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Sarcopenia had minor impact on hernia repair SSIs
according to findings from a prospective, single-institution study.
Steve R. Siegal, MD, and his colleagues at the Oregon Health & Science University, Portland, wrote in Hernia that risk factors for postoperative complications after hernia repair established in the literature include uncontrolled diabetes, active tobacco use, prior hernia repair, active infection, and obesity. Sarcopenia occurs in many physiological or pathological states, not only in the elderly but also in cases of immunosuppression, cirrhosis, trauma, prolonged immobility, and malignancy. Many opportunities exist for sarcopenia and hernia surgery to coincide but the role of sarcopenia in hernia repair outcomes has not been much studied.
The investigators began with the hypothesis that sarcopenia in hernia patients would lead to worse postoperative outcomes given the large metabolic requirement for postoperative healing of hernia defects and abdominal wall reconstruction.
The study involved 135 patients who underwent ventral hernia repair, 27% of whom had sarcopenia. The literature-based definition of sarcopenia was a muscle index cutoff of less than 52.4 cm2/m2 for men and less than 38.5 cm2/m2 for women. The investigators noted that the index cutoff was validated in oncology patients. Patients underwent a preoperative CT scan to assess muscle mass. The study group included patients with ventral hernia repair with or without mesh, component separation/abdominal wall reconstruction, and a hernia defect of 2 cm or larger.
With data on variables including gender, diabetes status, body mass index (BMI), chronic obstructive pulmonary disease (COPD), wound class, alcohol abuse status, and prior wound infections, the investigators created a multivariate model to look at primary outcomes of surgical site infection (SSI), surgical site occurrences (wound complications, other infections) and hernia recurrence. Secondary outcomes included length of hospital stay, morbidities, and other postoperative complications.
Patients with sarcopenia were more likely to have lower BMI (median 29.6 kg/m2 vs. 36.6 kg/m2), to be slightly older (median 63.1 vs. 59.2 years), and to have a history of immunosuppression (29.7% vs. 11.2%). The differences for the other variables (diabetes, tobacco use, COPD) were not significant.
The surprising finding was that sarcopenia was not significantly correlated with SSIs (P = 0.140), other complications (P = 0.113), or recurrence (P = 0.895) after ventral hernia repair. In-hospital morbidities and length of hospital stay did not differ significantly between the sarcopenic and nonsarcopenic patients. But sarcopenia combined with other factors did have an impact on outcomes. After adjustment for BMI and diabetes and critical care status, muscle mass as a continuous variable “was notable for a 1.44 increased odds [95% confidence interval, 1.00-2.07; P = 0.049] of inpatient morbidity with every decrease of 10 cm2/m2 of muscle index,” Dr. Siegal and his associates wrote.
The nonsignificant results of this study may be explained by the markedly lower BMI in the sarcopenic group, which could have been protective against worse outcomes, the investigators noted. However, they concluded, “Sarcopenia may still be a factor in adverse perioperative outcomes, but the established muscle index cutoff value may be inappropriately applied to benign patients, such as our ventral hernia cohort results in this study.”
The investigators declared no conflicts of interest and received no outside funding for this study.
SOURCE: Siegal SR et al. Hernia. 2018 May 11. doi: 10.1007/s10029-018-1770-8.
according to findings from a prospective, single-institution study.
Steve R. Siegal, MD, and his colleagues at the Oregon Health & Science University, Portland, wrote in Hernia that risk factors for postoperative complications after hernia repair established in the literature include uncontrolled diabetes, active tobacco use, prior hernia repair, active infection, and obesity. Sarcopenia occurs in many physiological or pathological states, not only in the elderly but also in cases of immunosuppression, cirrhosis, trauma, prolonged immobility, and malignancy. Many opportunities exist for sarcopenia and hernia surgery to coincide but the role of sarcopenia in hernia repair outcomes has not been much studied.
The investigators began with the hypothesis that sarcopenia in hernia patients would lead to worse postoperative outcomes given the large metabolic requirement for postoperative healing of hernia defects and abdominal wall reconstruction.
The study involved 135 patients who underwent ventral hernia repair, 27% of whom had sarcopenia. The literature-based definition of sarcopenia was a muscle index cutoff of less than 52.4 cm2/m2 for men and less than 38.5 cm2/m2 for women. The investigators noted that the index cutoff was validated in oncology patients. Patients underwent a preoperative CT scan to assess muscle mass. The study group included patients with ventral hernia repair with or without mesh, component separation/abdominal wall reconstruction, and a hernia defect of 2 cm or larger.
With data on variables including gender, diabetes status, body mass index (BMI), chronic obstructive pulmonary disease (COPD), wound class, alcohol abuse status, and prior wound infections, the investigators created a multivariate model to look at primary outcomes of surgical site infection (SSI), surgical site occurrences (wound complications, other infections) and hernia recurrence. Secondary outcomes included length of hospital stay, morbidities, and other postoperative complications.
Patients with sarcopenia were more likely to have lower BMI (median 29.6 kg/m2 vs. 36.6 kg/m2), to be slightly older (median 63.1 vs. 59.2 years), and to have a history of immunosuppression (29.7% vs. 11.2%). The differences for the other variables (diabetes, tobacco use, COPD) were not significant.
The surprising finding was that sarcopenia was not significantly correlated with SSIs (P = 0.140), other complications (P = 0.113), or recurrence (P = 0.895) after ventral hernia repair. In-hospital morbidities and length of hospital stay did not differ significantly between the sarcopenic and nonsarcopenic patients. But sarcopenia combined with other factors did have an impact on outcomes. After adjustment for BMI and diabetes and critical care status, muscle mass as a continuous variable “was notable for a 1.44 increased odds [95% confidence interval, 1.00-2.07; P = 0.049] of inpatient morbidity with every decrease of 10 cm2/m2 of muscle index,” Dr. Siegal and his associates wrote.
The nonsignificant results of this study may be explained by the markedly lower BMI in the sarcopenic group, which could have been protective against worse outcomes, the investigators noted. However, they concluded, “Sarcopenia may still be a factor in adverse perioperative outcomes, but the established muscle index cutoff value may be inappropriately applied to benign patients, such as our ventral hernia cohort results in this study.”
The investigators declared no conflicts of interest and received no outside funding for this study.
SOURCE: Siegal SR et al. Hernia. 2018 May 11. doi: 10.1007/s10029-018-1770-8.
according to findings from a prospective, single-institution study.
Steve R. Siegal, MD, and his colleagues at the Oregon Health & Science University, Portland, wrote in Hernia that risk factors for postoperative complications after hernia repair established in the literature include uncontrolled diabetes, active tobacco use, prior hernia repair, active infection, and obesity. Sarcopenia occurs in many physiological or pathological states, not only in the elderly but also in cases of immunosuppression, cirrhosis, trauma, prolonged immobility, and malignancy. Many opportunities exist for sarcopenia and hernia surgery to coincide but the role of sarcopenia in hernia repair outcomes has not been much studied.
The investigators began with the hypothesis that sarcopenia in hernia patients would lead to worse postoperative outcomes given the large metabolic requirement for postoperative healing of hernia defects and abdominal wall reconstruction.
The study involved 135 patients who underwent ventral hernia repair, 27% of whom had sarcopenia. The literature-based definition of sarcopenia was a muscle index cutoff of less than 52.4 cm2/m2 for men and less than 38.5 cm2/m2 for women. The investigators noted that the index cutoff was validated in oncology patients. Patients underwent a preoperative CT scan to assess muscle mass. The study group included patients with ventral hernia repair with or without mesh, component separation/abdominal wall reconstruction, and a hernia defect of 2 cm or larger.
With data on variables including gender, diabetes status, body mass index (BMI), chronic obstructive pulmonary disease (COPD), wound class, alcohol abuse status, and prior wound infections, the investigators created a multivariate model to look at primary outcomes of surgical site infection (SSI), surgical site occurrences (wound complications, other infections) and hernia recurrence. Secondary outcomes included length of hospital stay, morbidities, and other postoperative complications.
Patients with sarcopenia were more likely to have lower BMI (median 29.6 kg/m2 vs. 36.6 kg/m2), to be slightly older (median 63.1 vs. 59.2 years), and to have a history of immunosuppression (29.7% vs. 11.2%). The differences for the other variables (diabetes, tobacco use, COPD) were not significant.
The surprising finding was that sarcopenia was not significantly correlated with SSIs (P = 0.140), other complications (P = 0.113), or recurrence (P = 0.895) after ventral hernia repair. In-hospital morbidities and length of hospital stay did not differ significantly between the sarcopenic and nonsarcopenic patients. But sarcopenia combined with other factors did have an impact on outcomes. After adjustment for BMI and diabetes and critical care status, muscle mass as a continuous variable “was notable for a 1.44 increased odds [95% confidence interval, 1.00-2.07; P = 0.049] of inpatient morbidity with every decrease of 10 cm2/m2 of muscle index,” Dr. Siegal and his associates wrote.
The nonsignificant results of this study may be explained by the markedly lower BMI in the sarcopenic group, which could have been protective against worse outcomes, the investigators noted. However, they concluded, “Sarcopenia may still be a factor in adverse perioperative outcomes, but the established muscle index cutoff value may be inappropriately applied to benign patients, such as our ventral hernia cohort results in this study.”
The investigators declared no conflicts of interest and received no outside funding for this study.
SOURCE: Siegal SR et al. Hernia. 2018 May 11. doi: 10.1007/s10029-018-1770-8.
FROM HERNIA
Key clinical point: Sarcopenia was not correlated with surgical site infections, other complications, or recurrence after ventral hernia repair.
Major finding: After adjustment for body mass index and diabetes and critical care status, muscle mass as a continuous variable was notable for a 1.44 increased odds of inpatient morbidity.
Study details: A prospective, single-institution study of 135 patients who had ventral hernia repair, 27% of whom were sarcopenic.
Disclosures: The investigators declared no conflicts of interest and received no outside funding for this study.
Source: Siegal SR et al. Hernia. 2018 May 11. doi: 10.1007/s10029-018-1770-8.
How more midwives may mean healthier mothers
Since ProPublica launched Lost Mothers, we’ve covered many facets of the U.S. maternal mortality crisis. Despite spending more per capita on health care than any other country, the U.S. has the highest rate of deaths related to pregnancy and childbirth in the industrialized world.
Source: Vox and ProPublica
But what makes maternal health care in other affluent countries look so different than the U.S.? Among other things, midwives. Midwives in the U.S. participate in less than 10 percent of births. But in Sweden, Denmark and France, they lead around three-quarters of deliveries. In Great Britain, they deliver half of all babies, including all three of Kate Middleton’s. So if the midwifery model works for royal babies, why not our own?
Check out the video to find out how midwives have been at the center of a culture war that’s deeply rooted in race and class in America.
Today we see vestiges of that history in states with restrictive midwifery laws and barriers to entry for midwives. Earlier this year, one study was the first systematic look at how and where they practice, offering new evidence that empowering them could significantly boost maternal and infant health. Many of the states with poor health outcomes and hostility to midwives also have large black populations. And with black mothers three to four times more likely to die in pregnancy or childbirth, the study raises the possibility that greater use of midwives could reduce racial disparities in maternal health.
This story makes up the eighth installment in Vox’s collaboration with ProPublica. You can find this video and all of Vox’s videos on YouTube. Subscribe and stay tuned for more from our partnership.
Since ProPublica launched Lost Mothers, we’ve covered many facets of the U.S. maternal mortality crisis. Despite spending more per capita on health care than any other country, the U.S. has the highest rate of deaths related to pregnancy and childbirth in the industrialized world.
Source: Vox and ProPublica
But what makes maternal health care in other affluent countries look so different than the U.S.? Among other things, midwives. Midwives in the U.S. participate in less than 10 percent of births. But in Sweden, Denmark and France, they lead around three-quarters of deliveries. In Great Britain, they deliver half of all babies, including all three of Kate Middleton’s. So if the midwifery model works for royal babies, why not our own?
Check out the video to find out how midwives have been at the center of a culture war that’s deeply rooted in race and class in America.
Today we see vestiges of that history in states with restrictive midwifery laws and barriers to entry for midwives. Earlier this year, one study was the first systematic look at how and where they practice, offering new evidence that empowering them could significantly boost maternal and infant health. Many of the states with poor health outcomes and hostility to midwives also have large black populations. And with black mothers three to four times more likely to die in pregnancy or childbirth, the study raises the possibility that greater use of midwives could reduce racial disparities in maternal health.
This story makes up the eighth installment in Vox’s collaboration with ProPublica. You can find this video and all of Vox’s videos on YouTube. Subscribe and stay tuned for more from our partnership.
Since ProPublica launched Lost Mothers, we’ve covered many facets of the U.S. maternal mortality crisis. Despite spending more per capita on health care than any other country, the U.S. has the highest rate of deaths related to pregnancy and childbirth in the industrialized world.
Source: Vox and ProPublica
But what makes maternal health care in other affluent countries look so different than the U.S.? Among other things, midwives. Midwives in the U.S. participate in less than 10 percent of births. But in Sweden, Denmark and France, they lead around three-quarters of deliveries. In Great Britain, they deliver half of all babies, including all three of Kate Middleton’s. So if the midwifery model works for royal babies, why not our own?
Check out the video to find out how midwives have been at the center of a culture war that’s deeply rooted in race and class in America.
Today we see vestiges of that history in states with restrictive midwifery laws and barriers to entry for midwives. Earlier this year, one study was the first systematic look at how and where they practice, offering new evidence that empowering them could significantly boost maternal and infant health. Many of the states with poor health outcomes and hostility to midwives also have large black populations. And with black mothers three to four times more likely to die in pregnancy or childbirth, the study raises the possibility that greater use of midwives could reduce racial disparities in maternal health.
This story makes up the eighth installment in Vox’s collaboration with ProPublica. You can find this video and all of Vox’s videos on YouTube. Subscribe and stay tuned for more from our partnership.
Teaching opportunities of live surgery broadcasts debated
SAN DIEGO – Two thoracic societies are being challenged to review their rejection of at medical meetings.
The American Association for Thoracic Surgery and Society of Thoracic Surgeons “should modify their stance on live surgery as an educational tool like almost all of their sister organizations,” said Joseph E. Bavaria, MD, FACS, of the University of Pennsylvania, Philadelphia. “Presently, it is effectively a ban on the practice. But there are no data to suggest that it does harm to patients if done with proper constraints.”
Live broadcasts of surgeries at medical meetings are both common and controversial. Dr. Bavaria listed numerous recent thoracic meetings in Europe and Canada that featured live broadcasts. But, he noted, the AATS and STS are not supportive of the trend.
In a policy amended in 2017, the AATS states, among other things, that “national and international cardiothoracic societies should consider prohibiting live surgery broadcasts to large audiences at their annual meetings.” The STS policy, amended in 2016, is nearly identical. However, it adds language specifying that “violation of these guidelines may lead to disciplinary action by the Society.”
Both the AATS and STS policies state that surgeons should not take part in live broadcasts of operations that are intended for the public. And both policies say “generally, recorded broadcasts, either edited or unedited, are preferable to live surgery broadcasts because recordings intended for later broadcast pose fewer risks of harm to patients.”
The policies don’t elaborate on how a live broadcast of an operation might be more harmful than one aired at a later time. “Where are the data to support this statement?” Dr. Bavaria asked. “Is this what we call the expert opinion of a few people with gray hair? Our European and Canadian colleagues certainly don’t agree with [the policies] and might take issue with our sanctimonious lecturing that’s not supported by any data whatsoever.”
He pointed to a 2011 study that examined 250 cardiac procedures that were broadcast live to 32 scientific meetings. Researchers found that “there is no evidence for an excess perioperative risk for patients operated under the conditions of live broadcasting” (Eur J Cardiothorac Surg. 2011;40[2]:367-71).
A member of the audience at the AATS session pointed out that the study may be misleading because only top surgeons may be willing to perform procedures live on television. Dr. Bavaria responded by noting that the outcomes of surgeries performed on live video were not worse.
Skeptics have also expressed concern about the potential for sensationalism in live broadcasts and the drive for participants to make a splash: “the demands of ‘the performance,’ including questions and discussion with the audience, may divert the surgeon’s attention and produce an inferior outcome,” wrote three physicians in 2011 (J Surg Educ. 2011 Jan-Feb; 68[1]:58-61).
The trio also expressed worry about safety risks posed by extra equipment and extra people in the operating room during a live broadcast. However, Dr. Bavaria said the crowded conditions of an operation observed in person – instead of via video – could be worse: “You don’t have a sterile environment, you have people hanging around all over. A moderated live session could be better for the surgeon and the patient, rather than having a bunch of people in the room.”
Dr. Bavaria was also asked why surgeries couldn’t be recorded for airing later instead of being broadcast live, as this approach “takes you out of the nexus of having two masters, the patient and the audience.” In response, Dr. Bavaria said editing takes extra time in order to capture the nuances of the live procedure.
Dr. Bavaria reports no relevant disclosures.
Peter Angelos, MD, FACS, is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. Dr. Angelos has no disclosures.
Peter Angelos, MD, FACS, is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. Dr. Angelos has no disclosures.
Peter Angelos, MD, FACS, is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. Dr. Angelos has no disclosures.
SAN DIEGO – Two thoracic societies are being challenged to review their rejection of at medical meetings.
The American Association for Thoracic Surgery and Society of Thoracic Surgeons “should modify their stance on live surgery as an educational tool like almost all of their sister organizations,” said Joseph E. Bavaria, MD, FACS, of the University of Pennsylvania, Philadelphia. “Presently, it is effectively a ban on the practice. But there are no data to suggest that it does harm to patients if done with proper constraints.”
Live broadcasts of surgeries at medical meetings are both common and controversial. Dr. Bavaria listed numerous recent thoracic meetings in Europe and Canada that featured live broadcasts. But, he noted, the AATS and STS are not supportive of the trend.
In a policy amended in 2017, the AATS states, among other things, that “national and international cardiothoracic societies should consider prohibiting live surgery broadcasts to large audiences at their annual meetings.” The STS policy, amended in 2016, is nearly identical. However, it adds language specifying that “violation of these guidelines may lead to disciplinary action by the Society.”
Both the AATS and STS policies state that surgeons should not take part in live broadcasts of operations that are intended for the public. And both policies say “generally, recorded broadcasts, either edited or unedited, are preferable to live surgery broadcasts because recordings intended for later broadcast pose fewer risks of harm to patients.”
The policies don’t elaborate on how a live broadcast of an operation might be more harmful than one aired at a later time. “Where are the data to support this statement?” Dr. Bavaria asked. “Is this what we call the expert opinion of a few people with gray hair? Our European and Canadian colleagues certainly don’t agree with [the policies] and might take issue with our sanctimonious lecturing that’s not supported by any data whatsoever.”
He pointed to a 2011 study that examined 250 cardiac procedures that were broadcast live to 32 scientific meetings. Researchers found that “there is no evidence for an excess perioperative risk for patients operated under the conditions of live broadcasting” (Eur J Cardiothorac Surg. 2011;40[2]:367-71).
A member of the audience at the AATS session pointed out that the study may be misleading because only top surgeons may be willing to perform procedures live on television. Dr. Bavaria responded by noting that the outcomes of surgeries performed on live video were not worse.
Skeptics have also expressed concern about the potential for sensationalism in live broadcasts and the drive for participants to make a splash: “the demands of ‘the performance,’ including questions and discussion with the audience, may divert the surgeon’s attention and produce an inferior outcome,” wrote three physicians in 2011 (J Surg Educ. 2011 Jan-Feb; 68[1]:58-61).
The trio also expressed worry about safety risks posed by extra equipment and extra people in the operating room during a live broadcast. However, Dr. Bavaria said the crowded conditions of an operation observed in person – instead of via video – could be worse: “You don’t have a sterile environment, you have people hanging around all over. A moderated live session could be better for the surgeon and the patient, rather than having a bunch of people in the room.”
Dr. Bavaria was also asked why surgeries couldn’t be recorded for airing later instead of being broadcast live, as this approach “takes you out of the nexus of having two masters, the patient and the audience.” In response, Dr. Bavaria said editing takes extra time in order to capture the nuances of the live procedure.
Dr. Bavaria reports no relevant disclosures.
SAN DIEGO – Two thoracic societies are being challenged to review their rejection of at medical meetings.
The American Association for Thoracic Surgery and Society of Thoracic Surgeons “should modify their stance on live surgery as an educational tool like almost all of their sister organizations,” said Joseph E. Bavaria, MD, FACS, of the University of Pennsylvania, Philadelphia. “Presently, it is effectively a ban on the practice. But there are no data to suggest that it does harm to patients if done with proper constraints.”
Live broadcasts of surgeries at medical meetings are both common and controversial. Dr. Bavaria listed numerous recent thoracic meetings in Europe and Canada that featured live broadcasts. But, he noted, the AATS and STS are not supportive of the trend.
In a policy amended in 2017, the AATS states, among other things, that “national and international cardiothoracic societies should consider prohibiting live surgery broadcasts to large audiences at their annual meetings.” The STS policy, amended in 2016, is nearly identical. However, it adds language specifying that “violation of these guidelines may lead to disciplinary action by the Society.”
Both the AATS and STS policies state that surgeons should not take part in live broadcasts of operations that are intended for the public. And both policies say “generally, recorded broadcasts, either edited or unedited, are preferable to live surgery broadcasts because recordings intended for later broadcast pose fewer risks of harm to patients.”
The policies don’t elaborate on how a live broadcast of an operation might be more harmful than one aired at a later time. “Where are the data to support this statement?” Dr. Bavaria asked. “Is this what we call the expert opinion of a few people with gray hair? Our European and Canadian colleagues certainly don’t agree with [the policies] and might take issue with our sanctimonious lecturing that’s not supported by any data whatsoever.”
He pointed to a 2011 study that examined 250 cardiac procedures that were broadcast live to 32 scientific meetings. Researchers found that “there is no evidence for an excess perioperative risk for patients operated under the conditions of live broadcasting” (Eur J Cardiothorac Surg. 2011;40[2]:367-71).
A member of the audience at the AATS session pointed out that the study may be misleading because only top surgeons may be willing to perform procedures live on television. Dr. Bavaria responded by noting that the outcomes of surgeries performed on live video were not worse.
Skeptics have also expressed concern about the potential for sensationalism in live broadcasts and the drive for participants to make a splash: “the demands of ‘the performance,’ including questions and discussion with the audience, may divert the surgeon’s attention and produce an inferior outcome,” wrote three physicians in 2011 (J Surg Educ. 2011 Jan-Feb; 68[1]:58-61).
The trio also expressed worry about safety risks posed by extra equipment and extra people in the operating room during a live broadcast. However, Dr. Bavaria said the crowded conditions of an operation observed in person – instead of via video – could be worse: “You don’t have a sterile environment, you have people hanging around all over. A moderated live session could be better for the surgeon and the patient, rather than having a bunch of people in the room.”
Dr. Bavaria was also asked why surgeries couldn’t be recorded for airing later instead of being broadcast live, as this approach “takes you out of the nexus of having two masters, the patient and the audience.” In response, Dr. Bavaria said editing takes extra time in order to capture the nuances of the live procedure.
Dr. Bavaria reports no relevant disclosures.
REPORTING FROM AATS
Caution crucial for stem cell transplant in scleroderma, despite potential interest
SANDESTIN, FLA. – An expert called for restraint with the use of stem cell transplantation in scleroderma at the annual Congress of Clinical Rheumatology, emphasizing that the early mortality risk shows that the patient group that should be considered for the treatment is very narrow.
Results published earlier this year found a long-term benefit for myeloablative autologous stem cell transplantation, compared with cyclophosphamide, and were highly encouraging – but only in patients with severe disease (N Engl J Med. 2018;378:35-47). This might prompt patients to express interest in the treatment, many of whom are not suitable, said Janet Pope, MD, chair of rheumatology at St. Joseph’s Health Care in London, Ont.
Because of mortality seen in the first year in the stem cell transplant group, the benefit over cyclophosphamide was seen only in subsequent years, Dr. Pope stressed.
Consideration of the approach is only appropriate for patients with early diffuse scleroderma who have a 50% mortality risk over 5 years, Dr. Pope said. Patients in the SCOT trial had a modified Rodnan Skin Score (mRSS) of 30, with an average forced vital capacity of 74%, and 73 of the 75 patients in the trial had lung involvement. Essentially, Dr. Pope said, these are patients with some organ involvement that could be lethal, but not such severe organ involvement that it requires a transplant.
“These are our sick patients,” she said.
The results published this year are even more definitive, Dr. Pope said, considering that they largely meshed with results out of Europe, published in 2014, that showed that the stem cell transplant benefit was not seen after the first year because of early mortality (JAMA. 2014 Jun 25;311[24]:2490-8). In that trial, a 10% mortality risk was seen in the first year in the transplant group, and then a benefit to transplant in the long term over cyclophosphamide.
“These are very complementary positive trials,” Dr. Pope said. “We don’t want to kill 10% of our patients who don’t have perceived high chance of mortality in the next 5 years. ... These patients are highly selected, but I think it gives our patients hope and, for some of my patients, this will be a treatment for them.”
The long-term efficacy is also encouraging in that new but less potent treatments might yield good long-term results without the early deaths, she said. “It gives an idea and hope, and it helps us to understand that maybe with immune modulation, without the nuclear blast of stem cell transplant, maybe we can do better for our patients.”
Dr. Pope reported relevant financial relationships with Actelion, Bayer, Merck, Bristol-Myers Squibb, and Roche.
SANDESTIN, FLA. – An expert called for restraint with the use of stem cell transplantation in scleroderma at the annual Congress of Clinical Rheumatology, emphasizing that the early mortality risk shows that the patient group that should be considered for the treatment is very narrow.
Results published earlier this year found a long-term benefit for myeloablative autologous stem cell transplantation, compared with cyclophosphamide, and were highly encouraging – but only in patients with severe disease (N Engl J Med. 2018;378:35-47). This might prompt patients to express interest in the treatment, many of whom are not suitable, said Janet Pope, MD, chair of rheumatology at St. Joseph’s Health Care in London, Ont.
Because of mortality seen in the first year in the stem cell transplant group, the benefit over cyclophosphamide was seen only in subsequent years, Dr. Pope stressed.
Consideration of the approach is only appropriate for patients with early diffuse scleroderma who have a 50% mortality risk over 5 years, Dr. Pope said. Patients in the SCOT trial had a modified Rodnan Skin Score (mRSS) of 30, with an average forced vital capacity of 74%, and 73 of the 75 patients in the trial had lung involvement. Essentially, Dr. Pope said, these are patients with some organ involvement that could be lethal, but not such severe organ involvement that it requires a transplant.
“These are our sick patients,” she said.
The results published this year are even more definitive, Dr. Pope said, considering that they largely meshed with results out of Europe, published in 2014, that showed that the stem cell transplant benefit was not seen after the first year because of early mortality (JAMA. 2014 Jun 25;311[24]:2490-8). In that trial, a 10% mortality risk was seen in the first year in the transplant group, and then a benefit to transplant in the long term over cyclophosphamide.
“These are very complementary positive trials,” Dr. Pope said. “We don’t want to kill 10% of our patients who don’t have perceived high chance of mortality in the next 5 years. ... These patients are highly selected, but I think it gives our patients hope and, for some of my patients, this will be a treatment for them.”
The long-term efficacy is also encouraging in that new but less potent treatments might yield good long-term results without the early deaths, she said. “It gives an idea and hope, and it helps us to understand that maybe with immune modulation, without the nuclear blast of stem cell transplant, maybe we can do better for our patients.”
Dr. Pope reported relevant financial relationships with Actelion, Bayer, Merck, Bristol-Myers Squibb, and Roche.
SANDESTIN, FLA. – An expert called for restraint with the use of stem cell transplantation in scleroderma at the annual Congress of Clinical Rheumatology, emphasizing that the early mortality risk shows that the patient group that should be considered for the treatment is very narrow.
Results published earlier this year found a long-term benefit for myeloablative autologous stem cell transplantation, compared with cyclophosphamide, and were highly encouraging – but only in patients with severe disease (N Engl J Med. 2018;378:35-47). This might prompt patients to express interest in the treatment, many of whom are not suitable, said Janet Pope, MD, chair of rheumatology at St. Joseph’s Health Care in London, Ont.
Because of mortality seen in the first year in the stem cell transplant group, the benefit over cyclophosphamide was seen only in subsequent years, Dr. Pope stressed.
Consideration of the approach is only appropriate for patients with early diffuse scleroderma who have a 50% mortality risk over 5 years, Dr. Pope said. Patients in the SCOT trial had a modified Rodnan Skin Score (mRSS) of 30, with an average forced vital capacity of 74%, and 73 of the 75 patients in the trial had lung involvement. Essentially, Dr. Pope said, these are patients with some organ involvement that could be lethal, but not such severe organ involvement that it requires a transplant.
“These are our sick patients,” she said.
The results published this year are even more definitive, Dr. Pope said, considering that they largely meshed with results out of Europe, published in 2014, that showed that the stem cell transplant benefit was not seen after the first year because of early mortality (JAMA. 2014 Jun 25;311[24]:2490-8). In that trial, a 10% mortality risk was seen in the first year in the transplant group, and then a benefit to transplant in the long term over cyclophosphamide.
“These are very complementary positive trials,” Dr. Pope said. “We don’t want to kill 10% of our patients who don’t have perceived high chance of mortality in the next 5 years. ... These patients are highly selected, but I think it gives our patients hope and, for some of my patients, this will be a treatment for them.”
The long-term efficacy is also encouraging in that new but less potent treatments might yield good long-term results without the early deaths, she said. “It gives an idea and hope, and it helps us to understand that maybe with immune modulation, without the nuclear blast of stem cell transplant, maybe we can do better for our patients.”
Dr. Pope reported relevant financial relationships with Actelion, Bayer, Merck, Bristol-Myers Squibb, and Roche.
EXPERT ANALYSIS FROM CCR 18
Keratinocyte carcinoma added no VTE risk in cohort study
Keratinocyte carcinoma patients were not at increased risk of venous thromboembolism (VTE) compared with controls in a recent population-based study of more than 700,000 insurance claims, according to investigators.
That finding suggests that clinicians should more carefully consider use of prophylactic anticoagulation in patients with squamous or basal cell carcinoma, said Shannon F. Rudy, MD, of Stanford (Calif.) University, and her coinvestigators. The report was published in JAMA Facial Plastic Surgery.
“While chemoprophylaxis is important when treating patients with an increased risk of VTE, it is equally important that such agents are not administered inappropriately because they can lead to perioperative complications,” wrote Dr. Rudy and her coauthors.
In current practice, patients with keratinocyte carcinomas (i.e., squamous cell carcinoma or basal cell carcinoma) are routinely classified at higher risk of thromboembolic events because of their diagnosis. That subsequently impacts treatment decisions regarding perioperative anticoagulation, the investigators noted.
Their population-based, retrospective analysis was based on insurance claims made between Jan. 1, 2007, and Dec. 31, 2014. The investigators identified three cohorts: 417,839 keratinocyte carcinoma patients, 314,736 controls at average risk of VTE, and 7,671 individuals considered to be at high risk of VTE because of a prior diagnosis of acute myeloid leukemia or pancreatic cancer.
In the keratinocyte carcinoma cohort, investigators found VTE risk was lower compared with the high-risk cohort in univariable analysis, multivariable analysis, and after matching patient characteristics and risk factors (odds ratio, 0.52; 95% confidence interval, 0.35-0.78; P = .001).
Compared with the control cohort, the keratinocyte carcinoma cohort had a higher risk of VTE in univariable analysis; however, the risk was lower in multivariable analysis, and not statistically different when patient characteristics and risk factors were matched (OR, 0.95; 95% CI, 0.89-1.01; P = .08).
“These results argue for careful consideration of risk assessment models, such as the Caprini score, when a surgical procedure is planned for a patient with keratinocyte carcinoma and no other risk factors for VTE in order to limit unnecessary exposure to the potential risk of VTE chemoprophylaxis,” Dr. Rudy and her coauthors wrote.
The Caprini score is a commonly used, validated, VTE risk stratification model that assigns points to specific risk factors, producing a score that can be used to decide on prophylaxis regimens, they noted.
A present or previous cancer diagnosis is worth 2 points in the Caprini system, which would put a patient at the upper end of the “low risk” category, while one additional risk factor such as planned minor surgery would indicate moderate risk.
“Recently, Caprini has begun to exclude basal cell carcinoma from this calculation, but no reference to evidence is given,” the researchers wrote.
Dr. Rudy and her coauthors had no conflicts of interest to disclose.
SOURCE: Rudy SF et al. JAMA Facial Plast Surg. 2018 May 24. doi: 10.1001/jamafacial.2018.0331.
Keratinocyte carcinoma patients were not at increased risk of venous thromboembolism (VTE) compared with controls in a recent population-based study of more than 700,000 insurance claims, according to investigators.
That finding suggests that clinicians should more carefully consider use of prophylactic anticoagulation in patients with squamous or basal cell carcinoma, said Shannon F. Rudy, MD, of Stanford (Calif.) University, and her coinvestigators. The report was published in JAMA Facial Plastic Surgery.
“While chemoprophylaxis is important when treating patients with an increased risk of VTE, it is equally important that such agents are not administered inappropriately because they can lead to perioperative complications,” wrote Dr. Rudy and her coauthors.
In current practice, patients with keratinocyte carcinomas (i.e., squamous cell carcinoma or basal cell carcinoma) are routinely classified at higher risk of thromboembolic events because of their diagnosis. That subsequently impacts treatment decisions regarding perioperative anticoagulation, the investigators noted.
Their population-based, retrospective analysis was based on insurance claims made between Jan. 1, 2007, and Dec. 31, 2014. The investigators identified three cohorts: 417,839 keratinocyte carcinoma patients, 314,736 controls at average risk of VTE, and 7,671 individuals considered to be at high risk of VTE because of a prior diagnosis of acute myeloid leukemia or pancreatic cancer.
In the keratinocyte carcinoma cohort, investigators found VTE risk was lower compared with the high-risk cohort in univariable analysis, multivariable analysis, and after matching patient characteristics and risk factors (odds ratio, 0.52; 95% confidence interval, 0.35-0.78; P = .001).
Compared with the control cohort, the keratinocyte carcinoma cohort had a higher risk of VTE in univariable analysis; however, the risk was lower in multivariable analysis, and not statistically different when patient characteristics and risk factors were matched (OR, 0.95; 95% CI, 0.89-1.01; P = .08).
“These results argue for careful consideration of risk assessment models, such as the Caprini score, when a surgical procedure is planned for a patient with keratinocyte carcinoma and no other risk factors for VTE in order to limit unnecessary exposure to the potential risk of VTE chemoprophylaxis,” Dr. Rudy and her coauthors wrote.
The Caprini score is a commonly used, validated, VTE risk stratification model that assigns points to specific risk factors, producing a score that can be used to decide on prophylaxis regimens, they noted.
A present or previous cancer diagnosis is worth 2 points in the Caprini system, which would put a patient at the upper end of the “low risk” category, while one additional risk factor such as planned minor surgery would indicate moderate risk.
“Recently, Caprini has begun to exclude basal cell carcinoma from this calculation, but no reference to evidence is given,” the researchers wrote.
Dr. Rudy and her coauthors had no conflicts of interest to disclose.
SOURCE: Rudy SF et al. JAMA Facial Plast Surg. 2018 May 24. doi: 10.1001/jamafacial.2018.0331.
Keratinocyte carcinoma patients were not at increased risk of venous thromboembolism (VTE) compared with controls in a recent population-based study of more than 700,000 insurance claims, according to investigators.
That finding suggests that clinicians should more carefully consider use of prophylactic anticoagulation in patients with squamous or basal cell carcinoma, said Shannon F. Rudy, MD, of Stanford (Calif.) University, and her coinvestigators. The report was published in JAMA Facial Plastic Surgery.
“While chemoprophylaxis is important when treating patients with an increased risk of VTE, it is equally important that such agents are not administered inappropriately because they can lead to perioperative complications,” wrote Dr. Rudy and her coauthors.
In current practice, patients with keratinocyte carcinomas (i.e., squamous cell carcinoma or basal cell carcinoma) are routinely classified at higher risk of thromboembolic events because of their diagnosis. That subsequently impacts treatment decisions regarding perioperative anticoagulation, the investigators noted.
Their population-based, retrospective analysis was based on insurance claims made between Jan. 1, 2007, and Dec. 31, 2014. The investigators identified three cohorts: 417,839 keratinocyte carcinoma patients, 314,736 controls at average risk of VTE, and 7,671 individuals considered to be at high risk of VTE because of a prior diagnosis of acute myeloid leukemia or pancreatic cancer.
In the keratinocyte carcinoma cohort, investigators found VTE risk was lower compared with the high-risk cohort in univariable analysis, multivariable analysis, and after matching patient characteristics and risk factors (odds ratio, 0.52; 95% confidence interval, 0.35-0.78; P = .001).
Compared with the control cohort, the keratinocyte carcinoma cohort had a higher risk of VTE in univariable analysis; however, the risk was lower in multivariable analysis, and not statistically different when patient characteristics and risk factors were matched (OR, 0.95; 95% CI, 0.89-1.01; P = .08).
“These results argue for careful consideration of risk assessment models, such as the Caprini score, when a surgical procedure is planned for a patient with keratinocyte carcinoma and no other risk factors for VTE in order to limit unnecessary exposure to the potential risk of VTE chemoprophylaxis,” Dr. Rudy and her coauthors wrote.
The Caprini score is a commonly used, validated, VTE risk stratification model that assigns points to specific risk factors, producing a score that can be used to decide on prophylaxis regimens, they noted.
A present or previous cancer diagnosis is worth 2 points in the Caprini system, which would put a patient at the upper end of the “low risk” category, while one additional risk factor such as planned minor surgery would indicate moderate risk.
“Recently, Caprini has begun to exclude basal cell carcinoma from this calculation, but no reference to evidence is given,” the researchers wrote.
Dr. Rudy and her coauthors had no conflicts of interest to disclose.
SOURCE: Rudy SF et al. JAMA Facial Plast Surg. 2018 May 24. doi: 10.1001/jamafacial.2018.0331.
FROM JAMA FACIAL PLASTIC SURGERY
Key clinical point: Keratinocyte patients had no increased risk of venous thromboembolism (VTE) versus controls, suggesting the need to carefully consider whether prophylactic anticoagulation is needed at the time of surgery in these patients.
Major finding: Risk of VTE in the keratinocyte carcinoma cohort was not different compared with controls after adjustment for patient characteristics and risk factors (OR, 0.95; 95% CI, 0.89-1.01; P = .08).
Study details: A population-based retrospective analysis of insurance claims made between Jan. 1, 2007, and Dec. 31, 2014, including 417,839 keratinocyte carcinoma patients, 314,736 controls, and a high-risk cohort of 7,671 individuals.
Disclosures: The authors declared no conflicts of interest.
Source: Rudy SF et al. JAMA Facial Plast Surg. 2018 May 24. doi: 10.1001/jamafacial.2018.0331.
FDA to review FLT3 agent for refractory AML
The Food and Drug Administration has granted priority review to an FMS-like tyrosine kinase 3 (FLT3)–targeting agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML).
If approved, it would be the first FLT3 inhibitor available for this indication.
The application is based on the ongoing ADMIRAL trial, a phase 3, open-label, randomized study of gilteritinib versus salvage chemotherapy. The trial is designed to enroll 369 patients with FLT3 mutations present in bone marrow or whole blood who are refractory or have relapsed on first-line therapy. The primary endpoints are overall survival and rates of complete remission and complete remission with partial hematologic recovery.
The FDA has set Nov. 29 as a target date for reaching a decision on approval of the drug.
The Food and Drug Administration has granted priority review to an FMS-like tyrosine kinase 3 (FLT3)–targeting agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML).
If approved, it would be the first FLT3 inhibitor available for this indication.
The application is based on the ongoing ADMIRAL trial, a phase 3, open-label, randomized study of gilteritinib versus salvage chemotherapy. The trial is designed to enroll 369 patients with FLT3 mutations present in bone marrow or whole blood who are refractory or have relapsed on first-line therapy. The primary endpoints are overall survival and rates of complete remission and complete remission with partial hematologic recovery.
The FDA has set Nov. 29 as a target date for reaching a decision on approval of the drug.
The Food and Drug Administration has granted priority review to an FMS-like tyrosine kinase 3 (FLT3)–targeting agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML).
If approved, it would be the first FLT3 inhibitor available for this indication.
The application is based on the ongoing ADMIRAL trial, a phase 3, open-label, randomized study of gilteritinib versus salvage chemotherapy. The trial is designed to enroll 369 patients with FLT3 mutations present in bone marrow or whole blood who are refractory or have relapsed on first-line therapy. The primary endpoints are overall survival and rates of complete remission and complete remission with partial hematologic recovery.
The FDA has set Nov. 29 as a target date for reaching a decision on approval of the drug.
ASCO 2018: Dr. Walter M. Stadler gives his top picks in prostate cancer research
The theme of this year’s annual meeting of the American Society of Clinical Oncology is Delivering Discoveries: Expanding the Reach of Precision Medicine. Of the more than 2,500 abstracts accepted for presentation,
• 5000, A randomized, phase 3 trial between adjuvant docetaxel and surveillance after radical radiotherapy for intermediate and high-risk prostate cancer: Results of SPCG-13 trial.
• 5002, A randomized study of finite abiraterone acetate (AA) plus leuprolide (LHRHa) versus LHRHa in biochemically recurrent nonmetastatic hormone-naïve prostate cancer (M0HNPC).
• 5004, The PROPHECY trial: Multicenter prospective trial of circulating tumor cell (CTC) AR-V7 detection in men with mCRPC receiving abiraterone (A) or enzalutamide (E).
• LBA5005, Overall survival between African American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC).
• 5006, Results of PROSPECT: A randomized, phase 3 trial of PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
• 5007, KEYNOTE-199: Pembrolizumab (pembro) for docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC).
• 5020, Microsatellite instability in prostate cancer and response to immune checkpoint blockade.
• 5012, Phenotypic and genomic characterization of CTCs as a biomarker for prediction of Veliparib therapy benefit in mCRPC.
• 5022, Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up.
• 5032, Association of metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC).
• 5040, Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase 2 trial.
Dr. Walter M. Stadler, is the Fred C. Buffett Professor of Medicine and Surgery; deputy director of the University of Chicago Medicine Comprehensive Cancer Center; associate dean for clinical research; chief, section of hematology/oncology; and director, genitourinary oncology program at the University of Chicago.
The theme of this year’s annual meeting of the American Society of Clinical Oncology is Delivering Discoveries: Expanding the Reach of Precision Medicine. Of the more than 2,500 abstracts accepted for presentation,
• 5000, A randomized, phase 3 trial between adjuvant docetaxel and surveillance after radical radiotherapy for intermediate and high-risk prostate cancer: Results of SPCG-13 trial.
• 5002, A randomized study of finite abiraterone acetate (AA) plus leuprolide (LHRHa) versus LHRHa in biochemically recurrent nonmetastatic hormone-naïve prostate cancer (M0HNPC).
• 5004, The PROPHECY trial: Multicenter prospective trial of circulating tumor cell (CTC) AR-V7 detection in men with mCRPC receiving abiraterone (A) or enzalutamide (E).
• LBA5005, Overall survival between African American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC).
• 5006, Results of PROSPECT: A randomized, phase 3 trial of PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
• 5007, KEYNOTE-199: Pembrolizumab (pembro) for docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC).
• 5020, Microsatellite instability in prostate cancer and response to immune checkpoint blockade.
• 5012, Phenotypic and genomic characterization of CTCs as a biomarker for prediction of Veliparib therapy benefit in mCRPC.
• 5022, Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up.
• 5032, Association of metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC).
• 5040, Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase 2 trial.
Dr. Walter M. Stadler, is the Fred C. Buffett Professor of Medicine and Surgery; deputy director of the University of Chicago Medicine Comprehensive Cancer Center; associate dean for clinical research; chief, section of hematology/oncology; and director, genitourinary oncology program at the University of Chicago.
The theme of this year’s annual meeting of the American Society of Clinical Oncology is Delivering Discoveries: Expanding the Reach of Precision Medicine. Of the more than 2,500 abstracts accepted for presentation,
• 5000, A randomized, phase 3 trial between adjuvant docetaxel and surveillance after radical radiotherapy for intermediate and high-risk prostate cancer: Results of SPCG-13 trial.
• 5002, A randomized study of finite abiraterone acetate (AA) plus leuprolide (LHRHa) versus LHRHa in biochemically recurrent nonmetastatic hormone-naïve prostate cancer (M0HNPC).
• 5004, The PROPHECY trial: Multicenter prospective trial of circulating tumor cell (CTC) AR-V7 detection in men with mCRPC receiving abiraterone (A) or enzalutamide (E).
• LBA5005, Overall survival between African American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC).
• 5006, Results of PROSPECT: A randomized, phase 3 trial of PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
• 5007, KEYNOTE-199: Pembrolizumab (pembro) for docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC).
• 5020, Microsatellite instability in prostate cancer and response to immune checkpoint blockade.
• 5012, Phenotypic and genomic characterization of CTCs as a biomarker for prediction of Veliparib therapy benefit in mCRPC.
• 5022, Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up.
• 5032, Association of metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC).
• 5040, Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase 2 trial.
Dr. Walter M. Stadler, is the Fred C. Buffett Professor of Medicine and Surgery; deputy director of the University of Chicago Medicine Comprehensive Cancer Center; associate dean for clinical research; chief, section of hematology/oncology; and director, genitourinary oncology program at the University of Chicago.
IncobotulinumtoxinA May Reduce Sialorrhea in Parkinson’s Disease
LOS ANGELES—IncobotulinumtoxinA may treat sialorrhea in Parkinson’s disease and other neurologic disorders effectively, according to a trial described at the 70th Annual Meeting of the American Academy of Neurology. The treatment effect may persist for as long as 16 weeks.
Various neurologic disorders, such as Parkinson’s disease and amyotrophic lateral sclerosis (ALS), may cause troublesome sialorrhea. Olaf Michel, PhD, Vice Chair of the Department of Otorhinolaryngology at the University Hospital Brussels, and colleagues conducted a phase III trial to investigate the safety and efficacy of incobotulinumtoxinA as a treatment for sialorrhea.
The researchers enrolled 184 participants (age 18 to 80) with chronic troublesome sialorrhea resulting from Parkinson’s disease or atypical parkinsonism, stroke, or traumatic brain injury (TBI) into the trial. They randomized participants in a double-blinded fashion to 75 U of incobotulinumtoxinA (ie, the low-dose group), 100 U of incobotulinumtoxinA (ie, the high-dose group), or placebo. The low-dose group received 15 U in each submandibular gland and 22.5, in each parotid gland. The high-dose group received 20 U in each submandibular gland and 30 U in each parotid gland. Follow-up lasted for 16 weeks after injection. The study’s primary outcomes were unstimulated salivary flow rate (uSFR) at week four, compared with baseline, and Global Impression of Change Scale (GICS) at week four.
In all, 74 participants were randomized to the low dose, 74 to the high dose, and 36 to placebo. The three groups were well balanced, but the proportion of women in the placebo group was lower than that in the treatment groups. Sialorrhea was associated with Parkinson’s disease in 70.6% of patients, atypical Parkinson syndromes in 8.7%, stroke in 17.9%, and TBI in 2.7%.
The investigators localized injection sites using anatomical landmarks in 39.2% of the low-dose group, 44.6% of the high-dose group, and 50% of the placebo group. They used ultrasound guidance to localize injection sites in 60.8% of the low-dose group, 55.4% of the high-dose group, and 50% of the placebo group.
At week four, changes in uSFR and GICS were similar in the placebo and low-dose groups. Improvements in these measures reached statistical significance in the high-dose group at week four, however. At weeks eight through 12, the improvements in uSFR and GICS in both active treatment groups were significant. Improvements in the uSFR and GICS in both dose groups were maintained at week 16, but were lower in the low-dose group than in the high-dose group. Dr. Michel and colleagues observed no relevant differences in outcomes according to the technique used to localize injection sites. They also observed no unexpected side effects.
At the end of the 16-week study, all patients entered a 48-week extension period during which they received three additional injections of dose-blinded incobotulinumtoxinA at 16-week intervals. The treatment effect stabilized and did not decline during the extension, and the investigators observed no accumulation of adverse events.
LOS ANGELES—IncobotulinumtoxinA may treat sialorrhea in Parkinson’s disease and other neurologic disorders effectively, according to a trial described at the 70th Annual Meeting of the American Academy of Neurology. The treatment effect may persist for as long as 16 weeks.
Various neurologic disorders, such as Parkinson’s disease and amyotrophic lateral sclerosis (ALS), may cause troublesome sialorrhea. Olaf Michel, PhD, Vice Chair of the Department of Otorhinolaryngology at the University Hospital Brussels, and colleagues conducted a phase III trial to investigate the safety and efficacy of incobotulinumtoxinA as a treatment for sialorrhea.
The researchers enrolled 184 participants (age 18 to 80) with chronic troublesome sialorrhea resulting from Parkinson’s disease or atypical parkinsonism, stroke, or traumatic brain injury (TBI) into the trial. They randomized participants in a double-blinded fashion to 75 U of incobotulinumtoxinA (ie, the low-dose group), 100 U of incobotulinumtoxinA (ie, the high-dose group), or placebo. The low-dose group received 15 U in each submandibular gland and 22.5, in each parotid gland. The high-dose group received 20 U in each submandibular gland and 30 U in each parotid gland. Follow-up lasted for 16 weeks after injection. The study’s primary outcomes were unstimulated salivary flow rate (uSFR) at week four, compared with baseline, and Global Impression of Change Scale (GICS) at week four.
In all, 74 participants were randomized to the low dose, 74 to the high dose, and 36 to placebo. The three groups were well balanced, but the proportion of women in the placebo group was lower than that in the treatment groups. Sialorrhea was associated with Parkinson’s disease in 70.6% of patients, atypical Parkinson syndromes in 8.7%, stroke in 17.9%, and TBI in 2.7%.
The investigators localized injection sites using anatomical landmarks in 39.2% of the low-dose group, 44.6% of the high-dose group, and 50% of the placebo group. They used ultrasound guidance to localize injection sites in 60.8% of the low-dose group, 55.4% of the high-dose group, and 50% of the placebo group.
At week four, changes in uSFR and GICS were similar in the placebo and low-dose groups. Improvements in these measures reached statistical significance in the high-dose group at week four, however. At weeks eight through 12, the improvements in uSFR and GICS in both active treatment groups were significant. Improvements in the uSFR and GICS in both dose groups were maintained at week 16, but were lower in the low-dose group than in the high-dose group. Dr. Michel and colleagues observed no relevant differences in outcomes according to the technique used to localize injection sites. They also observed no unexpected side effects.
At the end of the 16-week study, all patients entered a 48-week extension period during which they received three additional injections of dose-blinded incobotulinumtoxinA at 16-week intervals. The treatment effect stabilized and did not decline during the extension, and the investigators observed no accumulation of adverse events.
LOS ANGELES—IncobotulinumtoxinA may treat sialorrhea in Parkinson’s disease and other neurologic disorders effectively, according to a trial described at the 70th Annual Meeting of the American Academy of Neurology. The treatment effect may persist for as long as 16 weeks.
Various neurologic disorders, such as Parkinson’s disease and amyotrophic lateral sclerosis (ALS), may cause troublesome sialorrhea. Olaf Michel, PhD, Vice Chair of the Department of Otorhinolaryngology at the University Hospital Brussels, and colleagues conducted a phase III trial to investigate the safety and efficacy of incobotulinumtoxinA as a treatment for sialorrhea.
The researchers enrolled 184 participants (age 18 to 80) with chronic troublesome sialorrhea resulting from Parkinson’s disease or atypical parkinsonism, stroke, or traumatic brain injury (TBI) into the trial. They randomized participants in a double-blinded fashion to 75 U of incobotulinumtoxinA (ie, the low-dose group), 100 U of incobotulinumtoxinA (ie, the high-dose group), or placebo. The low-dose group received 15 U in each submandibular gland and 22.5, in each parotid gland. The high-dose group received 20 U in each submandibular gland and 30 U in each parotid gland. Follow-up lasted for 16 weeks after injection. The study’s primary outcomes were unstimulated salivary flow rate (uSFR) at week four, compared with baseline, and Global Impression of Change Scale (GICS) at week four.
In all, 74 participants were randomized to the low dose, 74 to the high dose, and 36 to placebo. The three groups were well balanced, but the proportion of women in the placebo group was lower than that in the treatment groups. Sialorrhea was associated with Parkinson’s disease in 70.6% of patients, atypical Parkinson syndromes in 8.7%, stroke in 17.9%, and TBI in 2.7%.
The investigators localized injection sites using anatomical landmarks in 39.2% of the low-dose group, 44.6% of the high-dose group, and 50% of the placebo group. They used ultrasound guidance to localize injection sites in 60.8% of the low-dose group, 55.4% of the high-dose group, and 50% of the placebo group.
At week four, changes in uSFR and GICS were similar in the placebo and low-dose groups. Improvements in these measures reached statistical significance in the high-dose group at week four, however. At weeks eight through 12, the improvements in uSFR and GICS in both active treatment groups were significant. Improvements in the uSFR and GICS in both dose groups were maintained at week 16, but were lower in the low-dose group than in the high-dose group. Dr. Michel and colleagues observed no relevant differences in outcomes according to the technique used to localize injection sites. They also observed no unexpected side effects.
At the end of the 16-week study, all patients entered a 48-week extension period during which they received three additional injections of dose-blinded incobotulinumtoxinA at 16-week intervals. The treatment effect stabilized and did not decline during the extension, and the investigators observed no accumulation of adverse events.
Retinal Changes Indicate Parkinson’s Disease Pathology Severity
The accumulation of phosphorylated α-synuclein in the retina may serve as a biomarker of brain pathology severity and aid in diagnosis and monitoring of Parkinson’s disease, according to data published online ahead of print May 8 in Movement Disorders.
“These data suggest that phosphorylated α-synuclein accumulates in the retina in parallel with that in the brain, including in early stages preceding development of clinical signs of parkinsonism or dementia,” said Nicolás Cuenca, PhD, Assistant Professor of Physiology, Genetics, and Microbiology at the University of Alicante in Spain, and colleagues.
Parkinson’s disease pathology is mainly characterized by the accumulation of pathologic α-synuclein deposits in the brain, but little is known about how synucleinopathy affects the retina.
Dr. Cuenca and colleagues used immunohistochemistry to evaluate the presence of phosphorylated α-synuclein deposits in the retina of nine autopsied subjects with Parkinson’s disease, four with incidental Lewy body disease, and six controls. Eligible subjects had motor parkinsonism, Lewy body pathology, and pigmented neuron loss in the substantia nigra at autopsy. For each subject, the researchers compared the amount of retinal synucleinopathy with indicators of brain disease severity.
All subjects with Parkinson’s disease and three subjects with incidental Lewy body disease had phosphorylated α-synuclein deposits in ganglion cell perikarya, dendrites, and axons. Some of the deposits resembled brain Lewy bodies and Lewy neurites. Cells that contained phosphorylated α-synuclein had different morphologies, soma sizes (ie, from 15 µm to 30 µm), dendritic lengths (ie, from 570 µm to 1,620 µm), and receptive fields. Control subjects did not show any phosphorylated α-synuclein immunoreactivity in their retinas, however.
The Lewy-type synucleinopathy density in the retina significantly correlated with Lewy-type synucleinopathy density in the brain, with the Unified Parkinson’s disease pathology stage, and with the motor subscale of the Unifed Parkinson’s Disease Rating Scale. Confirmation of disease by autopsy partly compensated for the small number of subjects, according to the authors.
“Further investigations of the eye in Parkinson’s disease are desirable, given that ocular structures are involved in the pathology of several neurodegenerative diseases,” said Dr. Cuenca and colleagues.
—Erica Tricarico
Suggested Reading
Ortuño-Lizarán I, Beach TG, Serrano GE, et al. Phosphorylated α-synuclein in the retina is a biomarker of Parkinson’s disease pathology severity. Mov Disord. 2018 May 8 [Epub ahead of print].
Ma LJ, Xu LL, Mao CJ, et al. Progressive changes in the retinal structure of patients with Parkinson’s disease. J Parkinsons Dis. 2018;8(1):85-92.
The accumulation of phosphorylated α-synuclein in the retina may serve as a biomarker of brain pathology severity and aid in diagnosis and monitoring of Parkinson’s disease, according to data published online ahead of print May 8 in Movement Disorders.
“These data suggest that phosphorylated α-synuclein accumulates in the retina in parallel with that in the brain, including in early stages preceding development of clinical signs of parkinsonism or dementia,” said Nicolás Cuenca, PhD, Assistant Professor of Physiology, Genetics, and Microbiology at the University of Alicante in Spain, and colleagues.
Parkinson’s disease pathology is mainly characterized by the accumulation of pathologic α-synuclein deposits in the brain, but little is known about how synucleinopathy affects the retina.
Dr. Cuenca and colleagues used immunohistochemistry to evaluate the presence of phosphorylated α-synuclein deposits in the retina of nine autopsied subjects with Parkinson’s disease, four with incidental Lewy body disease, and six controls. Eligible subjects had motor parkinsonism, Lewy body pathology, and pigmented neuron loss in the substantia nigra at autopsy. For each subject, the researchers compared the amount of retinal synucleinopathy with indicators of brain disease severity.
All subjects with Parkinson’s disease and three subjects with incidental Lewy body disease had phosphorylated α-synuclein deposits in ganglion cell perikarya, dendrites, and axons. Some of the deposits resembled brain Lewy bodies and Lewy neurites. Cells that contained phosphorylated α-synuclein had different morphologies, soma sizes (ie, from 15 µm to 30 µm), dendritic lengths (ie, from 570 µm to 1,620 µm), and receptive fields. Control subjects did not show any phosphorylated α-synuclein immunoreactivity in their retinas, however.
The Lewy-type synucleinopathy density in the retina significantly correlated with Lewy-type synucleinopathy density in the brain, with the Unified Parkinson’s disease pathology stage, and with the motor subscale of the Unifed Parkinson’s Disease Rating Scale. Confirmation of disease by autopsy partly compensated for the small number of subjects, according to the authors.
“Further investigations of the eye in Parkinson’s disease are desirable, given that ocular structures are involved in the pathology of several neurodegenerative diseases,” said Dr. Cuenca and colleagues.
—Erica Tricarico
Suggested Reading
Ortuño-Lizarán I, Beach TG, Serrano GE, et al. Phosphorylated α-synuclein in the retina is a biomarker of Parkinson’s disease pathology severity. Mov Disord. 2018 May 8 [Epub ahead of print].
Ma LJ, Xu LL, Mao CJ, et al. Progressive changes in the retinal structure of patients with Parkinson’s disease. J Parkinsons Dis. 2018;8(1):85-92.
The accumulation of phosphorylated α-synuclein in the retina may serve as a biomarker of brain pathology severity and aid in diagnosis and monitoring of Parkinson’s disease, according to data published online ahead of print May 8 in Movement Disorders.
“These data suggest that phosphorylated α-synuclein accumulates in the retina in parallel with that in the brain, including in early stages preceding development of clinical signs of parkinsonism or dementia,” said Nicolás Cuenca, PhD, Assistant Professor of Physiology, Genetics, and Microbiology at the University of Alicante in Spain, and colleagues.
Parkinson’s disease pathology is mainly characterized by the accumulation of pathologic α-synuclein deposits in the brain, but little is known about how synucleinopathy affects the retina.
Dr. Cuenca and colleagues used immunohistochemistry to evaluate the presence of phosphorylated α-synuclein deposits in the retina of nine autopsied subjects with Parkinson’s disease, four with incidental Lewy body disease, and six controls. Eligible subjects had motor parkinsonism, Lewy body pathology, and pigmented neuron loss in the substantia nigra at autopsy. For each subject, the researchers compared the amount of retinal synucleinopathy with indicators of brain disease severity.
All subjects with Parkinson’s disease and three subjects with incidental Lewy body disease had phosphorylated α-synuclein deposits in ganglion cell perikarya, dendrites, and axons. Some of the deposits resembled brain Lewy bodies and Lewy neurites. Cells that contained phosphorylated α-synuclein had different morphologies, soma sizes (ie, from 15 µm to 30 µm), dendritic lengths (ie, from 570 µm to 1,620 µm), and receptive fields. Control subjects did not show any phosphorylated α-synuclein immunoreactivity in their retinas, however.
The Lewy-type synucleinopathy density in the retina significantly correlated with Lewy-type synucleinopathy density in the brain, with the Unified Parkinson’s disease pathology stage, and with the motor subscale of the Unifed Parkinson’s Disease Rating Scale. Confirmation of disease by autopsy partly compensated for the small number of subjects, according to the authors.
“Further investigations of the eye in Parkinson’s disease are desirable, given that ocular structures are involved in the pathology of several neurodegenerative diseases,” said Dr. Cuenca and colleagues.
—Erica Tricarico
Suggested Reading
Ortuño-Lizarán I, Beach TG, Serrano GE, et al. Phosphorylated α-synuclein in the retina is a biomarker of Parkinson’s disease pathology severity. Mov Disord. 2018 May 8 [Epub ahead of print].
Ma LJ, Xu LL, Mao CJ, et al. Progressive changes in the retinal structure of patients with Parkinson’s disease. J Parkinsons Dis. 2018;8(1):85-92.
How Common Are Comorbidities in Chronic Versus Episodic Migraine?
LOS ANGELES—Significantly more patients with chronic migraine versus episodic migraine report cardiovascular, respiratory, gastrointestinal, psychiatric, and sleep-related symptoms and conditions, according to research presented at the 70th Annual Meeting of the American Academy of Neurology.
Certain comorbidities, including allergies, insomnia, and neck pain, have relative frequencies in chronic migraine that are at least 10% greater than in episodic migraine. “Mechanisms explaining this association might include direct causality (eg, chronic migraine causes the comorbidity), reverse causality (eg, the condition increases chronic migraine risk), and shared genetic or environmental risk factors,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. Detection bias also may contribute to the association, they said.
Examining Relative Frequencies
Migraineurs often present with concomitant conditions that may exacerbate the disease, and many comorbidities occur more frequently in chronic migraine than in episodic migraine. To replicate and extend research on comorbid medical conditions in a systematically recruited sample of people with episodic and chronic migraine, Dr. Lipton and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, a prospective web-based survey designed to characterize self-reported headache symptoms and severity in a representative sample of people with migraine in the United States.
The CaMEO study included a comorbidities-and-endophenotypes module that asked respondents whether they ever had specific symptoms or conditions and, if present, whether they had been confirmed or diagnosed by a doctor. The investigators analyzed self-reported data for symptoms easily identified by respondents and physician-diagnosed data for conditions that required a medical diagnosis. The researchers used chi-squared analysis to compare the relative frequencies of symptoms and conditions. Percentages for female-specific conditions (eg, polycystic ovary syndrome) were calculated by comparison with female migraineurs. Dr. Lipton and colleagues presented data about respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities in one study and data about pain, psychiatric, and endocrine or neurologic comorbidities in another study.
In all, 16,763 CaMEO respondents with migraine received the comorbidities-and-endophenotypes module, and 12,810 provided valid responses. The analysis included 1,111 respondents (8.7%) with chronic migraine (ie, 15 or more headache days per month for more than three months) and 11,699 (91.3%) with episodic migraine (ie, fewer than 15 headache days per month). Compared with the episodic migraine group, the chronic migraine group had a similar mean age (41.3 vs 41.9), was more likely to be female (74.2% vs 81.5%), was more likely to be white (84.0% vs 88.7%), and had a higher mean BMI (27.7 kg/m2 vs 28.7 kg/m2). Compared with respondents with episodic migraine, respondents with chronic migraine more frequently reported allodynia, generalized anxiety disorder, and major depression and had a greater mean Migraine Disability Assessment Scale (MIDAS) score.
A Range of Symptoms and Conditions
Of the 31 respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 93.5%. The following five conditions or groups of conditions had relative frequencies at least 10% higher in chronic migraine than episodic migraine: allergies, hay fever, or allergic rhinitis (61.2% vs 51.2%); sinusitis or sinus infection (63.5% vs 52.7%); insomnia (50.2% vs 35.6%); vertigo, dizziness, or balance problems (29.7% vs 17.8%); and gastroesophageal reflux disease (24.4% vs 14.3%).
Of the 28 pain, psychiatric, and endocrine or neurologic comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 85.7%. The following five conditions had relative frequencies more than 10% higher in chronic migraine than in episodic migraine: chronic back pain (37.6% vs 22.5%), chronic pain (22.2% vs 7.4%), neck pain (55.3% vs 38.1%), anxiety (42.2% vs 25.7%), and depression (45.6% vs 28.1%).
The Likelihood of Medication Overuse
Of the eight endocrine or neurologic comorbidities assessed (ie, hyperhidrosis, diabetes, seizures, spasticity, underactive thyroid or thyroid medication, cervical dystonia, gout, and polycystic ovary syndrome), all but gout and polycystic ovary syndrome had significantly higher relative frequencies in chronic migraine.
When the researchers used latent class analysis to identify natural subgroups of migraine based on profiles of comorbidities and concomitant conditions, they found that a subgroup with the most comorbidities was more likely to include individuals with chronic migraine (23.1% vs 4.8%) and had greater proportions of individuals with grade IV MIDAS scores (ie, severe disability; 48.1% vs 15.1%), allodynia (67.6% vs 38.3%), medication overuse (36.4% vs 8.9%), and aura (40.1% vs 23.9%), compared with a subgroup with the fewest comorbidities
The studies were funded by Allergan.
—Jake Remaly
Suggested Reading
Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015;35(7):563-578.
LOS ANGELES—Significantly more patients with chronic migraine versus episodic migraine report cardiovascular, respiratory, gastrointestinal, psychiatric, and sleep-related symptoms and conditions, according to research presented at the 70th Annual Meeting of the American Academy of Neurology.
Certain comorbidities, including allergies, insomnia, and neck pain, have relative frequencies in chronic migraine that are at least 10% greater than in episodic migraine. “Mechanisms explaining this association might include direct causality (eg, chronic migraine causes the comorbidity), reverse causality (eg, the condition increases chronic migraine risk), and shared genetic or environmental risk factors,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. Detection bias also may contribute to the association, they said.
Examining Relative Frequencies
Migraineurs often present with concomitant conditions that may exacerbate the disease, and many comorbidities occur more frequently in chronic migraine than in episodic migraine. To replicate and extend research on comorbid medical conditions in a systematically recruited sample of people with episodic and chronic migraine, Dr. Lipton and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, a prospective web-based survey designed to characterize self-reported headache symptoms and severity in a representative sample of people with migraine in the United States.
The CaMEO study included a comorbidities-and-endophenotypes module that asked respondents whether they ever had specific symptoms or conditions and, if present, whether they had been confirmed or diagnosed by a doctor. The investigators analyzed self-reported data for symptoms easily identified by respondents and physician-diagnosed data for conditions that required a medical diagnosis. The researchers used chi-squared analysis to compare the relative frequencies of symptoms and conditions. Percentages for female-specific conditions (eg, polycystic ovary syndrome) were calculated by comparison with female migraineurs. Dr. Lipton and colleagues presented data about respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities in one study and data about pain, psychiatric, and endocrine or neurologic comorbidities in another study.
In all, 16,763 CaMEO respondents with migraine received the comorbidities-and-endophenotypes module, and 12,810 provided valid responses. The analysis included 1,111 respondents (8.7%) with chronic migraine (ie, 15 or more headache days per month for more than three months) and 11,699 (91.3%) with episodic migraine (ie, fewer than 15 headache days per month). Compared with the episodic migraine group, the chronic migraine group had a similar mean age (41.3 vs 41.9), was more likely to be female (74.2% vs 81.5%), was more likely to be white (84.0% vs 88.7%), and had a higher mean BMI (27.7 kg/m2 vs 28.7 kg/m2). Compared with respondents with episodic migraine, respondents with chronic migraine more frequently reported allodynia, generalized anxiety disorder, and major depression and had a greater mean Migraine Disability Assessment Scale (MIDAS) score.
A Range of Symptoms and Conditions
Of the 31 respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 93.5%. The following five conditions or groups of conditions had relative frequencies at least 10% higher in chronic migraine than episodic migraine: allergies, hay fever, or allergic rhinitis (61.2% vs 51.2%); sinusitis or sinus infection (63.5% vs 52.7%); insomnia (50.2% vs 35.6%); vertigo, dizziness, or balance problems (29.7% vs 17.8%); and gastroesophageal reflux disease (24.4% vs 14.3%).
Of the 28 pain, psychiatric, and endocrine or neurologic comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 85.7%. The following five conditions had relative frequencies more than 10% higher in chronic migraine than in episodic migraine: chronic back pain (37.6% vs 22.5%), chronic pain (22.2% vs 7.4%), neck pain (55.3% vs 38.1%), anxiety (42.2% vs 25.7%), and depression (45.6% vs 28.1%).
The Likelihood of Medication Overuse
Of the eight endocrine or neurologic comorbidities assessed (ie, hyperhidrosis, diabetes, seizures, spasticity, underactive thyroid or thyroid medication, cervical dystonia, gout, and polycystic ovary syndrome), all but gout and polycystic ovary syndrome had significantly higher relative frequencies in chronic migraine.
When the researchers used latent class analysis to identify natural subgroups of migraine based on profiles of comorbidities and concomitant conditions, they found that a subgroup with the most comorbidities was more likely to include individuals with chronic migraine (23.1% vs 4.8%) and had greater proportions of individuals with grade IV MIDAS scores (ie, severe disability; 48.1% vs 15.1%), allodynia (67.6% vs 38.3%), medication overuse (36.4% vs 8.9%), and aura (40.1% vs 23.9%), compared with a subgroup with the fewest comorbidities
The studies were funded by Allergan.
—Jake Remaly
Suggested Reading
Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015;35(7):563-578.
LOS ANGELES—Significantly more patients with chronic migraine versus episodic migraine report cardiovascular, respiratory, gastrointestinal, psychiatric, and sleep-related symptoms and conditions, according to research presented at the 70th Annual Meeting of the American Academy of Neurology.
Certain comorbidities, including allergies, insomnia, and neck pain, have relative frequencies in chronic migraine that are at least 10% greater than in episodic migraine. “Mechanisms explaining this association might include direct causality (eg, chronic migraine causes the comorbidity), reverse causality (eg, the condition increases chronic migraine risk), and shared genetic or environmental risk factors,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. Detection bias also may contribute to the association, they said.
Examining Relative Frequencies
Migraineurs often present with concomitant conditions that may exacerbate the disease, and many comorbidities occur more frequently in chronic migraine than in episodic migraine. To replicate and extend research on comorbid medical conditions in a systematically recruited sample of people with episodic and chronic migraine, Dr. Lipton and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, a prospective web-based survey designed to characterize self-reported headache symptoms and severity in a representative sample of people with migraine in the United States.
The CaMEO study included a comorbidities-and-endophenotypes module that asked respondents whether they ever had specific symptoms or conditions and, if present, whether they had been confirmed or diagnosed by a doctor. The investigators analyzed self-reported data for symptoms easily identified by respondents and physician-diagnosed data for conditions that required a medical diagnosis. The researchers used chi-squared analysis to compare the relative frequencies of symptoms and conditions. Percentages for female-specific conditions (eg, polycystic ovary syndrome) were calculated by comparison with female migraineurs. Dr. Lipton and colleagues presented data about respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities in one study and data about pain, psychiatric, and endocrine or neurologic comorbidities in another study.
In all, 16,763 CaMEO respondents with migraine received the comorbidities-and-endophenotypes module, and 12,810 provided valid responses. The analysis included 1,111 respondents (8.7%) with chronic migraine (ie, 15 or more headache days per month for more than three months) and 11,699 (91.3%) with episodic migraine (ie, fewer than 15 headache days per month). Compared with the episodic migraine group, the chronic migraine group had a similar mean age (41.3 vs 41.9), was more likely to be female (74.2% vs 81.5%), was more likely to be white (84.0% vs 88.7%), and had a higher mean BMI (27.7 kg/m2 vs 28.7 kg/m2). Compared with respondents with episodic migraine, respondents with chronic migraine more frequently reported allodynia, generalized anxiety disorder, and major depression and had a greater mean Migraine Disability Assessment Scale (MIDAS) score.
A Range of Symptoms and Conditions
Of the 31 respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 93.5%. The following five conditions or groups of conditions had relative frequencies at least 10% higher in chronic migraine than episodic migraine: allergies, hay fever, or allergic rhinitis (61.2% vs 51.2%); sinusitis or sinus infection (63.5% vs 52.7%); insomnia (50.2% vs 35.6%); vertigo, dizziness, or balance problems (29.7% vs 17.8%); and gastroesophageal reflux disease (24.4% vs 14.3%).
Of the 28 pain, psychiatric, and endocrine or neurologic comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 85.7%. The following five conditions had relative frequencies more than 10% higher in chronic migraine than in episodic migraine: chronic back pain (37.6% vs 22.5%), chronic pain (22.2% vs 7.4%), neck pain (55.3% vs 38.1%), anxiety (42.2% vs 25.7%), and depression (45.6% vs 28.1%).
The Likelihood of Medication Overuse
Of the eight endocrine or neurologic comorbidities assessed (ie, hyperhidrosis, diabetes, seizures, spasticity, underactive thyroid or thyroid medication, cervical dystonia, gout, and polycystic ovary syndrome), all but gout and polycystic ovary syndrome had significantly higher relative frequencies in chronic migraine.
When the researchers used latent class analysis to identify natural subgroups of migraine based on profiles of comorbidities and concomitant conditions, they found that a subgroup with the most comorbidities was more likely to include individuals with chronic migraine (23.1% vs 4.8%) and had greater proportions of individuals with grade IV MIDAS scores (ie, severe disability; 48.1% vs 15.1%), allodynia (67.6% vs 38.3%), medication overuse (36.4% vs 8.9%), and aura (40.1% vs 23.9%), compared with a subgroup with the fewest comorbidities
The studies were funded by Allergan.
—Jake Remaly
Suggested Reading
Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015;35(7):563-578.