Key clinical point: Addition of veliparib vs placebo to carboplatin + paclitaxel did not significantly improve the overall survival (OS) outcomes in patients with BRCA1/2-mutated human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: A combination of veliparib and carboplatin + paclitaxel vs placebo + carboplatin + paclitaxel led to numerical but nonsignificant improvements in median OS (32.4 vs 28.2 months; hazard ratio 0.916; P = .434). The addition of veliparib was generally well-tolerated, consistent with previous findings.

Study details: Findings are from the phase 3 BROCADE3 trial which included 509 patients with BRCA1/2-mutated HER2− advanced BC who had received at least two prior lines of chemotherapy and were randomly assigned to receive carboplatin + paclitaxel with either veliparib or placebo.

Disclosures: This study was funded by AbbVie. No other disclosures were reported in this study.

Source: Diéras V, Han HS, Wildiers H, et al. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): Final overall survival results from a randomized phase 3 trial. Eur J Cancer. 2024;200:113580. doi: 10.1016/j.ejca.2024.113580 Source

Key clinical point: Addition of veliparib vs placebo to carboplatin + paclitaxel did not significantly improve the overall survival (OS) outcomes in patients with BRCA1/2-mutated human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: A combination of veliparib and carboplatin + paclitaxel vs placebo + carboplatin + paclitaxel led to numerical but nonsignificant improvements in median OS (32.4 vs 28.2 months; hazard ratio 0.916; P = .434). The addition of veliparib was generally well-tolerated, consistent with previous findings.

Study details: Findings are from the phase 3 BROCADE3 trial which included 509 patients with BRCA1/2-mutated HER2− advanced BC who had received at least two prior lines of chemotherapy and were randomly assigned to receive carboplatin + paclitaxel with either veliparib or placebo.

Disclosures: This study was funded by AbbVie. No other disclosures were reported in this study.

Source: Diéras V, Han HS, Wildiers H, et al. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): Final overall survival results from a randomized phase 3 trial. Eur J Cancer. 2024;200:113580. doi: 10.1016/j.ejca.2024.113580 Source

Key clinical point: Addition of veliparib vs placebo to carboplatin + paclitaxel did not significantly improve the overall survival (OS) outcomes in patients with BRCA1/2-mutated human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: A combination of veliparib and carboplatin + paclitaxel vs placebo + carboplatin + paclitaxel led to numerical but nonsignificant improvements in median OS (32.4 vs 28.2 months; hazard ratio 0.916; P = .434). The addition of veliparib was generally well-tolerated, consistent with previous findings.

Study details: Findings are from the phase 3 BROCADE3 trial which included 509 patients with BRCA1/2-mutated HER2− advanced BC who had received at least two prior lines of chemotherapy and were randomly assigned to receive carboplatin + paclitaxel with either veliparib or placebo.

Disclosures: This study was funded by AbbVie. No other disclosures were reported in this study.

Source: Diéras V, Han HS, Wildiers H, et al. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): Final overall survival results from a randomized phase 3 trial. Eur J Cancer. 2024;200:113580. doi: 10.1016/j.ejca.2024.113580 Source

Key clinical point: Treatment with toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel significantly improved progression-free survival (PFS) and showed an acceptable safety profile in patients with programmed death ligand-1 (PD-L1)-positive metastatic or recurrent triple-negative breast cancer (TNBC).

Major finding: Toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel led to a significantly longer PFS (median 8.4 vs 5.6 months) in patients with PD-L1-positive TNBC (hazard ratio 0.65; P = .0102) and similar incidences of grade ≥3 treatment-emergent adverse events (56.4% vs 54.3%) and fatal adverse events (0.6% vs 3.4%).

Study details: Findings are from the phase 3 TORCHLIGHT trial which included 531 patients with metastatic or recurrent locally advanced TNBC who were previously untreated or treated with up to one systemic chemotherapy and were randomly assigned to receive toripalimab + nab-paclitaxel or placebo + nab-paclitaxel. Of these, 300 patients had PD-L1-positive TNBC.

Disclosures: This study was sponsored by Shanghai Junshi Biosciences and supported by other sources. Five authors declared being employees of Shanghai Junshi Biosciences or TopAlliance Biosciences. The other authors declared no competing interests.

Source: Jiang Z, Ouyang Q, Sun T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: A randomized phase 3 trial. Nat Med. 2024;30:249-256. doi: 10.1038/s41591-023-02677-x Source

Key clinical point: Treatment with toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel significantly improved progression-free survival (PFS) and showed an acceptable safety profile in patients with programmed death ligand-1 (PD-L1)-positive metastatic or recurrent triple-negative breast cancer (TNBC).

Major finding: Toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel led to a significantly longer PFS (median 8.4 vs 5.6 months) in patients with PD-L1-positive TNBC (hazard ratio 0.65; P = .0102) and similar incidences of grade ≥3 treatment-emergent adverse events (56.4% vs 54.3%) and fatal adverse events (0.6% vs 3.4%).

Study details: Findings are from the phase 3 TORCHLIGHT trial which included 531 patients with metastatic or recurrent locally advanced TNBC who were previously untreated or treated with up to one systemic chemotherapy and were randomly assigned to receive toripalimab + nab-paclitaxel or placebo + nab-paclitaxel. Of these, 300 patients had PD-L1-positive TNBC.

Disclosures: This study was sponsored by Shanghai Junshi Biosciences and supported by other sources. Five authors declared being employees of Shanghai Junshi Biosciences or TopAlliance Biosciences. The other authors declared no competing interests.

Source: Jiang Z, Ouyang Q, Sun T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: A randomized phase 3 trial. Nat Med. 2024;30:249-256. doi: 10.1038/s41591-023-02677-x Source

Key clinical point: Treatment with toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel significantly improved progression-free survival (PFS) and showed an acceptable safety profile in patients with programmed death ligand-1 (PD-L1)-positive metastatic or recurrent triple-negative breast cancer (TNBC).

Major finding: Toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel led to a significantly longer PFS (median 8.4 vs 5.6 months) in patients with PD-L1-positive TNBC (hazard ratio 0.65; P = .0102) and similar incidences of grade ≥3 treatment-emergent adverse events (56.4% vs 54.3%) and fatal adverse events (0.6% vs 3.4%).

Study details: Findings are from the phase 3 TORCHLIGHT trial which included 531 patients with metastatic or recurrent locally advanced TNBC who were previously untreated or treated with up to one systemic chemotherapy and were randomly assigned to receive toripalimab + nab-paclitaxel or placebo + nab-paclitaxel. Of these, 300 patients had PD-L1-positive TNBC.

Disclosures: This study was sponsored by Shanghai Junshi Biosciences and supported by other sources. Five authors declared being employees of Shanghai Junshi Biosciences or TopAlliance Biosciences. The other authors declared no competing interests.

Source: Jiang Z, Ouyang Q, Sun T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: A randomized phase 3 trial. Nat Med. 2024;30:249-256. doi: 10.1038/s41591-023-02677-x Source

Key clinical point: In patients with platinum-pretreated advanced triple-negative breast cancer (TNBC), a chemotherapy-free maintenance regimen containing olaparib with or without durvalumab vs continued platinum-based chemotherapy led to a greater improvement in progression-free survival (PFS) with no new safety signals.

Major finding: The median PFS was 4.0 months with olaparib and 6.1 months with olaparib + durvalumab, with both treatments providing greater PFS benefit than the historical control of continued platinum-based therapy (P = .0023 and P < .0001, respectively). No treatment-related deaths or new safety signals were reported.

Study details: Findings are from the phase 2 DORA trial which included 45 patients with advanced TNBC who had stable disease or complete or partial response after receiving platinum-based chemotherapy and were randomly assigned to receive olaparib or olaparib + durvalumab.

Disclosures: This study was supported by AstraZeneca Pharmaceuticals LP. Some authors declared receiving honoraria, research funding, or fees; owning stocks; or having other ties with AstraZeneca and various other sources.

Source: Tan TJ, Sammons S, Im YH, et al. Phase II DORA study of olaparib with or without durvalumab as a chemotherapy-free maintenance strategy in platinum-pretreated advanced triple-negative breast cancer. Clin Cancer Res. 2024 (Jan 18). doi: 10.1158/1078-0432.CCR-23-2513 Source

Key clinical point: In patients with platinum-pretreated advanced triple-negative breast cancer (TNBC), a chemotherapy-free maintenance regimen containing olaparib with or without durvalumab vs continued platinum-based chemotherapy led to a greater improvement in progression-free survival (PFS) with no new safety signals.

Major finding: The median PFS was 4.0 months with olaparib and 6.1 months with olaparib + durvalumab, with both treatments providing greater PFS benefit than the historical control of continued platinum-based therapy (P = .0023 and P < .0001, respectively). No treatment-related deaths or new safety signals were reported.

Study details: Findings are from the phase 2 DORA trial which included 45 patients with advanced TNBC who had stable disease or complete or partial response after receiving platinum-based chemotherapy and were randomly assigned to receive olaparib or olaparib + durvalumab.

Disclosures: This study was supported by AstraZeneca Pharmaceuticals LP. Some authors declared receiving honoraria, research funding, or fees; owning stocks; or having other ties with AstraZeneca and various other sources.

Source: Tan TJ, Sammons S, Im YH, et al. Phase II DORA study of olaparib with or without durvalumab as a chemotherapy-free maintenance strategy in platinum-pretreated advanced triple-negative breast cancer. Clin Cancer Res. 2024 (Jan 18). doi: 10.1158/1078-0432.CCR-23-2513 Source

Key clinical point: In patients with platinum-pretreated advanced triple-negative breast cancer (TNBC), a chemotherapy-free maintenance regimen containing olaparib with or without durvalumab vs continued platinum-based chemotherapy led to a greater improvement in progression-free survival (PFS) with no new safety signals.

Major finding: The median PFS was 4.0 months with olaparib and 6.1 months with olaparib + durvalumab, with both treatments providing greater PFS benefit than the historical control of continued platinum-based therapy (P = .0023 and P < .0001, respectively). No treatment-related deaths or new safety signals were reported.

Study details: Findings are from the phase 2 DORA trial which included 45 patients with advanced TNBC who had stable disease or complete or partial response after receiving platinum-based chemotherapy and were randomly assigned to receive olaparib or olaparib + durvalumab.

Disclosures: This study was supported by AstraZeneca Pharmaceuticals LP. Some authors declared receiving honoraria, research funding, or fees; owning stocks; or having other ties with AstraZeneca and various other sources.

Source: Tan TJ, Sammons S, Im YH, et al. Phase II DORA study of olaparib with or without durvalumab as a chemotherapy-free maintenance strategy in platinum-pretreated advanced triple-negative breast cancer. Clin Cancer Res. 2024 (Jan 18). doi: 10.1158/1078-0432.CCR-23-2513 Source

Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC).

Major finding: Both fulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks (−79.1% and −83.5% vs −80.6%, respectively; P ≥ .15).

Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.

Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.

Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038  Source

Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC).

Major finding: Both fulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks (−79.1% and −83.5% vs −80.6%, respectively; P ≥ .15).

Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.

Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.

Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038  Source

Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC).

Major finding: Both fulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks (−79.1% and −83.5% vs −80.6%, respectively; P ≥ .15).

Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.

Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.

Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038  Source

Key clinical point: High initial fat body mass was associated with a risk for vertebral fracture (VF) progression in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (BC) who received aromatase inhibitors (AI) plus denosumab.

Major finding: After 18 months of adjuvant therapy with AI and denosumab, 4.4% of patients had VF progression, with percentage of fat body mass (odds ratio [OR] 5.41; P = .01) and Fracture Risk Assessment Tool score (OR 3.95; P = .04) being independently associated with VF progression risk.

Study details: Findings are from a prospective cohort study including 237 postmenopausal women with HR+ early BC who received adjuvant therapy with AI and denosumab.

Disclosures: This study did not declare any specific funding. Three authors declared receiving personal fees or grants or having other ties with various sources.

Source: Cosentini D, Pedersini R, Mauro PD, et al. Fat body mass and vertebral fracture progression in women with breast cancer. JAMA Netw Open. 2024;7:e2350950. doi:10.1001/jamanetworkopen.2023.50950 Source

Key clinical point: High initial fat body mass was associated with a risk for vertebral fracture (VF) progression in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (BC) who received aromatase inhibitors (AI) plus denosumab.

Major finding: After 18 months of adjuvant therapy with AI and denosumab, 4.4% of patients had VF progression, with percentage of fat body mass (odds ratio [OR] 5.41; P = .01) and Fracture Risk Assessment Tool score (OR 3.95; P = .04) being independently associated with VF progression risk.

Study details: Findings are from a prospective cohort study including 237 postmenopausal women with HR+ early BC who received adjuvant therapy with AI and denosumab.

Disclosures: This study did not declare any specific funding. Three authors declared receiving personal fees or grants or having other ties with various sources.

Source: Cosentini D, Pedersini R, Mauro PD, et al. Fat body mass and vertebral fracture progression in women with breast cancer. JAMA Netw Open. 2024;7:e2350950. doi:10.1001/jamanetworkopen.2023.50950 Source

Key clinical point: High initial fat body mass was associated with a risk for vertebral fracture (VF) progression in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (BC) who received aromatase inhibitors (AI) plus denosumab.

Major finding: After 18 months of adjuvant therapy with AI and denosumab, 4.4% of patients had VF progression, with percentage of fat body mass (odds ratio [OR] 5.41; P = .01) and Fracture Risk Assessment Tool score (OR 3.95; P = .04) being independently associated with VF progression risk.

Study details: Findings are from a prospective cohort study including 237 postmenopausal women with HR+ early BC who received adjuvant therapy with AI and denosumab.

Disclosures: This study did not declare any specific funding. Three authors declared receiving personal fees or grants or having other ties with various sources.

Source: Cosentini D, Pedersini R, Mauro PD, et al. Fat body mass and vertebral fracture progression in women with breast cancer. JAMA Netw Open. 2024;7:e2350950. doi:10.1001/jamanetworkopen.2023.50950 Source

Complications during pregnancy may be a wake-up call pointing to a higher risk for cardiovascular (CVD) and other diseases later in life. Therefore, the postpartum and interpregnancy periods are opportune windows for reducing CVD susceptibility and providing preventive care, especially for mothers with a history of adverse pregnancy outcomes (APOs). To that end, the American Heart Association recently released a scientific statement in Circulation outlining pregnancy-related CVD risks and reviewing evidence for preventive lifestyle strategies based on the AHA’s Life’s Essential 8 recommendations.

The Life’s Essential 8 encompass healthy eating, sleeping, and activity patterns; controlling weight, blood pressure, cholesterol, and blood sugar; and avoiding tobacco use.

“The motivation behind this statement was that complications in pregnancy are becoming more common and we now have more understanding that these serve as important risk factors for heart disease later in life,” said Jennifer Lewey, MD, MPH, director of the Penn Women’s Cardiovascular Health Program and an assistant professor of medicine at the University of Pennsylvania Perelman School of Medicine in Philadelphia.

Perelman School of Medicine

“These risk factors are underrecognized and underappreciated. Clinicians don’t feel comfortable counseling their patients about how to reduce their cardiovascular disease risk,” Dr. Lewey, chair of the AHA writing group, said in an interview.

“So we thought this was the perfect time to highlight what we know and don’t know about how to care for this population,” she said.

APOs predispose mothers to heart disease and other long-term complications, including heart failure, stroke, chronic kidney disease, and vascular dementia. “Pregnancy is a significant stress on the body, and APOs such as preeclampsia can lead to vascular changes in the blood vessels and structural changes to the heart that can persist long term,” Dr. Lewey explained. Reduced maternal physical activity and unshed weight can compound the problem.

Varying by race and ethnicity, the proportion of mothers experiencing pregnancy complications, such as high blood pressure, gestational diabetes, and/or preterm birth is estimated at 10%-20%, the statement authors noted. These complications may serve as a wake-up call to young mothers.

The AHA panel believes that identifying at-risk women at younger ages will enable prevention through lifestyle changes and timely treatment. Little is known, however about what specific care may best reduce long-term CVD risk in women who had pregnancy complications, Dr. Lewey said. While randomized clinical trials have yet to evaluate the effects of postpartum interventions on CVD outcomes, the need for strategies supported by rigorous evidence is clear. “In particular, the fourth trimester, defined as the 12 weeks after delivery, is an optimal time to engage postpartum individuals in care to reduce maternal morbidity and improve care transitions,” the AHA group wrote.

An earlier AHA statement in 2021 recommended frequent cardiac risk factor screening in the first year postpartum at 6 and 12 weeks and again at 6 and 12 months, with appropriate transition from postpartum to longitudinal primary care around the 8- to 12-week mark.

Among the current statement’s findings: High blood pressure is the most prevalent cardiovascular condition during pregnancy, and the last two decades have seen a 25% increase in preeclampsia.

Hypertension during pregnancy carries a two- to fourfold higher risk of chronic hypertension within 2-7 years.

Women with one or more APOs experience heart attack and stroke at younger ages. Commenting on the statement but not involved in it, internist Natalie A. Cameron, MD, a primary and preventive care physician at Northwestern Medicine in Chicago, said, “This statement will be very helpful for physicians from a primary care perspective, especially since in internal medicine we don’t standardly receive education in cardiovascular health in the context of pregnancy and the first year postpartum.”

Northwestern Medicine

Complications during pregnancy may be a wake-up call pointing to a higher risk for cardiovascular (CVD) and other diseases later in life. Therefore, the postpartum and interpregnancy periods are opportune windows for reducing CVD susceptibility and providing preventive care, especially for mothers with a history of adverse pregnancy outcomes (APOs). To that end, the American Heart Association recently released a scientific statement in Circulation outlining pregnancy-related CVD risks and reviewing evidence for preventive lifestyle strategies based on the AHA’s Life’s Essential 8 recommendations.

The Life’s Essential 8 encompass healthy eating, sleeping, and activity patterns; controlling weight, blood pressure, cholesterol, and blood sugar; and avoiding tobacco use.

“The motivation behind this statement was that complications in pregnancy are becoming more common and we now have more understanding that these serve as important risk factors for heart disease later in life,” said Jennifer Lewey, MD, MPH, director of the Penn Women’s Cardiovascular Health Program and an assistant professor of medicine at the University of Pennsylvania Perelman School of Medicine in Philadelphia.

Perelman School of Medicine

“These risk factors are underrecognized and underappreciated. Clinicians don’t feel comfortable counseling their patients about how to reduce their cardiovascular disease risk,” Dr. Lewey, chair of the AHA writing group, said in an interview.

“So we thought this was the perfect time to highlight what we know and don’t know about how to care for this population,” she said.

APOs predispose mothers to heart disease and other long-term complications, including heart failure, stroke, chronic kidney disease, and vascular dementia. “Pregnancy is a significant stress on the body, and APOs such as preeclampsia can lead to vascular changes in the blood vessels and structural changes to the heart that can persist long term,” Dr. Lewey explained. Reduced maternal physical activity and unshed weight can compound the problem.

Varying by race and ethnicity, the proportion of mothers experiencing pregnancy complications, such as high blood pressure, gestational diabetes, and/or preterm birth is estimated at 10%-20%, the statement authors noted. These complications may serve as a wake-up call to young mothers.

The AHA panel believes that identifying at-risk women at younger ages will enable prevention through lifestyle changes and timely treatment. Little is known, however about what specific care may best reduce long-term CVD risk in women who had pregnancy complications, Dr. Lewey said. While randomized clinical trials have yet to evaluate the effects of postpartum interventions on CVD outcomes, the need for strategies supported by rigorous evidence is clear. “In particular, the fourth trimester, defined as the 12 weeks after delivery, is an optimal time to engage postpartum individuals in care to reduce maternal morbidity and improve care transitions,” the AHA group wrote.

An earlier AHA statement in 2021 recommended frequent cardiac risk factor screening in the first year postpartum at 6 and 12 weeks and again at 6 and 12 months, with appropriate transition from postpartum to longitudinal primary care around the 8- to 12-week mark.

Among the current statement’s findings: High blood pressure is the most prevalent cardiovascular condition during pregnancy, and the last two decades have seen a 25% increase in preeclampsia.

Hypertension during pregnancy carries a two- to fourfold higher risk of chronic hypertension within 2-7 years.

Women with one or more APOs experience heart attack and stroke at younger ages. Commenting on the statement but not involved in it, internist Natalie A. Cameron, MD, a primary and preventive care physician at Northwestern Medicine in Chicago, said, “This statement will be very helpful for physicians from a primary care perspective, especially since in internal medicine we don’t standardly receive education in cardiovascular health in the context of pregnancy and the first year postpartum.”

Northwestern Medicine

Complications during pregnancy may be a wake-up call pointing to a higher risk for cardiovascular (CVD) and other diseases later in life. Therefore, the postpartum and interpregnancy periods are opportune windows for reducing CVD susceptibility and providing preventive care, especially for mothers with a history of adverse pregnancy outcomes (APOs). To that end, the American Heart Association recently released a scientific statement in Circulation outlining pregnancy-related CVD risks and reviewing evidence for preventive lifestyle strategies based on the AHA’s Life’s Essential 8 recommendations.

The Life’s Essential 8 encompass healthy eating, sleeping, and activity patterns; controlling weight, blood pressure, cholesterol, and blood sugar; and avoiding tobacco use.

“The motivation behind this statement was that complications in pregnancy are becoming more common and we now have more understanding that these serve as important risk factors for heart disease later in life,” said Jennifer Lewey, MD, MPH, director of the Penn Women’s Cardiovascular Health Program and an assistant professor of medicine at the University of Pennsylvania Perelman School of Medicine in Philadelphia.

Perelman School of Medicine

“These risk factors are underrecognized and underappreciated. Clinicians don’t feel comfortable counseling their patients about how to reduce their cardiovascular disease risk,” Dr. Lewey, chair of the AHA writing group, said in an interview.

“So we thought this was the perfect time to highlight what we know and don’t know about how to care for this population,” she said.

APOs predispose mothers to heart disease and other long-term complications, including heart failure, stroke, chronic kidney disease, and vascular dementia. “Pregnancy is a significant stress on the body, and APOs such as preeclampsia can lead to vascular changes in the blood vessels and structural changes to the heart that can persist long term,” Dr. Lewey explained. Reduced maternal physical activity and unshed weight can compound the problem.

Varying by race and ethnicity, the proportion of mothers experiencing pregnancy complications, such as high blood pressure, gestational diabetes, and/or preterm birth is estimated at 10%-20%, the statement authors noted. These complications may serve as a wake-up call to young mothers.

The AHA panel believes that identifying at-risk women at younger ages will enable prevention through lifestyle changes and timely treatment. Little is known, however about what specific care may best reduce long-term CVD risk in women who had pregnancy complications, Dr. Lewey said. While randomized clinical trials have yet to evaluate the effects of postpartum interventions on CVD outcomes, the need for strategies supported by rigorous evidence is clear. “In particular, the fourth trimester, defined as the 12 weeks after delivery, is an optimal time to engage postpartum individuals in care to reduce maternal morbidity and improve care transitions,” the AHA group wrote.

An earlier AHA statement in 2021 recommended frequent cardiac risk factor screening in the first year postpartum at 6 and 12 weeks and again at 6 and 12 months, with appropriate transition from postpartum to longitudinal primary care around the 8- to 12-week mark.

Among the current statement’s findings: High blood pressure is the most prevalent cardiovascular condition during pregnancy, and the last two decades have seen a 25% increase in preeclampsia.

Hypertension during pregnancy carries a two- to fourfold higher risk of chronic hypertension within 2-7 years.

Women with one or more APOs experience heart attack and stroke at younger ages. Commenting on the statement but not involved in it, internist Natalie A. Cameron, MD, a primary and preventive care physician at Northwestern Medicine in Chicago, said, “This statement will be very helpful for physicians from a primary care perspective, especially since in internal medicine we don’t standardly receive education in cardiovascular health in the context of pregnancy and the first year postpartum.”

Northwestern Medicine

TOPLINE: 

In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.

METHODOLOGY:

• Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
• To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
• The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
• A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.

TAKEAWAY:

• Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
• During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
• During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
• Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).

IN PRACTICE:

Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”

SOURCE:

This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.

LIMITATIONS:

Misclassification of a late recurrence or metachronous CRC could have affected the findings.

DISCLOSURES:

This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.

METHODOLOGY:

• Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
• To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
• The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
• A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.

TAKEAWAY:

• Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
• During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
• During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
• Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).

IN PRACTICE:

Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”

SOURCE:

This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.

LIMITATIONS:

Misclassification of a late recurrence or metachronous CRC could have affected the findings.

DISCLOSURES:

This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.

METHODOLOGY:

• Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
• To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
• The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
• A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.

TAKEAWAY:

• Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
• During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
• During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
• Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).

IN PRACTICE:

Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”

SOURCE:

This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.

LIMITATIONS:

Misclassification of a late recurrence or metachronous CRC could have affected the findings.

DISCLOSURES:

This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.

A version of this article appeared on Medscape.com.

TOPLINE:

A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.

Yet, low WMT utilization hindered population-level benefit.

METHODOLOGY:

This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.

TAKEAWAY:

• From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
• Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
• Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
• In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.

IN PRACTICE:

“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”

“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”

SOURCE:

This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .

LIMITATIONS:

Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.

A version of this article appeared on Medscape.com.

TOPLINE:

A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.

Yet, low WMT utilization hindered population-level benefit.

METHODOLOGY:

This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.

TAKEAWAY:

• From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
• Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
• Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
• In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.

IN PRACTICE:

“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”

“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”

SOURCE:

This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .

LIMITATIONS:

Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.

A version of this article appeared on Medscape.com.

TOPLINE:

A cohort study of primary care patients with obesity found significant associations between weight management treatments (WMTs) and ≥ 5% weight loss for individuals.

Yet, low WMT utilization hindered population-level benefit.

METHODOLOGY:

This retrospective, population-based cross-sectional cohort study included 149,959 primary care patients from a Michigan academic health system between October 2015 and March 2020.

TAKEAWAY:

• From 2017 to 2019, the average unadjusted body mass index (BMI) increased from 29.34 kg/m2 to 29.61 kg/m2 and the prevalence of obesity from 39.2% to 40.7%.
• Among 31,284 patients with obesity in 2017, 25.9% (6665) achieved ≥ 5% weight loss at 2 years.
• Among 37,245 with obesity in either 2017 or 2019 and sufficient follow-up, 1-year WMT utilization increased from 5.3% in 2017 to 7.1% in 2019 (difference, 1.7%; 95% CI, 1.3%-2.2%), including nutritional counseling (6.3%), weight loss medication prescriptions (2.6%), and bariatric surgery (1.0%).
• In two groups of n = 5090 with and without WMT exposure who were propensity score–matched on covariates including BMI, sex, and age, the probabilities of ≥ 5% weight loss at 1 year were 15.6% without WMTs, 23.1% for nutrition counseling, 54.6% for meal replacement, 27.8% for weight loss medication, and 93% for bariatric surgery, with all approaches significant compared to no WMTs.

IN PRACTICE:

“Health systems and insurers should consider novel strategies to enhance preference-sensitive use of WMT to optimize achievement of 5% or greater weight loss among individuals and populations with obesity.”

“While we included glucagon-like peptide 1 receptor agonists for type 2 diabetes, including semaglutide 1.0 mg, in our analyses, the study period predated the [US Food and Drug Administration]-approval of semaglutide 2.4 mg for weight management. Future work should explore the potential for semaglutide 2.4 mg and other medications with substantial weight loss effectiveness to reduce weight at the population level.”

SOURCE:

This study was conducted by James Henderson, PhD, of the Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, and colleagues and was published online in JAMA Network Open .

LIMITATIONS:

Single health system. Electronic health record data may be subject to weight and WMT measurement error, lack of adherence data, and any information about outside WMT access. Retrospective, observational study, subject to bias. Study period occurred before FDA approval of semaglutide for weight management, and thus, the findings may understate current use and effectiveness of weight loss medications.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases, Michigan Center for Diabetes Translational Research, Michigan Nutrition Obesity Research Center, and the Elizabeth Weiser Caswell Diabetes Institute at the University of Michigan. Dr. Henderson had no further disclosures, but some of the coauthors had industry ties.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher body mass index (BMI) at the start of pregnancy is associated with increased risk for adverse maternal outcomes, including preeclampsia, and neonatal complications, such as respiratory distress syndrome (RDS), in a dose-dependent manner, new research shows.

METHODOLOGY:

• Researchers conducted a retrospective study of 58,497 singleton pregnancies delivered at an urban hospital between 2013 and 2021.
• They focused on pregnancies delivered between 24 and 42 weeks of gestation, for which information about BMI at the first prenatal visit was available.
• 21.1% of mothers had class I , 9.3% had class II obesity, and 6% had class III obesity.

TAKEAWAY: 

• Obesity was associated with a dose-dependent increase in cesarean deliveries (27% of deliveries without obesity vs 46% of deliveries with class III obesity).
• Severe preeclampsia occurred in 8% of mothers without obesity and in 19% of mothers with class III obesity.
• Infants born to mothers with class III obesity were more likely than were infants born to mothers without obesity to have RDS, with a relative risk (RR) of 2.66.
• With class II obesity, the RR was 1.77. With class I obesity, the RR was 1.3.
• Obesity also was associated with increased risk for grade III-IV  (RR), 4.58 for class III obesity) and  (RR, 3.76).

IN PRACTICE:

“Infants born to patients with higher classes of obesity have significant associated morbidity including a 2 to 4 times increased risk of neonatal acidosis, grades III-IV intraventricular hemorrhage, sepsis, and RDS,” the researchers reported. 

SOURCE:

Sara I. Jones, MD, with University of Texas Southwestern Medical Center in Dallas, presented the study on February 14 at the 2024 Pregnancy Meeting of the Society for Maternal-Fetal Medicine, in National Harbor, Maryland. 

DISCLOSURES:

The researchers had no conflicts of interest to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher body mass index (BMI) at the start of pregnancy is associated with increased risk for adverse maternal outcomes, including preeclampsia, and neonatal complications, such as respiratory distress syndrome (RDS), in a dose-dependent manner, new research shows.

METHODOLOGY:

• Researchers conducted a retrospective study of 58,497 singleton pregnancies delivered at an urban hospital between 2013 and 2021.
• They focused on pregnancies delivered between 24 and 42 weeks of gestation, for which information about BMI at the first prenatal visit was available.
• 21.1% of mothers had class I , 9.3% had class II obesity, and 6% had class III obesity.

TAKEAWAY: 

• Obesity was associated with a dose-dependent increase in cesarean deliveries (27% of deliveries without obesity vs 46% of deliveries with class III obesity).
• Severe preeclampsia occurred in 8% of mothers without obesity and in 19% of mothers with class III obesity.
• Infants born to mothers with class III obesity were more likely than were infants born to mothers without obesity to have RDS, with a relative risk (RR) of 2.66.
• With class II obesity, the RR was 1.77. With class I obesity, the RR was 1.3.
• Obesity also was associated with increased risk for grade III-IV  (RR), 4.58 for class III obesity) and  (RR, 3.76).

IN PRACTICE:

“Infants born to patients with higher classes of obesity have significant associated morbidity including a 2 to 4 times increased risk of neonatal acidosis, grades III-IV intraventricular hemorrhage, sepsis, and RDS,” the researchers reported. 

SOURCE:

Sara I. Jones, MD, with University of Texas Southwestern Medical Center in Dallas, presented the study on February 14 at the 2024 Pregnancy Meeting of the Society for Maternal-Fetal Medicine, in National Harbor, Maryland. 

DISCLOSURES:

The researchers had no conflicts of interest to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Higher body mass index (BMI) at the start of pregnancy is associated with increased risk for adverse maternal outcomes, including preeclampsia, and neonatal complications, such as respiratory distress syndrome (RDS), in a dose-dependent manner, new research shows.

METHODOLOGY:

• Researchers conducted a retrospective study of 58,497 singleton pregnancies delivered at an urban hospital between 2013 and 2021.
• They focused on pregnancies delivered between 24 and 42 weeks of gestation, for which information about BMI at the first prenatal visit was available.
• 21.1% of mothers had class I , 9.3% had class II obesity, and 6% had class III obesity.

TAKEAWAY: 

• Obesity was associated with a dose-dependent increase in cesarean deliveries (27% of deliveries without obesity vs 46% of deliveries with class III obesity).
• Severe preeclampsia occurred in 8% of mothers without obesity and in 19% of mothers with class III obesity.
• Infants born to mothers with class III obesity were more likely than were infants born to mothers without obesity to have RDS, with a relative risk (RR) of 2.66.
• With class II obesity, the RR was 1.77. With class I obesity, the RR was 1.3.
• Obesity also was associated with increased risk for grade III-IV  (RR), 4.58 for class III obesity) and  (RR, 3.76).

IN PRACTICE:

“Infants born to patients with higher classes of obesity have significant associated morbidity including a 2 to 4 times increased risk of neonatal acidosis, grades III-IV intraventricular hemorrhage, sepsis, and RDS,” the researchers reported. 

SOURCE:

Sara I. Jones, MD, with University of Texas Southwestern Medical Center in Dallas, presented the study on February 14 at the 2024 Pregnancy Meeting of the Society for Maternal-Fetal Medicine, in National Harbor, Maryland. 

DISCLOSURES:

The researchers had no conflicts of interest to disclose.

A version of this article appeared on Medscape.com.

An online program that helps parents apply principles of cognitive-behavioral therapy (CBT) using digital resources and remote support from a therapist is as effective as traditional talk therapies for overcoming child anxiety problems while substantially reducing cost and therapist time, new research showed.

In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.

“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.

“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”

The study was published online in The Lancet Psychiatry
 

Care Gaps for Common Problem

Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.

OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.

The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.

There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.

The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.

A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
 

‘Compelling’ Evidence

The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.

On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).

The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.

In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.

“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.

“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
 

‘Call to Action’

“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.

“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”

“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.

However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.

In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.

Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.

“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”

The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.

A version of this article appeared on Medscape.com.

An online program that helps parents apply principles of cognitive-behavioral therapy (CBT) using digital resources and remote support from a therapist is as effective as traditional talk therapies for overcoming child anxiety problems while substantially reducing cost and therapist time, new research showed.

In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.

“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.

“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”

The study was published online in The Lancet Psychiatry
 

Care Gaps for Common Problem

Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.

OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.

The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.

There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.

The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.

A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
 

‘Compelling’ Evidence

The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.

On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).

The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.

In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.

“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.

“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
 

‘Call to Action’

“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.

“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”

“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.

However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.

In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.

Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.

“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”

The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.

A version of this article appeared on Medscape.com.

An online program that helps parents apply principles of cognitive-behavioral therapy (CBT) using digital resources and remote support from a therapist is as effective as traditional talk therapies for overcoming child anxiety problems while substantially reducing cost and therapist time, new research showed.

In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.

“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.

“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”

The study was published online in The Lancet Psychiatry
 

Care Gaps for Common Problem

Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.

OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.

The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.

There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.

The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.

A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
 

‘Compelling’ Evidence

The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.

On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).

The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.

In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.

“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.

“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
 

‘Call to Action’

“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.

“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”

“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.

However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.

In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.

Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.

“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”

The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.

A version of this article appeared on Medscape.com.