Conference Coverage

Pancreatic cancer clinical trials conducted in the United States over the past few decades have not adequately reported or included racial and ethnic minority populations, results of a recent study suggest.

Adequate inclusion of underrepresented minorities in clinical trials is critical to reducing health care disparities and improving patient outcomes, according to investigator Kelly M. Herremans, MD, a surgical research fellow at the University of Florida in Gainesville. For the trials that did report race and ethnicity, Black, Asian/Pacific Islander, American Indian/Alaskan Native, and Hispanic patients were significantly underrepresented, according to the study, which was reported at the annual Digestive Disease Week® (DDW).

“It is unfortunate that we still have not made much headway regarding diversity in clinical trials in order to truly understand the impact that therapeutics may have on the population as a whole,” Dr. Herremans said in a media briefing. “We need to have an accurate representation of the entire population reflected in these studies.”

Only about half of the U.S. pancreatic cancer studies reported the race of participants, and slightly more than one-third reported ethnicity, Dr. Herremans said. She noted that certain racial and ethnic minorities, and in particular Black Americans, have a higher incidence of pancreatic cancer, are diagnosed at younger ages, and die sooner.

Racial and ethnic differences in pancreatic tumor biology have also been reported. Dr. Herremans said patients of African ancestry have both somatic and germline mutations when compared with other subgroups, meaning they may potentially respond differently to specific treatments. “Having diversity in trial participants is critical to ensuring that these differences can be clinically tested,” she said.
 

Objective data on an uncomfortable truth

This review of pancreatic cancer trials is an “excellent and much needed study,” said Antonio H. Mendoza-Ladd, MD, of the division of gastroenterology at Texas Tech University Health Sciences Center, El Paso. “It contributes objective data that brings to the mainstream an unspoken and uncomfortable truth: Systemic racism, bias, and discrimination exist in the medical system,” Dr. Mendoza-Ladd said in an interview.

Pancreatic cancer is one of deadliest malignancies in the world, and underrepresented minorities bear the brunt of its lethality, according to Dr. Mendoza-Ladd. He said researchers should follow the recommendations of the study authors to ensure that underrepresented minorities are enrolled in clinical trials in sufficient numbers. “Pancreatic cancer does not discriminate by ethnicity or socioeconomic status, even if the medical system does,” he said.
 

Pancreatic cancer trial disparities

In their study, Dr. Herremans and colleagues analyzed 207 clinical trials in the United States for pancreatic ductal adenocarcinoma between 2008 and 2020. They identified the studies using ClinicalTrials.gov, a national registry of clinical trial data, then gathered trial data and demographics on 8,429 participants from reported study results and related publications. Using that data, they were able to evaluate the rates at which race, ethnicity, and gender have been reported over the past few decades, as well as the rates of inclusion of racial and ethnic minorities in the studies.

Fewer than half of the trials (49.3%) reported race, and only about one-third (34.7%) reported ethnicity. By comparison, 99% of the studies reported gender. Results did suggest an increase over time in reporting of race and ethnicity, according to Dr. Herremans, particularly since October 2016, when the Food and Drug Administration clarified its expectations on the collection and reporting of race and ethnicity data in clinical trials. However, the clinical trial data suggest minorities were substantially underrepresented in clinical trials during the study period. “Despite this change, we’re not seeing the actual diversity improve in these clinical trials,” Dr Herremans said in an interview.

Black patients represented 8.2% of clinical trial participants despite constituting 12.4% of U.S. incident pancreatic cancer cases (P < .0001), according to data presented by Dr. Herremans. Likewise, the data show that Hispanic patients account for 8.5% of incident cases but made up 6.0% of clinical trial participants; Asian/Pacific Islanders total 3.3% of U.S. incident pancreatic cancer cases but represented 2.4% of trial participants; and American Indian/Alaskan Native patients constitute 0.4% of incident cases versus being 0.3% of participants (P < .0001 for all). Conversely, Dr. Herremans noted that White patients account for 82.3% of the incident cases but made up 84.7% of total trial participants (P = .002).

Dr. Herremans reported no financial disclosures related to the research. Dr. Mendoza-Ladd reported a relationship with ConMed.

Pancreatic cancer clinical trials conducted in the United States over the past few decades have not adequately reported or included racial and ethnic minority populations, results of a recent study suggest.

Adequate inclusion of underrepresented minorities in clinical trials is critical to reducing health care disparities and improving patient outcomes, according to investigator Kelly M. Herremans, MD, a surgical research fellow at the University of Florida in Gainesville. For the trials that did report race and ethnicity, Black, Asian/Pacific Islander, American Indian/Alaskan Native, and Hispanic patients were significantly underrepresented, according to the study, which was reported at the annual Digestive Disease Week® (DDW).

“It is unfortunate that we still have not made much headway regarding diversity in clinical trials in order to truly understand the impact that therapeutics may have on the population as a whole,” Dr. Herremans said in a media briefing. “We need to have an accurate representation of the entire population reflected in these studies.”

Only about half of the U.S. pancreatic cancer studies reported the race of participants, and slightly more than one-third reported ethnicity, Dr. Herremans said. She noted that certain racial and ethnic minorities, and in particular Black Americans, have a higher incidence of pancreatic cancer, are diagnosed at younger ages, and die sooner.

Racial and ethnic differences in pancreatic tumor biology have also been reported. Dr. Herremans said patients of African ancestry have both somatic and germline mutations when compared with other subgroups, meaning they may potentially respond differently to specific treatments. “Having diversity in trial participants is critical to ensuring that these differences can be clinically tested,” she said.
 

Objective data on an uncomfortable truth

This review of pancreatic cancer trials is an “excellent and much needed study,” said Antonio H. Mendoza-Ladd, MD, of the division of gastroenterology at Texas Tech University Health Sciences Center, El Paso. “It contributes objective data that brings to the mainstream an unspoken and uncomfortable truth: Systemic racism, bias, and discrimination exist in the medical system,” Dr. Mendoza-Ladd said in an interview.

Pancreatic cancer is one of deadliest malignancies in the world, and underrepresented minorities bear the brunt of its lethality, according to Dr. Mendoza-Ladd. He said researchers should follow the recommendations of the study authors to ensure that underrepresented minorities are enrolled in clinical trials in sufficient numbers. “Pancreatic cancer does not discriminate by ethnicity or socioeconomic status, even if the medical system does,” he said.
 

Pancreatic cancer trial disparities

In their study, Dr. Herremans and colleagues analyzed 207 clinical trials in the United States for pancreatic ductal adenocarcinoma between 2008 and 2020. They identified the studies using ClinicalTrials.gov, a national registry of clinical trial data, then gathered trial data and demographics on 8,429 participants from reported study results and related publications. Using that data, they were able to evaluate the rates at which race, ethnicity, and gender have been reported over the past few decades, as well as the rates of inclusion of racial and ethnic minorities in the studies.

Fewer than half of the trials (49.3%) reported race, and only about one-third (34.7%) reported ethnicity. By comparison, 99% of the studies reported gender. Results did suggest an increase over time in reporting of race and ethnicity, according to Dr. Herremans, particularly since October 2016, when the Food and Drug Administration clarified its expectations on the collection and reporting of race and ethnicity data in clinical trials. However, the clinical trial data suggest minorities were substantially underrepresented in clinical trials during the study period. “Despite this change, we’re not seeing the actual diversity improve in these clinical trials,” Dr Herremans said in an interview.

Black patients represented 8.2% of clinical trial participants despite constituting 12.4% of U.S. incident pancreatic cancer cases (P < .0001), according to data presented by Dr. Herremans. Likewise, the data show that Hispanic patients account for 8.5% of incident cases but made up 6.0% of clinical trial participants; Asian/Pacific Islanders total 3.3% of U.S. incident pancreatic cancer cases but represented 2.4% of trial participants; and American Indian/Alaskan Native patients constitute 0.4% of incident cases versus being 0.3% of participants (P < .0001 for all). Conversely, Dr. Herremans noted that White patients account for 82.3% of the incident cases but made up 84.7% of total trial participants (P = .002).

Dr. Herremans reported no financial disclosures related to the research. Dr. Mendoza-Ladd reported a relationship with ConMed.

Pancreatic cancer clinical trials conducted in the United States over the past few decades have not adequately reported or included racial and ethnic minority populations, results of a recent study suggest.

Adequate inclusion of underrepresented minorities in clinical trials is critical to reducing health care disparities and improving patient outcomes, according to investigator Kelly M. Herremans, MD, a surgical research fellow at the University of Florida in Gainesville. For the trials that did report race and ethnicity, Black, Asian/Pacific Islander, American Indian/Alaskan Native, and Hispanic patients were significantly underrepresented, according to the study, which was reported at the annual Digestive Disease Week® (DDW).

“It is unfortunate that we still have not made much headway regarding diversity in clinical trials in order to truly understand the impact that therapeutics may have on the population as a whole,” Dr. Herremans said in a media briefing. “We need to have an accurate representation of the entire population reflected in these studies.”

Only about half of the U.S. pancreatic cancer studies reported the race of participants, and slightly more than one-third reported ethnicity, Dr. Herremans said. She noted that certain racial and ethnic minorities, and in particular Black Americans, have a higher incidence of pancreatic cancer, are diagnosed at younger ages, and die sooner.

Racial and ethnic differences in pancreatic tumor biology have also been reported. Dr. Herremans said patients of African ancestry have both somatic and germline mutations when compared with other subgroups, meaning they may potentially respond differently to specific treatments. “Having diversity in trial participants is critical to ensuring that these differences can be clinically tested,” she said.
 

Objective data on an uncomfortable truth

This review of pancreatic cancer trials is an “excellent and much needed study,” said Antonio H. Mendoza-Ladd, MD, of the division of gastroenterology at Texas Tech University Health Sciences Center, El Paso. “It contributes objective data that brings to the mainstream an unspoken and uncomfortable truth: Systemic racism, bias, and discrimination exist in the medical system,” Dr. Mendoza-Ladd said in an interview.

Pancreatic cancer is one of deadliest malignancies in the world, and underrepresented minorities bear the brunt of its lethality, according to Dr. Mendoza-Ladd. He said researchers should follow the recommendations of the study authors to ensure that underrepresented minorities are enrolled in clinical trials in sufficient numbers. “Pancreatic cancer does not discriminate by ethnicity or socioeconomic status, even if the medical system does,” he said.
 

Pancreatic cancer trial disparities

In their study, Dr. Herremans and colleagues analyzed 207 clinical trials in the United States for pancreatic ductal adenocarcinoma between 2008 and 2020. They identified the studies using ClinicalTrials.gov, a national registry of clinical trial data, then gathered trial data and demographics on 8,429 participants from reported study results and related publications. Using that data, they were able to evaluate the rates at which race, ethnicity, and gender have been reported over the past few decades, as well as the rates of inclusion of racial and ethnic minorities in the studies.

Fewer than half of the trials (49.3%) reported race, and only about one-third (34.7%) reported ethnicity. By comparison, 99% of the studies reported gender. Results did suggest an increase over time in reporting of race and ethnicity, according to Dr. Herremans, particularly since October 2016, when the Food and Drug Administration clarified its expectations on the collection and reporting of race and ethnicity data in clinical trials. However, the clinical trial data suggest minorities were substantially underrepresented in clinical trials during the study period. “Despite this change, we’re not seeing the actual diversity improve in these clinical trials,” Dr Herremans said in an interview.

Black patients represented 8.2% of clinical trial participants despite constituting 12.4% of U.S. incident pancreatic cancer cases (P < .0001), according to data presented by Dr. Herremans. Likewise, the data show that Hispanic patients account for 8.5% of incident cases but made up 6.0% of clinical trial participants; Asian/Pacific Islanders total 3.3% of U.S. incident pancreatic cancer cases but represented 2.4% of trial participants; and American Indian/Alaskan Native patients constitute 0.4% of incident cases versus being 0.3% of participants (P < .0001 for all). Conversely, Dr. Herremans noted that White patients account for 82.3% of the incident cases but made up 84.7% of total trial participants (P = .002).

Dr. Herremans reported no financial disclosures related to the research. Dr. Mendoza-Ladd reported a relationship with ConMed.

A single treatment with a commercially available 1,060-nm diode laser that features integrated skin cooling was found to be safe and effective for the reduction of unwanted fat of the abdomen and flanks, a small single-center study showed.

Nonsurgical fat reduction was the third-most common nonsurgical aesthetic procedure in the United States in 2018 and includes lasers, high-intensity focused ultrasound, radiofrequency, photobiomodulation therapy, and cryolipolysis, according to 2018 data from the American Society for Aesthetic Plastic Surgery.

“Our study is unique because we used a 1,060-nm diode laser with integrated skin cooling to evaluate the efficacy and safety of its use for the reduction of unwanted fat of the abdomen and flanks,” lead study author Alison S. Kang, MD, told this news organization following the annual conference of the American Society for Laser Medicine and Surgery, where the data were presented. “A 1,060-nm laser works by delivering controlled thermal energy between 42 °C and 47 °C, temperatures at which adipocytes are permanently destroyed,” she explained.

Dr. Kang and Suzanne Kilmer, MD, both of the Laser & Skin Surgery Center of Northern California, Sacramento, enrolled 28 women and 2 men into the study. Each study participant received a single treatment with Venus Bliss, a 1,060-nm diode laser with four laser applicators and a built-in skin-cooling mechanism. Half received treatment of the flanks delivered at up to 1.4 watts per cm² on each diode for 25 minutes, while the other 15 received treatment of the abdomen with the same energy settings. Photos and ultrasound images were taken at baseline, 6 weeks, and 12 weeks, and the investigators administered a satisfaction questionnaire upon study exit. The primary endpoint was efficacy, defined as the percentage of correctly identified posttreatment photographs by three blinded reviewers (one plastic surgeon and two dermatologists). Secondary endpoints of interest were change in adipose thickness on ultrasound, subject satisfaction, and adverse events.

After losing 1 patient to follow-up, 29 completed the study. Dr. Kang reported that the blinded evaluators could identify the pretreatment image, compared with the posttreatment image in an average of 67% of patients. Between baseline and 12 weeks, the ultrasound images showed an average reduction in the adipose layer of 9% on the abdomen and 7% on the flank, while the average self-reported pain score based on the Wong-Baker FACES Pain Rating Scale was 2 out of 10 among those in the abdomen treatment group and 2.6 out of 10 among those in the flank treatment group.

In addition, 76% of subjects stated they were “satisfied” to “very satisfied” with the treatment, and 79% stated that they would recommend this treatment to a friend. The most common posttreatment responses in both groups were erythema and trace edema, but no serious or permanent adverse events were observed.

Dr. Kang acknowledged certain limitations of the study, including its small sample size. “Only one treatment was performed in our study, so it is unclear if multiple treatments will improve efficacy or if multiple treatments will have no effect on efficacy,” she said.

The work won a “best of session early career-clinical” abstract award from the ASLMS.

The study was funded by Venus Concept, the manufacturer of the Venus Bliss laser. Dr. Kang reported having no relevant financial disclosures. Dr. Kilmer has received grants and honoraria from Venus Concept.

dbrunk@mdedge.com

A single treatment with a commercially available 1,060-nm diode laser that features integrated skin cooling was found to be safe and effective for the reduction of unwanted fat of the abdomen and flanks, a small single-center study showed.

Nonsurgical fat reduction was the third-most common nonsurgical aesthetic procedure in the United States in 2018 and includes lasers, high-intensity focused ultrasound, radiofrequency, photobiomodulation therapy, and cryolipolysis, according to 2018 data from the American Society for Aesthetic Plastic Surgery.

“Our study is unique because we used a 1,060-nm diode laser with integrated skin cooling to evaluate the efficacy and safety of its use for the reduction of unwanted fat of the abdomen and flanks,” lead study author Alison S. Kang, MD, told this news organization following the annual conference of the American Society for Laser Medicine and Surgery, where the data were presented. “A 1,060-nm laser works by delivering controlled thermal energy between 42 °C and 47 °C, temperatures at which adipocytes are permanently destroyed,” she explained.

Dr. Kang and Suzanne Kilmer, MD, both of the Laser & Skin Surgery Center of Northern California, Sacramento, enrolled 28 women and 2 men into the study. Each study participant received a single treatment with Venus Bliss, a 1,060-nm diode laser with four laser applicators and a built-in skin-cooling mechanism. Half received treatment of the flanks delivered at up to 1.4 watts per cm² on each diode for 25 minutes, while the other 15 received treatment of the abdomen with the same energy settings. Photos and ultrasound images were taken at baseline, 6 weeks, and 12 weeks, and the investigators administered a satisfaction questionnaire upon study exit. The primary endpoint was efficacy, defined as the percentage of correctly identified posttreatment photographs by three blinded reviewers (one plastic surgeon and two dermatologists). Secondary endpoints of interest were change in adipose thickness on ultrasound, subject satisfaction, and adverse events.

After losing 1 patient to follow-up, 29 completed the study. Dr. Kang reported that the blinded evaluators could identify the pretreatment image, compared with the posttreatment image in an average of 67% of patients. Between baseline and 12 weeks, the ultrasound images showed an average reduction in the adipose layer of 9% on the abdomen and 7% on the flank, while the average self-reported pain score based on the Wong-Baker FACES Pain Rating Scale was 2 out of 10 among those in the abdomen treatment group and 2.6 out of 10 among those in the flank treatment group.

In addition, 76% of subjects stated they were “satisfied” to “very satisfied” with the treatment, and 79% stated that they would recommend this treatment to a friend. The most common posttreatment responses in both groups were erythema and trace edema, but no serious or permanent adverse events were observed.

Dr. Kang acknowledged certain limitations of the study, including its small sample size. “Only one treatment was performed in our study, so it is unclear if multiple treatments will improve efficacy or if multiple treatments will have no effect on efficacy,” she said.

The work won a “best of session early career-clinical” abstract award from the ASLMS.

The study was funded by Venus Concept, the manufacturer of the Venus Bliss laser. Dr. Kang reported having no relevant financial disclosures. Dr. Kilmer has received grants and honoraria from Venus Concept.

dbrunk@mdedge.com

A single treatment with a commercially available 1,060-nm diode laser that features integrated skin cooling was found to be safe and effective for the reduction of unwanted fat of the abdomen and flanks, a small single-center study showed.

Nonsurgical fat reduction was the third-most common nonsurgical aesthetic procedure in the United States in 2018 and includes lasers, high-intensity focused ultrasound, radiofrequency, photobiomodulation therapy, and cryolipolysis, according to 2018 data from the American Society for Aesthetic Plastic Surgery.

“Our study is unique because we used a 1,060-nm diode laser with integrated skin cooling to evaluate the efficacy and safety of its use for the reduction of unwanted fat of the abdomen and flanks,” lead study author Alison S. Kang, MD, told this news organization following the annual conference of the American Society for Laser Medicine and Surgery, where the data were presented. “A 1,060-nm laser works by delivering controlled thermal energy between 42 °C and 47 °C, temperatures at which adipocytes are permanently destroyed,” she explained.

Dr. Kang and Suzanne Kilmer, MD, both of the Laser & Skin Surgery Center of Northern California, Sacramento, enrolled 28 women and 2 men into the study. Each study participant received a single treatment with Venus Bliss, a 1,060-nm diode laser with four laser applicators and a built-in skin-cooling mechanism. Half received treatment of the flanks delivered at up to 1.4 watts per cm² on each diode for 25 minutes, while the other 15 received treatment of the abdomen with the same energy settings. Photos and ultrasound images were taken at baseline, 6 weeks, and 12 weeks, and the investigators administered a satisfaction questionnaire upon study exit. The primary endpoint was efficacy, defined as the percentage of correctly identified posttreatment photographs by three blinded reviewers (one plastic surgeon and two dermatologists). Secondary endpoints of interest were change in adipose thickness on ultrasound, subject satisfaction, and adverse events.

After losing 1 patient to follow-up, 29 completed the study. Dr. Kang reported that the blinded evaluators could identify the pretreatment image, compared with the posttreatment image in an average of 67% of patients. Between baseline and 12 weeks, the ultrasound images showed an average reduction in the adipose layer of 9% on the abdomen and 7% on the flank, while the average self-reported pain score based on the Wong-Baker FACES Pain Rating Scale was 2 out of 10 among those in the abdomen treatment group and 2.6 out of 10 among those in the flank treatment group.

In addition, 76% of subjects stated they were “satisfied” to “very satisfied” with the treatment, and 79% stated that they would recommend this treatment to a friend. The most common posttreatment responses in both groups were erythema and trace edema, but no serious or permanent adverse events were observed.

Dr. Kang acknowledged certain limitations of the study, including its small sample size. “Only one treatment was performed in our study, so it is unclear if multiple treatments will improve efficacy or if multiple treatments will have no effect on efficacy,” she said.

The work won a “best of session early career-clinical” abstract award from the ASLMS.

The study was funded by Venus Concept, the manufacturer of the Venus Bliss laser. Dr. Kang reported having no relevant financial disclosures. Dr. Kilmer has received grants and honoraria from Venus Concept.

dbrunk@mdedge.com

The long-term benefits of endocrine therapy in premenopausal breast cancer appear to differ according to whether patients are categorized as high or low molecular risk using the 70-gene signature (MammaPrint).

Based upon data from patients who had participated in the Stockholm tamoxifen (STO-5) trial, high-risk patients significantly benefited from goserelin treatment, whereas low-risk patients benefited more from tamoxifen treatment when compared with no endocrine therapy.

“Goserelin, tamoxifen, and the combination of the two, reduced the 20-year risk of distant occurrences and fatal breast cancer, compared to no endocrine therapy,” Annelie Johansson, MSc, said at the European Society for Medical Oncology: Breast Cancer virtual meeting.

“Our findings indicate that the long-term endocrine therapy benefit in premenopausal patients is influenced by molecular risk classification and thus tumor characteristics,” she added.

Ms. Johansson, a postdoctoral researcher in genomic breast cancer at the Karolinska Institutet in Stockholm, reported the results of the analysis as a late-breaking abstract at the meeting.

“I think this is an innovative translational study trying to use the multigene assay results to look at differential endocrine therapy effects,” said Prudence Francis, MD, the invited discussant for study.

However, there are relatively few patients in the various subgroups being tested, she added. “We’ve also got short duration of tamoxifen, only 2 years, we’ve got prior chemotherapy in some patients and absence of HER2 therapy, all of which might influence outcomes.”

As a result, Dr. Francis, who is head of medical oncology at the Peter MacCallum Cancer Centre and a consultant Medical Oncologist at St. Vincent’s Hospital Melbourne, called the findings purely “hypothesis generating.”
 

Study details and results

The analysis was based on data from the STO-5 trial, which had recruited just over 900 patients between 1990 and 1997. Patients were stratified according to their lymph node status and some received chemotherapy with or without locoregional radiotherapy before being randomized to one of four study arms: goserelin alone, tamoxifen alone, the combination of the two, or no endocrine therapy.

Ms. Johansson noted that they were able to obtain the primary tumor blocks from 729 patients in the past year, of whom 610 were estrogen receptor positive. The analysis according to the 70-gene signature was then based on data from 465 patients: 131 had been treated with goserelin, 105 with tamoxifen, 120 with both, and 109 had received no endocrine treatment.

We have complete 20-year follow-up from high-quality Swedish National registries,” Ms. Johansson said, observing that the median age in the trial was 46 years.

Before stratifying patients into high and low risk using the 70-gene signature, the risk for having a distant recurrence, compared with no endocrine therapy was reduced by 52% with goserelin (hazard ratio, .48), 41% with tamoxifen (HR, 0.59), and 33% with both in combination (HR, 0.67).

After stratification, however, goserelin was associated with a 78% reduction of distant recurrence versus no endocrine treatment in high-risk patients (HR, 0.22) and a 20% reduction in low-risk patients (HR, 0.80).

Results in high- and low-risk patients with tamoxifen versus no endocrine treatment were a respective 31% reduction (HR, 0.69) and 62% reduction (HR, 0.38), and a respective 36% (HR, 0.64) and 28% (HR, 0.72) for the combination.

A further analysis was performed to compare between the active treatment arms, and this suggested a greater benefit of goserelin in patients at high risk when compared with both tamoxifen (HR, 0.30) and the combination (HR, 0.33).

Dr. Francis commented: “it is a bit surprising to find that goserelin appeared to be also better than the combination,” and it is something that the research team is looking into.

“One hypothesis might be if you look how the different treatments are working,” Ms. Johansson said. “Goserelin is very efficient in lowering the estrogen levels in premenopausal patients, suppressing the ovarian production of estrogen whereas tamoxifen can act both as an antagonist and agonist.

“So, we are thinking that maybe the addition of tamoxifen, with the agonistic properties of tamoxifen, might then make the goserelin not as efficient. But that’s of course, just a hypothesis right now and we need to look into this further,” she said.

The work was funded by The Swedish Research Council (Vetenskapsrådet), The Swedish Research Council for Health, Working life and Welfare, and the Swedish Cancer Society (Cancerfonden). Ms. Johansson had no personal disclosures; one of the coauthors was a coinventor of MammaPrint. Dr. Francis disclosed receiving travel support for overseas lectures from Ipsen and Novartis and acting as a medical oncology editor for Elsevier.

The long-term benefits of endocrine therapy in premenopausal breast cancer appear to differ according to whether patients are categorized as high or low molecular risk using the 70-gene signature (MammaPrint).

Based upon data from patients who had participated in the Stockholm tamoxifen (STO-5) trial, high-risk patients significantly benefited from goserelin treatment, whereas low-risk patients benefited more from tamoxifen treatment when compared with no endocrine therapy.

“Goserelin, tamoxifen, and the combination of the two, reduced the 20-year risk of distant occurrences and fatal breast cancer, compared to no endocrine therapy,” Annelie Johansson, MSc, said at the European Society for Medical Oncology: Breast Cancer virtual meeting.

“Our findings indicate that the long-term endocrine therapy benefit in premenopausal patients is influenced by molecular risk classification and thus tumor characteristics,” she added.

Ms. Johansson, a postdoctoral researcher in genomic breast cancer at the Karolinska Institutet in Stockholm, reported the results of the analysis as a late-breaking abstract at the meeting.

“I think this is an innovative translational study trying to use the multigene assay results to look at differential endocrine therapy effects,” said Prudence Francis, MD, the invited discussant for study.

However, there are relatively few patients in the various subgroups being tested, she added. “We’ve also got short duration of tamoxifen, only 2 years, we’ve got prior chemotherapy in some patients and absence of HER2 therapy, all of which might influence outcomes.”

As a result, Dr. Francis, who is head of medical oncology at the Peter MacCallum Cancer Centre and a consultant Medical Oncologist at St. Vincent’s Hospital Melbourne, called the findings purely “hypothesis generating.”
 

Study details and results

The analysis was based on data from the STO-5 trial, which had recruited just over 900 patients between 1990 and 1997. Patients were stratified according to their lymph node status and some received chemotherapy with or without locoregional radiotherapy before being randomized to one of four study arms: goserelin alone, tamoxifen alone, the combination of the two, or no endocrine therapy.

Ms. Johansson noted that they were able to obtain the primary tumor blocks from 729 patients in the past year, of whom 610 were estrogen receptor positive. The analysis according to the 70-gene signature was then based on data from 465 patients: 131 had been treated with goserelin, 105 with tamoxifen, 120 with both, and 109 had received no endocrine treatment.

We have complete 20-year follow-up from high-quality Swedish National registries,” Ms. Johansson said, observing that the median age in the trial was 46 years.

Before stratifying patients into high and low risk using the 70-gene signature, the risk for having a distant recurrence, compared with no endocrine therapy was reduced by 52% with goserelin (hazard ratio, .48), 41% with tamoxifen (HR, 0.59), and 33% with both in combination (HR, 0.67).

After stratification, however, goserelin was associated with a 78% reduction of distant recurrence versus no endocrine treatment in high-risk patients (HR, 0.22) and a 20% reduction in low-risk patients (HR, 0.80).

Results in high- and low-risk patients with tamoxifen versus no endocrine treatment were a respective 31% reduction (HR, 0.69) and 62% reduction (HR, 0.38), and a respective 36% (HR, 0.64) and 28% (HR, 0.72) for the combination.

A further analysis was performed to compare between the active treatment arms, and this suggested a greater benefit of goserelin in patients at high risk when compared with both tamoxifen (HR, 0.30) and the combination (HR, 0.33).

Dr. Francis commented: “it is a bit surprising to find that goserelin appeared to be also better than the combination,” and it is something that the research team is looking into.

“One hypothesis might be if you look how the different treatments are working,” Ms. Johansson said. “Goserelin is very efficient in lowering the estrogen levels in premenopausal patients, suppressing the ovarian production of estrogen whereas tamoxifen can act both as an antagonist and agonist.

“So, we are thinking that maybe the addition of tamoxifen, with the agonistic properties of tamoxifen, might then make the goserelin not as efficient. But that’s of course, just a hypothesis right now and we need to look into this further,” she said.

The work was funded by The Swedish Research Council (Vetenskapsrådet), The Swedish Research Council for Health, Working life and Welfare, and the Swedish Cancer Society (Cancerfonden). Ms. Johansson had no personal disclosures; one of the coauthors was a coinventor of MammaPrint. Dr. Francis disclosed receiving travel support for overseas lectures from Ipsen and Novartis and acting as a medical oncology editor for Elsevier.

The long-term benefits of endocrine therapy in premenopausal breast cancer appear to differ according to whether patients are categorized as high or low molecular risk using the 70-gene signature (MammaPrint).

Based upon data from patients who had participated in the Stockholm tamoxifen (STO-5) trial, high-risk patients significantly benefited from goserelin treatment, whereas low-risk patients benefited more from tamoxifen treatment when compared with no endocrine therapy.

“Goserelin, tamoxifen, and the combination of the two, reduced the 20-year risk of distant occurrences and fatal breast cancer, compared to no endocrine therapy,” Annelie Johansson, MSc, said at the European Society for Medical Oncology: Breast Cancer virtual meeting.

“Our findings indicate that the long-term endocrine therapy benefit in premenopausal patients is influenced by molecular risk classification and thus tumor characteristics,” she added.

Ms. Johansson, a postdoctoral researcher in genomic breast cancer at the Karolinska Institutet in Stockholm, reported the results of the analysis as a late-breaking abstract at the meeting.

“I think this is an innovative translational study trying to use the multigene assay results to look at differential endocrine therapy effects,” said Prudence Francis, MD, the invited discussant for study.

However, there are relatively few patients in the various subgroups being tested, she added. “We’ve also got short duration of tamoxifen, only 2 years, we’ve got prior chemotherapy in some patients and absence of HER2 therapy, all of which might influence outcomes.”

As a result, Dr. Francis, who is head of medical oncology at the Peter MacCallum Cancer Centre and a consultant Medical Oncologist at St. Vincent’s Hospital Melbourne, called the findings purely “hypothesis generating.”
 

Study details and results

The analysis was based on data from the STO-5 trial, which had recruited just over 900 patients between 1990 and 1997. Patients were stratified according to their lymph node status and some received chemotherapy with or without locoregional radiotherapy before being randomized to one of four study arms: goserelin alone, tamoxifen alone, the combination of the two, or no endocrine therapy.

Ms. Johansson noted that they were able to obtain the primary tumor blocks from 729 patients in the past year, of whom 610 were estrogen receptor positive. The analysis according to the 70-gene signature was then based on data from 465 patients: 131 had been treated with goserelin, 105 with tamoxifen, 120 with both, and 109 had received no endocrine treatment.

We have complete 20-year follow-up from high-quality Swedish National registries,” Ms. Johansson said, observing that the median age in the trial was 46 years.

Before stratifying patients into high and low risk using the 70-gene signature, the risk for having a distant recurrence, compared with no endocrine therapy was reduced by 52% with goserelin (hazard ratio, .48), 41% with tamoxifen (HR, 0.59), and 33% with both in combination (HR, 0.67).

After stratification, however, goserelin was associated with a 78% reduction of distant recurrence versus no endocrine treatment in high-risk patients (HR, 0.22) and a 20% reduction in low-risk patients (HR, 0.80).

Results in high- and low-risk patients with tamoxifen versus no endocrine treatment were a respective 31% reduction (HR, 0.69) and 62% reduction (HR, 0.38), and a respective 36% (HR, 0.64) and 28% (HR, 0.72) for the combination.

A further analysis was performed to compare between the active treatment arms, and this suggested a greater benefit of goserelin in patients at high risk when compared with both tamoxifen (HR, 0.30) and the combination (HR, 0.33).

Dr. Francis commented: “it is a bit surprising to find that goserelin appeared to be also better than the combination,” and it is something that the research team is looking into.

“One hypothesis might be if you look how the different treatments are working,” Ms. Johansson said. “Goserelin is very efficient in lowering the estrogen levels in premenopausal patients, suppressing the ovarian production of estrogen whereas tamoxifen can act both as an antagonist and agonist.

“So, we are thinking that maybe the addition of tamoxifen, with the agonistic properties of tamoxifen, might then make the goserelin not as efficient. But that’s of course, just a hypothesis right now and we need to look into this further,” she said.

The work was funded by The Swedish Research Council (Vetenskapsrådet), The Swedish Research Council for Health, Working life and Welfare, and the Swedish Cancer Society (Cancerfonden). Ms. Johansson had no personal disclosures; one of the coauthors was a coinventor of MammaPrint. Dr. Francis disclosed receiving travel support for overseas lectures from Ipsen and Novartis and acting as a medical oncology editor for Elsevier.

Many Mohs surgeons are struggling on the job, and women seem to be especially vulnerable, a new survey suggests.

In a measurement of well-being, 40% of members of the American College of Mohs

Surgery (ACMS) who responded to the survey – and 52% of women – scored at a level considered “at-risk” for adverse outcomes, such as poor quality of life.

“I didn’t think the numbers were going to be that high,” said study author Kemi O. Awe, MD, PhD, a dermatology resident at the University of Alabama at Birmingham, especially in light of Mohs surgery’s reputation as being an especially desirable field in dermatology. She presented the findings at the annual meeting of the ACMS.

Dr. Awe, who hopes to become a Mohs surgeon herself, said in an interview that she launched the study in part to understand how colleagues are faring. “Dermatology is known as a specialty that has a good lifestyle and less stress, but the rate of burnout is actually going up.”

For the study, Dr. Awe and colleagues sent a survey to ACMS members between October and December 2020. The 91 respondents had an average age of 46, and 58% were male. Most practiced in academic facilities (56%), while the rest worked in private practice (39%) or multispecialty (4%) practices. Almost all (89%) were married or in partnerships.

The survey calculated scores on the expanded Physician Well Being Index, a validated tool for measuring physician distress. Forty percent of 68 respondents to this part of the survey got a score of 3 or higher, which the study describes as “a threshold for respondents who are ‘at-risk’ of adverse outcomes such as poor quality of life, depression, and a high level of fatigue.”

Women were more likely to be considered at risk (52%) than men (28%). “This isn’t different than what’s already out there: Female physicians are more likely to be burned out compared to men,” Dr. Awe said.

Compared with their male counterparts, female Mohs surgeons were more likely to say that time at work, malpractice concerns, insurance reimbursement, and compensation structure negatively affected their well-being (P ≤ .05).

It’s unclear whether there’s a well-being gender gap among dermatologists overall, however. Dr. Awe highlighted a 2019 survey of 108 dermatologists that found no significant difference in overall burnout between men and women – about 42% of both genders reported symptoms. But the survey did find that “dermatologists with children living at home had significantly higher levels of burnout,” with a P value of .03.

Dr. Awe said the findings offer insight into what to look out for when pursuing a career as a Mohs surgeon. “There’s potentially excess stress about being a Mohs surgeon,” she said, although the field also has a reputation as being fulfilling and rewarding.

In an interview, Stanford (Calif.) University dermatologist Zakia Rahman, MD, praised the study and said it “certainly provides a framework to address professional fulfillment amongst Mohs surgeons.”

For now, dermatologists can focus on strategies that can reduce burnout in the field, Sailesh Konda, MD, a Mohs surgeon at the Univeristy of Florida, Gainesville, said in an interview. Dr. Konda highlighted a report published in 2020 that, he said, "recommended focusing on incremental changes that help restore autonomy and control over work, connecting with colleagues within dermatology and the broader medical community, developing self-awareness and recognition of a perfectionist mindset, and restoring meaning and joy to patient care.”*

No funding is reported for the study. Dr. Awe, Dr. Rahman, and Dr. Konda have no relevant disclosures.

*This story was updated on June 2 for clarity.

Many Mohs surgeons are struggling on the job, and women seem to be especially vulnerable, a new survey suggests.

In a measurement of well-being, 40% of members of the American College of Mohs

Surgery (ACMS) who responded to the survey – and 52% of women – scored at a level considered “at-risk” for adverse outcomes, such as poor quality of life.

“I didn’t think the numbers were going to be that high,” said study author Kemi O. Awe, MD, PhD, a dermatology resident at the University of Alabama at Birmingham, especially in light of Mohs surgery’s reputation as being an especially desirable field in dermatology. She presented the findings at the annual meeting of the ACMS.

Dr. Awe, who hopes to become a Mohs surgeon herself, said in an interview that she launched the study in part to understand how colleagues are faring. “Dermatology is known as a specialty that has a good lifestyle and less stress, but the rate of burnout is actually going up.”

For the study, Dr. Awe and colleagues sent a survey to ACMS members between October and December 2020. The 91 respondents had an average age of 46, and 58% were male. Most practiced in academic facilities (56%), while the rest worked in private practice (39%) or multispecialty (4%) practices. Almost all (89%) were married or in partnerships.

The survey calculated scores on the expanded Physician Well Being Index, a validated tool for measuring physician distress. Forty percent of 68 respondents to this part of the survey got a score of 3 or higher, which the study describes as “a threshold for respondents who are ‘at-risk’ of adverse outcomes such as poor quality of life, depression, and a high level of fatigue.”

Women were more likely to be considered at risk (52%) than men (28%). “This isn’t different than what’s already out there: Female physicians are more likely to be burned out compared to men,” Dr. Awe said.

Compared with their male counterparts, female Mohs surgeons were more likely to say that time at work, malpractice concerns, insurance reimbursement, and compensation structure negatively affected their well-being (P ≤ .05).

It’s unclear whether there’s a well-being gender gap among dermatologists overall, however. Dr. Awe highlighted a 2019 survey of 108 dermatologists that found no significant difference in overall burnout between men and women – about 42% of both genders reported symptoms. But the survey did find that “dermatologists with children living at home had significantly higher levels of burnout,” with a P value of .03.

Dr. Awe said the findings offer insight into what to look out for when pursuing a career as a Mohs surgeon. “There’s potentially excess stress about being a Mohs surgeon,” she said, although the field also has a reputation as being fulfilling and rewarding.

In an interview, Stanford (Calif.) University dermatologist Zakia Rahman, MD, praised the study and said it “certainly provides a framework to address professional fulfillment amongst Mohs surgeons.”

For now, dermatologists can focus on strategies that can reduce burnout in the field, Sailesh Konda, MD, a Mohs surgeon at the Univeristy of Florida, Gainesville, said in an interview. Dr. Konda highlighted a report published in 2020 that, he said, "recommended focusing on incremental changes that help restore autonomy and control over work, connecting with colleagues within dermatology and the broader medical community, developing self-awareness and recognition of a perfectionist mindset, and restoring meaning and joy to patient care.”*

No funding is reported for the study. Dr. Awe, Dr. Rahman, and Dr. Konda have no relevant disclosures.

*This story was updated on June 2 for clarity.

Many Mohs surgeons are struggling on the job, and women seem to be especially vulnerable, a new survey suggests.

In a measurement of well-being, 40% of members of the American College of Mohs

Surgery (ACMS) who responded to the survey – and 52% of women – scored at a level considered “at-risk” for adverse outcomes, such as poor quality of life.

“I didn’t think the numbers were going to be that high,” said study author Kemi O. Awe, MD, PhD, a dermatology resident at the University of Alabama at Birmingham, especially in light of Mohs surgery’s reputation as being an especially desirable field in dermatology. She presented the findings at the annual meeting of the ACMS.

Dr. Awe, who hopes to become a Mohs surgeon herself, said in an interview that she launched the study in part to understand how colleagues are faring. “Dermatology is known as a specialty that has a good lifestyle and less stress, but the rate of burnout is actually going up.”

For the study, Dr. Awe and colleagues sent a survey to ACMS members between October and December 2020. The 91 respondents had an average age of 46, and 58% were male. Most practiced in academic facilities (56%), while the rest worked in private practice (39%) or multispecialty (4%) practices. Almost all (89%) were married or in partnerships.

The survey calculated scores on the expanded Physician Well Being Index, a validated tool for measuring physician distress. Forty percent of 68 respondents to this part of the survey got a score of 3 or higher, which the study describes as “a threshold for respondents who are ‘at-risk’ of adverse outcomes such as poor quality of life, depression, and a high level of fatigue.”

Women were more likely to be considered at risk (52%) than men (28%). “This isn’t different than what’s already out there: Female physicians are more likely to be burned out compared to men,” Dr. Awe said.

Compared with their male counterparts, female Mohs surgeons were more likely to say that time at work, malpractice concerns, insurance reimbursement, and compensation structure negatively affected their well-being (P ≤ .05).

It’s unclear whether there’s a well-being gender gap among dermatologists overall, however. Dr. Awe highlighted a 2019 survey of 108 dermatologists that found no significant difference in overall burnout between men and women – about 42% of both genders reported symptoms. But the survey did find that “dermatologists with children living at home had significantly higher levels of burnout,” with a P value of .03.

Dr. Awe said the findings offer insight into what to look out for when pursuing a career as a Mohs surgeon. “There’s potentially excess stress about being a Mohs surgeon,” she said, although the field also has a reputation as being fulfilling and rewarding.

In an interview, Stanford (Calif.) University dermatologist Zakia Rahman, MD, praised the study and said it “certainly provides a framework to address professional fulfillment amongst Mohs surgeons.”

For now, dermatologists can focus on strategies that can reduce burnout in the field, Sailesh Konda, MD, a Mohs surgeon at the Univeristy of Florida, Gainesville, said in an interview. Dr. Konda highlighted a report published in 2020 that, he said, "recommended focusing on incremental changes that help restore autonomy and control over work, connecting with colleagues within dermatology and the broader medical community, developing self-awareness and recognition of a perfectionist mindset, and restoring meaning and joy to patient care.”*

No funding is reported for the study. Dr. Awe, Dr. Rahman, and Dr. Konda have no relevant disclosures.

*This story was updated on June 2 for clarity.

After patients with peripheral artery disease undergo lower-extremity revascularization, they are at high risk for major adverse limb events, and new findings from a prespecified analysis of data from the VOYAGER-PAD trial show that treatment with the direct-acting oral anticoagulant rivaroxaban along with aspirin significantly cut the rate of total major adverse limb events in these patients.

courtesy American College of Cardiology

These findings confirm the drop in first major adverse limb events linked to rivaroxaban treatment that was VOYAGER-PAD’s primary result, reported just over a year ago.

The new total-event analysis also provides important insight into the huge magnitude of total major adverse limb events that patients with PAD can develop following lower-extremity revascularization (LER).

The 6,564 patients who all received aspirin and were randomized to either rivaroxaban (Xarelto) or placebo had 4,714 total events during a median follow-up of 2.5 years following their revascularization procedure. This included 1,092 first primary events (a composite of acute limb ischemia, major amputation for vascular causes, MI, ischemic stroke, or cardiovascular death), 522 primary events that occurred as second or subsequent events among patients after a first primary event (a nearly 50% increase from first events only), and 3,100 additional vascular events that did not fit into the primary-event category, most often a peripheral revascularization procedure, Rupert M. Bauersachs, MD, said at the annual scientific sessions of the American College of Cardiology.

“We were all astonished by this high event rate,” Dr. Bauersachs said during his report.

The total-event analysis that he reported showed that treatment with rivaroxaban resulted in a significant 14% relative reduction, compared with placebo in the incidence of total primary events, which closely tracks the significant 15% relative reduction in first primary events reported from the VOYAGER-PAD trial in 2020. Treatment with rivaroxaban also significantly linked with a 14% cut in total vascular events, compared with placebo, including the many events not included in the primary endpoint, said Dr. Bauersachs, who until his retirement in May 2021 was director of the Clinic for Vascular Medicine at the Darmstadt (Germany) Clinic. Concurrently with the report, the results appeared online.

“If one focuses only on first events, you miss the totality of disease burden. There is even greater benefit by reducing total events,” Dr. Bauersachs said during a press briefing. Adding rivaroxaban prevented roughly 2.6 first primary events for every 100 patients treated, but it also prevented 4.4 total primary events and 12.5 total vascular events for every 100 treated patients.

An ‘incredibly high’ event rate

“I don’t think any of us imagined the level of morbidity in this population. The event rate is incredibly high,” commented Joshua A. Beckman, MD, professor and director of vascular medicine at Vanderbilt University Medical Center, Nashville, Tenn.

Because treatment with rivaroxaban showed clear efficacy for also preventing subsequent events it should not be considered to have failed in patients who have a vascular event while on rivaroxaban treatment, he added as designated discussant for the report. Treatment with rivaroxaban “should be continued indefinitely,” he concluded.

“It’s quite astonishing to see the magnitude of [total] events in these patients,” commented Sahil A. Parikh, MD, a cardiologist and director of endovascular services at Columbia University Medical Center in New York. “We’ve always known that these are high-risk patients, but exactly how high their risk is was not well understood until these data came to light.”

Dr. Parikh also noted that, despite the clear evidence reported from VOYAGER-PAD more than a year ago proving the efficacy and safety of adding rivaroxaban to aspirin for long-term treatment of patients with PAD following LER, this regimen has not yet become standard U.S. practice.
 

Rivaroxaban use falls short of the expected level

“This paradigm shift has not seen the level of adoption that we would expect based on the data,” he said. “There have been numerous editorials and discussions of this at every major medical meeting” during the past year, but those expert opinions have not translated into changed practice. “Perhaps the pandemic has muted enthusiasm for adoption of a new therapeutic paradigm,” suggested Dr. Parikh, and “on top of that guidelines have yet to be updated,” although he noted that updated guidelines from the ACC and American Heart Association for PAD that include the types of patients enrolled in VOYAGER-PAD are now under review and should be released by the first half of 2022.

“I think the additional data [reported by Dr. Bauersachs] will encourage us to use rivaroxaban in patients with claudication,” Dr. Parikh said. “Perhaps we should use rivaroxaban and aspirin in a broader swath of patients, but it will take time to convince some constituencies.”

VOYAGER-PAD randomized patients with PAD who underwent successful LER within 10 days prior to enrollment at 542 sites in 34 countries during 2015-2018. In addition to every patient receiving 100 mg aspirin daily and either 2.5 mg rivaroxaban twice daily or placebo once daily, patients who received an intra-arterial device such as a stent could also receive the antiplatelet agent clopidogrel for a planned maximum of 30 days after revascularization at the discretion of their physician, and the trial protocol allowed for extending clopidogrel treatment to as many as 60 days.

In addition to the efficacy outcomes, the safety results showed that adding rivaroxaban to aspirin appeared to increase bleeding episodes, but at rates that generally did not reach significance and that were dwarfed by the efficacy benefit. The study’s primary safety outcome was the incidence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding episodes, which occurred in 2.65% of patients who received rivaroxaban and in 1.87% on those on placebo, a 43% relative increase that fell short of significance (P = .07). The analyses overall indicated that 10,000 similar patients treated for 1 year with rivaroxaban would have 181 fewer primary events, compared with placebo-treated patients at the cost of also having 29 additional TIMI major bleeding events compared with patient on placebo.

Adding clopidogrel adds little except bleeding

Further analysis showed that just over half of enrolled patients also received clopidogrel for a median of 29 days following their LER procedure. This added agent produced no significant added benefit during 3-year follow-up, but did boost bleeding risk, especially in patients who received clopidogrel for more than 30 days. This led the study investigators to suggest that, while rivaroxaban plus aspirin is indicated for long-term treatment, addition of clopidogrel on top of this should be limited to 30 days or fewer to minimize bleeding risk.

“I’m sure there is a bleeding hazard associated with rivaroxaban plus aspirin, but this is attenuated by using dual therapy and not using triple therapy” by also adding clopidogrel, noted Dr. Parikh.

The new VOYAGER-PAD results also showed that the ongoing risk faced by patients with PAD following LER applies globally to their peripheral arteries. Of the 3,034 total peripheral revascularizations performed in the cohort during follow-up, 64% occurred in the index limb and 36% in the contralateral limb. Another striking finding was that the need for ipsilateral repeat revascularization was more common after an index endovascular procedure, 2,329 repeat revascularizations in 4,379 of these patients (53%), compared with 2,185 patients who had surgical revascularization for their index procedure and subsequently 705 of these patients (32%) needed repeat revascularization.

But rivaroxaban treatment appeared to provide little benefit for the much less frequent incidence of first and subsequent events in the coronary and cerebral circulation. During follow-up, the rates of major adverse cardiovascular events – cardiovascular death, nonfatal MI, and nonfatal stroke – were virtually identical in the rivaroxaban and placebo groups.

“This study makes it clear that we are learning about differences in presentation between the vascular beds, and the benefits of specific treatments in each vascular bed,” Dr. Beckman said.

VOYAGER-PAD was sponsored by Bayer and Janssen, the companies that market rivaroxaban (Xarelto). Dr. Bauersachs has received personal fees from Bayer, as well as from Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer, and has received grant support from Aspen Pharma. Dr. Beckman been a consultant to and received honoraria from Janssen, as well as from Amgen, JanOne, Novartis, and Sanofi, and he has served on a data and safety monitoring board for Bayer. Dr. Parikh has been a consultant to and received honoraria from Janssen, as well as from Abbott, Boston Scientific, Cordis, Medtronic, Penumbra, Philips, and Terumo, he has been a speaker on behalf of Inari, and he has received grant support from Abbott, Shockwave Medical, Surmodics, and TriReme Medical.

mzoler@mdedge.com

After patients with peripheral artery disease undergo lower-extremity revascularization, they are at high risk for major adverse limb events, and new findings from a prespecified analysis of data from the VOYAGER-PAD trial show that treatment with the direct-acting oral anticoagulant rivaroxaban along with aspirin significantly cut the rate of total major adverse limb events in these patients.

courtesy American College of Cardiology

These findings confirm the drop in first major adverse limb events linked to rivaroxaban treatment that was VOYAGER-PAD’s primary result, reported just over a year ago.

The new total-event analysis also provides important insight into the huge magnitude of total major adverse limb events that patients with PAD can develop following lower-extremity revascularization (LER).

The 6,564 patients who all received aspirin and were randomized to either rivaroxaban (Xarelto) or placebo had 4,714 total events during a median follow-up of 2.5 years following their revascularization procedure. This included 1,092 first primary events (a composite of acute limb ischemia, major amputation for vascular causes, MI, ischemic stroke, or cardiovascular death), 522 primary events that occurred as second or subsequent events among patients after a first primary event (a nearly 50% increase from first events only), and 3,100 additional vascular events that did not fit into the primary-event category, most often a peripheral revascularization procedure, Rupert M. Bauersachs, MD, said at the annual scientific sessions of the American College of Cardiology.

“We were all astonished by this high event rate,” Dr. Bauersachs said during his report.

The total-event analysis that he reported showed that treatment with rivaroxaban resulted in a significant 14% relative reduction, compared with placebo in the incidence of total primary events, which closely tracks the significant 15% relative reduction in first primary events reported from the VOYAGER-PAD trial in 2020. Treatment with rivaroxaban also significantly linked with a 14% cut in total vascular events, compared with placebo, including the many events not included in the primary endpoint, said Dr. Bauersachs, who until his retirement in May 2021 was director of the Clinic for Vascular Medicine at the Darmstadt (Germany) Clinic. Concurrently with the report, the results appeared online.

“If one focuses only on first events, you miss the totality of disease burden. There is even greater benefit by reducing total events,” Dr. Bauersachs said during a press briefing. Adding rivaroxaban prevented roughly 2.6 first primary events for every 100 patients treated, but it also prevented 4.4 total primary events and 12.5 total vascular events for every 100 treated patients.

An ‘incredibly high’ event rate

“I don’t think any of us imagined the level of morbidity in this population. The event rate is incredibly high,” commented Joshua A. Beckman, MD, professor and director of vascular medicine at Vanderbilt University Medical Center, Nashville, Tenn.

Because treatment with rivaroxaban showed clear efficacy for also preventing subsequent events it should not be considered to have failed in patients who have a vascular event while on rivaroxaban treatment, he added as designated discussant for the report. Treatment with rivaroxaban “should be continued indefinitely,” he concluded.

“It’s quite astonishing to see the magnitude of [total] events in these patients,” commented Sahil A. Parikh, MD, a cardiologist and director of endovascular services at Columbia University Medical Center in New York. “We’ve always known that these are high-risk patients, but exactly how high their risk is was not well understood until these data came to light.”

Dr. Parikh also noted that, despite the clear evidence reported from VOYAGER-PAD more than a year ago proving the efficacy and safety of adding rivaroxaban to aspirin for long-term treatment of patients with PAD following LER, this regimen has not yet become standard U.S. practice.
 

Rivaroxaban use falls short of the expected level

“This paradigm shift has not seen the level of adoption that we would expect based on the data,” he said. “There have been numerous editorials and discussions of this at every major medical meeting” during the past year, but those expert opinions have not translated into changed practice. “Perhaps the pandemic has muted enthusiasm for adoption of a new therapeutic paradigm,” suggested Dr. Parikh, and “on top of that guidelines have yet to be updated,” although he noted that updated guidelines from the ACC and American Heart Association for PAD that include the types of patients enrolled in VOYAGER-PAD are now under review and should be released by the first half of 2022.

“I think the additional data [reported by Dr. Bauersachs] will encourage us to use rivaroxaban in patients with claudication,” Dr. Parikh said. “Perhaps we should use rivaroxaban and aspirin in a broader swath of patients, but it will take time to convince some constituencies.”

VOYAGER-PAD randomized patients with PAD who underwent successful LER within 10 days prior to enrollment at 542 sites in 34 countries during 2015-2018. In addition to every patient receiving 100 mg aspirin daily and either 2.5 mg rivaroxaban twice daily or placebo once daily, patients who received an intra-arterial device such as a stent could also receive the antiplatelet agent clopidogrel for a planned maximum of 30 days after revascularization at the discretion of their physician, and the trial protocol allowed for extending clopidogrel treatment to as many as 60 days.

In addition to the efficacy outcomes, the safety results showed that adding rivaroxaban to aspirin appeared to increase bleeding episodes, but at rates that generally did not reach significance and that were dwarfed by the efficacy benefit. The study’s primary safety outcome was the incidence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding episodes, which occurred in 2.65% of patients who received rivaroxaban and in 1.87% on those on placebo, a 43% relative increase that fell short of significance (P = .07). The analyses overall indicated that 10,000 similar patients treated for 1 year with rivaroxaban would have 181 fewer primary events, compared with placebo-treated patients at the cost of also having 29 additional TIMI major bleeding events compared with patient on placebo.

Adding clopidogrel adds little except bleeding

Further analysis showed that just over half of enrolled patients also received clopidogrel for a median of 29 days following their LER procedure. This added agent produced no significant added benefit during 3-year follow-up, but did boost bleeding risk, especially in patients who received clopidogrel for more than 30 days. This led the study investigators to suggest that, while rivaroxaban plus aspirin is indicated for long-term treatment, addition of clopidogrel on top of this should be limited to 30 days or fewer to minimize bleeding risk.

“I’m sure there is a bleeding hazard associated with rivaroxaban plus aspirin, but this is attenuated by using dual therapy and not using triple therapy” by also adding clopidogrel, noted Dr. Parikh.

The new VOYAGER-PAD results also showed that the ongoing risk faced by patients with PAD following LER applies globally to their peripheral arteries. Of the 3,034 total peripheral revascularizations performed in the cohort during follow-up, 64% occurred in the index limb and 36% in the contralateral limb. Another striking finding was that the need for ipsilateral repeat revascularization was more common after an index endovascular procedure, 2,329 repeat revascularizations in 4,379 of these patients (53%), compared with 2,185 patients who had surgical revascularization for their index procedure and subsequently 705 of these patients (32%) needed repeat revascularization.

But rivaroxaban treatment appeared to provide little benefit for the much less frequent incidence of first and subsequent events in the coronary and cerebral circulation. During follow-up, the rates of major adverse cardiovascular events – cardiovascular death, nonfatal MI, and nonfatal stroke – were virtually identical in the rivaroxaban and placebo groups.

“This study makes it clear that we are learning about differences in presentation between the vascular beds, and the benefits of specific treatments in each vascular bed,” Dr. Beckman said.

VOYAGER-PAD was sponsored by Bayer and Janssen, the companies that market rivaroxaban (Xarelto). Dr. Bauersachs has received personal fees from Bayer, as well as from Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer, and has received grant support from Aspen Pharma. Dr. Beckman been a consultant to and received honoraria from Janssen, as well as from Amgen, JanOne, Novartis, and Sanofi, and he has served on a data and safety monitoring board for Bayer. Dr. Parikh has been a consultant to and received honoraria from Janssen, as well as from Abbott, Boston Scientific, Cordis, Medtronic, Penumbra, Philips, and Terumo, he has been a speaker on behalf of Inari, and he has received grant support from Abbott, Shockwave Medical, Surmodics, and TriReme Medical.

mzoler@mdedge.com

After patients with peripheral artery disease undergo lower-extremity revascularization, they are at high risk for major adverse limb events, and new findings from a prespecified analysis of data from the VOYAGER-PAD trial show that treatment with the direct-acting oral anticoagulant rivaroxaban along with aspirin significantly cut the rate of total major adverse limb events in these patients.

courtesy American College of Cardiology

These findings confirm the drop in first major adverse limb events linked to rivaroxaban treatment that was VOYAGER-PAD’s primary result, reported just over a year ago.

The new total-event analysis also provides important insight into the huge magnitude of total major adverse limb events that patients with PAD can develop following lower-extremity revascularization (LER).

The 6,564 patients who all received aspirin and were randomized to either rivaroxaban (Xarelto) or placebo had 4,714 total events during a median follow-up of 2.5 years following their revascularization procedure. This included 1,092 first primary events (a composite of acute limb ischemia, major amputation for vascular causes, MI, ischemic stroke, or cardiovascular death), 522 primary events that occurred as second or subsequent events among patients after a first primary event (a nearly 50% increase from first events only), and 3,100 additional vascular events that did not fit into the primary-event category, most often a peripheral revascularization procedure, Rupert M. Bauersachs, MD, said at the annual scientific sessions of the American College of Cardiology.

“We were all astonished by this high event rate,” Dr. Bauersachs said during his report.

The total-event analysis that he reported showed that treatment with rivaroxaban resulted in a significant 14% relative reduction, compared with placebo in the incidence of total primary events, which closely tracks the significant 15% relative reduction in first primary events reported from the VOYAGER-PAD trial in 2020. Treatment with rivaroxaban also significantly linked with a 14% cut in total vascular events, compared with placebo, including the many events not included in the primary endpoint, said Dr. Bauersachs, who until his retirement in May 2021 was director of the Clinic for Vascular Medicine at the Darmstadt (Germany) Clinic. Concurrently with the report, the results appeared online.

“If one focuses only on first events, you miss the totality of disease burden. There is even greater benefit by reducing total events,” Dr. Bauersachs said during a press briefing. Adding rivaroxaban prevented roughly 2.6 first primary events for every 100 patients treated, but it also prevented 4.4 total primary events and 12.5 total vascular events for every 100 treated patients.

An ‘incredibly high’ event rate

“I don’t think any of us imagined the level of morbidity in this population. The event rate is incredibly high,” commented Joshua A. Beckman, MD, professor and director of vascular medicine at Vanderbilt University Medical Center, Nashville, Tenn.

Because treatment with rivaroxaban showed clear efficacy for also preventing subsequent events it should not be considered to have failed in patients who have a vascular event while on rivaroxaban treatment, he added as designated discussant for the report. Treatment with rivaroxaban “should be continued indefinitely,” he concluded.

“It’s quite astonishing to see the magnitude of [total] events in these patients,” commented Sahil A. Parikh, MD, a cardiologist and director of endovascular services at Columbia University Medical Center in New York. “We’ve always known that these are high-risk patients, but exactly how high their risk is was not well understood until these data came to light.”

Dr. Parikh also noted that, despite the clear evidence reported from VOYAGER-PAD more than a year ago proving the efficacy and safety of adding rivaroxaban to aspirin for long-term treatment of patients with PAD following LER, this regimen has not yet become standard U.S. practice.
 

Rivaroxaban use falls short of the expected level

“This paradigm shift has not seen the level of adoption that we would expect based on the data,” he said. “There have been numerous editorials and discussions of this at every major medical meeting” during the past year, but those expert opinions have not translated into changed practice. “Perhaps the pandemic has muted enthusiasm for adoption of a new therapeutic paradigm,” suggested Dr. Parikh, and “on top of that guidelines have yet to be updated,” although he noted that updated guidelines from the ACC and American Heart Association for PAD that include the types of patients enrolled in VOYAGER-PAD are now under review and should be released by the first half of 2022.

“I think the additional data [reported by Dr. Bauersachs] will encourage us to use rivaroxaban in patients with claudication,” Dr. Parikh said. “Perhaps we should use rivaroxaban and aspirin in a broader swath of patients, but it will take time to convince some constituencies.”

VOYAGER-PAD randomized patients with PAD who underwent successful LER within 10 days prior to enrollment at 542 sites in 34 countries during 2015-2018. In addition to every patient receiving 100 mg aspirin daily and either 2.5 mg rivaroxaban twice daily or placebo once daily, patients who received an intra-arterial device such as a stent could also receive the antiplatelet agent clopidogrel for a planned maximum of 30 days after revascularization at the discretion of their physician, and the trial protocol allowed for extending clopidogrel treatment to as many as 60 days.

In addition to the efficacy outcomes, the safety results showed that adding rivaroxaban to aspirin appeared to increase bleeding episodes, but at rates that generally did not reach significance and that were dwarfed by the efficacy benefit. The study’s primary safety outcome was the incidence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding episodes, which occurred in 2.65% of patients who received rivaroxaban and in 1.87% on those on placebo, a 43% relative increase that fell short of significance (P = .07). The analyses overall indicated that 10,000 similar patients treated for 1 year with rivaroxaban would have 181 fewer primary events, compared with placebo-treated patients at the cost of also having 29 additional TIMI major bleeding events compared with patient on placebo.

Adding clopidogrel adds little except bleeding

Further analysis showed that just over half of enrolled patients also received clopidogrel for a median of 29 days following their LER procedure. This added agent produced no significant added benefit during 3-year follow-up, but did boost bleeding risk, especially in patients who received clopidogrel for more than 30 days. This led the study investigators to suggest that, while rivaroxaban plus aspirin is indicated for long-term treatment, addition of clopidogrel on top of this should be limited to 30 days or fewer to minimize bleeding risk.

“I’m sure there is a bleeding hazard associated with rivaroxaban plus aspirin, but this is attenuated by using dual therapy and not using triple therapy” by also adding clopidogrel, noted Dr. Parikh.

The new VOYAGER-PAD results also showed that the ongoing risk faced by patients with PAD following LER applies globally to their peripheral arteries. Of the 3,034 total peripheral revascularizations performed in the cohort during follow-up, 64% occurred in the index limb and 36% in the contralateral limb. Another striking finding was that the need for ipsilateral repeat revascularization was more common after an index endovascular procedure, 2,329 repeat revascularizations in 4,379 of these patients (53%), compared with 2,185 patients who had surgical revascularization for their index procedure and subsequently 705 of these patients (32%) needed repeat revascularization.

But rivaroxaban treatment appeared to provide little benefit for the much less frequent incidence of first and subsequent events in the coronary and cerebral circulation. During follow-up, the rates of major adverse cardiovascular events – cardiovascular death, nonfatal MI, and nonfatal stroke – were virtually identical in the rivaroxaban and placebo groups.

“This study makes it clear that we are learning about differences in presentation between the vascular beds, and the benefits of specific treatments in each vascular bed,” Dr. Beckman said.

VOYAGER-PAD was sponsored by Bayer and Janssen, the companies that market rivaroxaban (Xarelto). Dr. Bauersachs has received personal fees from Bayer, as well as from Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer, and has received grant support from Aspen Pharma. Dr. Beckman been a consultant to and received honoraria from Janssen, as well as from Amgen, JanOne, Novartis, and Sanofi, and he has served on a data and safety monitoring board for Bayer. Dr. Parikh has been a consultant to and received honoraria from Janssen, as well as from Abbott, Boston Scientific, Cordis, Medtronic, Penumbra, Philips, and Terumo, he has been a speaker on behalf of Inari, and he has received grant support from Abbott, Shockwave Medical, Surmodics, and TriReme Medical.

mzoler@mdedge.com

Researchers examining GI endoscopes after colonoscopy and esophagogastroduodenoscopy (EGD) procedures found a “startlingly high” rate of retained biopsy samples in the endoscope accessory channel or cap.

Investigators found 64% of 105 total endoscopies featured retained biopsy samples, including 76% of EGDs and 50% of colonoscopies examined.

“The take-home message would be that retained biopsies are much more common than most endoscopists would think. In our institution, many endoscopists guessed 10%-15%, while the actual number was 64%,” Gregory Toy, MD, said in an interview.

Raising awareness about the high proportion of retained biopsy samples “could help change behavior to make this happen less often,” added Dr. Toy, an internal medicine resident at the University of Utah Health in Salt Lake City.

“Another finding of this study was that there were significantly more retained biopsies found in EGDs compared to colonoscopies,” Dr. Toy said.

Dr. Toy presented the findings at the annual Digestive Disease Week® (DDW).
 

‘Very surprising’ findings

“The study is very important as it points out a significant rate of tissue retention in the biopsy channel at the conclusion of endoscopic procedures,” session moderator Serge Sorser, MD, said in an interview. 

The high rate of tissue retention “is very surprising,” added Dr. Sorser, a gastroenterologist at Ascension Michigan Providence Hospital in Novi, Mich.

“Not only does this mean that not all tissue is submitted for pathologic review, but it also brings to light the need for diligent endoscope processing between procedures,” he said.

Because biopsy specimens during GI endoscopy procedures must pass through the device’s biopsy channel and cap, Dr. Toy and colleagues decided to examine the rate of potentially retained samples.

Endoscopists “have noted anecdotally that retained biopsies can be found in the accessory channel and/or cap,” Dr. Toy said during his presentation at DDW. “However, this has not been formally studied.”

After 55 EGDs and 50 colonoscopies, each a standard outpatient procedure, the researchers removed the cap and the male end where the cap attaches. They brushed these areas for residual tissue. Next, they applied a new suction trap and cleared the channel using water and suction. They then brushed the channel and repeated the water and suction procedure. As a final check, they visually inspected the cleaning brush.

They sent any recovered tissue – designated from either the cap or channel – to pathology for evaluation. “The new pathology reads from these retained biopsies changed or added to the diagnosis in only five of our patients. All of these changes were minor, and patients were already on appropriate treatment,” Dr. Toy said.

Dr. Toy and colleagues found no differences between EGDs and colonoscopies with and without retained biopsy samples according to procedure time, doses of propofol or fentanyl, and age or gender of the patient. Likewise, the number of samples collected did not appear to influence the retention rates.

Of retained samples discovered after 42 EGDs, 71% were in the cap, 35% were in the channel, and 29% were found in both locations. Of the 25 colonoscopies with retained samples, 40% were in the cap, 34% were in the channel, and 24% were found in both places.

“The overall incidence of retained biopsies during standard upper and lower endoscopy is high,” the researchers noted.

Inclusion of multiple endoscopists and a hospital outpatient setting were strengths of the study. Limitations included a single center study with a relatively small sample size.

Dr. Toy and Dr. Sorser have disclosed no relevant financial relationships.
 

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

Researchers examining GI endoscopes after colonoscopy and esophagogastroduodenoscopy (EGD) procedures found a “startlingly high” rate of retained biopsy samples in the endoscope accessory channel or cap.

Investigators found 64% of 105 total endoscopies featured retained biopsy samples, including 76% of EGDs and 50% of colonoscopies examined.

“The take-home message would be that retained biopsies are much more common than most endoscopists would think. In our institution, many endoscopists guessed 10%-15%, while the actual number was 64%,” Gregory Toy, MD, said in an interview.

Raising awareness about the high proportion of retained biopsy samples “could help change behavior to make this happen less often,” added Dr. Toy, an internal medicine resident at the University of Utah Health in Salt Lake City.

“Another finding of this study was that there were significantly more retained biopsies found in EGDs compared to colonoscopies,” Dr. Toy said.

Dr. Toy presented the findings at the annual Digestive Disease Week® (DDW).
 

‘Very surprising’ findings

“The study is very important as it points out a significant rate of tissue retention in the biopsy channel at the conclusion of endoscopic procedures,” session moderator Serge Sorser, MD, said in an interview. 

The high rate of tissue retention “is very surprising,” added Dr. Sorser, a gastroenterologist at Ascension Michigan Providence Hospital in Novi, Mich.

“Not only does this mean that not all tissue is submitted for pathologic review, but it also brings to light the need for diligent endoscope processing between procedures,” he said.

Because biopsy specimens during GI endoscopy procedures must pass through the device’s biopsy channel and cap, Dr. Toy and colleagues decided to examine the rate of potentially retained samples.

Endoscopists “have noted anecdotally that retained biopsies can be found in the accessory channel and/or cap,” Dr. Toy said during his presentation at DDW. “However, this has not been formally studied.”

After 55 EGDs and 50 colonoscopies, each a standard outpatient procedure, the researchers removed the cap and the male end where the cap attaches. They brushed these areas for residual tissue. Next, they applied a new suction trap and cleared the channel using water and suction. They then brushed the channel and repeated the water and suction procedure. As a final check, they visually inspected the cleaning brush.

They sent any recovered tissue – designated from either the cap or channel – to pathology for evaluation. “The new pathology reads from these retained biopsies changed or added to the diagnosis in only five of our patients. All of these changes were minor, and patients were already on appropriate treatment,” Dr. Toy said.

Dr. Toy and colleagues found no differences between EGDs and colonoscopies with and without retained biopsy samples according to procedure time, doses of propofol or fentanyl, and age or gender of the patient. Likewise, the number of samples collected did not appear to influence the retention rates.

Of retained samples discovered after 42 EGDs, 71% were in the cap, 35% were in the channel, and 29% were found in both locations. Of the 25 colonoscopies with retained samples, 40% were in the cap, 34% were in the channel, and 24% were found in both places.

“The overall incidence of retained biopsies during standard upper and lower endoscopy is high,” the researchers noted.

Inclusion of multiple endoscopists and a hospital outpatient setting were strengths of the study. Limitations included a single center study with a relatively small sample size.

Dr. Toy and Dr. Sorser have disclosed no relevant financial relationships.
 

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

Researchers examining GI endoscopes after colonoscopy and esophagogastroduodenoscopy (EGD) procedures found a “startlingly high” rate of retained biopsy samples in the endoscope accessory channel or cap.

Investigators found 64% of 105 total endoscopies featured retained biopsy samples, including 76% of EGDs and 50% of colonoscopies examined.

“The take-home message would be that retained biopsies are much more common than most endoscopists would think. In our institution, many endoscopists guessed 10%-15%, while the actual number was 64%,” Gregory Toy, MD, said in an interview.

Raising awareness about the high proportion of retained biopsy samples “could help change behavior to make this happen less often,” added Dr. Toy, an internal medicine resident at the University of Utah Health in Salt Lake City.

“Another finding of this study was that there were significantly more retained biopsies found in EGDs compared to colonoscopies,” Dr. Toy said.

Dr. Toy presented the findings at the annual Digestive Disease Week® (DDW).
 

‘Very surprising’ findings

“The study is very important as it points out a significant rate of tissue retention in the biopsy channel at the conclusion of endoscopic procedures,” session moderator Serge Sorser, MD, said in an interview. 

The high rate of tissue retention “is very surprising,” added Dr. Sorser, a gastroenterologist at Ascension Michigan Providence Hospital in Novi, Mich.

“Not only does this mean that not all tissue is submitted for pathologic review, but it also brings to light the need for diligent endoscope processing between procedures,” he said.

Because biopsy specimens during GI endoscopy procedures must pass through the device’s biopsy channel and cap, Dr. Toy and colleagues decided to examine the rate of potentially retained samples.

Endoscopists “have noted anecdotally that retained biopsies can be found in the accessory channel and/or cap,” Dr. Toy said during his presentation at DDW. “However, this has not been formally studied.”

After 55 EGDs and 50 colonoscopies, each a standard outpatient procedure, the researchers removed the cap and the male end where the cap attaches. They brushed these areas for residual tissue. Next, they applied a new suction trap and cleared the channel using water and suction. They then brushed the channel and repeated the water and suction procedure. As a final check, they visually inspected the cleaning brush.

They sent any recovered tissue – designated from either the cap or channel – to pathology for evaluation. “The new pathology reads from these retained biopsies changed or added to the diagnosis in only five of our patients. All of these changes were minor, and patients were already on appropriate treatment,” Dr. Toy said.

Dr. Toy and colleagues found no differences between EGDs and colonoscopies with and without retained biopsy samples according to procedure time, doses of propofol or fentanyl, and age or gender of the patient. Likewise, the number of samples collected did not appear to influence the retention rates.

Of retained samples discovered after 42 EGDs, 71% were in the cap, 35% were in the channel, and 29% were found in both locations. Of the 25 colonoscopies with retained samples, 40% were in the cap, 34% were in the channel, and 24% were found in both places.

“The overall incidence of retained biopsies during standard upper and lower endoscopy is high,” the researchers noted.

Inclusion of multiple endoscopists and a hospital outpatient setting were strengths of the study. Limitations included a single center study with a relatively small sample size.

Dr. Toy and Dr. Sorser have disclosed no relevant financial relationships.
 

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

Irritable bowel syndrome symptoms improved among patients who endured a prolonged COVID-19 lockdown in Argentina, a finding that was unexpected yet reaffirms the gut-brain connection in this gastrointestinal disorder, according to a coauthor of a study presented at the annual Digestive Disease Week® (DDW).

These patients with irritable bowel syndrome (IBS) reported improvements in disease severity and symptoms during the lockdown that were significant in comparison with the prepandemic period, according to Juan Pablo Stefanolo, MD, a lead author on the study.

The proportion of patients with severe IBS dropped from about 50% to 30%, accompanied by decreases in global and individual symptom scores, according to data presented at the meeting.

Investigators had assumed that IBS symptoms would worsen, fueled by new stresses and pressures related to a nationwide lockdown in Argentina that started in March 19, 2020, and didn’t fully end until November.

Now, the hypothesis has changed, according to Dr. Stefanolo, a physician in the neurogastroenterology and motility section at Hospital de Clínicas José de San Martín, Buenos Aires University.

“We think that probably just staying at home in a more relaxed way, and in a more controlled environment, could have improved those symptoms,” Dr. Stefanolo said in an interview.
 

Impact of lifestyle factors?

This reported decrease in overall severity and symptoms associated with IBS during the pandemic lockdown is an “interesting phenomenon” that deserves further study, said Purna C. Kashyap, MBBS, professor of medicine, physiology, and biomedical engineering at the Mayo Medical School, Rochester, Minn.

Diet, exercise, and other lifestyle factors such as spending more time with family could be contributing to the improvement in symptoms, said Dr. Kashyap, who was not involved in the study.

“A follow-up survey which includes these additional factors could help ascertain why there was an improvement in symptoms and could help with developing effective treatment strategies,” Dr. Kashyap said.

A more detailed follow-up survey is definitely warranted, Dr. Stefanolo said, particularly as Argentina faces new and sweeping pandemic-related restrictions caused by a second-wave COVID-19 surge that now includes more than 30,000 new cases per day.

On May 21, Argentina entered a strict 9-day confinement period as President Alberto Fernández said the country was facing its “worst moment” of the pandemic to date.

Although the circumstances are very unfortunate, worsening pandemic conditions in Argentina are nonetheless a “perfect scenario” to explore in more detail how external stress burden impacts IBS symptoms, said Dr. Stefanolo.
 

Study results

To study the impact of the 2020 mandatory lockdown on gut-brain axis symptomatology in IBS patients, Dr. Stefanolo and coauthors assessed a total of 129 patients with IBS-diarrhea or mixed bowel habits subtype. The mean age of participants was 54 years and 78% were female.

Patients were assessed by online survey or phone interview using the Irritable Bowel Syndrome Severity Scale (IBS-SS), Likert scales for IBS symptoms, and the Bristol Stool Scale, along with other measures of mood and comorbidities.

The proportion of patients with severe IBS dropped from 50% (65 patients) in the prepandemic period to 30% (39 patients) during the lockdown, Dr. Stefanolo and coauthors reported at the virtual DDW meeting. Similarly, mean IBS-SS scores dropped from 278.54 to 212.36 during lockdown, translating into a difference of 65.9 points.

Patients reported improvements in global IBS symptoms, pain, and distention. Stool consistency was also improved, with an average decrease on the Bristol scale of 2 points, according to the report.

Similar improvements from the prepandemic period were observed in anxiety and somatization scores, as well as in symptoms of fibromyalgia and chronic fatigue.

By contrast, headache and pyrosis and/or regurgitation symptoms increased from the prepandemic period, possibly because of weight gain, according to Dr. Stefanolo who said that about 60% of patients reported weight gain during the lockdown.
 

Lifestyle advice

The patients in this study were being seen at a tertiary care center, so they tended to have more severe disease than what would be seen in general clinical practice, according to Dr. Stefanolo. Because of that, he advised caution in extrapolating these results to a broader patient population.

Nevertheless, this study does suggest the potential for lifestyle interventions that could make a difference for the average IBS patient, he said.

“It reinforces that outside stress has something to do with it, and that food maybe has something to do with it,” he said. “I think that giving that advice – try to be more relaxed, and maybe control the quality or the type of food you have – could be great to improve ... those symptoms, maybe.”

The study authors reported no financial disclosures related to the research. Dr. Kashyap reported relationships with Novome Biotechnologies, Otsuka Pharmaceuticals, and Pendulum.

Help your patients better understand IBS and symptoms by sharing AGA patient education at www.gastro.org/IBS.

This article was update May 27, 2021.

Irritable bowel syndrome symptoms improved among patients who endured a prolonged COVID-19 lockdown in Argentina, a finding that was unexpected yet reaffirms the gut-brain connection in this gastrointestinal disorder, according to a coauthor of a study presented at the annual Digestive Disease Week® (DDW).

These patients with irritable bowel syndrome (IBS) reported improvements in disease severity and symptoms during the lockdown that were significant in comparison with the prepandemic period, according to Juan Pablo Stefanolo, MD, a lead author on the study.

The proportion of patients with severe IBS dropped from about 50% to 30%, accompanied by decreases in global and individual symptom scores, according to data presented at the meeting.

Investigators had assumed that IBS symptoms would worsen, fueled by new stresses and pressures related to a nationwide lockdown in Argentina that started in March 19, 2020, and didn’t fully end until November.

Now, the hypothesis has changed, according to Dr. Stefanolo, a physician in the neurogastroenterology and motility section at Hospital de Clínicas José de San Martín, Buenos Aires University.

“We think that probably just staying at home in a more relaxed way, and in a more controlled environment, could have improved those symptoms,” Dr. Stefanolo said in an interview.
 

Impact of lifestyle factors?

This reported decrease in overall severity and symptoms associated with IBS during the pandemic lockdown is an “interesting phenomenon” that deserves further study, said Purna C. Kashyap, MBBS, professor of medicine, physiology, and biomedical engineering at the Mayo Medical School, Rochester, Minn.

Diet, exercise, and other lifestyle factors such as spending more time with family could be contributing to the improvement in symptoms, said Dr. Kashyap, who was not involved in the study.

“A follow-up survey which includes these additional factors could help ascertain why there was an improvement in symptoms and could help with developing effective treatment strategies,” Dr. Kashyap said.

A more detailed follow-up survey is definitely warranted, Dr. Stefanolo said, particularly as Argentina faces new and sweeping pandemic-related restrictions caused by a second-wave COVID-19 surge that now includes more than 30,000 new cases per day.

On May 21, Argentina entered a strict 9-day confinement period as President Alberto Fernández said the country was facing its “worst moment” of the pandemic to date.

Although the circumstances are very unfortunate, worsening pandemic conditions in Argentina are nonetheless a “perfect scenario” to explore in more detail how external stress burden impacts IBS symptoms, said Dr. Stefanolo.
 

Study results

To study the impact of the 2020 mandatory lockdown on gut-brain axis symptomatology in IBS patients, Dr. Stefanolo and coauthors assessed a total of 129 patients with IBS-diarrhea or mixed bowel habits subtype. The mean age of participants was 54 years and 78% were female.

Patients were assessed by online survey or phone interview using the Irritable Bowel Syndrome Severity Scale (IBS-SS), Likert scales for IBS symptoms, and the Bristol Stool Scale, along with other measures of mood and comorbidities.

The proportion of patients with severe IBS dropped from 50% (65 patients) in the prepandemic period to 30% (39 patients) during the lockdown, Dr. Stefanolo and coauthors reported at the virtual DDW meeting. Similarly, mean IBS-SS scores dropped from 278.54 to 212.36 during lockdown, translating into a difference of 65.9 points.

Patients reported improvements in global IBS symptoms, pain, and distention. Stool consistency was also improved, with an average decrease on the Bristol scale of 2 points, according to the report.

Similar improvements from the prepandemic period were observed in anxiety and somatization scores, as well as in symptoms of fibromyalgia and chronic fatigue.

By contrast, headache and pyrosis and/or regurgitation symptoms increased from the prepandemic period, possibly because of weight gain, according to Dr. Stefanolo who said that about 60% of patients reported weight gain during the lockdown.
 

Lifestyle advice

The patients in this study were being seen at a tertiary care center, so they tended to have more severe disease than what would be seen in general clinical practice, according to Dr. Stefanolo. Because of that, he advised caution in extrapolating these results to a broader patient population.

Nevertheless, this study does suggest the potential for lifestyle interventions that could make a difference for the average IBS patient, he said.

“It reinforces that outside stress has something to do with it, and that food maybe has something to do with it,” he said. “I think that giving that advice – try to be more relaxed, and maybe control the quality or the type of food you have – could be great to improve ... those symptoms, maybe.”

The study authors reported no financial disclosures related to the research. Dr. Kashyap reported relationships with Novome Biotechnologies, Otsuka Pharmaceuticals, and Pendulum.

Help your patients better understand IBS and symptoms by sharing AGA patient education at www.gastro.org/IBS.

This article was update May 27, 2021.

Irritable bowel syndrome symptoms improved among patients who endured a prolonged COVID-19 lockdown in Argentina, a finding that was unexpected yet reaffirms the gut-brain connection in this gastrointestinal disorder, according to a coauthor of a study presented at the annual Digestive Disease Week® (DDW).

These patients with irritable bowel syndrome (IBS) reported improvements in disease severity and symptoms during the lockdown that were significant in comparison with the prepandemic period, according to Juan Pablo Stefanolo, MD, a lead author on the study.

The proportion of patients with severe IBS dropped from about 50% to 30%, accompanied by decreases in global and individual symptom scores, according to data presented at the meeting.

Investigators had assumed that IBS symptoms would worsen, fueled by new stresses and pressures related to a nationwide lockdown in Argentina that started in March 19, 2020, and didn’t fully end until November.

Now, the hypothesis has changed, according to Dr. Stefanolo, a physician in the neurogastroenterology and motility section at Hospital de Clínicas José de San Martín, Buenos Aires University.

“We think that probably just staying at home in a more relaxed way, and in a more controlled environment, could have improved those symptoms,” Dr. Stefanolo said in an interview.
 

Impact of lifestyle factors?

This reported decrease in overall severity and symptoms associated with IBS during the pandemic lockdown is an “interesting phenomenon” that deserves further study, said Purna C. Kashyap, MBBS, professor of medicine, physiology, and biomedical engineering at the Mayo Medical School, Rochester, Minn.

Diet, exercise, and other lifestyle factors such as spending more time with family could be contributing to the improvement in symptoms, said Dr. Kashyap, who was not involved in the study.

“A follow-up survey which includes these additional factors could help ascertain why there was an improvement in symptoms and could help with developing effective treatment strategies,” Dr. Kashyap said.

A more detailed follow-up survey is definitely warranted, Dr. Stefanolo said, particularly as Argentina faces new and sweeping pandemic-related restrictions caused by a second-wave COVID-19 surge that now includes more than 30,000 new cases per day.

On May 21, Argentina entered a strict 9-day confinement period as President Alberto Fernández said the country was facing its “worst moment” of the pandemic to date.

Although the circumstances are very unfortunate, worsening pandemic conditions in Argentina are nonetheless a “perfect scenario” to explore in more detail how external stress burden impacts IBS symptoms, said Dr. Stefanolo.
 

Study results

To study the impact of the 2020 mandatory lockdown on gut-brain axis symptomatology in IBS patients, Dr. Stefanolo and coauthors assessed a total of 129 patients with IBS-diarrhea or mixed bowel habits subtype. The mean age of participants was 54 years and 78% were female.

Patients were assessed by online survey or phone interview using the Irritable Bowel Syndrome Severity Scale (IBS-SS), Likert scales for IBS symptoms, and the Bristol Stool Scale, along with other measures of mood and comorbidities.

The proportion of patients with severe IBS dropped from 50% (65 patients) in the prepandemic period to 30% (39 patients) during the lockdown, Dr. Stefanolo and coauthors reported at the virtual DDW meeting. Similarly, mean IBS-SS scores dropped from 278.54 to 212.36 during lockdown, translating into a difference of 65.9 points.

Patients reported improvements in global IBS symptoms, pain, and distention. Stool consistency was also improved, with an average decrease on the Bristol scale of 2 points, according to the report.

Similar improvements from the prepandemic period were observed in anxiety and somatization scores, as well as in symptoms of fibromyalgia and chronic fatigue.

By contrast, headache and pyrosis and/or regurgitation symptoms increased from the prepandemic period, possibly because of weight gain, according to Dr. Stefanolo who said that about 60% of patients reported weight gain during the lockdown.
 

Lifestyle advice

The patients in this study were being seen at a tertiary care center, so they tended to have more severe disease than what would be seen in general clinical practice, according to Dr. Stefanolo. Because of that, he advised caution in extrapolating these results to a broader patient population.

Nevertheless, this study does suggest the potential for lifestyle interventions that could make a difference for the average IBS patient, he said.

“It reinforces that outside stress has something to do with it, and that food maybe has something to do with it,” he said. “I think that giving that advice – try to be more relaxed, and maybe control the quality or the type of food you have – could be great to improve ... those symptoms, maybe.”

The study authors reported no financial disclosures related to the research. Dr. Kashyap reported relationships with Novome Biotechnologies, Otsuka Pharmaceuticals, and Pendulum.

Help your patients better understand IBS and symptoms by sharing AGA patient education at www.gastro.org/IBS.

This article was update May 27, 2021.

For veterans, changes in colonoscopy screening caused by the COVID-19 pandemic may have increased risks of delayed colorectal cancer (CRC) diagnosis and could lead to worse CRC outcomes, based on data from more than 33,000 patients in the Veterans Health Administration.

After COVID-19 screening policies were implemented, a significantly lower rate of veterans with red-flag signs or symptoms for CRC underwent colonoscopy, lead author Joshua Demb, PhD, a cancer epidemiologist at the University of California, San Diego, reported at the annual Digestive Disease Week® (DDW).

“As a result of the COVID-19 pandemic, the Veterans Health Administration enacted risk mitigation and management strategies in March 2020, including postponement of nearly all colonoscopies,” the investigators reported. “Notably, this included veterans with red flag signs or symptoms for CRC, among whom delays in workup could increase risk for later-stage and fatal CRC, if present.”

To measure the effects of this policy change, Dr. Demb and colleagues performed a cohort study involving 33,804 veterans with red-flag signs or symptoms for CRC, including hematochezia, iron deficiency anemia, or abnormal guaiac fecal occult blood test or fecal immunochemical test (FIT). Veterans were divided into two cohorts based on date of first red flag diagnosis: either before the COVID-19 policy was implemented (April to October 2019; n = 19,472) or after (April to October 2020; n = 14,332), with an intervening 6-month washout period.

Primary outcomes were proportion completing colonoscopy and time to colonoscopy completion. Multivariable logistic regression incorporated a number of demographic and medical covariates, including race/ethnicity, sex, age, number of red-flag signs/symptoms, first red-flag sign/symptom, and others.

Before the COVID-19 policy change, 44% of individuals with red-flag signs or symptoms received a colonoscopy, compared with 32% after the policy was introduced (P < .01). Adjusted models showed that veterans in the COVID policy group were 42% less likely to receive a diagnostic colonoscopy than those in the prepolicy group (odds ratio, 0.58; 95% confidence interval, 0.55-0.61). While these findings showed greater likelihood of receiving a screening before the pandemic, postpolicy colonoscopies were conducted sooner, with a median time to procedure of 41 days, compared with 65 days before the pandemic (P < .01). Similar differences in screening rates between pre- and postpandemic groups were observed across all types of red flag signs and symptoms.

“Lower colonoscopy uptake was observed among individuals with red-flag signs/symptoms for CRC post- versus preimplementation of COVID-19 policies, suggesting increased future risk for delayed CRC diagnosis and adverse CRC outcomes,” the investigators concluded.

Prioritization may be needed to overcome backlog of colonoscopies

Jill Tinmouth, MD, PhD, lead scientist for ColonCancerCheck, Ontario’s organized colorectal cancer screening program, and a gastroenterologist and scientist at Sunnybrook Health Sciences Centre, Toronto, shared similar concerns about delayed diagnoses.

“We might expect these cancers to present ... at a more advanced stage, and that, as a result, the outcomes from these cancers could be worse,” Dr. Tinmouth said in an interview.

She also noted the change in colonoscopy timing.

“A particularly interesting finding was that, when a colonoscopy occurred, the time to colonoscopy was shorter during the COVID era than in the pre-COVID era,” Dr. Tinmouth said. “The authors suggested that this might be as a result of Veterans Health Administration policies implemented as a result of the pandemic that led to prioritization of more urgent procedures.”

According to Dr. Tinmouth, similar prioritization may be needed to catch up with the backlog of colonoscopies created by pandemic-related policy changes. In a recent study comparing two backlog management techniques, Dr. Tinmouth and colleagues concluded that redirecting low-yield colonoscopies to FIT without increasing hospital colonoscopy capacity could reduce time to recovery by more than half.

Even so, screening programs may be facing a long road to recovery.

“Recovery of the colonoscopy backlog is going to be a challenge that will take a while – maybe even years – to resolve,” Dr. Tinmouth said. “Jurisdictions/institutions that have a strong centralized intake or triage will likely be most successful in resolving the backlog quickly as they will be able to prioritize the most urgent cases, such as persons with an abnormal FIT or with symptoms, and to redirect persons scheduled for a ‘low-yield’ colonoscopy to have a FIT instead.” Ontario defines low-yield colonoscopies as primary screening for average-risk individuals and follow-up colonoscopies for patients with low-risk adenomas at baseline.

When asked about strategies to address future pandemics, Dr. Tinmouth said, “I think that two key learnings for me from this [pandemic] are: one, not to let our guard down, and to remain vigilant and prepared – in terms of monitoring, supply chain, equipment, etc.] ... and two to create a nimble and agile health system so that we are able to assess the challenges that the next pandemic brings and address them as quickly as possible.”The investigators and Dr. Tinmouth reported no conflicts of interest.

For veterans, changes in colonoscopy screening caused by the COVID-19 pandemic may have increased risks of delayed colorectal cancer (CRC) diagnosis and could lead to worse CRC outcomes, based on data from more than 33,000 patients in the Veterans Health Administration.

After COVID-19 screening policies were implemented, a significantly lower rate of veterans with red-flag signs or symptoms for CRC underwent colonoscopy, lead author Joshua Demb, PhD, a cancer epidemiologist at the University of California, San Diego, reported at the annual Digestive Disease Week® (DDW).

“As a result of the COVID-19 pandemic, the Veterans Health Administration enacted risk mitigation and management strategies in March 2020, including postponement of nearly all colonoscopies,” the investigators reported. “Notably, this included veterans with red flag signs or symptoms for CRC, among whom delays in workup could increase risk for later-stage and fatal CRC, if present.”

To measure the effects of this policy change, Dr. Demb and colleagues performed a cohort study involving 33,804 veterans with red-flag signs or symptoms for CRC, including hematochezia, iron deficiency anemia, or abnormal guaiac fecal occult blood test or fecal immunochemical test (FIT). Veterans were divided into two cohorts based on date of first red flag diagnosis: either before the COVID-19 policy was implemented (April to October 2019; n = 19,472) or after (April to October 2020; n = 14,332), with an intervening 6-month washout period.

Primary outcomes were proportion completing colonoscopy and time to colonoscopy completion. Multivariable logistic regression incorporated a number of demographic and medical covariates, including race/ethnicity, sex, age, number of red-flag signs/symptoms, first red-flag sign/symptom, and others.

Before the COVID-19 policy change, 44% of individuals with red-flag signs or symptoms received a colonoscopy, compared with 32% after the policy was introduced (P < .01). Adjusted models showed that veterans in the COVID policy group were 42% less likely to receive a diagnostic colonoscopy than those in the prepolicy group (odds ratio, 0.58; 95% confidence interval, 0.55-0.61). While these findings showed greater likelihood of receiving a screening before the pandemic, postpolicy colonoscopies were conducted sooner, with a median time to procedure of 41 days, compared with 65 days before the pandemic (P < .01). Similar differences in screening rates between pre- and postpandemic groups were observed across all types of red flag signs and symptoms.

“Lower colonoscopy uptake was observed among individuals with red-flag signs/symptoms for CRC post- versus preimplementation of COVID-19 policies, suggesting increased future risk for delayed CRC diagnosis and adverse CRC outcomes,” the investigators concluded.

Prioritization may be needed to overcome backlog of colonoscopies

Jill Tinmouth, MD, PhD, lead scientist for ColonCancerCheck, Ontario’s organized colorectal cancer screening program, and a gastroenterologist and scientist at Sunnybrook Health Sciences Centre, Toronto, shared similar concerns about delayed diagnoses.

“We might expect these cancers to present ... at a more advanced stage, and that, as a result, the outcomes from these cancers could be worse,” Dr. Tinmouth said in an interview.

She also noted the change in colonoscopy timing.

“A particularly interesting finding was that, when a colonoscopy occurred, the time to colonoscopy was shorter during the COVID era than in the pre-COVID era,” Dr. Tinmouth said. “The authors suggested that this might be as a result of Veterans Health Administration policies implemented as a result of the pandemic that led to prioritization of more urgent procedures.”

According to Dr. Tinmouth, similar prioritization may be needed to catch up with the backlog of colonoscopies created by pandemic-related policy changes. In a recent study comparing two backlog management techniques, Dr. Tinmouth and colleagues concluded that redirecting low-yield colonoscopies to FIT without increasing hospital colonoscopy capacity could reduce time to recovery by more than half.

Even so, screening programs may be facing a long road to recovery.

“Recovery of the colonoscopy backlog is going to be a challenge that will take a while – maybe even years – to resolve,” Dr. Tinmouth said. “Jurisdictions/institutions that have a strong centralized intake or triage will likely be most successful in resolving the backlog quickly as they will be able to prioritize the most urgent cases, such as persons with an abnormal FIT or with symptoms, and to redirect persons scheduled for a ‘low-yield’ colonoscopy to have a FIT instead.” Ontario defines low-yield colonoscopies as primary screening for average-risk individuals and follow-up colonoscopies for patients with low-risk adenomas at baseline.

When asked about strategies to address future pandemics, Dr. Tinmouth said, “I think that two key learnings for me from this [pandemic] are: one, not to let our guard down, and to remain vigilant and prepared – in terms of monitoring, supply chain, equipment, etc.] ... and two to create a nimble and agile health system so that we are able to assess the challenges that the next pandemic brings and address them as quickly as possible.”The investigators and Dr. Tinmouth reported no conflicts of interest.

For veterans, changes in colonoscopy screening caused by the COVID-19 pandemic may have increased risks of delayed colorectal cancer (CRC) diagnosis and could lead to worse CRC outcomes, based on data from more than 33,000 patients in the Veterans Health Administration.

After COVID-19 screening policies were implemented, a significantly lower rate of veterans with red-flag signs or symptoms for CRC underwent colonoscopy, lead author Joshua Demb, PhD, a cancer epidemiologist at the University of California, San Diego, reported at the annual Digestive Disease Week® (DDW).

“As a result of the COVID-19 pandemic, the Veterans Health Administration enacted risk mitigation and management strategies in March 2020, including postponement of nearly all colonoscopies,” the investigators reported. “Notably, this included veterans with red flag signs or symptoms for CRC, among whom delays in workup could increase risk for later-stage and fatal CRC, if present.”

To measure the effects of this policy change, Dr. Demb and colleagues performed a cohort study involving 33,804 veterans with red-flag signs or symptoms for CRC, including hematochezia, iron deficiency anemia, or abnormal guaiac fecal occult blood test or fecal immunochemical test (FIT). Veterans were divided into two cohorts based on date of first red flag diagnosis: either before the COVID-19 policy was implemented (April to October 2019; n = 19,472) or after (April to October 2020; n = 14,332), with an intervening 6-month washout period.

Primary outcomes were proportion completing colonoscopy and time to colonoscopy completion. Multivariable logistic regression incorporated a number of demographic and medical covariates, including race/ethnicity, sex, age, number of red-flag signs/symptoms, first red-flag sign/symptom, and others.

Before the COVID-19 policy change, 44% of individuals with red-flag signs or symptoms received a colonoscopy, compared with 32% after the policy was introduced (P < .01). Adjusted models showed that veterans in the COVID policy group were 42% less likely to receive a diagnostic colonoscopy than those in the prepolicy group (odds ratio, 0.58; 95% confidence interval, 0.55-0.61). While these findings showed greater likelihood of receiving a screening before the pandemic, postpolicy colonoscopies were conducted sooner, with a median time to procedure of 41 days, compared with 65 days before the pandemic (P < .01). Similar differences in screening rates between pre- and postpandemic groups were observed across all types of red flag signs and symptoms.

“Lower colonoscopy uptake was observed among individuals with red-flag signs/symptoms for CRC post- versus preimplementation of COVID-19 policies, suggesting increased future risk for delayed CRC diagnosis and adverse CRC outcomes,” the investigators concluded.

Prioritization may be needed to overcome backlog of colonoscopies

Jill Tinmouth, MD, PhD, lead scientist for ColonCancerCheck, Ontario’s organized colorectal cancer screening program, and a gastroenterologist and scientist at Sunnybrook Health Sciences Centre, Toronto, shared similar concerns about delayed diagnoses.

“We might expect these cancers to present ... at a more advanced stage, and that, as a result, the outcomes from these cancers could be worse,” Dr. Tinmouth said in an interview.

She also noted the change in colonoscopy timing.

“A particularly interesting finding was that, when a colonoscopy occurred, the time to colonoscopy was shorter during the COVID era than in the pre-COVID era,” Dr. Tinmouth said. “The authors suggested that this might be as a result of Veterans Health Administration policies implemented as a result of the pandemic that led to prioritization of more urgent procedures.”

According to Dr. Tinmouth, similar prioritization may be needed to catch up with the backlog of colonoscopies created by pandemic-related policy changes. In a recent study comparing two backlog management techniques, Dr. Tinmouth and colleagues concluded that redirecting low-yield colonoscopies to FIT without increasing hospital colonoscopy capacity could reduce time to recovery by more than half.

Even so, screening programs may be facing a long road to recovery.

“Recovery of the colonoscopy backlog is going to be a challenge that will take a while – maybe even years – to resolve,” Dr. Tinmouth said. “Jurisdictions/institutions that have a strong centralized intake or triage will likely be most successful in resolving the backlog quickly as they will be able to prioritize the most urgent cases, such as persons with an abnormal FIT or with symptoms, and to redirect persons scheduled for a ‘low-yield’ colonoscopy to have a FIT instead.” Ontario defines low-yield colonoscopies as primary screening for average-risk individuals and follow-up colonoscopies for patients with low-risk adenomas at baseline.

When asked about strategies to address future pandemics, Dr. Tinmouth said, “I think that two key learnings for me from this [pandemic] are: one, not to let our guard down, and to remain vigilant and prepared – in terms of monitoring, supply chain, equipment, etc.] ... and two to create a nimble and agile health system so that we are able to assess the challenges that the next pandemic brings and address them as quickly as possible.”The investigators and Dr. Tinmouth reported no conflicts of interest.

Irritable bowel syndrome symptoms improved among patients who endured a prolonged COVID-19 lockdown in Argentina, a finding that was unexpected yet reaffirms the gut-brain connection in this gastrointestinal disorder, according to a coauthor of a study presented at the annual Digestive Disease Week® (DDW).

These patients with irritable bowel syndrome (IBS) reported improvements in disease severity and symptoms during the lockdown that were significant in comparison with the prepandemic period, according to Juan Pablo Stefanolo, MD, a lead author on the study.

The proportion of patients with severe IBS dropped from about 50% to 30%, accompanied by decreases in global and individual symptom scores, according to data presented at the meeting.

Investigators had assumed that IBS symptoms would worsen, fueled by new stresses and pressures related to a nationwide lockdown in Argentina that started in March 19, 2020, and didn’t fully end until November.

Now, the hypothesis has changed, according to Dr. Stefanolo, a physician in the neurogastroenterology and motility section at Hospital de Clínicas José de San Martín, Buenos Aires University.

“We think that probably just staying at home in a more relaxed way, and in a more controlled environment, could have improved those symptoms,” Dr. Stefanolo said in an interview.
 

Impact of lifestyle factors?

This reported decrease in overall severity and symptoms associated with IBS during the pandemic lockdown is an “interesting phenomenon” that deserves further study, said Purna C. Kashyap, MBBS, professor of medicine, physiology, and biomedical engineering at the Mayo Medical School, Rochester, Minn.

Diet, exercise, and other lifestyle factors such as spending more time with family could be contributing to the improvement in symptoms, said Dr. Kashyap, who was not involved in the study.

“A follow-up survey which includes these additional factors could help ascertain why there was an improvement in symptoms and could help with developing effective treatment strategies,” Dr. Kashyap said.

A more detailed follow-up survey is definitely warranted, Dr. Stefanolo said, particularly as Argentina faces new and sweeping pandemic-related restrictions caused by a second-wave COVID-19 surge that now includes more than 30,000 new cases per day.

On May 21, Argentina entered a strict 9-day confinement period as President Alberto Fernández said the country was facing its “worst moment” of the pandemic to date.

Although the circumstances are very unfortunate, worsening pandemic conditions in Argentina are nonetheless a “perfect scenario” to explore in more detail how external stress burden impacts IBS symptoms, said Dr. Stefanolo.
 

Study results

To study the impact of the 2020 mandatory lockdown on gut-brain axis symptomatology in IBS patients, Dr. Stefanolo and coauthors assessed a total of 129 patients with IBS-diarrhea or mixed bowel habits subtype. The mean age of participants was 54 years and 78% were female.

Patients were assessed by online survey or phone interview using the Irritable Bowel Syndrome Severity Scale (IBS-SS), Likert scales for IBS symptoms, and the Bristol Stool Scale, along with other measures of mood and comorbidities.

The proportion of patients with severe IBS dropped from 50% (65 patients) in the prepandemic period to 30% (39 patients) during the lockdown, Dr. Stefanolo and coauthors reported at the virtual DDW meeting. Similarly, mean IBS-SS scores dropped from 278.54 to 212.36 during lockdown, translating into a difference of 65.9 points.

Patients reported improvements in global IBS symptoms, pain, and distention. Stool consistency was also improved, with an average decrease on the Bristol scale of 2 points, according to the report.

Similar improvements from the prepandemic period were observed in anxiety and somatization scores, as well as in symptoms of fibromyalgia and chronic fatigue.

By contrast, headache and pyrosis and/or regurgitation symptoms increased from the prepandemic period, possibly because of weight gain, according to Dr. Stefanolo who said that about 60% of patients reported weight gain during the lockdown.
 

Lifestyle advice

The patients in this study were being seen at a tertiary care center, so they tended to have more severe disease than what would be seen in general clinical practice, according to Dr. Stefanolo. Because of that, he advised caution in extrapolating these results to a broader patient population.

Nevertheless, this study does suggest the potential for lifestyle interventions that could make a difference for the average IBS patient, he said.

“It reinforces that outside stress has something to do with it, and that food maybe has something to do with it,” he said. “I think that giving that advice – try to be more relaxed, and maybe control the quality or the type of food you have – could be great to improve ... those symptoms, maybe.”

The study authors reported no financial disclosures related to the research. Dr. Kashyap reported relationships with Novome Biotechnologies, Otsuka Pharmaceuticals, and Pendulum.

Irritable bowel syndrome symptoms improved among patients who endured a prolonged COVID-19 lockdown in Argentina, a finding that was unexpected yet reaffirms the gut-brain connection in this gastrointestinal disorder, according to a coauthor of a study presented at the annual Digestive Disease Week® (DDW).

These patients with irritable bowel syndrome (IBS) reported improvements in disease severity and symptoms during the lockdown that were significant in comparison with the prepandemic period, according to Juan Pablo Stefanolo, MD, a lead author on the study.

The proportion of patients with severe IBS dropped from about 50% to 30%, accompanied by decreases in global and individual symptom scores, according to data presented at the meeting.

Investigators had assumed that IBS symptoms would worsen, fueled by new stresses and pressures related to a nationwide lockdown in Argentina that started in March 19, 2020, and didn’t fully end until November.

Now, the hypothesis has changed, according to Dr. Stefanolo, a physician in the neurogastroenterology and motility section at Hospital de Clínicas José de San Martín, Buenos Aires University.

“We think that probably just staying at home in a more relaxed way, and in a more controlled environment, could have improved those symptoms,” Dr. Stefanolo said in an interview.
 

Impact of lifestyle factors?

This reported decrease in overall severity and symptoms associated with IBS during the pandemic lockdown is an “interesting phenomenon” that deserves further study, said Purna C. Kashyap, MBBS, professor of medicine, physiology, and biomedical engineering at the Mayo Medical School, Rochester, Minn.

Diet, exercise, and other lifestyle factors such as spending more time with family could be contributing to the improvement in symptoms, said Dr. Kashyap, who was not involved in the study.

“A follow-up survey which includes these additional factors could help ascertain why there was an improvement in symptoms and could help with developing effective treatment strategies,” Dr. Kashyap said.

A more detailed follow-up survey is definitely warranted, Dr. Stefanolo said, particularly as Argentina faces new and sweeping pandemic-related restrictions caused by a second-wave COVID-19 surge that now includes more than 30,000 new cases per day.

On May 21, Argentina entered a strict 9-day confinement period as President Alberto Fernández said the country was facing its “worst moment” of the pandemic to date.

Although the circumstances are very unfortunate, worsening pandemic conditions in Argentina are nonetheless a “perfect scenario” to explore in more detail how external stress burden impacts IBS symptoms, said Dr. Stefanolo.
 

Study results

To study the impact of the 2020 mandatory lockdown on gut-brain axis symptomatology in IBS patients, Dr. Stefanolo and coauthors assessed a total of 129 patients with IBS-diarrhea or mixed bowel habits subtype. The mean age of participants was 54 years and 78% were female.

Patients were assessed by online survey or phone interview using the Irritable Bowel Syndrome Severity Scale (IBS-SS), Likert scales for IBS symptoms, and the Bristol Stool Scale, along with other measures of mood and comorbidities.

The proportion of patients with severe IBS dropped from 50% (65 patients) in the prepandemic period to 30% (39 patients) during the lockdown, Dr. Stefanolo and coauthors reported at the virtual DDW meeting. Similarly, mean IBS-SS scores dropped from 278.54 to 212.36 during lockdown, translating into a difference of 65.9 points.

Patients reported improvements in global IBS symptoms, pain, and distention. Stool consistency was also improved, with an average decrease on the Bristol scale of 2 points, according to the report.

Similar improvements from the prepandemic period were observed in anxiety and somatization scores, as well as in symptoms of fibromyalgia and chronic fatigue.

By contrast, headache and pyrosis and/or regurgitation symptoms increased from the prepandemic period, possibly because of weight gain, according to Dr. Stefanolo who said that about 60% of patients reported weight gain during the lockdown.
 

Lifestyle advice

The patients in this study were being seen at a tertiary care center, so they tended to have more severe disease than what would be seen in general clinical practice, according to Dr. Stefanolo. Because of that, he advised caution in extrapolating these results to a broader patient population.

Nevertheless, this study does suggest the potential for lifestyle interventions that could make a difference for the average IBS patient, he said.

“It reinforces that outside stress has something to do with it, and that food maybe has something to do with it,” he said. “I think that giving that advice – try to be more relaxed, and maybe control the quality or the type of food you have – could be great to improve ... those symptoms, maybe.”

The study authors reported no financial disclosures related to the research. Dr. Kashyap reported relationships with Novome Biotechnologies, Otsuka Pharmaceuticals, and Pendulum.

Irritable bowel syndrome symptoms improved among patients who endured a prolonged COVID-19 lockdown in Argentina, a finding that was unexpected yet reaffirms the gut-brain connection in this gastrointestinal disorder, according to a coauthor of a study presented at the annual Digestive Disease Week® (DDW).

These patients with irritable bowel syndrome (IBS) reported improvements in disease severity and symptoms during the lockdown that were significant in comparison with the prepandemic period, according to Juan Pablo Stefanolo, MD, a lead author on the study.

The proportion of patients with severe IBS dropped from about 50% to 30%, accompanied by decreases in global and individual symptom scores, according to data presented at the meeting.

Investigators had assumed that IBS symptoms would worsen, fueled by new stresses and pressures related to a nationwide lockdown in Argentina that started in March 19, 2020, and didn’t fully end until November.

Now, the hypothesis has changed, according to Dr. Stefanolo, a physician in the neurogastroenterology and motility section at Hospital de Clínicas José de San Martín, Buenos Aires University.

“We think that probably just staying at home in a more relaxed way, and in a more controlled environment, could have improved those symptoms,” Dr. Stefanolo said in an interview.
 

Impact of lifestyle factors?

This reported decrease in overall severity and symptoms associated with IBS during the pandemic lockdown is an “interesting phenomenon” that deserves further study, said Purna C. Kashyap, MBBS, professor of medicine, physiology, and biomedical engineering at the Mayo Medical School, Rochester, Minn.

Diet, exercise, and other lifestyle factors such as spending more time with family could be contributing to the improvement in symptoms, said Dr. Kashyap, who was not involved in the study.

“A follow-up survey which includes these additional factors could help ascertain why there was an improvement in symptoms and could help with developing effective treatment strategies,” Dr. Kashyap said.

A more detailed follow-up survey is definitely warranted, Dr. Stefanolo said, particularly as Argentina faces new and sweeping pandemic-related restrictions caused by a second-wave COVID-19 surge that now includes more than 30,000 new cases per day.

On May 21, Argentina entered a strict 9-day confinement period as President Alberto Fernández said the country was facing its “worst moment” of the pandemic to date.

Although the circumstances are very unfortunate, worsening pandemic conditions in Argentina are nonetheless a “perfect scenario” to explore in more detail how external stress burden impacts IBS symptoms, said Dr. Stefanolo.
 

Study results

To study the impact of the 2020 mandatory lockdown on gut-brain axis symptomatology in IBS patients, Dr. Stefanolo and coauthors assessed a total of 129 patients with IBS-diarrhea or mixed bowel habits subtype. The mean age of participants was 54 years and 78% were female.

Patients were assessed by online survey or phone interview using the Irritable Bowel Syndrome Severity Scale (IBS-SS), Likert scales for IBS symptoms, and the Bristol Stool Scale, along with other measures of mood and comorbidities.

The proportion of patients with severe IBS dropped from 50% (65 patients) in the prepandemic period to 30% (39 patients) during the lockdown, Dr. Stefanolo and coauthors reported at the virtual DDW meeting. Similarly, mean IBS-SS scores dropped from 278.54 to 212.36 during lockdown, translating into a difference of 65.9 points.

Patients reported improvements in global IBS symptoms, pain, and distention. Stool consistency was also improved, with an average decrease on the Bristol scale of 2 points, according to the report.

Similar improvements from the prepandemic period were observed in anxiety and somatization scores, as well as in symptoms of fibromyalgia and chronic fatigue.

By contrast, headache and pyrosis and/or regurgitation symptoms increased from the prepandemic period, possibly because of weight gain, according to Dr. Stefanolo who said that about 60% of patients reported weight gain during the lockdown.
 

Lifestyle advice

The patients in this study were being seen at a tertiary care center, so they tended to have more severe disease than what would be seen in general clinical practice, according to Dr. Stefanolo. Because of that, he advised caution in extrapolating these results to a broader patient population.

Nevertheless, this study does suggest the potential for lifestyle interventions that could make a difference for the average IBS patient, he said.

“It reinforces that outside stress has something to do with it, and that food maybe has something to do with it,” he said. “I think that giving that advice – try to be more relaxed, and maybe control the quality or the type of food you have – could be great to improve ... those symptoms, maybe.”

The study authors reported no financial disclosures related to the research. Dr. Kashyap reported relationships with Novome Biotechnologies, Otsuka Pharmaceuticals, and Pendulum.

Drinking one cup of coffee each day lowered individual risk for developing type 2 diabetes 4%-6%, according to data from a pair of large, population-based cohorts.

Coffee had previously been associated with a lower risk of type 2 diabetes, said Carolina Ochoa-Rosales, PhD, of Erasmus University Medical Center, Rotterdam, the Netherlands. However, the potential impact of coffee consumption on the subclinical inflammation associated with type 2 diabetes has not been well studied, she said.

amenic181/Getty Images

Large cohort adds credibility

Although the associations between coffee and type 2 diabetes have been previously reported, “this study offers important findings due to the carefully standardized analyses on these two major data sources,” Linda Van Horn, PhD, RD, said in an interview.

But what makes this study different is that “these investigators hypothesized that this association could be due to an anti-inflammatory benefit,” she said. 

The take-home message for clinicians is that drinking moderate amounts of filtered coffee offers a potentially reduced risk of developing type 2 diabetes, said Dr. Van Horn, of Northwestern University, Chicago. However, additional research is needed to account for the total amount of coffee per day, and whether additions such as cream or sugar or other additives make a difference in outcomes, she added.

“Also, the risk vs. benefit of drinking coffee over the life course, including childhood, pregnancy, and older age, with possible adverse drug-nutrient interactions, remain unexplored,” she noted.

Dr. Ochoa-Rosales disclosed study funding from the Institute for Scientific Information on Coffee but had no other financial conflicts to disclose. Dr. Van Horn had no financial conflicts to disclose.

Drinking one cup of coffee each day lowered individual risk for developing type 2 diabetes 4%-6%, according to data from a pair of large, population-based cohorts.

Coffee had previously been associated with a lower risk of type 2 diabetes, said Carolina Ochoa-Rosales, PhD, of Erasmus University Medical Center, Rotterdam, the Netherlands. However, the potential impact of coffee consumption on the subclinical inflammation associated with type 2 diabetes has not been well studied, she said.

amenic181/Getty Images

Large cohort adds credibility

Although the associations between coffee and type 2 diabetes have been previously reported, “this study offers important findings due to the carefully standardized analyses on these two major data sources,” Linda Van Horn, PhD, RD, said in an interview.

But what makes this study different is that “these investigators hypothesized that this association could be due to an anti-inflammatory benefit,” she said. 

The take-home message for clinicians is that drinking moderate amounts of filtered coffee offers a potentially reduced risk of developing type 2 diabetes, said Dr. Van Horn, of Northwestern University, Chicago. However, additional research is needed to account for the total amount of coffee per day, and whether additions such as cream or sugar or other additives make a difference in outcomes, she added.

“Also, the risk vs. benefit of drinking coffee over the life course, including childhood, pregnancy, and older age, with possible adverse drug-nutrient interactions, remain unexplored,” she noted.

Dr. Ochoa-Rosales disclosed study funding from the Institute for Scientific Information on Coffee but had no other financial conflicts to disclose. Dr. Van Horn had no financial conflicts to disclose.

Drinking one cup of coffee each day lowered individual risk for developing type 2 diabetes 4%-6%, according to data from a pair of large, population-based cohorts.

Coffee had previously been associated with a lower risk of type 2 diabetes, said Carolina Ochoa-Rosales, PhD, of Erasmus University Medical Center, Rotterdam, the Netherlands. However, the potential impact of coffee consumption on the subclinical inflammation associated with type 2 diabetes has not been well studied, she said.

amenic181/Getty Images

Large cohort adds credibility

Although the associations between coffee and type 2 diabetes have been previously reported, “this study offers important findings due to the carefully standardized analyses on these two major data sources,” Linda Van Horn, PhD, RD, said in an interview.

But what makes this study different is that “these investigators hypothesized that this association could be due to an anti-inflammatory benefit,” she said. 

The take-home message for clinicians is that drinking moderate amounts of filtered coffee offers a potentially reduced risk of developing type 2 diabetes, said Dr. Van Horn, of Northwestern University, Chicago. However, additional research is needed to account for the total amount of coffee per day, and whether additions such as cream or sugar or other additives make a difference in outcomes, she added.

“Also, the risk vs. benefit of drinking coffee over the life course, including childhood, pregnancy, and older age, with possible adverse drug-nutrient interactions, remain unexplored,” she noted.

Dr. Ochoa-Rosales disclosed study funding from the Institute for Scientific Information on Coffee but had no other financial conflicts to disclose. Dr. Van Horn had no financial conflicts to disclose.