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M. Alexander Otto began his reporting career early in 1999 covering the pharmaceutical industry for a national pharmacists' magazine and freelancing for the Washington Post and other newspapers. He then joined BNA, now part of Bloomberg News, covering health law and the protection of people and animals in medical research. Alex next worked for the McClatchy Company. Based on his work, Alex won a year-long Knight Science Journalism Fellowship to MIT in 2008-2009. He joined the company shortly thereafter. Alex has a newspaper journalism degree from Syracuse (N.Y.) University and a master's degree in medical science -- a physician assistant degree -- from George Washington University. Alex is based in Seattle.
Consider intraperitoneal ropivacaine for colectomy ERAS
SEATTLE – Intraperitoneal ropivacaine decreases postoperative pain and improves functional recovery after laparoscopic colectomy, according to randomized, blinded trial from the Royal Adelaide (Australia) Hospital.
“We recommend routine inclusion of IPLA [intraperitoneal local anesthetic] in the multimodal analgesia component of ERAS [enhanced-recovery-after-surgery] programs for laparoscopic colectomy,” the investigators concluded.
Recovery was smoother in the ropivacaine group. On a 90-point surgical recovery scale assessing fatigue, mental function, and the ability to do normal daily activities, ropivacaine patients were a few points ahead on days 1 and 3; the gap widened to about 10 points on days 7, 30, and 45. Ropivacaine might have helped reduced inflammation, accounting for the extended benefit, Dr. Lewis said.
Pain control was better with ropivacaine, as well. Ropivacaine patients were about 15-20 points lower on 50-point scales assessing both visceral and abdominal pain at postop hours 3 and 24, and day 7. The findings were statistically significant.
Several trends also favored ropivacaine. Ropivacaine patients had their first bowel movement at around 70 hours postop, versus about 82 hours in the control group. They were also discharged almost a day sooner, and had less postop vomiting. Just one patient in the ropivacaine group was diagnosed with ileus, versus four in the control arm.
There was also a trend for less opioid use in the ropivacaine group, which Dr. Lewis suspected would have been statistically significant if the trial had more patients.
Ropivacaine patients were a mean of 67 years old, versus 62 years old in the control group. There were slightly more men than women in each arm. The mean body mass index in the ropivacaine group was 28.5 kg/m2, and in the control group 26.4 kg/m2. Ropivacaine was discontinued in two patients due to possible toxicity.
An audience member noted that intravenous lidocaine has shown similar benefits in abdominal surgery.
The investigators had no disclosures.
SEATTLE – Intraperitoneal ropivacaine decreases postoperative pain and improves functional recovery after laparoscopic colectomy, according to randomized, blinded trial from the Royal Adelaide (Australia) Hospital.
“We recommend routine inclusion of IPLA [intraperitoneal local anesthetic] in the multimodal analgesia component of ERAS [enhanced-recovery-after-surgery] programs for laparoscopic colectomy,” the investigators concluded.
Recovery was smoother in the ropivacaine group. On a 90-point surgical recovery scale assessing fatigue, mental function, and the ability to do normal daily activities, ropivacaine patients were a few points ahead on days 1 and 3; the gap widened to about 10 points on days 7, 30, and 45. Ropivacaine might have helped reduced inflammation, accounting for the extended benefit, Dr. Lewis said.
Pain control was better with ropivacaine, as well. Ropivacaine patients were about 15-20 points lower on 50-point scales assessing both visceral and abdominal pain at postop hours 3 and 24, and day 7. The findings were statistically significant.
Several trends also favored ropivacaine. Ropivacaine patients had their first bowel movement at around 70 hours postop, versus about 82 hours in the control group. They were also discharged almost a day sooner, and had less postop vomiting. Just one patient in the ropivacaine group was diagnosed with ileus, versus four in the control arm.
There was also a trend for less opioid use in the ropivacaine group, which Dr. Lewis suspected would have been statistically significant if the trial had more patients.
Ropivacaine patients were a mean of 67 years old, versus 62 years old in the control group. There were slightly more men than women in each arm. The mean body mass index in the ropivacaine group was 28.5 kg/m2, and in the control group 26.4 kg/m2. Ropivacaine was discontinued in two patients due to possible toxicity.
An audience member noted that intravenous lidocaine has shown similar benefits in abdominal surgery.
The investigators had no disclosures.
SEATTLE – Intraperitoneal ropivacaine decreases postoperative pain and improves functional recovery after laparoscopic colectomy, according to randomized, blinded trial from the Royal Adelaide (Australia) Hospital.
“We recommend routine inclusion of IPLA [intraperitoneal local anesthetic] in the multimodal analgesia component of ERAS [enhanced-recovery-after-surgery] programs for laparoscopic colectomy,” the investigators concluded.
Recovery was smoother in the ropivacaine group. On a 90-point surgical recovery scale assessing fatigue, mental function, and the ability to do normal daily activities, ropivacaine patients were a few points ahead on days 1 and 3; the gap widened to about 10 points on days 7, 30, and 45. Ropivacaine might have helped reduced inflammation, accounting for the extended benefit, Dr. Lewis said.
Pain control was better with ropivacaine, as well. Ropivacaine patients were about 15-20 points lower on 50-point scales assessing both visceral and abdominal pain at postop hours 3 and 24, and day 7. The findings were statistically significant.
Several trends also favored ropivacaine. Ropivacaine patients had their first bowel movement at around 70 hours postop, versus about 82 hours in the control group. They were also discharged almost a day sooner, and had less postop vomiting. Just one patient in the ropivacaine group was diagnosed with ileus, versus four in the control arm.
There was also a trend for less opioid use in the ropivacaine group, which Dr. Lewis suspected would have been statistically significant if the trial had more patients.
Ropivacaine patients were a mean of 67 years old, versus 62 years old in the control group. There were slightly more men than women in each arm. The mean body mass index in the ropivacaine group was 28.5 kg/m2, and in the control group 26.4 kg/m2. Ropivacaine was discontinued in two patients due to possible toxicity.
An audience member noted that intravenous lidocaine has shown similar benefits in abdominal surgery.
The investigators had no disclosures.
AT ASCRS 2017
Key clinical point:
Major finding: On a 90-point surgical recovery scale assessing fatigue, mental function, and the ability to do normal daily activities, ropivacaine patients were a few points ahead of saline controls on postop days 1 and 3; the gap widened to about 10 points on days 7, 30, and 45.
Data source: Randomized, blinded trial with 51 patients
Disclosures: The investigators had no disclosures.
Sooner is better than later for acute UC surgery
AT ASCRS 2017
SEATTLE – Postponing surgery for acute ulcerative colitis more than a day increases postoperative complications, lengths of stay, and hospital costs, according to a review by Johns Hopkins University, Baltimore, of almost 2,000 patients.
It’s not uncommon to wait 5 or even 10 days to give biologics a chance to work when patients are admitted for acute ulcerative colitis (UC). Based on the review, however, “we believe that the need for prolonged medical therapy and resuscitation in this patient population prior to colectomy may be overstated,” and that “the lasting effects of persistent inflammation cascade are underestimated.”
There has to be “a conversation with the gastroenterologist to strike the right balance between medical and surgical therapy. Early surgical intervention” should be considered, lead author and general surgery resident Ira Leeds, MD, said at the American Society of Colon and Rectal Surgeons annual meeting.
The team reviewed 1,953 index UC admissions with emergent non-elective abdominal surgery in the National Inpatient Sample (NIS) database from 2008-13; 546 patients (28%) had early operations - within 24 hours of admission – and the other 1,407 had operations after that time.
Although it’s impossible to say for sure given the limits of administrative data in the NIS, patients who had surgery soon after admission were probably sicker. Even so, they were less likely to have complications than patients in the delayed surgery group (55% versus 43%), and they had shorter hospital stays, with just 8% in the hospital past 21 days, versus 29% of patients who had delayed operations. The findings were similar for both overall length of stay and post-op length of stay.
Renal complications (8% versus 14%), pulmonary complications (20% versus 25%), and thromboembolic events (4% versus 6%) were also less common in the early surgery group. On multivariable analysis, delayed surgery increased the complication rate by 64%.
With fewer complications and shorter hospital stays, early operations were also less expensive, with a mean total hospitalization cost of $19,985 versus $34,258. The findings were all statistically significant.
Dr. Leeds noted the limits of the study; medical management regimes and the reasons for variations in surgical timing are unknown, among other things. “This is not the final answer on what to do with patients like this, but it opens the door to prospective studies that could control” for such variables, he said.
Early surgery patients were more likely to be male (57% versus 51%) and from households with incomes higher than the national median. There were no difference in age, race, comorbidities, region, or hospital type between the two groups.
Dr. Leeds said he had no disclosures.
AGA Resource
Visit www.gastro.org/ibd for patient education guides that you can share with your patients to help them understand and manage their ulcerative colitis and IBD.
AT ASCRS 2017
SEATTLE – Postponing surgery for acute ulcerative colitis more than a day increases postoperative complications, lengths of stay, and hospital costs, according to a review by Johns Hopkins University, Baltimore, of almost 2,000 patients.
It’s not uncommon to wait 5 or even 10 days to give biologics a chance to work when patients are admitted for acute ulcerative colitis (UC). Based on the review, however, “we believe that the need for prolonged medical therapy and resuscitation in this patient population prior to colectomy may be overstated,” and that “the lasting effects of persistent inflammation cascade are underestimated.”
There has to be “a conversation with the gastroenterologist to strike the right balance between medical and surgical therapy. Early surgical intervention” should be considered, lead author and general surgery resident Ira Leeds, MD, said at the American Society of Colon and Rectal Surgeons annual meeting.
The team reviewed 1,953 index UC admissions with emergent non-elective abdominal surgery in the National Inpatient Sample (NIS) database from 2008-13; 546 patients (28%) had early operations - within 24 hours of admission – and the other 1,407 had operations after that time.
Although it’s impossible to say for sure given the limits of administrative data in the NIS, patients who had surgery soon after admission were probably sicker. Even so, they were less likely to have complications than patients in the delayed surgery group (55% versus 43%), and they had shorter hospital stays, with just 8% in the hospital past 21 days, versus 29% of patients who had delayed operations. The findings were similar for both overall length of stay and post-op length of stay.
Renal complications (8% versus 14%), pulmonary complications (20% versus 25%), and thromboembolic events (4% versus 6%) were also less common in the early surgery group. On multivariable analysis, delayed surgery increased the complication rate by 64%.
With fewer complications and shorter hospital stays, early operations were also less expensive, with a mean total hospitalization cost of $19,985 versus $34,258. The findings were all statistically significant.
Dr. Leeds noted the limits of the study; medical management regimes and the reasons for variations in surgical timing are unknown, among other things. “This is not the final answer on what to do with patients like this, but it opens the door to prospective studies that could control” for such variables, he said.
Early surgery patients were more likely to be male (57% versus 51%) and from households with incomes higher than the national median. There were no difference in age, race, comorbidities, region, or hospital type between the two groups.
Dr. Leeds said he had no disclosures.
AGA Resource
Visit www.gastro.org/ibd for patient education guides that you can share with your patients to help them understand and manage their ulcerative colitis and IBD.
AT ASCRS 2017
SEATTLE – Postponing surgery for acute ulcerative colitis more than a day increases postoperative complications, lengths of stay, and hospital costs, according to a review by Johns Hopkins University, Baltimore, of almost 2,000 patients.
It’s not uncommon to wait 5 or even 10 days to give biologics a chance to work when patients are admitted for acute ulcerative colitis (UC). Based on the review, however, “we believe that the need for prolonged medical therapy and resuscitation in this patient population prior to colectomy may be overstated,” and that “the lasting effects of persistent inflammation cascade are underestimated.”
There has to be “a conversation with the gastroenterologist to strike the right balance between medical and surgical therapy. Early surgical intervention” should be considered, lead author and general surgery resident Ira Leeds, MD, said at the American Society of Colon and Rectal Surgeons annual meeting.
The team reviewed 1,953 index UC admissions with emergent non-elective abdominal surgery in the National Inpatient Sample (NIS) database from 2008-13; 546 patients (28%) had early operations - within 24 hours of admission – and the other 1,407 had operations after that time.
Although it’s impossible to say for sure given the limits of administrative data in the NIS, patients who had surgery soon after admission were probably sicker. Even so, they were less likely to have complications than patients in the delayed surgery group (55% versus 43%), and they had shorter hospital stays, with just 8% in the hospital past 21 days, versus 29% of patients who had delayed operations. The findings were similar for both overall length of stay and post-op length of stay.
Renal complications (8% versus 14%), pulmonary complications (20% versus 25%), and thromboembolic events (4% versus 6%) were also less common in the early surgery group. On multivariable analysis, delayed surgery increased the complication rate by 64%.
With fewer complications and shorter hospital stays, early operations were also less expensive, with a mean total hospitalization cost of $19,985 versus $34,258. The findings were all statistically significant.
Dr. Leeds noted the limits of the study; medical management regimes and the reasons for variations in surgical timing are unknown, among other things. “This is not the final answer on what to do with patients like this, but it opens the door to prospective studies that could control” for such variables, he said.
Early surgery patients were more likely to be male (57% versus 51%) and from households with incomes higher than the national median. There were no difference in age, race, comorbidities, region, or hospital type between the two groups.
Dr. Leeds said he had no disclosures.
AGA Resource
Visit www.gastro.org/ibd for patient education guides that you can share with your patients to help them understand and manage their ulcerative colitis and IBD.
Key clinical point:
Major finding: Patients who had surgery soon after admission were probably sicker. Even so, they were less likely to have complications than patients in the delayed surgery group (55% versus 43%), and they had shorter hospital stays, with just 8% in the hospital past 21 days, versus 29% of patients who had delayed operations.
Data source: Review of almost 2,000 patients in the National Inpatient Sample
Disclosures: The lead investigator had no disclosures.
SEATTLE – Postponing surgery for acute ulcerative colitis more than a day increases postoperative complications, lengths of stay, and hospital costs, according to a review by Johns Hopkins University, Baltimore, of almost 2,000 patients.
It’s not uncommon to wait 5 or even 10 days to give biologics a chance to work when patients are admitted for acute ulcerative colitis (UC). Based on the review, however, “we believe that the need for prolonged medical therapy and resuscitation in this patient population prior to colectomy may be overstated,” and that “the lasting effects of persistent inflammation cascade are underestimated.”
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There has to be “a conversation with the gastroenterologist to strike the right balance between medical and surgical therapy. Early surgical intervention” should be considered, lead author and general surgery resident Ira Leeds, MD, said at the American Society of Colon and Rectal Surgeons annual meeting.
The team reviewed 1,953 index UC admissions with emergent non-elective abdominal surgery in the National Inpatient Sample (NIS) database from 2008-13; 546 patients (28%) had early operations - within 24 hours of admission – and the other 1,407 had operations after that time.
Although it’s impossible to say for sure given the limits of administrative data in the NIS, patients who had surgery soon after admission were probably sicker. Even so, they were less likely to have complications than patients in the delayed surgery group (55% versus 43%), and they had shorter hospital stays, with just 8% in the hospital past 21 days, versus 29% of patients who had delayed operations. The findings were similar for both overall length of stay and post-op length of stay.
Renal complications (8% versus 14%), pulmonary complications (20% versus 25%), and thromboembolic events (4% versus 6%) were also less common in the early surgery group. On multivariable analysis, delayed surgery increased the complication rate by 64%.
With fewer complications and shorter hospital stays, early operations were also less expensive, with a mean total hospitalization cost of $19,985 versus $34,258. The findings were all statistically significant.
Dr. Leeds noted the limits of the study; medical management regimes and the reasons for variations in surgical timing are unknown, among other things. “This is not the final answer on what to do with patients like this, but it opens the door to prospective studies that could control” for such variables, he said.
Early surgery patients were more likely to be male (57% versus 51%) and from households with incomes higher than the national median. There were no difference in age, race, comorbidities, region, or hospital type between the two groups.
Dr. Leeds said he had no disclosures.
Massive blood transfusions increase risk with CRS/HIPEC
Massive allogenic blood transfusion during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) increased the risk of major complications and reduced overall survival in a review of 936 cases at St. George Hospital near Sydney, Australia.
CRS/HIPEC is a long, complex procedure for peritoneal carcinomatosis, pseudomyxoma peritonei, peritoneal mesothelioma, and other abdominal cancers. The abdomen is opened, the cancer is debulked as much as possible, and the cavity is filled with heated chemotherapy drugs. Because CRS/HIPEC often requires multivisceral resection and dissection in multiple abdominal regions, up to 77% of patients require intraoperative transfusions, and up to 37% require massive allogenic blood transfusions (MABT) with five or more units.
Blood transfusions are known to be associated with poorer cancer surgery outcomes, but their effect in CRS/HIPEC hasn’t been much studied, which is “surprising given the extent to which blood products are used in” the procedure, said investigators led by Akshat Saxena, MD, a surgeon at St. George Hospital (J Gastrointest Surg. 2017 May 30. doi: 10.1007/s11605-017-3444-8).
Based on their findings, the researchers concluded that “there is a real need to evaluate new strategies to reduce the rate of MABT during CRS/HIPEC.”
The procedures in the study were performed from 1996 to 2016. The in-hospital mortality rate was 0.3% in patients who did not have MABT but 4.4% among the 337 patients (36%) who did. Even after adjusting for confounders on multivariate analysis, including the fact that MABT patients had more extensive disease and longer surgeries, MABT significantly increased the risk of in-hospital mortality (relative risk, 7.72; P = .021). In patients requiring MABT had a 5-year survival of 5%. In patients not requiring MABT, 5-year survival was at 36%. The difference remained significant on multivariate analysis.
MABT patients also had twice the risk of life-threatening complications and complications requiring surgical, endoscopic, or radiological intervention (62% versus 30%; RR, 2.05; P less than .001). MABT patients were more likely to stay in the ICU for 4 or more days and in the hospital for 28 or more days.
Worse overall survival with MABT was driven at least in part by patients who had CRS/HIPEC for colorectal cancer peritoneal carcinomatosis and pseudomyxoma peritonei. MABT did not seem to contribute to lower survival in patients who had the procedure for appendiceal or ovarian cancer. “It seems that the impact of long-term immunomodulation induced by blood transfusion” – the suspected mechanism through which transfusions cause problems – “varies according to the disease subtype. This warrants further investigation,” the investigators said.
Several strategies have been tried to reduce the need for transfusions during CRS/HIPEC. The study team previously reported that preemptive clotting factor replacement helps. Others have had success with preemptive tranexamic acid and cryoprecipitate to address low serum fibrinogen levels during CRS/HIPEC. “Further evaluation of both these strategies is warranted,” the researchers said.
Funding source and disclosure information were not included in the study report.
Massive allogenic blood transfusion during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) increased the risk of major complications and reduced overall survival in a review of 936 cases at St. George Hospital near Sydney, Australia.
CRS/HIPEC is a long, complex procedure for peritoneal carcinomatosis, pseudomyxoma peritonei, peritoneal mesothelioma, and other abdominal cancers. The abdomen is opened, the cancer is debulked as much as possible, and the cavity is filled with heated chemotherapy drugs. Because CRS/HIPEC often requires multivisceral resection and dissection in multiple abdominal regions, up to 77% of patients require intraoperative transfusions, and up to 37% require massive allogenic blood transfusions (MABT) with five or more units.
Blood transfusions are known to be associated with poorer cancer surgery outcomes, but their effect in CRS/HIPEC hasn’t been much studied, which is “surprising given the extent to which blood products are used in” the procedure, said investigators led by Akshat Saxena, MD, a surgeon at St. George Hospital (J Gastrointest Surg. 2017 May 30. doi: 10.1007/s11605-017-3444-8).
Based on their findings, the researchers concluded that “there is a real need to evaluate new strategies to reduce the rate of MABT during CRS/HIPEC.”
The procedures in the study were performed from 1996 to 2016. The in-hospital mortality rate was 0.3% in patients who did not have MABT but 4.4% among the 337 patients (36%) who did. Even after adjusting for confounders on multivariate analysis, including the fact that MABT patients had more extensive disease and longer surgeries, MABT significantly increased the risk of in-hospital mortality (relative risk, 7.72; P = .021). In patients requiring MABT had a 5-year survival of 5%. In patients not requiring MABT, 5-year survival was at 36%. The difference remained significant on multivariate analysis.
MABT patients also had twice the risk of life-threatening complications and complications requiring surgical, endoscopic, or radiological intervention (62% versus 30%; RR, 2.05; P less than .001). MABT patients were more likely to stay in the ICU for 4 or more days and in the hospital for 28 or more days.
Worse overall survival with MABT was driven at least in part by patients who had CRS/HIPEC for colorectal cancer peritoneal carcinomatosis and pseudomyxoma peritonei. MABT did not seem to contribute to lower survival in patients who had the procedure for appendiceal or ovarian cancer. “It seems that the impact of long-term immunomodulation induced by blood transfusion” – the suspected mechanism through which transfusions cause problems – “varies according to the disease subtype. This warrants further investigation,” the investigators said.
Several strategies have been tried to reduce the need for transfusions during CRS/HIPEC. The study team previously reported that preemptive clotting factor replacement helps. Others have had success with preemptive tranexamic acid and cryoprecipitate to address low serum fibrinogen levels during CRS/HIPEC. “Further evaluation of both these strategies is warranted,” the researchers said.
Funding source and disclosure information were not included in the study report.
Massive allogenic blood transfusion during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) increased the risk of major complications and reduced overall survival in a review of 936 cases at St. George Hospital near Sydney, Australia.
CRS/HIPEC is a long, complex procedure for peritoneal carcinomatosis, pseudomyxoma peritonei, peritoneal mesothelioma, and other abdominal cancers. The abdomen is opened, the cancer is debulked as much as possible, and the cavity is filled with heated chemotherapy drugs. Because CRS/HIPEC often requires multivisceral resection and dissection in multiple abdominal regions, up to 77% of patients require intraoperative transfusions, and up to 37% require massive allogenic blood transfusions (MABT) with five or more units.
Blood transfusions are known to be associated with poorer cancer surgery outcomes, but their effect in CRS/HIPEC hasn’t been much studied, which is “surprising given the extent to which blood products are used in” the procedure, said investigators led by Akshat Saxena, MD, a surgeon at St. George Hospital (J Gastrointest Surg. 2017 May 30. doi: 10.1007/s11605-017-3444-8).
Based on their findings, the researchers concluded that “there is a real need to evaluate new strategies to reduce the rate of MABT during CRS/HIPEC.”
The procedures in the study were performed from 1996 to 2016. The in-hospital mortality rate was 0.3% in patients who did not have MABT but 4.4% among the 337 patients (36%) who did. Even after adjusting for confounders on multivariate analysis, including the fact that MABT patients had more extensive disease and longer surgeries, MABT significantly increased the risk of in-hospital mortality (relative risk, 7.72; P = .021). In patients requiring MABT had a 5-year survival of 5%. In patients not requiring MABT, 5-year survival was at 36%. The difference remained significant on multivariate analysis.
MABT patients also had twice the risk of life-threatening complications and complications requiring surgical, endoscopic, or radiological intervention (62% versus 30%; RR, 2.05; P less than .001). MABT patients were more likely to stay in the ICU for 4 or more days and in the hospital for 28 or more days.
Worse overall survival with MABT was driven at least in part by patients who had CRS/HIPEC for colorectal cancer peritoneal carcinomatosis and pseudomyxoma peritonei. MABT did not seem to contribute to lower survival in patients who had the procedure for appendiceal or ovarian cancer. “It seems that the impact of long-term immunomodulation induced by blood transfusion” – the suspected mechanism through which transfusions cause problems – “varies according to the disease subtype. This warrants further investigation,” the investigators said.
Several strategies have been tried to reduce the need for transfusions during CRS/HIPEC. The study team previously reported that preemptive clotting factor replacement helps. Others have had success with preemptive tranexamic acid and cryoprecipitate to address low serum fibrinogen levels during CRS/HIPEC. “Further evaluation of both these strategies is warranted,” the researchers said.
Funding source and disclosure information were not included in the study report.
FROM THE JOURNAL OF GASTROINTESTINAL SURGERY
Key clinical point:
Major finding: Even after adjusting for confounders, MABT significantly increased the risk of in-hospital mortality (RR, 7.72; P = .021).
Data source: A single institution review of 936 cases.
Disclosures: Funding source and disclosure information were not included in the study report.
Sooner is better than later for acute UC surgery
SEATTLE – Postponing surgery for acute ulcerative colitis more than a day increases postoperative complications, lengths of stay, and hospital costs, according to a review by Johns Hopkins University, Baltimore, of almost 2,000 patients.
It’s not uncommon to wait 5 or even 10 days to give biologics a chance to work when patients are admitted for acute ulcerative colitis (UC). Based on the review, however, “we believe that the need for prolonged medical therapy and resuscitation in this patient population prior to colectomy may be overstated,” and that “the lasting effects of persistent inflammation cascade are underestimated.”
The team reviewed 1,953 index UC admissions with emergent non-elective abdominal surgery in the National Inpatient Sample (NIS) database from 2008-13; 546 patients (28%) had early operations - within 24 hours of admission – and the other 1,407 had operations after that time.
Although it’s impossible to say for sure given the limits of administrative data in the NIS, patients who had surgery soon after admission were probably sicker. Even so, they were less likely to have complications than patients in the delayed surgery group (55% versus 43%), and they had shorter hospital stays, with just 8% in the hospital past 21 days, versus 29% of patients who had delayed operations. The findings were similar for both overall length of stay and post-op length of stay.
Renal complications (8% versus 14%), pulmonary complications (20% versus 25%), and thromboembolic events (4% versus 6%) were also less common in the early surgery group. On multivariable analysis, delayed surgery increased the complication rate by 64%.
With fewer complications and shorter hospital stays, early operations were also less expensive, with a mean total hospitalization cost of $19,985 versus $34,258. The findings were all statistically significant.
Dr. Leeds noted the limits of the study; medical management regimes and the reasons for variations in surgical timing are unknown, among other things. “This is not the final answer on what to do with patients like this, but it opens the door to prospective studies that could control” for such variables, he said.
Early surgery patients were more likely to be male (57% versus 51%) and from households with incomes higher than the national median. There were no difference in age, race, comorbidities, region, or hospital type between the two groups.
Dr. Leeds said he had no disclosures.
SEATTLE – Postponing surgery for acute ulcerative colitis more than a day increases postoperative complications, lengths of stay, and hospital costs, according to a review by Johns Hopkins University, Baltimore, of almost 2,000 patients.
It’s not uncommon to wait 5 or even 10 days to give biologics a chance to work when patients are admitted for acute ulcerative colitis (UC). Based on the review, however, “we believe that the need for prolonged medical therapy and resuscitation in this patient population prior to colectomy may be overstated,” and that “the lasting effects of persistent inflammation cascade are underestimated.”
The team reviewed 1,953 index UC admissions with emergent non-elective abdominal surgery in the National Inpatient Sample (NIS) database from 2008-13; 546 patients (28%) had early operations - within 24 hours of admission – and the other 1,407 had operations after that time.
Although it’s impossible to say for sure given the limits of administrative data in the NIS, patients who had surgery soon after admission were probably sicker. Even so, they were less likely to have complications than patients in the delayed surgery group (55% versus 43%), and they had shorter hospital stays, with just 8% in the hospital past 21 days, versus 29% of patients who had delayed operations. The findings were similar for both overall length of stay and post-op length of stay.
Renal complications (8% versus 14%), pulmonary complications (20% versus 25%), and thromboembolic events (4% versus 6%) were also less common in the early surgery group. On multivariable analysis, delayed surgery increased the complication rate by 64%.
With fewer complications and shorter hospital stays, early operations were also less expensive, with a mean total hospitalization cost of $19,985 versus $34,258. The findings were all statistically significant.
Dr. Leeds noted the limits of the study; medical management regimes and the reasons for variations in surgical timing are unknown, among other things. “This is not the final answer on what to do with patients like this, but it opens the door to prospective studies that could control” for such variables, he said.
Early surgery patients were more likely to be male (57% versus 51%) and from households with incomes higher than the national median. There were no difference in age, race, comorbidities, region, or hospital type between the two groups.
Dr. Leeds said he had no disclosures.
SEATTLE – Postponing surgery for acute ulcerative colitis more than a day increases postoperative complications, lengths of stay, and hospital costs, according to a review by Johns Hopkins University, Baltimore, of almost 2,000 patients.
It’s not uncommon to wait 5 or even 10 days to give biologics a chance to work when patients are admitted for acute ulcerative colitis (UC). Based on the review, however, “we believe that the need for prolonged medical therapy and resuscitation in this patient population prior to colectomy may be overstated,” and that “the lasting effects of persistent inflammation cascade are underestimated.”
The team reviewed 1,953 index UC admissions with emergent non-elective abdominal surgery in the National Inpatient Sample (NIS) database from 2008-13; 546 patients (28%) had early operations - within 24 hours of admission – and the other 1,407 had operations after that time.
Although it’s impossible to say for sure given the limits of administrative data in the NIS, patients who had surgery soon after admission were probably sicker. Even so, they were less likely to have complications than patients in the delayed surgery group (55% versus 43%), and they had shorter hospital stays, with just 8% in the hospital past 21 days, versus 29% of patients who had delayed operations. The findings were similar for both overall length of stay and post-op length of stay.
Renal complications (8% versus 14%), pulmonary complications (20% versus 25%), and thromboembolic events (4% versus 6%) were also less common in the early surgery group. On multivariable analysis, delayed surgery increased the complication rate by 64%.
With fewer complications and shorter hospital stays, early operations were also less expensive, with a mean total hospitalization cost of $19,985 versus $34,258. The findings were all statistically significant.
Dr. Leeds noted the limits of the study; medical management regimes and the reasons for variations in surgical timing are unknown, among other things. “This is not the final answer on what to do with patients like this, but it opens the door to prospective studies that could control” for such variables, he said.
Early surgery patients were more likely to be male (57% versus 51%) and from households with incomes higher than the national median. There were no difference in age, race, comorbidities, region, or hospital type between the two groups.
Dr. Leeds said he had no disclosures.
AT ASCRS 2017
Key clinical point:
Major finding: Patients who had surgery soon after admission were probably sicker. Even so, they were less likely to have complications than patients in the delayed surgery group (55% versus 43%), and they had shorter hospital stays, with just 8% in the hospital past 21 days, versus 29% of patients who had delayed operations.
Data source: Review of almost 2,000 patients in the National Inpatient Sample
Disclosures: The lead investigator had no disclosures.
Anal dysplasia surveillance called into question
SEATTLE – Aggressive screening and treatment of HPV anal dysplasia probably doesn’t decrease the incidence of anal cancer, even in high-risk groups, according to investigators from Kaiser Permanente of Southern California.
The increase in anal squamous cell carcinoma (SCC) over the past 20 years has led to surveillance programs for anal dysplasia in many institutions, based on the assumption that finding and destroying the lesions will prevent anal cancer, similar to the reason why polyps are removed during colonoscopy to prevent colon cancer, said lead investigator Marco Tomassi, MD, a general surgeon with Kaiser in San Diego.
Kaiser in Southern California doesn’t have an intensive surveillance program for anal HPV. Instead, high risk patients – those with HIV, past cervical cancer, anogenital warts, among others – are screened with digital rectal exams and anoscopy every 3-12 months, and only anal warts and other grossly abnormal growths are removed.
Physicians there do not routinely use high resolution anoscopy (HRA), Pap smears, and other techniques to identify and destroy microscopic foci of dysplasia, as in more intensive programs.
To see how the approach has worked, Dr. Tomassi and his colleagues reviewed the incidence of anal SCC among almost 6 million Kaiser patients from 2005 through 2015.
The cumulative incidence in all groups of patients, even those at risk for the disease, was less than 1%; 425 of the 460 anal cancers (92%) were in the general population, among patients who would not have been part of a high risk surveillance program.
Even without an aggressive surveillance program, high grade anal dysplasia was identified in 377 patients; their incidence of anal SCC was 0.8%, the highest found in the study.
There were no incident cases of SCC among the 133 HIV patients with anal dysplasia. Among over 5,000 HIV patients in the study, the anal SCC incidence was 0.09%. In the general population of 5.86 million, it was 0.01%.
“The cumulative incidence in our group, despite not performing ablative techniques for dysplasia, was comparable to those institutions that routinely perform high resolution anoscopy and destruction of dysplasia. The low rate of malignant conversion suggests that aggressive surveillance regimens, such as HRA, may lead to unnecessary procedures even in high risk patients,” Dr. Tomassi said.
Intensive surveillance doesn’t seem to make much difference because “the incidence of anal cancer is very low even in very high risk populations,” and “most SCC cases develop in the general population,” so “regimens dedicated to identifying cancer in high risk groups will ultimate miss the majority of patients who will succumb to this disease,” he said.
“It’s rare that I come to a meeting and hear a paper that’s going to change my practice. Thank you for that,” an audience member said after Dr. Tomassi presented his findings at the American Society of Colon and Rectal Surgeons annual meeting.
Dr. Tomassi did not have any disclosures.
SEATTLE – Aggressive screening and treatment of HPV anal dysplasia probably doesn’t decrease the incidence of anal cancer, even in high-risk groups, according to investigators from Kaiser Permanente of Southern California.
The increase in anal squamous cell carcinoma (SCC) over the past 20 years has led to surveillance programs for anal dysplasia in many institutions, based on the assumption that finding and destroying the lesions will prevent anal cancer, similar to the reason why polyps are removed during colonoscopy to prevent colon cancer, said lead investigator Marco Tomassi, MD, a general surgeon with Kaiser in San Diego.
Kaiser in Southern California doesn’t have an intensive surveillance program for anal HPV. Instead, high risk patients – those with HIV, past cervical cancer, anogenital warts, among others – are screened with digital rectal exams and anoscopy every 3-12 months, and only anal warts and other grossly abnormal growths are removed.
Physicians there do not routinely use high resolution anoscopy (HRA), Pap smears, and other techniques to identify and destroy microscopic foci of dysplasia, as in more intensive programs.
To see how the approach has worked, Dr. Tomassi and his colleagues reviewed the incidence of anal SCC among almost 6 million Kaiser patients from 2005 through 2015.
The cumulative incidence in all groups of patients, even those at risk for the disease, was less than 1%; 425 of the 460 anal cancers (92%) were in the general population, among patients who would not have been part of a high risk surveillance program.
Even without an aggressive surveillance program, high grade anal dysplasia was identified in 377 patients; their incidence of anal SCC was 0.8%, the highest found in the study.
There were no incident cases of SCC among the 133 HIV patients with anal dysplasia. Among over 5,000 HIV patients in the study, the anal SCC incidence was 0.09%. In the general population of 5.86 million, it was 0.01%.
“The cumulative incidence in our group, despite not performing ablative techniques for dysplasia, was comparable to those institutions that routinely perform high resolution anoscopy and destruction of dysplasia. The low rate of malignant conversion suggests that aggressive surveillance regimens, such as HRA, may lead to unnecessary procedures even in high risk patients,” Dr. Tomassi said.
Intensive surveillance doesn’t seem to make much difference because “the incidence of anal cancer is very low even in very high risk populations,” and “most SCC cases develop in the general population,” so “regimens dedicated to identifying cancer in high risk groups will ultimate miss the majority of patients who will succumb to this disease,” he said.
“It’s rare that I come to a meeting and hear a paper that’s going to change my practice. Thank you for that,” an audience member said after Dr. Tomassi presented his findings at the American Society of Colon and Rectal Surgeons annual meeting.
Dr. Tomassi did not have any disclosures.
SEATTLE – Aggressive screening and treatment of HPV anal dysplasia probably doesn’t decrease the incidence of anal cancer, even in high-risk groups, according to investigators from Kaiser Permanente of Southern California.
The increase in anal squamous cell carcinoma (SCC) over the past 20 years has led to surveillance programs for anal dysplasia in many institutions, based on the assumption that finding and destroying the lesions will prevent anal cancer, similar to the reason why polyps are removed during colonoscopy to prevent colon cancer, said lead investigator Marco Tomassi, MD, a general surgeon with Kaiser in San Diego.
Kaiser in Southern California doesn’t have an intensive surveillance program for anal HPV. Instead, high risk patients – those with HIV, past cervical cancer, anogenital warts, among others – are screened with digital rectal exams and anoscopy every 3-12 months, and only anal warts and other grossly abnormal growths are removed.
Physicians there do not routinely use high resolution anoscopy (HRA), Pap smears, and other techniques to identify and destroy microscopic foci of dysplasia, as in more intensive programs.
To see how the approach has worked, Dr. Tomassi and his colleagues reviewed the incidence of anal SCC among almost 6 million Kaiser patients from 2005 through 2015.
The cumulative incidence in all groups of patients, even those at risk for the disease, was less than 1%; 425 of the 460 anal cancers (92%) were in the general population, among patients who would not have been part of a high risk surveillance program.
Even without an aggressive surveillance program, high grade anal dysplasia was identified in 377 patients; their incidence of anal SCC was 0.8%, the highest found in the study.
There were no incident cases of SCC among the 133 HIV patients with anal dysplasia. Among over 5,000 HIV patients in the study, the anal SCC incidence was 0.09%. In the general population of 5.86 million, it was 0.01%.
“The cumulative incidence in our group, despite not performing ablative techniques for dysplasia, was comparable to those institutions that routinely perform high resolution anoscopy and destruction of dysplasia. The low rate of malignant conversion suggests that aggressive surveillance regimens, such as HRA, may lead to unnecessary procedures even in high risk patients,” Dr. Tomassi said.
Intensive surveillance doesn’t seem to make much difference because “the incidence of anal cancer is very low even in very high risk populations,” and “most SCC cases develop in the general population,” so “regimens dedicated to identifying cancer in high risk groups will ultimate miss the majority of patients who will succumb to this disease,” he said.
“It’s rare that I come to a meeting and hear a paper that’s going to change my practice. Thank you for that,” an audience member said after Dr. Tomassi presented his findings at the American Society of Colon and Rectal Surgeons annual meeting.
Dr. Tomassi did not have any disclosures.
AT ASCRS 2017
Key clinical point:
Major finding: When high risk patients were not screened and treated for anal dysplasia, the cumulative incidence of anal squamous cell carcinoma was 0.8% or less, similar to programs that target and treat the lesions.
Data source: Review of almost 6 million patients at Kaiser Permanente of Southern California
Disclosures: The lead investigator had no disclosures.
‘Pink tax’ found on OTC minoxidil
Minoxidil 5% foam costs a mean of 40% more when it’s marketed to women instead of men, according to a review of 24 pharmacies in four northeastern states.
The statistically significant difference – $11.27/30 mL versus $8.05/30 mL – “could be a result of differential pricing by gender or could reflect production costs that are not related to medication strength,” reported the investigators from the University of Pennsylvania, Philadelphia. Also, the formulation for women, approved in 2014, is still on-patent and available only as Rogaine, whereas generics are available for the men’s foam (JAMA Dermatol. 2017 Jun 7. doi: 10.1001/jamadermatol.2017.1394).
The team also found that women’s 2% minoxidil solution costs about the same as men’s 5% minoxidil solution, despite the difference in strength ($7.61/30 mL versus $7.63/30 mL).
“These are products with the exact same ingredients. They come in different amounts and packaging based on gender, so, for the most part, women probably do not even realize they are paying more,” lead author Jules Lipoff, MD, of the department of dermatology, said in a University of Pennsylvania press release. “We recommend that our female patients buy the male version of the product because it doesn’t seem right to ask a woman to pay more when the products are, for all intents and purposes, identical,” he said.
Gender-based price differences – the “pink tax” – have been documented in consumer products before. A 2015 report found that women pay about 13% more than men for equivalent personal products in New York City. “However, to our knowledge, gender-based price differences for medications have not been previously studied,” the investigators said.
Pricing data came from CVS, Kroger, Rite Aid, Target, Walgreens, and Walmart pharmacies in Pennsylvania, New York, Ohio, and Indiana. The analysis included 14 OTC minoxidil preparations marketed to women and 27 marketed to men. Products were matched based on concentration and inactive ingredients to arrive at overall prices. When prices varied for the same product at different stores in the same chain, the mean price was used.
Dr. Lipoff reported receiving a grant from Pfizer. No other disclosures were reported.
Minoxidil 5% foam costs a mean of 40% more when it’s marketed to women instead of men, according to a review of 24 pharmacies in four northeastern states.
The statistically significant difference – $11.27/30 mL versus $8.05/30 mL – “could be a result of differential pricing by gender or could reflect production costs that are not related to medication strength,” reported the investigators from the University of Pennsylvania, Philadelphia. Also, the formulation for women, approved in 2014, is still on-patent and available only as Rogaine, whereas generics are available for the men’s foam (JAMA Dermatol. 2017 Jun 7. doi: 10.1001/jamadermatol.2017.1394).
The team also found that women’s 2% minoxidil solution costs about the same as men’s 5% minoxidil solution, despite the difference in strength ($7.61/30 mL versus $7.63/30 mL).
“These are products with the exact same ingredients. They come in different amounts and packaging based on gender, so, for the most part, women probably do not even realize they are paying more,” lead author Jules Lipoff, MD, of the department of dermatology, said in a University of Pennsylvania press release. “We recommend that our female patients buy the male version of the product because it doesn’t seem right to ask a woman to pay more when the products are, for all intents and purposes, identical,” he said.
Gender-based price differences – the “pink tax” – have been documented in consumer products before. A 2015 report found that women pay about 13% more than men for equivalent personal products in New York City. “However, to our knowledge, gender-based price differences for medications have not been previously studied,” the investigators said.
Pricing data came from CVS, Kroger, Rite Aid, Target, Walgreens, and Walmart pharmacies in Pennsylvania, New York, Ohio, and Indiana. The analysis included 14 OTC minoxidil preparations marketed to women and 27 marketed to men. Products were matched based on concentration and inactive ingredients to arrive at overall prices. When prices varied for the same product at different stores in the same chain, the mean price was used.
Dr. Lipoff reported receiving a grant from Pfizer. No other disclosures were reported.
Minoxidil 5% foam costs a mean of 40% more when it’s marketed to women instead of men, according to a review of 24 pharmacies in four northeastern states.
The statistically significant difference – $11.27/30 mL versus $8.05/30 mL – “could be a result of differential pricing by gender or could reflect production costs that are not related to medication strength,” reported the investigators from the University of Pennsylvania, Philadelphia. Also, the formulation for women, approved in 2014, is still on-patent and available only as Rogaine, whereas generics are available for the men’s foam (JAMA Dermatol. 2017 Jun 7. doi: 10.1001/jamadermatol.2017.1394).
The team also found that women’s 2% minoxidil solution costs about the same as men’s 5% minoxidil solution, despite the difference in strength ($7.61/30 mL versus $7.63/30 mL).
“These are products with the exact same ingredients. They come in different amounts and packaging based on gender, so, for the most part, women probably do not even realize they are paying more,” lead author Jules Lipoff, MD, of the department of dermatology, said in a University of Pennsylvania press release. “We recommend that our female patients buy the male version of the product because it doesn’t seem right to ask a woman to pay more when the products are, for all intents and purposes, identical,” he said.
Gender-based price differences – the “pink tax” – have been documented in consumer products before. A 2015 report found that women pay about 13% more than men for equivalent personal products in New York City. “However, to our knowledge, gender-based price differences for medications have not been previously studied,” the investigators said.
Pricing data came from CVS, Kroger, Rite Aid, Target, Walgreens, and Walmart pharmacies in Pennsylvania, New York, Ohio, and Indiana. The analysis included 14 OTC minoxidil preparations marketed to women and 27 marketed to men. Products were matched based on concentration and inactive ingredients to arrive at overall prices. When prices varied for the same product at different stores in the same chain, the mean price was used.
Dr. Lipoff reported receiving a grant from Pfizer. No other disclosures were reported.
FROM JAMA DERMATOLOGY
New approval lights up gliomas to aid resection
The Food and Drug Administration has approved aminolevulinic acid hydrochloride (Gleolan) to help visualize gliomas during surgery and allow for more complete resection.
Aminolevulinic acid hydrochloride lights up the tumor so surgeons can distinguish it from healthy tissue. Patients take the drug orally – 20 mg/kg – approximately 3 hours before anesthesia. Glioma cells take it up and convert it to the fluorescent chemical protoporphyrin IX. When illuminated under blue light, protoporphyrin in the tumor glows an intense red, while normal brain tissue appears blue, enabling “the surgeon to see the tumor more clearly during brain surgery and to remove it more accurately, sparing healthy brain tissue,” according to information from NX Development Corp, which markets Gleolan.
In a phase III trial of 349 patients with suspected malignant glioma amenable to complete resection, a contrast-enhanced tumor was resected in 64% of patients in the aminolevulinic acid (ALA) arm, versus 38 % of patients in the control-group, who had conventional resection under white light (P less than .001); 20.5 % of ALA patients versus 11 % patients in the control arm were alive at 6 months without progression.
FDA officials noted that there’s a risk of false negatives and positives with ALA, and that “an increase in the extent of resection might increase the risk of serious neurologic deficits in the short term.”
Side effects in preapproval studies included fever, hypotension, nausea, and vomiting in more than 1% percent of patients within a week of surgery. Adverse events included chills, abnormal liver function tests, and diarrhea in less than 1% of patients within 6 weeks of surgery.
The Food and Drug Administration has approved aminolevulinic acid hydrochloride (Gleolan) to help visualize gliomas during surgery and allow for more complete resection.
Aminolevulinic acid hydrochloride lights up the tumor so surgeons can distinguish it from healthy tissue. Patients take the drug orally – 20 mg/kg – approximately 3 hours before anesthesia. Glioma cells take it up and convert it to the fluorescent chemical protoporphyrin IX. When illuminated under blue light, protoporphyrin in the tumor glows an intense red, while normal brain tissue appears blue, enabling “the surgeon to see the tumor more clearly during brain surgery and to remove it more accurately, sparing healthy brain tissue,” according to information from NX Development Corp, which markets Gleolan.
In a phase III trial of 349 patients with suspected malignant glioma amenable to complete resection, a contrast-enhanced tumor was resected in 64% of patients in the aminolevulinic acid (ALA) arm, versus 38 % of patients in the control-group, who had conventional resection under white light (P less than .001); 20.5 % of ALA patients versus 11 % patients in the control arm were alive at 6 months without progression.
FDA officials noted that there’s a risk of false negatives and positives with ALA, and that “an increase in the extent of resection might increase the risk of serious neurologic deficits in the short term.”
Side effects in preapproval studies included fever, hypotension, nausea, and vomiting in more than 1% percent of patients within a week of surgery. Adverse events included chills, abnormal liver function tests, and diarrhea in less than 1% of patients within 6 weeks of surgery.
The Food and Drug Administration has approved aminolevulinic acid hydrochloride (Gleolan) to help visualize gliomas during surgery and allow for more complete resection.
Aminolevulinic acid hydrochloride lights up the tumor so surgeons can distinguish it from healthy tissue. Patients take the drug orally – 20 mg/kg – approximately 3 hours before anesthesia. Glioma cells take it up and convert it to the fluorescent chemical protoporphyrin IX. When illuminated under blue light, protoporphyrin in the tumor glows an intense red, while normal brain tissue appears blue, enabling “the surgeon to see the tumor more clearly during brain surgery and to remove it more accurately, sparing healthy brain tissue,” according to information from NX Development Corp, which markets Gleolan.
In a phase III trial of 349 patients with suspected malignant glioma amenable to complete resection, a contrast-enhanced tumor was resected in 64% of patients in the aminolevulinic acid (ALA) arm, versus 38 % of patients in the control-group, who had conventional resection under white light (P less than .001); 20.5 % of ALA patients versus 11 % patients in the control arm were alive at 6 months without progression.
FDA officials noted that there’s a risk of false negatives and positives with ALA, and that “an increase in the extent of resection might increase the risk of serious neurologic deficits in the short term.”
Side effects in preapproval studies included fever, hypotension, nausea, and vomiting in more than 1% percent of patients within a week of surgery. Adverse events included chills, abnormal liver function tests, and diarrhea in less than 1% of patients within 6 weeks of surgery.
Extended-release Aristada OK’d for 2-month dosing for schizophrenia
The Food and Drug Administration has expanded labeling of extended-release aripiprazole lauroxil (Aristada) to allow for administration once every 2 months at a dose of 1,064 mg, for schizophrenia.
Depending on patient needs, treatment now can be initiated at a dose of 441 mg, 662 mg, or 882 mg administered monthly; 882 mg administered every 6 weeks; or 1,064 mg administered every 2 months. For patients who have never taken aripiprazole, “establish tolerability with oral aripiprazole prior to initiating treatment with Aristada. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability,” according to the updated labeling. The new 2-month option is expected to be available in mid-June.
Another extended-release IM aripiprazole option, (Abilify Maintena, Otsuka) is approved only for once-a-month injection.
Approval of the bimonthly dose was based on pharmacokinetic data showing long-term therapeutic aripiprazole plasma levels. Labeling did not note whether the higher dose is associated with increased adverse events. Aristada originally was approved in 2015.
As with other atypical antipsychotics, Aristada labeling notes that the drug should not be used in elderly patients with dementia because of the increased risk of fatal strokes. The labeling also warns of the possibility of tardive dyskinesia, metabolic derangements, compulsive behaviors, agranulocytosis, and other risks.
The Food and Drug Administration has expanded labeling of extended-release aripiprazole lauroxil (Aristada) to allow for administration once every 2 months at a dose of 1,064 mg, for schizophrenia.
Depending on patient needs, treatment now can be initiated at a dose of 441 mg, 662 mg, or 882 mg administered monthly; 882 mg administered every 6 weeks; or 1,064 mg administered every 2 months. For patients who have never taken aripiprazole, “establish tolerability with oral aripiprazole prior to initiating treatment with Aristada. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability,” according to the updated labeling. The new 2-month option is expected to be available in mid-June.
Another extended-release IM aripiprazole option, (Abilify Maintena, Otsuka) is approved only for once-a-month injection.
Approval of the bimonthly dose was based on pharmacokinetic data showing long-term therapeutic aripiprazole plasma levels. Labeling did not note whether the higher dose is associated with increased adverse events. Aristada originally was approved in 2015.
As with other atypical antipsychotics, Aristada labeling notes that the drug should not be used in elderly patients with dementia because of the increased risk of fatal strokes. The labeling also warns of the possibility of tardive dyskinesia, metabolic derangements, compulsive behaviors, agranulocytosis, and other risks.
The Food and Drug Administration has expanded labeling of extended-release aripiprazole lauroxil (Aristada) to allow for administration once every 2 months at a dose of 1,064 mg, for schizophrenia.
Depending on patient needs, treatment now can be initiated at a dose of 441 mg, 662 mg, or 882 mg administered monthly; 882 mg administered every 6 weeks; or 1,064 mg administered every 2 months. For patients who have never taken aripiprazole, “establish tolerability with oral aripiprazole prior to initiating treatment with Aristada. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability,” according to the updated labeling. The new 2-month option is expected to be available in mid-June.
Another extended-release IM aripiprazole option, (Abilify Maintena, Otsuka) is approved only for once-a-month injection.
Approval of the bimonthly dose was based on pharmacokinetic data showing long-term therapeutic aripiprazole plasma levels. Labeling did not note whether the higher dose is associated with increased adverse events. Aristada originally was approved in 2015.
As with other atypical antipsychotics, Aristada labeling notes that the drug should not be used in elderly patients with dementia because of the increased risk of fatal strokes. The labeling also warns of the possibility of tardive dyskinesia, metabolic derangements, compulsive behaviors, agranulocytosis, and other risks.
Ulipristal acetate: A new option for endometriosis pain?
VANCOUVER – Not too long ago, clinicians at McMaster University in Hamilton, Ont., noticed that ulipristal acetate seemed to reduce pelvic pain in women who were taking it to shrink fibroids and reduce bleeding and other symptoms.
Fibroids aren’t usually painful, however, so they had a hunch it was helping with pain from other causes and decided to take a closer look.
All of the women at McMaster started out with moderate to severe pelvic pain, but ,while on the drug, nine (50%) said they had less pain, and seven (39%) said they had no pain at all. Most of the women reduced or stopped other pain medications.
Ten of the women had surgery, generally for fibroid control, and nine turned out to have endometriosis, adenomyosis, or both. The women were 25-49 years old and took the drug per Canadian fibroid labeling – 5 mg daily for 3 months.
“I was surprised by how many women actually had an improvement in their pain and how many went down to zero,” said lead investigator Sarah Scattolon, MD, a minimally invasive gynecologic surgery fellow at McMaster. Almost all of the women “had used multiple treatments in the past that didn’t work, including opioids. That makes a placebo effect less likely.”
The need for better endometriosis treatments was a frequent topic at the World Congress on Endometriosis, where Dr. Scattolon presented the study findings. Gonadotropin-releasing hormone agonists, progestins, and other options can help, but they don’t work for everyone, and some women can’t tolerate the side effects.
The idea that ulipristal acetate and other selective progesterone receptor modulators might be useful additions to the armamentarium has been around for a while, but there’s not much research. Dr. Scattolon said her next step is a prospective study among women with pelvic pain and, ultimately, a randomized trial. A small prospective study is already underway at Northwestern University, Chicago, for pelvic pain associated with endometriosis.
It’s unclear how the drug helps pelvic pain. It suppresses ovulation, which might help women with pain related to menstruation. “It presumably works in a different way” than other anovulatory options, Dr. Scattolon said.
Hot flashes and headaches are the most common adverse reactions, but Allergan’s Canadian Fibristal monograph states that side effects are mild or moderate and do not often lead to discontinuation.
Allergan wasn’t involved in the study, but Dr. Scattolon was scheduled to give her first paid talk for the company.
VANCOUVER – Not too long ago, clinicians at McMaster University in Hamilton, Ont., noticed that ulipristal acetate seemed to reduce pelvic pain in women who were taking it to shrink fibroids and reduce bleeding and other symptoms.
Fibroids aren’t usually painful, however, so they had a hunch it was helping with pain from other causes and decided to take a closer look.
All of the women at McMaster started out with moderate to severe pelvic pain, but ,while on the drug, nine (50%) said they had less pain, and seven (39%) said they had no pain at all. Most of the women reduced or stopped other pain medications.
Ten of the women had surgery, generally for fibroid control, and nine turned out to have endometriosis, adenomyosis, or both. The women were 25-49 years old and took the drug per Canadian fibroid labeling – 5 mg daily for 3 months.
“I was surprised by how many women actually had an improvement in their pain and how many went down to zero,” said lead investigator Sarah Scattolon, MD, a minimally invasive gynecologic surgery fellow at McMaster. Almost all of the women “had used multiple treatments in the past that didn’t work, including opioids. That makes a placebo effect less likely.”
The need for better endometriosis treatments was a frequent topic at the World Congress on Endometriosis, where Dr. Scattolon presented the study findings. Gonadotropin-releasing hormone agonists, progestins, and other options can help, but they don’t work for everyone, and some women can’t tolerate the side effects.
The idea that ulipristal acetate and other selective progesterone receptor modulators might be useful additions to the armamentarium has been around for a while, but there’s not much research. Dr. Scattolon said her next step is a prospective study among women with pelvic pain and, ultimately, a randomized trial. A small prospective study is already underway at Northwestern University, Chicago, for pelvic pain associated with endometriosis.
It’s unclear how the drug helps pelvic pain. It suppresses ovulation, which might help women with pain related to menstruation. “It presumably works in a different way” than other anovulatory options, Dr. Scattolon said.
Hot flashes and headaches are the most common adverse reactions, but Allergan’s Canadian Fibristal monograph states that side effects are mild or moderate and do not often lead to discontinuation.
Allergan wasn’t involved in the study, but Dr. Scattolon was scheduled to give her first paid talk for the company.
VANCOUVER – Not too long ago, clinicians at McMaster University in Hamilton, Ont., noticed that ulipristal acetate seemed to reduce pelvic pain in women who were taking it to shrink fibroids and reduce bleeding and other symptoms.
Fibroids aren’t usually painful, however, so they had a hunch it was helping with pain from other causes and decided to take a closer look.
All of the women at McMaster started out with moderate to severe pelvic pain, but ,while on the drug, nine (50%) said they had less pain, and seven (39%) said they had no pain at all. Most of the women reduced or stopped other pain medications.
Ten of the women had surgery, generally for fibroid control, and nine turned out to have endometriosis, adenomyosis, or both. The women were 25-49 years old and took the drug per Canadian fibroid labeling – 5 mg daily for 3 months.
“I was surprised by how many women actually had an improvement in their pain and how many went down to zero,” said lead investigator Sarah Scattolon, MD, a minimally invasive gynecologic surgery fellow at McMaster. Almost all of the women “had used multiple treatments in the past that didn’t work, including opioids. That makes a placebo effect less likely.”
The need for better endometriosis treatments was a frequent topic at the World Congress on Endometriosis, where Dr. Scattolon presented the study findings. Gonadotropin-releasing hormone agonists, progestins, and other options can help, but they don’t work for everyone, and some women can’t tolerate the side effects.
The idea that ulipristal acetate and other selective progesterone receptor modulators might be useful additions to the armamentarium has been around for a while, but there’s not much research. Dr. Scattolon said her next step is a prospective study among women with pelvic pain and, ultimately, a randomized trial. A small prospective study is already underway at Northwestern University, Chicago, for pelvic pain associated with endometriosis.
It’s unclear how the drug helps pelvic pain. It suppresses ovulation, which might help women with pain related to menstruation. “It presumably works in a different way” than other anovulatory options, Dr. Scattolon said.
Hot flashes and headaches are the most common adverse reactions, but Allergan’s Canadian Fibristal monograph states that side effects are mild or moderate and do not often lead to discontinuation.
Allergan wasn’t involved in the study, but Dr. Scattolon was scheduled to give her first paid talk for the company.
AT WCE 2017
Key clinical point:
Major finding: Of 18 women with moderate-to-severe pelvic pain, 9 (50%) noted less pain while on ulipristal acetate for fibroids, and 7 (39%) said they had no pain at all.
Data source: A chart review of 18 women.
Disclosures: Allergan, the drug’s maker, wasn’t involved in the study, but the lead investigator was scheduled to give her first paid talk for the company.
Biomarker panel promising for early endometriosis diagnosis
VANCOUVER – Investigators at McMaster University in Hamilton, Ontario, are zeroing in on a biomarker blood test panel to diagnose endometriosis without surgery.
At the World Congress on Endometriosis, they described a decision tree incorporating blood levels of brain-derived neurotrophic factor (BDNF), glycodelin, and zinc-alpha2-glycoprotein (ZAG), quantified by enzyme-linked immunosorbent assay. ZAG levels above 91.58 ng/mL – the first cut in the decision tree, glycodelin above 39.19 ng/mL – the second cut, and BDNF above 953.9 pg/mL identified endometriosis with a sensitivity of 89.2% and a specificity of 70.0%. The combination outperformed any biomarker on its own.
BDNF is a protein involved in neurogenesis, angiogenesis, and apoptosis resistance, all hallmark pathogenic features of endometriosis. Glycodelin and ZAG are associated with secretory endometrium.
The findings come from a comparison of blood levels in 65 women undergoing endometriosis surgery with the blood levels in 14 women undergoing surgery for benign gynecological problems, and in 16 healthy controls with no history of pelvic pain.
The need is great for a noninvasive test to diagnose endometriosis. Currently, diagnosis is made during surgery and can be delayed for several years. Like investigators at other institutions, the research team at McMaster is hoping to develop an easy, accurate way to catch and treat the disease early before complications set in.
Early diagnosis has “resisted our best efforts for years, but we are slowly moving closer to the end zone,” said senior investigator Warren Foster, PhD, a professor of obstetrics and gynecology at McMaster.
Other teams have reported favorable results for microRNAs, circulating endometrial stem cells, biomarker combinations, and other approaches. “It seems to me that there is a lot of progress being made. One of the big issues that we still have to solve is reproducibility, but there’s so much coming forward,” Dr. Foster said. “It’s an exciting time to be looking for novel diagnostic markers for endometriosis.”
The McMaster team next plans to test its panel prospectively in women with suspected early stage disease.
The work was funded by the Canadian Institutes of Health Research. Dr. Foster is in talks with industry to license the algorithm.
VANCOUVER – Investigators at McMaster University in Hamilton, Ontario, are zeroing in on a biomarker blood test panel to diagnose endometriosis without surgery.
At the World Congress on Endometriosis, they described a decision tree incorporating blood levels of brain-derived neurotrophic factor (BDNF), glycodelin, and zinc-alpha2-glycoprotein (ZAG), quantified by enzyme-linked immunosorbent assay. ZAG levels above 91.58 ng/mL – the first cut in the decision tree, glycodelin above 39.19 ng/mL – the second cut, and BDNF above 953.9 pg/mL identified endometriosis with a sensitivity of 89.2% and a specificity of 70.0%. The combination outperformed any biomarker on its own.
BDNF is a protein involved in neurogenesis, angiogenesis, and apoptosis resistance, all hallmark pathogenic features of endometriosis. Glycodelin and ZAG are associated with secretory endometrium.
The findings come from a comparison of blood levels in 65 women undergoing endometriosis surgery with the blood levels in 14 women undergoing surgery for benign gynecological problems, and in 16 healthy controls with no history of pelvic pain.
The need is great for a noninvasive test to diagnose endometriosis. Currently, diagnosis is made during surgery and can be delayed for several years. Like investigators at other institutions, the research team at McMaster is hoping to develop an easy, accurate way to catch and treat the disease early before complications set in.
Early diagnosis has “resisted our best efforts for years, but we are slowly moving closer to the end zone,” said senior investigator Warren Foster, PhD, a professor of obstetrics and gynecology at McMaster.
Other teams have reported favorable results for microRNAs, circulating endometrial stem cells, biomarker combinations, and other approaches. “It seems to me that there is a lot of progress being made. One of the big issues that we still have to solve is reproducibility, but there’s so much coming forward,” Dr. Foster said. “It’s an exciting time to be looking for novel diagnostic markers for endometriosis.”
The McMaster team next plans to test its panel prospectively in women with suspected early stage disease.
The work was funded by the Canadian Institutes of Health Research. Dr. Foster is in talks with industry to license the algorithm.
VANCOUVER – Investigators at McMaster University in Hamilton, Ontario, are zeroing in on a biomarker blood test panel to diagnose endometriosis without surgery.
At the World Congress on Endometriosis, they described a decision tree incorporating blood levels of brain-derived neurotrophic factor (BDNF), glycodelin, and zinc-alpha2-glycoprotein (ZAG), quantified by enzyme-linked immunosorbent assay. ZAG levels above 91.58 ng/mL – the first cut in the decision tree, glycodelin above 39.19 ng/mL – the second cut, and BDNF above 953.9 pg/mL identified endometriosis with a sensitivity of 89.2% and a specificity of 70.0%. The combination outperformed any biomarker on its own.
BDNF is a protein involved in neurogenesis, angiogenesis, and apoptosis resistance, all hallmark pathogenic features of endometriosis. Glycodelin and ZAG are associated with secretory endometrium.
The findings come from a comparison of blood levels in 65 women undergoing endometriosis surgery with the blood levels in 14 women undergoing surgery for benign gynecological problems, and in 16 healthy controls with no history of pelvic pain.
The need is great for a noninvasive test to diagnose endometriosis. Currently, diagnosis is made during surgery and can be delayed for several years. Like investigators at other institutions, the research team at McMaster is hoping to develop an easy, accurate way to catch and treat the disease early before complications set in.
Early diagnosis has “resisted our best efforts for years, but we are slowly moving closer to the end zone,” said senior investigator Warren Foster, PhD, a professor of obstetrics and gynecology at McMaster.
Other teams have reported favorable results for microRNAs, circulating endometrial stem cells, biomarker combinations, and other approaches. “It seems to me that there is a lot of progress being made. One of the big issues that we still have to solve is reproducibility, but there’s so much coming forward,” Dr. Foster said. “It’s an exciting time to be looking for novel diagnostic markers for endometriosis.”
The McMaster team next plans to test its panel prospectively in women with suspected early stage disease.
The work was funded by the Canadian Institutes of Health Research. Dr. Foster is in talks with industry to license the algorithm.
AT WCE 2017
Key clinical point:
Major finding: Zinc-alpha2-glycoprotein levels above 91.58 ng/mL, glycodelin above 39.19 ng/mL, and brain-derived neurotrophic factor above 953.30 pg/mL identified endometriosis with a sensitivity of 89.2% and a specificity of 70.0%.
Data source: A case-control review of 95 women.
Disclosures: The work was funded by the Canadian Institutes of Health Research. The investigators are in talks with industry to license the algorithm.