Painful Fungating Perianal Mass

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Painful Fungating Perianal Mass

The Diagnosis: Condyloma Latum

A punch biopsy of the perianal mass revealed epidermal acanthosis with elongated slender rete ridges, scattered intraepidermal neutrophils, and a dense dermal inflammatory infiltrate (Figure, A) with a prominent plasma cell component (Figure, B). A treponemal immunohistochemical stain revealed numerous coiled spirochetes concentrated in the lower epidermis (Figure, C). Serologic test results including rapid plasma reagin (titer 1:1024) and Treponema pallidum antibody were reactive, confirming the diagnosis of secondary syphilis with condyloma latum. The patient was treated with intramuscular penicillin G with resolution of the lesion 2 weeks later.

Punch biopsy of a perianal mass
Punch biopsy of a perianal mass. A, Epidermal acanthosis with elongated slender rete ridges, scattered intraepidermal neutrophils, and a dense dermal inflammatory infiltrate (H&E, original magnification ×100). B, A prominent plasma cell component was noted in the dermal inflammatory infiltrate (H&E, original magnification ×400). C, Treponemal immunohistochemical stain showed numerous coiled spirochetes concentrated in the lower epidermis (original magnification ×40).

Syphilis, a sexually transmitted infection caused by the spirochete T pallidum, reached historically low rates in the United States in the early 2000s due to the widespread use of penicillin and effective public health efforts.1 However, the rates of primary and secondary syphilis infections recently have markedly increased, resulting in the current epidemic of syphilis in the United States and Europe.1,2 Its wide variety of clinical and histopathologic manifestations make recognition challenging and lend it the moniker “the great imitator.”

Secondary syphilis results from the systemic spread of T pallidum and classically is characterized by the triad of a skin rash that frequently involves the palms and soles, mucosal ulceration such as condyloma latum, and lymphadenopathy.2,3 However, condyloma latum may represent the only manifestation of secondary syphilis in a subset of patients,4 as observed in our patient.

In the 2 months prior to diagnosis, our patient was evaluated at multiple emergency departments and primary care clinics, receiving diagnoses of condyloma acuminatum, genital herpes simplex virus, hemorrhoids, and suspicion for malignancy—entities that comprise the differential diagnosis for condyloma latum.2,5 Despite some degree of overlap in patient populations, risk factors, and presentations between these diagnostic considerations, recognition of certain clinical features, in addition to histopathologic evaluation, may facilitate navigation of this differential diagnosis.

Primary and secondary syphilis infections have been predominantly observed in men, mostly men who have sex with men and/or those who are infected with HIV.1 Condyloma acuminata, genital herpes simplex virus, and chancroid also are seen in younger individuals, more commonly in those with multiple sexual partners, but show a more even gender distribution and are not restricted to those partaking in anal intercourse. The clinical presentation of condyloma latum can be differentiated by its painless, flat, smooth, and commonly hypopigmented appearance, often with associated surface erosion and a gray exudate, in contrast to condyloma acuminatum, which typically presents as nontender, flesh-colored or hyperpigmented, exophytic papules that may coalesce into plaques.2,3,6 Genital herpes simplex virus infection presents with multiple small papulovesicular lesions with ulceration, most commonly on the tip or shaft of the penis, though perianal lesions may be seen in men who have sex with men.7 Similarly, chancroid presents with painful necrotizing genital ulcers most commonly on the penis, though perianal lesions also may be seen.8 Hemorrhoids classically are seen in middle-aged adults with a history of constipation, present with rectal bleeding, and may be associated with pain in the setting of thrombosis or ulceration.9 Finally, perianal squamous cell carcinoma primarily occurs in older adults, typically in the sixth decade of life. Verrucous carcinoma most commonly arises in the oropharynx or anogenital region in sites of chronic irritation and presents as a slow-growing exophytic mass. Classic squamous cell carcinoma most commonly occurs in association with human papillomavirus infection and presents with scaly erythematous papules or plaques.10

Our case highlighted the clinical difficulty in recognizing condyloma latum, as this lesion remained undiagnosed for 2 months, and our patient presumptively was treated for multiple perianal pathologies prior to a biopsy being performed. Due to the clinical similarity of various perianal lesions, the diagnosis of condyloma latum should be considered, and serologic studies should be performed in fitting clinical contexts, especially in light of recently rising rates of syphilis infection.1,2

References
  1. Ghanem KG, Ram S, Rice PA. The modern epidemic of syphilis. N Engl J Med. 2020;382:845-854.
  2. Tayal S, Shaban F, Dasgupta K, et al. A case of syphilitic anal condylomata lata mimicking malignancy. Int J Surg Case Rep. 2015; 17:69-71.
  3. Aung PP, Wimmer DB, Lester TR, et al. Perianal condylomata lata mimicking carcinoma. J Cutan Pathol. 2022;49:209-214.
  4. Pourang A, Fung MA, Tartar D, et al. Condyloma lata in secondary syphilis. JAAD Case Rep. 2021;10:18-21.
  5. Bruins FG, van Deudekom FJ, de Vries HJ. Syphilitic condylomata lata mimicking anogenital warts. BMJ. 2015;350:h1259.
  6. Leslie SW, Sajjad H, Kumar S. Genital warts. In: StatPearls. StatPearls Publishing; 2021.
  7. Groves MJ. Genital herpes: a review. Am Fam Physician. 2016; 93:928-934.
  8. Irizarry L, Velasquez J, Wray AA. Chancroid. In: StatPearls. StatPearls Publishing; 2022.
  9. Mounsey AL, Halladay J, Sadiq TS. Hemorrhoids. Am Fam Physician. 2011;84:204-210.
  10. Abbass MA, Valente MA. Premalignant and malignant perianal lesions. Clin Colon Rectal Surg. 2019;32:386-393.
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Dr. K.C. Marinelli is from Creighton University School of Medicine, Omaha, Nebraska. Drs. L.M. Marinelli and Wohltmann are from Brooke Army Medical Center, San Antonio, Texas. Dr. Marinelli is from the Department of Pathology and Area Laboratory Services, and Dr. Wohltmann is from the Departments of Dermatology and Pathology. Dr. Yoon is from the Department of General Surgery, Carl R. Darnall Army Medical Center, Fort Hood, Texas

The authors report no conflict of interest.

The views expressed herein are those of the authors and do not reflect the official policy or position of Brooke Army Medical Center, the US Army Medical Department, the US Army Office of the Surgeon General, the Department of the Army, the Department of the Air Force, the Department of Defense, or the US Government.

Correspondence: Wendi E. Wohltmann, MD, Brooke Army Medical Center, 3551 Roger Brooke Dr, San Antonio, TX 78234 ([email protected]).

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Dr. K.C. Marinelli is from Creighton University School of Medicine, Omaha, Nebraska. Drs. L.M. Marinelli and Wohltmann are from Brooke Army Medical Center, San Antonio, Texas. Dr. Marinelli is from the Department of Pathology and Area Laboratory Services, and Dr. Wohltmann is from the Departments of Dermatology and Pathology. Dr. Yoon is from the Department of General Surgery, Carl R. Darnall Army Medical Center, Fort Hood, Texas

The authors report no conflict of interest.

The views expressed herein are those of the authors and do not reflect the official policy or position of Brooke Army Medical Center, the US Army Medical Department, the US Army Office of the Surgeon General, the Department of the Army, the Department of the Air Force, the Department of Defense, or the US Government.

Correspondence: Wendi E. Wohltmann, MD, Brooke Army Medical Center, 3551 Roger Brooke Dr, San Antonio, TX 78234 ([email protected]).

Author and Disclosure Information

Dr. K.C. Marinelli is from Creighton University School of Medicine, Omaha, Nebraska. Drs. L.M. Marinelli and Wohltmann are from Brooke Army Medical Center, San Antonio, Texas. Dr. Marinelli is from the Department of Pathology and Area Laboratory Services, and Dr. Wohltmann is from the Departments of Dermatology and Pathology. Dr. Yoon is from the Department of General Surgery, Carl R. Darnall Army Medical Center, Fort Hood, Texas

The authors report no conflict of interest.

The views expressed herein are those of the authors and do not reflect the official policy or position of Brooke Army Medical Center, the US Army Medical Department, the US Army Office of the Surgeon General, the Department of the Army, the Department of the Air Force, the Department of Defense, or the US Government.

Correspondence: Wendi E. Wohltmann, MD, Brooke Army Medical Center, 3551 Roger Brooke Dr, San Antonio, TX 78234 ([email protected]).

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The Diagnosis: Condyloma Latum

A punch biopsy of the perianal mass revealed epidermal acanthosis with elongated slender rete ridges, scattered intraepidermal neutrophils, and a dense dermal inflammatory infiltrate (Figure, A) with a prominent plasma cell component (Figure, B). A treponemal immunohistochemical stain revealed numerous coiled spirochetes concentrated in the lower epidermis (Figure, C). Serologic test results including rapid plasma reagin (titer 1:1024) and Treponema pallidum antibody were reactive, confirming the diagnosis of secondary syphilis with condyloma latum. The patient was treated with intramuscular penicillin G with resolution of the lesion 2 weeks later.

Punch biopsy of a perianal mass
Punch biopsy of a perianal mass. A, Epidermal acanthosis with elongated slender rete ridges, scattered intraepidermal neutrophils, and a dense dermal inflammatory infiltrate (H&E, original magnification ×100). B, A prominent plasma cell component was noted in the dermal inflammatory infiltrate (H&E, original magnification ×400). C, Treponemal immunohistochemical stain showed numerous coiled spirochetes concentrated in the lower epidermis (original magnification ×40).

Syphilis, a sexually transmitted infection caused by the spirochete T pallidum, reached historically low rates in the United States in the early 2000s due to the widespread use of penicillin and effective public health efforts.1 However, the rates of primary and secondary syphilis infections recently have markedly increased, resulting in the current epidemic of syphilis in the United States and Europe.1,2 Its wide variety of clinical and histopathologic manifestations make recognition challenging and lend it the moniker “the great imitator.”

Secondary syphilis results from the systemic spread of T pallidum and classically is characterized by the triad of a skin rash that frequently involves the palms and soles, mucosal ulceration such as condyloma latum, and lymphadenopathy.2,3 However, condyloma latum may represent the only manifestation of secondary syphilis in a subset of patients,4 as observed in our patient.

In the 2 months prior to diagnosis, our patient was evaluated at multiple emergency departments and primary care clinics, receiving diagnoses of condyloma acuminatum, genital herpes simplex virus, hemorrhoids, and suspicion for malignancy—entities that comprise the differential diagnosis for condyloma latum.2,5 Despite some degree of overlap in patient populations, risk factors, and presentations between these diagnostic considerations, recognition of certain clinical features, in addition to histopathologic evaluation, may facilitate navigation of this differential diagnosis.

Primary and secondary syphilis infections have been predominantly observed in men, mostly men who have sex with men and/or those who are infected with HIV.1 Condyloma acuminata, genital herpes simplex virus, and chancroid also are seen in younger individuals, more commonly in those with multiple sexual partners, but show a more even gender distribution and are not restricted to those partaking in anal intercourse. The clinical presentation of condyloma latum can be differentiated by its painless, flat, smooth, and commonly hypopigmented appearance, often with associated surface erosion and a gray exudate, in contrast to condyloma acuminatum, which typically presents as nontender, flesh-colored or hyperpigmented, exophytic papules that may coalesce into plaques.2,3,6 Genital herpes simplex virus infection presents with multiple small papulovesicular lesions with ulceration, most commonly on the tip or shaft of the penis, though perianal lesions may be seen in men who have sex with men.7 Similarly, chancroid presents with painful necrotizing genital ulcers most commonly on the penis, though perianal lesions also may be seen.8 Hemorrhoids classically are seen in middle-aged adults with a history of constipation, present with rectal bleeding, and may be associated with pain in the setting of thrombosis or ulceration.9 Finally, perianal squamous cell carcinoma primarily occurs in older adults, typically in the sixth decade of life. Verrucous carcinoma most commonly arises in the oropharynx or anogenital region in sites of chronic irritation and presents as a slow-growing exophytic mass. Classic squamous cell carcinoma most commonly occurs in association with human papillomavirus infection and presents with scaly erythematous papules or plaques.10

Our case highlighted the clinical difficulty in recognizing condyloma latum, as this lesion remained undiagnosed for 2 months, and our patient presumptively was treated for multiple perianal pathologies prior to a biopsy being performed. Due to the clinical similarity of various perianal lesions, the diagnosis of condyloma latum should be considered, and serologic studies should be performed in fitting clinical contexts, especially in light of recently rising rates of syphilis infection.1,2

The Diagnosis: Condyloma Latum

A punch biopsy of the perianal mass revealed epidermal acanthosis with elongated slender rete ridges, scattered intraepidermal neutrophils, and a dense dermal inflammatory infiltrate (Figure, A) with a prominent plasma cell component (Figure, B). A treponemal immunohistochemical stain revealed numerous coiled spirochetes concentrated in the lower epidermis (Figure, C). Serologic test results including rapid plasma reagin (titer 1:1024) and Treponema pallidum antibody were reactive, confirming the diagnosis of secondary syphilis with condyloma latum. The patient was treated with intramuscular penicillin G with resolution of the lesion 2 weeks later.

Punch biopsy of a perianal mass
Punch biopsy of a perianal mass. A, Epidermal acanthosis with elongated slender rete ridges, scattered intraepidermal neutrophils, and a dense dermal inflammatory infiltrate (H&E, original magnification ×100). B, A prominent plasma cell component was noted in the dermal inflammatory infiltrate (H&E, original magnification ×400). C, Treponemal immunohistochemical stain showed numerous coiled spirochetes concentrated in the lower epidermis (original magnification ×40).

Syphilis, a sexually transmitted infection caused by the spirochete T pallidum, reached historically low rates in the United States in the early 2000s due to the widespread use of penicillin and effective public health efforts.1 However, the rates of primary and secondary syphilis infections recently have markedly increased, resulting in the current epidemic of syphilis in the United States and Europe.1,2 Its wide variety of clinical and histopathologic manifestations make recognition challenging and lend it the moniker “the great imitator.”

Secondary syphilis results from the systemic spread of T pallidum and classically is characterized by the triad of a skin rash that frequently involves the palms and soles, mucosal ulceration such as condyloma latum, and lymphadenopathy.2,3 However, condyloma latum may represent the only manifestation of secondary syphilis in a subset of patients,4 as observed in our patient.

In the 2 months prior to diagnosis, our patient was evaluated at multiple emergency departments and primary care clinics, receiving diagnoses of condyloma acuminatum, genital herpes simplex virus, hemorrhoids, and suspicion for malignancy—entities that comprise the differential diagnosis for condyloma latum.2,5 Despite some degree of overlap in patient populations, risk factors, and presentations between these diagnostic considerations, recognition of certain clinical features, in addition to histopathologic evaluation, may facilitate navigation of this differential diagnosis.

Primary and secondary syphilis infections have been predominantly observed in men, mostly men who have sex with men and/or those who are infected with HIV.1 Condyloma acuminata, genital herpes simplex virus, and chancroid also are seen in younger individuals, more commonly in those with multiple sexual partners, but show a more even gender distribution and are not restricted to those partaking in anal intercourse. The clinical presentation of condyloma latum can be differentiated by its painless, flat, smooth, and commonly hypopigmented appearance, often with associated surface erosion and a gray exudate, in contrast to condyloma acuminatum, which typically presents as nontender, flesh-colored or hyperpigmented, exophytic papules that may coalesce into plaques.2,3,6 Genital herpes simplex virus infection presents with multiple small papulovesicular lesions with ulceration, most commonly on the tip or shaft of the penis, though perianal lesions may be seen in men who have sex with men.7 Similarly, chancroid presents with painful necrotizing genital ulcers most commonly on the penis, though perianal lesions also may be seen.8 Hemorrhoids classically are seen in middle-aged adults with a history of constipation, present with rectal bleeding, and may be associated with pain in the setting of thrombosis or ulceration.9 Finally, perianal squamous cell carcinoma primarily occurs in older adults, typically in the sixth decade of life. Verrucous carcinoma most commonly arises in the oropharynx or anogenital region in sites of chronic irritation and presents as a slow-growing exophytic mass. Classic squamous cell carcinoma most commonly occurs in association with human papillomavirus infection and presents with scaly erythematous papules or plaques.10

Our case highlighted the clinical difficulty in recognizing condyloma latum, as this lesion remained undiagnosed for 2 months, and our patient presumptively was treated for multiple perianal pathologies prior to a biopsy being performed. Due to the clinical similarity of various perianal lesions, the diagnosis of condyloma latum should be considered, and serologic studies should be performed in fitting clinical contexts, especially in light of recently rising rates of syphilis infection.1,2

References
  1. Ghanem KG, Ram S, Rice PA. The modern epidemic of syphilis. N Engl J Med. 2020;382:845-854.
  2. Tayal S, Shaban F, Dasgupta K, et al. A case of syphilitic anal condylomata lata mimicking malignancy. Int J Surg Case Rep. 2015; 17:69-71.
  3. Aung PP, Wimmer DB, Lester TR, et al. Perianal condylomata lata mimicking carcinoma. J Cutan Pathol. 2022;49:209-214.
  4. Pourang A, Fung MA, Tartar D, et al. Condyloma lata in secondary syphilis. JAAD Case Rep. 2021;10:18-21.
  5. Bruins FG, van Deudekom FJ, de Vries HJ. Syphilitic condylomata lata mimicking anogenital warts. BMJ. 2015;350:h1259.
  6. Leslie SW, Sajjad H, Kumar S. Genital warts. In: StatPearls. StatPearls Publishing; 2021.
  7. Groves MJ. Genital herpes: a review. Am Fam Physician. 2016; 93:928-934.
  8. Irizarry L, Velasquez J, Wray AA. Chancroid. In: StatPearls. StatPearls Publishing; 2022.
  9. Mounsey AL, Halladay J, Sadiq TS. Hemorrhoids. Am Fam Physician. 2011;84:204-210.
  10. Abbass MA, Valente MA. Premalignant and malignant perianal lesions. Clin Colon Rectal Surg. 2019;32:386-393.
References
  1. Ghanem KG, Ram S, Rice PA. The modern epidemic of syphilis. N Engl J Med. 2020;382:845-854.
  2. Tayal S, Shaban F, Dasgupta K, et al. A case of syphilitic anal condylomata lata mimicking malignancy. Int J Surg Case Rep. 2015; 17:69-71.
  3. Aung PP, Wimmer DB, Lester TR, et al. Perianal condylomata lata mimicking carcinoma. J Cutan Pathol. 2022;49:209-214.
  4. Pourang A, Fung MA, Tartar D, et al. Condyloma lata in secondary syphilis. JAAD Case Rep. 2021;10:18-21.
  5. Bruins FG, van Deudekom FJ, de Vries HJ. Syphilitic condylomata lata mimicking anogenital warts. BMJ. 2015;350:h1259.
  6. Leslie SW, Sajjad H, Kumar S. Genital warts. In: StatPearls. StatPearls Publishing; 2021.
  7. Groves MJ. Genital herpes: a review. Am Fam Physician. 2016; 93:928-934.
  8. Irizarry L, Velasquez J, Wray AA. Chancroid. In: StatPearls. StatPearls Publishing; 2022.
  9. Mounsey AL, Halladay J, Sadiq TS. Hemorrhoids. Am Fam Physician. 2011;84:204-210.
  10. Abbass MA, Valente MA. Premalignant and malignant perianal lesions. Clin Colon Rectal Surg. 2019;32:386-393.
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A 21-year-old man presented to our clinic with rectal pain of 2 months’ duration that occurred in association with bowel movements and rectal bleeding in the setting of constipation. The patient’s symptoms had persisted despite multiple clinical encounters and treatment with sulfamethoxazole-trimethoprim, clotrimazole, valacyclovir, topical hydrocortisone and pramoxine, topical lidocaine, imiquimod, and psyllium seed. The patient denied engaging in receptive anal intercourse and had no notable medical or surgical history. Physical examination revealed a 6-cm hypopigmented fungating mass on the left gluteal cleft just external to the anal verge; there were no other abnormal findings. The patient denied any other systemic symptoms.

Perianal mass

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Supreme Court appears ready to overturn Roe

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The U.S. Supreme Court may be on the cusp of overturning 50 years of American abortion law, according to a draft opinion in a Mississippi case that was leaked to the news outlet Politico.

The draft opinion, written by Justice Samuel Alito, outlines ways a presumed majority of the nine justices believes the 1973 ruling in Roe v. Wade was incorrect. If signed by a majority of the court, the ruling would eliminate the protections for abortion rights that Roe provided and give the 50 states the power to legislate abortion.

“We hold that Roe and Casey must be overruled,” Justice Alito writes in the draft. “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

While a final ruling was not expected from the court until June, the leaked draft – a nearly unprecedented breach of the court’s internal workings – gives a strong signal of the court’s five most conservative members’ decisions. During oral arguments in the case in December, conservative justices appeared prepared to undo at least part of the country’s abortion protections.

President Joe Biden said his administration was already preparing for a potential ruling that struck down federal abortion protections.

The White House, he said in a statement, is working on a “response to the continued attack on abortion and reproductive rights, under a variety of possible outcomes in the cases pending before the Supreme Court. We will be ready when any ruling is issued.”

But if the draft opinion becomes final, he said the fight will move to the states.

“It will fall on our nation’s elected officials at all levels of government to protect a woman’s right to choose,” he said. “And it will fall on voters to elect pro-choice officials this November.”

With more pro-abortion rights members of Congress, it would be possible to pass federal legislation protecting abortion rights, “which I will work to pass and sign into law.”

Should the Alito draft become law, its first impact would be to allow a Mississippi law that bans abortions after 15 weeks to take effect.

But quickly after that, abortions would become illegal in many states. Several conservative-leaning states, mostly in the South and Midwest, have already passed laws severely restricting abortions well beyond what Roe allowed. Should Roe be overturned then, those laws would take effect without the threat of lengthy lawsuits or rulings from lower-court judges who have blocked them.

Nearly half of the states, mostly in the Northeast and West, would likely allow abortion to continue in some way. In fact, several states, including Colorado and Vermont, have already passed laws granting the right to an abortion into state law.

The leaked draft, however, is still a draft, meaning it remains possible Roe survives. Anthony Kreis, PhD, a professor of law at Georgia State University, says that could have been the point of whoever leaked the draft.

“It suggests to me that whoever leaked it knew that public outrage was the last resort to stopping the court from overturning Roe v. Wade and letting states ban all abortions,” Dr. Kreis said. “The danger that abortions won’t be legal in most of the country is very real.”

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

This article was updated 5/3/22.

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The U.S. Supreme Court may be on the cusp of overturning 50 years of American abortion law, according to a draft opinion in a Mississippi case that was leaked to the news outlet Politico.

The draft opinion, written by Justice Samuel Alito, outlines ways a presumed majority of the nine justices believes the 1973 ruling in Roe v. Wade was incorrect. If signed by a majority of the court, the ruling would eliminate the protections for abortion rights that Roe provided and give the 50 states the power to legislate abortion.

“We hold that Roe and Casey must be overruled,” Justice Alito writes in the draft. “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

While a final ruling was not expected from the court until June, the leaked draft – a nearly unprecedented breach of the court’s internal workings – gives a strong signal of the court’s five most conservative members’ decisions. During oral arguments in the case in December, conservative justices appeared prepared to undo at least part of the country’s abortion protections.

President Joe Biden said his administration was already preparing for a potential ruling that struck down federal abortion protections.

The White House, he said in a statement, is working on a “response to the continued attack on abortion and reproductive rights, under a variety of possible outcomes in the cases pending before the Supreme Court. We will be ready when any ruling is issued.”

But if the draft opinion becomes final, he said the fight will move to the states.

“It will fall on our nation’s elected officials at all levels of government to protect a woman’s right to choose,” he said. “And it will fall on voters to elect pro-choice officials this November.”

With more pro-abortion rights members of Congress, it would be possible to pass federal legislation protecting abortion rights, “which I will work to pass and sign into law.”

Should the Alito draft become law, its first impact would be to allow a Mississippi law that bans abortions after 15 weeks to take effect.

But quickly after that, abortions would become illegal in many states. Several conservative-leaning states, mostly in the South and Midwest, have already passed laws severely restricting abortions well beyond what Roe allowed. Should Roe be overturned then, those laws would take effect without the threat of lengthy lawsuits or rulings from lower-court judges who have blocked them.

Nearly half of the states, mostly in the Northeast and West, would likely allow abortion to continue in some way. In fact, several states, including Colorado and Vermont, have already passed laws granting the right to an abortion into state law.

The leaked draft, however, is still a draft, meaning it remains possible Roe survives. Anthony Kreis, PhD, a professor of law at Georgia State University, says that could have been the point of whoever leaked the draft.

“It suggests to me that whoever leaked it knew that public outrage was the last resort to stopping the court from overturning Roe v. Wade and letting states ban all abortions,” Dr. Kreis said. “The danger that abortions won’t be legal in most of the country is very real.”

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

This article was updated 5/3/22.

The U.S. Supreme Court may be on the cusp of overturning 50 years of American abortion law, according to a draft opinion in a Mississippi case that was leaked to the news outlet Politico.

The draft opinion, written by Justice Samuel Alito, outlines ways a presumed majority of the nine justices believes the 1973 ruling in Roe v. Wade was incorrect. If signed by a majority of the court, the ruling would eliminate the protections for abortion rights that Roe provided and give the 50 states the power to legislate abortion.

“We hold that Roe and Casey must be overruled,” Justice Alito writes in the draft. “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

While a final ruling was not expected from the court until June, the leaked draft – a nearly unprecedented breach of the court’s internal workings – gives a strong signal of the court’s five most conservative members’ decisions. During oral arguments in the case in December, conservative justices appeared prepared to undo at least part of the country’s abortion protections.

President Joe Biden said his administration was already preparing for a potential ruling that struck down federal abortion protections.

The White House, he said in a statement, is working on a “response to the continued attack on abortion and reproductive rights, under a variety of possible outcomes in the cases pending before the Supreme Court. We will be ready when any ruling is issued.”

But if the draft opinion becomes final, he said the fight will move to the states.

“It will fall on our nation’s elected officials at all levels of government to protect a woman’s right to choose,” he said. “And it will fall on voters to elect pro-choice officials this November.”

With more pro-abortion rights members of Congress, it would be possible to pass federal legislation protecting abortion rights, “which I will work to pass and sign into law.”

Should the Alito draft become law, its first impact would be to allow a Mississippi law that bans abortions after 15 weeks to take effect.

But quickly after that, abortions would become illegal in many states. Several conservative-leaning states, mostly in the South and Midwest, have already passed laws severely restricting abortions well beyond what Roe allowed. Should Roe be overturned then, those laws would take effect without the threat of lengthy lawsuits or rulings from lower-court judges who have blocked them.

Nearly half of the states, mostly in the Northeast and West, would likely allow abortion to continue in some way. In fact, several states, including Colorado and Vermont, have already passed laws granting the right to an abortion into state law.

The leaked draft, however, is still a draft, meaning it remains possible Roe survives. Anthony Kreis, PhD, a professor of law at Georgia State University, says that could have been the point of whoever leaked the draft.

“It suggests to me that whoever leaked it knew that public outrage was the last resort to stopping the court from overturning Roe v. Wade and letting states ban all abortions,” Dr. Kreis said. “The danger that abortions won’t be legal in most of the country is very real.”

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

This article was updated 5/3/22.

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Commentary: WHO, UNICEF warn about increased risk of measles outbreaks

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The newly released global estimate is now 25 million children (2 million more than in 2020) missing scheduled vaccines. This continues to bode badly for multiple vaccine-preventable infections, but maybe the most for measles in 2022. 

Specifically for measles vaccine, global two-dose coverage was only 71%. Coverage was less than 50% in 8 countries: ​Chad, Guinea,​ Samoa, North Korea, Central African Republic, Somalia, Angola, and South Sudan. These eight areas seem ripe for outbreaks this year and indeed Somalia is having an outbreak. 

Overall, worldwide measles cases increased 79% in early 2022, compared with 2021. The top 10 countries for measles cases from November 2021 to April 2022, per the World Health Organization, include Nigeria, India, Soma Ethiopia, Pakistan, DR Congo, Afghanistan, Liberia, Cameroon, and Ivory Coast.

In the United States, we have been lucky so far with only 55 cases since the start of 2021. However, MMR two-dose coverage has dropped since the pandemic’s start. The list of U.S. areas with the lowest overall two-dose MMR coverage as of 2021 were D.C. (78.9%), Houston (93.7%), Idaho (86.5%), Wisconsin (87.2%), Maryland (87.6%), Georgia (88.5%), Kentucky (88.9%), Ohio (89.6%), and Minnesota (89.8%). Only 14 states had rates over the targeted 95% rate needed for community (herd) immunity against measles (MMWR Morb Mortal Wkly Rep. 2022;71:561-8).  

Two bits of good news are that there seems to be some catch-up occurring in vaccine uptake overall (including MMR) and we now have two MMR suppliers in the United States since GlaxoSmithKline’s MMR was recently approved by the Food and Drug Administration for persons over 1 year of age. Let’s all redouble our efforts at adding to the catch-up efforts. 

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

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The newly released global estimate is now 25 million children (2 million more than in 2020) missing scheduled vaccines. This continues to bode badly for multiple vaccine-preventable infections, but maybe the most for measles in 2022. 

Specifically for measles vaccine, global two-dose coverage was only 71%. Coverage was less than 50% in 8 countries: ​Chad, Guinea,​ Samoa, North Korea, Central African Republic, Somalia, Angola, and South Sudan. These eight areas seem ripe for outbreaks this year and indeed Somalia is having an outbreak. 

Overall, worldwide measles cases increased 79% in early 2022, compared with 2021. The top 10 countries for measles cases from November 2021 to April 2022, per the World Health Organization, include Nigeria, India, Soma Ethiopia, Pakistan, DR Congo, Afghanistan, Liberia, Cameroon, and Ivory Coast.

In the United States, we have been lucky so far with only 55 cases since the start of 2021. However, MMR two-dose coverage has dropped since the pandemic’s start. The list of U.S. areas with the lowest overall two-dose MMR coverage as of 2021 were D.C. (78.9%), Houston (93.7%), Idaho (86.5%), Wisconsin (87.2%), Maryland (87.6%), Georgia (88.5%), Kentucky (88.9%), Ohio (89.6%), and Minnesota (89.8%). Only 14 states had rates over the targeted 95% rate needed for community (herd) immunity against measles (MMWR Morb Mortal Wkly Rep. 2022;71:561-8).  

Two bits of good news are that there seems to be some catch-up occurring in vaccine uptake overall (including MMR) and we now have two MMR suppliers in the United States since GlaxoSmithKline’s MMR was recently approved by the Food and Drug Administration for persons over 1 year of age. Let’s all redouble our efforts at adding to the catch-up efforts. 

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

The newly released global estimate is now 25 million children (2 million more than in 2020) missing scheduled vaccines. This continues to bode badly for multiple vaccine-preventable infections, but maybe the most for measles in 2022. 

Specifically for measles vaccine, global two-dose coverage was only 71%. Coverage was less than 50% in 8 countries: ​Chad, Guinea,​ Samoa, North Korea, Central African Republic, Somalia, Angola, and South Sudan. These eight areas seem ripe for outbreaks this year and indeed Somalia is having an outbreak. 

Overall, worldwide measles cases increased 79% in early 2022, compared with 2021. The top 10 countries for measles cases from November 2021 to April 2022, per the World Health Organization, include Nigeria, India, Soma Ethiopia, Pakistan, DR Congo, Afghanistan, Liberia, Cameroon, and Ivory Coast.

In the United States, we have been lucky so far with only 55 cases since the start of 2021. However, MMR two-dose coverage has dropped since the pandemic’s start. The list of U.S. areas with the lowest overall two-dose MMR coverage as of 2021 were D.C. (78.9%), Houston (93.7%), Idaho (86.5%), Wisconsin (87.2%), Maryland (87.6%), Georgia (88.5%), Kentucky (88.9%), Ohio (89.6%), and Minnesota (89.8%). Only 14 states had rates over the targeted 95% rate needed for community (herd) immunity against measles (MMWR Morb Mortal Wkly Rep. 2022;71:561-8).  

Two bits of good news are that there seems to be some catch-up occurring in vaccine uptake overall (including MMR) and we now have two MMR suppliers in the United States since GlaxoSmithKline’s MMR was recently approved by the Food and Drug Administration for persons over 1 year of age. Let’s all redouble our efforts at adding to the catch-up efforts. 

Christopher J. Harrison, MD, is professor, University of Missouri Kansas City School of Medicine, department of medicine, infectious diseases section, Kansas City. He has no financial conflicts of interest.

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Clinical Edge Journal Scan Commentary: Atopic Dermatitis May 2022

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Changed
Thu, 05/12/2022 - 11:43
Dr. Silverberg scans the journals, so you don’t have to!

Jonathan Silverberg, MD, PHD, MPH
Now 2 years into the COVID-19 pandemic, we have learned much about how to prevent and manage infections across different patient populations. There remain many questions about how SARS-CoV-2 affects patients with atopic dermatitis (AD), and the impact of various therapies on SARS-CoV-2 infection clinical outcomes and immunity.

  • Dupilumab is a subcutaneous injection therapy that inhibits the interleukin 4-receptor alpha subunit. It was approved in the United States for the treatment of adults with moderate to severe AD in 2017 and has since been approved for children and adolescents down to 6 years of age. Ungar and colleagues studied the effects of dupilumab on SARS-CoV-2 antibody responses in patients with moderate to severe AD. They previously found that dupilumab was associated with milder COVID-19 illness. In this study, they similarly found that dupilumab was associated with lower immunoglobulin G (IgG) antibody levels to SARS-CoV-2, consistent with less severe COVID-19 illness. Future studies are needed to confirm these results. However, these results reassure that taking dupilumab does not pose any major harms in regard to COVID-19 outcomes.
  • My patients with AD ask me on an almost daily basis about whether they should get vaccinated for SARS-CoV-2. I recommended that my patients get vaccinated, based on data from vaccine studies. However, there has been a dearth of data on the efficacy and safety of SARS-CoV-2 specifically in AD patients. Kridin and colleagues performed a population-based cohort study including 77,682 adults with AD, of which 58,582 patients had completed two doses of the BioNTech-Pfizer SARS-CoV-2 mRNA vaccine. They found that patients with AD who received both vs no vaccine doses had significantly lower risk for COVID-19, hospitalization, and mortality. These are the best data to date in support of SARS-CoV-2 vaccination in patients with AD. Of note, there was no significant impact of immunosuppressive drugs on vaccine efficacy against COVID-19. However, previous studies in other immune-mediated disorders suggest that immunosuppressants may lower vaccine immune responses.1,2 Some authors have advocated for temporarily discontinuing immunosuppressive agents for 1-2 weeks before and after administering SARS-CoV-2 vaccines. Currently, there is insufficient evidence to make strong recommendations.

 

Numerous in utero and early-life risk factors for AD have been examined over the years. Maternal stress and depression have been considered as potential risk factors for AD in children.

  • My research group showed a while back that depression during pregnancy and in the postpartum period was associated with higher likelihood of AD in children.3
  • Kawaguchi and colleagues recently analyzed data from the Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study in Japan, including 8377 mother-child dyads where the child had not developed AD by the age of 1 year. They found that mothers with vs without psychological distress in both prenatal and postnatal periods or even only in the postnatal period had significantly increased risk of their children developing AD at 1-2 years of age. It seems prudent that mothers try to minimize stress during pregnancy and postpartum, though, understandably, this is not always feasible. Additionally, children of mothers who experience a lot of stress during pregnancy or postpartum may benefit from closer surveillance for the development of AD and other atopic diseases.

 

Additional References

1.         Dayam RM, Law JC, Goetbebuer RL, et al. Accelerated waning of immunity to SARS-CoV-2 mRNA vaccines in patients with immune mediated inflammatory diseases. JCI Insight. 2022 (Apr 26). Doi: 10.1172/jci.insight.159721   Source

2.         Medeiros-Ribeiro AC, Bonfiglioli KR, Domiciano DS, et al. Distinct impact of DMARD combination and monotherapy in immunogenicity of an inactivated SARS-CoV-2 vaccine in rheumatoid arthritis. Ann Rheum Dis. 2022;81:710-719. Doi: 10.1136/annrheumdis-2021-221735 Source

3.         McKenzie C, Silverberg JI. Maternal depression and atopic dermatitis in American children and adolescents. Dermatitis. 2020;31:75-80. Doi: 10.1097/DER.0000000000000548 Source

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Jonathan Silverberg, MD, PHD, MPH
George Washington University School of Medicine and Health Sciences
Washington, DC

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Dr. Silverberg scans the journals, so you don’t have to!
Dr. Silverberg scans the journals, so you don’t have to!

Jonathan Silverberg, MD, PHD, MPH
Now 2 years into the COVID-19 pandemic, we have learned much about how to prevent and manage infections across different patient populations. There remain many questions about how SARS-CoV-2 affects patients with atopic dermatitis (AD), and the impact of various therapies on SARS-CoV-2 infection clinical outcomes and immunity.

  • Dupilumab is a subcutaneous injection therapy that inhibits the interleukin 4-receptor alpha subunit. It was approved in the United States for the treatment of adults with moderate to severe AD in 2017 and has since been approved for children and adolescents down to 6 years of age. Ungar and colleagues studied the effects of dupilumab on SARS-CoV-2 antibody responses in patients with moderate to severe AD. They previously found that dupilumab was associated with milder COVID-19 illness. In this study, they similarly found that dupilumab was associated with lower immunoglobulin G (IgG) antibody levels to SARS-CoV-2, consistent with less severe COVID-19 illness. Future studies are needed to confirm these results. However, these results reassure that taking dupilumab does not pose any major harms in regard to COVID-19 outcomes.
  • My patients with AD ask me on an almost daily basis about whether they should get vaccinated for SARS-CoV-2. I recommended that my patients get vaccinated, based on data from vaccine studies. However, there has been a dearth of data on the efficacy and safety of SARS-CoV-2 specifically in AD patients. Kridin and colleagues performed a population-based cohort study including 77,682 adults with AD, of which 58,582 patients had completed two doses of the BioNTech-Pfizer SARS-CoV-2 mRNA vaccine. They found that patients with AD who received both vs no vaccine doses had significantly lower risk for COVID-19, hospitalization, and mortality. These are the best data to date in support of SARS-CoV-2 vaccination in patients with AD. Of note, there was no significant impact of immunosuppressive drugs on vaccine efficacy against COVID-19. However, previous studies in other immune-mediated disorders suggest that immunosuppressants may lower vaccine immune responses.1,2 Some authors have advocated for temporarily discontinuing immunosuppressive agents for 1-2 weeks before and after administering SARS-CoV-2 vaccines. Currently, there is insufficient evidence to make strong recommendations.

 

Numerous in utero and early-life risk factors for AD have been examined over the years. Maternal stress and depression have been considered as potential risk factors for AD in children.

  • My research group showed a while back that depression during pregnancy and in the postpartum period was associated with higher likelihood of AD in children.3
  • Kawaguchi and colleagues recently analyzed data from the Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study in Japan, including 8377 mother-child dyads where the child had not developed AD by the age of 1 year. They found that mothers with vs without psychological distress in both prenatal and postnatal periods or even only in the postnatal period had significantly increased risk of their children developing AD at 1-2 years of age. It seems prudent that mothers try to minimize stress during pregnancy and postpartum, though, understandably, this is not always feasible. Additionally, children of mothers who experience a lot of stress during pregnancy or postpartum may benefit from closer surveillance for the development of AD and other atopic diseases.

 

Additional References

1.         Dayam RM, Law JC, Goetbebuer RL, et al. Accelerated waning of immunity to SARS-CoV-2 mRNA vaccines in patients with immune mediated inflammatory diseases. JCI Insight. 2022 (Apr 26). Doi: 10.1172/jci.insight.159721   Source

2.         Medeiros-Ribeiro AC, Bonfiglioli KR, Domiciano DS, et al. Distinct impact of DMARD combination and monotherapy in immunogenicity of an inactivated SARS-CoV-2 vaccine in rheumatoid arthritis. Ann Rheum Dis. 2022;81:710-719. Doi: 10.1136/annrheumdis-2021-221735 Source

3.         McKenzie C, Silverberg JI. Maternal depression and atopic dermatitis in American children and adolescents. Dermatitis. 2020;31:75-80. Doi: 10.1097/DER.0000000000000548 Source

Jonathan Silverberg, MD, PHD, MPH
Now 2 years into the COVID-19 pandemic, we have learned much about how to prevent and manage infections across different patient populations. There remain many questions about how SARS-CoV-2 affects patients with atopic dermatitis (AD), and the impact of various therapies on SARS-CoV-2 infection clinical outcomes and immunity.

  • Dupilumab is a subcutaneous injection therapy that inhibits the interleukin 4-receptor alpha subunit. It was approved in the United States for the treatment of adults with moderate to severe AD in 2017 and has since been approved for children and adolescents down to 6 years of age. Ungar and colleagues studied the effects of dupilumab on SARS-CoV-2 antibody responses in patients with moderate to severe AD. They previously found that dupilumab was associated with milder COVID-19 illness. In this study, they similarly found that dupilumab was associated with lower immunoglobulin G (IgG) antibody levels to SARS-CoV-2, consistent with less severe COVID-19 illness. Future studies are needed to confirm these results. However, these results reassure that taking dupilumab does not pose any major harms in regard to COVID-19 outcomes.
  • My patients with AD ask me on an almost daily basis about whether they should get vaccinated for SARS-CoV-2. I recommended that my patients get vaccinated, based on data from vaccine studies. However, there has been a dearth of data on the efficacy and safety of SARS-CoV-2 specifically in AD patients. Kridin and colleagues performed a population-based cohort study including 77,682 adults with AD, of which 58,582 patients had completed two doses of the BioNTech-Pfizer SARS-CoV-2 mRNA vaccine. They found that patients with AD who received both vs no vaccine doses had significantly lower risk for COVID-19, hospitalization, and mortality. These are the best data to date in support of SARS-CoV-2 vaccination in patients with AD. Of note, there was no significant impact of immunosuppressive drugs on vaccine efficacy against COVID-19. However, previous studies in other immune-mediated disorders suggest that immunosuppressants may lower vaccine immune responses.1,2 Some authors have advocated for temporarily discontinuing immunosuppressive agents for 1-2 weeks before and after administering SARS-CoV-2 vaccines. Currently, there is insufficient evidence to make strong recommendations.

 

Numerous in utero and early-life risk factors for AD have been examined over the years. Maternal stress and depression have been considered as potential risk factors for AD in children.

  • My research group showed a while back that depression during pregnancy and in the postpartum period was associated with higher likelihood of AD in children.3
  • Kawaguchi and colleagues recently analyzed data from the Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study in Japan, including 8377 mother-child dyads where the child had not developed AD by the age of 1 year. They found that mothers with vs without psychological distress in both prenatal and postnatal periods or even only in the postnatal period had significantly increased risk of their children developing AD at 1-2 years of age. It seems prudent that mothers try to minimize stress during pregnancy and postpartum, though, understandably, this is not always feasible. Additionally, children of mothers who experience a lot of stress during pregnancy or postpartum may benefit from closer surveillance for the development of AD and other atopic diseases.

 

Additional References

1.         Dayam RM, Law JC, Goetbebuer RL, et al. Accelerated waning of immunity to SARS-CoV-2 mRNA vaccines in patients with immune mediated inflammatory diseases. JCI Insight. 2022 (Apr 26). Doi: 10.1172/jci.insight.159721   Source

2.         Medeiros-Ribeiro AC, Bonfiglioli KR, Domiciano DS, et al. Distinct impact of DMARD combination and monotherapy in immunogenicity of an inactivated SARS-CoV-2 vaccine in rheumatoid arthritis. Ann Rheum Dis. 2022;81:710-719. Doi: 10.1136/annrheumdis-2021-221735 Source

3.         McKenzie C, Silverberg JI. Maternal depression and atopic dermatitis in American children and adolescents. Dermatitis. 2020;31:75-80. Doi: 10.1097/DER.0000000000000548 Source

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Paxlovid doesn’t prevent infection in households, Pfizer says

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Paxlovid works as a treatment for COVID-19 but not as a preventive measure, particularly if you’ve been exposed to the coronavirus through a household member who is infected, according to a new announcement from Pfizer.

In a clinical trial, the oral antiviral tablets were tested for postexposure prophylactic use, or tested for how well they prevented a coronavirus infection in people exposed to the virus. Paxlovid somewhat reduced the risk of infection, but the results weren’t statistically significant.

“We designed the clinical development program for Paxlovid to be comprehensive and ambitious with the aim of being able to help combat COVID-19 in a very broad population of patients,” Albert Bourla, PhD, Pfizer’s chairman and CEO, said in the announcement.

“While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness,” he said.

The trial included nearly 3,000 adults who were living with someone who recently tested positive for COVID-19 and had symptoms. The people in the trial, who tested negative and didn’t have symptoms, were given either Paxlovid twice daily for 5 or 10 days or a placebo. The study recruitment began in September 2021 and was completed during the peak of the Omicron wave.

Those who took the 5-day course of Paxlovid were found to be 32% less likely to become infected than the placebo group. Those who took the 10-day treatment had a 37% risk reduction. But the results weren’t statistically significant and may have been because of chance.

“Traditionally, it’s been difficult to use small-molecule antivirals for true prophylaxis because the biology of treating infection is different from the biology of preventing infection,” Daniel Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told STAT News.

He also noted that the Omicron variant could have played a role.

“That hyperinfectiousness probably makes it more difficult to prevent infections,” Dr. Barouch said.

The safety data was consistent with that of previous studies, Pfizer said, which found that the treatment was about 90% effective at preventing hospitalization or death in COVID-19 patients with a high risk of severe illness if the pills were taken for 5 days soon after symptoms started.

Paxlovid is approved or authorized for conditional or emergency use in more than 60 countries to treat high-risk COVID-19 patients, Pfizer said. In the United States, the drug is authorized for emergency use for the treatment of mild to moderate COVID-19 in those aged 12 and older who face high risks for severe disease, hospitalization, or death.

The full study data will be released in coming months and submitted to a peer-reviewed publication, the company said. More details are on the ClinicalTrials.gov website (NCT05047601).

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

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Paxlovid works as a treatment for COVID-19 but not as a preventive measure, particularly if you’ve been exposed to the coronavirus through a household member who is infected, according to a new announcement from Pfizer.

In a clinical trial, the oral antiviral tablets were tested for postexposure prophylactic use, or tested for how well they prevented a coronavirus infection in people exposed to the virus. Paxlovid somewhat reduced the risk of infection, but the results weren’t statistically significant.

“We designed the clinical development program for Paxlovid to be comprehensive and ambitious with the aim of being able to help combat COVID-19 in a very broad population of patients,” Albert Bourla, PhD, Pfizer’s chairman and CEO, said in the announcement.

“While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness,” he said.

The trial included nearly 3,000 adults who were living with someone who recently tested positive for COVID-19 and had symptoms. The people in the trial, who tested negative and didn’t have symptoms, were given either Paxlovid twice daily for 5 or 10 days or a placebo. The study recruitment began in September 2021 and was completed during the peak of the Omicron wave.

Those who took the 5-day course of Paxlovid were found to be 32% less likely to become infected than the placebo group. Those who took the 10-day treatment had a 37% risk reduction. But the results weren’t statistically significant and may have been because of chance.

“Traditionally, it’s been difficult to use small-molecule antivirals for true prophylaxis because the biology of treating infection is different from the biology of preventing infection,” Daniel Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told STAT News.

He also noted that the Omicron variant could have played a role.

“That hyperinfectiousness probably makes it more difficult to prevent infections,” Dr. Barouch said.

The safety data was consistent with that of previous studies, Pfizer said, which found that the treatment was about 90% effective at preventing hospitalization or death in COVID-19 patients with a high risk of severe illness if the pills were taken for 5 days soon after symptoms started.

Paxlovid is approved or authorized for conditional or emergency use in more than 60 countries to treat high-risk COVID-19 patients, Pfizer said. In the United States, the drug is authorized for emergency use for the treatment of mild to moderate COVID-19 in those aged 12 and older who face high risks for severe disease, hospitalization, or death.

The full study data will be released in coming months and submitted to a peer-reviewed publication, the company said. More details are on the ClinicalTrials.gov website (NCT05047601).

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

Paxlovid works as a treatment for COVID-19 but not as a preventive measure, particularly if you’ve been exposed to the coronavirus through a household member who is infected, according to a new announcement from Pfizer.

In a clinical trial, the oral antiviral tablets were tested for postexposure prophylactic use, or tested for how well they prevented a coronavirus infection in people exposed to the virus. Paxlovid somewhat reduced the risk of infection, but the results weren’t statistically significant.

“We designed the clinical development program for Paxlovid to be comprehensive and ambitious with the aim of being able to help combat COVID-19 in a very broad population of patients,” Albert Bourla, PhD, Pfizer’s chairman and CEO, said in the announcement.

“While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness,” he said.

The trial included nearly 3,000 adults who were living with someone who recently tested positive for COVID-19 and had symptoms. The people in the trial, who tested negative and didn’t have symptoms, were given either Paxlovid twice daily for 5 or 10 days or a placebo. The study recruitment began in September 2021 and was completed during the peak of the Omicron wave.

Those who took the 5-day course of Paxlovid were found to be 32% less likely to become infected than the placebo group. Those who took the 10-day treatment had a 37% risk reduction. But the results weren’t statistically significant and may have been because of chance.

“Traditionally, it’s been difficult to use small-molecule antivirals for true prophylaxis because the biology of treating infection is different from the biology of preventing infection,” Daniel Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told STAT News.

He also noted that the Omicron variant could have played a role.

“That hyperinfectiousness probably makes it more difficult to prevent infections,” Dr. Barouch said.

The safety data was consistent with that of previous studies, Pfizer said, which found that the treatment was about 90% effective at preventing hospitalization or death in COVID-19 patients with a high risk of severe illness if the pills were taken for 5 days soon after symptoms started.

Paxlovid is approved or authorized for conditional or emergency use in more than 60 countries to treat high-risk COVID-19 patients, Pfizer said. In the United States, the drug is authorized for emergency use for the treatment of mild to moderate COVID-19 in those aged 12 and older who face high risks for severe disease, hospitalization, or death.

The full study data will be released in coming months and submitted to a peer-reviewed publication, the company said. More details are on the ClinicalTrials.gov website (NCT05047601).

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

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Higher ‘chemical restraint’ rates in Black psych patients in the ED

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Black patients presenting with psychiatric disorders to hospital emergency departments across the United States have significantly higher rates of chemical restraint than their White counterparts, new research shows.

Results of a national study showed Black patients presenting to the ED were 63% more likely to receive chemical sedation than White patients. The investigators also found White patients were more likely to receive chemical sedation at hospitals with a higher proportion of Black patients – a finding that suggests hospital demographics influence practice patterns and that structural racism may be a root cause.

“There is a large disparity in the rates at which patients who presented to EDs nationally in the United States are restrained by race. You are 63% more likely, for the same set of chief complaints, to be chemically sedated if you are Black versus if you’re White,” senior investigator Ari Friedman, MD, PhD, an assistant professor of emergency medicine, and medical ethics and health policy, University of Pennsylvania, Philadelphia, told this news organization.

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“The major mediator of that difference is the institution you are at – hospitals that primarily serve Black patients are more likely to chemically sedate their patients for these chief complaints – including White patients. So, it’s mediated by the practice pattern and environment,” Dr. Friedman added.

The study was published in the May issue of Annals of Epidemiology.
 

First large-scale study

Chemical sedation, also known as chemical restraint, is used to calm and help protect patients from harming themselves or others. Previous research on racial differences in the care of ED psychiatric patients with agitation suggests that there may be treatment disparities.

“Previous research from single institutions [has] shown that Black patients are more likely than White patients to be physically restrained, and this has been shown to be true among adult patients and pediatric patients,” lead author Utsha Khatri, MD, assistant professor of emergency medicine at the Icahn School of Medicine, New York, told this news organization.

Specifically, two single-institution studies within the last year revealed similar disparities, with higher rates of physical restraint for Black and Hispanic psychiatric patients in the ED. Another recent study showed an association with race, ethnicity, and pharmacological restraint use among pediatric patients presenting to the ED for mental health concerns.

“There has been work in psychiatry on disparities in this context, although there is less work in emergency departments,” said Dr. Friedman. “We looked across all U.S. EDs as opposed to within a single health system. The major trade-offs for us were that we weren’t able to observe restraint orders, which don’t find their way into national datasets, so we had to make some inferences based on the type of medications given.”

For the study the investigators analyzed data from 2008-2018 through the National Hospital Ambulatory Medical Survey (NHAMCS) database. They examined the association of race and the administration of chemical sedation, with either an antipsychotic or ketamine, in ED visits for psychiatric disorders. These were any visit where the reason for the visit was “symptoms referable to psychological and mental disorders.”

Of the 76.2 million total ED visits evaluated, the researchers found that Black patients presenting with a psychiatric disorder were significantly more likely to receive chemical sedation with antipsychotics or ketamine than White patients presenting with the same conditions (5.3% vs. 3.0%; P < .01). This difference remained significant when accounting for admission or transfer to psychiatric facilities.
 

 

 

Combatting the forces of racism

When researchers accounted for the percent of hospital population that was Black, they found that patient race no longer affected the likelihood of chemical restraint.

“We found the key source of this racial disparity in use of chemical sedation is accounted for by the fact that hospitals that treat a higher proportion of Black patients tend to use more sedation,” said Dr. Khatri.

“Our findings suggest that patients who present to hospitals that serve a patient population that is 60% Black would have [a] roughly 1.8 times likelihood of getting chemically sedated, compared with a hospital that serves a population that is 10% Black,” she added.

“When a hospital has fewer resources, they often don’t have the staff or time to de-escalate a patient in distress and can have to resort to chemical sedation more quickly than a hospital with ample staff and resources,” said Dr. Friedman in a release.

Dr. Khatri added that the study highlights the need to combat the forces of racism by focusing not just on provider bias but by addressing the “underlying structural issues that lead to Black patients getting worse care based on where they live.”

“Hospitals have unequal distribution of resources and quality, largely patterned on the racial makeup of their patients. Dedicated training and funding for de-escalation techniques as well as sufficient staffing and availability of outpatient mental health care may help keep both patients and staff safe by reducing the use of physical restraint and chemical sedation in appropriate circumstances,” said Dr. Khatri.

Dr. Friedman noted that there will always be a need for restraint use to facilitate rapid medical evaluation and stabilization of patients, but “we want to make it as humane, thoughtful, and rare as possible, and to have a large armamentarium of alternative strategies that can be equitably applied across emergency departments.”
 

Need for widespread, systemic change

Commenting on the findings, Regina James, MD, the American Psychiatric Association’s chief of Diversity and Health Equity and deputy medical director, said the large-scale study confirms the widespread existence of racial and ethnic disparities in patients with psychiatric disorders.

Courtesy American Psychiatric Association
Dr. Regina James

“This study and previous studies, not only in psychiatry but in other areas of medicine, all bring to light that there continues to be evidence of racial and ethnic disparities in health care, and this is consistent across a range of illnesses and health care services,” said Dr. James.

“It’s important that as we think about the solution, we also think about the etiology of the problem and the layers that have contributed to it – understanding, embracing, and recognizing that these differences didn’t just come up de novo. It’s policies, practices, and behaviors that got us to this point, and it’s going to be policies, practices, and behaviors that are going to move us away from this point,” noted Dr. James.

She added that future research should focus on further understanding which factors exacerbate agitation among patients and what resources directed at the hospital level, including de-escalation training, nursing staff, and waiting room crowding, may be effective at reducing the use of chemical sedation when clinically appropriate.

The authors and Dr. James report no relevant financial conflicts of interest.

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

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Black patients presenting with psychiatric disorders to hospital emergency departments across the United States have significantly higher rates of chemical restraint than their White counterparts, new research shows.

Results of a national study showed Black patients presenting to the ED were 63% more likely to receive chemical sedation than White patients. The investigators also found White patients were more likely to receive chemical sedation at hospitals with a higher proportion of Black patients – a finding that suggests hospital demographics influence practice patterns and that structural racism may be a root cause.

“There is a large disparity in the rates at which patients who presented to EDs nationally in the United States are restrained by race. You are 63% more likely, for the same set of chief complaints, to be chemically sedated if you are Black versus if you’re White,” senior investigator Ari Friedman, MD, PhD, an assistant professor of emergency medicine, and medical ethics and health policy, University of Pennsylvania, Philadelphia, told this news organization.

University of Pennsylvania
Dr. Ari Friedman


“The major mediator of that difference is the institution you are at – hospitals that primarily serve Black patients are more likely to chemically sedate their patients for these chief complaints – including White patients. So, it’s mediated by the practice pattern and environment,” Dr. Friedman added.

The study was published in the May issue of Annals of Epidemiology.
 

First large-scale study

Chemical sedation, also known as chemical restraint, is used to calm and help protect patients from harming themselves or others. Previous research on racial differences in the care of ED psychiatric patients with agitation suggests that there may be treatment disparities.

“Previous research from single institutions [has] shown that Black patients are more likely than White patients to be physically restrained, and this has been shown to be true among adult patients and pediatric patients,” lead author Utsha Khatri, MD, assistant professor of emergency medicine at the Icahn School of Medicine, New York, told this news organization.

Specifically, two single-institution studies within the last year revealed similar disparities, with higher rates of physical restraint for Black and Hispanic psychiatric patients in the ED. Another recent study showed an association with race, ethnicity, and pharmacological restraint use among pediatric patients presenting to the ED for mental health concerns.

“There has been work in psychiatry on disparities in this context, although there is less work in emergency departments,” said Dr. Friedman. “We looked across all U.S. EDs as opposed to within a single health system. The major trade-offs for us were that we weren’t able to observe restraint orders, which don’t find their way into national datasets, so we had to make some inferences based on the type of medications given.”

For the study the investigators analyzed data from 2008-2018 through the National Hospital Ambulatory Medical Survey (NHAMCS) database. They examined the association of race and the administration of chemical sedation, with either an antipsychotic or ketamine, in ED visits for psychiatric disorders. These were any visit where the reason for the visit was “symptoms referable to psychological and mental disorders.”

Of the 76.2 million total ED visits evaluated, the researchers found that Black patients presenting with a psychiatric disorder were significantly more likely to receive chemical sedation with antipsychotics or ketamine than White patients presenting with the same conditions (5.3% vs. 3.0%; P < .01). This difference remained significant when accounting for admission or transfer to psychiatric facilities.
 

 

 

Combatting the forces of racism

When researchers accounted for the percent of hospital population that was Black, they found that patient race no longer affected the likelihood of chemical restraint.

“We found the key source of this racial disparity in use of chemical sedation is accounted for by the fact that hospitals that treat a higher proportion of Black patients tend to use more sedation,” said Dr. Khatri.

“Our findings suggest that patients who present to hospitals that serve a patient population that is 60% Black would have [a] roughly 1.8 times likelihood of getting chemically sedated, compared with a hospital that serves a population that is 10% Black,” she added.

“When a hospital has fewer resources, they often don’t have the staff or time to de-escalate a patient in distress and can have to resort to chemical sedation more quickly than a hospital with ample staff and resources,” said Dr. Friedman in a release.

Dr. Khatri added that the study highlights the need to combat the forces of racism by focusing not just on provider bias but by addressing the “underlying structural issues that lead to Black patients getting worse care based on where they live.”

“Hospitals have unequal distribution of resources and quality, largely patterned on the racial makeup of their patients. Dedicated training and funding for de-escalation techniques as well as sufficient staffing and availability of outpatient mental health care may help keep both patients and staff safe by reducing the use of physical restraint and chemical sedation in appropriate circumstances,” said Dr. Khatri.

Dr. Friedman noted that there will always be a need for restraint use to facilitate rapid medical evaluation and stabilization of patients, but “we want to make it as humane, thoughtful, and rare as possible, and to have a large armamentarium of alternative strategies that can be equitably applied across emergency departments.”
 

Need for widespread, systemic change

Commenting on the findings, Regina James, MD, the American Psychiatric Association’s chief of Diversity and Health Equity and deputy medical director, said the large-scale study confirms the widespread existence of racial and ethnic disparities in patients with psychiatric disorders.

Courtesy American Psychiatric Association
Dr. Regina James

“This study and previous studies, not only in psychiatry but in other areas of medicine, all bring to light that there continues to be evidence of racial and ethnic disparities in health care, and this is consistent across a range of illnesses and health care services,” said Dr. James.

“It’s important that as we think about the solution, we also think about the etiology of the problem and the layers that have contributed to it – understanding, embracing, and recognizing that these differences didn’t just come up de novo. It’s policies, practices, and behaviors that got us to this point, and it’s going to be policies, practices, and behaviors that are going to move us away from this point,” noted Dr. James.

She added that future research should focus on further understanding which factors exacerbate agitation among patients and what resources directed at the hospital level, including de-escalation training, nursing staff, and waiting room crowding, may be effective at reducing the use of chemical sedation when clinically appropriate.

The authors and Dr. James report no relevant financial conflicts of interest.

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

Black patients presenting with psychiatric disorders to hospital emergency departments across the United States have significantly higher rates of chemical restraint than their White counterparts, new research shows.

Results of a national study showed Black patients presenting to the ED were 63% more likely to receive chemical sedation than White patients. The investigators also found White patients were more likely to receive chemical sedation at hospitals with a higher proportion of Black patients – a finding that suggests hospital demographics influence practice patterns and that structural racism may be a root cause.

“There is a large disparity in the rates at which patients who presented to EDs nationally in the United States are restrained by race. You are 63% more likely, for the same set of chief complaints, to be chemically sedated if you are Black versus if you’re White,” senior investigator Ari Friedman, MD, PhD, an assistant professor of emergency medicine, and medical ethics and health policy, University of Pennsylvania, Philadelphia, told this news organization.

University of Pennsylvania
Dr. Ari Friedman


“The major mediator of that difference is the institution you are at – hospitals that primarily serve Black patients are more likely to chemically sedate their patients for these chief complaints – including White patients. So, it’s mediated by the practice pattern and environment,” Dr. Friedman added.

The study was published in the May issue of Annals of Epidemiology.
 

First large-scale study

Chemical sedation, also known as chemical restraint, is used to calm and help protect patients from harming themselves or others. Previous research on racial differences in the care of ED psychiatric patients with agitation suggests that there may be treatment disparities.

“Previous research from single institutions [has] shown that Black patients are more likely than White patients to be physically restrained, and this has been shown to be true among adult patients and pediatric patients,” lead author Utsha Khatri, MD, assistant professor of emergency medicine at the Icahn School of Medicine, New York, told this news organization.

Specifically, two single-institution studies within the last year revealed similar disparities, with higher rates of physical restraint for Black and Hispanic psychiatric patients in the ED. Another recent study showed an association with race, ethnicity, and pharmacological restraint use among pediatric patients presenting to the ED for mental health concerns.

“There has been work in psychiatry on disparities in this context, although there is less work in emergency departments,” said Dr. Friedman. “We looked across all U.S. EDs as opposed to within a single health system. The major trade-offs for us were that we weren’t able to observe restraint orders, which don’t find their way into national datasets, so we had to make some inferences based on the type of medications given.”

For the study the investigators analyzed data from 2008-2018 through the National Hospital Ambulatory Medical Survey (NHAMCS) database. They examined the association of race and the administration of chemical sedation, with either an antipsychotic or ketamine, in ED visits for psychiatric disorders. These were any visit where the reason for the visit was “symptoms referable to psychological and mental disorders.”

Of the 76.2 million total ED visits evaluated, the researchers found that Black patients presenting with a psychiatric disorder were significantly more likely to receive chemical sedation with antipsychotics or ketamine than White patients presenting with the same conditions (5.3% vs. 3.0%; P < .01). This difference remained significant when accounting for admission or transfer to psychiatric facilities.
 

 

 

Combatting the forces of racism

When researchers accounted for the percent of hospital population that was Black, they found that patient race no longer affected the likelihood of chemical restraint.

“We found the key source of this racial disparity in use of chemical sedation is accounted for by the fact that hospitals that treat a higher proportion of Black patients tend to use more sedation,” said Dr. Khatri.

“Our findings suggest that patients who present to hospitals that serve a patient population that is 60% Black would have [a] roughly 1.8 times likelihood of getting chemically sedated, compared with a hospital that serves a population that is 10% Black,” she added.

“When a hospital has fewer resources, they often don’t have the staff or time to de-escalate a patient in distress and can have to resort to chemical sedation more quickly than a hospital with ample staff and resources,” said Dr. Friedman in a release.

Dr. Khatri added that the study highlights the need to combat the forces of racism by focusing not just on provider bias but by addressing the “underlying structural issues that lead to Black patients getting worse care based on where they live.”

“Hospitals have unequal distribution of resources and quality, largely patterned on the racial makeup of their patients. Dedicated training and funding for de-escalation techniques as well as sufficient staffing and availability of outpatient mental health care may help keep both patients and staff safe by reducing the use of physical restraint and chemical sedation in appropriate circumstances,” said Dr. Khatri.

Dr. Friedman noted that there will always be a need for restraint use to facilitate rapid medical evaluation and stabilization of patients, but “we want to make it as humane, thoughtful, and rare as possible, and to have a large armamentarium of alternative strategies that can be equitably applied across emergency departments.”
 

Need for widespread, systemic change

Commenting on the findings, Regina James, MD, the American Psychiatric Association’s chief of Diversity and Health Equity and deputy medical director, said the large-scale study confirms the widespread existence of racial and ethnic disparities in patients with psychiatric disorders.

Courtesy American Psychiatric Association
Dr. Regina James

“This study and previous studies, not only in psychiatry but in other areas of medicine, all bring to light that there continues to be evidence of racial and ethnic disparities in health care, and this is consistent across a range of illnesses and health care services,” said Dr. James.

“It’s important that as we think about the solution, we also think about the etiology of the problem and the layers that have contributed to it – understanding, embracing, and recognizing that these differences didn’t just come up de novo. It’s policies, practices, and behaviors that got us to this point, and it’s going to be policies, practices, and behaviors that are going to move us away from this point,” noted Dr. James.

She added that future research should focus on further understanding which factors exacerbate agitation among patients and what resources directed at the hospital level, including de-escalation training, nursing staff, and waiting room crowding, may be effective at reducing the use of chemical sedation when clinically appropriate.

The authors and Dr. James report no relevant financial conflicts of interest.

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

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Cutting dementia risk in atrial fibrillation: Does rhythm control strategy matter?

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The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. But a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD alone at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., said in an interview. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings at the annual scientific sessions of the Heart Rhythm Society.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ont., who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

The finding “strongly suggests these people were healthier and that there’s some sort of selection bias. They were at lower risk of death, they were at lower risk of dementia, and they were probably also at lower risk of strokemyocardial infarction, thrombosis, and cancer because they were just probably a little healthier than the others,” Dr. Conen said. The ablation and AAD groups “were two very different populations from the get-go.”

The analysis was based on U.S. insurance and Medicare claims data from AFib patients who either underwent catheter ablation after at least one AAD trial or filled prescriptions for at least two different antiarrhythmic agents in the year after AFib diagnosis. Patients with history of dementia, catheter or surgical AFib ablation, or a valve procedure were excluded.

The ablation and AAD-only groups each consisted of 19,066 patients after propensity matching, and the groups were balanced with respect to age, sex, type of insurance, CHA2DS2-VASc scores, and use of renin-angiotensin system inhibitors, oral anticoagulants, and antiplatelets.

The overall risk for dementia was 1.9% for the ablation group and 3.3% for AAD-only patients (hazard ratio, 0.59; 95% confidence interval, 0.52-0.67). Corresponding HRs by sex were 0.55 (95% CI, 0.46-0.66) for men and 0.60 (95% CI, 0.50-0.72) for women.

The competing risk for death was also significantly decreased in the ablation group (HR, 0.51; 95% CI, 0.46-0.55).

Dr. Zeitler pointed to a randomized trial now in the early stages called Neurocognition and Greater Maintenance of Sinus Rhythm in Atrial Fibrillation, or NOGGIN-AF, which will explore relationships between rhythm control therapy and dementia in patients with AFib, whether catheter ablation or AAD can mitigate that risk, and whether either strategy works better than the other, among other goals.

“I’m optimistic,” she said, “and I think it’s going to add to the growing motivations to get patients ablated more quickly and more broadly.”

The analysis was funded by Biosense-Webster. Dr. Zeitler disclosed consulting for Biosense-Webster and Arena Pharmaceuticals (now Pfizer); fees for speaking from Medtronic; and receiving research support from Boston Scientific, Sanofi, and Biosense-Webster. Dr. Conen has previously reported receiving speaker fees from Servier Canada.

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

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The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. But a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD alone at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., said in an interview. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings at the annual scientific sessions of the Heart Rhythm Society.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ont., who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

The finding “strongly suggests these people were healthier and that there’s some sort of selection bias. They were at lower risk of death, they were at lower risk of dementia, and they were probably also at lower risk of strokemyocardial infarction, thrombosis, and cancer because they were just probably a little healthier than the others,” Dr. Conen said. The ablation and AAD groups “were two very different populations from the get-go.”

The analysis was based on U.S. insurance and Medicare claims data from AFib patients who either underwent catheter ablation after at least one AAD trial or filled prescriptions for at least two different antiarrhythmic agents in the year after AFib diagnosis. Patients with history of dementia, catheter or surgical AFib ablation, or a valve procedure were excluded.

The ablation and AAD-only groups each consisted of 19,066 patients after propensity matching, and the groups were balanced with respect to age, sex, type of insurance, CHA2DS2-VASc scores, and use of renin-angiotensin system inhibitors, oral anticoagulants, and antiplatelets.

The overall risk for dementia was 1.9% for the ablation group and 3.3% for AAD-only patients (hazard ratio, 0.59; 95% confidence interval, 0.52-0.67). Corresponding HRs by sex were 0.55 (95% CI, 0.46-0.66) for men and 0.60 (95% CI, 0.50-0.72) for women.

The competing risk for death was also significantly decreased in the ablation group (HR, 0.51; 95% CI, 0.46-0.55).

Dr. Zeitler pointed to a randomized trial now in the early stages called Neurocognition and Greater Maintenance of Sinus Rhythm in Atrial Fibrillation, or NOGGIN-AF, which will explore relationships between rhythm control therapy and dementia in patients with AFib, whether catheter ablation or AAD can mitigate that risk, and whether either strategy works better than the other, among other goals.

“I’m optimistic,” she said, “and I think it’s going to add to the growing motivations to get patients ablated more quickly and more broadly.”

The analysis was funded by Biosense-Webster. Dr. Zeitler disclosed consulting for Biosense-Webster and Arena Pharmaceuticals (now Pfizer); fees for speaking from Medtronic; and receiving research support from Boston Scientific, Sanofi, and Biosense-Webster. Dr. Conen has previously reported receiving speaker fees from Servier Canada.

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

The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. But a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD alone at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., said in an interview. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings at the annual scientific sessions of the Heart Rhythm Society.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ont., who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

The finding “strongly suggests these people were healthier and that there’s some sort of selection bias. They were at lower risk of death, they were at lower risk of dementia, and they were probably also at lower risk of strokemyocardial infarction, thrombosis, and cancer because they were just probably a little healthier than the others,” Dr. Conen said. The ablation and AAD groups “were two very different populations from the get-go.”

The analysis was based on U.S. insurance and Medicare claims data from AFib patients who either underwent catheter ablation after at least one AAD trial or filled prescriptions for at least two different antiarrhythmic agents in the year after AFib diagnosis. Patients with history of dementia, catheter or surgical AFib ablation, or a valve procedure were excluded.

The ablation and AAD-only groups each consisted of 19,066 patients after propensity matching, and the groups were balanced with respect to age, sex, type of insurance, CHA2DS2-VASc scores, and use of renin-angiotensin system inhibitors, oral anticoagulants, and antiplatelets.

The overall risk for dementia was 1.9% for the ablation group and 3.3% for AAD-only patients (hazard ratio, 0.59; 95% confidence interval, 0.52-0.67). Corresponding HRs by sex were 0.55 (95% CI, 0.46-0.66) for men and 0.60 (95% CI, 0.50-0.72) for women.

The competing risk for death was also significantly decreased in the ablation group (HR, 0.51; 95% CI, 0.46-0.55).

Dr. Zeitler pointed to a randomized trial now in the early stages called Neurocognition and Greater Maintenance of Sinus Rhythm in Atrial Fibrillation, or NOGGIN-AF, which will explore relationships between rhythm control therapy and dementia in patients with AFib, whether catheter ablation or AAD can mitigate that risk, and whether either strategy works better than the other, among other goals.

“I’m optimistic,” she said, “and I think it’s going to add to the growing motivations to get patients ablated more quickly and more broadly.”

The analysis was funded by Biosense-Webster. Dr. Zeitler disclosed consulting for Biosense-Webster and Arena Pharmaceuticals (now Pfizer); fees for speaking from Medtronic; and receiving research support from Boston Scientific, Sanofi, and Biosense-Webster. Dr. Conen has previously reported receiving speaker fees from Servier Canada.

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

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CDC reports first human case of H5 bird flu in the U.S.

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Wed, 05/04/2022 - 14:25

A man who worked on a commercial poultry farm in Colorado has tested positive for avian influenza A(H5) virus, better known as H5 bird flu, the CDC announced on April 28.

This is the first case of H5 bird flu in humans in the United States and only the second case in the world, the CDC said in a news release. The first case was detected last December in a man who raised birds in the United Kingdom. That man had no symptoms.

The only symptom the man in Colorado reported was fatigue, the Colorado Department of Public Health and Environment (CDPHE) reported. He has recovered and is isolating and being treated with oseltamivir, an antiviral drug.

The CDC said the man was helping kill poultry that likely had the H5N1 bird flu.

He is a state prison inmate who was working on a commercial poultry farm in Montrose County in a prerelease employment program, the CDPHE said. The flock he was working with has been euthanized, and the response team and other inmates working on the farm were given protective equipment, the CDPHE said.

“Repeat testing on the person was negative for influenza,” the department said. “Because the person was in close contact with infected poultry, the virus may have been in the person’s nose without causing infection.”

This CDC said the case does not change the risk of bird flu for the general public, which is considered low. People who work with birds should continue to take safety precautions, such as wearing gloves when handling birds and avoiding birds that appear to be dead or ill, the CDC said.

“We want to reassure Coloradans that the risk to them is low,” said Rachel Herlihy, MD, state epidemiologist with the CDPHE. “I am grateful for the seamless collaboration between CDC, Department of Corrections, Department of Agriculture, and CDPHE, as we continue to monitor this virus and protect all Coloradans.”

The federal government says the H5N1 virus has been found in commercial and backyard birds in 29 states and in wild birds in 34 states since the first cases were detected in late 2021.

The CDC says it has tracked the health of 2,500 people exposed to birds infected with H5N1 and only found one case of human infection, in Colorado.

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

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A man who worked on a commercial poultry farm in Colorado has tested positive for avian influenza A(H5) virus, better known as H5 bird flu, the CDC announced on April 28.

This is the first case of H5 bird flu in humans in the United States and only the second case in the world, the CDC said in a news release. The first case was detected last December in a man who raised birds in the United Kingdom. That man had no symptoms.

The only symptom the man in Colorado reported was fatigue, the Colorado Department of Public Health and Environment (CDPHE) reported. He has recovered and is isolating and being treated with oseltamivir, an antiviral drug.

The CDC said the man was helping kill poultry that likely had the H5N1 bird flu.

He is a state prison inmate who was working on a commercial poultry farm in Montrose County in a prerelease employment program, the CDPHE said. The flock he was working with has been euthanized, and the response team and other inmates working on the farm were given protective equipment, the CDPHE said.

“Repeat testing on the person was negative for influenza,” the department said. “Because the person was in close contact with infected poultry, the virus may have been in the person’s nose without causing infection.”

This CDC said the case does not change the risk of bird flu for the general public, which is considered low. People who work with birds should continue to take safety precautions, such as wearing gloves when handling birds and avoiding birds that appear to be dead or ill, the CDC said.

“We want to reassure Coloradans that the risk to them is low,” said Rachel Herlihy, MD, state epidemiologist with the CDPHE. “I am grateful for the seamless collaboration between CDC, Department of Corrections, Department of Agriculture, and CDPHE, as we continue to monitor this virus and protect all Coloradans.”

The federal government says the H5N1 virus has been found in commercial and backyard birds in 29 states and in wild birds in 34 states since the first cases were detected in late 2021.

The CDC says it has tracked the health of 2,500 people exposed to birds infected with H5N1 and only found one case of human infection, in Colorado.

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

A man who worked on a commercial poultry farm in Colorado has tested positive for avian influenza A(H5) virus, better known as H5 bird flu, the CDC announced on April 28.

This is the first case of H5 bird flu in humans in the United States and only the second case in the world, the CDC said in a news release. The first case was detected last December in a man who raised birds in the United Kingdom. That man had no symptoms.

The only symptom the man in Colorado reported was fatigue, the Colorado Department of Public Health and Environment (CDPHE) reported. He has recovered and is isolating and being treated with oseltamivir, an antiviral drug.

The CDC said the man was helping kill poultry that likely had the H5N1 bird flu.

He is a state prison inmate who was working on a commercial poultry farm in Montrose County in a prerelease employment program, the CDPHE said. The flock he was working with has been euthanized, and the response team and other inmates working on the farm were given protective equipment, the CDPHE said.

“Repeat testing on the person was negative for influenza,” the department said. “Because the person was in close contact with infected poultry, the virus may have been in the person’s nose without causing infection.”

This CDC said the case does not change the risk of bird flu for the general public, which is considered low. People who work with birds should continue to take safety precautions, such as wearing gloves when handling birds and avoiding birds that appear to be dead or ill, the CDC said.

“We want to reassure Coloradans that the risk to them is low,” said Rachel Herlihy, MD, state epidemiologist with the CDPHE. “I am grateful for the seamless collaboration between CDC, Department of Corrections, Department of Agriculture, and CDPHE, as we continue to monitor this virus and protect all Coloradans.”

The federal government says the H5N1 virus has been found in commercial and backyard birds in 29 states and in wild birds in 34 states since the first cases were detected in late 2021.

The CDC says it has tracked the health of 2,500 people exposed to birds infected with H5N1 and only found one case of human infection, in Colorado.

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

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Traumatic brain injury linked to ‘striking’ risk for CVD, diabetes, brain disorders

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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.

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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.

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FROM JAMA NETWORK OPEN

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Publish date: May 2, 2022
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A tip of the cap

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Mon, 05/02/2022 - 14:06

“It was my wife’s walker, and I’ve never used one before. Sorry that I keep bumping into things.”

He was in his early 70s, recently widowed. He hadn’t needed a walker until yesterday, and his son had gotten it out of the garage where they’d just stowed it away. I showed him how to change the height setting on it so he didn’t have to lean so far over.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

His daughter was a longstanding patient of mine, and now she and her brother were worried about their dad. He’d been so healthy for years, taking care of their mother as she declined with cancer. Now, 2 months since her death, he’d started going downhill. He’d been, understandably, depressed and had lost some weight. A few weeks ago he’d had some nonspecific upper respiratory crud, and now they were worried he wasn’t eating. He’d gotten progressively weaker in the last few days, leading to their getting out the walker.

I knew my patient for several years. She wasn’t given to panicking, and was worried about her dad. By this time, I was too. Twenty-eight years of neurology training and practice puts you on the edge for some things. The “Spidey Sense,” as I’ve always called it, was tingling.

It took a very quick neurologic exam to find what I needed. He was indeed weak, had decreased distal sensation, and was completely areflexic. It was time to take the most-dreaded outpatient neurology gamble: The direct office-to-ER admission.

I told his daughter to take him to the nearby ER and scribbled a note that said “Probable Guillain-Barré. Needs urgent workup.” They were somewhat taken aback, as they had dinner plans that night, but his daughter knew me well enough to know that I don’t pull fire alarms for fun.

As soon as they’d left I called the ER doctor and told her what was coming. My hospital days ended 2 years ago, but I wanted to do everything I could to make sure the right ball was rolling.

Then my part was over. I had other patients waiting, tests to review, phone calls to make.

This is where the anxiety began. Nobody wants to be the person who cries wolf, or admits “dumps.” I’ve been on both sides of admissions, and bashing outpatient docs for unnecessary hospital referrals is a perennial pastime of inpatient care.

I was sure of my actions, but as the hours crept by some doubt came in. What if he got to the hospital and suddenly wasn’t weak? Or it was all from a medication error he’d made at home?

No one wants to claim they saw a flare when there wasn’t one, or get the reputation of being past their game. I was worried about the patient, but also began to worry I’d screwed up and missed something else.

I finished the day and went home. After closing out my usual end-of-the-day stuff I logged into the hospital system to see what was going on.

Normal cervical spine MRI. Spinal fluid had zero cells and elevated protein.

I breathed a sigh of relief and relaxed back into my chair. I’d made the right call. The hospital neurologist had ordered IVIG. The patient would hopefully recover. No one would think I’d screwed up a potentially serious case. And, somewhere in the back of my mind, the Sherlock Holmes inside every neurologist tipped his deerstalker cap at me and gave a slight nod.

There’s the relief of having done the right thing for the patient, having made the correct diagnosis, and, at the end of the day, being reassured that (some days at least) I still know what I’m doing.

It’s those feelings that brought me here and still keep me going.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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“It was my wife’s walker, and I’ve never used one before. Sorry that I keep bumping into things.”

He was in his early 70s, recently widowed. He hadn’t needed a walker until yesterday, and his son had gotten it out of the garage where they’d just stowed it away. I showed him how to change the height setting on it so he didn’t have to lean so far over.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

His daughter was a longstanding patient of mine, and now she and her brother were worried about their dad. He’d been so healthy for years, taking care of their mother as she declined with cancer. Now, 2 months since her death, he’d started going downhill. He’d been, understandably, depressed and had lost some weight. A few weeks ago he’d had some nonspecific upper respiratory crud, and now they were worried he wasn’t eating. He’d gotten progressively weaker in the last few days, leading to their getting out the walker.

I knew my patient for several years. She wasn’t given to panicking, and was worried about her dad. By this time, I was too. Twenty-eight years of neurology training and practice puts you on the edge for some things. The “Spidey Sense,” as I’ve always called it, was tingling.

It took a very quick neurologic exam to find what I needed. He was indeed weak, had decreased distal sensation, and was completely areflexic. It was time to take the most-dreaded outpatient neurology gamble: The direct office-to-ER admission.

I told his daughter to take him to the nearby ER and scribbled a note that said “Probable Guillain-Barré. Needs urgent workup.” They were somewhat taken aback, as they had dinner plans that night, but his daughter knew me well enough to know that I don’t pull fire alarms for fun.

As soon as they’d left I called the ER doctor and told her what was coming. My hospital days ended 2 years ago, but I wanted to do everything I could to make sure the right ball was rolling.

Then my part was over. I had other patients waiting, tests to review, phone calls to make.

This is where the anxiety began. Nobody wants to be the person who cries wolf, or admits “dumps.” I’ve been on both sides of admissions, and bashing outpatient docs for unnecessary hospital referrals is a perennial pastime of inpatient care.

I was sure of my actions, but as the hours crept by some doubt came in. What if he got to the hospital and suddenly wasn’t weak? Or it was all from a medication error he’d made at home?

No one wants to claim they saw a flare when there wasn’t one, or get the reputation of being past their game. I was worried about the patient, but also began to worry I’d screwed up and missed something else.

I finished the day and went home. After closing out my usual end-of-the-day stuff I logged into the hospital system to see what was going on.

Normal cervical spine MRI. Spinal fluid had zero cells and elevated protein.

I breathed a sigh of relief and relaxed back into my chair. I’d made the right call. The hospital neurologist had ordered IVIG. The patient would hopefully recover. No one would think I’d screwed up a potentially serious case. And, somewhere in the back of my mind, the Sherlock Holmes inside every neurologist tipped his deerstalker cap at me and gave a slight nod.

There’s the relief of having done the right thing for the patient, having made the correct diagnosis, and, at the end of the day, being reassured that (some days at least) I still know what I’m doing.

It’s those feelings that brought me here and still keep me going.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

“It was my wife’s walker, and I’ve never used one before. Sorry that I keep bumping into things.”

He was in his early 70s, recently widowed. He hadn’t needed a walker until yesterday, and his son had gotten it out of the garage where they’d just stowed it away. I showed him how to change the height setting on it so he didn’t have to lean so far over.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block

His daughter was a longstanding patient of mine, and now she and her brother were worried about their dad. He’d been so healthy for years, taking care of their mother as she declined with cancer. Now, 2 months since her death, he’d started going downhill. He’d been, understandably, depressed and had lost some weight. A few weeks ago he’d had some nonspecific upper respiratory crud, and now they were worried he wasn’t eating. He’d gotten progressively weaker in the last few days, leading to their getting out the walker.

I knew my patient for several years. She wasn’t given to panicking, and was worried about her dad. By this time, I was too. Twenty-eight years of neurology training and practice puts you on the edge for some things. The “Spidey Sense,” as I’ve always called it, was tingling.

It took a very quick neurologic exam to find what I needed. He was indeed weak, had decreased distal sensation, and was completely areflexic. It was time to take the most-dreaded outpatient neurology gamble: The direct office-to-ER admission.

I told his daughter to take him to the nearby ER and scribbled a note that said “Probable Guillain-Barré. Needs urgent workup.” They were somewhat taken aback, as they had dinner plans that night, but his daughter knew me well enough to know that I don’t pull fire alarms for fun.

As soon as they’d left I called the ER doctor and told her what was coming. My hospital days ended 2 years ago, but I wanted to do everything I could to make sure the right ball was rolling.

Then my part was over. I had other patients waiting, tests to review, phone calls to make.

This is where the anxiety began. Nobody wants to be the person who cries wolf, or admits “dumps.” I’ve been on both sides of admissions, and bashing outpatient docs for unnecessary hospital referrals is a perennial pastime of inpatient care.

I was sure of my actions, but as the hours crept by some doubt came in. What if he got to the hospital and suddenly wasn’t weak? Or it was all from a medication error he’d made at home?

No one wants to claim they saw a flare when there wasn’t one, or get the reputation of being past their game. I was worried about the patient, but also began to worry I’d screwed up and missed something else.

I finished the day and went home. After closing out my usual end-of-the-day stuff I logged into the hospital system to see what was going on.

Normal cervical spine MRI. Spinal fluid had zero cells and elevated protein.

I breathed a sigh of relief and relaxed back into my chair. I’d made the right call. The hospital neurologist had ordered IVIG. The patient would hopefully recover. No one would think I’d screwed up a potentially serious case. And, somewhere in the back of my mind, the Sherlock Holmes inside every neurologist tipped his deerstalker cap at me and gave a slight nod.

There’s the relief of having done the right thing for the patient, having made the correct diagnosis, and, at the end of the day, being reassured that (some days at least) I still know what I’m doing.

It’s those feelings that brought me here and still keep me going.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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