Hypertension

Many strategies widely considered “standard care” for managing spontaneous intracerebral hemorrhage (ICH) are not as effective as previously thought and are no longer recommended in updated guidelines from the American Heart Association/American Stroke Association (ASA).

Compression stockings, antiseizure medication, and steroid treatment are among the treatments with uncertain effectiveness, the writing group says.

The 2022 Guideline for the Management of Patients With Spontaneous ICH was published online  in Stroke. The 80-page document contains major changes and refinements to the 2015 guideline on ICH management.

“Advances have been made in an array of fields related to ICH, including the organization of regional health care systems, reversal of the negative effects of blood thinners, minimally invasive surgical procedures, and the underlying disease in small blood vessels,” Steven M. Greenberg, MD, PhD, chair of the guideline writing group with Harvard Medical School and Massachusetts General Hospital, both in Boston, said in a news release.

“We’ve updated sections across the board. There’s probably no area that went untouched with some tweaking and new evidence added that led to some changes in level of evidence or strength of a recommendation,” Dr. Greenberg added in an interview with this news organization.

“Each section comes with knowledge gaps, and it wasn’t hard to come up with knowledge gaps in every section,” Dr. Greenberg acknowledged.

Time-honored treatments no more?

Among the key updates are changes to some “time-honored” treatments that continue to be used with some “regularity” for patients with ICH, yet appear to confer either no benefit or harm, Dr. Greenberg said.

For example, for emergency or critical care treatment of ICH, prophylactic corticosteroids or continuous hyperosmolar therapy is not recommended, because it appears to have no benefit for outcome, while use of platelet transfusions outside the setting of emergency surgery or severe thrombocytopenia appears to worsen outcome, the authors say.

Use of graduated knee- or thigh-high compression stockings alone is not an effective prophylactic therapy for prevention of deep vein thrombosis (DVT). Instead, intermittent pneumatic compression (IPC) starting on the day of diagnosis is now recommended for DVT prophylaxis.

“This is an area where we still have a lot of exploration to do. It is unclear whether even specialized compression devices reduce the risks of deep vein thrombosis or improve the overall health of people with a brain bleed,” Dr. Greenberg said in the release.

The new guidance advises against use of antiseizure or antidepressant medications for ICH patients in whom there is no evidence of seizures or depression.

In clinical trials, antiseizure medication did not contribute to improvements in functionality or long-term seizure control, and the use of antidepressants increased the chance of bone fractures, the authors say.

The guideline also provides updated recommendations for acute reversal of anticoagulation after ICH. It highlights the use of protein complex concentrate for reversal of vitamin K antagonists, such as warfarin; idarucizumab for reversal of the thrombin inhibitor dabigatran; and andexanet alfa for reversal of factor Xa inhibitors, such as rivaroxaban, apixaban, and edoxaban.

For acute blood pressure lowering after mild to moderate ICH, treatment regimens that limit blood pressure variability and achieve smooth, sustained blood pressure control appear to reduce hematoma expansion and yield better functional outcome, the guideline says.

It also notes that minimally invasive approaches for hematoma evacuation, compared with medical management alone‚ have been shown to reduce mortality.

For patients with cerebellar hemorrhage, indications for immediate surgical evacuation with or without an external ventricular drain to reduce mortality now include larger volume (> 15 mL) in addition to previously recommended indications of neurologic deterioration, brainstem compression, and hydrocephalus, the authors note.

However, a “major knowledge gap is whether we can improve functional outcome with hematoma evacuation,” Dr. Greenberg said.
 

Multidisciplinary care

For rehabilitation after ICH, the guideline reinforces the importance of having a multidisciplinary team to develop a comprehensive plan for recovery.

Starting rehabilitation activities such as stretching and functional task training may be considered 24 to 48 hours following mild or moderate ICH. However, early aggressive mobilization within the first 24 hours has been linked to an increased risk of death within 14 days after an ICH, the guideline says.

Knowledge gaps include how soon it’s safe to return to work, drive, and participate in other social engagements. Recommendations on sexual activity and exercise levels that are safe after a stroke are also needed.

“People need additional help with these lifestyle changes, whether it’s moving around more, curbing their alcohol use, or eating healthier foods. This all happens after they leave the hospital, and we need to be sure we are empowering families with the information they may need to be properly supportive,” Dr. Greenberg says in the release.

The guideline points to the patient’s home caregiver as a “key and sometimes overlooked” member of the care team. It recommends psychosocial education, practical support, and training for the caregiver to improve the patient’s balance, activity level, and overall quality of life.
 

Opportunity for prevention?

The guideline also suggests there may be an opportunity to prevent ICH in some people through neuroimaging markers.

While neuroimaging is not routinely performed as a part of risk stratification for primary ICH risk, damage to small blood vessels that is associated with ICH may be evident on MRI that could signal future ICH risk, the guideline says.

“We added to the guidelines for the first time a section on mostly imaging markers of risk for having a first-ever hemorrhage,” Dr. Greenberg said in an interview.

“We don’t make any recommendations as to how to act on these markers because there is a knowledge gap. The hope is that we’ll see growth in our ability to predict first-ever hemorrhage and be able to do things to prevent first-ever hemorrhage,” he said.

“We believe the wide range of knowledge set forth in the new guideline will translate into meaningful improvements in ICH care,” Dr. Greenberg adds in the release.

The updated guideline has been endorsed by the American Association of Neurological Surgeons and Congress of Neurological Surgeons, the Society of Vascular and Interventional Neurology, and the Neurocritical Care Society. The American Academy of Neurology has affirmed the value of this statement as an educational tool for neurologists.

This research had no commercial funding. Dr. Greenberg has disclosed no relevant financial relationships. A complete list of disclosures for the guideline group is available with the original article.

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

Many strategies widely considered “standard care” for managing spontaneous intracerebral hemorrhage (ICH) are not as effective as previously thought and are no longer recommended in updated guidelines from the American Heart Association/American Stroke Association (ASA).

Compression stockings, antiseizure medication, and steroid treatment are among the treatments with uncertain effectiveness, the writing group says.

The 2022 Guideline for the Management of Patients With Spontaneous ICH was published online  in Stroke. The 80-page document contains major changes and refinements to the 2015 guideline on ICH management.

“Advances have been made in an array of fields related to ICH, including the organization of regional health care systems, reversal of the negative effects of blood thinners, minimally invasive surgical procedures, and the underlying disease in small blood vessels,” Steven M. Greenberg, MD, PhD, chair of the guideline writing group with Harvard Medical School and Massachusetts General Hospital, both in Boston, said in a news release.

“We’ve updated sections across the board. There’s probably no area that went untouched with some tweaking and new evidence added that led to some changes in level of evidence or strength of a recommendation,” Dr. Greenberg added in an interview with this news organization.

“Each section comes with knowledge gaps, and it wasn’t hard to come up with knowledge gaps in every section,” Dr. Greenberg acknowledged.

Time-honored treatments no more?

Among the key updates are changes to some “time-honored” treatments that continue to be used with some “regularity” for patients with ICH, yet appear to confer either no benefit or harm, Dr. Greenberg said.

For example, for emergency or critical care treatment of ICH, prophylactic corticosteroids or continuous hyperosmolar therapy is not recommended, because it appears to have no benefit for outcome, while use of platelet transfusions outside the setting of emergency surgery or severe thrombocytopenia appears to worsen outcome, the authors say.

Use of graduated knee- or thigh-high compression stockings alone is not an effective prophylactic therapy for prevention of deep vein thrombosis (DVT). Instead, intermittent pneumatic compression (IPC) starting on the day of diagnosis is now recommended for DVT prophylaxis.

“This is an area where we still have a lot of exploration to do. It is unclear whether even specialized compression devices reduce the risks of deep vein thrombosis or improve the overall health of people with a brain bleed,” Dr. Greenberg said in the release.

The new guidance advises against use of antiseizure or antidepressant medications for ICH patients in whom there is no evidence of seizures or depression.

In clinical trials, antiseizure medication did not contribute to improvements in functionality or long-term seizure control, and the use of antidepressants increased the chance of bone fractures, the authors say.

The guideline also provides updated recommendations for acute reversal of anticoagulation after ICH. It highlights the use of protein complex concentrate for reversal of vitamin K antagonists, such as warfarin; idarucizumab for reversal of the thrombin inhibitor dabigatran; and andexanet alfa for reversal of factor Xa inhibitors, such as rivaroxaban, apixaban, and edoxaban.

For acute blood pressure lowering after mild to moderate ICH, treatment regimens that limit blood pressure variability and achieve smooth, sustained blood pressure control appear to reduce hematoma expansion and yield better functional outcome, the guideline says.

It also notes that minimally invasive approaches for hematoma evacuation, compared with medical management alone‚ have been shown to reduce mortality.

For patients with cerebellar hemorrhage, indications for immediate surgical evacuation with or without an external ventricular drain to reduce mortality now include larger volume (> 15 mL) in addition to previously recommended indications of neurologic deterioration, brainstem compression, and hydrocephalus, the authors note.

However, a “major knowledge gap is whether we can improve functional outcome with hematoma evacuation,” Dr. Greenberg said.
 

Multidisciplinary care

For rehabilitation after ICH, the guideline reinforces the importance of having a multidisciplinary team to develop a comprehensive plan for recovery.

Starting rehabilitation activities such as stretching and functional task training may be considered 24 to 48 hours following mild or moderate ICH. However, early aggressive mobilization within the first 24 hours has been linked to an increased risk of death within 14 days after an ICH, the guideline says.

Knowledge gaps include how soon it’s safe to return to work, drive, and participate in other social engagements. Recommendations on sexual activity and exercise levels that are safe after a stroke are also needed.

“People need additional help with these lifestyle changes, whether it’s moving around more, curbing their alcohol use, or eating healthier foods. This all happens after they leave the hospital, and we need to be sure we are empowering families with the information they may need to be properly supportive,” Dr. Greenberg says in the release.

The guideline points to the patient’s home caregiver as a “key and sometimes overlooked” member of the care team. It recommends psychosocial education, practical support, and training for the caregiver to improve the patient’s balance, activity level, and overall quality of life.
 

Opportunity for prevention?

The guideline also suggests there may be an opportunity to prevent ICH in some people through neuroimaging markers.

While neuroimaging is not routinely performed as a part of risk stratification for primary ICH risk, damage to small blood vessels that is associated with ICH may be evident on MRI that could signal future ICH risk, the guideline says.

“We added to the guidelines for the first time a section on mostly imaging markers of risk for having a first-ever hemorrhage,” Dr. Greenberg said in an interview.

“We don’t make any recommendations as to how to act on these markers because there is a knowledge gap. The hope is that we’ll see growth in our ability to predict first-ever hemorrhage and be able to do things to prevent first-ever hemorrhage,” he said.

“We believe the wide range of knowledge set forth in the new guideline will translate into meaningful improvements in ICH care,” Dr. Greenberg adds in the release.

The updated guideline has been endorsed by the American Association of Neurological Surgeons and Congress of Neurological Surgeons, the Society of Vascular and Interventional Neurology, and the Neurocritical Care Society. The American Academy of Neurology has affirmed the value of this statement as an educational tool for neurologists.

This research had no commercial funding. Dr. Greenberg has disclosed no relevant financial relationships. A complete list of disclosures for the guideline group is available with the original article.

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

Many strategies widely considered “standard care” for managing spontaneous intracerebral hemorrhage (ICH) are not as effective as previously thought and are no longer recommended in updated guidelines from the American Heart Association/American Stroke Association (ASA).

Compression stockings, antiseizure medication, and steroid treatment are among the treatments with uncertain effectiveness, the writing group says.

The 2022 Guideline for the Management of Patients With Spontaneous ICH was published online  in Stroke. The 80-page document contains major changes and refinements to the 2015 guideline on ICH management.

“Advances have been made in an array of fields related to ICH, including the organization of regional health care systems, reversal of the negative effects of blood thinners, minimally invasive surgical procedures, and the underlying disease in small blood vessels,” Steven M. Greenberg, MD, PhD, chair of the guideline writing group with Harvard Medical School and Massachusetts General Hospital, both in Boston, said in a news release.

“We’ve updated sections across the board. There’s probably no area that went untouched with some tweaking and new evidence added that led to some changes in level of evidence or strength of a recommendation,” Dr. Greenberg added in an interview with this news organization.

“Each section comes with knowledge gaps, and it wasn’t hard to come up with knowledge gaps in every section,” Dr. Greenberg acknowledged.

Time-honored treatments no more?

Among the key updates are changes to some “time-honored” treatments that continue to be used with some “regularity” for patients with ICH, yet appear to confer either no benefit or harm, Dr. Greenberg said.

For example, for emergency or critical care treatment of ICH, prophylactic corticosteroids or continuous hyperosmolar therapy is not recommended, because it appears to have no benefit for outcome, while use of platelet transfusions outside the setting of emergency surgery or severe thrombocytopenia appears to worsen outcome, the authors say.

Use of graduated knee- or thigh-high compression stockings alone is not an effective prophylactic therapy for prevention of deep vein thrombosis (DVT). Instead, intermittent pneumatic compression (IPC) starting on the day of diagnosis is now recommended for DVT prophylaxis.

“This is an area where we still have a lot of exploration to do. It is unclear whether even specialized compression devices reduce the risks of deep vein thrombosis or improve the overall health of people with a brain bleed,” Dr. Greenberg said in the release.

The new guidance advises against use of antiseizure or antidepressant medications for ICH patients in whom there is no evidence of seizures or depression.

In clinical trials, antiseizure medication did not contribute to improvements in functionality or long-term seizure control, and the use of antidepressants increased the chance of bone fractures, the authors say.

The guideline also provides updated recommendations for acute reversal of anticoagulation after ICH. It highlights the use of protein complex concentrate for reversal of vitamin K antagonists, such as warfarin; idarucizumab for reversal of the thrombin inhibitor dabigatran; and andexanet alfa for reversal of factor Xa inhibitors, such as rivaroxaban, apixaban, and edoxaban.

For acute blood pressure lowering after mild to moderate ICH, treatment regimens that limit blood pressure variability and achieve smooth, sustained blood pressure control appear to reduce hematoma expansion and yield better functional outcome, the guideline says.

It also notes that minimally invasive approaches for hematoma evacuation, compared with medical management alone‚ have been shown to reduce mortality.

For patients with cerebellar hemorrhage, indications for immediate surgical evacuation with or without an external ventricular drain to reduce mortality now include larger volume (> 15 mL) in addition to previously recommended indications of neurologic deterioration, brainstem compression, and hydrocephalus, the authors note.

However, a “major knowledge gap is whether we can improve functional outcome with hematoma evacuation,” Dr. Greenberg said.
 

Multidisciplinary care

For rehabilitation after ICH, the guideline reinforces the importance of having a multidisciplinary team to develop a comprehensive plan for recovery.

Starting rehabilitation activities such as stretching and functional task training may be considered 24 to 48 hours following mild or moderate ICH. However, early aggressive mobilization within the first 24 hours has been linked to an increased risk of death within 14 days after an ICH, the guideline says.

Knowledge gaps include how soon it’s safe to return to work, drive, and participate in other social engagements. Recommendations on sexual activity and exercise levels that are safe after a stroke are also needed.

“People need additional help with these lifestyle changes, whether it’s moving around more, curbing their alcohol use, or eating healthier foods. This all happens after they leave the hospital, and we need to be sure we are empowering families with the information they may need to be properly supportive,” Dr. Greenberg says in the release.

The guideline points to the patient’s home caregiver as a “key and sometimes overlooked” member of the care team. It recommends psychosocial education, practical support, and training for the caregiver to improve the patient’s balance, activity level, and overall quality of life.
 

Opportunity for prevention?

The guideline also suggests there may be an opportunity to prevent ICH in some people through neuroimaging markers.

While neuroimaging is not routinely performed as a part of risk stratification for primary ICH risk, damage to small blood vessels that is associated with ICH may be evident on MRI that could signal future ICH risk, the guideline says.

“We added to the guidelines for the first time a section on mostly imaging markers of risk for having a first-ever hemorrhage,” Dr. Greenberg said in an interview.

“We don’t make any recommendations as to how to act on these markers because there is a knowledge gap. The hope is that we’ll see growth in our ability to predict first-ever hemorrhage and be able to do things to prevent first-ever hemorrhage,” he said.

“We believe the wide range of knowledge set forth in the new guideline will translate into meaningful improvements in ICH care,” Dr. Greenberg adds in the release.

The updated guideline has been endorsed by the American Association of Neurological Surgeons and Congress of Neurological Surgeons, the Society of Vascular and Interventional Neurology, and the Neurocritical Care Society. The American Academy of Neurology has affirmed the value of this statement as an educational tool for neurologists.

This research had no commercial funding. Dr. Greenberg has disclosed no relevant financial relationships. A complete list of disclosures for the guideline group is available with the original article.

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

Advanced maternal age and maternal hypertension are a one-two punch that boosts the risk of cesarean births, a new study reports.

While the findings presented at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists aren’t surprising, the insight they provide can be helpful in counseling women at risk about delivery options, lead author and Loma Linda (Calif.) University maternal-fetal medicine physician Sarah D. Smithson, DO, said in an interview.

The prospect of a cesarean birth “can be introduced early and often, which can be important in managing expectations,” she said, especially since women can feel depression and a sense of failure if it turns out they can’t give birth vaginally as they anticipated.

As Dr. Smithson noted, there’s a continuum of maternal hypertension conditions from less severe to more severe. The physicians need to hurry delivery along in the most severe cases. “The clock is clicking when you have preeclampsia, and you do not have time for an induction that could take 2-3 days if you’re having a hard time controlling blood pressure. You may consider cesarean to expedite delivery,” she said.

For the new study, Dr. Smithson and colleagues sought to understand how a combination of maternal hypertension and advanced maternal age affected cesarean delivery rates. They retrospectively tracked 1,625 women with maternal hypertension (chronic hypertension, gestational hypertension, preeclampsia without severe features, and preeclampsia with severe features) who were treated in the Oregon Health & Science University system from 2013 to 2018.

Of the women, 450 were older than 35, and they were more likely than younger women to have cesarean deliveries (46% vs. 34%; P < .001; adjusted OR, 1.7; 95% CI, 1.0-2.7; P = .03).

“We aim to get our cesarean section rates below 20%,” Dr. Smithson said. “These are high rates, and the fact that they’re significantly higher in the advanced maternal age group is compelling.”

The cesarean rates were higher at a statistically significant rate in patients with gestational hypertension (37% in older women vs. 26% in younger women; P = .021) and in those with preeclampsia with severe features (57% vs. 44%, respectively; P = .02). However, the differences were not statistically significant in the groups with chronic hypertension and preeclampsia without severe features.

In an interview, maternal-fetal medicine specialist Alex C. Vidaeff, MD, MPH, of Baylor College of Medicine, Houston, questioned the usefulness of the subgroup analysis, which he thinks may be statistically misleading. “How would one otherwise explain that the rate difference between advanced maternal-age and non–advanced maternal-age subjects is statistically significant for gestational hypertension but not for preeclampsia without severe features?”

He added: “With the very limited information provided by this study, important questions remained unanswered. What is causing the increased rate of cesarean delivery? Provider’s bias or preferences? It would have been useful to know if the cesarean deliveries were elective, without labor, or cesarean deliveries performed during labor or even emergency cesarean deliveries.”

No study funding or disclosures are reported.

Advanced maternal age and maternal hypertension are a one-two punch that boosts the risk of cesarean births, a new study reports.

While the findings presented at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists aren’t surprising, the insight they provide can be helpful in counseling women at risk about delivery options, lead author and Loma Linda (Calif.) University maternal-fetal medicine physician Sarah D. Smithson, DO, said in an interview.

The prospect of a cesarean birth “can be introduced early and often, which can be important in managing expectations,” she said, especially since women can feel depression and a sense of failure if it turns out they can’t give birth vaginally as they anticipated.

As Dr. Smithson noted, there’s a continuum of maternal hypertension conditions from less severe to more severe. The physicians need to hurry delivery along in the most severe cases. “The clock is clicking when you have preeclampsia, and you do not have time for an induction that could take 2-3 days if you’re having a hard time controlling blood pressure. You may consider cesarean to expedite delivery,” she said.

For the new study, Dr. Smithson and colleagues sought to understand how a combination of maternal hypertension and advanced maternal age affected cesarean delivery rates. They retrospectively tracked 1,625 women with maternal hypertension (chronic hypertension, gestational hypertension, preeclampsia without severe features, and preeclampsia with severe features) who were treated in the Oregon Health & Science University system from 2013 to 2018.

Of the women, 450 were older than 35, and they were more likely than younger women to have cesarean deliveries (46% vs. 34%; P < .001; adjusted OR, 1.7; 95% CI, 1.0-2.7; P = .03).

“We aim to get our cesarean section rates below 20%,” Dr. Smithson said. “These are high rates, and the fact that they’re significantly higher in the advanced maternal age group is compelling.”

The cesarean rates were higher at a statistically significant rate in patients with gestational hypertension (37% in older women vs. 26% in younger women; P = .021) and in those with preeclampsia with severe features (57% vs. 44%, respectively; P = .02). However, the differences were not statistically significant in the groups with chronic hypertension and preeclampsia without severe features.

In an interview, maternal-fetal medicine specialist Alex C. Vidaeff, MD, MPH, of Baylor College of Medicine, Houston, questioned the usefulness of the subgroup analysis, which he thinks may be statistically misleading. “How would one otherwise explain that the rate difference between advanced maternal-age and non–advanced maternal-age subjects is statistically significant for gestational hypertension but not for preeclampsia without severe features?”

He added: “With the very limited information provided by this study, important questions remained unanswered. What is causing the increased rate of cesarean delivery? Provider’s bias or preferences? It would have been useful to know if the cesarean deliveries were elective, without labor, or cesarean deliveries performed during labor or even emergency cesarean deliveries.”

No study funding or disclosures are reported.

Advanced maternal age and maternal hypertension are a one-two punch that boosts the risk of cesarean births, a new study reports.

While the findings presented at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists aren’t surprising, the insight they provide can be helpful in counseling women at risk about delivery options, lead author and Loma Linda (Calif.) University maternal-fetal medicine physician Sarah D. Smithson, DO, said in an interview.

The prospect of a cesarean birth “can be introduced early and often, which can be important in managing expectations,” she said, especially since women can feel depression and a sense of failure if it turns out they can’t give birth vaginally as they anticipated.

As Dr. Smithson noted, there’s a continuum of maternal hypertension conditions from less severe to more severe. The physicians need to hurry delivery along in the most severe cases. “The clock is clicking when you have preeclampsia, and you do not have time for an induction that could take 2-3 days if you’re having a hard time controlling blood pressure. You may consider cesarean to expedite delivery,” she said.

For the new study, Dr. Smithson and colleagues sought to understand how a combination of maternal hypertension and advanced maternal age affected cesarean delivery rates. They retrospectively tracked 1,625 women with maternal hypertension (chronic hypertension, gestational hypertension, preeclampsia without severe features, and preeclampsia with severe features) who were treated in the Oregon Health & Science University system from 2013 to 2018.

Of the women, 450 were older than 35, and they were more likely than younger women to have cesarean deliveries (46% vs. 34%; P < .001; adjusted OR, 1.7; 95% CI, 1.0-2.7; P = .03).

“We aim to get our cesarean section rates below 20%,” Dr. Smithson said. “These are high rates, and the fact that they’re significantly higher in the advanced maternal age group is compelling.”

The cesarean rates were higher at a statistically significant rate in patients with gestational hypertension (37% in older women vs. 26% in younger women; P = .021) and in those with preeclampsia with severe features (57% vs. 44%, respectively; P = .02). However, the differences were not statistically significant in the groups with chronic hypertension and preeclampsia without severe features.

In an interview, maternal-fetal medicine specialist Alex C. Vidaeff, MD, MPH, of Baylor College of Medicine, Houston, questioned the usefulness of the subgroup analysis, which he thinks may be statistically misleading. “How would one otherwise explain that the rate difference between advanced maternal-age and non–advanced maternal-age subjects is statistically significant for gestational hypertension but not for preeclampsia without severe features?”

He added: “With the very limited information provided by this study, important questions remained unanswered. What is causing the increased rate of cesarean delivery? Provider’s bias or preferences? It would have been useful to know if the cesarean deliveries were elective, without labor, or cesarean deliveries performed during labor or even emergency cesarean deliveries.”

No study funding or disclosures are reported.

Patients who mix a diuretic and renin-angiotensin system (RAS) inhibitor with a nonsteroidal anti-inflammatory drug (NSAID) could face a higher risk of developing acute kidney injury (AKI), a new analysis confirms.

The study also looked at risk factors associated with the effect of triple therapy with these agents, which has been called “triple whammy” AKI.

“It’s not that everyone who happens to take this combination of drugs is going to have problems,” Anita Layton, PhD, University of Waterloo, Ontario, said in a statement. “But the research shows it’s enough of a problem that you should exercise caution.”

The study was published online in Mathematical Biosciences.   

In an earlier study, triple therapy with a diuretic, RAS inhibitor, and NSAID was associated with a 31% increased risk for AKI, relative to diuretic and RAS inhibitor therapy only.  

However, the factors that predispose some patients to develop “triple whammy” AKI are unclear.

To better understand the mechanism by which triple therapy increases risk for AKI, Dr. Layton and colleagues used computational models to gauge interactions between concurrent use of a diuretic, a RAS inhibitor, and an NSAID.

They identified dehydration and high sensitivity to drug treatment as key contributing factors to the development of triple whammy AKI.

Their model simulations suggested that low water intake, the myogenic response (that is, the reflex response of arteries and arterioles to changes in blood pressure to maintain consistent blood flow), and drug sensitivity “may predispose patients with hypertension to develop triple whammy-induced AKI,” they wrote.

“We hypothesize that individuals with an impaired myogenic response may be particularly susceptible to triple whammy AKI. Additionally, increased drug sensitivity or low water intake can predispose patients to triple whammy AKI,” they added.

In the absence of additional risk factors, there was no indication of an elevated risk for AKI when an angiotensin-converting enzyme (ACE) inhibitor and NSAID are combined, the study team said. 

In contrast, when an ACE inhibitor, diuretic, and NSAID are combined, critical blood pressure and glomerular filtration rate (GFR) regulatory mechanisms are simultaneously interrupted, they reported.

“Perhaps not unexpectedly, model simulations indicate that triple treatment reduces GFR more than single or double treatments in all individuals. However, under triple treatment, urine volume and GFR have not been predicted to fall sufficiently far to indicate AKI,” they wrote. “This result is consistent with the fact that only a fraction of individuals develop AKI following triple treatment.”

They expect, therefore, that hypertensive patients who are otherwise healthy will be able to withstand triple treatment, in the absence of these aggravating factors, the researchers concluded.

Nonetheless, it’s wise to “always be careful when mixing medications,” Dr. Layton told this news organization.

She noted that “triple whammy AKI is known among kidney researchers and nephrologists. To what extent nonspecialists are aware, it isn’t clear.

“More importantly,” Dr. Layton said, “NSAIDs can be obtained over the counter, and triple whammy AKI isn’t common knowledge outside of the medical community.”

This research was supported by the Canada 150 Research Chair program and by the Natural Sciences and Engineering Research Council of Canada. The authors have declared no conflicts of interest.

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

Patients who mix a diuretic and renin-angiotensin system (RAS) inhibitor with a nonsteroidal anti-inflammatory drug (NSAID) could face a higher risk of developing acute kidney injury (AKI), a new analysis confirms.

The study also looked at risk factors associated with the effect of triple therapy with these agents, which has been called “triple whammy” AKI.

“It’s not that everyone who happens to take this combination of drugs is going to have problems,” Anita Layton, PhD, University of Waterloo, Ontario, said in a statement. “But the research shows it’s enough of a problem that you should exercise caution.”

The study was published online in Mathematical Biosciences.   

In an earlier study, triple therapy with a diuretic, RAS inhibitor, and NSAID was associated with a 31% increased risk for AKI, relative to diuretic and RAS inhibitor therapy only.  

However, the factors that predispose some patients to develop “triple whammy” AKI are unclear.

To better understand the mechanism by which triple therapy increases risk for AKI, Dr. Layton and colleagues used computational models to gauge interactions between concurrent use of a diuretic, a RAS inhibitor, and an NSAID.

They identified dehydration and high sensitivity to drug treatment as key contributing factors to the development of triple whammy AKI.

Their model simulations suggested that low water intake, the myogenic response (that is, the reflex response of arteries and arterioles to changes in blood pressure to maintain consistent blood flow), and drug sensitivity “may predispose patients with hypertension to develop triple whammy-induced AKI,” they wrote.

“We hypothesize that individuals with an impaired myogenic response may be particularly susceptible to triple whammy AKI. Additionally, increased drug sensitivity or low water intake can predispose patients to triple whammy AKI,” they added.

In the absence of additional risk factors, there was no indication of an elevated risk for AKI when an angiotensin-converting enzyme (ACE) inhibitor and NSAID are combined, the study team said. 

In contrast, when an ACE inhibitor, diuretic, and NSAID are combined, critical blood pressure and glomerular filtration rate (GFR) regulatory mechanisms are simultaneously interrupted, they reported.

“Perhaps not unexpectedly, model simulations indicate that triple treatment reduces GFR more than single or double treatments in all individuals. However, under triple treatment, urine volume and GFR have not been predicted to fall sufficiently far to indicate AKI,” they wrote. “This result is consistent with the fact that only a fraction of individuals develop AKI following triple treatment.”

They expect, therefore, that hypertensive patients who are otherwise healthy will be able to withstand triple treatment, in the absence of these aggravating factors, the researchers concluded.

Nonetheless, it’s wise to “always be careful when mixing medications,” Dr. Layton told this news organization.

She noted that “triple whammy AKI is known among kidney researchers and nephrologists. To what extent nonspecialists are aware, it isn’t clear.

“More importantly,” Dr. Layton said, “NSAIDs can be obtained over the counter, and triple whammy AKI isn’t common knowledge outside of the medical community.”

This research was supported by the Canada 150 Research Chair program and by the Natural Sciences and Engineering Research Council of Canada. The authors have declared no conflicts of interest.

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

Patients who mix a diuretic and renin-angiotensin system (RAS) inhibitor with a nonsteroidal anti-inflammatory drug (NSAID) could face a higher risk of developing acute kidney injury (AKI), a new analysis confirms.

The study also looked at risk factors associated with the effect of triple therapy with these agents, which has been called “triple whammy” AKI.

“It’s not that everyone who happens to take this combination of drugs is going to have problems,” Anita Layton, PhD, University of Waterloo, Ontario, said in a statement. “But the research shows it’s enough of a problem that you should exercise caution.”

The study was published online in Mathematical Biosciences.   

In an earlier study, triple therapy with a diuretic, RAS inhibitor, and NSAID was associated with a 31% increased risk for AKI, relative to diuretic and RAS inhibitor therapy only.  

However, the factors that predispose some patients to develop “triple whammy” AKI are unclear.

To better understand the mechanism by which triple therapy increases risk for AKI, Dr. Layton and colleagues used computational models to gauge interactions between concurrent use of a diuretic, a RAS inhibitor, and an NSAID.

They identified dehydration and high sensitivity to drug treatment as key contributing factors to the development of triple whammy AKI.

Their model simulations suggested that low water intake, the myogenic response (that is, the reflex response of arteries and arterioles to changes in blood pressure to maintain consistent blood flow), and drug sensitivity “may predispose patients with hypertension to develop triple whammy-induced AKI,” they wrote.

“We hypothesize that individuals with an impaired myogenic response may be particularly susceptible to triple whammy AKI. Additionally, increased drug sensitivity or low water intake can predispose patients to triple whammy AKI,” they added.

In the absence of additional risk factors, there was no indication of an elevated risk for AKI when an angiotensin-converting enzyme (ACE) inhibitor and NSAID are combined, the study team said. 

In contrast, when an ACE inhibitor, diuretic, and NSAID are combined, critical blood pressure and glomerular filtration rate (GFR) regulatory mechanisms are simultaneously interrupted, they reported.

“Perhaps not unexpectedly, model simulations indicate that triple treatment reduces GFR more than single or double treatments in all individuals. However, under triple treatment, urine volume and GFR have not been predicted to fall sufficiently far to indicate AKI,” they wrote. “This result is consistent with the fact that only a fraction of individuals develop AKI following triple treatment.”

They expect, therefore, that hypertensive patients who are otherwise healthy will be able to withstand triple treatment, in the absence of these aggravating factors, the researchers concluded.

Nonetheless, it’s wise to “always be careful when mixing medications,” Dr. Layton told this news organization.

She noted that “triple whammy AKI is known among kidney researchers and nephrologists. To what extent nonspecialists are aware, it isn’t clear.

“More importantly,” Dr. Layton said, “NSAIDs can be obtained over the counter, and triple whammy AKI isn’t common knowledge outside of the medical community.”

This research was supported by the Canada 150 Research Chair program and by the Natural Sciences and Engineering Research Council of Canada. The authors have declared no conflicts of interest.

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

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

Nearly three-quarters of clinicians reported screening patients for hypertensive disorders of pregnancy, but only one-quarter comprehensively identified cardiovascular risk, based on survey data from approximately 1,500 clinicians in the United States.

Rates of hypertensive disorders of pregnancy have been on the rise in the United States for the past decade, and women with a history of these disorders require cardiovascular risk monitoring during the postpartum period and beyond, wrote Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Specifically, the American College of Obstetricians and Gynecologists recommends cardiovascular risk evaluation and lifestyle modification for these individuals, the researchers said.

The most effective management of women with a history of hypertensive disorders of pregnancy will likely involve a team effort by primary care, ob.gyns., and cardiologists, but data on clinician screening and referrals are limited, they added.

In a study published in Obstetrics & Gynecology, the researchers reviewed data from a cross-sectional, web-based survey of clinicians practicing in the United States (Fall DocStyles 2020). The study population of 1,502 respondents with complete surveys included 1,000 primary care physicians, 251 ob.gyns., and 251 nurse practitioners or physician assistants. Approximately 60% of the respondents were male, and approximately 65% had been in practice for at least 10 years.

Overall, 73.6% of clinicians reported screening patients for a history of hypertensive disorders of pregnancy. The screening rates were highest among ob.gyns. (94.8%).

However, although 93.9% of clinicians overall correctly identified at least one potential risk associated with hypertensive disorders of pregnancy, only 24.8% correctly identified all cardiovascular risks associated with hypertensive disorders of pregnancy listed in the survey, the researchers noted.

Screening rates ranged from 49% to 91% for pregnant women, 34%-75% for postpartum women, 26%-61% for nonpregnant reproductive-age women, 20%-45% for perimenopausal or menopausal women, and 1%-4% for others outside of these categories.

The most often–cited barriers to referral were lack of patient follow-through (51.5%) and patient refusal (33.6%). To improve and facilitate referrals, respondents’ most frequent resource request was for more referral options (42.9%), followed by patient education materials (36.2%), and professional guidelines (34.1%).

In a multivariate analysis, primary care physicians were more than five times as likely to report not screening patients for hypertensive disorders of pregnancy (adjusted prevalence ratio, 5.54); nurse practitioners and physician assistants were more than seven times as likely (adjusted prevalence ratio, 7.42).

The researchers also found that clinicians who saw fewer than 80 patients per week were almost twice as likely not to screen for hypertensive disorders of pregnancy than those who saw 110 or more patients per week (adjusted prevalence ratio, 1.81).

“Beyond the immediate postpartum period, there is a lack of clear guidance on CVD [cardiovascular disease] evaluation and ongoing monitoring in women with history of hypertensive disorders of pregnancy,” the researchers wrote in their discussion. “Recognizing hypertensive disorders of pregnancy as a risk factor for CVD may allow clinicians to identify women requiring early evaluation and intervention,” they said.

The study findings were limited by several factors including potentially biased estimates of screening practices, and the potential for selection bias because of the convenience sample used to recruit survey participants, the researchers noted.

However, the results were strengthened by the inclusion of data from several clinician types and the relatively large sample size, and are consistent with those of previous studies, they said. Based on the findings, addressing barriers at both the patient and clinician level and increasing both patient and clinician education about the long-term risks of hypertensive disorders of pregnancy might increase cardiovascular screening and subsequent referrals, they concluded.
 

More education, improved screening tools needed

“Unfortunately, most CVD risk stratification scores such as the Framingham score do not include pregnancy complications, despite excellent evidence that pregnancy complications increase risk of CVD,” said Catherine M. Albright, MD, MS, of the University of Washington, Seattle, in an interview. “This is likely because these scores were developed primarily to screen for CVD risk in men. Given the rising incidence of hypertensive disorders of pregnancy and the clear evidence that this is a risk factor for future CVD, more studies like this one are needed in order to help guide patient and provider education,” said Dr. Albright, who was not involved in the study.

“It is generally well reported within the ob.gyn. literature about the increased lifetime CVD risk related to hypertensive disorders of pregnancy and we, as ob.gyns., always ask about pregnancy history because of our specialty, which gives us the opportunity to counsel about future risks,” she said.

“Women’s health [including during pregnancy] has been undervalued and underresearched for a long time,” with limited focus on pregnancy-related issues until recently, Dr. Albright noted. “This is clear in the attitudes and education of the primary care providers in this study,” she said.

A major barrier to screening in clinical practice has been that the standard screening guidelines for CVD (for example, those published by the United States Preventive Services Taskforce) have not included pregnancy history, said Dr. Albright. “Subsequently, these questions are not asked during routine annual visits,” she said. Ideally, “we should be able to leverage the electronic medical record to prompt providers to view a previously recorded pregnancy history or to ask about pregnancy history as a routine part of CVD risk assessment, and, of course, additional education outside of ob.gyn. and cardiology is needed,” she said.

The clinical takeaway from the current study is that “every annual visit with a person who has been pregnant is an opportunity to ask about and document pregnancy history,” Dr. Albright said. “After the completion of childbearing, many patients no longer see an ob.gyn., so other providers need to feel comfortable asking about and counseling about risks related to pregnancy complications,” she added.

“It is clear that adverse pregnancy outcomes pose lifetime health risks,” said Dr. Albright. “We will continue to look into the mechanisms of this through research. However, right now the additional research that is needed is to determine the optimal screening and follow-up for patients with a history of hypertensive disorders of pregnancy, as well as to examine how existing CVD-screening algorithms can be modified to include adverse pregnancy outcomes,” she emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Nearly three-quarters of clinicians reported screening patients for hypertensive disorders of pregnancy, but only one-quarter comprehensively identified cardiovascular risk, based on survey data from approximately 1,500 clinicians in the United States.

Rates of hypertensive disorders of pregnancy have been on the rise in the United States for the past decade, and women with a history of these disorders require cardiovascular risk monitoring during the postpartum period and beyond, wrote Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Specifically, the American College of Obstetricians and Gynecologists recommends cardiovascular risk evaluation and lifestyle modification for these individuals, the researchers said.

The most effective management of women with a history of hypertensive disorders of pregnancy will likely involve a team effort by primary care, ob.gyns., and cardiologists, but data on clinician screening and referrals are limited, they added.

In a study published in Obstetrics & Gynecology, the researchers reviewed data from a cross-sectional, web-based survey of clinicians practicing in the United States (Fall DocStyles 2020). The study population of 1,502 respondents with complete surveys included 1,000 primary care physicians, 251 ob.gyns., and 251 nurse practitioners or physician assistants. Approximately 60% of the respondents were male, and approximately 65% had been in practice for at least 10 years.

Overall, 73.6% of clinicians reported screening patients for a history of hypertensive disorders of pregnancy. The screening rates were highest among ob.gyns. (94.8%).

However, although 93.9% of clinicians overall correctly identified at least one potential risk associated with hypertensive disorders of pregnancy, only 24.8% correctly identified all cardiovascular risks associated with hypertensive disorders of pregnancy listed in the survey, the researchers noted.

Screening rates ranged from 49% to 91% for pregnant women, 34%-75% for postpartum women, 26%-61% for nonpregnant reproductive-age women, 20%-45% for perimenopausal or menopausal women, and 1%-4% for others outside of these categories.

The most often–cited barriers to referral were lack of patient follow-through (51.5%) and patient refusal (33.6%). To improve and facilitate referrals, respondents’ most frequent resource request was for more referral options (42.9%), followed by patient education materials (36.2%), and professional guidelines (34.1%).

In a multivariate analysis, primary care physicians were more than five times as likely to report not screening patients for hypertensive disorders of pregnancy (adjusted prevalence ratio, 5.54); nurse practitioners and physician assistants were more than seven times as likely (adjusted prevalence ratio, 7.42).

The researchers also found that clinicians who saw fewer than 80 patients per week were almost twice as likely not to screen for hypertensive disorders of pregnancy than those who saw 110 or more patients per week (adjusted prevalence ratio, 1.81).

“Beyond the immediate postpartum period, there is a lack of clear guidance on CVD [cardiovascular disease] evaluation and ongoing monitoring in women with history of hypertensive disorders of pregnancy,” the researchers wrote in their discussion. “Recognizing hypertensive disorders of pregnancy as a risk factor for CVD may allow clinicians to identify women requiring early evaluation and intervention,” they said.

The study findings were limited by several factors including potentially biased estimates of screening practices, and the potential for selection bias because of the convenience sample used to recruit survey participants, the researchers noted.

However, the results were strengthened by the inclusion of data from several clinician types and the relatively large sample size, and are consistent with those of previous studies, they said. Based on the findings, addressing barriers at both the patient and clinician level and increasing both patient and clinician education about the long-term risks of hypertensive disorders of pregnancy might increase cardiovascular screening and subsequent referrals, they concluded.
 

More education, improved screening tools needed

“Unfortunately, most CVD risk stratification scores such as the Framingham score do not include pregnancy complications, despite excellent evidence that pregnancy complications increase risk of CVD,” said Catherine M. Albright, MD, MS, of the University of Washington, Seattle, in an interview. “This is likely because these scores were developed primarily to screen for CVD risk in men. Given the rising incidence of hypertensive disorders of pregnancy and the clear evidence that this is a risk factor for future CVD, more studies like this one are needed in order to help guide patient and provider education,” said Dr. Albright, who was not involved in the study.

“It is generally well reported within the ob.gyn. literature about the increased lifetime CVD risk related to hypertensive disorders of pregnancy and we, as ob.gyns., always ask about pregnancy history because of our specialty, which gives us the opportunity to counsel about future risks,” she said.

“Women’s health [including during pregnancy] has been undervalued and underresearched for a long time,” with limited focus on pregnancy-related issues until recently, Dr. Albright noted. “This is clear in the attitudes and education of the primary care providers in this study,” she said.

A major barrier to screening in clinical practice has been that the standard screening guidelines for CVD (for example, those published by the United States Preventive Services Taskforce) have not included pregnancy history, said Dr. Albright. “Subsequently, these questions are not asked during routine annual visits,” she said. Ideally, “we should be able to leverage the electronic medical record to prompt providers to view a previously recorded pregnancy history or to ask about pregnancy history as a routine part of CVD risk assessment, and, of course, additional education outside of ob.gyn. and cardiology is needed,” she said.

The clinical takeaway from the current study is that “every annual visit with a person who has been pregnant is an opportunity to ask about and document pregnancy history,” Dr. Albright said. “After the completion of childbearing, many patients no longer see an ob.gyn., so other providers need to feel comfortable asking about and counseling about risks related to pregnancy complications,” she added.

“It is clear that adverse pregnancy outcomes pose lifetime health risks,” said Dr. Albright. “We will continue to look into the mechanisms of this through research. However, right now the additional research that is needed is to determine the optimal screening and follow-up for patients with a history of hypertensive disorders of pregnancy, as well as to examine how existing CVD-screening algorithms can be modified to include adverse pregnancy outcomes,” she emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Nearly three-quarters of clinicians reported screening patients for hypertensive disorders of pregnancy, but only one-quarter comprehensively identified cardiovascular risk, based on survey data from approximately 1,500 clinicians in the United States.

Rates of hypertensive disorders of pregnancy have been on the rise in the United States for the past decade, and women with a history of these disorders require cardiovascular risk monitoring during the postpartum period and beyond, wrote Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Specifically, the American College of Obstetricians and Gynecologists recommends cardiovascular risk evaluation and lifestyle modification for these individuals, the researchers said.

The most effective management of women with a history of hypertensive disorders of pregnancy will likely involve a team effort by primary care, ob.gyns., and cardiologists, but data on clinician screening and referrals are limited, they added.

In a study published in Obstetrics & Gynecology, the researchers reviewed data from a cross-sectional, web-based survey of clinicians practicing in the United States (Fall DocStyles 2020). The study population of 1,502 respondents with complete surveys included 1,000 primary care physicians, 251 ob.gyns., and 251 nurse practitioners or physician assistants. Approximately 60% of the respondents were male, and approximately 65% had been in practice for at least 10 years.

Overall, 73.6% of clinicians reported screening patients for a history of hypertensive disorders of pregnancy. The screening rates were highest among ob.gyns. (94.8%).

However, although 93.9% of clinicians overall correctly identified at least one potential risk associated with hypertensive disorders of pregnancy, only 24.8% correctly identified all cardiovascular risks associated with hypertensive disorders of pregnancy listed in the survey, the researchers noted.

Screening rates ranged from 49% to 91% for pregnant women, 34%-75% for postpartum women, 26%-61% for nonpregnant reproductive-age women, 20%-45% for perimenopausal or menopausal women, and 1%-4% for others outside of these categories.

The most often–cited barriers to referral were lack of patient follow-through (51.5%) and patient refusal (33.6%). To improve and facilitate referrals, respondents’ most frequent resource request was for more referral options (42.9%), followed by patient education materials (36.2%), and professional guidelines (34.1%).

In a multivariate analysis, primary care physicians were more than five times as likely to report not screening patients for hypertensive disorders of pregnancy (adjusted prevalence ratio, 5.54); nurse practitioners and physician assistants were more than seven times as likely (adjusted prevalence ratio, 7.42).

The researchers also found that clinicians who saw fewer than 80 patients per week were almost twice as likely not to screen for hypertensive disorders of pregnancy than those who saw 110 or more patients per week (adjusted prevalence ratio, 1.81).

“Beyond the immediate postpartum period, there is a lack of clear guidance on CVD [cardiovascular disease] evaluation and ongoing monitoring in women with history of hypertensive disorders of pregnancy,” the researchers wrote in their discussion. “Recognizing hypertensive disorders of pregnancy as a risk factor for CVD may allow clinicians to identify women requiring early evaluation and intervention,” they said.

The study findings were limited by several factors including potentially biased estimates of screening practices, and the potential for selection bias because of the convenience sample used to recruit survey participants, the researchers noted.

However, the results were strengthened by the inclusion of data from several clinician types and the relatively large sample size, and are consistent with those of previous studies, they said. Based on the findings, addressing barriers at both the patient and clinician level and increasing both patient and clinician education about the long-term risks of hypertensive disorders of pregnancy might increase cardiovascular screening and subsequent referrals, they concluded.
 

More education, improved screening tools needed

“Unfortunately, most CVD risk stratification scores such as the Framingham score do not include pregnancy complications, despite excellent evidence that pregnancy complications increase risk of CVD,” said Catherine M. Albright, MD, MS, of the University of Washington, Seattle, in an interview. “This is likely because these scores were developed primarily to screen for CVD risk in men. Given the rising incidence of hypertensive disorders of pregnancy and the clear evidence that this is a risk factor for future CVD, more studies like this one are needed in order to help guide patient and provider education,” said Dr. Albright, who was not involved in the study.

“It is generally well reported within the ob.gyn. literature about the increased lifetime CVD risk related to hypertensive disorders of pregnancy and we, as ob.gyns., always ask about pregnancy history because of our specialty, which gives us the opportunity to counsel about future risks,” she said.

“Women’s health [including during pregnancy] has been undervalued and underresearched for a long time,” with limited focus on pregnancy-related issues until recently, Dr. Albright noted. “This is clear in the attitudes and education of the primary care providers in this study,” she said.

A major barrier to screening in clinical practice has been that the standard screening guidelines for CVD (for example, those published by the United States Preventive Services Taskforce) have not included pregnancy history, said Dr. Albright. “Subsequently, these questions are not asked during routine annual visits,” she said. Ideally, “we should be able to leverage the electronic medical record to prompt providers to view a previously recorded pregnancy history or to ask about pregnancy history as a routine part of CVD risk assessment, and, of course, additional education outside of ob.gyn. and cardiology is needed,” she said.

The clinical takeaway from the current study is that “every annual visit with a person who has been pregnant is an opportunity to ask about and document pregnancy history,” Dr. Albright said. “After the completion of childbearing, many patients no longer see an ob.gyn., so other providers need to feel comfortable asking about and counseling about risks related to pregnancy complications,” she added.

“It is clear that adverse pregnancy outcomes pose lifetime health risks,” said Dr. Albright. “We will continue to look into the mechanisms of this through research. However, right now the additional research that is needed is to determine the optimal screening and follow-up for patients with a history of hypertensive disorders of pregnancy, as well as to examine how existing CVD-screening algorithms can be modified to include adverse pregnancy outcomes,” she emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

Hypertensive disorders in pregnancy affect nearly 16% of women who give birth in U.S. hospitals and appear to be increasing, according to an April 29 report from the Centers for Disease Control and Prevention.

Older patients and Black women are substantially more likely to experience hypertension in pregnancy, the analysis found.

“Addressing hypertensive disorders in pregnancy is a key strategy in reducing inequities in pregnancy-related mortality,” study coauthor Wanda Barfield, MD, MPH, director of CDC’s Division of Reproductive Health, said in a statement.
 

Age, obesity, diabetes

The overall prevalence of hypertensive disorders in pregnancy increased from 13.3% in 2017 to 15.9% in 2019, the researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

The uptick in hypertension coincides with trends toward older maternal age and higher rates of obesity and diabetes, which may explain the increase, they said.

For the study, Dr. Barfield and her colleagues analyzed nationally representative data from the National Inpatient Sample. They identified patients with a diagnosis of chronic hypertension, pregnancy-associated hypertension, or unspecified maternal hypertension during their hospitalization.

Among women aged 45-55 years, the prevalence of hypertension was 31%. Among those aged 35-44 years, it was 18%.

Hypertension diagnoses were more common in women who were Black (20.9%) or American Indian or Alaska Native (16.4%), than in other groups.

Of patients who died during delivery hospitalization, 31.6% had a hypertensive disorder.

The study shows a marked increase in hypertensive disorders over a relatively short time, according to Jane van Dis, MD, of the department of obstetrics and gynecology at the University of Rochester (N.Y.), who was not involved in the research. The phenomenon is consistent with her own experience, she said.

“When I am admitting patients, I’m oftentimes surprised when someone does not have a hypertensive disorder because I feel like the majority of patients these days do,” Dr. van Dis told this news organization.

Dr. Van Dis speculated that factors related to the environment, including air pollution and endocrine disrupters, could contribute to elevated rates of hypertensive disorders.

Natalie Bello, MD, MPH, director of hypertension research at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said rates of hypertension today could be even higher than in the study.

The CDC report relied on pre-COVID data, and the pandemic “increased disparities in health outcomes,” Dr. Bello said in an interview. “I’m worried that in actuality these numbers are an underestimation of the current state of hypertension in pregnancy.”

Dr. Bello, who has studied the need for better training in cardio-obstetrics, applauded Vice President Kamala Harris’ efforts to improve maternal health.

“The racial and geographic disparities that we continue to see in the field are disheartening but should be a call to action to redouble our work to improve maternal outcomes,” Dr. Bello told this news organization. “The good news is that a lot of morbidity related to hypertension can be avoided with timely diagnosis and treatment of blood pressure. However, we need to act to provide all pregnant persons with optimal care.”

Janet Wright, MD, director of CDC’s Division for Heart Disease and Stroke Prevention, said blood pressure home monitoring is a “great example” of a strategy clinicians can use to identify and manage patients with hypertension.

But one approach – self-monitoring blood pressure from home during pregnancy – did not significantly improve the health of pregnant women, according to new results from randomized trials in the United Kingdom.

Trial results published in JAMA show that blood pressure home-monitoring coupled to telemonitoring, as compared with usual care, did not significantly improve blood pressure control among patients with chronic or gestational hypertension.

A second trial published in JAMA that included patients at risk for preeclampsia found that self-monitoring with telemonitoring did not lead to significantly earlier diagnoses of hypertension.

“Individuals at risk for a hypertensive disorder of pregnancy, or with gestational or chronic hypertension, cannot be treated with a single approach,” Malavika Prabhu, MD, with Weill Cornell Medicine, New York, and coauthors write in an editorial accompanying the JAMA studies. Although the data suggest that self-monitoring of blood pressure is practical and tolerated, “More research is needed to determine optimal, high-value, equitable approaches to averting adverse perinatal outcomes associated with hypertensive disorders of pregnancy,” they write.

The CDC study authors and Dr. van Dis have disclosed no relevant financial relationships. Dr. Bello is funded by the National Institutes of Health to study blood pressure monitoring in pregnancy. The JAMA editorial authors disclosed university, government, and corporate grants and work with publishing companies.

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

Hypertensive disorders in pregnancy affect nearly 16% of women who give birth in U.S. hospitals and appear to be increasing, according to an April 29 report from the Centers for Disease Control and Prevention.

Older patients and Black women are substantially more likely to experience hypertension in pregnancy, the analysis found.

“Addressing hypertensive disorders in pregnancy is a key strategy in reducing inequities in pregnancy-related mortality,” study coauthor Wanda Barfield, MD, MPH, director of CDC’s Division of Reproductive Health, said in a statement.
 

Age, obesity, diabetes

The overall prevalence of hypertensive disorders in pregnancy increased from 13.3% in 2017 to 15.9% in 2019, the researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

The uptick in hypertension coincides with trends toward older maternal age and higher rates of obesity and diabetes, which may explain the increase, they said.

For the study, Dr. Barfield and her colleagues analyzed nationally representative data from the National Inpatient Sample. They identified patients with a diagnosis of chronic hypertension, pregnancy-associated hypertension, or unspecified maternal hypertension during their hospitalization.

Among women aged 45-55 years, the prevalence of hypertension was 31%. Among those aged 35-44 years, it was 18%.

Hypertension diagnoses were more common in women who were Black (20.9%) or American Indian or Alaska Native (16.4%), than in other groups.

Of patients who died during delivery hospitalization, 31.6% had a hypertensive disorder.

The study shows a marked increase in hypertensive disorders over a relatively short time, according to Jane van Dis, MD, of the department of obstetrics and gynecology at the University of Rochester (N.Y.), who was not involved in the research. The phenomenon is consistent with her own experience, she said.

“When I am admitting patients, I’m oftentimes surprised when someone does not have a hypertensive disorder because I feel like the majority of patients these days do,” Dr. van Dis told this news organization.

Dr. Van Dis speculated that factors related to the environment, including air pollution and endocrine disrupters, could contribute to elevated rates of hypertensive disorders.

Natalie Bello, MD, MPH, director of hypertension research at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said rates of hypertension today could be even higher than in the study.

The CDC report relied on pre-COVID data, and the pandemic “increased disparities in health outcomes,” Dr. Bello said in an interview. “I’m worried that in actuality these numbers are an underestimation of the current state of hypertension in pregnancy.”

Dr. Bello, who has studied the need for better training in cardio-obstetrics, applauded Vice President Kamala Harris’ efforts to improve maternal health.

“The racial and geographic disparities that we continue to see in the field are disheartening but should be a call to action to redouble our work to improve maternal outcomes,” Dr. Bello told this news organization. “The good news is that a lot of morbidity related to hypertension can be avoided with timely diagnosis and treatment of blood pressure. However, we need to act to provide all pregnant persons with optimal care.”

Janet Wright, MD, director of CDC’s Division for Heart Disease and Stroke Prevention, said blood pressure home monitoring is a “great example” of a strategy clinicians can use to identify and manage patients with hypertension.

But one approach – self-monitoring blood pressure from home during pregnancy – did not significantly improve the health of pregnant women, according to new results from randomized trials in the United Kingdom.

Trial results published in JAMA show that blood pressure home-monitoring coupled to telemonitoring, as compared with usual care, did not significantly improve blood pressure control among patients with chronic or gestational hypertension.

A second trial published in JAMA that included patients at risk for preeclampsia found that self-monitoring with telemonitoring did not lead to significantly earlier diagnoses of hypertension.

“Individuals at risk for a hypertensive disorder of pregnancy, or with gestational or chronic hypertension, cannot be treated with a single approach,” Malavika Prabhu, MD, with Weill Cornell Medicine, New York, and coauthors write in an editorial accompanying the JAMA studies. Although the data suggest that self-monitoring of blood pressure is practical and tolerated, “More research is needed to determine optimal, high-value, equitable approaches to averting adverse perinatal outcomes associated with hypertensive disorders of pregnancy,” they write.

The CDC study authors and Dr. van Dis have disclosed no relevant financial relationships. Dr. Bello is funded by the National Institutes of Health to study blood pressure monitoring in pregnancy. The JAMA editorial authors disclosed university, government, and corporate grants and work with publishing companies.

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

Hypertensive disorders in pregnancy affect nearly 16% of women who give birth in U.S. hospitals and appear to be increasing, according to an April 29 report from the Centers for Disease Control and Prevention.

Older patients and Black women are substantially more likely to experience hypertension in pregnancy, the analysis found.

“Addressing hypertensive disorders in pregnancy is a key strategy in reducing inequities in pregnancy-related mortality,” study coauthor Wanda Barfield, MD, MPH, director of CDC’s Division of Reproductive Health, said in a statement.
 

Age, obesity, diabetes

The overall prevalence of hypertensive disorders in pregnancy increased from 13.3% in 2017 to 15.9% in 2019, the researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

The uptick in hypertension coincides with trends toward older maternal age and higher rates of obesity and diabetes, which may explain the increase, they said.

For the study, Dr. Barfield and her colleagues analyzed nationally representative data from the National Inpatient Sample. They identified patients with a diagnosis of chronic hypertension, pregnancy-associated hypertension, or unspecified maternal hypertension during their hospitalization.

Among women aged 45-55 years, the prevalence of hypertension was 31%. Among those aged 35-44 years, it was 18%.

Hypertension diagnoses were more common in women who were Black (20.9%) or American Indian or Alaska Native (16.4%), than in other groups.

Of patients who died during delivery hospitalization, 31.6% had a hypertensive disorder.

The study shows a marked increase in hypertensive disorders over a relatively short time, according to Jane van Dis, MD, of the department of obstetrics and gynecology at the University of Rochester (N.Y.), who was not involved in the research. The phenomenon is consistent with her own experience, she said.

“When I am admitting patients, I’m oftentimes surprised when someone does not have a hypertensive disorder because I feel like the majority of patients these days do,” Dr. van Dis told this news organization.

Dr. Van Dis speculated that factors related to the environment, including air pollution and endocrine disrupters, could contribute to elevated rates of hypertensive disorders.

Natalie Bello, MD, MPH, director of hypertension research at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said rates of hypertension today could be even higher than in the study.

The CDC report relied on pre-COVID data, and the pandemic “increased disparities in health outcomes,” Dr. Bello said in an interview. “I’m worried that in actuality these numbers are an underestimation of the current state of hypertension in pregnancy.”

Dr. Bello, who has studied the need for better training in cardio-obstetrics, applauded Vice President Kamala Harris’ efforts to improve maternal health.

“The racial and geographic disparities that we continue to see in the field are disheartening but should be a call to action to redouble our work to improve maternal outcomes,” Dr. Bello told this news organization. “The good news is that a lot of morbidity related to hypertension can be avoided with timely diagnosis and treatment of blood pressure. However, we need to act to provide all pregnant persons with optimal care.”

Janet Wright, MD, director of CDC’s Division for Heart Disease and Stroke Prevention, said blood pressure home monitoring is a “great example” of a strategy clinicians can use to identify and manage patients with hypertension.

But one approach – self-monitoring blood pressure from home during pregnancy – did not significantly improve the health of pregnant women, according to new results from randomized trials in the United Kingdom.

Trial results published in JAMA show that blood pressure home-monitoring coupled to telemonitoring, as compared with usual care, did not significantly improve blood pressure control among patients with chronic or gestational hypertension.

A second trial published in JAMA that included patients at risk for preeclampsia found that self-monitoring with telemonitoring did not lead to significantly earlier diagnoses of hypertension.

“Individuals at risk for a hypertensive disorder of pregnancy, or with gestational or chronic hypertension, cannot be treated with a single approach,” Malavika Prabhu, MD, with Weill Cornell Medicine, New York, and coauthors write in an editorial accompanying the JAMA studies. Although the data suggest that self-monitoring of blood pressure is practical and tolerated, “More research is needed to determine optimal, high-value, equitable approaches to averting adverse perinatal outcomes associated with hypertensive disorders of pregnancy,” they write.

The CDC study authors and Dr. van Dis have disclosed no relevant financial relationships. Dr. Bello is funded by the National Institutes of Health to study blood pressure monitoring in pregnancy. The JAMA editorial authors disclosed university, government, and corporate grants and work with publishing companies.

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

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

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

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

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

Mild traumatic brain injury (TBI) is linked to a significantly increased risk for a host of subsequent cardiovascular, endocrine, neurologic, and psychiatric disorders, new research shows.

Incidence of hypertension, coronary heart disease, diabetes, stroke, depression, and dementia all began to increase soon after the brain injury and persisted over a decade in both mild and moderate to severe TBI.

Researchers found the multisystem comorbidities in all age groups, including in patients as young as 18. They also found that patients who developed multiple postinjury problems had higher mortality during the decade-long follow-up.

The findings suggest patients with TBI may require longer follow-up and proactive screening for multisystem disease, regardless of age or injury severity.

“The fact that both patients with mild and moderate to severe injuries both had long-term ongoing associations with comorbidities that continued over time and that they are cardiovascular, endocrine, neurologic, and behavioral health oriented was pretty striking,” study author Ross Zafonte, DO, PhD, president of Spaulding Rehab Hospital and professor and chair of physical medicine and rehab at Harvard Medical School, both in Boston, told this news organization.

The study was published online in JAMA Network Open.
 

Injury severity not a factor

An estimated 2.8 million individuals in the United States experience TBI every year. Worldwide, the figure may be as high as 74 million.

Studies have long suggested a link between brain injury and subsequent neurologic disorders, but research suggesting a possible link to cardiovascular and endocrine problems has recently gained attention.

Building on a 2021 study that showed increased incidence of cardiovascular issues following a concussion, the researchers examined medical records of previously healthy patients treated for TBI between 2000 and 2015 who also had at least 1 follow-up visit between 6 months and 10 years after the initial injury.

Researchers analyzed data from 13,053 individuals – 4,351 with mild injury (mTBI), 4351 with moderate to severe injury (msTBI), and 4351 with no TBI. The most common cause of injury was a fall. Patients with sports-related injuries were excluded.

Incidence of hypertension was significantly higher among patients with mTBI (hazard ratio, 2.5; 95% confidence interval, 2.1-2.9) and msTBI (HR, 2.4; 95% CI, 2.0-2.9), compared with the unaffected group. Risk for other cardiovascular problems, including hyperlipidemia, obesity, and coronary artery disease, were also higher in the affected groups.

TBI patients also reported higher incidence of endocrine diseases, including diabetes (mTBI: HR, 1.9; 95% CI, 1.4-2.7; msTBI: HR, 1.9; 95% CI, 1.4-2.6). Elevated risk for ischemic stroke or transient ischemic attack was also increased (mTBI: HR, 2.2; 95% CI, 1.4-3.3; msTBI: HR, 3.6; 95% CI, 2.4-5.3).

Regardless of injury severity, patients with TBI had a higher risk for neurologic and psychiatric diseases, particularly depression, dementia, and psychotic disorders. “This tells us that mild TBI is not clean of events,” Dr. Zafonte said.

Surprising rate of comorbidity in youth

Investigators found increased risk for posttrauma comorbidities in all age groups, but researchers were struck by the high rates in younger patients, aged 18-40. Compared with age-matched individuals with no TBI history, hypertension risk was nearly six times higher in those with mTBI (HR, 5.9; 95% CI, 3.9-9.1) and nearly four times higher in patients with msTBI (HR, 3.9; 95% CI, 2.5-6.1).

Rates of hyperlipidemia and diabetes were also higher in younger patients in the mTBI group and posttraumatic seizures and psychiatric disorders were elevated regardless of TBI severity.

Overall, patients with msTBI, but not those with mTBI, were at higher risk for mortality, compared with the unexposed group (432 deaths [9.9%] vs. 250 deaths [5.7%]; P < .001).

“It’s clear that what we may be dealing with is that it holds up even for the younger people,” Dr. Zafonte said. “We used to think brain injury risk is worse in the severe cases, which it is, and it’s worse later on among those who are older, which it is. But our younger folks don’t get away either.”

While the study offers associations between TBI and multisystem health problems, Dr. Zafonte said it’s impossible to say at this point whether the brain injury caused the increased risk for cardiovascular or endocrine problems. Other organ injuries sustained in the trauma may be a contributing factor.

“Further data is needed to elucidate the mechanism and the causative relationships, which we do not have here,” he said.

Many of the postinjury comorbidities emerged a median of 3.5 years after TBI, regardless of severity. But some of the cardiovascular and psychiatric conditions emerged far sooner than that.

That’s important because research suggests less than half of patients with TBI receive follow-up care.

“It does make sense for folks who are interacting with people who’ve had a TBI to be suspicious of medical comorbidities relatively early on, within the first couple of years,” Dr. Zafonte said.

In an invited commentary, Vijay Krishnamoorthy, MD, MPH, PhD, Duke University, Durham, N.C., and Monica S. Vavilala, MD, University of Washington, Seattle, highlight some of the study’s limitations, including a lack of information on comorbidity severity and the lack of a matched group of patients who experienced non-head trauma.

Despite those limitations, the study offers important information on how TBI may affect organs beyond the brain, they noted.

“These observations, if replicated in future studies, raise intriguing implications in the future care of patients with TBI, including heightened chronic disease-screening measures and possibly enhanced guidelines for chronic extracranial organ system care for patients who experience TBI,” Dr. Krishnamoorthy and Dr. Vavilala wrote.

The study received no specific funding. Dr. Zafonte reported having received personal fees from Springer/Demos, serving on scientific advisory boards for Myomo and OnCare and has received funding from the Football Players Health Study at Harvard, funded in part by the National Football League Players Association. Dr. Krishnamoorthy and Dr. Vavilala disclosed no relevant financial relationships.

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

The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
 

‘Revolutionary’ change

The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.

In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.

The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.

Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.

“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.

The product information for mavacamten includes a boxed warning citing a risk for heart failure.

Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.

Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.

Full prescribing information is available online.

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

The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
 

‘Revolutionary’ change

The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.

In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.

The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.

Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.

“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.

The product information for mavacamten includes a boxed warning citing a risk for heart failure.

Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.

Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.

Full prescribing information is available online.

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

The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
 

‘Revolutionary’ change

The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.

In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.

The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.

Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.

“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.

The product information for mavacamten includes a boxed warning citing a risk for heart failure.

Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.

Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.

Full prescribing information is available online.

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

Pfizer is voluntarily recalling five lots of Accupril (quinapril HCI) due to unacceptable levels of a nitrosamine, N-nitroso-quinapril, a potential carcinogen, the company announced.

The Accupril recall comes one month after Pfizer recalled six lots of Accuretic (Quinapril HCI/hydrochlorathiazide) tablets for the same problem.

Accupril is indicated for the treatment of hypertension and management of heart failure when added to conventional therapy, including diuretics and/or digitalis.

To date, Pfizer is not aware of any reports of adverse events related to the Accupril recall, and the company believes the benefit/risk profile remains positive based on currently available data.

“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” the company said April 22 in a news release.

Patients currently taking the recalled products are asked to consult with their doctor about alternative treatment options.

The recalled Accupril tablets were sold in 90-count bottles distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. 

National drug codes (NDC), lot numbers, and expiration dates are listed in the company announcement posted on the Food and Drug Administration’s website.

Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-345-0481 Monday through Friday from 8 AM to 5 PM ET for instructions on how to return the product and obtain reimbursement.

Healthcare providers with questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday from 8 AM to 9 PM ET.

Adverse reactions or quality problems related to this recall should be reported to the FDA’s MedWatch program.

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

Pfizer is voluntarily recalling five lots of Accupril (quinapril HCI) due to unacceptable levels of a nitrosamine, N-nitroso-quinapril, a potential carcinogen, the company announced.

The Accupril recall comes one month after Pfizer recalled six lots of Accuretic (Quinapril HCI/hydrochlorathiazide) tablets for the same problem.

Accupril is indicated for the treatment of hypertension and management of heart failure when added to conventional therapy, including diuretics and/or digitalis.

To date, Pfizer is not aware of any reports of adverse events related to the Accupril recall, and the company believes the benefit/risk profile remains positive based on currently available data.

“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” the company said April 22 in a news release.

Patients currently taking the recalled products are asked to consult with their doctor about alternative treatment options.

The recalled Accupril tablets were sold in 90-count bottles distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. 

National drug codes (NDC), lot numbers, and expiration dates are listed in the company announcement posted on the Food and Drug Administration’s website.

Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-345-0481 Monday through Friday from 8 AM to 5 PM ET for instructions on how to return the product and obtain reimbursement.

Healthcare providers with questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday from 8 AM to 9 PM ET.

Adverse reactions or quality problems related to this recall should be reported to the FDA’s MedWatch program.

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

Pfizer is voluntarily recalling five lots of Accupril (quinapril HCI) due to unacceptable levels of a nitrosamine, N-nitroso-quinapril, a potential carcinogen, the company announced.

The Accupril recall comes one month after Pfizer recalled six lots of Accuretic (Quinapril HCI/hydrochlorathiazide) tablets for the same problem.

Accupril is indicated for the treatment of hypertension and management of heart failure when added to conventional therapy, including diuretics and/or digitalis.

To date, Pfizer is not aware of any reports of adverse events related to the Accupril recall, and the company believes the benefit/risk profile remains positive based on currently available data.

“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” the company said April 22 in a news release.

Patients currently taking the recalled products are asked to consult with their doctor about alternative treatment options.

The recalled Accupril tablets were sold in 90-count bottles distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. 

National drug codes (NDC), lot numbers, and expiration dates are listed in the company announcement posted on the Food and Drug Administration’s website.

Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-345-0481 Monday through Friday from 8 AM to 5 PM ET for instructions on how to return the product and obtain reimbursement.

Healthcare providers with questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday from 8 AM to 9 PM ET.

Adverse reactions or quality problems related to this recall should be reported to the FDA’s MedWatch program.

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