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ACS WiSC seeks ACS Fellows to serve as new members
The mission of the WiSC is to enable women surgeons of all ages, specialties, and practice types to develop their individual potential as professionals; promote an environment that fosters inclusion, respect, and success; develop, encourage, and advance women surgeons as leaders; and provide a forum and networking opportunities to enhance women’s surgical career satisfaction.
Surgeons interested in advancing the role of women in the ACS and encouraging and mentoring women in surgery should apply. Nominations are open to both men and women, and the committee encourages representation by individuals of diverse cultural, racial, and ethnic backgrounds.
Read the full eligibility requirements and how to apply on the ACS website at facs.org/about-acs/governance/acs-committees/women-in-surgery-committee/wisc-call. Eligible candidates will be selected and notified by the committee in June, and will be invited to attend the October 22 meeting of the WiSC, held in conjunction with Clinical Congress 2018 in Boston, MA. Travel reimbursement will not be provided.
Apply online at www.surveymonkey.com/r/2018WiSCMbrApp. Applications are due May 31, 2018. Questions can be directed to Connie Bura at [email protected].
The mission of the WiSC is to enable women surgeons of all ages, specialties, and practice types to develop their individual potential as professionals; promote an environment that fosters inclusion, respect, and success; develop, encourage, and advance women surgeons as leaders; and provide a forum and networking opportunities to enhance women’s surgical career satisfaction.
Surgeons interested in advancing the role of women in the ACS and encouraging and mentoring women in surgery should apply. Nominations are open to both men and women, and the committee encourages representation by individuals of diverse cultural, racial, and ethnic backgrounds.
Read the full eligibility requirements and how to apply on the ACS website at facs.org/about-acs/governance/acs-committees/women-in-surgery-committee/wisc-call. Eligible candidates will be selected and notified by the committee in June, and will be invited to attend the October 22 meeting of the WiSC, held in conjunction with Clinical Congress 2018 in Boston, MA. Travel reimbursement will not be provided.
Apply online at www.surveymonkey.com/r/2018WiSCMbrApp. Applications are due May 31, 2018. Questions can be directed to Connie Bura at [email protected].
The mission of the WiSC is to enable women surgeons of all ages, specialties, and practice types to develop their individual potential as professionals; promote an environment that fosters inclusion, respect, and success; develop, encourage, and advance women surgeons as leaders; and provide a forum and networking opportunities to enhance women’s surgical career satisfaction.
Surgeons interested in advancing the role of women in the ACS and encouraging and mentoring women in surgery should apply. Nominations are open to both men and women, and the committee encourages representation by individuals of diverse cultural, racial, and ethnic backgrounds.
Read the full eligibility requirements and how to apply on the ACS website at facs.org/about-acs/governance/acs-committees/women-in-surgery-committee/wisc-call. Eligible candidates will be selected and notified by the committee in June, and will be invited to attend the October 22 meeting of the WiSC, held in conjunction with Clinical Congress 2018 in Boston, MA. Travel reimbursement will not be provided.
Apply online at www.surveymonkey.com/r/2018WiSCMbrApp. Applications are due May 31, 2018. Questions can be directed to Connie Bura at [email protected].
Disproportionately low U.S. research funding targets gynecologic cancers
NEW ORLEANS – The National Cancer Institute is woefully underfunding gynecologic cancer research, compared with several other cancer types, when the money the institute is spending annually is factored by the incidence and lethal impact of each cancer using U.S. data from 2007 to 2014.
That period featured “systematic and pervasive underfunding of gynecologic cancers in relation to other cancer sites,” Ryan J. Spencer, MD, said at the annual meeting of the Society of Gynecologic Oncology. The trends over the period he studied worsened with time and pose the risk that progress in gynecologic cancers – uterine, cervical, and ovarian – will “lag behind” other cancers’ progress in prevention, treatment, and improved survival, said Dr. Spencer, a gynecologic oncologist at the University of Wisconsin–Madison.
Additional time trend analyses showed that the annual funding-to-lethality score for each of the three gynecologic cancers declined during the period studied.
“We must do everything we can to reverse these trends,” Dr. Spencer concluded.
SOURCE: Spencer R et al. SGO 2018, Abstract 3.
The data reported by Dr. Spencer and his associates are very sobering. They present an elegant analysis that documents a lag and decline in funding for gynecologic cancers that factors in the lethality of various cancers. By several other measures as well, funding for research into gynecologic cancers has been slipping in recent years. During 2011-2016, we saw a 90% drop in enrollment into U.S. clinical trials for gynecologic cancers, and from a peak in 2012-2016 the total number of trials for gynecologic cancers fell by more than two-thirds.
Paola A. Gehrig, MD , is professor of ob.gyn. and director of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no disclosures. She made these comments as designated discussant for the report.
The data reported by Dr. Spencer and his associates are very sobering. They present an elegant analysis that documents a lag and decline in funding for gynecologic cancers that factors in the lethality of various cancers. By several other measures as well, funding for research into gynecologic cancers has been slipping in recent years. During 2011-2016, we saw a 90% drop in enrollment into U.S. clinical trials for gynecologic cancers, and from a peak in 2012-2016 the total number of trials for gynecologic cancers fell by more than two-thirds.
Paola A. Gehrig, MD , is professor of ob.gyn. and director of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no disclosures. She made these comments as designated discussant for the report.
The data reported by Dr. Spencer and his associates are very sobering. They present an elegant analysis that documents a lag and decline in funding for gynecologic cancers that factors in the lethality of various cancers. By several other measures as well, funding for research into gynecologic cancers has been slipping in recent years. During 2011-2016, we saw a 90% drop in enrollment into U.S. clinical trials for gynecologic cancers, and from a peak in 2012-2016 the total number of trials for gynecologic cancers fell by more than two-thirds.
Paola A. Gehrig, MD , is professor of ob.gyn. and director of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no disclosures. She made these comments as designated discussant for the report.
NEW ORLEANS – The National Cancer Institute is woefully underfunding gynecologic cancer research, compared with several other cancer types, when the money the institute is spending annually is factored by the incidence and lethal impact of each cancer using U.S. data from 2007 to 2014.
That period featured “systematic and pervasive underfunding of gynecologic cancers in relation to other cancer sites,” Ryan J. Spencer, MD, said at the annual meeting of the Society of Gynecologic Oncology. The trends over the period he studied worsened with time and pose the risk that progress in gynecologic cancers – uterine, cervical, and ovarian – will “lag behind” other cancers’ progress in prevention, treatment, and improved survival, said Dr. Spencer, a gynecologic oncologist at the University of Wisconsin–Madison.
Additional time trend analyses showed that the annual funding-to-lethality score for each of the three gynecologic cancers declined during the period studied.
“We must do everything we can to reverse these trends,” Dr. Spencer concluded.
SOURCE: Spencer R et al. SGO 2018, Abstract 3.
NEW ORLEANS – The National Cancer Institute is woefully underfunding gynecologic cancer research, compared with several other cancer types, when the money the institute is spending annually is factored by the incidence and lethal impact of each cancer using U.S. data from 2007 to 2014.
That period featured “systematic and pervasive underfunding of gynecologic cancers in relation to other cancer sites,” Ryan J. Spencer, MD, said at the annual meeting of the Society of Gynecologic Oncology. The trends over the period he studied worsened with time and pose the risk that progress in gynecologic cancers – uterine, cervical, and ovarian – will “lag behind” other cancers’ progress in prevention, treatment, and improved survival, said Dr. Spencer, a gynecologic oncologist at the University of Wisconsin–Madison.
Additional time trend analyses showed that the annual funding-to-lethality score for each of the three gynecologic cancers declined during the period studied.
“We must do everything we can to reverse these trends,” Dr. Spencer concluded.
SOURCE: Spencer R et al. SGO 2018, Abstract 3.
REPORTING FROM SGO 2018
Key clinical point: The National Cancer Institute underfunds gynecologic cancer research.
Major finding: Ovarian cancer research funding averaged $97,000 per year of life lost per 100 new cases, compared with $1.8 million for both breast and prostate cancer.
Study details: A review of U.S. data collected by the National Cancer Institute during 2007-2014.
Disclosures: Dr. Spencer had no disclosures.
Source: Spencer R et al. SGO 2018, Abstract 3.
Hyaluronic acid filler preferred for infraorbital hollowing
Most patients who responded to surveys reported being satisfied after off-label treatment with Juvéderm Voluma XC hyaluronic acid filler for infraorbital hollowing, a study finds.
Adverse effects were reported in 12% of patients.
The treatment’s “high patient satisfaction profile and a similar safety profile among other soft-tissue fillers make it an excellent adjunct in the plastic surgeon’s armamentarium,” reported Michael B. Hall, MD, and his associates at their private, ambulatory facial plastic and reconstructive surgery practice in Austin, Texas, in JAMA Facial Plastic Surgery.
According to the researchers, the Food and Drug Administration has not approved any soft-tissue fillers for the periorbital complex. At their practice, Dr. Hall and his associates treat infraorbital hollows with Juvéderm Voluma XC, which is approved by the FDA for certain types of cheek augmentation. Other studies have examined Belotero or Restylane as treatments for building volume in the periorbital area, the authors wrote, but research into cosmetic injections of Juvéderm Voluma XC is lacking.
For the new study, the researchers retrospectively analyzed the cases of 101 patients (aged 32-75 years, with average age of 54 years; 89% female; 54% Fitzpatrick skin type II; racial breakdown not reported) who were electively treated with the filler for infraorbital hollowing in 2016 and 2017. The patients received an average 1 mL of the treatment gel.
The patients were photographed and answered surveys, and they were evaluated using the Allergan Infraorbital Hollows Scale. Follow-up time averaged 12 months.
A total of 18 patients (18%) required touch-up within 3 months, and 2 required multiple touch-ups. A total of 12 subjects (12%) had adverse effects (including 3 who had more than one), which included bruising (10%), contour irregularities (2%), edema (3%) and Tyndall effect (1%). Hyaluronidase was required in 3 patients (3%), and 24 patients sought further treatment after 3 months.
The researchers sent two satisfaction surveys to the participants. A total of 41% responded to the FACE-Q Satisfaction With Eyes survey, and 42% responded to the FACE-Q Satisfaction With Decision survey.
Depending on the question, 70%-85% of the respondents to the Satisfaction With Eyes survey said they were “definitely” or “somewhat” satisfied with the treatment outcome.
The highest levels of dissatisfaction came in response to a questions about whether the subjects felt their eyes looked alert (not tired) or youthful. The highest levels of satisfaction were in response to questions about whether the subjects were happy with the shape, attractiveness, and openness of their eyes.
Depending on the question, 73%-85% of the subjects who took the Satisfaction With Decision survey reported that they “definitely” or “somewhat” agree with positive statements about the treatment. While differences were small, they agreed the most with a statement saying the procedure was “worth the time and effort.”
No external funding or remuneration was received. The study authors reported no relevant disclosures.
SOURCE: Hall MB et al. JAMA Facial Plast Surg. 2018 Apr 5. doi:10.1001/jamafacial.2018.0230.
Most patients who responded to surveys reported being satisfied after off-label treatment with Juvéderm Voluma XC hyaluronic acid filler for infraorbital hollowing, a study finds.
Adverse effects were reported in 12% of patients.
The treatment’s “high patient satisfaction profile and a similar safety profile among other soft-tissue fillers make it an excellent adjunct in the plastic surgeon’s armamentarium,” reported Michael B. Hall, MD, and his associates at their private, ambulatory facial plastic and reconstructive surgery practice in Austin, Texas, in JAMA Facial Plastic Surgery.
According to the researchers, the Food and Drug Administration has not approved any soft-tissue fillers for the periorbital complex. At their practice, Dr. Hall and his associates treat infraorbital hollows with Juvéderm Voluma XC, which is approved by the FDA for certain types of cheek augmentation. Other studies have examined Belotero or Restylane as treatments for building volume in the periorbital area, the authors wrote, but research into cosmetic injections of Juvéderm Voluma XC is lacking.
For the new study, the researchers retrospectively analyzed the cases of 101 patients (aged 32-75 years, with average age of 54 years; 89% female; 54% Fitzpatrick skin type II; racial breakdown not reported) who were electively treated with the filler for infraorbital hollowing in 2016 and 2017. The patients received an average 1 mL of the treatment gel.
The patients were photographed and answered surveys, and they were evaluated using the Allergan Infraorbital Hollows Scale. Follow-up time averaged 12 months.
A total of 18 patients (18%) required touch-up within 3 months, and 2 required multiple touch-ups. A total of 12 subjects (12%) had adverse effects (including 3 who had more than one), which included bruising (10%), contour irregularities (2%), edema (3%) and Tyndall effect (1%). Hyaluronidase was required in 3 patients (3%), and 24 patients sought further treatment after 3 months.
The researchers sent two satisfaction surveys to the participants. A total of 41% responded to the FACE-Q Satisfaction With Eyes survey, and 42% responded to the FACE-Q Satisfaction With Decision survey.
Depending on the question, 70%-85% of the respondents to the Satisfaction With Eyes survey said they were “definitely” or “somewhat” satisfied with the treatment outcome.
The highest levels of dissatisfaction came in response to a questions about whether the subjects felt their eyes looked alert (not tired) or youthful. The highest levels of satisfaction were in response to questions about whether the subjects were happy with the shape, attractiveness, and openness of their eyes.
Depending on the question, 73%-85% of the subjects who took the Satisfaction With Decision survey reported that they “definitely” or “somewhat” agree with positive statements about the treatment. While differences were small, they agreed the most with a statement saying the procedure was “worth the time and effort.”
No external funding or remuneration was received. The study authors reported no relevant disclosures.
SOURCE: Hall MB et al. JAMA Facial Plast Surg. 2018 Apr 5. doi:10.1001/jamafacial.2018.0230.
Most patients who responded to surveys reported being satisfied after off-label treatment with Juvéderm Voluma XC hyaluronic acid filler for infraorbital hollowing, a study finds.
Adverse effects were reported in 12% of patients.
The treatment’s “high patient satisfaction profile and a similar safety profile among other soft-tissue fillers make it an excellent adjunct in the plastic surgeon’s armamentarium,” reported Michael B. Hall, MD, and his associates at their private, ambulatory facial plastic and reconstructive surgery practice in Austin, Texas, in JAMA Facial Plastic Surgery.
According to the researchers, the Food and Drug Administration has not approved any soft-tissue fillers for the periorbital complex. At their practice, Dr. Hall and his associates treat infraorbital hollows with Juvéderm Voluma XC, which is approved by the FDA for certain types of cheek augmentation. Other studies have examined Belotero or Restylane as treatments for building volume in the periorbital area, the authors wrote, but research into cosmetic injections of Juvéderm Voluma XC is lacking.
For the new study, the researchers retrospectively analyzed the cases of 101 patients (aged 32-75 years, with average age of 54 years; 89% female; 54% Fitzpatrick skin type II; racial breakdown not reported) who were electively treated with the filler for infraorbital hollowing in 2016 and 2017. The patients received an average 1 mL of the treatment gel.
The patients were photographed and answered surveys, and they were evaluated using the Allergan Infraorbital Hollows Scale. Follow-up time averaged 12 months.
A total of 18 patients (18%) required touch-up within 3 months, and 2 required multiple touch-ups. A total of 12 subjects (12%) had adverse effects (including 3 who had more than one), which included bruising (10%), contour irregularities (2%), edema (3%) and Tyndall effect (1%). Hyaluronidase was required in 3 patients (3%), and 24 patients sought further treatment after 3 months.
The researchers sent two satisfaction surveys to the participants. A total of 41% responded to the FACE-Q Satisfaction With Eyes survey, and 42% responded to the FACE-Q Satisfaction With Decision survey.
Depending on the question, 70%-85% of the respondents to the Satisfaction With Eyes survey said they were “definitely” or “somewhat” satisfied with the treatment outcome.
The highest levels of dissatisfaction came in response to a questions about whether the subjects felt their eyes looked alert (not tired) or youthful. The highest levels of satisfaction were in response to questions about whether the subjects were happy with the shape, attractiveness, and openness of their eyes.
Depending on the question, 73%-85% of the subjects who took the Satisfaction With Decision survey reported that they “definitely” or “somewhat” agree with positive statements about the treatment. While differences were small, they agreed the most with a statement saying the procedure was “worth the time and effort.”
No external funding or remuneration was received. The study authors reported no relevant disclosures.
SOURCE: Hall MB et al. JAMA Facial Plast Surg. 2018 Apr 5. doi:10.1001/jamafacial.2018.0230.
FROM JAMA FACIAL PLASTIC SURGERY
Key clinical point:
Major finding: Adverse effects occurred at a rate of 12%, and most who responded to surveys reported satisfaction postprocedure (70%-85%).
Study details: A retrospective observational study of 101 patients.
Disclosures: No external funding or remuneration was received. The study authors reported no relevant disclosures.
Source: Hall MB et al. JAMA Facial Plast Surg. 2018 Apr 5. doi:10.1001/jamafacial.2018.0230.
Cancer clinics continue to close and consolidate
and increased costs in the process, according to the Community Oncology Alliance.
From 2008 to 2018, a total of 1,653 oncology clinics and/or practices were affected in the following ways: 423 clinics closed, 658 practices were acquired by hospitals, 168 practices merged or were acquired by a corporate entity, 359 practices reported that they were struggling financially, and 45 practices sent patients elsewhere for chemotherapy, the COA said its 2018 Practice Impact Report.
“The shifting and shrinking community cancer care system reduces access to cancer care, inflates spending at the more expensive hospital setting, and is a disservice to patients, their caregivers, and support networks,” Jeff Vacirca, MD, president of COA said in a written statement.
Crunching the numbers another way shows that 13.8 practices a month have closed, been acquired by hospitals, or undergone mergers since 2008. The number of community clinics that have closed increased by 11.3% since the 2016 Practice Impact Report, and consolidations with hospitals rose by 8%. Practices with financial struggles were down by 7.9% from 2016, “which is proportional to the number of practices that have been acquired or moved into the hospital setting,” the COA said in the 2018 report.
“No one can look at [recent] trends and say that there hasn’t been a clear and negative dismantling of our cancer care system over the last decade,” Ted Okon, executive director of COA, said in the statement accompanying the report. “This situation is the direct result of the misguided 340B [drug discount program] and [the 2013] sequester cut allowed to take place by our elected officials in Washington. The pressures of these misguided public policies have been a one-two punch, pushing and pulling community oncology practices to close, consolidate, or be acquired by hospitals, all at the expense of patients.”
and increased costs in the process, according to the Community Oncology Alliance.
From 2008 to 2018, a total of 1,653 oncology clinics and/or practices were affected in the following ways: 423 clinics closed, 658 practices were acquired by hospitals, 168 practices merged or were acquired by a corporate entity, 359 practices reported that they were struggling financially, and 45 practices sent patients elsewhere for chemotherapy, the COA said its 2018 Practice Impact Report.
“The shifting and shrinking community cancer care system reduces access to cancer care, inflates spending at the more expensive hospital setting, and is a disservice to patients, their caregivers, and support networks,” Jeff Vacirca, MD, president of COA said in a written statement.
Crunching the numbers another way shows that 13.8 practices a month have closed, been acquired by hospitals, or undergone mergers since 2008. The number of community clinics that have closed increased by 11.3% since the 2016 Practice Impact Report, and consolidations with hospitals rose by 8%. Practices with financial struggles were down by 7.9% from 2016, “which is proportional to the number of practices that have been acquired or moved into the hospital setting,” the COA said in the 2018 report.
“No one can look at [recent] trends and say that there hasn’t been a clear and negative dismantling of our cancer care system over the last decade,” Ted Okon, executive director of COA, said in the statement accompanying the report. “This situation is the direct result of the misguided 340B [drug discount program] and [the 2013] sequester cut allowed to take place by our elected officials in Washington. The pressures of these misguided public policies have been a one-two punch, pushing and pulling community oncology practices to close, consolidate, or be acquired by hospitals, all at the expense of patients.”
and increased costs in the process, according to the Community Oncology Alliance.
From 2008 to 2018, a total of 1,653 oncology clinics and/or practices were affected in the following ways: 423 clinics closed, 658 practices were acquired by hospitals, 168 practices merged or were acquired by a corporate entity, 359 practices reported that they were struggling financially, and 45 practices sent patients elsewhere for chemotherapy, the COA said its 2018 Practice Impact Report.
“The shifting and shrinking community cancer care system reduces access to cancer care, inflates spending at the more expensive hospital setting, and is a disservice to patients, their caregivers, and support networks,” Jeff Vacirca, MD, president of COA said in a written statement.
Crunching the numbers another way shows that 13.8 practices a month have closed, been acquired by hospitals, or undergone mergers since 2008. The number of community clinics that have closed increased by 11.3% since the 2016 Practice Impact Report, and consolidations with hospitals rose by 8%. Practices with financial struggles were down by 7.9% from 2016, “which is proportional to the number of practices that have been acquired or moved into the hospital setting,” the COA said in the 2018 report.
“No one can look at [recent] trends and say that there hasn’t been a clear and negative dismantling of our cancer care system over the last decade,” Ted Okon, executive director of COA, said in the statement accompanying the report. “This situation is the direct result of the misguided 340B [drug discount program] and [the 2013] sequester cut allowed to take place by our elected officials in Washington. The pressures of these misguided public policies have been a one-two punch, pushing and pulling community oncology practices to close, consolidate, or be acquired by hospitals, all at the expense of patients.”
More Older Patients Should be Included in Epilepsy Drug Trials
Too few older adults are included in antiepileptic drug trials according to a systematic review and meta-analysis that included 184 studies.
- In 1991 to 1992, the mean age of patients included in clinical trials was 27 years, which had increased to about 42 years in 2015 to 2016.
- In 83 studies (44%), inclusion criteria included a maximum age limit.
- The requirement for limiting a participant’s maximum age did not decline significantly over time between the two time periods (r = 0.072, P=.816).
- The only disease-related exclusion criteria for entry into a clinical trial for antiepileptic drugs that was linked to a drop in the average age of enrolled patients were neurological conditions other than epilepsy.
Desmarais P, Miville C, Milán-Tomás A, et al. Age representation in antiepileptic drug trials: a systematic review and meta-analysis. Epilepsy Res. 2018;142:9-15.
Too few older adults are included in antiepileptic drug trials according to a systematic review and meta-analysis that included 184 studies.
- In 1991 to 1992, the mean age of patients included in clinical trials was 27 years, which had increased to about 42 years in 2015 to 2016.
- In 83 studies (44%), inclusion criteria included a maximum age limit.
- The requirement for limiting a participant’s maximum age did not decline significantly over time between the two time periods (r = 0.072, P=.816).
- The only disease-related exclusion criteria for entry into a clinical trial for antiepileptic drugs that was linked to a drop in the average age of enrolled patients were neurological conditions other than epilepsy.
Desmarais P, Miville C, Milán-Tomás A, et al. Age representation in antiepileptic drug trials: a systematic review and meta-analysis. Epilepsy Res. 2018;142:9-15.
Too few older adults are included in antiepileptic drug trials according to a systematic review and meta-analysis that included 184 studies.
- In 1991 to 1992, the mean age of patients included in clinical trials was 27 years, which had increased to about 42 years in 2015 to 2016.
- In 83 studies (44%), inclusion criteria included a maximum age limit.
- The requirement for limiting a participant’s maximum age did not decline significantly over time between the two time periods (r = 0.072, P=.816).
- The only disease-related exclusion criteria for entry into a clinical trial for antiepileptic drugs that was linked to a drop in the average age of enrolled patients were neurological conditions other than epilepsy.
Desmarais P, Miville C, Milán-Tomás A, et al. Age representation in antiepileptic drug trials: a systematic review and meta-analysis. Epilepsy Res. 2018;142:9-15.
New Definitions for NORSE and FIRES
An international team of experts has published standardized definitions of several seizure-related disorders, including new-onset refractory status epilepticus (NORSE), febrile infection-related epilepsy syndrome (FIRES), and related disorders.
- NORSE is described as a clinical presentation rather than a specific diagnosis.
- NORSE occurs in a patient who is not experiencing active epilepsy or any other preexisting neurological disorder.
- In NORSE, the patient does not have a clear acute or active structural, toxic or metabolic cause of their condition.
- The expert group defined FIRES as a subtype of NORSE that involves a prior febrile infection that started between 2 weeks and 24 hours before the refractory status epilepticus began.
- The experts also offered standardized definitions for infantile hemiconvulsion-hemiplegia and epilepsy syndrome (IHHE) and for prolonged, refractory and super-refractory status epilepticus.
Hirsch LJ, Gaspard N, van Baalen A, et al. Proposed consensus definitions for new-onset refractory status epilepticus (NORSE), febrile infection-related epilepsy syndrome (FIRES), and related conditions. Epilepsia. 2018;59(4):739-744.
An international team of experts has published standardized definitions of several seizure-related disorders, including new-onset refractory status epilepticus (NORSE), febrile infection-related epilepsy syndrome (FIRES), and related disorders.
- NORSE is described as a clinical presentation rather than a specific diagnosis.
- NORSE occurs in a patient who is not experiencing active epilepsy or any other preexisting neurological disorder.
- In NORSE, the patient does not have a clear acute or active structural, toxic or metabolic cause of their condition.
- The expert group defined FIRES as a subtype of NORSE that involves a prior febrile infection that started between 2 weeks and 24 hours before the refractory status epilepticus began.
- The experts also offered standardized definitions for infantile hemiconvulsion-hemiplegia and epilepsy syndrome (IHHE) and for prolonged, refractory and super-refractory status epilepticus.
Hirsch LJ, Gaspard N, van Baalen A, et al. Proposed consensus definitions for new-onset refractory status epilepticus (NORSE), febrile infection-related epilepsy syndrome (FIRES), and related conditions. Epilepsia. 2018;59(4):739-744.
An international team of experts has published standardized definitions of several seizure-related disorders, including new-onset refractory status epilepticus (NORSE), febrile infection-related epilepsy syndrome (FIRES), and related disorders.
- NORSE is described as a clinical presentation rather than a specific diagnosis.
- NORSE occurs in a patient who is not experiencing active epilepsy or any other preexisting neurological disorder.
- In NORSE, the patient does not have a clear acute or active structural, toxic or metabolic cause of their condition.
- The expert group defined FIRES as a subtype of NORSE that involves a prior febrile infection that started between 2 weeks and 24 hours before the refractory status epilepticus began.
- The experts also offered standardized definitions for infantile hemiconvulsion-hemiplegia and epilepsy syndrome (IHHE) and for prolonged, refractory and super-refractory status epilepticus.
Hirsch LJ, Gaspard N, van Baalen A, et al. Proposed consensus definitions for new-onset refractory status epilepticus (NORSE), febrile infection-related epilepsy syndrome (FIRES), and related conditions. Epilepsia. 2018;59(4):739-744.
Understanding and Managing Sunflower Syndrome
Sunflower syndrome, a type of reflex seizure usually accompanied by eyelid myoclonia, can be managed with valproate or polypharmacy suggests a recent study of affected patients managed by the Department of Neurology, Division of Child Neurology, Stanford University School of Medicine.
- Sunflower syndrome, a photosensitive epilepsy, is triggered when patients wave their hands in front of the sun.
- A review of 13 cases, occurring mostly in girls with an average age of onset of 5.5 years, found that many of these patients had intellectual, attentional, or academic problems.
- Most patients had eyelid myoclonia, with or without absence seizures, while six also had spontaneous seizures.
- Nine children received valproate, of which 66% experienced significant improvement or stopped having seizures.
- No patients taking levetiracetam or lamotrigine monotherapy saw their seizures resolve, but 3 patients did improve on polypharmacy.
Baumer FM, Porter BE. Clinical and electrographic features of sunflower syndrome. Epilepsy Res. 2018;142:58-63.
Sunflower syndrome, a type of reflex seizure usually accompanied by eyelid myoclonia, can be managed with valproate or polypharmacy suggests a recent study of affected patients managed by the Department of Neurology, Division of Child Neurology, Stanford University School of Medicine.
- Sunflower syndrome, a photosensitive epilepsy, is triggered when patients wave their hands in front of the sun.
- A review of 13 cases, occurring mostly in girls with an average age of onset of 5.5 years, found that many of these patients had intellectual, attentional, or academic problems.
- Most patients had eyelid myoclonia, with or without absence seizures, while six also had spontaneous seizures.
- Nine children received valproate, of which 66% experienced significant improvement or stopped having seizures.
- No patients taking levetiracetam or lamotrigine monotherapy saw their seizures resolve, but 3 patients did improve on polypharmacy.
Baumer FM, Porter BE. Clinical and electrographic features of sunflower syndrome. Epilepsy Res. 2018;142:58-63.
Sunflower syndrome, a type of reflex seizure usually accompanied by eyelid myoclonia, can be managed with valproate or polypharmacy suggests a recent study of affected patients managed by the Department of Neurology, Division of Child Neurology, Stanford University School of Medicine.
- Sunflower syndrome, a photosensitive epilepsy, is triggered when patients wave their hands in front of the sun.
- A review of 13 cases, occurring mostly in girls with an average age of onset of 5.5 years, found that many of these patients had intellectual, attentional, or academic problems.
- Most patients had eyelid myoclonia, with or without absence seizures, while six also had spontaneous seizures.
- Nine children received valproate, of which 66% experienced significant improvement or stopped having seizures.
- No patients taking levetiracetam or lamotrigine monotherapy saw their seizures resolve, but 3 patients did improve on polypharmacy.
Baumer FM, Porter BE. Clinical and electrographic features of sunflower syndrome. Epilepsy Res. 2018;142:58-63.
Take action to prevent maternal mortality
The facts
While other industrialized nations are seeing a decrease in their maternal mortality rates, the United States has noted a 26% increase over a 15-year period. This is especially true for women of color: black women are nearly 4 times as likely to die from pregnancy related causes as compared to non-Hispanic white women. Postpartum hemorrhage and preeclampsia are often the leading causes of maternal death; however, suicide and overdoses are becoming increasingly more common. This information is highlighted in the March 2018 OBG Management article “Factors critical to reducing US maternal mortality and morbidity,” by Lucia DiVenere, MA, Government and Political Affairs, at the American College of Obstetricians and Gynecologists (ACOG).1
Although there are efforts to improve these outcomes, programs vary by state. One initiative is the perinatal quality collaboratives (PQCs), state or multistate networks of teams working to improve the quality of care for mothers and babies (see “Has your state established a perinatal quality collaborative?”).
Currently, only 33 states have a maternal mortality review committee (MMRC) comprised of an interdisciplinary team of ObGyns, nurses, and other stakeholders. The MMRC reviews each maternal death in their state and provides recommendations and policy changes to help prevent further loss of life.
Many states currently have active collaboratives, and others are in development. The CDC’s Division of Reproductive Health (DRH) currently provides support for state-based PQCs in Colorado, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Minnesota, Mississippi, New Jersey, New York, Oregon, and Wisconsin. The status of PQCs in Maine, Rhode Island, Pennsylvania, Missouri, South Dakota, and Wyoming is unknown.1
The CDC can help people establish a collaborative. Visit: https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pqc-states.html.
Reference
- Centers for Disease Control and Prevention. Reproductive health: State Perinatal Quality Collaboratives. CDC website. https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pqc-states.html Updated October 17, 2017. Accessed April 4, 2018.
The bill
Preventing Maternal Deaths Act/Maternal Health Accountability Act (H.R. 1318/S. 1112) is a bipartisan, bicameral effort to reduce maternal mortality and reduce health care disparities.
The bills authorize the Centers for Disease Control and Prevention (CDC) to help states create or expand state MMRCs through annual grant funding of $7 million through fiscal year 2022. Through the MMRCs, the CDC would have the ability to gather data on maternal mortality and health care disparities, allowing the agency to better understand leading causes of maternal death as well as a state’s successes and pitfalls in interventions.
Currently the House bill (H.R. 1318) has 102 cosponsors (https://cqrcengage.com/acog/app/bill/903056?0) and the Senate bill (S. 1112) has 17 cosponsors (https://cqrcengage.com/acog/app/bill/943204?1). Click these links to see if your representative is a cosponsor.
Not sure who your representative is? Click here to find out: http://cqrcengage.com/acog/app/lookup?1&m=29525.
Take action
Both the Senate and House bills have been referred to health committees. However, no advances have been made since March 2017. In order for the bills to move forward, your representatives need to hear from you.
If your representative is a cosponsor of the bill, thank them for their support, but also ask what we can do to ensure this bill becomes law.
If your representative is not a cosponsor, follow this link to email your representative: http://cqrcengage.com/acog/app/onestep-write-a-letter?0&engagementId=306574. You also can call your representative’s office and speak directly to a staff member.
When calling or emailing, highlight the following:
- I am an ObGyn and I am asking [your Representative/Senator] to support H.R. 1318 or S. 1112.
- While maternal mortality rates are decreasing in other parts of the world, they are increasing in the United States. We have the highest maternal mortality rate in the developing world.
- This bill gives all states the opportunity to have a maternal mortality review committee, allowing health care leaders to review each maternal death and analyze how further deaths can be prevented.
- Congress has invested in programs addressing infant mortality, birth defects, and preterm birth. It is time we put the same investment into saving our nation’s mothers.
- As an ObGyn, I urge you to support this bill.
More from ACOG
Want to know what other advocacy opportunities are available? Check out ACOG action at http://cqrcengage.com/acog/home?3.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- DiVenere L. Factors critical to reducing US maternal mortality and morbidity. OBG Manag. 2018;30(3):30−33.
The facts
While other industrialized nations are seeing a decrease in their maternal mortality rates, the United States has noted a 26% increase over a 15-year period. This is especially true for women of color: black women are nearly 4 times as likely to die from pregnancy related causes as compared to non-Hispanic white women. Postpartum hemorrhage and preeclampsia are often the leading causes of maternal death; however, suicide and overdoses are becoming increasingly more common. This information is highlighted in the March 2018 OBG Management article “Factors critical to reducing US maternal mortality and morbidity,” by Lucia DiVenere, MA, Government and Political Affairs, at the American College of Obstetricians and Gynecologists (ACOG).1
Although there are efforts to improve these outcomes, programs vary by state. One initiative is the perinatal quality collaboratives (PQCs), state or multistate networks of teams working to improve the quality of care for mothers and babies (see “Has your state established a perinatal quality collaborative?”).
Currently, only 33 states have a maternal mortality review committee (MMRC) comprised of an interdisciplinary team of ObGyns, nurses, and other stakeholders. The MMRC reviews each maternal death in their state and provides recommendations and policy changes to help prevent further loss of life.
Many states currently have active collaboratives, and others are in development. The CDC’s Division of Reproductive Health (DRH) currently provides support for state-based PQCs in Colorado, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Minnesota, Mississippi, New Jersey, New York, Oregon, and Wisconsin. The status of PQCs in Maine, Rhode Island, Pennsylvania, Missouri, South Dakota, and Wyoming is unknown.1
The CDC can help people establish a collaborative. Visit: https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pqc-states.html.
Reference
- Centers for Disease Control and Prevention. Reproductive health: State Perinatal Quality Collaboratives. CDC website. https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pqc-states.html Updated October 17, 2017. Accessed April 4, 2018.
The bill
Preventing Maternal Deaths Act/Maternal Health Accountability Act (H.R. 1318/S. 1112) is a bipartisan, bicameral effort to reduce maternal mortality and reduce health care disparities.
The bills authorize the Centers for Disease Control and Prevention (CDC) to help states create or expand state MMRCs through annual grant funding of $7 million through fiscal year 2022. Through the MMRCs, the CDC would have the ability to gather data on maternal mortality and health care disparities, allowing the agency to better understand leading causes of maternal death as well as a state’s successes and pitfalls in interventions.
Currently the House bill (H.R. 1318) has 102 cosponsors (https://cqrcengage.com/acog/app/bill/903056?0) and the Senate bill (S. 1112) has 17 cosponsors (https://cqrcengage.com/acog/app/bill/943204?1). Click these links to see if your representative is a cosponsor.
Not sure who your representative is? Click here to find out: http://cqrcengage.com/acog/app/lookup?1&m=29525.
Take action
Both the Senate and House bills have been referred to health committees. However, no advances have been made since March 2017. In order for the bills to move forward, your representatives need to hear from you.
If your representative is a cosponsor of the bill, thank them for their support, but also ask what we can do to ensure this bill becomes law.
If your representative is not a cosponsor, follow this link to email your representative: http://cqrcengage.com/acog/app/onestep-write-a-letter?0&engagementId=306574. You also can call your representative’s office and speak directly to a staff member.
When calling or emailing, highlight the following:
- I am an ObGyn and I am asking [your Representative/Senator] to support H.R. 1318 or S. 1112.
- While maternal mortality rates are decreasing in other parts of the world, they are increasing in the United States. We have the highest maternal mortality rate in the developing world.
- This bill gives all states the opportunity to have a maternal mortality review committee, allowing health care leaders to review each maternal death and analyze how further deaths can be prevented.
- Congress has invested in programs addressing infant mortality, birth defects, and preterm birth. It is time we put the same investment into saving our nation’s mothers.
- As an ObGyn, I urge you to support this bill.
More from ACOG
Want to know what other advocacy opportunities are available? Check out ACOG action at http://cqrcengage.com/acog/home?3.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
The facts
While other industrialized nations are seeing a decrease in their maternal mortality rates, the United States has noted a 26% increase over a 15-year period. This is especially true for women of color: black women are nearly 4 times as likely to die from pregnancy related causes as compared to non-Hispanic white women. Postpartum hemorrhage and preeclampsia are often the leading causes of maternal death; however, suicide and overdoses are becoming increasingly more common. This information is highlighted in the March 2018 OBG Management article “Factors critical to reducing US maternal mortality and morbidity,” by Lucia DiVenere, MA, Government and Political Affairs, at the American College of Obstetricians and Gynecologists (ACOG).1
Although there are efforts to improve these outcomes, programs vary by state. One initiative is the perinatal quality collaboratives (PQCs), state or multistate networks of teams working to improve the quality of care for mothers and babies (see “Has your state established a perinatal quality collaborative?”).
Currently, only 33 states have a maternal mortality review committee (MMRC) comprised of an interdisciplinary team of ObGyns, nurses, and other stakeholders. The MMRC reviews each maternal death in their state and provides recommendations and policy changes to help prevent further loss of life.
Many states currently have active collaboratives, and others are in development. The CDC’s Division of Reproductive Health (DRH) currently provides support for state-based PQCs in Colorado, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Minnesota, Mississippi, New Jersey, New York, Oregon, and Wisconsin. The status of PQCs in Maine, Rhode Island, Pennsylvania, Missouri, South Dakota, and Wyoming is unknown.1
The CDC can help people establish a collaborative. Visit: https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pqc-states.html.
Reference
- Centers for Disease Control and Prevention. Reproductive health: State Perinatal Quality Collaboratives. CDC website. https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pqc-states.html Updated October 17, 2017. Accessed April 4, 2018.
The bill
Preventing Maternal Deaths Act/Maternal Health Accountability Act (H.R. 1318/S. 1112) is a bipartisan, bicameral effort to reduce maternal mortality and reduce health care disparities.
The bills authorize the Centers for Disease Control and Prevention (CDC) to help states create or expand state MMRCs through annual grant funding of $7 million through fiscal year 2022. Through the MMRCs, the CDC would have the ability to gather data on maternal mortality and health care disparities, allowing the agency to better understand leading causes of maternal death as well as a state’s successes and pitfalls in interventions.
Currently the House bill (H.R. 1318) has 102 cosponsors (https://cqrcengage.com/acog/app/bill/903056?0) and the Senate bill (S. 1112) has 17 cosponsors (https://cqrcengage.com/acog/app/bill/943204?1). Click these links to see if your representative is a cosponsor.
Not sure who your representative is? Click here to find out: http://cqrcengage.com/acog/app/lookup?1&m=29525.
Take action
Both the Senate and House bills have been referred to health committees. However, no advances have been made since March 2017. In order for the bills to move forward, your representatives need to hear from you.
If your representative is a cosponsor of the bill, thank them for their support, but also ask what we can do to ensure this bill becomes law.
If your representative is not a cosponsor, follow this link to email your representative: http://cqrcengage.com/acog/app/onestep-write-a-letter?0&engagementId=306574. You also can call your representative’s office and speak directly to a staff member.
When calling or emailing, highlight the following:
- I am an ObGyn and I am asking [your Representative/Senator] to support H.R. 1318 or S. 1112.
- While maternal mortality rates are decreasing in other parts of the world, they are increasing in the United States. We have the highest maternal mortality rate in the developing world.
- This bill gives all states the opportunity to have a maternal mortality review committee, allowing health care leaders to review each maternal death and analyze how further deaths can be prevented.
- Congress has invested in programs addressing infant mortality, birth defects, and preterm birth. It is time we put the same investment into saving our nation’s mothers.
- As an ObGyn, I urge you to support this bill.
More from ACOG
Want to know what other advocacy opportunities are available? Check out ACOG action at http://cqrcengage.com/acog/home?3.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- DiVenere L. Factors critical to reducing US maternal mortality and morbidity. OBG Manag. 2018;30(3):30−33.
- DiVenere L. Factors critical to reducing US maternal mortality and morbidity. OBG Manag. 2018;30(3):30−33.
Combined Cholesterol and Blood Pressure Lowering Treatment Reduces First Stroke Risk
LOS ANGELES—Among adults with an intermediate risk of cardiovascular disease, a combination of blood pressure and cholesterol lowering treatments significantly reduces the risk of a first stroke, compared with placebo, according to a study presented at the International Stroke Conference 2018. “Use of these well-tolerated and simple-to-implement therapies has the potential to reduce stroke by 44%,” said Jackie Bosch, PhD, Associate Professor at the School of Rehabilitation Science at McMaster University in Hamilton, Ontario.
“These results indicate that to prevent stroke in those at moderate risk, blood pressure lowering plus lipid lowering should be considered in those with elevated blood pressure, and lipid lowering should be considered by all,” said Dr. Bosch.
Seventy-five percent of strokes are first strokes, which often result in permanent disability or death, said Dr. Bosch. Blood pressure and cholesterol account for about two-thirds of stroke risk. Treatment for high blood pressure and high cholesterol is recommended for high-risk patients. Data for patients who are at moderate risk are lacking, however, she said.
The HOPE-3 Trial
To examine the role of antihypertensive therapy and statins for primary stroke prevention, Dr. Bosch and colleagues analyzed data from the Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial. They sought to investigate whether a combination of cholesterol lowering and blood pressure lowering drugs safely reduces major cardiovascular events in individuals at intermediate risk who have had no previous vascular events.
Researchers recruited an intermediate stroke risk population with an estimated 1% risk of major cardiovascular events per year. The researchers included women age 65 and older and men age 55 and older with at least one additional risk factor (ie, increased waist-to-hip ratio, current or recent tobacco use, low HDL cholesterol, dysglycemia, mild renal dysfunction, or a family history of coronary heart disease). Patients with cardiovascular disease or an indication or contraindication for any of the medicines studied were excluded.
Researchers randomized 12,705 participants from 21 countries to receive either candesartan (16 mg) plus hydrochlorothiazide (12.5 mg) daily or placebo, as well as rosuvastatin (10 mg) daily or placebo.
The coprimary study outcomes were the composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke and the composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, resuscitated cardiac arrest, heart failure, and arterial revascularization. The primary outcomes were published in 2016. The present analysis focused on stroke outcomes.
Combined Therapies Significantly Reduced Stroke Risk
The mean age of participants was 66, and 46% of participants were women. The mean baseline blood pressure was 138/82 mm Hg. In all, 166 strokes occurred during a median follow-up of 5.6 years.
Candesartan plus hydrochlorothiazide reduced stroke by 20%, compared with placebo, although this effect was not statistically significant. Rosuvastatin significantly reduced stroke by 30%, compared with placebo. In a prespecified subgroup analysis of participants in the upper third of systolic blood pressure (> 143.5 mm Hg), candesartan plus hydrochlorothiazide reduced stroke by 42%, versus placebo, said Dr. Bosch. The combination of cholesterol and blood pressure lowering treatments (rosuvastatin and candesartan plus hydrochlorothiazide) reduced stroke risk by 44% and reduced disabling stroke risk by 45%, compared with placebo. The number needed to treat with combination therapy for one year to prevent one stroke was 714.
Rates of permanent discontinuation did not differ significantly between active and placebo-assigned patients, said the researchers.
—Erica Tricarico
LOS ANGELES—Among adults with an intermediate risk of cardiovascular disease, a combination of blood pressure and cholesterol lowering treatments significantly reduces the risk of a first stroke, compared with placebo, according to a study presented at the International Stroke Conference 2018. “Use of these well-tolerated and simple-to-implement therapies has the potential to reduce stroke by 44%,” said Jackie Bosch, PhD, Associate Professor at the School of Rehabilitation Science at McMaster University in Hamilton, Ontario.
“These results indicate that to prevent stroke in those at moderate risk, blood pressure lowering plus lipid lowering should be considered in those with elevated blood pressure, and lipid lowering should be considered by all,” said Dr. Bosch.
Seventy-five percent of strokes are first strokes, which often result in permanent disability or death, said Dr. Bosch. Blood pressure and cholesterol account for about two-thirds of stroke risk. Treatment for high blood pressure and high cholesterol is recommended for high-risk patients. Data for patients who are at moderate risk are lacking, however, she said.
The HOPE-3 Trial
To examine the role of antihypertensive therapy and statins for primary stroke prevention, Dr. Bosch and colleagues analyzed data from the Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial. They sought to investigate whether a combination of cholesterol lowering and blood pressure lowering drugs safely reduces major cardiovascular events in individuals at intermediate risk who have had no previous vascular events.
Researchers recruited an intermediate stroke risk population with an estimated 1% risk of major cardiovascular events per year. The researchers included women age 65 and older and men age 55 and older with at least one additional risk factor (ie, increased waist-to-hip ratio, current or recent tobacco use, low HDL cholesterol, dysglycemia, mild renal dysfunction, or a family history of coronary heart disease). Patients with cardiovascular disease or an indication or contraindication for any of the medicines studied were excluded.
Researchers randomized 12,705 participants from 21 countries to receive either candesartan (16 mg) plus hydrochlorothiazide (12.5 mg) daily or placebo, as well as rosuvastatin (10 mg) daily or placebo.
The coprimary study outcomes were the composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke and the composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, resuscitated cardiac arrest, heart failure, and arterial revascularization. The primary outcomes were published in 2016. The present analysis focused on stroke outcomes.
Combined Therapies Significantly Reduced Stroke Risk
The mean age of participants was 66, and 46% of participants were women. The mean baseline blood pressure was 138/82 mm Hg. In all, 166 strokes occurred during a median follow-up of 5.6 years.
Candesartan plus hydrochlorothiazide reduced stroke by 20%, compared with placebo, although this effect was not statistically significant. Rosuvastatin significantly reduced stroke by 30%, compared with placebo. In a prespecified subgroup analysis of participants in the upper third of systolic blood pressure (> 143.5 mm Hg), candesartan plus hydrochlorothiazide reduced stroke by 42%, versus placebo, said Dr. Bosch. The combination of cholesterol and blood pressure lowering treatments (rosuvastatin and candesartan plus hydrochlorothiazide) reduced stroke risk by 44% and reduced disabling stroke risk by 45%, compared with placebo. The number needed to treat with combination therapy for one year to prevent one stroke was 714.
Rates of permanent discontinuation did not differ significantly between active and placebo-assigned patients, said the researchers.
—Erica Tricarico
LOS ANGELES—Among adults with an intermediate risk of cardiovascular disease, a combination of blood pressure and cholesterol lowering treatments significantly reduces the risk of a first stroke, compared with placebo, according to a study presented at the International Stroke Conference 2018. “Use of these well-tolerated and simple-to-implement therapies has the potential to reduce stroke by 44%,” said Jackie Bosch, PhD, Associate Professor at the School of Rehabilitation Science at McMaster University in Hamilton, Ontario.
“These results indicate that to prevent stroke in those at moderate risk, blood pressure lowering plus lipid lowering should be considered in those with elevated blood pressure, and lipid lowering should be considered by all,” said Dr. Bosch.
Seventy-five percent of strokes are first strokes, which often result in permanent disability or death, said Dr. Bosch. Blood pressure and cholesterol account for about two-thirds of stroke risk. Treatment for high blood pressure and high cholesterol is recommended for high-risk patients. Data for patients who are at moderate risk are lacking, however, she said.
The HOPE-3 Trial
To examine the role of antihypertensive therapy and statins for primary stroke prevention, Dr. Bosch and colleagues analyzed data from the Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial. They sought to investigate whether a combination of cholesterol lowering and blood pressure lowering drugs safely reduces major cardiovascular events in individuals at intermediate risk who have had no previous vascular events.
Researchers recruited an intermediate stroke risk population with an estimated 1% risk of major cardiovascular events per year. The researchers included women age 65 and older and men age 55 and older with at least one additional risk factor (ie, increased waist-to-hip ratio, current or recent tobacco use, low HDL cholesterol, dysglycemia, mild renal dysfunction, or a family history of coronary heart disease). Patients with cardiovascular disease or an indication or contraindication for any of the medicines studied were excluded.
Researchers randomized 12,705 participants from 21 countries to receive either candesartan (16 mg) plus hydrochlorothiazide (12.5 mg) daily or placebo, as well as rosuvastatin (10 mg) daily or placebo.
The coprimary study outcomes were the composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke and the composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, resuscitated cardiac arrest, heart failure, and arterial revascularization. The primary outcomes were published in 2016. The present analysis focused on stroke outcomes.
Combined Therapies Significantly Reduced Stroke Risk
The mean age of participants was 66, and 46% of participants were women. The mean baseline blood pressure was 138/82 mm Hg. In all, 166 strokes occurred during a median follow-up of 5.6 years.
Candesartan plus hydrochlorothiazide reduced stroke by 20%, compared with placebo, although this effect was not statistically significant. Rosuvastatin significantly reduced stroke by 30%, compared with placebo. In a prespecified subgroup analysis of participants in the upper third of systolic blood pressure (> 143.5 mm Hg), candesartan plus hydrochlorothiazide reduced stroke by 42%, versus placebo, said Dr. Bosch. The combination of cholesterol and blood pressure lowering treatments (rosuvastatin and candesartan plus hydrochlorothiazide) reduced stroke risk by 44% and reduced disabling stroke risk by 45%, compared with placebo. The number needed to treat with combination therapy for one year to prevent one stroke was 714.
Rates of permanent discontinuation did not differ significantly between active and placebo-assigned patients, said the researchers.
—Erica Tricarico
OlympiAD: No statistically significant boost in OS with olaparib in HER2-negative mBC
CHICAGO – Median overall survival (OS) in patients with HER2-negative metastatic breast cancer (mBC) and germline BRCA mutation (gBRCAm), although not statistically significant, was 2.2 months longer with olaparib versus physician’s choice chemotherapy (TPC), according to the final analysis of the OlympiAD study.
The results suggested the possibility of greater benefit among chemotherapy naive patients for metastatic breast cancer, with no cumulative toxicity reported with extended exposure, Mark E. Robson, MD, said at the annual meeting of the American Association for Cancer Research.
OlympiAD was a randomized, controlled, open-label, multicenter, phase 3 study of olaparib tablet monotherapy (300 mg, twice daily) compared with predeclared TPC monotherapy (capecitabine, vinorelbine, or eribulin). Patients were stratified by prior chemotherapy, prior platinum, and receptor status (ER+ and/or PR+ vs. TNBC). Of 302 randomized patients, 205 received olaparib and 91 received TPC (6 TPC patients declined treatment). Eligible patients had HER2-negative mBC and a germline BRCA mutation. In addition, patients should have received less than or equal to two chemotherapy lines in the metastatic setting, with prior anthracycline and taxane treatment either as (neo)adjuvant therapy or in the metastatic setting.
The data presented at AACR was a follow-up on the primary progression-free survival (PFS) analysis, which demonstrated significant benefit in olaparib over standard chemotherapy TPC (7.0 vs 4.2 months, HR 0.58, 95% confidence interval, 0.43-0.80, P less than .001). Overall response rate (ORR) in the olaparib arm was double of that observed on the TPC arm in measurable disease patients (59.9% vs. 28.8%).
At the final OS analysis with 192 deaths, HR for OS in the olaparib vs TPC group was 0.90 (95% CI, 0.66-1.23; P = .513), reported Dr. Robson of Memorial Sloan Kettering Cancer Center, New York.
“The preplanned subgroup analyses according to the stratification factors were not powered to detect survival advantages, and were considered only hypothesis generating,” he said.
In patients who had not received chemotherapy in the metastatic setting, there was a median difference in OS of 7.9 months with olaparib (HR 0.51, 95% CI, 0.29-0.90; nominal P = .02; median 22.6 vs. 14.7 months).
Median follow-up for OS was 18.9 months for olaparib vs. 15.5 months in the TPC group.
No differences were observed between patients that were ER and/or PgR positive vs. TNBC, or whether patients received prior platinum, Dr. Robson said.
Grade 3 adverse events were similar to those in the primary analysis with no cumulative toxicity with extended exposure, he said.
SOURCE: Robson ME et al. AACR Annual Meeting Abstract CT038.
CHICAGO – Median overall survival (OS) in patients with HER2-negative metastatic breast cancer (mBC) and germline BRCA mutation (gBRCAm), although not statistically significant, was 2.2 months longer with olaparib versus physician’s choice chemotherapy (TPC), according to the final analysis of the OlympiAD study.
The results suggested the possibility of greater benefit among chemotherapy naive patients for metastatic breast cancer, with no cumulative toxicity reported with extended exposure, Mark E. Robson, MD, said at the annual meeting of the American Association for Cancer Research.
OlympiAD was a randomized, controlled, open-label, multicenter, phase 3 study of olaparib tablet monotherapy (300 mg, twice daily) compared with predeclared TPC monotherapy (capecitabine, vinorelbine, or eribulin). Patients were stratified by prior chemotherapy, prior platinum, and receptor status (ER+ and/or PR+ vs. TNBC). Of 302 randomized patients, 205 received olaparib and 91 received TPC (6 TPC patients declined treatment). Eligible patients had HER2-negative mBC and a germline BRCA mutation. In addition, patients should have received less than or equal to two chemotherapy lines in the metastatic setting, with prior anthracycline and taxane treatment either as (neo)adjuvant therapy or in the metastatic setting.
The data presented at AACR was a follow-up on the primary progression-free survival (PFS) analysis, which demonstrated significant benefit in olaparib over standard chemotherapy TPC (7.0 vs 4.2 months, HR 0.58, 95% confidence interval, 0.43-0.80, P less than .001). Overall response rate (ORR) in the olaparib arm was double of that observed on the TPC arm in measurable disease patients (59.9% vs. 28.8%).
At the final OS analysis with 192 deaths, HR for OS in the olaparib vs TPC group was 0.90 (95% CI, 0.66-1.23; P = .513), reported Dr. Robson of Memorial Sloan Kettering Cancer Center, New York.
“The preplanned subgroup analyses according to the stratification factors were not powered to detect survival advantages, and were considered only hypothesis generating,” he said.
In patients who had not received chemotherapy in the metastatic setting, there was a median difference in OS of 7.9 months with olaparib (HR 0.51, 95% CI, 0.29-0.90; nominal P = .02; median 22.6 vs. 14.7 months).
Median follow-up for OS was 18.9 months for olaparib vs. 15.5 months in the TPC group.
No differences were observed between patients that were ER and/or PgR positive vs. TNBC, or whether patients received prior platinum, Dr. Robson said.
Grade 3 adverse events were similar to those in the primary analysis with no cumulative toxicity with extended exposure, he said.
SOURCE: Robson ME et al. AACR Annual Meeting Abstract CT038.
CHICAGO – Median overall survival (OS) in patients with HER2-negative metastatic breast cancer (mBC) and germline BRCA mutation (gBRCAm), although not statistically significant, was 2.2 months longer with olaparib versus physician’s choice chemotherapy (TPC), according to the final analysis of the OlympiAD study.
The results suggested the possibility of greater benefit among chemotherapy naive patients for metastatic breast cancer, with no cumulative toxicity reported with extended exposure, Mark E. Robson, MD, said at the annual meeting of the American Association for Cancer Research.
OlympiAD was a randomized, controlled, open-label, multicenter, phase 3 study of olaparib tablet monotherapy (300 mg, twice daily) compared with predeclared TPC monotherapy (capecitabine, vinorelbine, or eribulin). Patients were stratified by prior chemotherapy, prior platinum, and receptor status (ER+ and/or PR+ vs. TNBC). Of 302 randomized patients, 205 received olaparib and 91 received TPC (6 TPC patients declined treatment). Eligible patients had HER2-negative mBC and a germline BRCA mutation. In addition, patients should have received less than or equal to two chemotherapy lines in the metastatic setting, with prior anthracycline and taxane treatment either as (neo)adjuvant therapy or in the metastatic setting.
The data presented at AACR was a follow-up on the primary progression-free survival (PFS) analysis, which demonstrated significant benefit in olaparib over standard chemotherapy TPC (7.0 vs 4.2 months, HR 0.58, 95% confidence interval, 0.43-0.80, P less than .001). Overall response rate (ORR) in the olaparib arm was double of that observed on the TPC arm in measurable disease patients (59.9% vs. 28.8%).
At the final OS analysis with 192 deaths, HR for OS in the olaparib vs TPC group was 0.90 (95% CI, 0.66-1.23; P = .513), reported Dr. Robson of Memorial Sloan Kettering Cancer Center, New York.
“The preplanned subgroup analyses according to the stratification factors were not powered to detect survival advantages, and were considered only hypothesis generating,” he said.
In patients who had not received chemotherapy in the metastatic setting, there was a median difference in OS of 7.9 months with olaparib (HR 0.51, 95% CI, 0.29-0.90; nominal P = .02; median 22.6 vs. 14.7 months).
Median follow-up for OS was 18.9 months for olaparib vs. 15.5 months in the TPC group.
No differences were observed between patients that were ER and/or PgR positive vs. TNBC, or whether patients received prior platinum, Dr. Robson said.
Grade 3 adverse events were similar to those in the primary analysis with no cumulative toxicity with extended exposure, he said.
SOURCE: Robson ME et al. AACR Annual Meeting Abstract CT038.
FROM THE AACR ANNUAL MEETING
Key clinical point: Median overall survival was not significantly different with olaparib versus chemotherapy in patients with BRCA-mutated, HER2-negative metastatic breast cancer.
Major finding: Median overall survival in patients with HER2-negative metastatic breast cancer and a germline BRCA mutation was 19.3 months versus 17.1 months for olaparib versus chemotherapy (HR 0.90 95% CI 0.66, 1.23; P = .513).
Study details: Randomized, controlled, open-label, phase 3 trial (OlympiAD) of olaparib tablet monotherapy (300 mg, twice daily) compared with predeclared physician’s choice chemotherapy (capecitabine, vinorelbine, or eribulin).
Disclosures: Dr. Robson disclosed relationships with AstraZeneca, AbbVie, McKesson, Myriad Genetics, and Medivation.
Source: Robson ME et al. AACR Annual Meeting Abstract CT038.