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Michael Alosco, PhD
Announcing the 2018 Section Research Mentor Award recipients
The AGA Institute Council Section Research Mentor Award acknowledges AGA members for their achievements as outstanding mentors in a specific area of research. We are pleased to announce the 2018 recipients who will be recognized by each of the 13 AGA Institute Council sections during Digestive Disease Week® (DDW) 2018. Congratulations to these exceptional mentors!
AGA Institute Council 2018 Section Research Mentor Award recipients
Basic & Clinical Intestinal Disorders
Gary D. Wu, MD
Cellular & Molecular Gastroenterology
Charalabos Pothoulakis, MD
Clinical Practice
Amnon Sonnenberg, MD, MSc
Esophageal, Gastric & Duodenal Disorders
Nicholas J. Shaheen, MD, MPH, AGAF
Gastrointestinal Oncology
Randall W. Burt, MD, AGAF
Growth, Development & Child Health
Deborah L. Gumucio, PhD
Imaging, Endoscopy & Advanced Technology
Michael B. Wallace, MD, MPH, AGAF
Immunology, Microbiology & Inflammatory Bowel Diseases
Claudio Fiocchi, MD
Liver & Biliary
Scott L. Friedman, MD
Microbiome & Microbial Diseases in the Gastrointestinal Tract
Jeffrey I. Gordon, MD
Neurogastroenterology & Motility
Richard W. McCallum, MD, AGAF
Obesity, Metabolism & Nutrition
Lee M. Kaplan, MD, PhD, AGAF
Pancreatic Disorders
Suresh T. Chari, MD
The AGA Institute Council Section Research Mentor Award acknowledges AGA members for their achievements as outstanding mentors in a specific area of research. We are pleased to announce the 2018 recipients who will be recognized by each of the 13 AGA Institute Council sections during Digestive Disease Week® (DDW) 2018. Congratulations to these exceptional mentors!
AGA Institute Council 2018 Section Research Mentor Award recipients
Basic & Clinical Intestinal Disorders
Gary D. Wu, MD
Cellular & Molecular Gastroenterology
Charalabos Pothoulakis, MD
Clinical Practice
Amnon Sonnenberg, MD, MSc
Esophageal, Gastric & Duodenal Disorders
Nicholas J. Shaheen, MD, MPH, AGAF
Gastrointestinal Oncology
Randall W. Burt, MD, AGAF
Growth, Development & Child Health
Deborah L. Gumucio, PhD
Imaging, Endoscopy & Advanced Technology
Michael B. Wallace, MD, MPH, AGAF
Immunology, Microbiology & Inflammatory Bowel Diseases
Claudio Fiocchi, MD
Liver & Biliary
Scott L. Friedman, MD
Microbiome & Microbial Diseases in the Gastrointestinal Tract
Jeffrey I. Gordon, MD
Neurogastroenterology & Motility
Richard W. McCallum, MD, AGAF
Obesity, Metabolism & Nutrition
Lee M. Kaplan, MD, PhD, AGAF
Pancreatic Disorders
Suresh T. Chari, MD
The AGA Institute Council Section Research Mentor Award acknowledges AGA members for their achievements as outstanding mentors in a specific area of research. We are pleased to announce the 2018 recipients who will be recognized by each of the 13 AGA Institute Council sections during Digestive Disease Week® (DDW) 2018. Congratulations to these exceptional mentors!
AGA Institute Council 2018 Section Research Mentor Award recipients
Basic & Clinical Intestinal Disorders
Gary D. Wu, MD
Cellular & Molecular Gastroenterology
Charalabos Pothoulakis, MD
Clinical Practice
Amnon Sonnenberg, MD, MSc
Esophageal, Gastric & Duodenal Disorders
Nicholas J. Shaheen, MD, MPH, AGAF
Gastrointestinal Oncology
Randall W. Burt, MD, AGAF
Growth, Development & Child Health
Deborah L. Gumucio, PhD
Imaging, Endoscopy & Advanced Technology
Michael B. Wallace, MD, MPH, AGAF
Immunology, Microbiology & Inflammatory Bowel Diseases
Claudio Fiocchi, MD
Liver & Biliary
Scott L. Friedman, MD
Microbiome & Microbial Diseases in the Gastrointestinal Tract
Jeffrey I. Gordon, MD
Neurogastroenterology & Motility
Richard W. McCallum, MD, AGAF
Obesity, Metabolism & Nutrition
Lee M. Kaplan, MD, PhD, AGAF
Pancreatic Disorders
Suresh T. Chari, MD
FDA advisory panelists reject Buvaya for acute pain
HYATTSVILLE, MD. – Two Food and Drug Administration advisory panels voted May 22 to reject buprenorphine sublingual spray for the treatment of moderate to severe postoperative pain.
At a joint meeting, advisers of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18 to 1 not to recommend the spray for approval. The proposed trade name for the spray is Buvaya.
“I think that if this were a standard schedule II opioid with the efficacy profile of this drug, we probably would not be here,”stated Steven Meisel, PharmD, system director of medication safety at Fairview Health Services, Minneapolis. “We would not be here, because the efficacy [is] so weak compared to what is already out there. It just does not work for acute postoperative pain.”
According to INSYS Therapeutics, developer of the buprenorphine sublingual spray, opioid painkillers remain one of the best treatment options in managing moderate to severe pain despite the risk of addiction. The sublingual spray formulation also has a lower abuse potential, according to the company. This was corroborated in a briefing document of currently marketed buprenorphine products by the FDA.
Buprenorphine, an opioid partial agonist-antagonist, is a long-acting Schedule III opioid. The sublingual spray was developed as part of the Buprenorphine Sublingual Spray clinical development program, consisting of 10 studies including 7 phase 1 studies, a phase 2 open label study, and two phase 3 efficacy studies. The company’s application was based on the results of those two efficacy studies. Both phase 3 studies had similar designs, randomizing patients to receive varying doses of the sublingual spray. They also shared the primary endpoint of assessing postoperative pain using the Numeric Rating Scale (NRS) Summed Pain and Intensity Difference 48 hours (SPID-48) after surgery. The similarities continued with secondary endpoints, with both phase 3 studies looking at NRS-SPID scores at 4, 8, and 24 hours after surgery, NRS pain intensity difference (NRS PID) and score at each time point, and total pain relief (TOTPAR) at 4, 8, 24, and 48 hours after surgery. The only difference between the studies were the doses of sublingual buprenorphine administered to patients.
One of the phase 3 trials was discontinued when several patients because of sedation events at higher doses, but that trial still was used to guide the dose selection for the pivotal phase 3 study. In that study, 40 patients postoperative bunionectomy patients were randomized to receive placebo, 0.5 mg, or 1.0 mg of sublingual buprenorphine (SBS) three times daily (t.i.d.) or 1.0 mg of SBS twice a day (b.i.d.). The study demonstrated that all doses were superior to placebo in reducing pain based on reductions in NRS SPID-48 scores. In fact, the mean NRS SPID-48 scores were 260%, 216%, and 236% higher for the 0.5-mg t.i.d., 1.0-mg b.i.d., and 1.0-mg t.i.d. doses, respectively, compared with placebo, indicating a decrease in pain. The study also found that sublingual buprenorphine doses of greater than 0.5 mg were not more effective in treating postoperative pain.
The pivotal phase 3 efficacy study randomized 322 patients after bunionectomy into one of four treatment groups: placebo, 0.5 mg t.i.d., 0.25 mg t.i.d., or 0.125 mg t.i.d. Sublingual buprenorphine was much more effective in reducing pain and SPID-48 scores, compared with placebo. Patients taking placebo had SPID-48 scores of 93.40, compared with 135.84, 125.75, and 182.81 for the 0.125-mg, 0.25-mg, and 0.5-mg SBS groups, respectively.
The most common adverse events were nausea, vomiting, and hypoxia. Specifically, in the pivotal study, nausea was reported at all three doses of 0.125 mg, 0.25 mg, and 0.50 mg in 43.9%, 58.8%, and 83.3% of patients.
Anne-Michelle Ruha, MD, of the University of Arizona, Phoenix, cited the risk of hypoxia as her biggest concern. “There’s so many factors that we can’t predict, like undiagnosed sleep apnea,” she said. “We just don’t know when the respiratory depression worsens, so I’m uncomfortable with the high rate of hypoxia.”
Although not directly related to this application, INSYS had been the subject of an investigation by the federal government in regard to an illegal marketing scheme that provided incentives for doctors to prescribe Subsys, a powerful and highly addictive synthetic opioid. Documents recently have been unsealed in federal court that prompted the federal government to investigate INSYS. The company has addressed the previous allegations of wrongdoing and states that INSYS has become a “... new and better company in many important respects across the organization,” according to a statement.The FDA usually follows the recommendations of its advisory panels, but they are not binding.
HYATTSVILLE, MD. – Two Food and Drug Administration advisory panels voted May 22 to reject buprenorphine sublingual spray for the treatment of moderate to severe postoperative pain.
At a joint meeting, advisers of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18 to 1 not to recommend the spray for approval. The proposed trade name for the spray is Buvaya.
“I think that if this were a standard schedule II opioid with the efficacy profile of this drug, we probably would not be here,”stated Steven Meisel, PharmD, system director of medication safety at Fairview Health Services, Minneapolis. “We would not be here, because the efficacy [is] so weak compared to what is already out there. It just does not work for acute postoperative pain.”
According to INSYS Therapeutics, developer of the buprenorphine sublingual spray, opioid painkillers remain one of the best treatment options in managing moderate to severe pain despite the risk of addiction. The sublingual spray formulation also has a lower abuse potential, according to the company. This was corroborated in a briefing document of currently marketed buprenorphine products by the FDA.
Buprenorphine, an opioid partial agonist-antagonist, is a long-acting Schedule III opioid. The sublingual spray was developed as part of the Buprenorphine Sublingual Spray clinical development program, consisting of 10 studies including 7 phase 1 studies, a phase 2 open label study, and two phase 3 efficacy studies. The company’s application was based on the results of those two efficacy studies. Both phase 3 studies had similar designs, randomizing patients to receive varying doses of the sublingual spray. They also shared the primary endpoint of assessing postoperative pain using the Numeric Rating Scale (NRS) Summed Pain and Intensity Difference 48 hours (SPID-48) after surgery. The similarities continued with secondary endpoints, with both phase 3 studies looking at NRS-SPID scores at 4, 8, and 24 hours after surgery, NRS pain intensity difference (NRS PID) and score at each time point, and total pain relief (TOTPAR) at 4, 8, 24, and 48 hours after surgery. The only difference between the studies were the doses of sublingual buprenorphine administered to patients.
One of the phase 3 trials was discontinued when several patients because of sedation events at higher doses, but that trial still was used to guide the dose selection for the pivotal phase 3 study. In that study, 40 patients postoperative bunionectomy patients were randomized to receive placebo, 0.5 mg, or 1.0 mg of sublingual buprenorphine (SBS) three times daily (t.i.d.) or 1.0 mg of SBS twice a day (b.i.d.). The study demonstrated that all doses were superior to placebo in reducing pain based on reductions in NRS SPID-48 scores. In fact, the mean NRS SPID-48 scores were 260%, 216%, and 236% higher for the 0.5-mg t.i.d., 1.0-mg b.i.d., and 1.0-mg t.i.d. doses, respectively, compared with placebo, indicating a decrease in pain. The study also found that sublingual buprenorphine doses of greater than 0.5 mg were not more effective in treating postoperative pain.
The pivotal phase 3 efficacy study randomized 322 patients after bunionectomy into one of four treatment groups: placebo, 0.5 mg t.i.d., 0.25 mg t.i.d., or 0.125 mg t.i.d. Sublingual buprenorphine was much more effective in reducing pain and SPID-48 scores, compared with placebo. Patients taking placebo had SPID-48 scores of 93.40, compared with 135.84, 125.75, and 182.81 for the 0.125-mg, 0.25-mg, and 0.5-mg SBS groups, respectively.
The most common adverse events were nausea, vomiting, and hypoxia. Specifically, in the pivotal study, nausea was reported at all three doses of 0.125 mg, 0.25 mg, and 0.50 mg in 43.9%, 58.8%, and 83.3% of patients.
Anne-Michelle Ruha, MD, of the University of Arizona, Phoenix, cited the risk of hypoxia as her biggest concern. “There’s so many factors that we can’t predict, like undiagnosed sleep apnea,” she said. “We just don’t know when the respiratory depression worsens, so I’m uncomfortable with the high rate of hypoxia.”
Although not directly related to this application, INSYS had been the subject of an investigation by the federal government in regard to an illegal marketing scheme that provided incentives for doctors to prescribe Subsys, a powerful and highly addictive synthetic opioid. Documents recently have been unsealed in federal court that prompted the federal government to investigate INSYS. The company has addressed the previous allegations of wrongdoing and states that INSYS has become a “... new and better company in many important respects across the organization,” according to a statement.The FDA usually follows the recommendations of its advisory panels, but they are not binding.
HYATTSVILLE, MD. – Two Food and Drug Administration advisory panels voted May 22 to reject buprenorphine sublingual spray for the treatment of moderate to severe postoperative pain.
At a joint meeting, advisers of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18 to 1 not to recommend the spray for approval. The proposed trade name for the spray is Buvaya.
“I think that if this were a standard schedule II opioid with the efficacy profile of this drug, we probably would not be here,”stated Steven Meisel, PharmD, system director of medication safety at Fairview Health Services, Minneapolis. “We would not be here, because the efficacy [is] so weak compared to what is already out there. It just does not work for acute postoperative pain.”
According to INSYS Therapeutics, developer of the buprenorphine sublingual spray, opioid painkillers remain one of the best treatment options in managing moderate to severe pain despite the risk of addiction. The sublingual spray formulation also has a lower abuse potential, according to the company. This was corroborated in a briefing document of currently marketed buprenorphine products by the FDA.
Buprenorphine, an opioid partial agonist-antagonist, is a long-acting Schedule III opioid. The sublingual spray was developed as part of the Buprenorphine Sublingual Spray clinical development program, consisting of 10 studies including 7 phase 1 studies, a phase 2 open label study, and two phase 3 efficacy studies. The company’s application was based on the results of those two efficacy studies. Both phase 3 studies had similar designs, randomizing patients to receive varying doses of the sublingual spray. They also shared the primary endpoint of assessing postoperative pain using the Numeric Rating Scale (NRS) Summed Pain and Intensity Difference 48 hours (SPID-48) after surgery. The similarities continued with secondary endpoints, with both phase 3 studies looking at NRS-SPID scores at 4, 8, and 24 hours after surgery, NRS pain intensity difference (NRS PID) and score at each time point, and total pain relief (TOTPAR) at 4, 8, 24, and 48 hours after surgery. The only difference between the studies were the doses of sublingual buprenorphine administered to patients.
One of the phase 3 trials was discontinued when several patients because of sedation events at higher doses, but that trial still was used to guide the dose selection for the pivotal phase 3 study. In that study, 40 patients postoperative bunionectomy patients were randomized to receive placebo, 0.5 mg, or 1.0 mg of sublingual buprenorphine (SBS) three times daily (t.i.d.) or 1.0 mg of SBS twice a day (b.i.d.). The study demonstrated that all doses were superior to placebo in reducing pain based on reductions in NRS SPID-48 scores. In fact, the mean NRS SPID-48 scores were 260%, 216%, and 236% higher for the 0.5-mg t.i.d., 1.0-mg b.i.d., and 1.0-mg t.i.d. doses, respectively, compared with placebo, indicating a decrease in pain. The study also found that sublingual buprenorphine doses of greater than 0.5 mg were not more effective in treating postoperative pain.
The pivotal phase 3 efficacy study randomized 322 patients after bunionectomy into one of four treatment groups: placebo, 0.5 mg t.i.d., 0.25 mg t.i.d., or 0.125 mg t.i.d. Sublingual buprenorphine was much more effective in reducing pain and SPID-48 scores, compared with placebo. Patients taking placebo had SPID-48 scores of 93.40, compared with 135.84, 125.75, and 182.81 for the 0.125-mg, 0.25-mg, and 0.5-mg SBS groups, respectively.
The most common adverse events were nausea, vomiting, and hypoxia. Specifically, in the pivotal study, nausea was reported at all three doses of 0.125 mg, 0.25 mg, and 0.50 mg in 43.9%, 58.8%, and 83.3% of patients.
Anne-Michelle Ruha, MD, of the University of Arizona, Phoenix, cited the risk of hypoxia as her biggest concern. “There’s so many factors that we can’t predict, like undiagnosed sleep apnea,” she said. “We just don’t know when the respiratory depression worsens, so I’m uncomfortable with the high rate of hypoxia.”
Although not directly related to this application, INSYS had been the subject of an investigation by the federal government in regard to an illegal marketing scheme that provided incentives for doctors to prescribe Subsys, a powerful and highly addictive synthetic opioid. Documents recently have been unsealed in federal court that prompted the federal government to investigate INSYS. The company has addressed the previous allegations of wrongdoing and states that INSYS has become a “... new and better company in many important respects across the organization,” according to a statement.The FDA usually follows the recommendations of its advisory panels, but they are not binding.
In abdominal myomectomy, cell salvage may reduce transfusions
ORLANDO – Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy, according to findings from a retrospective cohort study.
Of 138 women who underwent abdominal myomectomy, 52 had no cell salvage and 86 had cell salvage ordered. Of those who had cell salvage ordered, 60 had salvage fully set up and 26 had salvage on standby; 46 of the 60 with full set-up had autologous blood returned, and of those, 14 required subsequent allogeneic transfusion of more than 20 U of blood, Julian A. Gingold, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Notable differences between those who did and those who did not have cell salvage ordered included the number of patients with fibroids weighing more than 250 g (52% vs. 13%) and with five or more total fibroids (83% vs. 56%), he said.
“And interestingly, reproductive surgeons were less likely (than general surgeons) to order cell salvage,” he said.
Surgery was performed by a reproductive surgeon in 25% of cases in the cell salvage group vs. in 67% of cases in the non–cell salvage group.
The finding of comparable allogeneic transfusion requirement between the two groups despite differences in blood loss and “arguably less complex surgeries [in those] without cell salvage” was striking, Dr. Gingold said.
“If you take these 86 patients who had cell salvage intraoperatively, 14 of them ultimately required donor blood, and that amounted to 23 units, giving kind of a lower limit for the potential benefit of cell salvage in this patient cohort,” he said.
Abdominal myomectomy often has a high rate of blood loss, with about a 10%-20% rate of transfusion. While the technique of cell salvage is widely used in other fields, it hasn’t been fully investigated in the context of gynecologic surgery, he said, explaining the rationale for the study.
Subjects included were women aged 18-60 years who underwent abdominal myomectomy for benign indications at the Cleveland Clinic during 2011-2016. Those with current malignancy or with surgery performed by a gynecologic oncologist were excluded.
The non–cell salvage and cell salvage groups were comparable with respect to age, body mass index, ethnicity, and preoperative and postoperative hemoglobin.
Dr. Gingold noted that “prospective study with randomization will be required to better define the role of cell salvage in abdominal myomectomies.”
During a question and answer session following his presentation, Charles Ascher-Walsh, MD, of Mount Sinai Health System, N.Y. noted that the transfusion rates and blood loss were high in the study, and that solid data support the use of tourniquets for patients undergoing abdominal myomectomy, with studies showing only a 1%-2% transfusion rate with continuous tourniquet use. Dr. Gingold said the use of tourniquets in the study was low and was dictated by surgeon preference. He agreed that tourniquet use is “certainly an option that should be adjunctive,” and that it would be useful to look at the outcomes in the cases with and without tourniquet use.
Dr. Gingold reported having no disclosures.
SOURCE: Gingold J et al. SGS 2018 Oral Poster 18.
ORLANDO – Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy, according to findings from a retrospective cohort study.
Of 138 women who underwent abdominal myomectomy, 52 had no cell salvage and 86 had cell salvage ordered. Of those who had cell salvage ordered, 60 had salvage fully set up and 26 had salvage on standby; 46 of the 60 with full set-up had autologous blood returned, and of those, 14 required subsequent allogeneic transfusion of more than 20 U of blood, Julian A. Gingold, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Notable differences between those who did and those who did not have cell salvage ordered included the number of patients with fibroids weighing more than 250 g (52% vs. 13%) and with five or more total fibroids (83% vs. 56%), he said.
“And interestingly, reproductive surgeons were less likely (than general surgeons) to order cell salvage,” he said.
Surgery was performed by a reproductive surgeon in 25% of cases in the cell salvage group vs. in 67% of cases in the non–cell salvage group.
The finding of comparable allogeneic transfusion requirement between the two groups despite differences in blood loss and “arguably less complex surgeries [in those] without cell salvage” was striking, Dr. Gingold said.
“If you take these 86 patients who had cell salvage intraoperatively, 14 of them ultimately required donor blood, and that amounted to 23 units, giving kind of a lower limit for the potential benefit of cell salvage in this patient cohort,” he said.
Abdominal myomectomy often has a high rate of blood loss, with about a 10%-20% rate of transfusion. While the technique of cell salvage is widely used in other fields, it hasn’t been fully investigated in the context of gynecologic surgery, he said, explaining the rationale for the study.
Subjects included were women aged 18-60 years who underwent abdominal myomectomy for benign indications at the Cleveland Clinic during 2011-2016. Those with current malignancy or with surgery performed by a gynecologic oncologist were excluded.
The non–cell salvage and cell salvage groups were comparable with respect to age, body mass index, ethnicity, and preoperative and postoperative hemoglobin.
Dr. Gingold noted that “prospective study with randomization will be required to better define the role of cell salvage in abdominal myomectomies.”
During a question and answer session following his presentation, Charles Ascher-Walsh, MD, of Mount Sinai Health System, N.Y. noted that the transfusion rates and blood loss were high in the study, and that solid data support the use of tourniquets for patients undergoing abdominal myomectomy, with studies showing only a 1%-2% transfusion rate with continuous tourniquet use. Dr. Gingold said the use of tourniquets in the study was low and was dictated by surgeon preference. He agreed that tourniquet use is “certainly an option that should be adjunctive,” and that it would be useful to look at the outcomes in the cases with and without tourniquet use.
Dr. Gingold reported having no disclosures.
SOURCE: Gingold J et al. SGS 2018 Oral Poster 18.
ORLANDO – Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy, according to findings from a retrospective cohort study.
Of 138 women who underwent abdominal myomectomy, 52 had no cell salvage and 86 had cell salvage ordered. Of those who had cell salvage ordered, 60 had salvage fully set up and 26 had salvage on standby; 46 of the 60 with full set-up had autologous blood returned, and of those, 14 required subsequent allogeneic transfusion of more than 20 U of blood, Julian A. Gingold, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Notable differences between those who did and those who did not have cell salvage ordered included the number of patients with fibroids weighing more than 250 g (52% vs. 13%) and with five or more total fibroids (83% vs. 56%), he said.
“And interestingly, reproductive surgeons were less likely (than general surgeons) to order cell salvage,” he said.
Surgery was performed by a reproductive surgeon in 25% of cases in the cell salvage group vs. in 67% of cases in the non–cell salvage group.
The finding of comparable allogeneic transfusion requirement between the two groups despite differences in blood loss and “arguably less complex surgeries [in those] without cell salvage” was striking, Dr. Gingold said.
“If you take these 86 patients who had cell salvage intraoperatively, 14 of them ultimately required donor blood, and that amounted to 23 units, giving kind of a lower limit for the potential benefit of cell salvage in this patient cohort,” he said.
Abdominal myomectomy often has a high rate of blood loss, with about a 10%-20% rate of transfusion. While the technique of cell salvage is widely used in other fields, it hasn’t been fully investigated in the context of gynecologic surgery, he said, explaining the rationale for the study.
Subjects included were women aged 18-60 years who underwent abdominal myomectomy for benign indications at the Cleveland Clinic during 2011-2016. Those with current malignancy or with surgery performed by a gynecologic oncologist were excluded.
The non–cell salvage and cell salvage groups were comparable with respect to age, body mass index, ethnicity, and preoperative and postoperative hemoglobin.
Dr. Gingold noted that “prospective study with randomization will be required to better define the role of cell salvage in abdominal myomectomies.”
During a question and answer session following his presentation, Charles Ascher-Walsh, MD, of Mount Sinai Health System, N.Y. noted that the transfusion rates and blood loss were high in the study, and that solid data support the use of tourniquets for patients undergoing abdominal myomectomy, with studies showing only a 1%-2% transfusion rate with continuous tourniquet use. Dr. Gingold said the use of tourniquets in the study was low and was dictated by surgeon preference. He agreed that tourniquet use is “certainly an option that should be adjunctive,” and that it would be useful to look at the outcomes in the cases with and without tourniquet use.
Dr. Gingold reported having no disclosures.
SOURCE: Gingold J et al. SGS 2018 Oral Poster 18.
REPORTING FROM SGS 2018
Key clinical point: Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy.
Major finding: Transfusion rates were similar (23% and 17%) despite greater blood loss in the cell salvage group.
Study details: A retrospective review of 138 patients’ charts.
Disclosures: Dr. Gingold reported having no disclosures.
Source: Gingold J et al. SGS 2018 Oral poster 18.
Recent studies of microbiota offer insights into digestive disease management
LAS VEGAS – Recent studies of human microbiota are yielding new insights that could improve the diagnosis, evaluation, and treatment of digestive diseases, according to Eamonn M. Quigley, MD.
There are “many possibilities” for new therapeutics that focus on the assemblage of bacteria and other microorganisms present in the human body, said Dr. Quigley, director of the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist.
The role of the microbiota has already been well established, for example, in cases of Helicobacter pylori infection and Clostridium difficile–associated disease. “They’re the classics,” Dr. Quigley told attendees. “They’re the templates for studies in other diseases.”
Dr. Quigley shared results of one recent treatment-related study that he said could have important implications for sepsis prevention in infants. The randomized trial showed that administration of a particular synbiotic – a probiotic plus a prebiotic substance – may have reduced sepsis incidence among infants in rural India.
The study comprised 4,556 infants with no signs of sepsis who were given an oral synbiotic preparation of Lactobacillus plantarum plus fructooligosaccharide. The composite outcome of sepsis and death was reduced in the treatment arm of the study (risk ratio, 0.60; 95% confidence interval, 0.48-0.74).
Based on that outcome, investigators said in their report that the preparation could prevent a “large proportion” of neonatal sepsis in developing countries.
“This is a very dramatic result for a very simple and cheap intervention in a high-risk population,” Dr. Quigley said in his presentation at the meeting.
He also provided a short list of studies showing “exciting recent data” regarding the predictive role of microbiota.
In one such study, investigators showed that the oral microbiota associated with colorectal cancer is distinctive, raising the possibility that analyzing microbiota could help identify patients at risk for development of colon cancer or offer an alternative cancer screening method.
In other studies, Dr. Quigley said, microbiota have been associated with response to metformin, and to the immune checkpoint inhibitors that have become important in the treatment of cancers.
In addition, microbiota have been associated with predicting response to low fermentable, oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diets in irritable bowel syndrome patients, and predicting metabolic response to high-fiber diets, he added.
Diagnostics is another area where microbiota could soon become important: “In diseases like [inflammatory bowel disease and irritable bowel syndrome] where we have a very heterogeneous population, looking at the microbiota might allow us to define new disease categories,” Dr. Quigley said.
Despite the promise, much research is still needed to confirm many of the findings of experimental studies.
“I think it’s clear that the microbiota is important in health and disease,” Dr. Quigley said. “However, host/microbiome interactions in [humans] are complex and far from completely understood, and unfortunately, some of the elegant work in animal models has not quite translated into man.”
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Quigley reported disclosures related to Alimentary Health, Almirall, Biocodex, 4D Pharma, Menarini, Pharmasierra, Salix, Synergy, and Vibrant.
LAS VEGAS – Recent studies of human microbiota are yielding new insights that could improve the diagnosis, evaluation, and treatment of digestive diseases, according to Eamonn M. Quigley, MD.
There are “many possibilities” for new therapeutics that focus on the assemblage of bacteria and other microorganisms present in the human body, said Dr. Quigley, director of the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist.
The role of the microbiota has already been well established, for example, in cases of Helicobacter pylori infection and Clostridium difficile–associated disease. “They’re the classics,” Dr. Quigley told attendees. “They’re the templates for studies in other diseases.”
Dr. Quigley shared results of one recent treatment-related study that he said could have important implications for sepsis prevention in infants. The randomized trial showed that administration of a particular synbiotic – a probiotic plus a prebiotic substance – may have reduced sepsis incidence among infants in rural India.
The study comprised 4,556 infants with no signs of sepsis who were given an oral synbiotic preparation of Lactobacillus plantarum plus fructooligosaccharide. The composite outcome of sepsis and death was reduced in the treatment arm of the study (risk ratio, 0.60; 95% confidence interval, 0.48-0.74).
Based on that outcome, investigators said in their report that the preparation could prevent a “large proportion” of neonatal sepsis in developing countries.
“This is a very dramatic result for a very simple and cheap intervention in a high-risk population,” Dr. Quigley said in his presentation at the meeting.
He also provided a short list of studies showing “exciting recent data” regarding the predictive role of microbiota.
In one such study, investigators showed that the oral microbiota associated with colorectal cancer is distinctive, raising the possibility that analyzing microbiota could help identify patients at risk for development of colon cancer or offer an alternative cancer screening method.
In other studies, Dr. Quigley said, microbiota have been associated with response to metformin, and to the immune checkpoint inhibitors that have become important in the treatment of cancers.
In addition, microbiota have been associated with predicting response to low fermentable, oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diets in irritable bowel syndrome patients, and predicting metabolic response to high-fiber diets, he added.
Diagnostics is another area where microbiota could soon become important: “In diseases like [inflammatory bowel disease and irritable bowel syndrome] where we have a very heterogeneous population, looking at the microbiota might allow us to define new disease categories,” Dr. Quigley said.
Despite the promise, much research is still needed to confirm many of the findings of experimental studies.
“I think it’s clear that the microbiota is important in health and disease,” Dr. Quigley said. “However, host/microbiome interactions in [humans] are complex and far from completely understood, and unfortunately, some of the elegant work in animal models has not quite translated into man.”
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Quigley reported disclosures related to Alimentary Health, Almirall, Biocodex, 4D Pharma, Menarini, Pharmasierra, Salix, Synergy, and Vibrant.
LAS VEGAS – Recent studies of human microbiota are yielding new insights that could improve the diagnosis, evaluation, and treatment of digestive diseases, according to Eamonn M. Quigley, MD.
There are “many possibilities” for new therapeutics that focus on the assemblage of bacteria and other microorganisms present in the human body, said Dr. Quigley, director of the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist.
The role of the microbiota has already been well established, for example, in cases of Helicobacter pylori infection and Clostridium difficile–associated disease. “They’re the classics,” Dr. Quigley told attendees. “They’re the templates for studies in other diseases.”
Dr. Quigley shared results of one recent treatment-related study that he said could have important implications for sepsis prevention in infants. The randomized trial showed that administration of a particular synbiotic – a probiotic plus a prebiotic substance – may have reduced sepsis incidence among infants in rural India.
The study comprised 4,556 infants with no signs of sepsis who were given an oral synbiotic preparation of Lactobacillus plantarum plus fructooligosaccharide. The composite outcome of sepsis and death was reduced in the treatment arm of the study (risk ratio, 0.60; 95% confidence interval, 0.48-0.74).
Based on that outcome, investigators said in their report that the preparation could prevent a “large proportion” of neonatal sepsis in developing countries.
“This is a very dramatic result for a very simple and cheap intervention in a high-risk population,” Dr. Quigley said in his presentation at the meeting.
He also provided a short list of studies showing “exciting recent data” regarding the predictive role of microbiota.
In one such study, investigators showed that the oral microbiota associated with colorectal cancer is distinctive, raising the possibility that analyzing microbiota could help identify patients at risk for development of colon cancer or offer an alternative cancer screening method.
In other studies, Dr. Quigley said, microbiota have been associated with response to metformin, and to the immune checkpoint inhibitors that have become important in the treatment of cancers.
In addition, microbiota have been associated with predicting response to low fermentable, oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) diets in irritable bowel syndrome patients, and predicting metabolic response to high-fiber diets, he added.
Diagnostics is another area where microbiota could soon become important: “In diseases like [inflammatory bowel disease and irritable bowel syndrome] where we have a very heterogeneous population, looking at the microbiota might allow us to define new disease categories,” Dr. Quigley said.
Despite the promise, much research is still needed to confirm many of the findings of experimental studies.
“I think it’s clear that the microbiota is important in health and disease,” Dr. Quigley said. “However, host/microbiome interactions in [humans] are complex and far from completely understood, and unfortunately, some of the elegant work in animal models has not quite translated into man.”
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Quigley reported disclosures related to Alimentary Health, Almirall, Biocodex, 4D Pharma, Menarini, Pharmasierra, Salix, Synergy, and Vibrant.
REPORTING FROM PERSPECTIVES IN DIGESTIVE DISEASES
FDA approves Doptelet for liver disease patients undergoing procedures
Doptelet (avatrombopag) is the first drug to be approved by the Food and Drug Administration for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure, the FDA announced in a statement.
“Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Doptelet was demonstrated to safely increase the platelet count. This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions.”
The safety and efficacy of two different doses of Doptelet administered orally over 5 days, as compared with placebo, was studied in the ADAPT trials (ADAPT-1 and ADAPT-2) involving 435 patients with chronic liver disease and severe thrombocytopenia who were scheduled to undergo a procedure that would typically require platelet transfusion. At both dose levels of Doptelet, a higher proportion of patients had increased platelet counts and did not require platelet transfusion or any rescue therapy on the day of the procedure and up to 7 days following the procedure as compared with those treated with placebo.
The most common side effects reported by clinical trial participants who received Doptelet were fever, stomach (abdominal) pain, nausea, headache, fatigue and edema in the hands or feet. People with chronic liver disease and people with certain blood clotting conditions may have an increased risk of developing blood clots when taking Doptelet, the FDA said in a press release announcing the approval.
The FDA granted the Doptelet approval to AkaRx.
Doptelet (avatrombopag) is the first drug to be approved by the Food and Drug Administration for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure, the FDA announced in a statement.
“Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Doptelet was demonstrated to safely increase the platelet count. This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions.”
The safety and efficacy of two different doses of Doptelet administered orally over 5 days, as compared with placebo, was studied in the ADAPT trials (ADAPT-1 and ADAPT-2) involving 435 patients with chronic liver disease and severe thrombocytopenia who were scheduled to undergo a procedure that would typically require platelet transfusion. At both dose levels of Doptelet, a higher proportion of patients had increased platelet counts and did not require platelet transfusion or any rescue therapy on the day of the procedure and up to 7 days following the procedure as compared with those treated with placebo.
The most common side effects reported by clinical trial participants who received Doptelet were fever, stomach (abdominal) pain, nausea, headache, fatigue and edema in the hands or feet. People with chronic liver disease and people with certain blood clotting conditions may have an increased risk of developing blood clots when taking Doptelet, the FDA said in a press release announcing the approval.
The FDA granted the Doptelet approval to AkaRx.
Doptelet (avatrombopag) is the first drug to be approved by the Food and Drug Administration for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure, the FDA announced in a statement.
“Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Doptelet was demonstrated to safely increase the platelet count. This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions.”
The safety and efficacy of two different doses of Doptelet administered orally over 5 days, as compared with placebo, was studied in the ADAPT trials (ADAPT-1 and ADAPT-2) involving 435 patients with chronic liver disease and severe thrombocytopenia who were scheduled to undergo a procedure that would typically require platelet transfusion. At both dose levels of Doptelet, a higher proportion of patients had increased platelet counts and did not require platelet transfusion or any rescue therapy on the day of the procedure and up to 7 days following the procedure as compared with those treated with placebo.
The most common side effects reported by clinical trial participants who received Doptelet were fever, stomach (abdominal) pain, nausea, headache, fatigue and edema in the hands or feet. People with chronic liver disease and people with certain blood clotting conditions may have an increased risk of developing blood clots when taking Doptelet, the FDA said in a press release announcing the approval.
The FDA granted the Doptelet approval to AkaRx.
TAVR safe in low-risk aortic stenosis, early data indicate
WASHINGTON – , according to results of the first U.S. study to evaluate mortality in a low-risk population.
Other complications were also low relative to those seen in previously published studies with higher-risk populations. The preliminary results are “reassuring,” Ronald Waksman, MD, associate director of the division of cardiology, Medstar Health Institute, Washington, DC, reported at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
In this study, a low-risk eligibility criterion is a Society of Thoracic Surgeons score of 3% or less. The mean score in the first 125 patients was 1.9%.
At 30 days, there were no myocardial infarctions, no acute kidney injuries of stage II or greater, and no transient ischemic attacks. There was one nondisabling stroke, one paravalvular leak, and one coronary obstruction that required a coronary artery bypass graft. The rates of new onset atrial fibrillation, major vascular complications, and life-threatening or major bleeding events were lower than 5%.
Surgical atrial valve replacement (SAVR) currently has a IB recommendation for the treatment of symptomatic low-risk aortic stenosis, but TAVR is not currently indicated in this population, according to 2017 American Heart Association/American College of Cardiology guidelines. There is, however, substantial interest in extending TAVR to a low-risk population, according to Dr. Waksman.
“We know that there are potential benefits for TAVR versus SAVR that include reduced ICU and hospital length of stay, more rapid quality of life recovery, lower risk of bleeding, and lower risk of postprocedure AF [atrial fibrillation],” said Dr. Waksman in explaining the rationale for this and other ongoing studies testing TAVR in low-risk patients.
In this investigator-initiated study, which was conducted without industry support, 11 sites participated. Most were relatively low-volume centers with fewer than 150 TAVR procedures performed annually, according to Dr. Waksman. The choice of TAVR device was left to the discretion of the operator.
Reflecting a lower-risk population, the mean age of 74.6 years is younger than that of participants in previous TAVR trials. The mean left ventricular ejection fraction was 62.9%. Only 4.8% had a prior MI and 19.2% had a prior coronary artery bypass graft. Most procedures were performed under conscious sedation with fewer than 20% receiving general anesthesia. The mean fluoroscopy time was 16 minutes.
The degree of improvement in hemodynamics following TAVR in this population was called “excellent,” but Dr. Waksman did report a 12.5% incidence of hypo-attenuating leaflet thickening (HALT), an 11% incidence of reduced leaflet motion, and a 9.3% incidence of hypo-attenuation affecting motion. All were subclinical effects.
In a closer analysis of HALT, the rate was 14.4% in the 80.8% of patients who received antiplatelet therapy versus 4.8% in the 17.5% who received oral anticoagulation (some received neither). Dr. Waksman called the greater association of HALT with antiplatelet therapy “a potential signal” that deserves further study.
Full results from all 200 patients are expected in the fall of 2018.
Jeffrey Popma, MD, director of the interventional cardiology clinical service, Beth Israel Deaconess Hospital, Boston, and moderator of the session where the data were presented, called for a direct comparison with SAVR in low-risk patients to place the relative role of these options into context.
Neil Moat, a consultant cardiac surgeon at Royal Brompton & Harefield Hospital, London, agreed. Although he is also encouraged by the evidence of safety in low-risk patients, he labeled the rate of HALT in this study “a concern.”
Dr. Waksman reported financial relationships with Abbott Vascular, Amgen, AstraZeneca, Life Technologies, Med Alliance, Medtronic Vascular, and Symetis, among other companies.
WASHINGTON – , according to results of the first U.S. study to evaluate mortality in a low-risk population.
Other complications were also low relative to those seen in previously published studies with higher-risk populations. The preliminary results are “reassuring,” Ronald Waksman, MD, associate director of the division of cardiology, Medstar Health Institute, Washington, DC, reported at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
In this study, a low-risk eligibility criterion is a Society of Thoracic Surgeons score of 3% or less. The mean score in the first 125 patients was 1.9%.
At 30 days, there were no myocardial infarctions, no acute kidney injuries of stage II or greater, and no transient ischemic attacks. There was one nondisabling stroke, one paravalvular leak, and one coronary obstruction that required a coronary artery bypass graft. The rates of new onset atrial fibrillation, major vascular complications, and life-threatening or major bleeding events were lower than 5%.
Surgical atrial valve replacement (SAVR) currently has a IB recommendation for the treatment of symptomatic low-risk aortic stenosis, but TAVR is not currently indicated in this population, according to 2017 American Heart Association/American College of Cardiology guidelines. There is, however, substantial interest in extending TAVR to a low-risk population, according to Dr. Waksman.
“We know that there are potential benefits for TAVR versus SAVR that include reduced ICU and hospital length of stay, more rapid quality of life recovery, lower risk of bleeding, and lower risk of postprocedure AF [atrial fibrillation],” said Dr. Waksman in explaining the rationale for this and other ongoing studies testing TAVR in low-risk patients.
In this investigator-initiated study, which was conducted without industry support, 11 sites participated. Most were relatively low-volume centers with fewer than 150 TAVR procedures performed annually, according to Dr. Waksman. The choice of TAVR device was left to the discretion of the operator.
Reflecting a lower-risk population, the mean age of 74.6 years is younger than that of participants in previous TAVR trials. The mean left ventricular ejection fraction was 62.9%. Only 4.8% had a prior MI and 19.2% had a prior coronary artery bypass graft. Most procedures were performed under conscious sedation with fewer than 20% receiving general anesthesia. The mean fluoroscopy time was 16 minutes.
The degree of improvement in hemodynamics following TAVR in this population was called “excellent,” but Dr. Waksman did report a 12.5% incidence of hypo-attenuating leaflet thickening (HALT), an 11% incidence of reduced leaflet motion, and a 9.3% incidence of hypo-attenuation affecting motion. All were subclinical effects.
In a closer analysis of HALT, the rate was 14.4% in the 80.8% of patients who received antiplatelet therapy versus 4.8% in the 17.5% who received oral anticoagulation (some received neither). Dr. Waksman called the greater association of HALT with antiplatelet therapy “a potential signal” that deserves further study.
Full results from all 200 patients are expected in the fall of 2018.
Jeffrey Popma, MD, director of the interventional cardiology clinical service, Beth Israel Deaconess Hospital, Boston, and moderator of the session where the data were presented, called for a direct comparison with SAVR in low-risk patients to place the relative role of these options into context.
Neil Moat, a consultant cardiac surgeon at Royal Brompton & Harefield Hospital, London, agreed. Although he is also encouraged by the evidence of safety in low-risk patients, he labeled the rate of HALT in this study “a concern.”
Dr. Waksman reported financial relationships with Abbott Vascular, Amgen, AstraZeneca, Life Technologies, Med Alliance, Medtronic Vascular, and Symetis, among other companies.
WASHINGTON – , according to results of the first U.S. study to evaluate mortality in a low-risk population.
Other complications were also low relative to those seen in previously published studies with higher-risk populations. The preliminary results are “reassuring,” Ronald Waksman, MD, associate director of the division of cardiology, Medstar Health Institute, Washington, DC, reported at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
In this study, a low-risk eligibility criterion is a Society of Thoracic Surgeons score of 3% or less. The mean score in the first 125 patients was 1.9%.
At 30 days, there were no myocardial infarctions, no acute kidney injuries of stage II or greater, and no transient ischemic attacks. There was one nondisabling stroke, one paravalvular leak, and one coronary obstruction that required a coronary artery bypass graft. The rates of new onset atrial fibrillation, major vascular complications, and life-threatening or major bleeding events were lower than 5%.
Surgical atrial valve replacement (SAVR) currently has a IB recommendation for the treatment of symptomatic low-risk aortic stenosis, but TAVR is not currently indicated in this population, according to 2017 American Heart Association/American College of Cardiology guidelines. There is, however, substantial interest in extending TAVR to a low-risk population, according to Dr. Waksman.
“We know that there are potential benefits for TAVR versus SAVR that include reduced ICU and hospital length of stay, more rapid quality of life recovery, lower risk of bleeding, and lower risk of postprocedure AF [atrial fibrillation],” said Dr. Waksman in explaining the rationale for this and other ongoing studies testing TAVR in low-risk patients.
In this investigator-initiated study, which was conducted without industry support, 11 sites participated. Most were relatively low-volume centers with fewer than 150 TAVR procedures performed annually, according to Dr. Waksman. The choice of TAVR device was left to the discretion of the operator.
Reflecting a lower-risk population, the mean age of 74.6 years is younger than that of participants in previous TAVR trials. The mean left ventricular ejection fraction was 62.9%. Only 4.8% had a prior MI and 19.2% had a prior coronary artery bypass graft. Most procedures were performed under conscious sedation with fewer than 20% receiving general anesthesia. The mean fluoroscopy time was 16 minutes.
The degree of improvement in hemodynamics following TAVR in this population was called “excellent,” but Dr. Waksman did report a 12.5% incidence of hypo-attenuating leaflet thickening (HALT), an 11% incidence of reduced leaflet motion, and a 9.3% incidence of hypo-attenuation affecting motion. All were subclinical effects.
In a closer analysis of HALT, the rate was 14.4% in the 80.8% of patients who received antiplatelet therapy versus 4.8% in the 17.5% who received oral anticoagulation (some received neither). Dr. Waksman called the greater association of HALT with antiplatelet therapy “a potential signal” that deserves further study.
Full results from all 200 patients are expected in the fall of 2018.
Jeffrey Popma, MD, director of the interventional cardiology clinical service, Beth Israel Deaconess Hospital, Boston, and moderator of the session where the data were presented, called for a direct comparison with SAVR in low-risk patients to place the relative role of these options into context.
Neil Moat, a consultant cardiac surgeon at Royal Brompton & Harefield Hospital, London, agreed. Although he is also encouraged by the evidence of safety in low-risk patients, he labeled the rate of HALT in this study “a concern.”
Dr. Waksman reported financial relationships with Abbott Vascular, Amgen, AstraZeneca, Life Technologies, Med Alliance, Medtronic Vascular, and Symetis, among other companies.
REPORTING FROM CRT 2018
Key clinical point: In an interim analysis, transcatheter aortic valve replacement was found safe in low-risk patients with symptomatic aortic stenosis.
Major finding: Through 30 days of follow-up, the mortality rate was 0% or lower than observed in studies conducted in higher-risk populations.
Study details: Interim analysis of 125 patients in a prospective registry study.
Disclosures: Dr. Waksman reported financial relationships with Abbott Vascular, Amgen, AstraZeneca, Life Technologies, Med Alliance, Medtronic Vascular, and Symetis, among other companies.
CKD triples risk of bad outcomes in HIV
BOSTON – A lot of people do well with HIV thanks to potent antiretrovirals, but there’s still at least one group that needs extra attention: HIV patients with chronic kidney disease (CKD), according to Lene Ryom, MD, PhD, an HIV researcher at the University of Copenhagen.
She was the lead investigator on a review of 2,467 HIV patients with CKD – which is becoming more common in HIV as patients live longer – and 33,427 HIV patients without CKD.
The incidence of serious clinical events following CKD diagnosis was 68.9 events per 1,000 patient-years. Among the HIV patients without CKD, the incidence was 23 events per 1,000 patient-years.
“In an era when many HIV patients require much less management due to effective antiretroviral treatment, those living with CKD have a much higher burden of serious clinical events and require much closer monitoring. Modifiable risk factors ... play a central role in CKD morbidity and mortality, highlighting the need for increased awareness, effective treatment, and preventative measures. In particular, smoking seems to be quite important for all” serious adverse outcomes, “so that’s a good place to start,” Dr. Ryom said at the Conference on Retroviruses & Opportunistic Infections.
Most of the 2,467 HIV patients with CKD were white men who have sex with men. At baseline, the median age was 60 years, and median CD4 cell count was above 500. One in three were smokers, 22.4% were HCV positive, and most had viral loads below 400 copies/mL. More than half of the patients were estimated to have died within 5 years of CKD diagnosis.
CKD was defined as two estimated glomerular filtration rates at or below 60 mL/min per 1.73 m2 taken at least 3 months apart, or a 25% decrease in eGFR when patients entered the study at that level.
The subjects were all participants in the D:A:D project [Data Collection on Adverse Events of Anti-HIV Drugs], an ongoing international cohort study based at the University of Copenhagen, and funded by pharmaceutical companies, among others.
Dr. Ryom had no disclosures.
SOURCE: Ryom L et al. CROI, Abstract 75.
BOSTON – A lot of people do well with HIV thanks to potent antiretrovirals, but there’s still at least one group that needs extra attention: HIV patients with chronic kidney disease (CKD), according to Lene Ryom, MD, PhD, an HIV researcher at the University of Copenhagen.
She was the lead investigator on a review of 2,467 HIV patients with CKD – which is becoming more common in HIV as patients live longer – and 33,427 HIV patients without CKD.
The incidence of serious clinical events following CKD diagnosis was 68.9 events per 1,000 patient-years. Among the HIV patients without CKD, the incidence was 23 events per 1,000 patient-years.
“In an era when many HIV patients require much less management due to effective antiretroviral treatment, those living with CKD have a much higher burden of serious clinical events and require much closer monitoring. Modifiable risk factors ... play a central role in CKD morbidity and mortality, highlighting the need for increased awareness, effective treatment, and preventative measures. In particular, smoking seems to be quite important for all” serious adverse outcomes, “so that’s a good place to start,” Dr. Ryom said at the Conference on Retroviruses & Opportunistic Infections.
Most of the 2,467 HIV patients with CKD were white men who have sex with men. At baseline, the median age was 60 years, and median CD4 cell count was above 500. One in three were smokers, 22.4% were HCV positive, and most had viral loads below 400 copies/mL. More than half of the patients were estimated to have died within 5 years of CKD diagnosis.
CKD was defined as two estimated glomerular filtration rates at or below 60 mL/min per 1.73 m2 taken at least 3 months apart, or a 25% decrease in eGFR when patients entered the study at that level.
The subjects were all participants in the D:A:D project [Data Collection on Adverse Events of Anti-HIV Drugs], an ongoing international cohort study based at the University of Copenhagen, and funded by pharmaceutical companies, among others.
Dr. Ryom had no disclosures.
SOURCE: Ryom L et al. CROI, Abstract 75.
BOSTON – A lot of people do well with HIV thanks to potent antiretrovirals, but there’s still at least one group that needs extra attention: HIV patients with chronic kidney disease (CKD), according to Lene Ryom, MD, PhD, an HIV researcher at the University of Copenhagen.
She was the lead investigator on a review of 2,467 HIV patients with CKD – which is becoming more common in HIV as patients live longer – and 33,427 HIV patients without CKD.
The incidence of serious clinical events following CKD diagnosis was 68.9 events per 1,000 patient-years. Among the HIV patients without CKD, the incidence was 23 events per 1,000 patient-years.
“In an era when many HIV patients require much less management due to effective antiretroviral treatment, those living with CKD have a much higher burden of serious clinical events and require much closer monitoring. Modifiable risk factors ... play a central role in CKD morbidity and mortality, highlighting the need for increased awareness, effective treatment, and preventative measures. In particular, smoking seems to be quite important for all” serious adverse outcomes, “so that’s a good place to start,” Dr. Ryom said at the Conference on Retroviruses & Opportunistic Infections.
Most of the 2,467 HIV patients with CKD were white men who have sex with men. At baseline, the median age was 60 years, and median CD4 cell count was above 500. One in three were smokers, 22.4% were HCV positive, and most had viral loads below 400 copies/mL. More than half of the patients were estimated to have died within 5 years of CKD diagnosis.
CKD was defined as two estimated glomerular filtration rates at or below 60 mL/min per 1.73 m2 taken at least 3 months apart, or a 25% decrease in eGFR when patients entered the study at that level.
The subjects were all participants in the D:A:D project [Data Collection on Adverse Events of Anti-HIV Drugs], an ongoing international cohort study based at the University of Copenhagen, and funded by pharmaceutical companies, among others.
Dr. Ryom had no disclosures.
SOURCE: Ryom L et al. CROI, Abstract 75.
REPORTING FROM CROI
Key clinical point: Smoking, diabetes, dyslipidemia, low body mass index, and poor HIV control increase the risk of poor outcomes in HIV patients who have chronic kidney disease.
Major finding: In HIV patients with CKD, the incidence of a serious clinical event is 68.9 per 1,000 patient-years; in HIV patients without CKD, it’s 23 events per 1,000 patient-years.
Study details: Review of nearly 36,000 HIV patients.
Disclosures: The lead investigator had no disclosures. Funding came from pharmaceutical companies, among others.
Source: Ryom L et al. CROI, Abstract 75.
Ruptured abdominal aortic aneurysm repair: Preop measures that predict death
Four preoperative variables – age over 76 years, creatinine concentration greater than 2.0 mg/dL, pH less than 7.2, and lowest ever systolic blood pressure less than 70 mm Hg – predicted 30-day mortality following repair of ruptured abdominal aortic aneurysms (rAAAs), in a retrospective study of 303 patients treated at Harborview Medical Center at the University of Washington, Seattle.
Brandon T. Garland, MD, and his colleagues at Harborview, reviewed the data set of patients, noting 50% were aged older than 76 years and 80% were male. Many patients had typical vascular risk factors: 65% had hypertension, 39% had coronary artery disease, and 22% had chronic obstructive vascular disease. Patients who were treated for rAAA after 2007 and had preoperative computed tomography scans were assessed for endovascular aneurysm repair (rEVAR) based on infrarenal neck length and diameter and access vessel size. Noneligible patients and all patients treated prior to 2007 had open repair (rOR) surgery.
A primary screen of selected preoperative variables included age, hematocrit, systolic blood pressure values, use of cardiopulmonary resuscitation, pH, international normalized ratio, creatinine concentration, temperature, partial thromboplastin time, weight, history of coronary artery disease, and loss of consciousness at any time.
The four statistically significant associations were age over 76 years (odds ratio, 2.11; P less than 0.11), creatinine concentration over 2.0 mg/dL (OR, 3.66; P less than .001), pH less than 7.2 (OR 2.58; P less than .009) and lowest ever systolic blood pressure less than 70 mm Hg (OR, 2.70; P less than .002) Each of the four predictive preoperative rAAA variables was assigned a value of 1 point. Individualized scores are simply calculated by totaling the number of preoperative risk predictors.
Of the original 303 patients, 154 were alive at 30 days following rAAA repair, and there was a significant benefit from using rEVAR. Overall, patients with 1-, 2-, 3-, and 4-point mortality scores had 30-day mortality risks of 22%, 69%, 80%, and 100%, respectively. rEVAR mortalities dropped to 7% for a 1-point score and to 70% for a 3-point score. There were no 30-day survivors with 4-point risk scores regardless of whether they had rEVAR or rOR procedures.
The predictive risk scores for rAAA mortality outcomes provide helpful guides for patient care recommendations, and can be used to supplement the rOR-validated Glasgow Aneurysm Score, Hardman index, and Vascular Study Group of New England risk-predicting algorithms to “aid in clinical decision-making in the endovascular era,” the researchers wrote. The scores also add “prognostic information to the decision to transfer patients to tertiary care centers and aid in preoperative discussions with patients and their families.”
The authors reported that they had no conflicts of interest.
SOURCE: Garland BT et al. J Vasc Surg. 2018 May 9. doi: 10.1016/j.jvs.2017.12.075.
Four preoperative variables – age over 76 years, creatinine concentration greater than 2.0 mg/dL, pH less than 7.2, and lowest ever systolic blood pressure less than 70 mm Hg – predicted 30-day mortality following repair of ruptured abdominal aortic aneurysms (rAAAs), in a retrospective study of 303 patients treated at Harborview Medical Center at the University of Washington, Seattle.
Brandon T. Garland, MD, and his colleagues at Harborview, reviewed the data set of patients, noting 50% were aged older than 76 years and 80% were male. Many patients had typical vascular risk factors: 65% had hypertension, 39% had coronary artery disease, and 22% had chronic obstructive vascular disease. Patients who were treated for rAAA after 2007 and had preoperative computed tomography scans were assessed for endovascular aneurysm repair (rEVAR) based on infrarenal neck length and diameter and access vessel size. Noneligible patients and all patients treated prior to 2007 had open repair (rOR) surgery.
A primary screen of selected preoperative variables included age, hematocrit, systolic blood pressure values, use of cardiopulmonary resuscitation, pH, international normalized ratio, creatinine concentration, temperature, partial thromboplastin time, weight, history of coronary artery disease, and loss of consciousness at any time.
The four statistically significant associations were age over 76 years (odds ratio, 2.11; P less than 0.11), creatinine concentration over 2.0 mg/dL (OR, 3.66; P less than .001), pH less than 7.2 (OR 2.58; P less than .009) and lowest ever systolic blood pressure less than 70 mm Hg (OR, 2.70; P less than .002) Each of the four predictive preoperative rAAA variables was assigned a value of 1 point. Individualized scores are simply calculated by totaling the number of preoperative risk predictors.
Of the original 303 patients, 154 were alive at 30 days following rAAA repair, and there was a significant benefit from using rEVAR. Overall, patients with 1-, 2-, 3-, and 4-point mortality scores had 30-day mortality risks of 22%, 69%, 80%, and 100%, respectively. rEVAR mortalities dropped to 7% for a 1-point score and to 70% for a 3-point score. There were no 30-day survivors with 4-point risk scores regardless of whether they had rEVAR or rOR procedures.
The predictive risk scores for rAAA mortality outcomes provide helpful guides for patient care recommendations, and can be used to supplement the rOR-validated Glasgow Aneurysm Score, Hardman index, and Vascular Study Group of New England risk-predicting algorithms to “aid in clinical decision-making in the endovascular era,” the researchers wrote. The scores also add “prognostic information to the decision to transfer patients to tertiary care centers and aid in preoperative discussions with patients and their families.”
The authors reported that they had no conflicts of interest.
SOURCE: Garland BT et al. J Vasc Surg. 2018 May 9. doi: 10.1016/j.jvs.2017.12.075.
Four preoperative variables – age over 76 years, creatinine concentration greater than 2.0 mg/dL, pH less than 7.2, and lowest ever systolic blood pressure less than 70 mm Hg – predicted 30-day mortality following repair of ruptured abdominal aortic aneurysms (rAAAs), in a retrospective study of 303 patients treated at Harborview Medical Center at the University of Washington, Seattle.
Brandon T. Garland, MD, and his colleagues at Harborview, reviewed the data set of patients, noting 50% were aged older than 76 years and 80% were male. Many patients had typical vascular risk factors: 65% had hypertension, 39% had coronary artery disease, and 22% had chronic obstructive vascular disease. Patients who were treated for rAAA after 2007 and had preoperative computed tomography scans were assessed for endovascular aneurysm repair (rEVAR) based on infrarenal neck length and diameter and access vessel size. Noneligible patients and all patients treated prior to 2007 had open repair (rOR) surgery.
A primary screen of selected preoperative variables included age, hematocrit, systolic blood pressure values, use of cardiopulmonary resuscitation, pH, international normalized ratio, creatinine concentration, temperature, partial thromboplastin time, weight, history of coronary artery disease, and loss of consciousness at any time.
The four statistically significant associations were age over 76 years (odds ratio, 2.11; P less than 0.11), creatinine concentration over 2.0 mg/dL (OR, 3.66; P less than .001), pH less than 7.2 (OR 2.58; P less than .009) and lowest ever systolic blood pressure less than 70 mm Hg (OR, 2.70; P less than .002) Each of the four predictive preoperative rAAA variables was assigned a value of 1 point. Individualized scores are simply calculated by totaling the number of preoperative risk predictors.
Of the original 303 patients, 154 were alive at 30 days following rAAA repair, and there was a significant benefit from using rEVAR. Overall, patients with 1-, 2-, 3-, and 4-point mortality scores had 30-day mortality risks of 22%, 69%, 80%, and 100%, respectively. rEVAR mortalities dropped to 7% for a 1-point score and to 70% for a 3-point score. There were no 30-day survivors with 4-point risk scores regardless of whether they had rEVAR or rOR procedures.
The predictive risk scores for rAAA mortality outcomes provide helpful guides for patient care recommendations, and can be used to supplement the rOR-validated Glasgow Aneurysm Score, Hardman index, and Vascular Study Group of New England risk-predicting algorithms to “aid in clinical decision-making in the endovascular era,” the researchers wrote. The scores also add “prognostic information to the decision to transfer patients to tertiary care centers and aid in preoperative discussions with patients and their families.”
The authors reported that they had no conflicts of interest.
SOURCE: Garland BT et al. J Vasc Surg. 2018 May 9. doi: 10.1016/j.jvs.2017.12.075.
FROM THE JOURNAL OF VASCULAR SURGERY
Key clinical point: Age, creatinine concentration, pH, and systolic blood pressure measures can be used to determine a 30-day mortality risk score for patients undergoing repair of ruptured abdominal aortic aneurysms (rAAAs).
Major finding: The Harborview Medical Center risk scores range from 0 to 4 points with 1-, 2-, and 3-point scores corresponding respectively to 22%, 69%, and 80% risks of 30-day mortality following rAAA repair.
Study details: A single-location retrospective study of 303 patients presenting with ruptured rAAAs.
Disclosures: The authors reported that they had no conflicts of interest.
Source: Garland BT et al. J Vasc Surg. 2018 May 9. doi: 10.1016/j.jvs.2017.12.075.
CBC values linked to CVD risk in psoriasis
ORLANDO – conducted by researchers at Case Western Reserve University, Cleveland.*
It’s generally accepted that psoriasis increases the risk of cardiovascular disease (CVD), but it’s not clear who’s most at risk. “We really wanted to find something that is cheap and easy to risk stratify these patients” said lead investigator Rosalynn Conic, MD, of Case Western’s department of dermatology.
What they found was “very impressive, for sure,” Dr. Conic said at the International Investigative Dermatology meeting.
The incidence of MI was highest among the 1,920 patients (5%) with elevated RDW and MPV (odds ratio, 3.4; 95% confidence interval, 2.7-4.2; P less than .001), followed by the 7,060 (18%) patients with high RDW and normal MPV (OR, 2.4; 95% CI, 2.1-2.8; P less than .001), as compared with normal/low MPV and RDW patients.
Elevated RDW or elevated RDW plus MPV increased the odds of atrial fibrillation, coronary artery disease, heart failure, and peripheral vascular disease anywhere from 2 to 8.3 times (P less than .001). Among psoriatic arthritis patients, elevated RDW almost doubled the risk of MI (OR, 1.8; P less than .001). Results were adjusted for age, gender, and hypertension.
In a subanalysis of treatment effects, 4 of 23 psoriasis patients at Case Western had elevated RDWs at baseline. Values normalized in the three patients who achieved a 75% reduction in the Psoriasis Area and Severity Index score after about a year of systemic treatment.
“We aim to validate [the study results] with a Veterans Administration data set,” Dr. Conic said. If it pans out, “one use would be to send [patients with elevated values] to a cardiologist earlier” so other CVD risk factors can be monitored and treated. The findings also add to the case for good control, she noted.
Systemic inflammation is the common denominator between the blood value elevations and CVD. The same inflammatory cytokines that cause skin problems in psoriasis also stimulate bone marrow to release immature red blood cells, which are larger than mature cells, leading to an increased RDW. Similarly, elevated MPV indicates a higher number of larger, younger platelets in the blood.
“It’s probably something along those lines, but I think we need to go back to basic science and really figure it out,” Dr. Conic said.
Patients were 18-65 years old. The study excluded patients with diabetes, Crohn’s disease, RA, and generalized atherosclerosis.
The National Institutes of Health funded the work. Dr. Conic reported no relevant financial disclosures.
*This article was updated on May 30, 2018.
SOURCE: Conic R et al. IID 2018, Abstract 550.
ORLANDO – conducted by researchers at Case Western Reserve University, Cleveland.*
It’s generally accepted that psoriasis increases the risk of cardiovascular disease (CVD), but it’s not clear who’s most at risk. “We really wanted to find something that is cheap and easy to risk stratify these patients” said lead investigator Rosalynn Conic, MD, of Case Western’s department of dermatology.
What they found was “very impressive, for sure,” Dr. Conic said at the International Investigative Dermatology meeting.
The incidence of MI was highest among the 1,920 patients (5%) with elevated RDW and MPV (odds ratio, 3.4; 95% confidence interval, 2.7-4.2; P less than .001), followed by the 7,060 (18%) patients with high RDW and normal MPV (OR, 2.4; 95% CI, 2.1-2.8; P less than .001), as compared with normal/low MPV and RDW patients.
Elevated RDW or elevated RDW plus MPV increased the odds of atrial fibrillation, coronary artery disease, heart failure, and peripheral vascular disease anywhere from 2 to 8.3 times (P less than .001). Among psoriatic arthritis patients, elevated RDW almost doubled the risk of MI (OR, 1.8; P less than .001). Results were adjusted for age, gender, and hypertension.
In a subanalysis of treatment effects, 4 of 23 psoriasis patients at Case Western had elevated RDWs at baseline. Values normalized in the three patients who achieved a 75% reduction in the Psoriasis Area and Severity Index score after about a year of systemic treatment.
“We aim to validate [the study results] with a Veterans Administration data set,” Dr. Conic said. If it pans out, “one use would be to send [patients with elevated values] to a cardiologist earlier” so other CVD risk factors can be monitored and treated. The findings also add to the case for good control, she noted.
Systemic inflammation is the common denominator between the blood value elevations and CVD. The same inflammatory cytokines that cause skin problems in psoriasis also stimulate bone marrow to release immature red blood cells, which are larger than mature cells, leading to an increased RDW. Similarly, elevated MPV indicates a higher number of larger, younger platelets in the blood.
“It’s probably something along those lines, but I think we need to go back to basic science and really figure it out,” Dr. Conic said.
Patients were 18-65 years old. The study excluded patients with diabetes, Crohn’s disease, RA, and generalized atherosclerosis.
The National Institutes of Health funded the work. Dr. Conic reported no relevant financial disclosures.
*This article was updated on May 30, 2018.
SOURCE: Conic R et al. IID 2018, Abstract 550.
ORLANDO – conducted by researchers at Case Western Reserve University, Cleveland.*
It’s generally accepted that psoriasis increases the risk of cardiovascular disease (CVD), but it’s not clear who’s most at risk. “We really wanted to find something that is cheap and easy to risk stratify these patients” said lead investigator Rosalynn Conic, MD, of Case Western’s department of dermatology.
What they found was “very impressive, for sure,” Dr. Conic said at the International Investigative Dermatology meeting.
The incidence of MI was highest among the 1,920 patients (5%) with elevated RDW and MPV (odds ratio, 3.4; 95% confidence interval, 2.7-4.2; P less than .001), followed by the 7,060 (18%) patients with high RDW and normal MPV (OR, 2.4; 95% CI, 2.1-2.8; P less than .001), as compared with normal/low MPV and RDW patients.
Elevated RDW or elevated RDW plus MPV increased the odds of atrial fibrillation, coronary artery disease, heart failure, and peripheral vascular disease anywhere from 2 to 8.3 times (P less than .001). Among psoriatic arthritis patients, elevated RDW almost doubled the risk of MI (OR, 1.8; P less than .001). Results were adjusted for age, gender, and hypertension.
In a subanalysis of treatment effects, 4 of 23 psoriasis patients at Case Western had elevated RDWs at baseline. Values normalized in the three patients who achieved a 75% reduction in the Psoriasis Area and Severity Index score after about a year of systemic treatment.
“We aim to validate [the study results] with a Veterans Administration data set,” Dr. Conic said. If it pans out, “one use would be to send [patients with elevated values] to a cardiologist earlier” so other CVD risk factors can be monitored and treated. The findings also add to the case for good control, she noted.
Systemic inflammation is the common denominator between the blood value elevations and CVD. The same inflammatory cytokines that cause skin problems in psoriasis also stimulate bone marrow to release immature red blood cells, which are larger than mature cells, leading to an increased RDW. Similarly, elevated MPV indicates a higher number of larger, younger platelets in the blood.
“It’s probably something along those lines, but I think we need to go back to basic science and really figure it out,” Dr. Conic said.
Patients were 18-65 years old. The study excluded patients with diabetes, Crohn’s disease, RA, and generalized atherosclerosis.
The National Institutes of Health funded the work. Dr. Conic reported no relevant financial disclosures.
*This article was updated on May 30, 2018.
SOURCE: Conic R et al. IID 2018, Abstract 550.
REPORTING FROM IID 2018
Key clinical point: Elevated red blood cell distribution width and mean platelet volume might identify psoriasis patients at risk for cardiovascular disease.
Major finding: The incidence of MI was highest among the 1,920 patients with elevated red cell distribution width and mean platelet volume (odds ratio, 3.4; 95% confidence interval, 2.7-4.2; P less than .001).
Study details: A database review of 39,510 patients with psoriasis.
Disclosures: The National Institutes of Health funded the work. The lead investigator had no disclosures to report.
Source: Conic R et al. IID 2018, Abstract 550.