Federal Practitioner

Among patients with diabetes, women are just as likely as men to suffer from sexual dysfunction, but their issues are overlooked, with the narrative focusing mainly on the impact of this issue on men, say experts.

Women with diabetes can experience reduced sexual desire, painful sex, reduced lubrication, and sexual distress, increasing the risk of depression, and such issues often go unnoticed despite treatments being available, said Kirsty Winkley, PhD, diabetes nurse and health psychologist, King’s College London.

There is also the “embarrassment factor” on the side of both the health care professional and the patient, she said in a session she chaired at the Diabetes UK Professional Conference 2022. Many women with diabetes “wouldn’t necessarily know” that their sexual dysfunction “is related to their diabetes,” she told this news organization.

For women, sexual health conversations are “often about contraception and pregnancy,” as well as menstrual disorders, genital infections, and hormone replacement therapy. “As health care professionals, you’re trained to focus on those things, and you’re not really considering there might be sexual dysfunction. If women aren’t aware that it’s related to diabetes, you’ve got the perfect situation where it goes under the radar.”

However, cochair Debbie Cooke, PhD, health psychologist at the University of Surrey in Guildford, explained that having psychotherapy embedded within the diabetes team and “integrated throughout the whole service” means that the problem can be identified and treatment offered.

The issue is that such integration is “very uncommon” and access needs to be improved, Dr. Cooke said in an interview.
 

Sexual dysfunction major predictor of depression in women

Jacqueline Fosbury, psychotherapy lead at Diabetes Care for You, Sussex Community NHS Foundation Trust, said that “intimate activity is clearly beneficial for emotional and physical health,” as it is associated with increased oxytocin release, the burning of calories, better immunity, and improved sleep.

Sexual dysfunction is common in people with diabetes, she noted. Poor glycemic control can “damage” blood vessels and nerves, causing reduced blood flow and loss of sensation in sexual organs.

A recent study led by Belgian researchers found that among more than 750 adults with diabetes, 36% of men and 33% of women reported sexual dysfunction.

Sexual dysfunction was more common in women with type 1 diabetes, at 36%, compared with 26% for those with type 2 diabetes. The most commonly reported issues were decreased sexual desire, lubrication problems, orgasmic dysfunction, and pain. Body image problems and fear of hypoglycemia also affect sexuality and intimacy, leading to “sexual distress.”

Moreover, Ms. Fosbury said female sexual dysfunction has been identified as a “major predictor” of depression, which in turn reduces libido.

Treatments for women can include lubricants, local estrogen, and medications that are prescribed off-label, such as sildenafil. The same is true of testosterone therapy, which can be used to boost libido.
 

Couples therapy?

Next, Trudy Hannington, a psychosexual therapist with Leger Clinic, Doncaster, U.K., talked about how to use an integrated approach to address sexuality overall in people with diabetes.

She said this should be seen in a biopsychosocial context, with emphasis on the couple, on sensation and communication, and sexual growth, as well as changes in daily routines.

There should be a move away from “penetrative sex,” Ms. Hannington said, with the goal being “enjoyment, not orgasm.” Pleasure should be facilitated and the opportunities for “performance pressure and/or anxiety” reduced.

She discussed the case of Marie, a 27-year-old woman with type 1 diabetes who had been referred with painful sex and vaginal dryness. Marie had “never experienced orgasm,” despite being in a same-sex relationship with Emily.

Marie’s treatment involved a sexual growth program, to which Emily was invited, as well as recommendations to use lubricants, vibrators, and to try sildenafil.
 

Prioritize women

Ms. Fosbury reiterated that, in men, sexual dysfunction is “readily identified as a complication of diabetes” and is described as “traumatic” and “crucial to well-being.” It is also seen as “easy to treat” with medication, such as that for erectile dysfunction.

It is therefore crucial to talk to women with diabetes about possible sexual dysfunction, and the scene must be set before the appointment to explain that the subject will be broached. In addition, handouts and leaflets should be available for patients in the clinic so they can read about female sexual health and to lower the stigma around discussing it.

“Cultural stereotypes diminish the importance of female sexuality and prevent us from providing equal consideration to the sexual difficulties of our patients,” she concluded.

No funding declared. No relevant financial relationships declared.

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

Among patients with diabetes, women are just as likely as men to suffer from sexual dysfunction, but their issues are overlooked, with the narrative focusing mainly on the impact of this issue on men, say experts.

Women with diabetes can experience reduced sexual desire, painful sex, reduced lubrication, and sexual distress, increasing the risk of depression, and such issues often go unnoticed despite treatments being available, said Kirsty Winkley, PhD, diabetes nurse and health psychologist, King’s College London.

There is also the “embarrassment factor” on the side of both the health care professional and the patient, she said in a session she chaired at the Diabetes UK Professional Conference 2022. Many women with diabetes “wouldn’t necessarily know” that their sexual dysfunction “is related to their diabetes,” she told this news organization.

For women, sexual health conversations are “often about contraception and pregnancy,” as well as menstrual disorders, genital infections, and hormone replacement therapy. “As health care professionals, you’re trained to focus on those things, and you’re not really considering there might be sexual dysfunction. If women aren’t aware that it’s related to diabetes, you’ve got the perfect situation where it goes under the radar.”

However, cochair Debbie Cooke, PhD, health psychologist at the University of Surrey in Guildford, explained that having psychotherapy embedded within the diabetes team and “integrated throughout the whole service” means that the problem can be identified and treatment offered.

The issue is that such integration is “very uncommon” and access needs to be improved, Dr. Cooke said in an interview.
 

Sexual dysfunction major predictor of depression in women

Jacqueline Fosbury, psychotherapy lead at Diabetes Care for You, Sussex Community NHS Foundation Trust, said that “intimate activity is clearly beneficial for emotional and physical health,” as it is associated with increased oxytocin release, the burning of calories, better immunity, and improved sleep.

Sexual dysfunction is common in people with diabetes, she noted. Poor glycemic control can “damage” blood vessels and nerves, causing reduced blood flow and loss of sensation in sexual organs.

A recent study led by Belgian researchers found that among more than 750 adults with diabetes, 36% of men and 33% of women reported sexual dysfunction.

Sexual dysfunction was more common in women with type 1 diabetes, at 36%, compared with 26% for those with type 2 diabetes. The most commonly reported issues were decreased sexual desire, lubrication problems, orgasmic dysfunction, and pain. Body image problems and fear of hypoglycemia also affect sexuality and intimacy, leading to “sexual distress.”

Moreover, Ms. Fosbury said female sexual dysfunction has been identified as a “major predictor” of depression, which in turn reduces libido.

Treatments for women can include lubricants, local estrogen, and medications that are prescribed off-label, such as sildenafil. The same is true of testosterone therapy, which can be used to boost libido.
 

Couples therapy?

Next, Trudy Hannington, a psychosexual therapist with Leger Clinic, Doncaster, U.K., talked about how to use an integrated approach to address sexuality overall in people with diabetes.

She said this should be seen in a biopsychosocial context, with emphasis on the couple, on sensation and communication, and sexual growth, as well as changes in daily routines.

There should be a move away from “penetrative sex,” Ms. Hannington said, with the goal being “enjoyment, not orgasm.” Pleasure should be facilitated and the opportunities for “performance pressure and/or anxiety” reduced.

She discussed the case of Marie, a 27-year-old woman with type 1 diabetes who had been referred with painful sex and vaginal dryness. Marie had “never experienced orgasm,” despite being in a same-sex relationship with Emily.

Marie’s treatment involved a sexual growth program, to which Emily was invited, as well as recommendations to use lubricants, vibrators, and to try sildenafil.
 

Prioritize women

Ms. Fosbury reiterated that, in men, sexual dysfunction is “readily identified as a complication of diabetes” and is described as “traumatic” and “crucial to well-being.” It is also seen as “easy to treat” with medication, such as that for erectile dysfunction.

It is therefore crucial to talk to women with diabetes about possible sexual dysfunction, and the scene must be set before the appointment to explain that the subject will be broached. In addition, handouts and leaflets should be available for patients in the clinic so they can read about female sexual health and to lower the stigma around discussing it.

“Cultural stereotypes diminish the importance of female sexuality and prevent us from providing equal consideration to the sexual difficulties of our patients,” she concluded.

No funding declared. No relevant financial relationships declared.

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

Among patients with diabetes, women are just as likely as men to suffer from sexual dysfunction, but their issues are overlooked, with the narrative focusing mainly on the impact of this issue on men, say experts.

Women with diabetes can experience reduced sexual desire, painful sex, reduced lubrication, and sexual distress, increasing the risk of depression, and such issues often go unnoticed despite treatments being available, said Kirsty Winkley, PhD, diabetes nurse and health psychologist, King’s College London.

There is also the “embarrassment factor” on the side of both the health care professional and the patient, she said in a session she chaired at the Diabetes UK Professional Conference 2022. Many women with diabetes “wouldn’t necessarily know” that their sexual dysfunction “is related to their diabetes,” she told this news organization.

For women, sexual health conversations are “often about contraception and pregnancy,” as well as menstrual disorders, genital infections, and hormone replacement therapy. “As health care professionals, you’re trained to focus on those things, and you’re not really considering there might be sexual dysfunction. If women aren’t aware that it’s related to diabetes, you’ve got the perfect situation where it goes under the radar.”

However, cochair Debbie Cooke, PhD, health psychologist at the University of Surrey in Guildford, explained that having psychotherapy embedded within the diabetes team and “integrated throughout the whole service” means that the problem can be identified and treatment offered.

The issue is that such integration is “very uncommon” and access needs to be improved, Dr. Cooke said in an interview.
 

Sexual dysfunction major predictor of depression in women

Jacqueline Fosbury, psychotherapy lead at Diabetes Care for You, Sussex Community NHS Foundation Trust, said that “intimate activity is clearly beneficial for emotional and physical health,” as it is associated with increased oxytocin release, the burning of calories, better immunity, and improved sleep.

Sexual dysfunction is common in people with diabetes, she noted. Poor glycemic control can “damage” blood vessels and nerves, causing reduced blood flow and loss of sensation in sexual organs.

A recent study led by Belgian researchers found that among more than 750 adults with diabetes, 36% of men and 33% of women reported sexual dysfunction.

Sexual dysfunction was more common in women with type 1 diabetes, at 36%, compared with 26% for those with type 2 diabetes. The most commonly reported issues were decreased sexual desire, lubrication problems, orgasmic dysfunction, and pain. Body image problems and fear of hypoglycemia also affect sexuality and intimacy, leading to “sexual distress.”

Moreover, Ms. Fosbury said female sexual dysfunction has been identified as a “major predictor” of depression, which in turn reduces libido.

Treatments for women can include lubricants, local estrogen, and medications that are prescribed off-label, such as sildenafil. The same is true of testosterone therapy, which can be used to boost libido.
 

Couples therapy?

Next, Trudy Hannington, a psychosexual therapist with Leger Clinic, Doncaster, U.K., talked about how to use an integrated approach to address sexuality overall in people with diabetes.

She said this should be seen in a biopsychosocial context, with emphasis on the couple, on sensation and communication, and sexual growth, as well as changes in daily routines.

There should be a move away from “penetrative sex,” Ms. Hannington said, with the goal being “enjoyment, not orgasm.” Pleasure should be facilitated and the opportunities for “performance pressure and/or anxiety” reduced.

She discussed the case of Marie, a 27-year-old woman with type 1 diabetes who had been referred with painful sex and vaginal dryness. Marie had “never experienced orgasm,” despite being in a same-sex relationship with Emily.

Marie’s treatment involved a sexual growth program, to which Emily was invited, as well as recommendations to use lubricants, vibrators, and to try sildenafil.
 

Prioritize women

Ms. Fosbury reiterated that, in men, sexual dysfunction is “readily identified as a complication of diabetes” and is described as “traumatic” and “crucial to well-being.” It is also seen as “easy to treat” with medication, such as that for erectile dysfunction.

It is therefore crucial to talk to women with diabetes about possible sexual dysfunction, and the scene must be set before the appointment to explain that the subject will be broached. In addition, handouts and leaflets should be available for patients in the clinic so they can read about female sexual health and to lower the stigma around discussing it.

“Cultural stereotypes diminish the importance of female sexuality and prevent us from providing equal consideration to the sexual difficulties of our patients,” she concluded.

No funding declared. No relevant financial relationships declared.

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

Outcomes for patients with bacteremic Streptococcus pneumoniae were significantly worse than those for patients with Legionnaires disease (LD), based on data from 106 individuals.

Reported cases of LD in the United States have increased in recent decades, but they are likely under-reported, wrote Sima Salahie, MD, of Wayne State University School of Medicine, Detroit, and Central Michigan University College of Medicine, Grosse Pointe Woods, and colleagues.

Clinical presentations may be similar for both conditions, but different antimicrobial therapies are needed; therefore, identifying distinguishing factors can promote better management of hospitalized patients, they reported.

In a retrospective case companion study published in the American Journal of the Medical Sciences, the researchers reviewed data from 51 adults with LD and 55 with bacteremic S. pneumoniae pneumonia (SP) who were hospitalized at a single center between 2013 and 2018. Diagnoses were confirmed by laboratory and radiology results. In addition, data were collected on clinical features including body mass index, systolic and diastolic blood pressure, pulse, respiratory rate, and temperature.

Overall, patients with SP were significantly more likely than those with LD to require mechanical ventilation (P = .04), intensive care unit stay (P = .004), and to die (P = .002). Patients with SP also had higher rates of septic shock compared to LD patients, although this difference fell short of statistical significance (49.1% vs. 30.4%; P = .06).

In a multivariate analysis, male sex, diarrhea, higher body mass index, hyponatremia, and lower Charleston Weighted Index of Comorbidity (CWIC) score were significant independent predictors of LD, with odds ratios of 21.6, 4.5, 1.13, 5.6, and 0.61, respectively.

The incidence of LD peaked in summer, while the incidence of SP peaked in the winter, the researchers noted. “Seasonality is a variable that has not always been included in previous scoring systems but should be considered in future modeling,” they said.

“Noteworthy is that LD represented almost as many cases as documented bacteremic pneumococcal pneumonia,” the researchers wrote in their discussion. “This occurred at a time when there was no outbreak of L. pneumophila in our community, and as these were all community acquired, there was no evidence of a nosocomial outbreak in our institution,” they said.

The study findings were limited by several factors, including the possible underestimation of SP because of the requirement for positive blood cultures and the lack of other methods of diagnosing SP, the researchers noted.

“However, the data suggest variables to distinguish LD from SP,” they said. “Establishing reliable clinical and laboratory parameters embedded in a simple diagnostic score that can accurately identify patients with LD may be helpful in aiding physicians’ early diagnosis in distinguishing LD from SP but will need to be defined.”

The study received no outside funding. The researchers disclosed no financial conflicts.

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

Outcomes for patients with bacteremic Streptococcus pneumoniae were significantly worse than those for patients with Legionnaires disease (LD), based on data from 106 individuals.

Reported cases of LD in the United States have increased in recent decades, but they are likely under-reported, wrote Sima Salahie, MD, of Wayne State University School of Medicine, Detroit, and Central Michigan University College of Medicine, Grosse Pointe Woods, and colleagues.

Clinical presentations may be similar for both conditions, but different antimicrobial therapies are needed; therefore, identifying distinguishing factors can promote better management of hospitalized patients, they reported.

In a retrospective case companion study published in the American Journal of the Medical Sciences, the researchers reviewed data from 51 adults with LD and 55 with bacteremic S. pneumoniae pneumonia (SP) who were hospitalized at a single center between 2013 and 2018. Diagnoses were confirmed by laboratory and radiology results. In addition, data were collected on clinical features including body mass index, systolic and diastolic blood pressure, pulse, respiratory rate, and temperature.

Overall, patients with SP were significantly more likely than those with LD to require mechanical ventilation (P = .04), intensive care unit stay (P = .004), and to die (P = .002). Patients with SP also had higher rates of septic shock compared to LD patients, although this difference fell short of statistical significance (49.1% vs. 30.4%; P = .06).

In a multivariate analysis, male sex, diarrhea, higher body mass index, hyponatremia, and lower Charleston Weighted Index of Comorbidity (CWIC) score were significant independent predictors of LD, with odds ratios of 21.6, 4.5, 1.13, 5.6, and 0.61, respectively.

The incidence of LD peaked in summer, while the incidence of SP peaked in the winter, the researchers noted. “Seasonality is a variable that has not always been included in previous scoring systems but should be considered in future modeling,” they said.

“Noteworthy is that LD represented almost as many cases as documented bacteremic pneumococcal pneumonia,” the researchers wrote in their discussion. “This occurred at a time when there was no outbreak of L. pneumophila in our community, and as these were all community acquired, there was no evidence of a nosocomial outbreak in our institution,” they said.

The study findings were limited by several factors, including the possible underestimation of SP because of the requirement for positive blood cultures and the lack of other methods of diagnosing SP, the researchers noted.

“However, the data suggest variables to distinguish LD from SP,” they said. “Establishing reliable clinical and laboratory parameters embedded in a simple diagnostic score that can accurately identify patients with LD may be helpful in aiding physicians’ early diagnosis in distinguishing LD from SP but will need to be defined.”

The study received no outside funding. The researchers disclosed no financial conflicts.

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

Outcomes for patients with bacteremic Streptococcus pneumoniae were significantly worse than those for patients with Legionnaires disease (LD), based on data from 106 individuals.

Reported cases of LD in the United States have increased in recent decades, but they are likely under-reported, wrote Sima Salahie, MD, of Wayne State University School of Medicine, Detroit, and Central Michigan University College of Medicine, Grosse Pointe Woods, and colleagues.

Clinical presentations may be similar for both conditions, but different antimicrobial therapies are needed; therefore, identifying distinguishing factors can promote better management of hospitalized patients, they reported.

In a retrospective case companion study published in the American Journal of the Medical Sciences, the researchers reviewed data from 51 adults with LD and 55 with bacteremic S. pneumoniae pneumonia (SP) who were hospitalized at a single center between 2013 and 2018. Diagnoses were confirmed by laboratory and radiology results. In addition, data were collected on clinical features including body mass index, systolic and diastolic blood pressure, pulse, respiratory rate, and temperature.

Overall, patients with SP were significantly more likely than those with LD to require mechanical ventilation (P = .04), intensive care unit stay (P = .004), and to die (P = .002). Patients with SP also had higher rates of septic shock compared to LD patients, although this difference fell short of statistical significance (49.1% vs. 30.4%; P = .06).

In a multivariate analysis, male sex, diarrhea, higher body mass index, hyponatremia, and lower Charleston Weighted Index of Comorbidity (CWIC) score were significant independent predictors of LD, with odds ratios of 21.6, 4.5, 1.13, 5.6, and 0.61, respectively.

The incidence of LD peaked in summer, while the incidence of SP peaked in the winter, the researchers noted. “Seasonality is a variable that has not always been included in previous scoring systems but should be considered in future modeling,” they said.

“Noteworthy is that LD represented almost as many cases as documented bacteremic pneumococcal pneumonia,” the researchers wrote in their discussion. “This occurred at a time when there was no outbreak of L. pneumophila in our community, and as these were all community acquired, there was no evidence of a nosocomial outbreak in our institution,” they said.

The study findings were limited by several factors, including the possible underestimation of SP because of the requirement for positive blood cultures and the lack of other methods of diagnosing SP, the researchers noted.

“However, the data suggest variables to distinguish LD from SP,” they said. “Establishing reliable clinical and laboratory parameters embedded in a simple diagnostic score that can accurately identify patients with LD may be helpful in aiding physicians’ early diagnosis in distinguishing LD from SP but will need to be defined.”

The study received no outside funding. The researchers disclosed no financial conflicts.

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

Antidopaminergic antiemetics (ADAs) that are widely used for nausea and vomiting, including that related to chemotherapy, have been associated with an increased risk of ischemic stroke in a new study from France.

The authors found that ADA users could be at a threefold increased risk of stroke shortly after the initiation of treatment.

Further analysis showed that all three ADAs studied (domperidone, metopimazine, and metoclopramide) were associated with an increased risk, especially in the first days of use, but the highest increase was found for metopimazine and metoclopramide.

The study was published online March 23, 2022, in the BMJ.

“Our results show that the risk of ischemic stroke appears to be associated with ADA use,” wrote the authors, led by Anne Bénard-Laribière, PharmD, MS, of the University of Bordeaux (France). They emphasized, however, that this is an observational study and cannot therefore establish causation.

One important note about this study is that patients with a history of cancer were specifically excluded. The authors did not elaborate on what the ADAs were being used for, other than to say that ADAs are used for nausea and vomiting of “variable origins,” and a press release noted that these drugs are often used by patients with migraine.

Hence it is not clear what relevance these findings have for patients with cancer, suggested an expert unrelated to the study, Ian Olver, MD, PhD, professorial research fellow, faculty of health and medical sciences, University of Adelaide.

“So the best that can be said, from my viewpoint, is that the ADAs studied have been associated with an increased risk of stroke in patients other than cancer patients,” he told this news organization.

In addition, he also emphasized that an observational study cannot establish causation.

For their study, the authors used data from the nationwide reimbursement database. Hence, they “needed to make the assumption that the date of reimbursement approximated to the date of administration, and that would not be the case for drugs used prophylactically prior to chemotherapy or radiotherapy,” Dr. Olver commented.

The authors were also unable to make any statement about dose and schedule. “Certainly chemotherapy-induced nausea and vomiting would require more intermittent dosing compared to noncancer uses,” Dr. Olver said. In addition, “metoclopramide in conventional doses is not very effective for this purpose and metopimazine is mainly used in Europe.”

Most patients with cancer would not be receiving these drugs, he suggested: “These days they would be receiving 5HT3 receptor antagonists and NK1 receptor antagonists and steroids.”
 

Study details

The French study investigated the risk of ischemic stroke associated with ADA use in a real-world setting. The authors conducted a case-time-control study using data from the nationwide French reimbursement health care system database Système National des Données de Santé.

They identified 2,612 patients from the database who had experienced a first ischemic stroke between 2012 and 2016 and had also received at least one reimbursement for domperidone, metopimazine, or metoclopramide during the 70-day period prior to their stroke.

The frequency of reimbursements for ADAs was compared with a risk period (1-14 days before a stroke) and three matched reference periods (57-70 days, 43-56 days, and 29-42 days before stroke).

Patients who had experienced a stroke were matched to a control group of 21,859 randomly selected healthy people who also received an ADA in the same time period.

Within the stroke cohort, 1,250 patients received an ADA at least once during the designated risk period and 1,060 in the reference periods. Among the controls, 5,128 and 13,165 received an ADA at least one time in the risk and reference periods, respectively.

This yielded a case-time-control ratio of adjusted odds ratios of 3.12, of a risk of stroke among new users. Stratification by age (<70 years and ≥70 years), sex, history of dementia, and gastroenteritis epidemic periods revealed similar results, although the highest case-time-control ratio observed in men(aOR, 3.59).

The risk of stroke appeared to increase for all ADAs, but the highest was for metopimazine (3.62-fold increase) and metoclopramide (a 3.53-fold increase), which are both drugs that have the ability to cross the blood-brain barrier.

The study was funded by Agence Nationale de Sécurité du Médicament et des Produits de Santé through a partnership with the Health Product Epidemiology Scientific Interest Group. All authors had financial support from ANSM for the submitted work; one coauthor disclosed relationships with Pfizer and Roche. Dr. Olver disclosed no relevant financial relationships.

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

Antidopaminergic antiemetics (ADAs) that are widely used for nausea and vomiting, including that related to chemotherapy, have been associated with an increased risk of ischemic stroke in a new study from France.

The authors found that ADA users could be at a threefold increased risk of stroke shortly after the initiation of treatment.

Further analysis showed that all three ADAs studied (domperidone, metopimazine, and metoclopramide) were associated with an increased risk, especially in the first days of use, but the highest increase was found for metopimazine and metoclopramide.

The study was published online March 23, 2022, in the BMJ.

“Our results show that the risk of ischemic stroke appears to be associated with ADA use,” wrote the authors, led by Anne Bénard-Laribière, PharmD, MS, of the University of Bordeaux (France). They emphasized, however, that this is an observational study and cannot therefore establish causation.

One important note about this study is that patients with a history of cancer were specifically excluded. The authors did not elaborate on what the ADAs were being used for, other than to say that ADAs are used for nausea and vomiting of “variable origins,” and a press release noted that these drugs are often used by patients with migraine.

Hence it is not clear what relevance these findings have for patients with cancer, suggested an expert unrelated to the study, Ian Olver, MD, PhD, professorial research fellow, faculty of health and medical sciences, University of Adelaide.

“So the best that can be said, from my viewpoint, is that the ADAs studied have been associated with an increased risk of stroke in patients other than cancer patients,” he told this news organization.

In addition, he also emphasized that an observational study cannot establish causation.

For their study, the authors used data from the nationwide reimbursement database. Hence, they “needed to make the assumption that the date of reimbursement approximated to the date of administration, and that would not be the case for drugs used prophylactically prior to chemotherapy or radiotherapy,” Dr. Olver commented.

The authors were also unable to make any statement about dose and schedule. “Certainly chemotherapy-induced nausea and vomiting would require more intermittent dosing compared to noncancer uses,” Dr. Olver said. In addition, “metoclopramide in conventional doses is not very effective for this purpose and metopimazine is mainly used in Europe.”

Most patients with cancer would not be receiving these drugs, he suggested: “These days they would be receiving 5HT3 receptor antagonists and NK1 receptor antagonists and steroids.”
 

Study details

The French study investigated the risk of ischemic stroke associated with ADA use in a real-world setting. The authors conducted a case-time-control study using data from the nationwide French reimbursement health care system database Système National des Données de Santé.

They identified 2,612 patients from the database who had experienced a first ischemic stroke between 2012 and 2016 and had also received at least one reimbursement for domperidone, metopimazine, or metoclopramide during the 70-day period prior to their stroke.

The frequency of reimbursements for ADAs was compared with a risk period (1-14 days before a stroke) and three matched reference periods (57-70 days, 43-56 days, and 29-42 days before stroke).

Patients who had experienced a stroke were matched to a control group of 21,859 randomly selected healthy people who also received an ADA in the same time period.

Within the stroke cohort, 1,250 patients received an ADA at least once during the designated risk period and 1,060 in the reference periods. Among the controls, 5,128 and 13,165 received an ADA at least one time in the risk and reference periods, respectively.

This yielded a case-time-control ratio of adjusted odds ratios of 3.12, of a risk of stroke among new users. Stratification by age (<70 years and ≥70 years), sex, history of dementia, and gastroenteritis epidemic periods revealed similar results, although the highest case-time-control ratio observed in men(aOR, 3.59).

The risk of stroke appeared to increase for all ADAs, but the highest was for metopimazine (3.62-fold increase) and metoclopramide (a 3.53-fold increase), which are both drugs that have the ability to cross the blood-brain barrier.

The study was funded by Agence Nationale de Sécurité du Médicament et des Produits de Santé through a partnership with the Health Product Epidemiology Scientific Interest Group. All authors had financial support from ANSM for the submitted work; one coauthor disclosed relationships with Pfizer and Roche. Dr. Olver disclosed no relevant financial relationships.

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

Antidopaminergic antiemetics (ADAs) that are widely used for nausea and vomiting, including that related to chemotherapy, have been associated with an increased risk of ischemic stroke in a new study from France.

The authors found that ADA users could be at a threefold increased risk of stroke shortly after the initiation of treatment.

Further analysis showed that all three ADAs studied (domperidone, metopimazine, and metoclopramide) were associated with an increased risk, especially in the first days of use, but the highest increase was found for metopimazine and metoclopramide.

The study was published online March 23, 2022, in the BMJ.

“Our results show that the risk of ischemic stroke appears to be associated with ADA use,” wrote the authors, led by Anne Bénard-Laribière, PharmD, MS, of the University of Bordeaux (France). They emphasized, however, that this is an observational study and cannot therefore establish causation.

One important note about this study is that patients with a history of cancer were specifically excluded. The authors did not elaborate on what the ADAs were being used for, other than to say that ADAs are used for nausea and vomiting of “variable origins,” and a press release noted that these drugs are often used by patients with migraine.

Hence it is not clear what relevance these findings have for patients with cancer, suggested an expert unrelated to the study, Ian Olver, MD, PhD, professorial research fellow, faculty of health and medical sciences, University of Adelaide.

“So the best that can be said, from my viewpoint, is that the ADAs studied have been associated with an increased risk of stroke in patients other than cancer patients,” he told this news organization.

In addition, he also emphasized that an observational study cannot establish causation.

For their study, the authors used data from the nationwide reimbursement database. Hence, they “needed to make the assumption that the date of reimbursement approximated to the date of administration, and that would not be the case for drugs used prophylactically prior to chemotherapy or radiotherapy,” Dr. Olver commented.

The authors were also unable to make any statement about dose and schedule. “Certainly chemotherapy-induced nausea and vomiting would require more intermittent dosing compared to noncancer uses,” Dr. Olver said. In addition, “metoclopramide in conventional doses is not very effective for this purpose and metopimazine is mainly used in Europe.”

Most patients with cancer would not be receiving these drugs, he suggested: “These days they would be receiving 5HT3 receptor antagonists and NK1 receptor antagonists and steroids.”
 

Study details

The French study investigated the risk of ischemic stroke associated with ADA use in a real-world setting. The authors conducted a case-time-control study using data from the nationwide French reimbursement health care system database Système National des Données de Santé.

They identified 2,612 patients from the database who had experienced a first ischemic stroke between 2012 and 2016 and had also received at least one reimbursement for domperidone, metopimazine, or metoclopramide during the 70-day period prior to their stroke.

The frequency of reimbursements for ADAs was compared with a risk period (1-14 days before a stroke) and three matched reference periods (57-70 days, 43-56 days, and 29-42 days before stroke).

Patients who had experienced a stroke were matched to a control group of 21,859 randomly selected healthy people who also received an ADA in the same time period.

Within the stroke cohort, 1,250 patients received an ADA at least once during the designated risk period and 1,060 in the reference periods. Among the controls, 5,128 and 13,165 received an ADA at least one time in the risk and reference periods, respectively.

This yielded a case-time-control ratio of adjusted odds ratios of 3.12, of a risk of stroke among new users. Stratification by age (<70 years and ≥70 years), sex, history of dementia, and gastroenteritis epidemic periods revealed similar results, although the highest case-time-control ratio observed in men(aOR, 3.59).

The risk of stroke appeared to increase for all ADAs, but the highest was for metopimazine (3.62-fold increase) and metoclopramide (a 3.53-fold increase), which are both drugs that have the ability to cross the blood-brain barrier.

The study was funded by Agence Nationale de Sécurité du Médicament et des Produits de Santé through a partnership with the Health Product Epidemiology Scientific Interest Group. All authors had financial support from ANSM for the submitted work; one coauthor disclosed relationships with Pfizer and Roche. Dr. Olver disclosed no relevant financial relationships.

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

Dietary supplements that contain omega-3 fatty acids have been widely consumed for years. Researchers have been investigating the benefits of such preparations for cardiovascular, neurologic, and psychological conditions. A recently published study on omega-3 fatty acids and depression inspired neurologist Hans-Christoph Diener, MD, PhD, of the Institute for Epidemiology at the University Duisburg-Essen (Germany), to examine scientific publications concerning omega-3 fatty acids or fish-oil capsules in more detail.

Prevention of depression

Dr. Diener told the story of how he stumbled upon an interesting article in JAMA  in December 2021. It was about a placebo-controlled study that investigated whether omega-3 fatty acids can prevent incident depression.

As the study authors reported, treatment with omega-3 preparations in adults aged 50 years or older without clinically relevant symptoms of depression at study initiation was associated with a small but statistically significant increase in the risk for depression or clinically relevant symptoms of depression. There was no difference in mood scale value, however, over a median follow-up of 5.3 years. According to the study authors, these results did not support the administration of omega-3 preparations for the prevention of depression.

This study was, as Dr. Diener said, somewhat negative, but it did arouse his interest in questions such as what biological effects omega-3 fatty acids have and what is known “about this topic with regard to neurology,” he said. When reviewing the literature, he noticed that there “were association studies, i.e., studies that describe that the intake of omega-3 fatty acids may possibly be associated with a lower risk of certain diseases.”
 

Beginning with the Inuit

It all started “with observations of the Inuit [population] in Greenland and Alaska after World War II, because it was remarked upon that these people ate a lot of fish and seal meat and had a very low incidence of cardiovascular diseases.” Over the years, a large number of association studies have been published, which may have encouraged the assumption that omega-3 fatty acids have positive health effects on various conditions, such as cardiovascular diseases, hyperlipidemia, type 2 diabetes, various malignancies, cognitive impairments, Alzheimer’s disease, depression and anxiety disorders, heart failure, slipped disks, ADHD, symptoms of menopause, rheumatoid arthritis, asthma, periodontitis, epilepsy, chemotherapy tolerance, premenstrual syndrome, and nonalcoholic fatty liver disease.

Dr. Diener believes that the problem is that these are association studies. But association does not mean that there is a causal relationship.
 

Disappointing study results

On the contrary, the results from the randomized placebo-controlled studies are truly frustrating, according to the neurologist. A meta-analysis of the use of omega-3 fatty acids in cardiovascular diseases included 86 studies with over 162,000 patients. According to Dr. Diener, it did not reveal any benefit for overall and cardiovascular mortality, nor any benefit for the reduction of myocardial infarction and stroke.

The results did indicate a trend, however, for reduced mortality in coronary heart disease. Even so, the number needed to treat for this was 334, which means that 334 people would have to take omega-3 fatty acids for years to prevent one fatal cardiac event.

Aside from this study, Dr. Diener found six studies on Alzheimer’s disease and three studies on dementia with patient populations between 600 and 800. In these studies, too, a positive effect of omega-3 fatty acids could not be identified. Then he discovered another 31 placebo-controlled studies of omega-3 fatty acids for the treatment or prevention of depression and anxiety disorder. Despite including 50,000 patients, these studies also did not show any positive effect.

“I see a significant discrepancy between the promotion of omega-3 fatty acids, whether it’s on television, in the ‘yellow’ [journalism] press, or in advertisements, and the actual scientific evidence,” said Dr. Diener. “At least from a neurological perspective, there is no evidence that omega-3 fatty acids have any benefit. This is true for strokes, dementia, Alzheimer’s disease, depression, and anxiety disorders.”
 

Potential adverse effects

Omega-3 fatty acids also have potentially adverse effects. The VITAL Rhythm study recently provided evidence that, depending on the dose, preparations with omega-3 fatty acids may increase the risk for atrial fibrillation. As the authors wrote, the results do not support taking omega-3 fatty acids to prevent atrial fibrillation.

In 2019, the global market for omega-3 fatty acids reached a value of $4.1 billion. This value is expected to double by 2025, according to a comment by Gregory Curfman, MD, deputy editor of JAMA and lecturer in health care policy at Harvard Medical School, Boston.

As Dr. Curfman wrote, this impressive amount of expenditure shows how beloved these products are and how strongly many people believe that omega-3 fatty acids are beneficial for their health. It is therefore important to know the potential risks of such preparations. One such example for this would be the risk for atrial fibrillation.

According to Dr. Curfman, in the last 2 years, four randomized clinical studies have provided data on the risk for atrial fibrillation associated with omega-3 fatty acids. In the STRENGTH study, 13,078 high-risk patients with cardiovascular diseases were randomly assigned to one of two groups. The subjects received either a high dose (4 g/day) of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil. After a median of 42 months, there was no significant difference between the two groups in the primary composite cardiovascular endpoint, but more frequent atrial fibrillation in the omega-3 fatty acid group, compared with the corn oil group (2.2% vs. 1.3%; hazard ratio, 1.69; 95% confidence interval, 1.29-2.21; P < .001).

In the REDUCE-IT study, 8179 subjects were randomly assigned to a high dose (4 g/day, as in STRENGTH) of an omega-3 fatty acid preparation consisting of a purified EPA (icosapent ethyl) or mineral oil. After a median observation period of 4.9 years, icosapent ethyl was associated with a relative reduction of the primary composite cardiovascular endpoint by 25%, compared with mineral oil. As in the STRENGTH study, this study found that the risk for atrial fibrillation associated with omega-3 fatty acids, compared with mineral oil, was significantly higher (5.3% vs. 3.9%; P = .003).

In a third study (OMEMI), as Dr. Curfman reported, 1027 elderly patients who had recently had a myocardial infarction were randomly assigned to receive either a median dose of 1.8 g/day of omega-3 fatty acids (a combination of EPA and DHA) or corn oil. After 2 years, there was no significant difference between the two groups in primary composite cardiovascular endpoints, but 7.2% of the patients taking omega-3 fatty acids developed atrial fibrillation. In the corn oil group, this proportion was 4% (HR, 1.84; 95% CI, 0.98-3.45; P = .06).

The data from the four studies together indicate a potential dose-dependent risk for atrial fibrillation associated with omega-3 fatty acids, according to Dr. Curfman. At a dose of 4.0 g/day, there is a highly significant risk increase (almost double). With a median dose of 1.8 g/day, the risk increase (HR, 1.84) did not reach statistical significance. At a daily standard dose of 840 mg/day, an increase in risk could not be determined.

Dr. Curfman’s recommendation is that patients who take, or want to take, preparations with omega-3 fatty acids be informed of the potential development of arrhythmia at higher dosages. These patients also should undergo cardiological monitoring.

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

Dietary supplements that contain omega-3 fatty acids have been widely consumed for years. Researchers have been investigating the benefits of such preparations for cardiovascular, neurologic, and psychological conditions. A recently published study on omega-3 fatty acids and depression inspired neurologist Hans-Christoph Diener, MD, PhD, of the Institute for Epidemiology at the University Duisburg-Essen (Germany), to examine scientific publications concerning omega-3 fatty acids or fish-oil capsules in more detail.

Prevention of depression

Dr. Diener told the story of how he stumbled upon an interesting article in JAMA  in December 2021. It was about a placebo-controlled study that investigated whether omega-3 fatty acids can prevent incident depression.

As the study authors reported, treatment with omega-3 preparations in adults aged 50 years or older without clinically relevant symptoms of depression at study initiation was associated with a small but statistically significant increase in the risk for depression or clinically relevant symptoms of depression. There was no difference in mood scale value, however, over a median follow-up of 5.3 years. According to the study authors, these results did not support the administration of omega-3 preparations for the prevention of depression.

This study was, as Dr. Diener said, somewhat negative, but it did arouse his interest in questions such as what biological effects omega-3 fatty acids have and what is known “about this topic with regard to neurology,” he said. When reviewing the literature, he noticed that there “were association studies, i.e., studies that describe that the intake of omega-3 fatty acids may possibly be associated with a lower risk of certain diseases.”
 

Beginning with the Inuit

It all started “with observations of the Inuit [population] in Greenland and Alaska after World War II, because it was remarked upon that these people ate a lot of fish and seal meat and had a very low incidence of cardiovascular diseases.” Over the years, a large number of association studies have been published, which may have encouraged the assumption that omega-3 fatty acids have positive health effects on various conditions, such as cardiovascular diseases, hyperlipidemia, type 2 diabetes, various malignancies, cognitive impairments, Alzheimer’s disease, depression and anxiety disorders, heart failure, slipped disks, ADHD, symptoms of menopause, rheumatoid arthritis, asthma, periodontitis, epilepsy, chemotherapy tolerance, premenstrual syndrome, and nonalcoholic fatty liver disease.

Dr. Diener believes that the problem is that these are association studies. But association does not mean that there is a causal relationship.
 

Disappointing study results

On the contrary, the results from the randomized placebo-controlled studies are truly frustrating, according to the neurologist. A meta-analysis of the use of omega-3 fatty acids in cardiovascular diseases included 86 studies with over 162,000 patients. According to Dr. Diener, it did not reveal any benefit for overall and cardiovascular mortality, nor any benefit for the reduction of myocardial infarction and stroke.

The results did indicate a trend, however, for reduced mortality in coronary heart disease. Even so, the number needed to treat for this was 334, which means that 334 people would have to take omega-3 fatty acids for years to prevent one fatal cardiac event.

Aside from this study, Dr. Diener found six studies on Alzheimer’s disease and three studies on dementia with patient populations between 600 and 800. In these studies, too, a positive effect of omega-3 fatty acids could not be identified. Then he discovered another 31 placebo-controlled studies of omega-3 fatty acids for the treatment or prevention of depression and anxiety disorder. Despite including 50,000 patients, these studies also did not show any positive effect.

“I see a significant discrepancy between the promotion of omega-3 fatty acids, whether it’s on television, in the ‘yellow’ [journalism] press, or in advertisements, and the actual scientific evidence,” said Dr. Diener. “At least from a neurological perspective, there is no evidence that omega-3 fatty acids have any benefit. This is true for strokes, dementia, Alzheimer’s disease, depression, and anxiety disorders.”
 

Potential adverse effects

Omega-3 fatty acids also have potentially adverse effects. The VITAL Rhythm study recently provided evidence that, depending on the dose, preparations with omega-3 fatty acids may increase the risk for atrial fibrillation. As the authors wrote, the results do not support taking omega-3 fatty acids to prevent atrial fibrillation.

In 2019, the global market for omega-3 fatty acids reached a value of $4.1 billion. This value is expected to double by 2025, according to a comment by Gregory Curfman, MD, deputy editor of JAMA and lecturer in health care policy at Harvard Medical School, Boston.

As Dr. Curfman wrote, this impressive amount of expenditure shows how beloved these products are and how strongly many people believe that omega-3 fatty acids are beneficial for their health. It is therefore important to know the potential risks of such preparations. One such example for this would be the risk for atrial fibrillation.

According to Dr. Curfman, in the last 2 years, four randomized clinical studies have provided data on the risk for atrial fibrillation associated with omega-3 fatty acids. In the STRENGTH study, 13,078 high-risk patients with cardiovascular diseases were randomly assigned to one of two groups. The subjects received either a high dose (4 g/day) of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil. After a median of 42 months, there was no significant difference between the two groups in the primary composite cardiovascular endpoint, but more frequent atrial fibrillation in the omega-3 fatty acid group, compared with the corn oil group (2.2% vs. 1.3%; hazard ratio, 1.69; 95% confidence interval, 1.29-2.21; P < .001).

In the REDUCE-IT study, 8179 subjects were randomly assigned to a high dose (4 g/day, as in STRENGTH) of an omega-3 fatty acid preparation consisting of a purified EPA (icosapent ethyl) or mineral oil. After a median observation period of 4.9 years, icosapent ethyl was associated with a relative reduction of the primary composite cardiovascular endpoint by 25%, compared with mineral oil. As in the STRENGTH study, this study found that the risk for atrial fibrillation associated with omega-3 fatty acids, compared with mineral oil, was significantly higher (5.3% vs. 3.9%; P = .003).

In a third study (OMEMI), as Dr. Curfman reported, 1027 elderly patients who had recently had a myocardial infarction were randomly assigned to receive either a median dose of 1.8 g/day of omega-3 fatty acids (a combination of EPA and DHA) or corn oil. After 2 years, there was no significant difference between the two groups in primary composite cardiovascular endpoints, but 7.2% of the patients taking omega-3 fatty acids developed atrial fibrillation. In the corn oil group, this proportion was 4% (HR, 1.84; 95% CI, 0.98-3.45; P = .06).

The data from the four studies together indicate a potential dose-dependent risk for atrial fibrillation associated with omega-3 fatty acids, according to Dr. Curfman. At a dose of 4.0 g/day, there is a highly significant risk increase (almost double). With a median dose of 1.8 g/day, the risk increase (HR, 1.84) did not reach statistical significance. At a daily standard dose of 840 mg/day, an increase in risk could not be determined.

Dr. Curfman’s recommendation is that patients who take, or want to take, preparations with omega-3 fatty acids be informed of the potential development of arrhythmia at higher dosages. These patients also should undergo cardiological monitoring.

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

Dietary supplements that contain omega-3 fatty acids have been widely consumed for years. Researchers have been investigating the benefits of such preparations for cardiovascular, neurologic, and psychological conditions. A recently published study on omega-3 fatty acids and depression inspired neurologist Hans-Christoph Diener, MD, PhD, of the Institute for Epidemiology at the University Duisburg-Essen (Germany), to examine scientific publications concerning omega-3 fatty acids or fish-oil capsules in more detail.

Prevention of depression

Dr. Diener told the story of how he stumbled upon an interesting article in JAMA  in December 2021. It was about a placebo-controlled study that investigated whether omega-3 fatty acids can prevent incident depression.

As the study authors reported, treatment with omega-3 preparations in adults aged 50 years or older without clinically relevant symptoms of depression at study initiation was associated with a small but statistically significant increase in the risk for depression or clinically relevant symptoms of depression. There was no difference in mood scale value, however, over a median follow-up of 5.3 years. According to the study authors, these results did not support the administration of omega-3 preparations for the prevention of depression.

This study was, as Dr. Diener said, somewhat negative, but it did arouse his interest in questions such as what biological effects omega-3 fatty acids have and what is known “about this topic with regard to neurology,” he said. When reviewing the literature, he noticed that there “were association studies, i.e., studies that describe that the intake of omega-3 fatty acids may possibly be associated with a lower risk of certain diseases.”
 

Beginning with the Inuit

It all started “with observations of the Inuit [population] in Greenland and Alaska after World War II, because it was remarked upon that these people ate a lot of fish and seal meat and had a very low incidence of cardiovascular diseases.” Over the years, a large number of association studies have been published, which may have encouraged the assumption that omega-3 fatty acids have positive health effects on various conditions, such as cardiovascular diseases, hyperlipidemia, type 2 diabetes, various malignancies, cognitive impairments, Alzheimer’s disease, depression and anxiety disorders, heart failure, slipped disks, ADHD, symptoms of menopause, rheumatoid arthritis, asthma, periodontitis, epilepsy, chemotherapy tolerance, premenstrual syndrome, and nonalcoholic fatty liver disease.

Dr. Diener believes that the problem is that these are association studies. But association does not mean that there is a causal relationship.
 

Disappointing study results

On the contrary, the results from the randomized placebo-controlled studies are truly frustrating, according to the neurologist. A meta-analysis of the use of omega-3 fatty acids in cardiovascular diseases included 86 studies with over 162,000 patients. According to Dr. Diener, it did not reveal any benefit for overall and cardiovascular mortality, nor any benefit for the reduction of myocardial infarction and stroke.

The results did indicate a trend, however, for reduced mortality in coronary heart disease. Even so, the number needed to treat for this was 334, which means that 334 people would have to take omega-3 fatty acids for years to prevent one fatal cardiac event.

Aside from this study, Dr. Diener found six studies on Alzheimer’s disease and three studies on dementia with patient populations between 600 and 800. In these studies, too, a positive effect of omega-3 fatty acids could not be identified. Then he discovered another 31 placebo-controlled studies of omega-3 fatty acids for the treatment or prevention of depression and anxiety disorder. Despite including 50,000 patients, these studies also did not show any positive effect.

“I see a significant discrepancy between the promotion of omega-3 fatty acids, whether it’s on television, in the ‘yellow’ [journalism] press, or in advertisements, and the actual scientific evidence,” said Dr. Diener. “At least from a neurological perspective, there is no evidence that omega-3 fatty acids have any benefit. This is true for strokes, dementia, Alzheimer’s disease, depression, and anxiety disorders.”
 

Potential adverse effects

Omega-3 fatty acids also have potentially adverse effects. The VITAL Rhythm study recently provided evidence that, depending on the dose, preparations with omega-3 fatty acids may increase the risk for atrial fibrillation. As the authors wrote, the results do not support taking omega-3 fatty acids to prevent atrial fibrillation.

In 2019, the global market for omega-3 fatty acids reached a value of $4.1 billion. This value is expected to double by 2025, according to a comment by Gregory Curfman, MD, deputy editor of JAMA and lecturer in health care policy at Harvard Medical School, Boston.

As Dr. Curfman wrote, this impressive amount of expenditure shows how beloved these products are and how strongly many people believe that omega-3 fatty acids are beneficial for their health. It is therefore important to know the potential risks of such preparations. One such example for this would be the risk for atrial fibrillation.

According to Dr. Curfman, in the last 2 years, four randomized clinical studies have provided data on the risk for atrial fibrillation associated with omega-3 fatty acids. In the STRENGTH study, 13,078 high-risk patients with cardiovascular diseases were randomly assigned to one of two groups. The subjects received either a high dose (4 g/day) of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil. After a median of 42 months, there was no significant difference between the two groups in the primary composite cardiovascular endpoint, but more frequent atrial fibrillation in the omega-3 fatty acid group, compared with the corn oil group (2.2% vs. 1.3%; hazard ratio, 1.69; 95% confidence interval, 1.29-2.21; P < .001).

In the REDUCE-IT study, 8179 subjects were randomly assigned to a high dose (4 g/day, as in STRENGTH) of an omega-3 fatty acid preparation consisting of a purified EPA (icosapent ethyl) or mineral oil. After a median observation period of 4.9 years, icosapent ethyl was associated with a relative reduction of the primary composite cardiovascular endpoint by 25%, compared with mineral oil. As in the STRENGTH study, this study found that the risk for atrial fibrillation associated with omega-3 fatty acids, compared with mineral oil, was significantly higher (5.3% vs. 3.9%; P = .003).

In a third study (OMEMI), as Dr. Curfman reported, 1027 elderly patients who had recently had a myocardial infarction were randomly assigned to receive either a median dose of 1.8 g/day of omega-3 fatty acids (a combination of EPA and DHA) or corn oil. After 2 years, there was no significant difference between the two groups in primary composite cardiovascular endpoints, but 7.2% of the patients taking omega-3 fatty acids developed atrial fibrillation. In the corn oil group, this proportion was 4% (HR, 1.84; 95% CI, 0.98-3.45; P = .06).

The data from the four studies together indicate a potential dose-dependent risk for atrial fibrillation associated with omega-3 fatty acids, according to Dr. Curfman. At a dose of 4.0 g/day, there is a highly significant risk increase (almost double). With a median dose of 1.8 g/day, the risk increase (HR, 1.84) did not reach statistical significance. At a daily standard dose of 840 mg/day, an increase in risk could not be determined.

Dr. Curfman’s recommendation is that patients who take, or want to take, preparations with omega-3 fatty acids be informed of the potential development of arrhythmia at higher dosages. These patients also should undergo cardiological monitoring.

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

Click to view more from Cancer Data Trends 2022.

Click to view more from Cancer Data Trends 2022.

Click to view more from Cancer Data Trends 2022.