation.

Disclosures: The study received no specific funding. Some authors reported receiving personal fees or grants from various sources.

Source: Iannone LF et al. Eur J Neurol. 2022 (Jan 31). Doi: 10.1111/ene.15260

Key clinical point: The efficacy and safety of eptinezumab in preventing migraine realized in the PROMISE-1 and PROMISE-2 trials remain unperturbed by the intrinsic baseline characteristics of the study participants, including sex, age, and body mass index (BMI).

Main finding: The ≥50% migraine responder rate (MRR) was ≥10% higher with eptinezumab relative to placebo for most demographic factors, except in the case of obesity; although patients with a BMI of 30-35 kg/m² receiving eptinezumab vs. placebo showed improved ≥50% MRR, the separation was <10%. Eptinezumab was generally safe, and no new treatment-emergent adverse events were identified.

Study details: This was a post hoc subgroup analysis of adult patients with episodic or chronic migraine from the phase 3 PROMISE-1 and PROMISE-2 trials, respectively, which included a total of 1,960 patients in the safety analysis and 1,737 patients (99.8%) in the efficacy analysis.

Disclosures: The study received financial support from H. Lundbeck A/S. The authors disclosed having no conflicts of interest.

Source: Martin V et al. Clin Ther. 2022 (Feb 9). Doi: 10.1016/j.clinthera.2022.01.006

Key clinical point: The efficacy and safety of eptinezumab in preventing migraine realized in the PROMISE-1 and PROMISE-2 trials remain unperturbed by the intrinsic baseline characteristics of the study participants, including sex, age, and body mass index (BMI).

Main finding: The ≥50% migraine responder rate (MRR) was ≥10% higher with eptinezumab relative to placebo for most demographic factors, except in the case of obesity; although patients with a BMI of 30-35 kg/m² receiving eptinezumab vs. placebo showed improved ≥50% MRR, the separation was <10%. Eptinezumab was generally safe, and no new treatment-emergent adverse events were identified.

Study details: This was a post hoc subgroup analysis of adult patients with episodic or chronic migraine from the phase 3 PROMISE-1 and PROMISE-2 trials, respectively, which included a total of 1,960 patients in the safety analysis and 1,737 patients (99.8%) in the efficacy analysis.

Disclosures: The study received financial support from H. Lundbeck A/S. The authors disclosed having no conflicts of interest.

Source: Martin V et al. Clin Ther. 2022 (Feb 9). Doi: 10.1016/j.clinthera.2022.01.006

Key clinical point: The efficacy and safety of eptinezumab in preventing migraine realized in the PROMISE-1 and PROMISE-2 trials remain unperturbed by the intrinsic baseline characteristics of the study participants, including sex, age, and body mass index (BMI).

Main finding: The ≥50% migraine responder rate (MRR) was ≥10% higher with eptinezumab relative to placebo for most demographic factors, except in the case of obesity; although patients with a BMI of 30-35 kg/m² receiving eptinezumab vs. placebo showed improved ≥50% MRR, the separation was <10%. Eptinezumab was generally safe, and no new treatment-emergent adverse events were identified.

Study details: This was a post hoc subgroup analysis of adult patients with episodic or chronic migraine from the phase 3 PROMISE-1 and PROMISE-2 trials, respectively, which included a total of 1,960 patients in the safety analysis and 1,737 patients (99.8%) in the efficacy analysis.

Disclosures: The study received financial support from H. Lundbeck A/S. The authors disclosed having no conflicts of interest.

Source: Martin V et al. Clin Ther. 2022 (Feb 9). Doi: 10.1016/j.clinthera.2022.01.006

Key clinical point: Patients with migraine present with a 20% higher risk of developing neovascular age-related macular degeneration (AMD) compared with individuals without migraine.

Main finding: A significantly higher proportion of patients with neovascular AMD vs. control individuals had migraine before the index date (6.1% vs. 4.9%; P < .001), with an adjusted (for age, sex, monthly income, geographic location, urbanization, hyperlipidemia, diabetes, coronary heart disease, hypertension, and cataract surgery) odds ratio of 1.201 (P < .001).

Study details: This nationwide, population-based study included 20,333 patients aged 40 years or older diagnosed with neovascular AMD in at least 2 claims, with the first diagnosis date defined as the index date. They were propensity score-matched (1:4) with 81,332 nonneovascular AMD control individuals.

Disclosures: No source of funding was declared. None of the authors identified any conflicts of interest.

Source: Kuang TM et al. Sci Rep. 2022;12:1792 (Feb 2). Doi: 10.1038/s41598-022-05638-5

Key clinical point: Patients with migraine present with a 20% higher risk of developing neovascular age-related macular degeneration (AMD) compared with individuals without migraine.

Main finding: A significantly higher proportion of patients with neovascular AMD vs. control individuals had migraine before the index date (6.1% vs. 4.9%; P < .001), with an adjusted (for age, sex, monthly income, geographic location, urbanization, hyperlipidemia, diabetes, coronary heart disease, hypertension, and cataract surgery) odds ratio of 1.201 (P < .001).

Study details: This nationwide, population-based study included 20,333 patients aged 40 years or older diagnosed with neovascular AMD in at least 2 claims, with the first diagnosis date defined as the index date. They were propensity score-matched (1:4) with 81,332 nonneovascular AMD control individuals.

Disclosures: No source of funding was declared. None of the authors identified any conflicts of interest.

Source: Kuang TM et al. Sci Rep. 2022;12:1792 (Feb 2). Doi: 10.1038/s41598-022-05638-5

Key clinical point: Patients with migraine present with a 20% higher risk of developing neovascular age-related macular degeneration (AMD) compared with individuals without migraine.

Main finding: A significantly higher proportion of patients with neovascular AMD vs. control individuals had migraine before the index date (6.1% vs. 4.9%; P < .001), with an adjusted (for age, sex, monthly income, geographic location, urbanization, hyperlipidemia, diabetes, coronary heart disease, hypertension, and cataract surgery) odds ratio of 1.201 (P < .001).

Study details: This nationwide, population-based study included 20,333 patients aged 40 years or older diagnosed with neovascular AMD in at least 2 claims, with the first diagnosis date defined as the index date. They were propensity score-matched (1:4) with 81,332 nonneovascular AMD control individuals.

Disclosures: No source of funding was declared. None of the authors identified any conflicts of interest.

Source: Kuang TM et al. Sci Rep. 2022;12:1792 (Feb 2). Doi: 10.1038/s41598-022-05638-5