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Circulating tumor DNA may predict poor prognosis in breast cancer
a new meta-analysis and systematic review found.
“Circulating tumor DNA (ctDNA) has been extensively studied as a prognostic biomarker in early breast cancer. However, there is a significant heterogeneity in the study results, which is probably related to the fact that each individual study included different patient populations, collected blood at different time points, and used different methods (assays) for ctDNA analysis,” said Guilherme Nader Marta, MD, of the Institut Jules Bordet, Anderlecht, Belgium, in an interview.
“The aim of our study was to summarize the available evidence that has been presented so far on this topic by performing a systematic review and meta-analysis including studies that reported the association between ctDNA detection and long-term outcomes,” said Dr. Nader Marta, who coauthored the new research, which was presented as a poster (Poster 26P) at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
Methods and results
The authors identified 57 studies including data from 5,729 individuals with early breast cancer. The 44.5% for whom stages were reported consisted of 18.3% with stage I disease, 60.0% with stage II, and 21.5% with stage III. Patients’ ctDNA collection was divided into three groups: baseline, after neoadjuvant therapy (End-of-NAT), and during follow-up care; ctDNA assays were classified as tumor-informed or non–tumor-informed.
The detection of ctDNA at any time point during diagnosis and treatment was associated with worse disease-free survival (DFS) and overall survival (OS), compared with no ctDNA. The association was stronger in tumor-informed assays, the researchers said.
For disease-free survival, the overall multivariate hazard ratios were 2.5, 5.5, and 7.2 for ctDNA detection at baseline, End-of-NAT, and follow-up, respectively.
For overall survival, the overall multivariate hazard ratios were 3.0, 12.9, and 5.6, for ctDNA detection at baseline, End-of-NAT, and follow-up, respectively.
The pooled hazard ratios were numerically higher for both DFS and OS when ctDNA was detected at either End-of-NAT or follow-up.
In addition, detection of ctDNA was associated with a high degree of specificity (from 0.7 to 1.0) for breast cancer relapse; sensitivity ranged from 0.31 to 1.0, the researchers noted. The mean lead time from ctDNA detection to breast cancer recurrence in these cases was approximately 10 months.
Results show ctDNA detection is associated with worse survival
“Our study results demonstrate that ctDNA detection is associated with worse disease-free survival and overall survival in patients with early breast cancer, particularly when measured after treatment with tumor-informed assays,” Dr. Nader Marta said in an interview.
“As next steps, we need to build on this evidence to bring the potential benefits of this powerful prognostic tool to our patients,” said Dr. Nader Marta. “Ongoing studies exploring different management strategies based on serial ctDNA assessments will help us understand the exact role of this technology in our clinical practice.”
The study received no outside funding. Dr. Nader Marta disclosed relationships with companies including Roche and Bayer.
a new meta-analysis and systematic review found.
“Circulating tumor DNA (ctDNA) has been extensively studied as a prognostic biomarker in early breast cancer. However, there is a significant heterogeneity in the study results, which is probably related to the fact that each individual study included different patient populations, collected blood at different time points, and used different methods (assays) for ctDNA analysis,” said Guilherme Nader Marta, MD, of the Institut Jules Bordet, Anderlecht, Belgium, in an interview.
“The aim of our study was to summarize the available evidence that has been presented so far on this topic by performing a systematic review and meta-analysis including studies that reported the association between ctDNA detection and long-term outcomes,” said Dr. Nader Marta, who coauthored the new research, which was presented as a poster (Poster 26P) at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
Methods and results
The authors identified 57 studies including data from 5,729 individuals with early breast cancer. The 44.5% for whom stages were reported consisted of 18.3% with stage I disease, 60.0% with stage II, and 21.5% with stage III. Patients’ ctDNA collection was divided into three groups: baseline, after neoadjuvant therapy (End-of-NAT), and during follow-up care; ctDNA assays were classified as tumor-informed or non–tumor-informed.
The detection of ctDNA at any time point during diagnosis and treatment was associated with worse disease-free survival (DFS) and overall survival (OS), compared with no ctDNA. The association was stronger in tumor-informed assays, the researchers said.
For disease-free survival, the overall multivariate hazard ratios were 2.5, 5.5, and 7.2 for ctDNA detection at baseline, End-of-NAT, and follow-up, respectively.
For overall survival, the overall multivariate hazard ratios were 3.0, 12.9, and 5.6, for ctDNA detection at baseline, End-of-NAT, and follow-up, respectively.
The pooled hazard ratios were numerically higher for both DFS and OS when ctDNA was detected at either End-of-NAT or follow-up.
In addition, detection of ctDNA was associated with a high degree of specificity (from 0.7 to 1.0) for breast cancer relapse; sensitivity ranged from 0.31 to 1.0, the researchers noted. The mean lead time from ctDNA detection to breast cancer recurrence in these cases was approximately 10 months.
Results show ctDNA detection is associated with worse survival
“Our study results demonstrate that ctDNA detection is associated with worse disease-free survival and overall survival in patients with early breast cancer, particularly when measured after treatment with tumor-informed assays,” Dr. Nader Marta said in an interview.
“As next steps, we need to build on this evidence to bring the potential benefits of this powerful prognostic tool to our patients,” said Dr. Nader Marta. “Ongoing studies exploring different management strategies based on serial ctDNA assessments will help us understand the exact role of this technology in our clinical practice.”
The study received no outside funding. Dr. Nader Marta disclosed relationships with companies including Roche and Bayer.
a new meta-analysis and systematic review found.
“Circulating tumor DNA (ctDNA) has been extensively studied as a prognostic biomarker in early breast cancer. However, there is a significant heterogeneity in the study results, which is probably related to the fact that each individual study included different patient populations, collected blood at different time points, and used different methods (assays) for ctDNA analysis,” said Guilherme Nader Marta, MD, of the Institut Jules Bordet, Anderlecht, Belgium, in an interview.
“The aim of our study was to summarize the available evidence that has been presented so far on this topic by performing a systematic review and meta-analysis including studies that reported the association between ctDNA detection and long-term outcomes,” said Dr. Nader Marta, who coauthored the new research, which was presented as a poster (Poster 26P) at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
Methods and results
The authors identified 57 studies including data from 5,729 individuals with early breast cancer. The 44.5% for whom stages were reported consisted of 18.3% with stage I disease, 60.0% with stage II, and 21.5% with stage III. Patients’ ctDNA collection was divided into three groups: baseline, after neoadjuvant therapy (End-of-NAT), and during follow-up care; ctDNA assays were classified as tumor-informed or non–tumor-informed.
The detection of ctDNA at any time point during diagnosis and treatment was associated with worse disease-free survival (DFS) and overall survival (OS), compared with no ctDNA. The association was stronger in tumor-informed assays, the researchers said.
For disease-free survival, the overall multivariate hazard ratios were 2.5, 5.5, and 7.2 for ctDNA detection at baseline, End-of-NAT, and follow-up, respectively.
For overall survival, the overall multivariate hazard ratios were 3.0, 12.9, and 5.6, for ctDNA detection at baseline, End-of-NAT, and follow-up, respectively.
The pooled hazard ratios were numerically higher for both DFS and OS when ctDNA was detected at either End-of-NAT or follow-up.
In addition, detection of ctDNA was associated with a high degree of specificity (from 0.7 to 1.0) for breast cancer relapse; sensitivity ranged from 0.31 to 1.0, the researchers noted. The mean lead time from ctDNA detection to breast cancer recurrence in these cases was approximately 10 months.
Results show ctDNA detection is associated with worse survival
“Our study results demonstrate that ctDNA detection is associated with worse disease-free survival and overall survival in patients with early breast cancer, particularly when measured after treatment with tumor-informed assays,” Dr. Nader Marta said in an interview.
“As next steps, we need to build on this evidence to bring the potential benefits of this powerful prognostic tool to our patients,” said Dr. Nader Marta. “Ongoing studies exploring different management strategies based on serial ctDNA assessments will help us understand the exact role of this technology in our clinical practice.”
The study received no outside funding. Dr. Nader Marta disclosed relationships with companies including Roche and Bayer.
ESMO BREAST CANCER 2023
Scheduled bleeding may boost tolerability of hormone implants
BALTIMORE – The bleeding causes some women to have the device removed, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
In a randomized, double-blinded, placebo-controlled trial of 51 patients desiring the implants – which suppress ovulation by releasing progestin over a 3-year period – taking norethindrone acetate for 1 week every 4 weeks led to 80% of participants in the treatment group reporting satisfactory bleeding patterns with the etonogestrel implants in place.
Rates of early discontinuation have been variable, according to published literature, ranging from 13% to 21.1%, said Jordan Gray, MD, a fourth-year resident in ob.gyn. at Baylor Scott and White Medical Center, Temple, Tex., who helped conduct the new study. Reasons included bothersome bleeding. Dr. Gray and colleagues found that 24% of women in the placebo group requested removal of the implant, compared with 9% of those in the treatment group. Among these women, none requested removal for bothersome bleeding but rather for reasons such as wanting to get pregnant. One person requested removal because she did not like amenorrhea.
While the results of the study did not achieve statistical significance, owing to its size and noncompliance among some participants, it does indicate that norethindrone acetate may be helpful, Dr. Gray said.
During the study, participants in the treatment group (n = 22) received a monthly treatment regimen of 5 mg of oral norethindrone acetate daily for 7 days each month for the first 6 months after placement of an etonogestrel implant. The placebo group (n = 29) was given inert tablets prescribed in the same regimen. Both groups received products from a mail-order pharmacy.
Participants were women aged 18-48 years who desired an implant or those aged 14 years who had permission from a parent or guardian to receive the contraceptive. The study excluded people with known or suspected pregnancy, those less than 8 weeks’ post partum, those who experienced menarche less than 2 years ago, those with body mass index greater than 40, and those who received depot medroxyprogesterone acetate within the previous 12 weeks. Excessive bleeding was defined as bleeding or spotting on more than 7 consecutive days or a fifth episode of bleeding in 90 days.
Overall, 11 patients (38%) in the placebo group and 10 (45%) in the treatment arm withdrew from the study. Reasons included wanting to get pregnant, mood changes, or noncompliance with study parameters, which included not responding or returning bleeding diaries, Dr. Gray said.
A limitation of the study was that compliance was less than expected. In addition, there were challenges with rates of responses, Dr. Gray said. The study was conducted during the COVID-19 pandemic, when all in-person visits were transitioned to telehealth. Although the investigators offered payment to participants, not all returned text-message surveys. The researchers had intended to enroll 124 participants but curtailed the study early, owing to the limited number of participants.
Given that there is no standard approach to treating prolonged or excessive bleeding with etonogestrel implants, Dr. Gray said, “Our data suggests that this regimen is a simple and acceptable method to treat bothersome bleeding and that predictable bleeding may be more satisfactory than unpredictable bleeding.”
Veronica Maria Pimentel, MD, moderator of the session and a maternal-fetal medicine specialist and director of research for the ob.gyn. residency program at St. Francis Hospital, part of Trinity Health of New England in Hartford, Conn., praised the researchers for a well-designed study.
“However, unfortunately, they were not able to recruit the number of patients that they needed in order to achieve the power to show the difference [between treatment arms], so another study would have to be done to show if there is a difference,” Dr. Pimentel said.
Dr. Pimentel complimented Dr. Gray following her presentation, congratulating her for conducting a randomized, controlled trial: “That’s not easy, as you have shown, but it’s also a good try, so you can actually see how hard it is to obtain quality data from research.”
The study was supported in part by a research grant from the Investigator-Initiated Studies Program of Organon. Dr. Gray is a consultant for Johnson & Johnson. Dr. Pimentel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BALTIMORE – The bleeding causes some women to have the device removed, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
In a randomized, double-blinded, placebo-controlled trial of 51 patients desiring the implants – which suppress ovulation by releasing progestin over a 3-year period – taking norethindrone acetate for 1 week every 4 weeks led to 80% of participants in the treatment group reporting satisfactory bleeding patterns with the etonogestrel implants in place.
Rates of early discontinuation have been variable, according to published literature, ranging from 13% to 21.1%, said Jordan Gray, MD, a fourth-year resident in ob.gyn. at Baylor Scott and White Medical Center, Temple, Tex., who helped conduct the new study. Reasons included bothersome bleeding. Dr. Gray and colleagues found that 24% of women in the placebo group requested removal of the implant, compared with 9% of those in the treatment group. Among these women, none requested removal for bothersome bleeding but rather for reasons such as wanting to get pregnant. One person requested removal because she did not like amenorrhea.
While the results of the study did not achieve statistical significance, owing to its size and noncompliance among some participants, it does indicate that norethindrone acetate may be helpful, Dr. Gray said.
During the study, participants in the treatment group (n = 22) received a monthly treatment regimen of 5 mg of oral norethindrone acetate daily for 7 days each month for the first 6 months after placement of an etonogestrel implant. The placebo group (n = 29) was given inert tablets prescribed in the same regimen. Both groups received products from a mail-order pharmacy.
Participants were women aged 18-48 years who desired an implant or those aged 14 years who had permission from a parent or guardian to receive the contraceptive. The study excluded people with known or suspected pregnancy, those less than 8 weeks’ post partum, those who experienced menarche less than 2 years ago, those with body mass index greater than 40, and those who received depot medroxyprogesterone acetate within the previous 12 weeks. Excessive bleeding was defined as bleeding or spotting on more than 7 consecutive days or a fifth episode of bleeding in 90 days.
Overall, 11 patients (38%) in the placebo group and 10 (45%) in the treatment arm withdrew from the study. Reasons included wanting to get pregnant, mood changes, or noncompliance with study parameters, which included not responding or returning bleeding diaries, Dr. Gray said.
A limitation of the study was that compliance was less than expected. In addition, there were challenges with rates of responses, Dr. Gray said. The study was conducted during the COVID-19 pandemic, when all in-person visits were transitioned to telehealth. Although the investigators offered payment to participants, not all returned text-message surveys. The researchers had intended to enroll 124 participants but curtailed the study early, owing to the limited number of participants.
Given that there is no standard approach to treating prolonged or excessive bleeding with etonogestrel implants, Dr. Gray said, “Our data suggests that this regimen is a simple and acceptable method to treat bothersome bleeding and that predictable bleeding may be more satisfactory than unpredictable bleeding.”
Veronica Maria Pimentel, MD, moderator of the session and a maternal-fetal medicine specialist and director of research for the ob.gyn. residency program at St. Francis Hospital, part of Trinity Health of New England in Hartford, Conn., praised the researchers for a well-designed study.
“However, unfortunately, they were not able to recruit the number of patients that they needed in order to achieve the power to show the difference [between treatment arms], so another study would have to be done to show if there is a difference,” Dr. Pimentel said.
Dr. Pimentel complimented Dr. Gray following her presentation, congratulating her for conducting a randomized, controlled trial: “That’s not easy, as you have shown, but it’s also a good try, so you can actually see how hard it is to obtain quality data from research.”
The study was supported in part by a research grant from the Investigator-Initiated Studies Program of Organon. Dr. Gray is a consultant for Johnson & Johnson. Dr. Pimentel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BALTIMORE – The bleeding causes some women to have the device removed, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
In a randomized, double-blinded, placebo-controlled trial of 51 patients desiring the implants – which suppress ovulation by releasing progestin over a 3-year period – taking norethindrone acetate for 1 week every 4 weeks led to 80% of participants in the treatment group reporting satisfactory bleeding patterns with the etonogestrel implants in place.
Rates of early discontinuation have been variable, according to published literature, ranging from 13% to 21.1%, said Jordan Gray, MD, a fourth-year resident in ob.gyn. at Baylor Scott and White Medical Center, Temple, Tex., who helped conduct the new study. Reasons included bothersome bleeding. Dr. Gray and colleagues found that 24% of women in the placebo group requested removal of the implant, compared with 9% of those in the treatment group. Among these women, none requested removal for bothersome bleeding but rather for reasons such as wanting to get pregnant. One person requested removal because she did not like amenorrhea.
While the results of the study did not achieve statistical significance, owing to its size and noncompliance among some participants, it does indicate that norethindrone acetate may be helpful, Dr. Gray said.
During the study, participants in the treatment group (n = 22) received a monthly treatment regimen of 5 mg of oral norethindrone acetate daily for 7 days each month for the first 6 months after placement of an etonogestrel implant. The placebo group (n = 29) was given inert tablets prescribed in the same regimen. Both groups received products from a mail-order pharmacy.
Participants were women aged 18-48 years who desired an implant or those aged 14 years who had permission from a parent or guardian to receive the contraceptive. The study excluded people with known or suspected pregnancy, those less than 8 weeks’ post partum, those who experienced menarche less than 2 years ago, those with body mass index greater than 40, and those who received depot medroxyprogesterone acetate within the previous 12 weeks. Excessive bleeding was defined as bleeding or spotting on more than 7 consecutive days or a fifth episode of bleeding in 90 days.
Overall, 11 patients (38%) in the placebo group and 10 (45%) in the treatment arm withdrew from the study. Reasons included wanting to get pregnant, mood changes, or noncompliance with study parameters, which included not responding or returning bleeding diaries, Dr. Gray said.
A limitation of the study was that compliance was less than expected. In addition, there were challenges with rates of responses, Dr. Gray said. The study was conducted during the COVID-19 pandemic, when all in-person visits were transitioned to telehealth. Although the investigators offered payment to participants, not all returned text-message surveys. The researchers had intended to enroll 124 participants but curtailed the study early, owing to the limited number of participants.
Given that there is no standard approach to treating prolonged or excessive bleeding with etonogestrel implants, Dr. Gray said, “Our data suggests that this regimen is a simple and acceptable method to treat bothersome bleeding and that predictable bleeding may be more satisfactory than unpredictable bleeding.”
Veronica Maria Pimentel, MD, moderator of the session and a maternal-fetal medicine specialist and director of research for the ob.gyn. residency program at St. Francis Hospital, part of Trinity Health of New England in Hartford, Conn., praised the researchers for a well-designed study.
“However, unfortunately, they were not able to recruit the number of patients that they needed in order to achieve the power to show the difference [between treatment arms], so another study would have to be done to show if there is a difference,” Dr. Pimentel said.
Dr. Pimentel complimented Dr. Gray following her presentation, congratulating her for conducting a randomized, controlled trial: “That’s not easy, as you have shown, but it’s also a good try, so you can actually see how hard it is to obtain quality data from research.”
The study was supported in part by a research grant from the Investigator-Initiated Studies Program of Organon. Dr. Gray is a consultant for Johnson & Johnson. Dr. Pimentel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ACOG 2023
Once-daily nifedipine sufficient for hypertension in pregnancy
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.*
The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.
“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.
Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.
Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose – the most common adjustment – and 20.7% needed both an increase in nifedipine and an additional medication.
The researchers observed no statistically significant differences in the proportion of patients who required a dose increase or an additional antihypertensive in the group taking the twice-daily dose (33.8%) or those receiving the once-daily dose (35.7%). This finding remained statistically insignificant after controlling for gestational diabetes, delivery mode, administration of Lasix, and receipt of emergency antihypertensive treatment (P = .71). The time that passed before patients needed a dose increase was also statistically similar between the groups: 24.3 hours in the twice-daily group and 24 hours in the once-daily group (P = .49).
There were no statistically significant differences in the need for a dose increase or an additional hypertensive agent based on race, ethnicity, body mass index, or history of preeclampsia as well. However, 24.5% of those taking the once-daily dosage had a history of preeclampsia, compared with 7.2% of those taking the twice-daily dosage (P < .001). Further, the median number of prior pregnancies was two in the twice-daily group versus three in the once-daily group (P = .002).
The authors found no significant difference between the two dosing groups in the need for emergency hypertensive treatment after reaching the study dose or in readmission for blood pressure control. In the twice-daily group, 21.6% of patients needed emergency antihypertensive treatment, compared with 14.3% in the once-daily group (P = .19). Readmission was necessary for 7.2% of the twice-daily group and 6.1% of the once-daily group (P > .99).
A subgroup analysis compared those who started nifedipine antepartum and those who started it post partum, but again, no significant difference in the dosing regimens existed.
Michael Ruma, MD, a maternal-fetal medicine specialist at Perinatal Associates of New Mexico in Albuquerque, was not involved in the study and said he welcomed the results.
“We have too many choices in medicine, so we need to just simplify the plan of attack,” reducing the number of things that clinicians need to think about, Dr. Ruma said in an interview. “A singular dose is always easiest for the patient, always easier for nursing staff, and usually, if you can optimize the dosing, that’s the best approach.”
Annabeth Brewton, MD, a resident at University of Tennessee, Knoxville, agreed, adding that new parents already have a lot going on immediately post partum.
“They’re going to be breastfeeding, they’re not sleeping, they’re going to forget to take that [second] dose,” Dr. Brewton said.
Ms. Band and Dr. Brewton had no disclosures. Dr. Ruma reported consulting and speaking for Hologic and consulting for Philips Ultrasound.
Correction, 5/24/23: An earlier version of this article misstated the daily doses of nifedipine. The study compared a
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.*
The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.
“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.
Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.
Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose – the most common adjustment – and 20.7% needed both an increase in nifedipine and an additional medication.
The researchers observed no statistically significant differences in the proportion of patients who required a dose increase or an additional antihypertensive in the group taking the twice-daily dose (33.8%) or those receiving the once-daily dose (35.7%). This finding remained statistically insignificant after controlling for gestational diabetes, delivery mode, administration of Lasix, and receipt of emergency antihypertensive treatment (P = .71). The time that passed before patients needed a dose increase was also statistically similar between the groups: 24.3 hours in the twice-daily group and 24 hours in the once-daily group (P = .49).
There were no statistically significant differences in the need for a dose increase or an additional hypertensive agent based on race, ethnicity, body mass index, or history of preeclampsia as well. However, 24.5% of those taking the once-daily dosage had a history of preeclampsia, compared with 7.2% of those taking the twice-daily dosage (P < .001). Further, the median number of prior pregnancies was two in the twice-daily group versus three in the once-daily group (P = .002).
The authors found no significant difference between the two dosing groups in the need for emergency hypertensive treatment after reaching the study dose or in readmission for blood pressure control. In the twice-daily group, 21.6% of patients needed emergency antihypertensive treatment, compared with 14.3% in the once-daily group (P = .19). Readmission was necessary for 7.2% of the twice-daily group and 6.1% of the once-daily group (P > .99).
A subgroup analysis compared those who started nifedipine antepartum and those who started it post partum, but again, no significant difference in the dosing regimens existed.
Michael Ruma, MD, a maternal-fetal medicine specialist at Perinatal Associates of New Mexico in Albuquerque, was not involved in the study and said he welcomed the results.
“We have too many choices in medicine, so we need to just simplify the plan of attack,” reducing the number of things that clinicians need to think about, Dr. Ruma said in an interview. “A singular dose is always easiest for the patient, always easier for nursing staff, and usually, if you can optimize the dosing, that’s the best approach.”
Annabeth Brewton, MD, a resident at University of Tennessee, Knoxville, agreed, adding that new parents already have a lot going on immediately post partum.
“They’re going to be breastfeeding, they’re not sleeping, they’re going to forget to take that [second] dose,” Dr. Brewton said.
Ms. Band and Dr. Brewton had no disclosures. Dr. Ruma reported consulting and speaking for Hologic and consulting for Philips Ultrasound.
Correction, 5/24/23: An earlier version of this article misstated the daily doses of nifedipine. The study compared a
BALTIMORE – , according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.*
The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.
“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.
Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.
Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose – the most common adjustment – and 20.7% needed both an increase in nifedipine and an additional medication.
The researchers observed no statistically significant differences in the proportion of patients who required a dose increase or an additional antihypertensive in the group taking the twice-daily dose (33.8%) or those receiving the once-daily dose (35.7%). This finding remained statistically insignificant after controlling for gestational diabetes, delivery mode, administration of Lasix, and receipt of emergency antihypertensive treatment (P = .71). The time that passed before patients needed a dose increase was also statistically similar between the groups: 24.3 hours in the twice-daily group and 24 hours in the once-daily group (P = .49).
There were no statistically significant differences in the need for a dose increase or an additional hypertensive agent based on race, ethnicity, body mass index, or history of preeclampsia as well. However, 24.5% of those taking the once-daily dosage had a history of preeclampsia, compared with 7.2% of those taking the twice-daily dosage (P < .001). Further, the median number of prior pregnancies was two in the twice-daily group versus three in the once-daily group (P = .002).
The authors found no significant difference between the two dosing groups in the need for emergency hypertensive treatment after reaching the study dose or in readmission for blood pressure control. In the twice-daily group, 21.6% of patients needed emergency antihypertensive treatment, compared with 14.3% in the once-daily group (P = .19). Readmission was necessary for 7.2% of the twice-daily group and 6.1% of the once-daily group (P > .99).
A subgroup analysis compared those who started nifedipine antepartum and those who started it post partum, but again, no significant difference in the dosing regimens existed.
Michael Ruma, MD, a maternal-fetal medicine specialist at Perinatal Associates of New Mexico in Albuquerque, was not involved in the study and said he welcomed the results.
“We have too many choices in medicine, so we need to just simplify the plan of attack,” reducing the number of things that clinicians need to think about, Dr. Ruma said in an interview. “A singular dose is always easiest for the patient, always easier for nursing staff, and usually, if you can optimize the dosing, that’s the best approach.”
Annabeth Brewton, MD, a resident at University of Tennessee, Knoxville, agreed, adding that new parents already have a lot going on immediately post partum.
“They’re going to be breastfeeding, they’re not sleeping, they’re going to forget to take that [second] dose,” Dr. Brewton said.
Ms. Band and Dr. Brewton had no disclosures. Dr. Ruma reported consulting and speaking for Hologic and consulting for Philips Ultrasound.
Correction, 5/24/23: An earlier version of this article misstated the daily doses of nifedipine. The study compared a
AT ACOG 2023
Over half of pregnant patients not properly screened for thyroid disease
BALTIMORE – Less than half of the pregnant patients who met the criteria for thyroid screening were actually screened by their clinician, according to a retrospective cohort study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists in Baltimore. Those who met criteria and did receive screening had higher live birth rates and lower miscarriage rates than those who met the criteria but did not undergo screening, the study found.
“These results suggest that improving thyroid screening adherence may lead to improved pregnancy outcomes,” lead author Allan Dong, MD, of Advocate Lutheran General Hospital in Des Plaines, Ill., told attendees. “However, following targeted screening guidelines can be difficult for clinicians. In practice, universal screening for diabetes and pregnancy may provide more comprehensive screening coverage and potentially lead to improved outcomes.”
Instead of universal screening for thyroid disease, ACOG and the American Thyroid Association recommend targeted screening of high-risk patients, though ATA’s criteria are substantially broader than ACOG’s. But, Dr. Dong told attendees, “guidelines are only beneficial if they are followed appropriately,” and Ob.Gyns. have limited time to screen for risk factors in the midst of other clinical priorities. So he aimed to learn whether Ob.Gyns. were following the guidelines of either organization in screening people at higher risk for thyroid disease.
Dr. Dong and his coauthor, Melisa Lott, DO, reviewed the charts of all 1,025 patients who presented at their institution for new obstetrical visits in 2020 to determine which ones had risk factors that would qualify them for screening under ATA or ACOG guidelines. ACOG’s screening criteria included having a personal or family history of thyroid disease or type 1 diabetes, or there being clinical suspicion for thyroid disease. ATA’s screening criteria included the following:
- Personal or family history of thyroid disease.
- History of head or neck radiation.
- History of a prior thyroid surgery.
- Over age 30.
- Any autoimmune disease.
- A body mass index greater than 40 kg/m2.
- History of pregnancy loss, preterm delivery, or infertility.
- Recently used amiodarone lithium or iodine-based contrast.
- Lived in an area of known iodine deficiency.
- Clinical suspicion of thyroid disease.
ATA screening criteria identified four times as many patients requiring screening than did ACOG criteria, Dr. Dong noted. Of the 198 patients who met ACOG’s criteria, 43.9% were screened with thyroid function testing. Meanwhile, 826 patients – including all those who met ACOG’s criteria – met ATA’s criteria for screening, but only 13.1% of them underwent thyroid function testing.
Live birth rates were significantly higher among patients who met ATA criteria and were screened (92.6%) than among patients who met ATA criteria but were not screened (83.3%, P = .006). Similarly, the miscarriage rate was 4.6% in patients who met ATA criteria and were screened, compared to 12.4% in patients who met the criteria but did not undergo thyroid function testing (P = .009).
“A similar difference, although not statistically significant, was noted when comparing patients who were screened appropriately per ACOG criteria with those who met criteria for screening but were not screened,” Dr. Dong told attendees. “However, our study was underpowered to detect this difference due to the lower number of patients who meet criteria for screening under ACOG guidelines.”
The researchers did not find any significant difference in preterm delivery rates.
Anna Whelan, MD, of Women & Infants Hospital of Brown University, Providence, R.I., was not involved in the study but viewed the poster and pointed out that many of the patients, if seen by a primary care provider prior to pregnancy, would likely have been screened by their PCP. The rate of underscreening therefore suggests that patients “are not getting good, consistent primary care because there’s a lack of primary care physicians,” Dr. Whelan said in an interview.
In addition, she added, “maybe not all obstetricians and those providing care, such as midwives and other providers, are aware of the [ATA] guidelines on who should be screened.” She added that additional education about thyroid screening guidelines might be helpful for providers.
Dr. Dong reported being a stock shareholder in 3M, AbbVie, General Electric, Johnson & Johnson, Medtronic, Pfizer, and Viking Therapeutics. Dr. Whelan had no disclosures.
BALTIMORE – Less than half of the pregnant patients who met the criteria for thyroid screening were actually screened by their clinician, according to a retrospective cohort study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists in Baltimore. Those who met criteria and did receive screening had higher live birth rates and lower miscarriage rates than those who met the criteria but did not undergo screening, the study found.
“These results suggest that improving thyroid screening adherence may lead to improved pregnancy outcomes,” lead author Allan Dong, MD, of Advocate Lutheran General Hospital in Des Plaines, Ill., told attendees. “However, following targeted screening guidelines can be difficult for clinicians. In practice, universal screening for diabetes and pregnancy may provide more comprehensive screening coverage and potentially lead to improved outcomes.”
Instead of universal screening for thyroid disease, ACOG and the American Thyroid Association recommend targeted screening of high-risk patients, though ATA’s criteria are substantially broader than ACOG’s. But, Dr. Dong told attendees, “guidelines are only beneficial if they are followed appropriately,” and Ob.Gyns. have limited time to screen for risk factors in the midst of other clinical priorities. So he aimed to learn whether Ob.Gyns. were following the guidelines of either organization in screening people at higher risk for thyroid disease.
Dr. Dong and his coauthor, Melisa Lott, DO, reviewed the charts of all 1,025 patients who presented at their institution for new obstetrical visits in 2020 to determine which ones had risk factors that would qualify them for screening under ATA or ACOG guidelines. ACOG’s screening criteria included having a personal or family history of thyroid disease or type 1 diabetes, or there being clinical suspicion for thyroid disease. ATA’s screening criteria included the following:
- Personal or family history of thyroid disease.
- History of head or neck radiation.
- History of a prior thyroid surgery.
- Over age 30.
- Any autoimmune disease.
- A body mass index greater than 40 kg/m2.
- History of pregnancy loss, preterm delivery, or infertility.
- Recently used amiodarone lithium or iodine-based contrast.
- Lived in an area of known iodine deficiency.
- Clinical suspicion of thyroid disease.
ATA screening criteria identified four times as many patients requiring screening than did ACOG criteria, Dr. Dong noted. Of the 198 patients who met ACOG’s criteria, 43.9% were screened with thyroid function testing. Meanwhile, 826 patients – including all those who met ACOG’s criteria – met ATA’s criteria for screening, but only 13.1% of them underwent thyroid function testing.
Live birth rates were significantly higher among patients who met ATA criteria and were screened (92.6%) than among patients who met ATA criteria but were not screened (83.3%, P = .006). Similarly, the miscarriage rate was 4.6% in patients who met ATA criteria and were screened, compared to 12.4% in patients who met the criteria but did not undergo thyroid function testing (P = .009).
“A similar difference, although not statistically significant, was noted when comparing patients who were screened appropriately per ACOG criteria with those who met criteria for screening but were not screened,” Dr. Dong told attendees. “However, our study was underpowered to detect this difference due to the lower number of patients who meet criteria for screening under ACOG guidelines.”
The researchers did not find any significant difference in preterm delivery rates.
Anna Whelan, MD, of Women & Infants Hospital of Brown University, Providence, R.I., was not involved in the study but viewed the poster and pointed out that many of the patients, if seen by a primary care provider prior to pregnancy, would likely have been screened by their PCP. The rate of underscreening therefore suggests that patients “are not getting good, consistent primary care because there’s a lack of primary care physicians,” Dr. Whelan said in an interview.
In addition, she added, “maybe not all obstetricians and those providing care, such as midwives and other providers, are aware of the [ATA] guidelines on who should be screened.” She added that additional education about thyroid screening guidelines might be helpful for providers.
Dr. Dong reported being a stock shareholder in 3M, AbbVie, General Electric, Johnson & Johnson, Medtronic, Pfizer, and Viking Therapeutics. Dr. Whelan had no disclosures.
BALTIMORE – Less than half of the pregnant patients who met the criteria for thyroid screening were actually screened by their clinician, according to a retrospective cohort study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists in Baltimore. Those who met criteria and did receive screening had higher live birth rates and lower miscarriage rates than those who met the criteria but did not undergo screening, the study found.
“These results suggest that improving thyroid screening adherence may lead to improved pregnancy outcomes,” lead author Allan Dong, MD, of Advocate Lutheran General Hospital in Des Plaines, Ill., told attendees. “However, following targeted screening guidelines can be difficult for clinicians. In practice, universal screening for diabetes and pregnancy may provide more comprehensive screening coverage and potentially lead to improved outcomes.”
Instead of universal screening for thyroid disease, ACOG and the American Thyroid Association recommend targeted screening of high-risk patients, though ATA’s criteria are substantially broader than ACOG’s. But, Dr. Dong told attendees, “guidelines are only beneficial if they are followed appropriately,” and Ob.Gyns. have limited time to screen for risk factors in the midst of other clinical priorities. So he aimed to learn whether Ob.Gyns. were following the guidelines of either organization in screening people at higher risk for thyroid disease.
Dr. Dong and his coauthor, Melisa Lott, DO, reviewed the charts of all 1,025 patients who presented at their institution for new obstetrical visits in 2020 to determine which ones had risk factors that would qualify them for screening under ATA or ACOG guidelines. ACOG’s screening criteria included having a personal or family history of thyroid disease or type 1 diabetes, or there being clinical suspicion for thyroid disease. ATA’s screening criteria included the following:
- Personal or family history of thyroid disease.
- History of head or neck radiation.
- History of a prior thyroid surgery.
- Over age 30.
- Any autoimmune disease.
- A body mass index greater than 40 kg/m2.
- History of pregnancy loss, preterm delivery, or infertility.
- Recently used amiodarone lithium or iodine-based contrast.
- Lived in an area of known iodine deficiency.
- Clinical suspicion of thyroid disease.
ATA screening criteria identified four times as many patients requiring screening than did ACOG criteria, Dr. Dong noted. Of the 198 patients who met ACOG’s criteria, 43.9% were screened with thyroid function testing. Meanwhile, 826 patients – including all those who met ACOG’s criteria – met ATA’s criteria for screening, but only 13.1% of them underwent thyroid function testing.
Live birth rates were significantly higher among patients who met ATA criteria and were screened (92.6%) than among patients who met ATA criteria but were not screened (83.3%, P = .006). Similarly, the miscarriage rate was 4.6% in patients who met ATA criteria and were screened, compared to 12.4% in patients who met the criteria but did not undergo thyroid function testing (P = .009).
“A similar difference, although not statistically significant, was noted when comparing patients who were screened appropriately per ACOG criteria with those who met criteria for screening but were not screened,” Dr. Dong told attendees. “However, our study was underpowered to detect this difference due to the lower number of patients who meet criteria for screening under ACOG guidelines.”
The researchers did not find any significant difference in preterm delivery rates.
Anna Whelan, MD, of Women & Infants Hospital of Brown University, Providence, R.I., was not involved in the study but viewed the poster and pointed out that many of the patients, if seen by a primary care provider prior to pregnancy, would likely have been screened by their PCP. The rate of underscreening therefore suggests that patients “are not getting good, consistent primary care because there’s a lack of primary care physicians,” Dr. Whelan said in an interview.
In addition, she added, “maybe not all obstetricians and those providing care, such as midwives and other providers, are aware of the [ATA] guidelines on who should be screened.” She added that additional education about thyroid screening guidelines might be helpful for providers.
Dr. Dong reported being a stock shareholder in 3M, AbbVie, General Electric, Johnson & Johnson, Medtronic, Pfizer, and Viking Therapeutics. Dr. Whelan had no disclosures.
FROM ACOG 2023
Unveiling sexual dysfunction: Clinicians can do more
AURORA, COLO. – Do you ask your patients about their sexual health? Many providers do not broach the topic – whether because they lack the time, feel awkward, or their patients have other, more pressing concerns to discuss.
Yet nearly half of women experience some form of sexual dysfunction, such as low sex drive, pain during sex (dyspareunia), or trouble reaching orgasm. When dysfunction is paired with significant distress, the condition is called hypoactive sexual desire disorder (HSDD).
At the annual meeting of the Society of General Internal Medicine, experts said patients want to talk about these problems, but they need their physicians to be ready for the conversation.
Hannah Abumusa, MD, clinical instructor of medicine at the University of Pittsburgh Medical Center, recommended implementing the “5As” framework.
- Ask. Start by asking patients if they would be comfortable with you posing a few questions about their sexual health.
- Advise. Make sure your patient knows many women struggle with the problem they have raised.
- Assess. Ask a set of standardized assessment questions.
- Assist. Tell your patient about treatment options.
- Arrange. Arrange a follow-up visit to see if treatment has been effective.
Kathryn Leyens, MD, admitted she does not discuss sexual health enough with her patients, although she believes the topic is important.
“If it’s brought up, I’m comfortable talking about it,” said Dr. Leyens, a clinical assistant professor of medicine at the University of Pittsburgh. “But I think it’s something that I could initiate more often.”
The 5As framework offers a helpful way to initiate those conversations, she said.
Medications might be to blame
Holly Thomas, MD, an assistant professor of medicine at the University of Pittsburgh, first conducts a medication review when discussing low sexual desire with her patients.
“There are definitely medications that we commonly use in primary care that can have negative effects on sexual function,” Dr. Thomas said. “But we’re not always the best at talking with patients about these things, and I think sometimes patients get the message that they should deprioritize their sex lives to their medication needs.”
For example, sexual dysfunction is a common side effect of antidepressants, with paroxetine, fluvoxamine, sertraline, and fluoxetine carrying the highest frequency of this reported effect. Beta-blockers are also known to cause sexual dysfunction in women.
Pharmacologic options
Once clinicians conduct a medication review, they can discuss treatment options with patients, which can range from prescription drugs to therapy.
Several medications have been shown in clinical trials to increase sexual desire in women. Flibanserin (Addyi), a once-daily pill, boosted libido in about half of women who used the drug in studies leading to its approvalby the Food and Drug Administration in 2015.
The most common adverse effects reported in clinical trials included dizziness, syncope, and somnolence, which occurred in roughly 12% of users. The FDA recommends people avoid alcohol 2 hours before and after taking the drug.
Bremelanotide (Vyleesi) is an on-demand medication, like sildenafil for men, which in trials led to modest increases in desire among 25% of women who took the drug. About 40% of users reported experiencing nausea. Hyperpigmentation can also be a side effect, which in rare cases can be permanent, Dr. Thomas said. Patients can use a maximum of eight doses per month of the drug.
Testosterone serves as an off-label treatment, as the FDA has not approved the hormone for women. Adverse effects can include acne and weight gain. Data on the safety of its use past 2 years are scarce.
“But up until then, there’s pretty strong evidence for the efficacy and safety of testosterone for treatment of hypoactive sexual desire disorder in women,” Dr. Thomas said.
Hormone replacement therapy is another potential treatment option, which could include estrogen plus progesterone.
“It’s not FDA approved for HSDD, but if you’re using it for other menopausal symptoms, it’s likely to improve sexual function with small- to moderate-effect sizes,” she said.
Bupropion (multiple brands) is a cost-effective option also prescribed for depression, Dr. Thomas said. A recently published systematic review provided further data to support the efficacy of the drug.
“That’s something that a lot of us are very familiar with and maybe more comfortable prescribing if we’re less familiar with some of the newer options,” she said.
Nonpharmacologic interventions
Dr. Thomas encouraged clinicians to consider nonpharmacologic approaches, too, such as referring patients to sex therapists.
“There’s something called ‘sensate focus,’ which is a type of sex therapy that’s been around for decades, but it’s still very effective,” Dr. Thomas said.
Cognitive-behavioral therapy (CBT) is another option, she said. A systematic review published in 2022 showed CBT was an effective tool for treating HSDD, although Dr. Thomas noted the evidence is limited.
A newer treatment gaining traction is mindfulness meditation, often provided by therapists, which focuses on present moment and nonjudgmental bodily awareness. Dr. Thomas recommended referring patients to educational literature such as “Better Sex Through Mindfulness: How Women Can Cultivate Desire” by Lori Brotto (Vancouver: Greystone Books, 2018). The book also comes with a workbook.
“This has actually been shown in multiple trials to be effective for the treatment of low sexual desire with moderate to large effect sizes,” she said.
Dr. Abumusa, Dr. Leyens, and Dr. Thomas reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AURORA, COLO. – Do you ask your patients about their sexual health? Many providers do not broach the topic – whether because they lack the time, feel awkward, or their patients have other, more pressing concerns to discuss.
Yet nearly half of women experience some form of sexual dysfunction, such as low sex drive, pain during sex (dyspareunia), or trouble reaching orgasm. When dysfunction is paired with significant distress, the condition is called hypoactive sexual desire disorder (HSDD).
At the annual meeting of the Society of General Internal Medicine, experts said patients want to talk about these problems, but they need their physicians to be ready for the conversation.
Hannah Abumusa, MD, clinical instructor of medicine at the University of Pittsburgh Medical Center, recommended implementing the “5As” framework.
- Ask. Start by asking patients if they would be comfortable with you posing a few questions about their sexual health.
- Advise. Make sure your patient knows many women struggle with the problem they have raised.
- Assess. Ask a set of standardized assessment questions.
- Assist. Tell your patient about treatment options.
- Arrange. Arrange a follow-up visit to see if treatment has been effective.
Kathryn Leyens, MD, admitted she does not discuss sexual health enough with her patients, although she believes the topic is important.
“If it’s brought up, I’m comfortable talking about it,” said Dr. Leyens, a clinical assistant professor of medicine at the University of Pittsburgh. “But I think it’s something that I could initiate more often.”
The 5As framework offers a helpful way to initiate those conversations, she said.
Medications might be to blame
Holly Thomas, MD, an assistant professor of medicine at the University of Pittsburgh, first conducts a medication review when discussing low sexual desire with her patients.
“There are definitely medications that we commonly use in primary care that can have negative effects on sexual function,” Dr. Thomas said. “But we’re not always the best at talking with patients about these things, and I think sometimes patients get the message that they should deprioritize their sex lives to their medication needs.”
For example, sexual dysfunction is a common side effect of antidepressants, with paroxetine, fluvoxamine, sertraline, and fluoxetine carrying the highest frequency of this reported effect. Beta-blockers are also known to cause sexual dysfunction in women.
Pharmacologic options
Once clinicians conduct a medication review, they can discuss treatment options with patients, which can range from prescription drugs to therapy.
Several medications have been shown in clinical trials to increase sexual desire in women. Flibanserin (Addyi), a once-daily pill, boosted libido in about half of women who used the drug in studies leading to its approvalby the Food and Drug Administration in 2015.
The most common adverse effects reported in clinical trials included dizziness, syncope, and somnolence, which occurred in roughly 12% of users. The FDA recommends people avoid alcohol 2 hours before and after taking the drug.
Bremelanotide (Vyleesi) is an on-demand medication, like sildenafil for men, which in trials led to modest increases in desire among 25% of women who took the drug. About 40% of users reported experiencing nausea. Hyperpigmentation can also be a side effect, which in rare cases can be permanent, Dr. Thomas said. Patients can use a maximum of eight doses per month of the drug.
Testosterone serves as an off-label treatment, as the FDA has not approved the hormone for women. Adverse effects can include acne and weight gain. Data on the safety of its use past 2 years are scarce.
“But up until then, there’s pretty strong evidence for the efficacy and safety of testosterone for treatment of hypoactive sexual desire disorder in women,” Dr. Thomas said.
Hormone replacement therapy is another potential treatment option, which could include estrogen plus progesterone.
“It’s not FDA approved for HSDD, but if you’re using it for other menopausal symptoms, it’s likely to improve sexual function with small- to moderate-effect sizes,” she said.
Bupropion (multiple brands) is a cost-effective option also prescribed for depression, Dr. Thomas said. A recently published systematic review provided further data to support the efficacy of the drug.
“That’s something that a lot of us are very familiar with and maybe more comfortable prescribing if we’re less familiar with some of the newer options,” she said.
Nonpharmacologic interventions
Dr. Thomas encouraged clinicians to consider nonpharmacologic approaches, too, such as referring patients to sex therapists.
“There’s something called ‘sensate focus,’ which is a type of sex therapy that’s been around for decades, but it’s still very effective,” Dr. Thomas said.
Cognitive-behavioral therapy (CBT) is another option, she said. A systematic review published in 2022 showed CBT was an effective tool for treating HSDD, although Dr. Thomas noted the evidence is limited.
A newer treatment gaining traction is mindfulness meditation, often provided by therapists, which focuses on present moment and nonjudgmental bodily awareness. Dr. Thomas recommended referring patients to educational literature such as “Better Sex Through Mindfulness: How Women Can Cultivate Desire” by Lori Brotto (Vancouver: Greystone Books, 2018). The book also comes with a workbook.
“This has actually been shown in multiple trials to be effective for the treatment of low sexual desire with moderate to large effect sizes,” she said.
Dr. Abumusa, Dr. Leyens, and Dr. Thomas reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AURORA, COLO. – Do you ask your patients about their sexual health? Many providers do not broach the topic – whether because they lack the time, feel awkward, or their patients have other, more pressing concerns to discuss.
Yet nearly half of women experience some form of sexual dysfunction, such as low sex drive, pain during sex (dyspareunia), or trouble reaching orgasm. When dysfunction is paired with significant distress, the condition is called hypoactive sexual desire disorder (HSDD).
At the annual meeting of the Society of General Internal Medicine, experts said patients want to talk about these problems, but they need their physicians to be ready for the conversation.
Hannah Abumusa, MD, clinical instructor of medicine at the University of Pittsburgh Medical Center, recommended implementing the “5As” framework.
- Ask. Start by asking patients if they would be comfortable with you posing a few questions about their sexual health.
- Advise. Make sure your patient knows many women struggle with the problem they have raised.
- Assess. Ask a set of standardized assessment questions.
- Assist. Tell your patient about treatment options.
- Arrange. Arrange a follow-up visit to see if treatment has been effective.
Kathryn Leyens, MD, admitted she does not discuss sexual health enough with her patients, although she believes the topic is important.
“If it’s brought up, I’m comfortable talking about it,” said Dr. Leyens, a clinical assistant professor of medicine at the University of Pittsburgh. “But I think it’s something that I could initiate more often.”
The 5As framework offers a helpful way to initiate those conversations, she said.
Medications might be to blame
Holly Thomas, MD, an assistant professor of medicine at the University of Pittsburgh, first conducts a medication review when discussing low sexual desire with her patients.
“There are definitely medications that we commonly use in primary care that can have negative effects on sexual function,” Dr. Thomas said. “But we’re not always the best at talking with patients about these things, and I think sometimes patients get the message that they should deprioritize their sex lives to their medication needs.”
For example, sexual dysfunction is a common side effect of antidepressants, with paroxetine, fluvoxamine, sertraline, and fluoxetine carrying the highest frequency of this reported effect. Beta-blockers are also known to cause sexual dysfunction in women.
Pharmacologic options
Once clinicians conduct a medication review, they can discuss treatment options with patients, which can range from prescription drugs to therapy.
Several medications have been shown in clinical trials to increase sexual desire in women. Flibanserin (Addyi), a once-daily pill, boosted libido in about half of women who used the drug in studies leading to its approvalby the Food and Drug Administration in 2015.
The most common adverse effects reported in clinical trials included dizziness, syncope, and somnolence, which occurred in roughly 12% of users. The FDA recommends people avoid alcohol 2 hours before and after taking the drug.
Bremelanotide (Vyleesi) is an on-demand medication, like sildenafil for men, which in trials led to modest increases in desire among 25% of women who took the drug. About 40% of users reported experiencing nausea. Hyperpigmentation can also be a side effect, which in rare cases can be permanent, Dr. Thomas said. Patients can use a maximum of eight doses per month of the drug.
Testosterone serves as an off-label treatment, as the FDA has not approved the hormone for women. Adverse effects can include acne and weight gain. Data on the safety of its use past 2 years are scarce.
“But up until then, there’s pretty strong evidence for the efficacy and safety of testosterone for treatment of hypoactive sexual desire disorder in women,” Dr. Thomas said.
Hormone replacement therapy is another potential treatment option, which could include estrogen plus progesterone.
“It’s not FDA approved for HSDD, but if you’re using it for other menopausal symptoms, it’s likely to improve sexual function with small- to moderate-effect sizes,” she said.
Bupropion (multiple brands) is a cost-effective option also prescribed for depression, Dr. Thomas said. A recently published systematic review provided further data to support the efficacy of the drug.
“That’s something that a lot of us are very familiar with and maybe more comfortable prescribing if we’re less familiar with some of the newer options,” she said.
Nonpharmacologic interventions
Dr. Thomas encouraged clinicians to consider nonpharmacologic approaches, too, such as referring patients to sex therapists.
“There’s something called ‘sensate focus,’ which is a type of sex therapy that’s been around for decades, but it’s still very effective,” Dr. Thomas said.
Cognitive-behavioral therapy (CBT) is another option, she said. A systematic review published in 2022 showed CBT was an effective tool for treating HSDD, although Dr. Thomas noted the evidence is limited.
A newer treatment gaining traction is mindfulness meditation, often provided by therapists, which focuses on present moment and nonjudgmental bodily awareness. Dr. Thomas recommended referring patients to educational literature such as “Better Sex Through Mindfulness: How Women Can Cultivate Desire” by Lori Brotto (Vancouver: Greystone Books, 2018). The book also comes with a workbook.
“This has actually been shown in multiple trials to be effective for the treatment of low sexual desire with moderate to large effect sizes,” she said.
Dr. Abumusa, Dr. Leyens, and Dr. Thomas reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT SGIM 2023
How primary care fails new mothers
AURORA, COLO. – Imagine that you are covering for a colleague over the weekend, and you get call from a patient.
The patient is a 36-year-old woman who is 3 days postpartum after a spontaneous vaginal delivery. She has a headache and just arrived home after hospital discharge. She’s calling because after using the blood pressure cuff that the hospital sent her home with, her reading is > 150/90 mm Hg, indicating that she is hypertensive.
You try to pull up her records but realize her delivery hospital isn’t part of your system’s electronic health record. What do you do?
This scenario was presented at a session of the annual meeting of the Society of General Internal Medicine during a panel focused on providing care in the fourth trimester as patients transition between ob.gyn. care and primary care.
“If you send her to the emergency room, she might get sent home,” said Chloe A. Zera, MD, MPH, a maternal-fetal medicine specialist at Beth Israel Deaconess Medical Center, Boston. “I would strongly recommend you figure out where she delivered and tell her to go back there because she will almost certainly get readmitted for blood pressure control.”
When stepping in to treat someone who recently gave birth, Dr. Zera said that clinicians have to be mindful that though many of the deaths of mothers and infants occur on the day of birth, a substantial proportion occur within the first 6-7 weeks postpartum. Clinicians must be aware of possible complications and ask probing questions if they don’t have a patient’s medical records at hand.
“Maternal mortality is a crisis in the United States, which is probably reflective of the sort of social and political realities we’re living in right now,” said Dr. Zera, associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston. “About 700 women die each year in the U.S. from a pregnancy or its complications.”
Dr. Zera recommended that clinicians ask about patients’ birth stories specifically, at how many weeks they gave birth, what kind of delivery they had, and whether they were they induced for any reason.
“Everybody’s birth story is really important in their lives, people know the details and want to talk about their birth stories,” she said.
Starting point
Clinicians should start out by asking questions regarding how the patient delivered but also how much the baby weighed at birth.
“Both really small and really large babies are associated with later maternal complications,” Dr. Zera said. “For example, an 8-pound baby at 34 weeks is off the charts while at 42 weeks, that’s totally normal.”
Clinicians should also ask about complications prior to the birth, which might include questions regarding high blood pressure, blood sugar concerns, hospitalizations before birth, length of stay for the birth, and whether the infant had a neonatal intensive care stay.
Any of these factors can weigh into adverse pregnancy outcomes. Experiencing a hypertensive pregnancy, for example, can put patients at a higher risk for cardiovascular events, and up to 10% of all pregnancies are complicated by hypertensive disorders.
Women who experience preeclampsia have two to four times the risk for coronary heart disease.
Hypertensive pregnancies can also result in patients developing posttraumatic stress disorder, anxiety, and even producing less milk, according to Ann C. Celi, MD, MPH, an internal medicine specialist at Brigham and Women’s Hospital.
More questions
Dr. Celi, who spoke on the panel, runs a clinic that helps people transition back to a primary care provider after a hypertensive pregnancy. She said that she wants to help clinicians better manage the shift.
Clinicians can probe patients on how much sleep they’re getting and whether a support system is present back at home. These are all related to the recovery process, and Dr. Celi recommended that clinicians encourage their patients to prioritize asking for help from external sources.
“Bring in your community: ‘Do you have some best friends from work or somebody who might be able to help with meals? Is there someone in the family that could travel to help [you] as [you’re] recovering? Is the father of the baby involved? Can he help?’ ” said Dr. Celi, offering question suggestions for clinicians to ask.
Dr. Celi recommends that clinicians prescribe hypertensive-friendly birth control options as part of a follow-up care plan, such as progestin-only birth control pills.
She also recommends that clinicians evaluate women with a history of preeclampsia 3-6 months after a birth for cardiovascular risk factors, with an annual follow-up on blood pressure, body mass index, fasting glucose or A1c, and lipids.
Follow-up care
“At least 40% of people don’t even make it to that 6-week visit, and we lose them,” Dr. Zera said. “It turns out, having a pregnancy complication does not make it any more likely that you’re going to come to your postpartum visit.”
For some patients, insurance coverage often changes after delivery. For example, in states without a Medicaid extension or expansion, the program is only required to provide 60 days of coverage after delivery. Even among patients with commercial insurance, churn rates are high. People may quit their jobs and switch to the partner’s insurance or get a new job with a different insurance plan. If the new insurance doesn’t include the patient’s established clinician, the patient may switch clinicians or skip the follow-up appointment entirely.
Another barrier to care is patients feeling like their doctors don’t care about them, Dr. Zera said.
“This is kind of simple stuff, but bond with your patients,” she said. “Tell them, ‘I want to see you when you’re pregnant and beyond,’ because that makes a huge difference.”
No relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
AURORA, COLO. – Imagine that you are covering for a colleague over the weekend, and you get call from a patient.
The patient is a 36-year-old woman who is 3 days postpartum after a spontaneous vaginal delivery. She has a headache and just arrived home after hospital discharge. She’s calling because after using the blood pressure cuff that the hospital sent her home with, her reading is > 150/90 mm Hg, indicating that she is hypertensive.
You try to pull up her records but realize her delivery hospital isn’t part of your system’s electronic health record. What do you do?
This scenario was presented at a session of the annual meeting of the Society of General Internal Medicine during a panel focused on providing care in the fourth trimester as patients transition between ob.gyn. care and primary care.
“If you send her to the emergency room, she might get sent home,” said Chloe A. Zera, MD, MPH, a maternal-fetal medicine specialist at Beth Israel Deaconess Medical Center, Boston. “I would strongly recommend you figure out where she delivered and tell her to go back there because she will almost certainly get readmitted for blood pressure control.”
When stepping in to treat someone who recently gave birth, Dr. Zera said that clinicians have to be mindful that though many of the deaths of mothers and infants occur on the day of birth, a substantial proportion occur within the first 6-7 weeks postpartum. Clinicians must be aware of possible complications and ask probing questions if they don’t have a patient’s medical records at hand.
“Maternal mortality is a crisis in the United States, which is probably reflective of the sort of social and political realities we’re living in right now,” said Dr. Zera, associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston. “About 700 women die each year in the U.S. from a pregnancy or its complications.”
Dr. Zera recommended that clinicians ask about patients’ birth stories specifically, at how many weeks they gave birth, what kind of delivery they had, and whether they were they induced for any reason.
“Everybody’s birth story is really important in their lives, people know the details and want to talk about their birth stories,” she said.
Starting point
Clinicians should start out by asking questions regarding how the patient delivered but also how much the baby weighed at birth.
“Both really small and really large babies are associated with later maternal complications,” Dr. Zera said. “For example, an 8-pound baby at 34 weeks is off the charts while at 42 weeks, that’s totally normal.”
Clinicians should also ask about complications prior to the birth, which might include questions regarding high blood pressure, blood sugar concerns, hospitalizations before birth, length of stay for the birth, and whether the infant had a neonatal intensive care stay.
Any of these factors can weigh into adverse pregnancy outcomes. Experiencing a hypertensive pregnancy, for example, can put patients at a higher risk for cardiovascular events, and up to 10% of all pregnancies are complicated by hypertensive disorders.
Women who experience preeclampsia have two to four times the risk for coronary heart disease.
Hypertensive pregnancies can also result in patients developing posttraumatic stress disorder, anxiety, and even producing less milk, according to Ann C. Celi, MD, MPH, an internal medicine specialist at Brigham and Women’s Hospital.
More questions
Dr. Celi, who spoke on the panel, runs a clinic that helps people transition back to a primary care provider after a hypertensive pregnancy. She said that she wants to help clinicians better manage the shift.
Clinicians can probe patients on how much sleep they’re getting and whether a support system is present back at home. These are all related to the recovery process, and Dr. Celi recommended that clinicians encourage their patients to prioritize asking for help from external sources.
“Bring in your community: ‘Do you have some best friends from work or somebody who might be able to help with meals? Is there someone in the family that could travel to help [you] as [you’re] recovering? Is the father of the baby involved? Can he help?’ ” said Dr. Celi, offering question suggestions for clinicians to ask.
Dr. Celi recommends that clinicians prescribe hypertensive-friendly birth control options as part of a follow-up care plan, such as progestin-only birth control pills.
She also recommends that clinicians evaluate women with a history of preeclampsia 3-6 months after a birth for cardiovascular risk factors, with an annual follow-up on blood pressure, body mass index, fasting glucose or A1c, and lipids.
Follow-up care
“At least 40% of people don’t even make it to that 6-week visit, and we lose them,” Dr. Zera said. “It turns out, having a pregnancy complication does not make it any more likely that you’re going to come to your postpartum visit.”
For some patients, insurance coverage often changes after delivery. For example, in states without a Medicaid extension or expansion, the program is only required to provide 60 days of coverage after delivery. Even among patients with commercial insurance, churn rates are high. People may quit their jobs and switch to the partner’s insurance or get a new job with a different insurance plan. If the new insurance doesn’t include the patient’s established clinician, the patient may switch clinicians or skip the follow-up appointment entirely.
Another barrier to care is patients feeling like their doctors don’t care about them, Dr. Zera said.
“This is kind of simple stuff, but bond with your patients,” she said. “Tell them, ‘I want to see you when you’re pregnant and beyond,’ because that makes a huge difference.”
No relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
AURORA, COLO. – Imagine that you are covering for a colleague over the weekend, and you get call from a patient.
The patient is a 36-year-old woman who is 3 days postpartum after a spontaneous vaginal delivery. She has a headache and just arrived home after hospital discharge. She’s calling because after using the blood pressure cuff that the hospital sent her home with, her reading is > 150/90 mm Hg, indicating that she is hypertensive.
You try to pull up her records but realize her delivery hospital isn’t part of your system’s electronic health record. What do you do?
This scenario was presented at a session of the annual meeting of the Society of General Internal Medicine during a panel focused on providing care in the fourth trimester as patients transition between ob.gyn. care and primary care.
“If you send her to the emergency room, she might get sent home,” said Chloe A. Zera, MD, MPH, a maternal-fetal medicine specialist at Beth Israel Deaconess Medical Center, Boston. “I would strongly recommend you figure out where she delivered and tell her to go back there because she will almost certainly get readmitted for blood pressure control.”
When stepping in to treat someone who recently gave birth, Dr. Zera said that clinicians have to be mindful that though many of the deaths of mothers and infants occur on the day of birth, a substantial proportion occur within the first 6-7 weeks postpartum. Clinicians must be aware of possible complications and ask probing questions if they don’t have a patient’s medical records at hand.
“Maternal mortality is a crisis in the United States, which is probably reflective of the sort of social and political realities we’re living in right now,” said Dr. Zera, associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston. “About 700 women die each year in the U.S. from a pregnancy or its complications.”
Dr. Zera recommended that clinicians ask about patients’ birth stories specifically, at how many weeks they gave birth, what kind of delivery they had, and whether they were they induced for any reason.
“Everybody’s birth story is really important in their lives, people know the details and want to talk about their birth stories,” she said.
Starting point
Clinicians should start out by asking questions regarding how the patient delivered but also how much the baby weighed at birth.
“Both really small and really large babies are associated with later maternal complications,” Dr. Zera said. “For example, an 8-pound baby at 34 weeks is off the charts while at 42 weeks, that’s totally normal.”
Clinicians should also ask about complications prior to the birth, which might include questions regarding high blood pressure, blood sugar concerns, hospitalizations before birth, length of stay for the birth, and whether the infant had a neonatal intensive care stay.
Any of these factors can weigh into adverse pregnancy outcomes. Experiencing a hypertensive pregnancy, for example, can put patients at a higher risk for cardiovascular events, and up to 10% of all pregnancies are complicated by hypertensive disorders.
Women who experience preeclampsia have two to four times the risk for coronary heart disease.
Hypertensive pregnancies can also result in patients developing posttraumatic stress disorder, anxiety, and even producing less milk, according to Ann C. Celi, MD, MPH, an internal medicine specialist at Brigham and Women’s Hospital.
More questions
Dr. Celi, who spoke on the panel, runs a clinic that helps people transition back to a primary care provider after a hypertensive pregnancy. She said that she wants to help clinicians better manage the shift.
Clinicians can probe patients on how much sleep they’re getting and whether a support system is present back at home. These are all related to the recovery process, and Dr. Celi recommended that clinicians encourage their patients to prioritize asking for help from external sources.
“Bring in your community: ‘Do you have some best friends from work or somebody who might be able to help with meals? Is there someone in the family that could travel to help [you] as [you’re] recovering? Is the father of the baby involved? Can he help?’ ” said Dr. Celi, offering question suggestions for clinicians to ask.
Dr. Celi recommends that clinicians prescribe hypertensive-friendly birth control options as part of a follow-up care plan, such as progestin-only birth control pills.
She also recommends that clinicians evaluate women with a history of preeclampsia 3-6 months after a birth for cardiovascular risk factors, with an annual follow-up on blood pressure, body mass index, fasting glucose or A1c, and lipids.
Follow-up care
“At least 40% of people don’t even make it to that 6-week visit, and we lose them,” Dr. Zera said. “It turns out, having a pregnancy complication does not make it any more likely that you’re going to come to your postpartum visit.”
For some patients, insurance coverage often changes after delivery. For example, in states without a Medicaid extension or expansion, the program is only required to provide 60 days of coverage after delivery. Even among patients with commercial insurance, churn rates are high. People may quit their jobs and switch to the partner’s insurance or get a new job with a different insurance plan. If the new insurance doesn’t include the patient’s established clinician, the patient may switch clinicians or skip the follow-up appointment entirely.
Another barrier to care is patients feeling like their doctors don’t care about them, Dr. Zera said.
“This is kind of simple stuff, but bond with your patients,” she said. “Tell them, ‘I want to see you when you’re pregnant and beyond,’ because that makes a huge difference.”
No relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
AT SGIM 2023
‘Robust evidence’ that exercise cuts Parkinson’s risk in women
Investigators found that among almost 99,000 women participating in the ongoing E3N study, those who exercised the most frequently had up to a 25% lower risk for PD than their less-active counterparts.
The results highlight the importance of exercising early in mid-life to prevent PD later on, study investigator Alexis Elbaz, MD, PhD, research director, French Institute of Health and Medical Research (Inserm), Paris, said in an interview.
This is especially critical since there is no cure nor disease-modifying treatments. The medications that are available are aimed at symptom reduction.
“Finding ways to prevent or delay the onset of Parkinson’s is really important, and physical activity seems to be one of the possible strategies to reduce the risk,” Dr. Elbaz said.
The study was published online in Neurology.
Direct protective effect?
Results from previous research examining the relationship physical activity and PD has been inconsistent. One meta-analysis showed a statistically significant association among men but a nonsignificant link in women.
The investigators noted that some of the findings from previous studies may have been affected by reverse causation. As nonmotor symptoms such as constipation and subtle motor signs such as tremor and balance issues can present years before a PD diagnosis, patients may reduce their physical activity because of such symptoms.
To address this potential confounder, the researchers used “lag” analyses, where data on physical activity levels in the years close to a PD diagnosis are omitted.
The study relied on data from the E3N, an ongoing cohort study of 98,995 women, born between 1925 and 1950 and recruited in 1990, who were affiliated with a French national health insurance plan that primarily covers teachers. Participants completed a questionnaire on lifestyle and medical history at baseline and follow-up questionnaires every 2-3 years.
In six of the questionnaires, participants provided details about various recreational, sports, and household activities – for example, walking, climbing stairs, gardening, and cleaning. The authors attributed metabolic equivalent of task (MET) values to each activity and multiplied METs by their frequency and duration to obtain a physical activity score.
Definite and probable PD cases were determined through self-reported physician diagnoses, anti-parkinsonian drug claims, and medical records, with diagnoses verified by an expert panel.
Researchers investigated the relationship between physical activity and PD onset in a nested-case control study that included 25,075 women (1,196 PD cases and 23,879 controls) with a mean age of 71.9 years. They found physical activity was significantly lower in cases than in controls throughout follow-up.
The difference between cases and controls began to increase at 10 years before diagnosis (P-interaction = .003). “When we looked at the trajectories of physical activity in PD patients and in controls, we saw that in the 10 years before the diagnosis, physical activity declined at a steeper rate in controls. We think this is because those subtle prodromal symptoms cause people to exercise less,” said Dr. Elbaz.
In the main analysis, which had a 10-year lag, 1,074 women developed incident PD during a mean follow-up of 17.2 years. Those in the highest quartile of physical activity had a 25% lower risk for PD vs. those in the lowest quartile (adjusted hazard ratio [HR], 0.75, 95% confidence interval [CI], 0.63-0.89).
The risk for PD decreased with increasing levels of physical activity in a linear fashion, noted Dr. Elbaz. “So doing even a little bit of physical activity is better than doing nothing at all.”
Analyses that included 15-year and 20-year lag times had similar findings.
Sensitivity analyses that adjusted for the Mediterranean diet and caffeine and dairy intake also yielded comparable results. This was also true for analyses that adjusted for comorbidities such as body mass index, hypertension, hypercholesterolemia, diabetes, and cardiovascular disease, all of which can affect PD risk.
“This gives weight to the idea that diabetes or cardiovascular diseases do not explain the relationship between physical activity and PD, which means the most likely hypothesis is that physical activity has a direct protective effect on the brain,” said Dr. Elbaz.
Studies have shown that physical activity affects brain plasticity and can reduce oxidative stress in the brain – a key mechanism involved in PD, he added.
Physical activity is a low-risk, inexpensive, and accessible intervention. But the study was not designed to determine the types of physical activity that are most protective against PD.
The study’s main limitation is that it used self-reported physical activity rather than objective measures such as accelerometers. In addition, the participants were not necessarily representative of the general population.
Robust evidence
In an accompanying editorial, Lana M. Chahine, MD, associate professor in the department of neurology at the University of Pittsburgh, and Sirwan K. L. Darweesh, MD, PhD, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Center of Expertise for Parkinson and Movement Disorders, Nijmegen, the Netherlands, said the study “provides robust evidence” that physical activity reduces risk for PD in women.
“These results show that the field is moving in the right direction and provide a clear rationale for exercise trials to prevent or delay the onset of manifest PD in at-risk individuals” they wrote.
The study highlights “gaps” in knowledge that merit closer attention and that “further insight is warranted on how much the effects on PD vary by type, intensity, frequency, and duration of physical activity,” the editorialists noted.
Another gap is how the accuracy of assessment of physical activity can be improved beyond self-report. “Wearable sensor technology now offers the potential to assess physical activity remotely and objectively in prevention trials,” they added.
Other areas that need exploring relate to mechanisms by which physical activity reduces PD risk, and to what extent effects of physical activity vary between individuals, Dr. Chahine and Dr. Darweesh noted.
Commenting for this article, Michael S. Okun, MD, executive director of the Fixel Institute for Neurological Diseases at University of Florida Health, and medical adviser for the Parkinson’s Foundation, said the findings are “significant and important.”
Based on only a handful of previous studies, it was assumed that physical activity was associated with reduced Parkinson’s diagnosis only in men, said Dr. Okun. “The current dataset was larger and included longer-term outcomes, and it informs the field that exercise may be important for reducing the risk of Parkinson’s disease in men as well as in women.”
The investigators, the editorialists, and Dr. Okun reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Investigators found that among almost 99,000 women participating in the ongoing E3N study, those who exercised the most frequently had up to a 25% lower risk for PD than their less-active counterparts.
The results highlight the importance of exercising early in mid-life to prevent PD later on, study investigator Alexis Elbaz, MD, PhD, research director, French Institute of Health and Medical Research (Inserm), Paris, said in an interview.
This is especially critical since there is no cure nor disease-modifying treatments. The medications that are available are aimed at symptom reduction.
“Finding ways to prevent or delay the onset of Parkinson’s is really important, and physical activity seems to be one of the possible strategies to reduce the risk,” Dr. Elbaz said.
The study was published online in Neurology.
Direct protective effect?
Results from previous research examining the relationship physical activity and PD has been inconsistent. One meta-analysis showed a statistically significant association among men but a nonsignificant link in women.
The investigators noted that some of the findings from previous studies may have been affected by reverse causation. As nonmotor symptoms such as constipation and subtle motor signs such as tremor and balance issues can present years before a PD diagnosis, patients may reduce their physical activity because of such symptoms.
To address this potential confounder, the researchers used “lag” analyses, where data on physical activity levels in the years close to a PD diagnosis are omitted.
The study relied on data from the E3N, an ongoing cohort study of 98,995 women, born between 1925 and 1950 and recruited in 1990, who were affiliated with a French national health insurance plan that primarily covers teachers. Participants completed a questionnaire on lifestyle and medical history at baseline and follow-up questionnaires every 2-3 years.
In six of the questionnaires, participants provided details about various recreational, sports, and household activities – for example, walking, climbing stairs, gardening, and cleaning. The authors attributed metabolic equivalent of task (MET) values to each activity and multiplied METs by their frequency and duration to obtain a physical activity score.
Definite and probable PD cases were determined through self-reported physician diagnoses, anti-parkinsonian drug claims, and medical records, with diagnoses verified by an expert panel.
Researchers investigated the relationship between physical activity and PD onset in a nested-case control study that included 25,075 women (1,196 PD cases and 23,879 controls) with a mean age of 71.9 years. They found physical activity was significantly lower in cases than in controls throughout follow-up.
The difference between cases and controls began to increase at 10 years before diagnosis (P-interaction = .003). “When we looked at the trajectories of physical activity in PD patients and in controls, we saw that in the 10 years before the diagnosis, physical activity declined at a steeper rate in controls. We think this is because those subtle prodromal symptoms cause people to exercise less,” said Dr. Elbaz.
In the main analysis, which had a 10-year lag, 1,074 women developed incident PD during a mean follow-up of 17.2 years. Those in the highest quartile of physical activity had a 25% lower risk for PD vs. those in the lowest quartile (adjusted hazard ratio [HR], 0.75, 95% confidence interval [CI], 0.63-0.89).
The risk for PD decreased with increasing levels of physical activity in a linear fashion, noted Dr. Elbaz. “So doing even a little bit of physical activity is better than doing nothing at all.”
Analyses that included 15-year and 20-year lag times had similar findings.
Sensitivity analyses that adjusted for the Mediterranean diet and caffeine and dairy intake also yielded comparable results. This was also true for analyses that adjusted for comorbidities such as body mass index, hypertension, hypercholesterolemia, diabetes, and cardiovascular disease, all of which can affect PD risk.
“This gives weight to the idea that diabetes or cardiovascular diseases do not explain the relationship between physical activity and PD, which means the most likely hypothesis is that physical activity has a direct protective effect on the brain,” said Dr. Elbaz.
Studies have shown that physical activity affects brain plasticity and can reduce oxidative stress in the brain – a key mechanism involved in PD, he added.
Physical activity is a low-risk, inexpensive, and accessible intervention. But the study was not designed to determine the types of physical activity that are most protective against PD.
The study’s main limitation is that it used self-reported physical activity rather than objective measures such as accelerometers. In addition, the participants were not necessarily representative of the general population.
Robust evidence
In an accompanying editorial, Lana M. Chahine, MD, associate professor in the department of neurology at the University of Pittsburgh, and Sirwan K. L. Darweesh, MD, PhD, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Center of Expertise for Parkinson and Movement Disorders, Nijmegen, the Netherlands, said the study “provides robust evidence” that physical activity reduces risk for PD in women.
“These results show that the field is moving in the right direction and provide a clear rationale for exercise trials to prevent or delay the onset of manifest PD in at-risk individuals” they wrote.
The study highlights “gaps” in knowledge that merit closer attention and that “further insight is warranted on how much the effects on PD vary by type, intensity, frequency, and duration of physical activity,” the editorialists noted.
Another gap is how the accuracy of assessment of physical activity can be improved beyond self-report. “Wearable sensor technology now offers the potential to assess physical activity remotely and objectively in prevention trials,” they added.
Other areas that need exploring relate to mechanisms by which physical activity reduces PD risk, and to what extent effects of physical activity vary between individuals, Dr. Chahine and Dr. Darweesh noted.
Commenting for this article, Michael S. Okun, MD, executive director of the Fixel Institute for Neurological Diseases at University of Florida Health, and medical adviser for the Parkinson’s Foundation, said the findings are “significant and important.”
Based on only a handful of previous studies, it was assumed that physical activity was associated with reduced Parkinson’s diagnosis only in men, said Dr. Okun. “The current dataset was larger and included longer-term outcomes, and it informs the field that exercise may be important for reducing the risk of Parkinson’s disease in men as well as in women.”
The investigators, the editorialists, and Dr. Okun reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Investigators found that among almost 99,000 women participating in the ongoing E3N study, those who exercised the most frequently had up to a 25% lower risk for PD than their less-active counterparts.
The results highlight the importance of exercising early in mid-life to prevent PD later on, study investigator Alexis Elbaz, MD, PhD, research director, French Institute of Health and Medical Research (Inserm), Paris, said in an interview.
This is especially critical since there is no cure nor disease-modifying treatments. The medications that are available are aimed at symptom reduction.
“Finding ways to prevent or delay the onset of Parkinson’s is really important, and physical activity seems to be one of the possible strategies to reduce the risk,” Dr. Elbaz said.
The study was published online in Neurology.
Direct protective effect?
Results from previous research examining the relationship physical activity and PD has been inconsistent. One meta-analysis showed a statistically significant association among men but a nonsignificant link in women.
The investigators noted that some of the findings from previous studies may have been affected by reverse causation. As nonmotor symptoms such as constipation and subtle motor signs such as tremor and balance issues can present years before a PD diagnosis, patients may reduce their physical activity because of such symptoms.
To address this potential confounder, the researchers used “lag” analyses, where data on physical activity levels in the years close to a PD diagnosis are omitted.
The study relied on data from the E3N, an ongoing cohort study of 98,995 women, born between 1925 and 1950 and recruited in 1990, who were affiliated with a French national health insurance plan that primarily covers teachers. Participants completed a questionnaire on lifestyle and medical history at baseline and follow-up questionnaires every 2-3 years.
In six of the questionnaires, participants provided details about various recreational, sports, and household activities – for example, walking, climbing stairs, gardening, and cleaning. The authors attributed metabolic equivalent of task (MET) values to each activity and multiplied METs by their frequency and duration to obtain a physical activity score.
Definite and probable PD cases were determined through self-reported physician diagnoses, anti-parkinsonian drug claims, and medical records, with diagnoses verified by an expert panel.
Researchers investigated the relationship between physical activity and PD onset in a nested-case control study that included 25,075 women (1,196 PD cases and 23,879 controls) with a mean age of 71.9 years. They found physical activity was significantly lower in cases than in controls throughout follow-up.
The difference between cases and controls began to increase at 10 years before diagnosis (P-interaction = .003). “When we looked at the trajectories of physical activity in PD patients and in controls, we saw that in the 10 years before the diagnosis, physical activity declined at a steeper rate in controls. We think this is because those subtle prodromal symptoms cause people to exercise less,” said Dr. Elbaz.
In the main analysis, which had a 10-year lag, 1,074 women developed incident PD during a mean follow-up of 17.2 years. Those in the highest quartile of physical activity had a 25% lower risk for PD vs. those in the lowest quartile (adjusted hazard ratio [HR], 0.75, 95% confidence interval [CI], 0.63-0.89).
The risk for PD decreased with increasing levels of physical activity in a linear fashion, noted Dr. Elbaz. “So doing even a little bit of physical activity is better than doing nothing at all.”
Analyses that included 15-year and 20-year lag times had similar findings.
Sensitivity analyses that adjusted for the Mediterranean diet and caffeine and dairy intake also yielded comparable results. This was also true for analyses that adjusted for comorbidities such as body mass index, hypertension, hypercholesterolemia, diabetes, and cardiovascular disease, all of which can affect PD risk.
“This gives weight to the idea that diabetes or cardiovascular diseases do not explain the relationship between physical activity and PD, which means the most likely hypothesis is that physical activity has a direct protective effect on the brain,” said Dr. Elbaz.
Studies have shown that physical activity affects brain plasticity and can reduce oxidative stress in the brain – a key mechanism involved in PD, he added.
Physical activity is a low-risk, inexpensive, and accessible intervention. But the study was not designed to determine the types of physical activity that are most protective against PD.
The study’s main limitation is that it used self-reported physical activity rather than objective measures such as accelerometers. In addition, the participants were not necessarily representative of the general population.
Robust evidence
In an accompanying editorial, Lana M. Chahine, MD, associate professor in the department of neurology at the University of Pittsburgh, and Sirwan K. L. Darweesh, MD, PhD, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Center of Expertise for Parkinson and Movement Disorders, Nijmegen, the Netherlands, said the study “provides robust evidence” that physical activity reduces risk for PD in women.
“These results show that the field is moving in the right direction and provide a clear rationale for exercise trials to prevent or delay the onset of manifest PD in at-risk individuals” they wrote.
The study highlights “gaps” in knowledge that merit closer attention and that “further insight is warranted on how much the effects on PD vary by type, intensity, frequency, and duration of physical activity,” the editorialists noted.
Another gap is how the accuracy of assessment of physical activity can be improved beyond self-report. “Wearable sensor technology now offers the potential to assess physical activity remotely and objectively in prevention trials,” they added.
Other areas that need exploring relate to mechanisms by which physical activity reduces PD risk, and to what extent effects of physical activity vary between individuals, Dr. Chahine and Dr. Darweesh noted.
Commenting for this article, Michael S. Okun, MD, executive director of the Fixel Institute for Neurological Diseases at University of Florida Health, and medical adviser for the Parkinson’s Foundation, said the findings are “significant and important.”
Based on only a handful of previous studies, it was assumed that physical activity was associated with reduced Parkinson’s diagnosis only in men, said Dr. Okun. “The current dataset was larger and included longer-term outcomes, and it informs the field that exercise may be important for reducing the risk of Parkinson’s disease in men as well as in women.”
The investigators, the editorialists, and Dr. Okun reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM NEUROLOGY
Breast cancer survivors need a comprehensive care plan, says doctor
said Patricia A. Ganz, MD, during a presentation at the European Society for Medical Oncology Breast Cancer annual congress.
Several studies suggest that many breast cancer patients are not well prepared to move forward after a breast cancer diagnosis and subsequent treatments, continued Dr. Ganz, who works at the UCLA Jonsson Comprehensive Cancer Center, Los Angeles.
Meeting the survivorship needs of breast cancer patients requires addressing both their physical and psychosocial needs, Dr. Ganz said. She explained how to achieve that, but first pointed to research elaborating on what's missing from some breast cancer survivors' care and barriers to these patients having their variety of health-related needs met.
In a 2021 study published in the Journal of Cancer Survivorship, Dr. Ganz and colleagues conducted a survey of approximately 200 medical oncologists in the United States. They determined that less than 50% provide survivorship care plans to patients at the end of treatment or communicate with patients’ other physicians about follow-up care.
In a secondary analysis of data from the same survey published in 2022 in Breast Cancer Research and Treatment, Dr. Ganz and colleagues examined medical oncologists’ perceived barriers to addressing both physical and psychosocial long-term effects in breast cancer survivors. For both, lack of time was the greatest perceived barrier, cited by nearly two-thirds of oncologists. Other barriers to addressing physical effects included lack of evidence-based, effective interventions, lack of clinical algorithms to guide care, and ambiguity regarding professional responsibility at the end of treatment. Other top barriers to addressing psychosocial issues included lack of mental health providers, lack of psychosocial resources, and lack of clinician knowledge and skills.
Data from additional studies suggest that, overall, cancer patients with greater physical burdens, such as more complex and lengthy treatment regimens, also have greater psychosocial needs, Dr. Ganz noted. Plus, approximately 15%-20% of cancer survivors have ongoing anxiety and depressive symptoms.
Shift to primary care
As more breast cancer and other cancer patients survive for longer periods, more care will likely occur in general medical settings, Dr. Ganz said. Issues to be addressed will include the potential increased risk of comorbid conditions for these survivors, and whether survivorship interventions earlier in the disease trajectory will impact survivorship. For cancer patients who achieve remission after treatment, the first 5 years after a diagnosis involves treatment and short-term surveillance for late effects. Beyond 5 years, care for cancer survivors mainly involves primary care and management of any comorbid conditions, as well as surveillance for late effects and recurrences, and awareness of new research.
A patient consultation early in the process after diagnosis is the start of a continuum of care, Dr. Ganz said. A patient consultation should address symptoms related to initial treatments, such as neuropathy, pain, fatigue, and insomnia, as well as the psychological symptoms of anxiety and depression. An early consultation also should evaluate adherence to endocrine therapy and management of symptoms, if needed, with the larger goal of preparing patients for recovery and the transition to survivorship, and what to expect for long-term follow-up.
Delivering the three P’s
The “Three P’s” of survivor care for breast cancer patients are palliation, prevention, and promotion of health, according to Dr. Ganz .
The first “P,” for palliative, is a key part of survivorship care, said Dr. Ganz. Palliative care is defined as care that focuses on reducing symptom severity and improving quality of life. The biological effects of cancer treatment can be associated with physical effects, such as functional limitations and frailty, and behavioral/cognitive effects such as depression, fatigue, and cognitive deficits, she said. To manage these effects and provide palliative care, consultation is needed with specialists in relevant areas including mental health, pain management, physical medicine/rehabilitation, endocrinology, cardiology, and neurology.
The second “P,” which is for prevention in survivorship care, refers to ongoing follow-up screening to identify any potentially serious late-onset complications such as osteoporosis or cardiac disease so they can be addressed, said Dr. Ganz. Other considerations include chemoprevention if available and genetic counseling for patients with hereditary cancers. Prevention also includes counseling patients about lifestyle modifications to help prevent additional cancer.
The goal of the third “P,” which is for health promotion, is to promote risk reduction for the health problems associated with accelerated aging that may arise in cancer survivors, said Dr. Ganz.
Health promotion strategies include maintaining a healthy weight, increasing physical activity, and avoiding harmful exposures, she said. Healthy lifestyle interventions can also reduce the risk of other chronic diseases such as diabetes and heart disease.
To that end, Dr. Ganz outlined several behavioral interventions that may mitigate the effects of cancer treatment on the accelerated aging process, including stress reduction in the form of meditation or yoga, cognitive behavioral therapy, improving sleep, increasing physical activity, reducing obesity, and decreasing tobacco and alcohol use. These interventions may help reduce inflammation and promote tissue repair and healing.
For cancer survivors, the life span may be longer than the health span, and these patients may benefit from an integrated model of care, with systematic screening and consolidated appointments, rather than a fragmented model in which departments and referrals are siloed, which may result in conflicting advice or redundancy, said Dr. Ganz.
Looking ahead, more research is needed to explore models of care delivery, as requirements for survivor care will vary among patients and care settings, Dr. Ganz said.
However, regardless of setting, treatment plans and shared decision-making can help reduce potential long-term or late-emerging effects, she said. Developing a survivorship care plan can help patients learn how to enhance their recovery.
During a question and answer session, Dr. Ganz was asked about whether hormone therapy could be used for patients with hormone negative breast cancer. “I think vaginal estrogen can be used if someone is on tamoxifen,” she said. However, “we need to be cautious” in case there are remaining estrogen positive cells, in order to avoid potential metastases, and use of hormone therapy in breast cancer survivors is an individualized decision based in part on quality of life.
Engaging a patient’s partner early can be helpful
If possible, engage the patient’s partner in survivorship discussions, said Luzia Travado, PhD, head of psycho-oncology at the Champalimaud Foundation, Lisbon, who presented on the topic of sexuality and commented on survivorship during the discussion. For those women with partners, engaging the partner early in treatment often means they are more likely to play a larger role in the post treatment and long term by providing stability and emotional support.
“Make sure partners are engaged and understand that they have a role, and that this role is valued,” she said. Unfortunately, there are a lot of divorced women with breast cancer, as the disease can take a toll on relationships. However, remember “sexuality is not just sex; it is caring, loving, and intimacy.”
“To end on a positive note, it is important to empower patients, and to give them self-management skills so they can make things even better in their survivorship,” said Dr. Ganz. In spite of discussing difficulties and challenges, one of the goals of the session was to offer potential solutions and answers.
Dr. Ganz disclosed serving as editor of the cancer survivorship section on Up-to-Date, and serving as a consultant for Blue Note Therapeutics, GRAIL, InformedDNA, and Roche-Genentech. Dr. Travado had no relevant financial conflicts to disclose.
said Patricia A. Ganz, MD, during a presentation at the European Society for Medical Oncology Breast Cancer annual congress.
Several studies suggest that many breast cancer patients are not well prepared to move forward after a breast cancer diagnosis and subsequent treatments, continued Dr. Ganz, who works at the UCLA Jonsson Comprehensive Cancer Center, Los Angeles.
Meeting the survivorship needs of breast cancer patients requires addressing both their physical and psychosocial needs, Dr. Ganz said. She explained how to achieve that, but first pointed to research elaborating on what's missing from some breast cancer survivors' care and barriers to these patients having their variety of health-related needs met.
In a 2021 study published in the Journal of Cancer Survivorship, Dr. Ganz and colleagues conducted a survey of approximately 200 medical oncologists in the United States. They determined that less than 50% provide survivorship care plans to patients at the end of treatment or communicate with patients’ other physicians about follow-up care.
In a secondary analysis of data from the same survey published in 2022 in Breast Cancer Research and Treatment, Dr. Ganz and colleagues examined medical oncologists’ perceived barriers to addressing both physical and psychosocial long-term effects in breast cancer survivors. For both, lack of time was the greatest perceived barrier, cited by nearly two-thirds of oncologists. Other barriers to addressing physical effects included lack of evidence-based, effective interventions, lack of clinical algorithms to guide care, and ambiguity regarding professional responsibility at the end of treatment. Other top barriers to addressing psychosocial issues included lack of mental health providers, lack of psychosocial resources, and lack of clinician knowledge and skills.
Data from additional studies suggest that, overall, cancer patients with greater physical burdens, such as more complex and lengthy treatment regimens, also have greater psychosocial needs, Dr. Ganz noted. Plus, approximately 15%-20% of cancer survivors have ongoing anxiety and depressive symptoms.
Shift to primary care
As more breast cancer and other cancer patients survive for longer periods, more care will likely occur in general medical settings, Dr. Ganz said. Issues to be addressed will include the potential increased risk of comorbid conditions for these survivors, and whether survivorship interventions earlier in the disease trajectory will impact survivorship. For cancer patients who achieve remission after treatment, the first 5 years after a diagnosis involves treatment and short-term surveillance for late effects. Beyond 5 years, care for cancer survivors mainly involves primary care and management of any comorbid conditions, as well as surveillance for late effects and recurrences, and awareness of new research.
A patient consultation early in the process after diagnosis is the start of a continuum of care, Dr. Ganz said. A patient consultation should address symptoms related to initial treatments, such as neuropathy, pain, fatigue, and insomnia, as well as the psychological symptoms of anxiety and depression. An early consultation also should evaluate adherence to endocrine therapy and management of symptoms, if needed, with the larger goal of preparing patients for recovery and the transition to survivorship, and what to expect for long-term follow-up.
Delivering the three P’s
The “Three P’s” of survivor care for breast cancer patients are palliation, prevention, and promotion of health, according to Dr. Ganz .
The first “P,” for palliative, is a key part of survivorship care, said Dr. Ganz. Palliative care is defined as care that focuses on reducing symptom severity and improving quality of life. The biological effects of cancer treatment can be associated with physical effects, such as functional limitations and frailty, and behavioral/cognitive effects such as depression, fatigue, and cognitive deficits, she said. To manage these effects and provide palliative care, consultation is needed with specialists in relevant areas including mental health, pain management, physical medicine/rehabilitation, endocrinology, cardiology, and neurology.
The second “P,” which is for prevention in survivorship care, refers to ongoing follow-up screening to identify any potentially serious late-onset complications such as osteoporosis or cardiac disease so they can be addressed, said Dr. Ganz. Other considerations include chemoprevention if available and genetic counseling for patients with hereditary cancers. Prevention also includes counseling patients about lifestyle modifications to help prevent additional cancer.
The goal of the third “P,” which is for health promotion, is to promote risk reduction for the health problems associated with accelerated aging that may arise in cancer survivors, said Dr. Ganz.
Health promotion strategies include maintaining a healthy weight, increasing physical activity, and avoiding harmful exposures, she said. Healthy lifestyle interventions can also reduce the risk of other chronic diseases such as diabetes and heart disease.
To that end, Dr. Ganz outlined several behavioral interventions that may mitigate the effects of cancer treatment on the accelerated aging process, including stress reduction in the form of meditation or yoga, cognitive behavioral therapy, improving sleep, increasing physical activity, reducing obesity, and decreasing tobacco and alcohol use. These interventions may help reduce inflammation and promote tissue repair and healing.
For cancer survivors, the life span may be longer than the health span, and these patients may benefit from an integrated model of care, with systematic screening and consolidated appointments, rather than a fragmented model in which departments and referrals are siloed, which may result in conflicting advice or redundancy, said Dr. Ganz.
Looking ahead, more research is needed to explore models of care delivery, as requirements for survivor care will vary among patients and care settings, Dr. Ganz said.
However, regardless of setting, treatment plans and shared decision-making can help reduce potential long-term or late-emerging effects, she said. Developing a survivorship care plan can help patients learn how to enhance their recovery.
During a question and answer session, Dr. Ganz was asked about whether hormone therapy could be used for patients with hormone negative breast cancer. “I think vaginal estrogen can be used if someone is on tamoxifen,” she said. However, “we need to be cautious” in case there are remaining estrogen positive cells, in order to avoid potential metastases, and use of hormone therapy in breast cancer survivors is an individualized decision based in part on quality of life.
Engaging a patient’s partner early can be helpful
If possible, engage the patient’s partner in survivorship discussions, said Luzia Travado, PhD, head of psycho-oncology at the Champalimaud Foundation, Lisbon, who presented on the topic of sexuality and commented on survivorship during the discussion. For those women with partners, engaging the partner early in treatment often means they are more likely to play a larger role in the post treatment and long term by providing stability and emotional support.
“Make sure partners are engaged and understand that they have a role, and that this role is valued,” she said. Unfortunately, there are a lot of divorced women with breast cancer, as the disease can take a toll on relationships. However, remember “sexuality is not just sex; it is caring, loving, and intimacy.”
“To end on a positive note, it is important to empower patients, and to give them self-management skills so they can make things even better in their survivorship,” said Dr. Ganz. In spite of discussing difficulties and challenges, one of the goals of the session was to offer potential solutions and answers.
Dr. Ganz disclosed serving as editor of the cancer survivorship section on Up-to-Date, and serving as a consultant for Blue Note Therapeutics, GRAIL, InformedDNA, and Roche-Genentech. Dr. Travado had no relevant financial conflicts to disclose.
said Patricia A. Ganz, MD, during a presentation at the European Society for Medical Oncology Breast Cancer annual congress.
Several studies suggest that many breast cancer patients are not well prepared to move forward after a breast cancer diagnosis and subsequent treatments, continued Dr. Ganz, who works at the UCLA Jonsson Comprehensive Cancer Center, Los Angeles.
Meeting the survivorship needs of breast cancer patients requires addressing both their physical and psychosocial needs, Dr. Ganz said. She explained how to achieve that, but first pointed to research elaborating on what's missing from some breast cancer survivors' care and barriers to these patients having their variety of health-related needs met.
In a 2021 study published in the Journal of Cancer Survivorship, Dr. Ganz and colleagues conducted a survey of approximately 200 medical oncologists in the United States. They determined that less than 50% provide survivorship care plans to patients at the end of treatment or communicate with patients’ other physicians about follow-up care.
In a secondary analysis of data from the same survey published in 2022 in Breast Cancer Research and Treatment, Dr. Ganz and colleagues examined medical oncologists’ perceived barriers to addressing both physical and psychosocial long-term effects in breast cancer survivors. For both, lack of time was the greatest perceived barrier, cited by nearly two-thirds of oncologists. Other barriers to addressing physical effects included lack of evidence-based, effective interventions, lack of clinical algorithms to guide care, and ambiguity regarding professional responsibility at the end of treatment. Other top barriers to addressing psychosocial issues included lack of mental health providers, lack of psychosocial resources, and lack of clinician knowledge and skills.
Data from additional studies suggest that, overall, cancer patients with greater physical burdens, such as more complex and lengthy treatment regimens, also have greater psychosocial needs, Dr. Ganz noted. Plus, approximately 15%-20% of cancer survivors have ongoing anxiety and depressive symptoms.
Shift to primary care
As more breast cancer and other cancer patients survive for longer periods, more care will likely occur in general medical settings, Dr. Ganz said. Issues to be addressed will include the potential increased risk of comorbid conditions for these survivors, and whether survivorship interventions earlier in the disease trajectory will impact survivorship. For cancer patients who achieve remission after treatment, the first 5 years after a diagnosis involves treatment and short-term surveillance for late effects. Beyond 5 years, care for cancer survivors mainly involves primary care and management of any comorbid conditions, as well as surveillance for late effects and recurrences, and awareness of new research.
A patient consultation early in the process after diagnosis is the start of a continuum of care, Dr. Ganz said. A patient consultation should address symptoms related to initial treatments, such as neuropathy, pain, fatigue, and insomnia, as well as the psychological symptoms of anxiety and depression. An early consultation also should evaluate adherence to endocrine therapy and management of symptoms, if needed, with the larger goal of preparing patients for recovery and the transition to survivorship, and what to expect for long-term follow-up.
Delivering the three P’s
The “Three P’s” of survivor care for breast cancer patients are palliation, prevention, and promotion of health, according to Dr. Ganz .
The first “P,” for palliative, is a key part of survivorship care, said Dr. Ganz. Palliative care is defined as care that focuses on reducing symptom severity and improving quality of life. The biological effects of cancer treatment can be associated with physical effects, such as functional limitations and frailty, and behavioral/cognitive effects such as depression, fatigue, and cognitive deficits, she said. To manage these effects and provide palliative care, consultation is needed with specialists in relevant areas including mental health, pain management, physical medicine/rehabilitation, endocrinology, cardiology, and neurology.
The second “P,” which is for prevention in survivorship care, refers to ongoing follow-up screening to identify any potentially serious late-onset complications such as osteoporosis or cardiac disease so they can be addressed, said Dr. Ganz. Other considerations include chemoprevention if available and genetic counseling for patients with hereditary cancers. Prevention also includes counseling patients about lifestyle modifications to help prevent additional cancer.
The goal of the third “P,” which is for health promotion, is to promote risk reduction for the health problems associated with accelerated aging that may arise in cancer survivors, said Dr. Ganz.
Health promotion strategies include maintaining a healthy weight, increasing physical activity, and avoiding harmful exposures, she said. Healthy lifestyle interventions can also reduce the risk of other chronic diseases such as diabetes and heart disease.
To that end, Dr. Ganz outlined several behavioral interventions that may mitigate the effects of cancer treatment on the accelerated aging process, including stress reduction in the form of meditation or yoga, cognitive behavioral therapy, improving sleep, increasing physical activity, reducing obesity, and decreasing tobacco and alcohol use. These interventions may help reduce inflammation and promote tissue repair and healing.
For cancer survivors, the life span may be longer than the health span, and these patients may benefit from an integrated model of care, with systematic screening and consolidated appointments, rather than a fragmented model in which departments and referrals are siloed, which may result in conflicting advice or redundancy, said Dr. Ganz.
Looking ahead, more research is needed to explore models of care delivery, as requirements for survivor care will vary among patients and care settings, Dr. Ganz said.
However, regardless of setting, treatment plans and shared decision-making can help reduce potential long-term or late-emerging effects, she said. Developing a survivorship care plan can help patients learn how to enhance their recovery.
During a question and answer session, Dr. Ganz was asked about whether hormone therapy could be used for patients with hormone negative breast cancer. “I think vaginal estrogen can be used if someone is on tamoxifen,” she said. However, “we need to be cautious” in case there are remaining estrogen positive cells, in order to avoid potential metastases, and use of hormone therapy in breast cancer survivors is an individualized decision based in part on quality of life.
Engaging a patient’s partner early can be helpful
If possible, engage the patient’s partner in survivorship discussions, said Luzia Travado, PhD, head of psycho-oncology at the Champalimaud Foundation, Lisbon, who presented on the topic of sexuality and commented on survivorship during the discussion. For those women with partners, engaging the partner early in treatment often means they are more likely to play a larger role in the post treatment and long term by providing stability and emotional support.
“Make sure partners are engaged and understand that they have a role, and that this role is valued,” she said. Unfortunately, there are a lot of divorced women with breast cancer, as the disease can take a toll on relationships. However, remember “sexuality is not just sex; it is caring, loving, and intimacy.”
“To end on a positive note, it is important to empower patients, and to give them self-management skills so they can make things even better in their survivorship,” said Dr. Ganz. In spite of discussing difficulties and challenges, one of the goals of the session was to offer potential solutions and answers.
Dr. Ganz disclosed serving as editor of the cancer survivorship section on Up-to-Date, and serving as a consultant for Blue Note Therapeutics, GRAIL, InformedDNA, and Roche-Genentech. Dr. Travado had no relevant financial conflicts to disclose.
FROM ESMO BREAST CANCER 2023
Mailed HPV test kits boost cervical cancer screening
The self-sampling kits, which detect human papillomavirus (HPV), are available only for use in clinical trials, but the researchers hope that eventually these kits will be approved for use by the general public.
The researchers, from the University of North Carolina, explored use of these kits in the My Body, My Test-3 study, which was published online in The Lancet Public Health.
In a commentary published with the study, Runzhi Wang, MD, and Jennell Coleman, MD, MPH, both of Johns Hopkins University, Baltimore, said it “provides the required evidence that ... self-collected samples can be an effective strategy for hard-to-reach populations.”
The study involved 665 women (aged 25-64) in North Carolina who were either uninsured or enrolled in Medicaid or Medicare. The patients had low-income backgrounds and lived in urban areas. More than half self-reported as Black or Hispanic (55%), uninsured (78%) or unemployed (57%). None had a Pap smear in at least 4 years or a high-risk HPV test in the last 6 years.
Two-thirds of the women were mailed an HPV self-collection kit and received assistance with scheduling an in-person screening appointment. The kit included a Viba-Brush device, which is inserted into the vagina like a tampon to collect the sample.
The other third of women, the control group, only received scheduling assistance.
The team found that mailing the self-collection tests along with helping women book in-clinic appointments improved screening rates twofold, compared with just assisting patients to schedule an appointment.
Screening success among those who received the at-home collection kit was 72%, compared with 37% in the control group.
Of those who received the kits, 78% returned them. This is “impressive,” said Dr. Wang and Dr. Coleman, as previous studies have reported return rates of only 8%-20%.
About 23% of eligible women are overdue for cervical cancer screening by at least a year, according to the National Cancer Institute. Jennifer Smith, PhD, MPH, professor of epidemiology at the University of North Carolina at Chapel Hill and an author of the study, believes every woman deserves equal access to cervical screening.
“I think we really need to make efforts to increase cervical cancer screening among women who are overdue for screening by a year or more from the recommended guidelines,” Dr. Smith said. “We’ve proven along with the wide evidence both in the U.S. and globally that self-collection intervention works well and can motivate screening uptake by breaking down barriers for populations that have less access to care.”
“We’re hoping this research in combination with all of the extensive evidence on the positive performance of HPV self-collection will provide additional information to be considered by the FDA for approval of the kits for primary screening,” Dr. Smith said.
“Government approval of at-home HPV tests would have a huge impact,” said coauthor Noel Brewer, PhD, also of UNC Chapel Hill. “We could better reach those in rural areas where cervical cancer screening is hard to come by.”
Dr. Smith has received research grants, supply donations, and consultancies for Hologic and BD Diagnostics. Dr. Brewer, Dr. Wang, and Dr. Coleman reported no conflicts of interest.
A version of this article first appeared on WebMD.com.
The self-sampling kits, which detect human papillomavirus (HPV), are available only for use in clinical trials, but the researchers hope that eventually these kits will be approved for use by the general public.
The researchers, from the University of North Carolina, explored use of these kits in the My Body, My Test-3 study, which was published online in The Lancet Public Health.
In a commentary published with the study, Runzhi Wang, MD, and Jennell Coleman, MD, MPH, both of Johns Hopkins University, Baltimore, said it “provides the required evidence that ... self-collected samples can be an effective strategy for hard-to-reach populations.”
The study involved 665 women (aged 25-64) in North Carolina who were either uninsured or enrolled in Medicaid or Medicare. The patients had low-income backgrounds and lived in urban areas. More than half self-reported as Black or Hispanic (55%), uninsured (78%) or unemployed (57%). None had a Pap smear in at least 4 years or a high-risk HPV test in the last 6 years.
Two-thirds of the women were mailed an HPV self-collection kit and received assistance with scheduling an in-person screening appointment. The kit included a Viba-Brush device, which is inserted into the vagina like a tampon to collect the sample.
The other third of women, the control group, only received scheduling assistance.
The team found that mailing the self-collection tests along with helping women book in-clinic appointments improved screening rates twofold, compared with just assisting patients to schedule an appointment.
Screening success among those who received the at-home collection kit was 72%, compared with 37% in the control group.
Of those who received the kits, 78% returned them. This is “impressive,” said Dr. Wang and Dr. Coleman, as previous studies have reported return rates of only 8%-20%.
About 23% of eligible women are overdue for cervical cancer screening by at least a year, according to the National Cancer Institute. Jennifer Smith, PhD, MPH, professor of epidemiology at the University of North Carolina at Chapel Hill and an author of the study, believes every woman deserves equal access to cervical screening.
“I think we really need to make efforts to increase cervical cancer screening among women who are overdue for screening by a year or more from the recommended guidelines,” Dr. Smith said. “We’ve proven along with the wide evidence both in the U.S. and globally that self-collection intervention works well and can motivate screening uptake by breaking down barriers for populations that have less access to care.”
“We’re hoping this research in combination with all of the extensive evidence on the positive performance of HPV self-collection will provide additional information to be considered by the FDA for approval of the kits for primary screening,” Dr. Smith said.
“Government approval of at-home HPV tests would have a huge impact,” said coauthor Noel Brewer, PhD, also of UNC Chapel Hill. “We could better reach those in rural areas where cervical cancer screening is hard to come by.”
Dr. Smith has received research grants, supply donations, and consultancies for Hologic and BD Diagnostics. Dr. Brewer, Dr. Wang, and Dr. Coleman reported no conflicts of interest.
A version of this article first appeared on WebMD.com.
The self-sampling kits, which detect human papillomavirus (HPV), are available only for use in clinical trials, but the researchers hope that eventually these kits will be approved for use by the general public.
The researchers, from the University of North Carolina, explored use of these kits in the My Body, My Test-3 study, which was published online in The Lancet Public Health.
In a commentary published with the study, Runzhi Wang, MD, and Jennell Coleman, MD, MPH, both of Johns Hopkins University, Baltimore, said it “provides the required evidence that ... self-collected samples can be an effective strategy for hard-to-reach populations.”
The study involved 665 women (aged 25-64) in North Carolina who were either uninsured or enrolled in Medicaid or Medicare. The patients had low-income backgrounds and lived in urban areas. More than half self-reported as Black or Hispanic (55%), uninsured (78%) or unemployed (57%). None had a Pap smear in at least 4 years or a high-risk HPV test in the last 6 years.
Two-thirds of the women were mailed an HPV self-collection kit and received assistance with scheduling an in-person screening appointment. The kit included a Viba-Brush device, which is inserted into the vagina like a tampon to collect the sample.
The other third of women, the control group, only received scheduling assistance.
The team found that mailing the self-collection tests along with helping women book in-clinic appointments improved screening rates twofold, compared with just assisting patients to schedule an appointment.
Screening success among those who received the at-home collection kit was 72%, compared with 37% in the control group.
Of those who received the kits, 78% returned them. This is “impressive,” said Dr. Wang and Dr. Coleman, as previous studies have reported return rates of only 8%-20%.
About 23% of eligible women are overdue for cervical cancer screening by at least a year, according to the National Cancer Institute. Jennifer Smith, PhD, MPH, professor of epidemiology at the University of North Carolina at Chapel Hill and an author of the study, believes every woman deserves equal access to cervical screening.
“I think we really need to make efforts to increase cervical cancer screening among women who are overdue for screening by a year or more from the recommended guidelines,” Dr. Smith said. “We’ve proven along with the wide evidence both in the U.S. and globally that self-collection intervention works well and can motivate screening uptake by breaking down barriers for populations that have less access to care.”
“We’re hoping this research in combination with all of the extensive evidence on the positive performance of HPV self-collection will provide additional information to be considered by the FDA for approval of the kits for primary screening,” Dr. Smith said.
“Government approval of at-home HPV tests would have a huge impact,” said coauthor Noel Brewer, PhD, also of UNC Chapel Hill. “We could better reach those in rural areas where cervical cancer screening is hard to come by.”
Dr. Smith has received research grants, supply donations, and consultancies for Hologic and BD Diagnostics. Dr. Brewer, Dr. Wang, and Dr. Coleman reported no conflicts of interest.
A version of this article first appeared on WebMD.com.
FROM THE LANCET PUBLIC HEALTH
Gestational HTN, preeclampsia worsen long-term risk for ischemic, nonischemic heart failure
, an observational study suggests.
The risks were most pronounced, jumping more than sixfold in the case of ischemic HF, during the first 6 years after the pregnancy. They then receded to plateau at a lower, still significantly elevated level of risk that persisted even years later, in the analysis of women in a Swedish medical birth registry.
The case-matching study compared women with no history of cardiovascular (CV) disease and a first successful pregnancy during which they either developed or did not experience gestational hypertension or preeclampsia.
It’s among the first studies to explore the impact of pregnancy-induced hypertensive disease on subsequent HF risk separately for both ischemic and nonischemic HF and to find that the severity of such risk differs for the two HF etiologies, according to a report published in JACC: Heart Failure.
The adjusted risk for any HF during a median of 13 years after the pregnancy rose 70% for those who had developed gestational hypertension or preeclampsia. Their risk of nonischemic HF went up 60%, and their risk of ischemic HF more than doubled.
Hypertensive disorders of pregnancy “are so much more than short-term disorders confined to the pregnancy period. They have long-term implications throughout a lifetime,” lead author Ängla Mantel, MD, PhD, said in an interview.
Obstetric history doesn’t figure into any formal HF risk scoring systems, observed Dr. Mantel of Karolinska Institutet, Stockholm. Still, women who develop gestational hypertension, preeclampsia, or other pregnancy complications “should be considered a high-risk population even after the pregnancy and monitored for cardiovascular risk factors regularly throughout life.”
In many studies, she said, “knowledge of women-specific risk factors for cardiovascular disease is poor among both clinicians and patients.” The current findings should help raise awareness about such obstetric risk factors for HF, “especially” in patients with HF with preserved ejection fraction (HFpEF), which isn’t closely related to a number of traditional CV risk factors.
Even though pregnancy complications such as gestational hypertension and preeclampsia don’t feature in risk calculators, “they are actually risk enhancers per the 2019 primary prevention guidelines,” Natalie A. Bello, MD, MPH, who was not involved in the current study, said in an interview.
“We’re working to educate physicians and cardiovascular team members to take a pregnancy history” for risk stratification of women in primary prevention,” said Dr. Bello, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles.
The current study, she said, “is an important step” for its finding that hypertensive disorders of pregnancy are associated separately with both ischemic and nonischemic HF.
She pointed out, however, that because the study excluded women with peripartum cardiomyopathy, a form of nonischemic HF, it may “underestimate the impact of hypertensive disorders on the short-term risk of nonischemic heart failure.” Women who had peripartum cardiomyopathy were excluded to avoid misclassification of other HF outcomes, the authors stated.
Also, Dr. Bello said, the study’s inclusion of patients with either gestational hypertension or preeclampsia may complicate its interpretation. Compared with the former condition, she said, preeclampsia “involves more inflammation and more endothelial dysfunction. It may cause a different impact on the heart and the vasculature.”
In the analysis, about 79,000 women with gestational hypertension or preeclampsia were identified among more than 1.4 million primiparous women who entered the Swedish Medical Birth Register over a period of about 30 years. They were matched with about 396,000 women in the registry who had normotensive pregnancies.
Excluded, besides women with peripartum cardiomyopathy, were women with a prepregnancy history of HF, hypertension, ischemic heart disease, atrial fibrillation, or valvular heart disease.
Hazard ratios (HRs) for HF, ischemic HF, and nonischemic HF were significantly elevated over among the women with gestational hypertension or preeclampsia compared to those with normotensive pregnancies:
- Any HF: HR, 1.70 (95% confidence interval [CI], 1.51-1.91)
- Nonischemic HF: HR, 1.60 (95% CI, 1.40-1.83)
- Ischemic HF: HR, 2.28 (95% CI, 1.74-2.98)
The analyses were adjusted for maternal age at delivery, year of delivery, prepregnancy comorbidities, maternal education level, smoking status, and body mass index.
Sharper risk increases were seen among women with gestational hypertension or preeclampsia who delivered prior to gestational week 34:
- Any HF: HR, 2.46 (95% CI, 1.82-3.32)
- Nonischemic HF: HR, 2.33 (95% CI, 1.65-3.31)
- Ischemic HF: HR, 3.64 (95% CI, 1.97-6.74)
Risks for HF developing within 6 years of pregnancy characterized by gestational hypertension or preeclampsia were far more pronounced for ischemic HF than for nonischemic HF:
- Any HF: HR, 2.09 (95% CI, 1.52-2.89)
- Nonischemic HF: HR, 1.86 (95% CI, 1.32-2.61)
- Ischemic HF: HR, 6.52 (95% CI, 2.00-12.34).
The study couldn’t directly explore potential mechanisms for the associations between pregnancy-induced hypertensive disorders and different forms of HF, but it may have provided clues, Dr. Mantel said.
The hypertensive disorders and ischemic HF appear to share risk factors that could lead to both conditions, she noted. Also, hypertension itself is a risk factor for ischemic heart disease.
In contrast, “the risk of nonischemic heart failure might be driven by other factors, such as the inflammatory profile, endothelial dysfunction, and cardiac remodeling induced by preeclampsia or gestational hypertension.”
Those disorders, moreover, are associated with cardiac structural changes that are also seen in HFpEF, Dr. Mantel said. And both HFpEF and preeclampsia are characterized by systemic inflammation and endothelial dysfunction.
“These pathophysiological similarities,” she proposed, “might explain the link between pregnancy-induced hypertensive disorder and HFpEF.”
The authors have disclosed no relevant financial relationships. Dr. Bello has received grants from the National Institutes of Health.
A version of this article first appeared on Medscape.com.
, an observational study suggests.
The risks were most pronounced, jumping more than sixfold in the case of ischemic HF, during the first 6 years after the pregnancy. They then receded to plateau at a lower, still significantly elevated level of risk that persisted even years later, in the analysis of women in a Swedish medical birth registry.
The case-matching study compared women with no history of cardiovascular (CV) disease and a first successful pregnancy during which they either developed or did not experience gestational hypertension or preeclampsia.
It’s among the first studies to explore the impact of pregnancy-induced hypertensive disease on subsequent HF risk separately for both ischemic and nonischemic HF and to find that the severity of such risk differs for the two HF etiologies, according to a report published in JACC: Heart Failure.
The adjusted risk for any HF during a median of 13 years after the pregnancy rose 70% for those who had developed gestational hypertension or preeclampsia. Their risk of nonischemic HF went up 60%, and their risk of ischemic HF more than doubled.
Hypertensive disorders of pregnancy “are so much more than short-term disorders confined to the pregnancy period. They have long-term implications throughout a lifetime,” lead author Ängla Mantel, MD, PhD, said in an interview.
Obstetric history doesn’t figure into any formal HF risk scoring systems, observed Dr. Mantel of Karolinska Institutet, Stockholm. Still, women who develop gestational hypertension, preeclampsia, or other pregnancy complications “should be considered a high-risk population even after the pregnancy and monitored for cardiovascular risk factors regularly throughout life.”
In many studies, she said, “knowledge of women-specific risk factors for cardiovascular disease is poor among both clinicians and patients.” The current findings should help raise awareness about such obstetric risk factors for HF, “especially” in patients with HF with preserved ejection fraction (HFpEF), which isn’t closely related to a number of traditional CV risk factors.
Even though pregnancy complications such as gestational hypertension and preeclampsia don’t feature in risk calculators, “they are actually risk enhancers per the 2019 primary prevention guidelines,” Natalie A. Bello, MD, MPH, who was not involved in the current study, said in an interview.
“We’re working to educate physicians and cardiovascular team members to take a pregnancy history” for risk stratification of women in primary prevention,” said Dr. Bello, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles.
The current study, she said, “is an important step” for its finding that hypertensive disorders of pregnancy are associated separately with both ischemic and nonischemic HF.
She pointed out, however, that because the study excluded women with peripartum cardiomyopathy, a form of nonischemic HF, it may “underestimate the impact of hypertensive disorders on the short-term risk of nonischemic heart failure.” Women who had peripartum cardiomyopathy were excluded to avoid misclassification of other HF outcomes, the authors stated.
Also, Dr. Bello said, the study’s inclusion of patients with either gestational hypertension or preeclampsia may complicate its interpretation. Compared with the former condition, she said, preeclampsia “involves more inflammation and more endothelial dysfunction. It may cause a different impact on the heart and the vasculature.”
In the analysis, about 79,000 women with gestational hypertension or preeclampsia were identified among more than 1.4 million primiparous women who entered the Swedish Medical Birth Register over a period of about 30 years. They were matched with about 396,000 women in the registry who had normotensive pregnancies.
Excluded, besides women with peripartum cardiomyopathy, were women with a prepregnancy history of HF, hypertension, ischemic heart disease, atrial fibrillation, or valvular heart disease.
Hazard ratios (HRs) for HF, ischemic HF, and nonischemic HF were significantly elevated over among the women with gestational hypertension or preeclampsia compared to those with normotensive pregnancies:
- Any HF: HR, 1.70 (95% confidence interval [CI], 1.51-1.91)
- Nonischemic HF: HR, 1.60 (95% CI, 1.40-1.83)
- Ischemic HF: HR, 2.28 (95% CI, 1.74-2.98)
The analyses were adjusted for maternal age at delivery, year of delivery, prepregnancy comorbidities, maternal education level, smoking status, and body mass index.
Sharper risk increases were seen among women with gestational hypertension or preeclampsia who delivered prior to gestational week 34:
- Any HF: HR, 2.46 (95% CI, 1.82-3.32)
- Nonischemic HF: HR, 2.33 (95% CI, 1.65-3.31)
- Ischemic HF: HR, 3.64 (95% CI, 1.97-6.74)
Risks for HF developing within 6 years of pregnancy characterized by gestational hypertension or preeclampsia were far more pronounced for ischemic HF than for nonischemic HF:
- Any HF: HR, 2.09 (95% CI, 1.52-2.89)
- Nonischemic HF: HR, 1.86 (95% CI, 1.32-2.61)
- Ischemic HF: HR, 6.52 (95% CI, 2.00-12.34).
The study couldn’t directly explore potential mechanisms for the associations between pregnancy-induced hypertensive disorders and different forms of HF, but it may have provided clues, Dr. Mantel said.
The hypertensive disorders and ischemic HF appear to share risk factors that could lead to both conditions, she noted. Also, hypertension itself is a risk factor for ischemic heart disease.
In contrast, “the risk of nonischemic heart failure might be driven by other factors, such as the inflammatory profile, endothelial dysfunction, and cardiac remodeling induced by preeclampsia or gestational hypertension.”
Those disorders, moreover, are associated with cardiac structural changes that are also seen in HFpEF, Dr. Mantel said. And both HFpEF and preeclampsia are characterized by systemic inflammation and endothelial dysfunction.
“These pathophysiological similarities,” she proposed, “might explain the link between pregnancy-induced hypertensive disorder and HFpEF.”
The authors have disclosed no relevant financial relationships. Dr. Bello has received grants from the National Institutes of Health.
A version of this article first appeared on Medscape.com.
, an observational study suggests.
The risks were most pronounced, jumping more than sixfold in the case of ischemic HF, during the first 6 years after the pregnancy. They then receded to plateau at a lower, still significantly elevated level of risk that persisted even years later, in the analysis of women in a Swedish medical birth registry.
The case-matching study compared women with no history of cardiovascular (CV) disease and a first successful pregnancy during which they either developed or did not experience gestational hypertension or preeclampsia.
It’s among the first studies to explore the impact of pregnancy-induced hypertensive disease on subsequent HF risk separately for both ischemic and nonischemic HF and to find that the severity of such risk differs for the two HF etiologies, according to a report published in JACC: Heart Failure.
The adjusted risk for any HF during a median of 13 years after the pregnancy rose 70% for those who had developed gestational hypertension or preeclampsia. Their risk of nonischemic HF went up 60%, and their risk of ischemic HF more than doubled.
Hypertensive disorders of pregnancy “are so much more than short-term disorders confined to the pregnancy period. They have long-term implications throughout a lifetime,” lead author Ängla Mantel, MD, PhD, said in an interview.
Obstetric history doesn’t figure into any formal HF risk scoring systems, observed Dr. Mantel of Karolinska Institutet, Stockholm. Still, women who develop gestational hypertension, preeclampsia, or other pregnancy complications “should be considered a high-risk population even after the pregnancy and monitored for cardiovascular risk factors regularly throughout life.”
In many studies, she said, “knowledge of women-specific risk factors for cardiovascular disease is poor among both clinicians and patients.” The current findings should help raise awareness about such obstetric risk factors for HF, “especially” in patients with HF with preserved ejection fraction (HFpEF), which isn’t closely related to a number of traditional CV risk factors.
Even though pregnancy complications such as gestational hypertension and preeclampsia don’t feature in risk calculators, “they are actually risk enhancers per the 2019 primary prevention guidelines,” Natalie A. Bello, MD, MPH, who was not involved in the current study, said in an interview.
“We’re working to educate physicians and cardiovascular team members to take a pregnancy history” for risk stratification of women in primary prevention,” said Dr. Bello, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles.
The current study, she said, “is an important step” for its finding that hypertensive disorders of pregnancy are associated separately with both ischemic and nonischemic HF.
She pointed out, however, that because the study excluded women with peripartum cardiomyopathy, a form of nonischemic HF, it may “underestimate the impact of hypertensive disorders on the short-term risk of nonischemic heart failure.” Women who had peripartum cardiomyopathy were excluded to avoid misclassification of other HF outcomes, the authors stated.
Also, Dr. Bello said, the study’s inclusion of patients with either gestational hypertension or preeclampsia may complicate its interpretation. Compared with the former condition, she said, preeclampsia “involves more inflammation and more endothelial dysfunction. It may cause a different impact on the heart and the vasculature.”
In the analysis, about 79,000 women with gestational hypertension or preeclampsia were identified among more than 1.4 million primiparous women who entered the Swedish Medical Birth Register over a period of about 30 years. They were matched with about 396,000 women in the registry who had normotensive pregnancies.
Excluded, besides women with peripartum cardiomyopathy, were women with a prepregnancy history of HF, hypertension, ischemic heart disease, atrial fibrillation, or valvular heart disease.
Hazard ratios (HRs) for HF, ischemic HF, and nonischemic HF were significantly elevated over among the women with gestational hypertension or preeclampsia compared to those with normotensive pregnancies:
- Any HF: HR, 1.70 (95% confidence interval [CI], 1.51-1.91)
- Nonischemic HF: HR, 1.60 (95% CI, 1.40-1.83)
- Ischemic HF: HR, 2.28 (95% CI, 1.74-2.98)
The analyses were adjusted for maternal age at delivery, year of delivery, prepregnancy comorbidities, maternal education level, smoking status, and body mass index.
Sharper risk increases were seen among women with gestational hypertension or preeclampsia who delivered prior to gestational week 34:
- Any HF: HR, 2.46 (95% CI, 1.82-3.32)
- Nonischemic HF: HR, 2.33 (95% CI, 1.65-3.31)
- Ischemic HF: HR, 3.64 (95% CI, 1.97-6.74)
Risks for HF developing within 6 years of pregnancy characterized by gestational hypertension or preeclampsia were far more pronounced for ischemic HF than for nonischemic HF:
- Any HF: HR, 2.09 (95% CI, 1.52-2.89)
- Nonischemic HF: HR, 1.86 (95% CI, 1.32-2.61)
- Ischemic HF: HR, 6.52 (95% CI, 2.00-12.34).
The study couldn’t directly explore potential mechanisms for the associations between pregnancy-induced hypertensive disorders and different forms of HF, but it may have provided clues, Dr. Mantel said.
The hypertensive disorders and ischemic HF appear to share risk factors that could lead to both conditions, she noted. Also, hypertension itself is a risk factor for ischemic heart disease.
In contrast, “the risk of nonischemic heart failure might be driven by other factors, such as the inflammatory profile, endothelial dysfunction, and cardiac remodeling induced by preeclampsia or gestational hypertension.”
Those disorders, moreover, are associated with cardiac structural changes that are also seen in HFpEF, Dr. Mantel said. And both HFpEF and preeclampsia are characterized by systemic inflammation and endothelial dysfunction.
“These pathophysiological similarities,” she proposed, “might explain the link between pregnancy-induced hypertensive disorder and HFpEF.”
The authors have disclosed no relevant financial relationships. Dr. Bello has received grants from the National Institutes of Health.
A version of this article first appeared on Medscape.com.
FROM JACC: HEART FAILURE