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Nivolumab shows promise in early-stage resectable NSCLC
(NSCLC), according to the results of a 21-patient pilot trial.
Eighty percent of patients were alive and recurrence-free a year after surgery, said Patrick M. Forde, MBBCh, and his colleagues from Johns Hopkins University, Baltimore. The only grade 3 or higher adverse event was treatment-related pneumonia, which did not prevent surgery. The findings were reported at the annual meeting of the American Association for Cancer Research and simultaneously in the New England Journal of Medicine.
For the study (NCT02259621), 21 patients with treatment-naive, stage I, II, or III NSCLC received two preoperative doses of nivolumab (3 mg/kg) 2 weeks apart, with surgery timed for 4 weeks after the first dose. In all, 62% of patients had adenocarcinoma, 81% had stage II or IIIa disease, and 86% were current or former smokers. Patients were followed for a median of 12 months after surgery (range, 0.8-19.7 months), and the researchers assessed safety, tumor response, programmed death ligand 1 mutational burden, and T-cell response.
Among 20 patients with evaluable resected primary tumors, nine (45%) showed a major pathologic response, defined as having 10% or fewer residual viable tumor cells. Twelve-month, recurrence-free survival was 83% (95% confidence interval, 66%-100%). The three progressors included one patient with 75% residual tumor at resection who subsequently developed a brain lesion, a patient with 5% residual tumor at resection who developed mediastinal lymph node recurrence, and a patient with 80% residual tumor at resection. The first two patients had durable responses to stereotactic radiotherapy or chemoradiotherapy, while the third patient developed fatal distal metastatic disease.
Sequencing of 11 completely resected tumors linked major pathologic response with higher tumor mutational burden (P = .01). Mutational burden did not correlate with tumor programmed death ligand 1 expression. Deep sequencing of T-cell receptor–beta chain CDR3 regions also correlated major pathologic response with increased clonality of tumor-infiltrating T-cell clones that also expanded into peripheral blood. “Many of these clones were not detected in peripheral blood before treatment,” the investigators wrote.
In all, five (23%) patients developed treatment-related adverse events, and many developed more than one side effect. Grade 1-2 anorexia, taste distortion, vomiting, and diarrhea were most common, with isolated cases of grade 1-2 fever, infusion reaction, abdominal pain, abnormal liver function, dry skin, and delirium. The case of grade 3 pneumonia developed after the first dose of nivolumab. The patient stopped treatment and underwent uncomplicated surgical resection.
Funders included Cancer Research Institute–Stand Up 2 Cancer; Johns Hopkins Bloomberg–Kimmel Institute for Cancer Immunotherapy; Bristol-Myers Squibb; International Immuno-Oncology Network, LUNGevity Foundation; International Association for the Study of Lung Cancer; Lung Cancer Foundation of America; and numerous other foundations and universities. Bristol-Myers Squibb makes nivolumab and supplied the study drug. Dr. Forde disclosed study grant support from Bristol-Myers Squibb. He reported ties to Bristol-Myers Squibb, AbbVie, and other pharmaceutical companies outside the submitted work.
SOURCE: Forde PM. AACR Annual Meeting 2018. Forde PM et al. N Engl J Med. 2018 Apr 16. doi: 10.1056/NEJMoa1716078.
(NSCLC), according to the results of a 21-patient pilot trial.
Eighty percent of patients were alive and recurrence-free a year after surgery, said Patrick M. Forde, MBBCh, and his colleagues from Johns Hopkins University, Baltimore. The only grade 3 or higher adverse event was treatment-related pneumonia, which did not prevent surgery. The findings were reported at the annual meeting of the American Association for Cancer Research and simultaneously in the New England Journal of Medicine.
For the study (NCT02259621), 21 patients with treatment-naive, stage I, II, or III NSCLC received two preoperative doses of nivolumab (3 mg/kg) 2 weeks apart, with surgery timed for 4 weeks after the first dose. In all, 62% of patients had adenocarcinoma, 81% had stage II or IIIa disease, and 86% were current or former smokers. Patients were followed for a median of 12 months after surgery (range, 0.8-19.7 months), and the researchers assessed safety, tumor response, programmed death ligand 1 mutational burden, and T-cell response.
Among 20 patients with evaluable resected primary tumors, nine (45%) showed a major pathologic response, defined as having 10% or fewer residual viable tumor cells. Twelve-month, recurrence-free survival was 83% (95% confidence interval, 66%-100%). The three progressors included one patient with 75% residual tumor at resection who subsequently developed a brain lesion, a patient with 5% residual tumor at resection who developed mediastinal lymph node recurrence, and a patient with 80% residual tumor at resection. The first two patients had durable responses to stereotactic radiotherapy or chemoradiotherapy, while the third patient developed fatal distal metastatic disease.
Sequencing of 11 completely resected tumors linked major pathologic response with higher tumor mutational burden (P = .01). Mutational burden did not correlate with tumor programmed death ligand 1 expression. Deep sequencing of T-cell receptor–beta chain CDR3 regions also correlated major pathologic response with increased clonality of tumor-infiltrating T-cell clones that also expanded into peripheral blood. “Many of these clones were not detected in peripheral blood before treatment,” the investigators wrote.
In all, five (23%) patients developed treatment-related adverse events, and many developed more than one side effect. Grade 1-2 anorexia, taste distortion, vomiting, and diarrhea were most common, with isolated cases of grade 1-2 fever, infusion reaction, abdominal pain, abnormal liver function, dry skin, and delirium. The case of grade 3 pneumonia developed after the first dose of nivolumab. The patient stopped treatment and underwent uncomplicated surgical resection.
Funders included Cancer Research Institute–Stand Up 2 Cancer; Johns Hopkins Bloomberg–Kimmel Institute for Cancer Immunotherapy; Bristol-Myers Squibb; International Immuno-Oncology Network, LUNGevity Foundation; International Association for the Study of Lung Cancer; Lung Cancer Foundation of America; and numerous other foundations and universities. Bristol-Myers Squibb makes nivolumab and supplied the study drug. Dr. Forde disclosed study grant support from Bristol-Myers Squibb. He reported ties to Bristol-Myers Squibb, AbbVie, and other pharmaceutical companies outside the submitted work.
SOURCE: Forde PM. AACR Annual Meeting 2018. Forde PM et al. N Engl J Med. 2018 Apr 16. doi: 10.1056/NEJMoa1716078.
(NSCLC), according to the results of a 21-patient pilot trial.
Eighty percent of patients were alive and recurrence-free a year after surgery, said Patrick M. Forde, MBBCh, and his colleagues from Johns Hopkins University, Baltimore. The only grade 3 or higher adverse event was treatment-related pneumonia, which did not prevent surgery. The findings were reported at the annual meeting of the American Association for Cancer Research and simultaneously in the New England Journal of Medicine.
For the study (NCT02259621), 21 patients with treatment-naive, stage I, II, or III NSCLC received two preoperative doses of nivolumab (3 mg/kg) 2 weeks apart, with surgery timed for 4 weeks after the first dose. In all, 62% of patients had adenocarcinoma, 81% had stage II or IIIa disease, and 86% were current or former smokers. Patients were followed for a median of 12 months after surgery (range, 0.8-19.7 months), and the researchers assessed safety, tumor response, programmed death ligand 1 mutational burden, and T-cell response.
Among 20 patients with evaluable resected primary tumors, nine (45%) showed a major pathologic response, defined as having 10% or fewer residual viable tumor cells. Twelve-month, recurrence-free survival was 83% (95% confidence interval, 66%-100%). The three progressors included one patient with 75% residual tumor at resection who subsequently developed a brain lesion, a patient with 5% residual tumor at resection who developed mediastinal lymph node recurrence, and a patient with 80% residual tumor at resection. The first two patients had durable responses to stereotactic radiotherapy or chemoradiotherapy, while the third patient developed fatal distal metastatic disease.
Sequencing of 11 completely resected tumors linked major pathologic response with higher tumor mutational burden (P = .01). Mutational burden did not correlate with tumor programmed death ligand 1 expression. Deep sequencing of T-cell receptor–beta chain CDR3 regions also correlated major pathologic response with increased clonality of tumor-infiltrating T-cell clones that also expanded into peripheral blood. “Many of these clones were not detected in peripheral blood before treatment,” the investigators wrote.
In all, five (23%) patients developed treatment-related adverse events, and many developed more than one side effect. Grade 1-2 anorexia, taste distortion, vomiting, and diarrhea were most common, with isolated cases of grade 1-2 fever, infusion reaction, abdominal pain, abnormal liver function, dry skin, and delirium. The case of grade 3 pneumonia developed after the first dose of nivolumab. The patient stopped treatment and underwent uncomplicated surgical resection.
Funders included Cancer Research Institute–Stand Up 2 Cancer; Johns Hopkins Bloomberg–Kimmel Institute for Cancer Immunotherapy; Bristol-Myers Squibb; International Immuno-Oncology Network, LUNGevity Foundation; International Association for the Study of Lung Cancer; Lung Cancer Foundation of America; and numerous other foundations and universities. Bristol-Myers Squibb makes nivolumab and supplied the study drug. Dr. Forde disclosed study grant support from Bristol-Myers Squibb. He reported ties to Bristol-Myers Squibb, AbbVie, and other pharmaceutical companies outside the submitted work.
SOURCE: Forde PM. AACR Annual Meeting 2018. Forde PM et al. N Engl J Med. 2018 Apr 16. doi: 10.1056/NEJMoa1716078.
REPORTING FROM AACR ANNUAL MEETING
Key clinical point: Neoadjuvant nivolumab was tolerable and induced robust responses in resectable non–small cell lung cancers.
Major finding: In all, 45% of evaluable tumors showed a major pathological response. Eighty percent of resected patients were alive and recurrence-free a median of 12 months after surgery. One patient (5%) developed a grade 3 treatment-related adverse event.
Study details: Pilot study of 21 adults with early-stage resectable non–small cell lung cancer (NCT02259621).
Disclosures: Funders included Cancer Research Institute–Stand Up 2 Cancer; Johns Hopkins Bloomberg–Kimmel Institute for Cancer Immunotherapy; Bristol-Myers Squibb; International Immuno-Oncology Network, LUNGevity Foundation; International Association for the Study of Lung Cancer; Lung Cancer Foundation of America; and numerous other foundations and universities. Bristol-Myers Squibb makes nivolumab and supplied the study drug. Dr. Forde disclosed study grant support from Bristol-Myers Squibb. He reported ties to Bristol-Myers Squibb, AbbVie, and other pharmaceutical companies outside the submitted work.
Source: Forde PM. AACR Annual Meeting 2018. Forde PM et al. N Engl J Med. 2018 Apr 16. doi: 10.1056/NEJMoa1716078.
Send Us Your Photos of Your Vascular Team
The theme of this year’s Vascular Annual Meeting is “Home of the Vascular Team – Partners in Patient Care.” To celebrate the work of all of the members of the vascular team, we want you to send in your team pictures. Round up the staff and take a picture with your cell phone or tablet. Then send it by May 15 to [email protected]. We’ll use these team photos for social media and, during the meeting itself, in various slide shows. VAM will be June 20 to 23 in Boston. Exhibits are June 21-22 and scientific sessions are June 21-23.
The theme of this year’s Vascular Annual Meeting is “Home of the Vascular Team – Partners in Patient Care.” To celebrate the work of all of the members of the vascular team, we want you to send in your team pictures. Round up the staff and take a picture with your cell phone or tablet. Then send it by May 15 to [email protected]. We’ll use these team photos for social media and, during the meeting itself, in various slide shows. VAM will be June 20 to 23 in Boston. Exhibits are June 21-22 and scientific sessions are June 21-23.
The theme of this year’s Vascular Annual Meeting is “Home of the Vascular Team – Partners in Patient Care.” To celebrate the work of all of the members of the vascular team, we want you to send in your team pictures. Round up the staff and take a picture with your cell phone or tablet. Then send it by May 15 to [email protected]. We’ll use these team photos for social media and, during the meeting itself, in various slide shows. VAM will be June 20 to 23 in Boston. Exhibits are June 21-22 and scientific sessions are June 21-23.
Learn to Negotiate Physician Compensation Agreements
SVS and the SVS Community Practice Committee will hold an informative webinar for SVS members on April 30 on “Negotiating Physician Employment Agreements.” The 75-minute webinar will begin at 8 p.m. Eastern, 7 p.m. Central, 6 p.m. Mountain and 5 p.m. Pacific times. Topics will include current trends, regulatory overview and key contractual provisions. Register here.
SVS and the SVS Community Practice Committee will hold an informative webinar for SVS members on April 30 on “Negotiating Physician Employment Agreements.” The 75-minute webinar will begin at 8 p.m. Eastern, 7 p.m. Central, 6 p.m. Mountain and 5 p.m. Pacific times. Topics will include current trends, regulatory overview and key contractual provisions. Register here.
SVS and the SVS Community Practice Committee will hold an informative webinar for SVS members on April 30 on “Negotiating Physician Employment Agreements.” The 75-minute webinar will begin at 8 p.m. Eastern, 7 p.m. Central, 6 p.m. Mountain and 5 p.m. Pacific times. Topics will include current trends, regulatory overview and key contractual provisions. Register here.
SVS 2018 Vascular Annual Meeting to Host Vascular Teams
When: June 20-23
Where: Hynes Convention Center, Boston
Scientific Sessions: June 21-23
Exhibit Hall: June 21-22
Register: vsweb.org/VAM18
#VAM18
What’s happening this year at the Society for Vascular Surgery’s Vascular Annual Meeting?
- Enhanced online program planner that syncs with meeting app and makes it simple to plan your schedule. Follow this link to start now
- New opportunities for audience participation and discussion
- Programming aimed at physicians and the vascular team in all practice settings
- Cooperative scheduling with the Society for Vascular Nursing and physician assistants
- Great minds, stimulating discussions and events that include the entire vascular team
The 2018 VAM, sponsored by the SVS, will be at the Hynes Convention Center in Boston, Mass., June 20-23. The scientific sessions and exhibit hall open June 21. Registration numbers are already exceeding last year’s benchmarks, organizers said.
Abstracts for all the scientific sessions will be available in the June Journal of Vascular Surgery supplement.
Some of the highlights:
Inclusive. – This year’s meeting has a theme: The Vascular Team: Partners in Patient Care. Every member of the vascular team – surgeons, nurses, nurse practitioners, PAs – will find a reason to attend.
The meeting provides programming across all practice settings with an even stronger focus on practical, take-home information for all.
View Dr. Darling’s “wicked awesome” Welcome to VAM18 video
The Society for Vascular Nursing’s annual meeting will be in the same location June 20-21. Registration for the SVN meeting includes access to VAM.
This year, the newly established membership section for vascular PAs will present PA-focused education. Within just the past few months, more than 130 PAs joined SVS and many are expected to be at VAM.
An Intuitive Planner - VAM18 meeting will see a new online program planner that allows attendees to filter by session type, areas of interest, faculty, and more. Attendees can favorite a session to build their own meeting schedule. The online planner will sync with the new meeting mobile app, so that attendees can carry their schedule with them. The mobile app will be available through the SVS store in June.
Interactive sessions - Meeting organizers have added more opportunities for small group and audience interaction during and after sessions.
Industry’s best – This year’s Exhibit Hall will run for two days with longer hours each day than in previous years. It will feature the crowd-pleasing Vascular Live sessions each day, as well as exhibits showing off innovative devices and offering a chance to chat one-on-one with company representatives. To add to the festivities, a scavenger hunt will foster interaction.
Familiar favorites will be back – workshops, postgraduate courses, international sessions, posters, collaborative events with other societies and many, many chances to network and catch up with old friends. The essential VAM on Demand post-meeting slides, audio and video will help members revisit VAM anytime.
Learn more about the 2018 VAM here: All about VAM18
When: June 20-23
Where: Hynes Convention Center, Boston
Scientific Sessions: June 21-23
Exhibit Hall: June 21-22
Register: vsweb.org/VAM18
#VAM18
What’s happening this year at the Society for Vascular Surgery’s Vascular Annual Meeting?
- Enhanced online program planner that syncs with meeting app and makes it simple to plan your schedule. Follow this link to start now
- New opportunities for audience participation and discussion
- Programming aimed at physicians and the vascular team in all practice settings
- Cooperative scheduling with the Society for Vascular Nursing and physician assistants
- Great minds, stimulating discussions and events that include the entire vascular team
The 2018 VAM, sponsored by the SVS, will be at the Hynes Convention Center in Boston, Mass., June 20-23. The scientific sessions and exhibit hall open June 21. Registration numbers are already exceeding last year’s benchmarks, organizers said.
Abstracts for all the scientific sessions will be available in the June Journal of Vascular Surgery supplement.
Some of the highlights:
Inclusive. – This year’s meeting has a theme: The Vascular Team: Partners in Patient Care. Every member of the vascular team – surgeons, nurses, nurse practitioners, PAs – will find a reason to attend.
The meeting provides programming across all practice settings with an even stronger focus on practical, take-home information for all.
View Dr. Darling’s “wicked awesome” Welcome to VAM18 video
The Society for Vascular Nursing’s annual meeting will be in the same location June 20-21. Registration for the SVN meeting includes access to VAM.
This year, the newly established membership section for vascular PAs will present PA-focused education. Within just the past few months, more than 130 PAs joined SVS and many are expected to be at VAM.
An Intuitive Planner - VAM18 meeting will see a new online program planner that allows attendees to filter by session type, areas of interest, faculty, and more. Attendees can favorite a session to build their own meeting schedule. The online planner will sync with the new meeting mobile app, so that attendees can carry their schedule with them. The mobile app will be available through the SVS store in June.
Interactive sessions - Meeting organizers have added more opportunities for small group and audience interaction during and after sessions.
Industry’s best – This year’s Exhibit Hall will run for two days with longer hours each day than in previous years. It will feature the crowd-pleasing Vascular Live sessions each day, as well as exhibits showing off innovative devices and offering a chance to chat one-on-one with company representatives. To add to the festivities, a scavenger hunt will foster interaction.
Familiar favorites will be back – workshops, postgraduate courses, international sessions, posters, collaborative events with other societies and many, many chances to network and catch up with old friends. The essential VAM on Demand post-meeting slides, audio and video will help members revisit VAM anytime.
Learn more about the 2018 VAM here: All about VAM18
When: June 20-23
Where: Hynes Convention Center, Boston
Scientific Sessions: June 21-23
Exhibit Hall: June 21-22
Register: vsweb.org/VAM18
#VAM18
What’s happening this year at the Society for Vascular Surgery’s Vascular Annual Meeting?
- Enhanced online program planner that syncs with meeting app and makes it simple to plan your schedule. Follow this link to start now
- New opportunities for audience participation and discussion
- Programming aimed at physicians and the vascular team in all practice settings
- Cooperative scheduling with the Society for Vascular Nursing and physician assistants
- Great minds, stimulating discussions and events that include the entire vascular team
The 2018 VAM, sponsored by the SVS, will be at the Hynes Convention Center in Boston, Mass., June 20-23. The scientific sessions and exhibit hall open June 21. Registration numbers are already exceeding last year’s benchmarks, organizers said.
Abstracts for all the scientific sessions will be available in the June Journal of Vascular Surgery supplement.
Some of the highlights:
Inclusive. – This year’s meeting has a theme: The Vascular Team: Partners in Patient Care. Every member of the vascular team – surgeons, nurses, nurse practitioners, PAs – will find a reason to attend.
The meeting provides programming across all practice settings with an even stronger focus on practical, take-home information for all.
View Dr. Darling’s “wicked awesome” Welcome to VAM18 video
The Society for Vascular Nursing’s annual meeting will be in the same location June 20-21. Registration for the SVN meeting includes access to VAM.
This year, the newly established membership section for vascular PAs will present PA-focused education. Within just the past few months, more than 130 PAs joined SVS and many are expected to be at VAM.
An Intuitive Planner - VAM18 meeting will see a new online program planner that allows attendees to filter by session type, areas of interest, faculty, and more. Attendees can favorite a session to build their own meeting schedule. The online planner will sync with the new meeting mobile app, so that attendees can carry their schedule with them. The mobile app will be available through the SVS store in June.
Interactive sessions - Meeting organizers have added more opportunities for small group and audience interaction during and after sessions.
Industry’s best – This year’s Exhibit Hall will run for two days with longer hours each day than in previous years. It will feature the crowd-pleasing Vascular Live sessions each day, as well as exhibits showing off innovative devices and offering a chance to chat one-on-one with company representatives. To add to the festivities, a scavenger hunt will foster interaction.
Familiar favorites will be back – workshops, postgraduate courses, international sessions, posters, collaborative events with other societies and many, many chances to network and catch up with old friends. The essential VAM on Demand post-meeting slides, audio and video will help members revisit VAM anytime.
Learn more about the 2018 VAM here: All about VAM18
MDedge Daily News: Shingles boosts stroke risk
Herpes zoster boosts short-term stroke and TIA risk. Americans don’t know about cancer drug shortages – but they want to. Complication rates rise after uterine fibroid morcellation’s boxed warning. And marijuana use may spur change in safety-sensitive industries.
Listen to the MDedge Daily News podcast for all the details on today’s top news.
Herpes zoster boosts short-term stroke and TIA risk. Americans don’t know about cancer drug shortages – but they want to. Complication rates rise after uterine fibroid morcellation’s boxed warning. And marijuana use may spur change in safety-sensitive industries.
Listen to the MDedge Daily News podcast for all the details on today’s top news.
Herpes zoster boosts short-term stroke and TIA risk. Americans don’t know about cancer drug shortages – but they want to. Complication rates rise after uterine fibroid morcellation’s boxed warning. And marijuana use may spur change in safety-sensitive industries.
Listen to the MDedge Daily News podcast for all the details on today’s top news.
Smoking increases heart failure risk in blacks
Cigarette smoking is an important risk factor for heart failure in blacks, according to results of an investigation of patients in the Jackson Heart Study.
Current smoking among blacks was associated with higher mean left ventricular (LV) mass and lower mean LV systolic function, even after adjustment for confounding factors, authors of the analysis reported in the journal Circulation.
While blacks are known to have a higher incidence of heart failure than do whites, Hispanics, and Asians, this is believed to be the first prospective study of a large black cohort demonstrating a dose-response relationship between smoking and incident heart failure.
“Smoking cessation may be a potential strategy to attenuate the higher rate of heart failure in blacks,” wrote Dr. Kamimura and coauthors.
The published analysis included data on 4,129 participants in the Jackson Heart Study, a large, prospective, community-based observational study investigating cardiovascular risk factors in blacks.
That group, which was 63% female, included 503 current smokers, 742 former smokers, and 2,884 individuals who had never smoked.
At baseline, no patients had a history of heart failure or coronary heart disease, and over a median follow-up of 8.0 years, there were 147 hospitalizations for heart failure in the cohort, the investigators reported.
Current smoking, compared with never smoking, was significantly associated with incident heart failure hospitalization after adjusting for risk factors and coronary heart disease (hazard ratio, 2.82; 95% confidence interval, 1.71-4.64).
Likewise, smoking intensity of at least 20 cigarettes a day (HR, 3.48; 95% CI, 1.65-7.32) and smoking burden of at least 15 pack-years (HR, 2.06; 95% CI, 1.29-3.33) both were significantly associated with incident heart failure hospitalization .
Compared with never smoking, current smoking was significantly associated with higher mean LV mass index and lower mean LV circumferential strain, even after adjusting for confounding variables (P less than 0.05 for both comparisons).
Smoking status also was associated with higher mean levels of brain natriuretic peptide, as were smoking intensity and burden (P less than 0.05 for all three comparisons), data show.
While cigarette smoking is a well-known risk factor for cardiovascular disease, Dr. Kamimura and coauthors said the influences on cardiac structure and function may not be fully appreciated because of the strong association with coronary heart disease, a major cause of heart failure.
“These relationships were significant after adjustment for coronary heart disease, suggesting mechanisms beyond atherosclerosis probably contribute to myocardial dysfunction and increased risk of heart failure in smokers,” they wrote in a discussion of the results.
Authors reported that they had no conflicts of interest related to the study. The Jackson Heart Study is supported by Jackson (Miss.) State University, Tougaloo College, and the University of Mississippi Medical Center, all in Jackson, contracts from the National Heart, Lung, and Blood Institute and the National Institute for Minority Health and Health Disparities. This study was supported by the NHLBI. One author has also received support from the National Institute of Diabetes and Digestive and Kidney Diseases and The National Institute of General Medical Sciences.
SOURCE: Kamimura D et al. Circulation. 2018. doi: 10.1161/CIRCULATIONAHA.117.031912.
Cigarette smoking is an important risk factor for heart failure in blacks, according to results of an investigation of patients in the Jackson Heart Study.
Current smoking among blacks was associated with higher mean left ventricular (LV) mass and lower mean LV systolic function, even after adjustment for confounding factors, authors of the analysis reported in the journal Circulation.
While blacks are known to have a higher incidence of heart failure than do whites, Hispanics, and Asians, this is believed to be the first prospective study of a large black cohort demonstrating a dose-response relationship between smoking and incident heart failure.
“Smoking cessation may be a potential strategy to attenuate the higher rate of heart failure in blacks,” wrote Dr. Kamimura and coauthors.
The published analysis included data on 4,129 participants in the Jackson Heart Study, a large, prospective, community-based observational study investigating cardiovascular risk factors in blacks.
That group, which was 63% female, included 503 current smokers, 742 former smokers, and 2,884 individuals who had never smoked.
At baseline, no patients had a history of heart failure or coronary heart disease, and over a median follow-up of 8.0 years, there were 147 hospitalizations for heart failure in the cohort, the investigators reported.
Current smoking, compared with never smoking, was significantly associated with incident heart failure hospitalization after adjusting for risk factors and coronary heart disease (hazard ratio, 2.82; 95% confidence interval, 1.71-4.64).
Likewise, smoking intensity of at least 20 cigarettes a day (HR, 3.48; 95% CI, 1.65-7.32) and smoking burden of at least 15 pack-years (HR, 2.06; 95% CI, 1.29-3.33) both were significantly associated with incident heart failure hospitalization .
Compared with never smoking, current smoking was significantly associated with higher mean LV mass index and lower mean LV circumferential strain, even after adjusting for confounding variables (P less than 0.05 for both comparisons).
Smoking status also was associated with higher mean levels of brain natriuretic peptide, as were smoking intensity and burden (P less than 0.05 for all three comparisons), data show.
While cigarette smoking is a well-known risk factor for cardiovascular disease, Dr. Kamimura and coauthors said the influences on cardiac structure and function may not be fully appreciated because of the strong association with coronary heart disease, a major cause of heart failure.
“These relationships were significant after adjustment for coronary heart disease, suggesting mechanisms beyond atherosclerosis probably contribute to myocardial dysfunction and increased risk of heart failure in smokers,” they wrote in a discussion of the results.
Authors reported that they had no conflicts of interest related to the study. The Jackson Heart Study is supported by Jackson (Miss.) State University, Tougaloo College, and the University of Mississippi Medical Center, all in Jackson, contracts from the National Heart, Lung, and Blood Institute and the National Institute for Minority Health and Health Disparities. This study was supported by the NHLBI. One author has also received support from the National Institute of Diabetes and Digestive and Kidney Diseases and The National Institute of General Medical Sciences.
SOURCE: Kamimura D et al. Circulation. 2018. doi: 10.1161/CIRCULATIONAHA.117.031912.
Cigarette smoking is an important risk factor for heart failure in blacks, according to results of an investigation of patients in the Jackson Heart Study.
Current smoking among blacks was associated with higher mean left ventricular (LV) mass and lower mean LV systolic function, even after adjustment for confounding factors, authors of the analysis reported in the journal Circulation.
While blacks are known to have a higher incidence of heart failure than do whites, Hispanics, and Asians, this is believed to be the first prospective study of a large black cohort demonstrating a dose-response relationship between smoking and incident heart failure.
“Smoking cessation may be a potential strategy to attenuate the higher rate of heart failure in blacks,” wrote Dr. Kamimura and coauthors.
The published analysis included data on 4,129 participants in the Jackson Heart Study, a large, prospective, community-based observational study investigating cardiovascular risk factors in blacks.
That group, which was 63% female, included 503 current smokers, 742 former smokers, and 2,884 individuals who had never smoked.
At baseline, no patients had a history of heart failure or coronary heart disease, and over a median follow-up of 8.0 years, there were 147 hospitalizations for heart failure in the cohort, the investigators reported.
Current smoking, compared with never smoking, was significantly associated with incident heart failure hospitalization after adjusting for risk factors and coronary heart disease (hazard ratio, 2.82; 95% confidence interval, 1.71-4.64).
Likewise, smoking intensity of at least 20 cigarettes a day (HR, 3.48; 95% CI, 1.65-7.32) and smoking burden of at least 15 pack-years (HR, 2.06; 95% CI, 1.29-3.33) both were significantly associated with incident heart failure hospitalization .
Compared with never smoking, current smoking was significantly associated with higher mean LV mass index and lower mean LV circumferential strain, even after adjusting for confounding variables (P less than 0.05 for both comparisons).
Smoking status also was associated with higher mean levels of brain natriuretic peptide, as were smoking intensity and burden (P less than 0.05 for all three comparisons), data show.
While cigarette smoking is a well-known risk factor for cardiovascular disease, Dr. Kamimura and coauthors said the influences on cardiac structure and function may not be fully appreciated because of the strong association with coronary heart disease, a major cause of heart failure.
“These relationships were significant after adjustment for coronary heart disease, suggesting mechanisms beyond atherosclerosis probably contribute to myocardial dysfunction and increased risk of heart failure in smokers,” they wrote in a discussion of the results.
Authors reported that they had no conflicts of interest related to the study. The Jackson Heart Study is supported by Jackson (Miss.) State University, Tougaloo College, and the University of Mississippi Medical Center, all in Jackson, contracts from the National Heart, Lung, and Blood Institute and the National Institute for Minority Health and Health Disparities. This study was supported by the NHLBI. One author has also received support from the National Institute of Diabetes and Digestive and Kidney Diseases and The National Institute of General Medical Sciences.
SOURCE: Kamimura D et al. Circulation. 2018. doi: 10.1161/CIRCULATIONAHA.117.031912.
FROM CIRCULATION
Key clinical point: Major finding: Current smoking, cigarettes per day, and smoking burden in pack-years were all independently associated with incident heart failure hospitalization (hazard ratio 2.82, 3.48, and 2.06, respectively) even after adjusting for risk factors and coronary heart disease.
Study details: Analysis of 4,129 participants in the Jackson Heart Study, a large, prospective, community-based observational study investigating cardiovascular risk factors in blacks.
Disclosures: Authors reported that they had no conflicts of interest related to the study. The Jackson Heart Study is supported by Jackson (Miss.) State University; Tougaloo College, and the University of Mississippi Medical Center, all in Jackson, contracts from the National Heart, Lung, and Blood Institute and the National Institute for Minority Health and Health Disparities. This study was supported by the NHLBI. One author has received support from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of General Medical Sciences.
Source: Kamimura D et al. Circulation. 2018. doi: 10.1161/CIRCULATIONAHA.117.031912.
A Cluster of Idiopathic Pulmonary Fibrosis Cases
In 2016, a Virginia dentist who had been recently diagnosed with idiopathic pulmonary fibrosis (IPF) was being treated at a specialty clinic. The CDC was contacted to report concerns that IPF had been diagnosed in multiple dentists, also from Virginia, who had also sought treatment at the same specialty clinic.
CDC researchers reviewed medical records of 894 patients treated for IPF at the tertiary care center between 1996-2017. They found 8 patients were dentists and 1 was a dental technician. Seven of the patients had died.
Idiopathic pulmonary fibrosis is a chronic, progressive, fibrosing interstitial pneumonia. This is the first known described cluster of IPF among dental personnel, the CDC says. Although no clear etiology could be found, it is possible that occupational exposure contributed to the development of IPF. Viral infections, cigarette smoking, and exposure to dust, wood dust, and metal dust have been implicated. One of the surviving patients reported polishing dental appliances and preparing amalgams and impressions without respiratory protection, which could have exposed him to silica, alginate, and other compounds with known or potential respiratory toxicity.
The CDC researchers note that dental personnel are exposed to infectious agents, chemicals, airborne particulates, ionizing radiation, and other potentially hazardous materials. They cite the case of a dentist who died of respiratory failure. Postmortem analysis identified pneumoconiosis; examination of lung tissue revealed particles consistent with alginate impression powders.
Idiopathic pulmonary fibrosis has not previously been described among dental personnel, the researchers say. But when they queried the National Occupational Respiratory Mortality System for “other interstitial pulmonary diseases with fibrosis” listed as the underlying or contributing cause of death, they found 35 decedents categorized as having worked in dentists’ offices or as dentists. During 2016, dentists accounted for an estimated 0.038% of US residents, yet represented 0.893% of patients being treated for IPF at a tertiary care center—nearly a 23-fold difference. Those findings suggest, the researchers say, that a higher rate of IPF might occur among dental personnel than among the general population.
In 2016, a Virginia dentist who had been recently diagnosed with idiopathic pulmonary fibrosis (IPF) was being treated at a specialty clinic. The CDC was contacted to report concerns that IPF had been diagnosed in multiple dentists, also from Virginia, who had also sought treatment at the same specialty clinic.
CDC researchers reviewed medical records of 894 patients treated for IPF at the tertiary care center between 1996-2017. They found 8 patients were dentists and 1 was a dental technician. Seven of the patients had died.
Idiopathic pulmonary fibrosis is a chronic, progressive, fibrosing interstitial pneumonia. This is the first known described cluster of IPF among dental personnel, the CDC says. Although no clear etiology could be found, it is possible that occupational exposure contributed to the development of IPF. Viral infections, cigarette smoking, and exposure to dust, wood dust, and metal dust have been implicated. One of the surviving patients reported polishing dental appliances and preparing amalgams and impressions without respiratory protection, which could have exposed him to silica, alginate, and other compounds with known or potential respiratory toxicity.
The CDC researchers note that dental personnel are exposed to infectious agents, chemicals, airborne particulates, ionizing radiation, and other potentially hazardous materials. They cite the case of a dentist who died of respiratory failure. Postmortem analysis identified pneumoconiosis; examination of lung tissue revealed particles consistent with alginate impression powders.
Idiopathic pulmonary fibrosis has not previously been described among dental personnel, the researchers say. But when they queried the National Occupational Respiratory Mortality System for “other interstitial pulmonary diseases with fibrosis” listed as the underlying or contributing cause of death, they found 35 decedents categorized as having worked in dentists’ offices or as dentists. During 2016, dentists accounted for an estimated 0.038% of US residents, yet represented 0.893% of patients being treated for IPF at a tertiary care center—nearly a 23-fold difference. Those findings suggest, the researchers say, that a higher rate of IPF might occur among dental personnel than among the general population.
In 2016, a Virginia dentist who had been recently diagnosed with idiopathic pulmonary fibrosis (IPF) was being treated at a specialty clinic. The CDC was contacted to report concerns that IPF had been diagnosed in multiple dentists, also from Virginia, who had also sought treatment at the same specialty clinic.
CDC researchers reviewed medical records of 894 patients treated for IPF at the tertiary care center between 1996-2017. They found 8 patients were dentists and 1 was a dental technician. Seven of the patients had died.
Idiopathic pulmonary fibrosis is a chronic, progressive, fibrosing interstitial pneumonia. This is the first known described cluster of IPF among dental personnel, the CDC says. Although no clear etiology could be found, it is possible that occupational exposure contributed to the development of IPF. Viral infections, cigarette smoking, and exposure to dust, wood dust, and metal dust have been implicated. One of the surviving patients reported polishing dental appliances and preparing amalgams and impressions without respiratory protection, which could have exposed him to silica, alginate, and other compounds with known or potential respiratory toxicity.
The CDC researchers note that dental personnel are exposed to infectious agents, chemicals, airborne particulates, ionizing radiation, and other potentially hazardous materials. They cite the case of a dentist who died of respiratory failure. Postmortem analysis identified pneumoconiosis; examination of lung tissue revealed particles consistent with alginate impression powders.
Idiopathic pulmonary fibrosis has not previously been described among dental personnel, the researchers say. But when they queried the National Occupational Respiratory Mortality System for “other interstitial pulmonary diseases with fibrosis” listed as the underlying or contributing cause of death, they found 35 decedents categorized as having worked in dentists’ offices or as dentists. During 2016, dentists accounted for an estimated 0.038% of US residents, yet represented 0.893% of patients being treated for IPF at a tertiary care center—nearly a 23-fold difference. Those findings suggest, the researchers say, that a higher rate of IPF might occur among dental personnel than among the general population.
Esketamine nasal spray brings fast relief of depressive symptoms
Esketamine nasal spray, combined with standard-of-care treatment, quickly improved depression symptoms and suicidal ideation, according to results of a phase 2 study published April 16 in the American Journal of Psychiatry.
In a study of 68 patients randomly assigned to either esketamine or placebo with standard-of-care treatment, patients in the treatment group had a significantly greater improvement in scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 4 hours’ and 24 hours’ follow-up after the first dose, reported Carla M. Canuso, MD, and her coauthors.
Esketamine, a more potent sibling of ketamine, is an N-methyl-D-aspartate receptor antagonist that modulates glutamatergic transmission. It is “being developed as an intranasal formulation for treatment-resistant depression and for rapid reduction of symptoms of major depressive disorder, including suicidal ideation, in patients at imminent risk for suicide,” Dr. Canuso and her coauthors reported.
In the study, participants were assigned randomly to twice-weekly treatment with either placebo or 84 mg of intranasal esketamine (or a reduced dose of 56 mg in the event of intolerance). The study included 4 weeks of double-blind treatment followed by 8 weeks of follow-up.
Depressive and suicidal symptoms were evaluated using MADRS criteria 4 hours and 24 hours after the initial dose, on day 25, and all visits during posttreatment follow-up. Severity of suicide risk was evaluated using the Suicide Ideation and Behavior Assessment Tool.
MADRS scores were significantly improved in the esketamine group, compared with the placebo group, both 4 hours and 24 hours after initial dosing, but not at 25 days, Dr. Canuso and her colleagues reported. The esketamine group also had significantly greater improvement on the MADRS suicidal thoughts item 4 hours after first dose (P = .002), but not 24 hours after the first dose (P = .129) or at day 25 (P = .143).
The analysis also showed that, 4 hours after the first dose, 21.2% of participants in the esketamine group achieved resolution of suicide risk, compared with 9.7% for placebo patients. At 24 hours’ follow-up, 40% of esketamine patients and 6.5% of placebo patients had achieved resolution of suicide risk.
Serious adverse events (including suicidal ideation and suicide attempts) occurred in four participants in the esketamine group during the double-blind study phase. During the follow-up period, serious adverse events occurred in one patient in the treatment group and five patients in the placebo group. Other adverse events included nausea, dizziness, dysgeusia, and dissociation.
The results “may reflect a promising breakthrough in the clinical management of a potentially lethal condition for which there are no approved pharmacotherapies,” Dr. Canuso and her colleagues wrote. However, future research still is needed to evaluate the risk of dependence, they cautioned.
“Further investigation is needed to determine the rapid effect of esketamine on measures of suicidal ideation as well as the benefit of repeated esketamine dosing on symptoms of depression in this acutely ill patient population,” the authors concluded.
The investigators reported that, in addition to Dr. Canuso, several of the other authors are employed by Janssen Research and Development – and hold stock and/or stock options in Johnson & Johnson. The study was funded by Janssen Research and Development.
SOURCE: Canuso CM et al. Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.17060720.
Before ketamine is offered as a treatment option for depression or suicidal ideation, the potential risks for dependence and abuse need to be carefully evaluated, wrote Robert Freedman, MD, professor and former chair of the department of psychiatry at the University of Colorado at Denver, Aurora, and his coauthors.
“In order to obtain FDA [Food and Drug Administration] approval for marketing, phase 3 trials need to include rigorous monitoring of patients’ craving after ketamine administration and urine monitoring before each subsequent administration to detect evidence of drug seeking from other sources,” he and his coauthors wrote.
Physicians have a responsibility to try to prevent epidemics such as the opioid crisis, and preemptive research into ketamine’s addictive properties may be one way to avoid another such crisis, he added.
“It would be wise for physicians, regulatory agencies, and the pharmaceutical industry to work together preemptively to establish a suitable framework for its therapeutic use,” he wrote. “Education of the public and physicians needs to balance both potential benefits and the risk of abuse.”
Dr. Freedman did not report any relevant disclosures.
Robert Freedman, MD, and his coauthors are members of the American Journal of Psychiatry’s editorial board. Their comments came in an editorial accompanying the study (Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.18030290).
Before ketamine is offered as a treatment option for depression or suicidal ideation, the potential risks for dependence and abuse need to be carefully evaluated, wrote Robert Freedman, MD, professor and former chair of the department of psychiatry at the University of Colorado at Denver, Aurora, and his coauthors.
“In order to obtain FDA [Food and Drug Administration] approval for marketing, phase 3 trials need to include rigorous monitoring of patients’ craving after ketamine administration and urine monitoring before each subsequent administration to detect evidence of drug seeking from other sources,” he and his coauthors wrote.
Physicians have a responsibility to try to prevent epidemics such as the opioid crisis, and preemptive research into ketamine’s addictive properties may be one way to avoid another such crisis, he added.
“It would be wise for physicians, regulatory agencies, and the pharmaceutical industry to work together preemptively to establish a suitable framework for its therapeutic use,” he wrote. “Education of the public and physicians needs to balance both potential benefits and the risk of abuse.”
Dr. Freedman did not report any relevant disclosures.
Robert Freedman, MD, and his coauthors are members of the American Journal of Psychiatry’s editorial board. Their comments came in an editorial accompanying the study (Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.18030290).
Before ketamine is offered as a treatment option for depression or suicidal ideation, the potential risks for dependence and abuse need to be carefully evaluated, wrote Robert Freedman, MD, professor and former chair of the department of psychiatry at the University of Colorado at Denver, Aurora, and his coauthors.
“In order to obtain FDA [Food and Drug Administration] approval for marketing, phase 3 trials need to include rigorous monitoring of patients’ craving after ketamine administration and urine monitoring before each subsequent administration to detect evidence of drug seeking from other sources,” he and his coauthors wrote.
Physicians have a responsibility to try to prevent epidemics such as the opioid crisis, and preemptive research into ketamine’s addictive properties may be one way to avoid another such crisis, he added.
“It would be wise for physicians, regulatory agencies, and the pharmaceutical industry to work together preemptively to establish a suitable framework for its therapeutic use,” he wrote. “Education of the public and physicians needs to balance both potential benefits and the risk of abuse.”
Dr. Freedman did not report any relevant disclosures.
Robert Freedman, MD, and his coauthors are members of the American Journal of Psychiatry’s editorial board. Their comments came in an editorial accompanying the study (Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.18030290).
Esketamine nasal spray, combined with standard-of-care treatment, quickly improved depression symptoms and suicidal ideation, according to results of a phase 2 study published April 16 in the American Journal of Psychiatry.
In a study of 68 patients randomly assigned to either esketamine or placebo with standard-of-care treatment, patients in the treatment group had a significantly greater improvement in scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 4 hours’ and 24 hours’ follow-up after the first dose, reported Carla M. Canuso, MD, and her coauthors.
Esketamine, a more potent sibling of ketamine, is an N-methyl-D-aspartate receptor antagonist that modulates glutamatergic transmission. It is “being developed as an intranasal formulation for treatment-resistant depression and for rapid reduction of symptoms of major depressive disorder, including suicidal ideation, in patients at imminent risk for suicide,” Dr. Canuso and her coauthors reported.
In the study, participants were assigned randomly to twice-weekly treatment with either placebo or 84 mg of intranasal esketamine (or a reduced dose of 56 mg in the event of intolerance). The study included 4 weeks of double-blind treatment followed by 8 weeks of follow-up.
Depressive and suicidal symptoms were evaluated using MADRS criteria 4 hours and 24 hours after the initial dose, on day 25, and all visits during posttreatment follow-up. Severity of suicide risk was evaluated using the Suicide Ideation and Behavior Assessment Tool.
MADRS scores were significantly improved in the esketamine group, compared with the placebo group, both 4 hours and 24 hours after initial dosing, but not at 25 days, Dr. Canuso and her colleagues reported. The esketamine group also had significantly greater improvement on the MADRS suicidal thoughts item 4 hours after first dose (P = .002), but not 24 hours after the first dose (P = .129) or at day 25 (P = .143).
The analysis also showed that, 4 hours after the first dose, 21.2% of participants in the esketamine group achieved resolution of suicide risk, compared with 9.7% for placebo patients. At 24 hours’ follow-up, 40% of esketamine patients and 6.5% of placebo patients had achieved resolution of suicide risk.
Serious adverse events (including suicidal ideation and suicide attempts) occurred in four participants in the esketamine group during the double-blind study phase. During the follow-up period, serious adverse events occurred in one patient in the treatment group and five patients in the placebo group. Other adverse events included nausea, dizziness, dysgeusia, and dissociation.
The results “may reflect a promising breakthrough in the clinical management of a potentially lethal condition for which there are no approved pharmacotherapies,” Dr. Canuso and her colleagues wrote. However, future research still is needed to evaluate the risk of dependence, they cautioned.
“Further investigation is needed to determine the rapid effect of esketamine on measures of suicidal ideation as well as the benefit of repeated esketamine dosing on symptoms of depression in this acutely ill patient population,” the authors concluded.
The investigators reported that, in addition to Dr. Canuso, several of the other authors are employed by Janssen Research and Development – and hold stock and/or stock options in Johnson & Johnson. The study was funded by Janssen Research and Development.
SOURCE: Canuso CM et al. Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.17060720.
Esketamine nasal spray, combined with standard-of-care treatment, quickly improved depression symptoms and suicidal ideation, according to results of a phase 2 study published April 16 in the American Journal of Psychiatry.
In a study of 68 patients randomly assigned to either esketamine or placebo with standard-of-care treatment, patients in the treatment group had a significantly greater improvement in scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 4 hours’ and 24 hours’ follow-up after the first dose, reported Carla M. Canuso, MD, and her coauthors.
Esketamine, a more potent sibling of ketamine, is an N-methyl-D-aspartate receptor antagonist that modulates glutamatergic transmission. It is “being developed as an intranasal formulation for treatment-resistant depression and for rapid reduction of symptoms of major depressive disorder, including suicidal ideation, in patients at imminent risk for suicide,” Dr. Canuso and her coauthors reported.
In the study, participants were assigned randomly to twice-weekly treatment with either placebo or 84 mg of intranasal esketamine (or a reduced dose of 56 mg in the event of intolerance). The study included 4 weeks of double-blind treatment followed by 8 weeks of follow-up.
Depressive and suicidal symptoms were evaluated using MADRS criteria 4 hours and 24 hours after the initial dose, on day 25, and all visits during posttreatment follow-up. Severity of suicide risk was evaluated using the Suicide Ideation and Behavior Assessment Tool.
MADRS scores were significantly improved in the esketamine group, compared with the placebo group, both 4 hours and 24 hours after initial dosing, but not at 25 days, Dr. Canuso and her colleagues reported. The esketamine group also had significantly greater improvement on the MADRS suicidal thoughts item 4 hours after first dose (P = .002), but not 24 hours after the first dose (P = .129) or at day 25 (P = .143).
The analysis also showed that, 4 hours after the first dose, 21.2% of participants in the esketamine group achieved resolution of suicide risk, compared with 9.7% for placebo patients. At 24 hours’ follow-up, 40% of esketamine patients and 6.5% of placebo patients had achieved resolution of suicide risk.
Serious adverse events (including suicidal ideation and suicide attempts) occurred in four participants in the esketamine group during the double-blind study phase. During the follow-up period, serious adverse events occurred in one patient in the treatment group and five patients in the placebo group. Other adverse events included nausea, dizziness, dysgeusia, and dissociation.
The results “may reflect a promising breakthrough in the clinical management of a potentially lethal condition for which there are no approved pharmacotherapies,” Dr. Canuso and her colleagues wrote. However, future research still is needed to evaluate the risk of dependence, they cautioned.
“Further investigation is needed to determine the rapid effect of esketamine on measures of suicidal ideation as well as the benefit of repeated esketamine dosing on symptoms of depression in this acutely ill patient population,” the authors concluded.
The investigators reported that, in addition to Dr. Canuso, several of the other authors are employed by Janssen Research and Development – and hold stock and/or stock options in Johnson & Johnson. The study was funded by Janssen Research and Development.
SOURCE: Canuso CM et al. Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.17060720.
FROM THE AMERICAN JOURNAL OF PSYCHIATRY
Key clinical point: Esketamine nasal spray, combined with standard-of-care treatment, quickly improved depression symptoms and suicidal ideation.
Major finding: Patients in the esketamine treatment group had a significantly greater improvement in scores on MADRS at 4 hours and 24 hours follow-up.
Study details: A double-blind, proof-of-concept, phase 2 study of 68 patients with major depressive disorder.
Disclosures: The study was funded by Janssen Research and Development.
Source: Canuso CM et al. Am J Psychiatry. 2018. doi: 10.1176/appi.ajp.2018.17060720.
Short Takes
Giving iron supplements every other day may be superior to daily divided doses
Serum hepcidin levels and iron absorption were compared in women given daily dosing of ferrous sulfate, women given alternate-day dosing, and women given two divided doses daily. Women on the alternate-day regimen and the single-day regimens had higher iron absorption and lower hepcidin levels than did the women on the split-dosing regimen; these findings need to be confirmed in patients with iron-deficiency anemia.
Immediate percutaneous coronary intervention (PCI) of the culprit lesion only in patients presenting with acute myocardial infarction and cardiogenic shock may lead to better outcomes, even in those with multivessel disease
A total of 706 patients with multivessel coronary artery disease who presented with acute MI and cardiogenic shock were randomized to either PCI of the culprit lesion only (followed by optional staged revascularization of nonculprit lesions) or to immediate multivessel PCI. Patients who received PCI of the culprit lesion only had a lower 30-day risk of death or severe renal failure leading to renal-replacement therapy than did those who underwent immediate multivessel PCI.
Citation: Thiele H et al. PCI strategies in patients with acute myocardial infarction and cardiogenic shock. N Engl J Med. 2017 Oct. doi: 10.1056/NEJMoa1710261 (epub ahead of print).
Giving iron supplements every other day may be superior to daily divided doses
Serum hepcidin levels and iron absorption were compared in women given daily dosing of ferrous sulfate, women given alternate-day dosing, and women given two divided doses daily. Women on the alternate-day regimen and the single-day regimens had higher iron absorption and lower hepcidin levels than did the women on the split-dosing regimen; these findings need to be confirmed in patients with iron-deficiency anemia.
Immediate percutaneous coronary intervention (PCI) of the culprit lesion only in patients presenting with acute myocardial infarction and cardiogenic shock may lead to better outcomes, even in those with multivessel disease
A total of 706 patients with multivessel coronary artery disease who presented with acute MI and cardiogenic shock were randomized to either PCI of the culprit lesion only (followed by optional staged revascularization of nonculprit lesions) or to immediate multivessel PCI. Patients who received PCI of the culprit lesion only had a lower 30-day risk of death or severe renal failure leading to renal-replacement therapy than did those who underwent immediate multivessel PCI.
Citation: Thiele H et al. PCI strategies in patients with acute myocardial infarction and cardiogenic shock. N Engl J Med. 2017 Oct. doi: 10.1056/NEJMoa1710261 (epub ahead of print).
Giving iron supplements every other day may be superior to daily divided doses
Serum hepcidin levels and iron absorption were compared in women given daily dosing of ferrous sulfate, women given alternate-day dosing, and women given two divided doses daily. Women on the alternate-day regimen and the single-day regimens had higher iron absorption and lower hepcidin levels than did the women on the split-dosing regimen; these findings need to be confirmed in patients with iron-deficiency anemia.
Immediate percutaneous coronary intervention (PCI) of the culprit lesion only in patients presenting with acute myocardial infarction and cardiogenic shock may lead to better outcomes, even in those with multivessel disease
A total of 706 patients with multivessel coronary artery disease who presented with acute MI and cardiogenic shock were randomized to either PCI of the culprit lesion only (followed by optional staged revascularization of nonculprit lesions) or to immediate multivessel PCI. Patients who received PCI of the culprit lesion only had a lower 30-day risk of death or severe renal failure leading to renal-replacement therapy than did those who underwent immediate multivessel PCI.
Citation: Thiele H et al. PCI strategies in patients with acute myocardial infarction and cardiogenic shock. N Engl J Med. 2017 Oct. doi: 10.1056/NEJMoa1710261 (epub ahead of print).
Robotic approach falls short for sleeve gastrectomy
SEATTLE – according to a review of 86,953 cases in the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database.
“Robotic sleeve gastrectomy increases [use of] hospital resources. ... These findings may explain the low utilization rate of the robotic approach to sleeve gastrectomy,” said lead investigator Reza Alizadeh, MD, a surgery resident at the University of California, Irvine.
Sleeve gastrectomy has eclipsed gastric bypass as the most common weight loss surgery in United States. While most are done laparoscopically, the use of robots is becoming more common, so the investigators wanted to compare outcomes in a large number of cases. They turned to the metabolic and bariatric surgery database, which is jointly maintained by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. Emergent, converted, and revision cases were excluded from the analysis to avoid confounding.
Almost 94% of the cases were done laparoscopically, with the rest done robotically. Mean operative time was 101 min in the robotic arm, and 1.5% of patients developed anastomotic leaks. Mean operative time in the laparoscopic group was 74 minutes, and 0.5% of patients developed leaks. After adjustment for potential confounders, leaks were 3.4 times more likely with the robotic approach (95% confidence interval, 2.47-4.0; P less than .01). It wasn’t possible to determine whether there were any differences in the type of stapling done in the two groups.
Meanwhile, 0.8% of robotic surgery patients developed surgical site infections versus 0.6% of the laparoscopic cases. After adjustment, infections were 38% more likely with the robot (95% CI, 1.01-1.89; P = 0.03). Dr. Alizadeh noted that the database only goes out to 30 days, so “the true complication rates may be underestimated.”
The findings are consistent with previous investigations. It’s unclear whether there’s something inherently riskier about robotic sleeve gastrectomy itself or whether surgeons haven’t quite got the knack of it yet. The higher leak rate with robotic surgery, “I believe, is mostly related to the small number of [robotic] cases being done. We are still in the beginning stages of utilizing the robotic approach. Maybe there’s a learning curve, and we need more experience and more practice,” Dr. Alizadeh said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
Indeed, others have reported that it takes more than two dozen cases to become proficient in another procedure, robotic esophagectomy.
The mean length of stay in the study was slightly, but not statistically significantly, longer in the robotic arm (1.8 vs. 1.7 days; P = 0.17). There was no statistically significant difference in in-hospital mortality.
The laparoscopic group had more men than did the robotic group (21.4% vs. 19.7%, respectively) and more chronic steroid use (1.7% vs. 1.3%), plus more patients were dependent on oxygen (0.7% vs. 0.3%). The robotic group had more obstructive sleep apnea than did the laparoscopic group (37.3% vs. 36% of cases) and a higher incidence of hypoalbuminemia (8.4% vs. 7%). The analysis adjusted for the differences.
The findings were pretty much the same when the team repeated their analysis with the 2016 database numbers, which were released while the SAGES presentation was being prepared. The only big difference was an increase in the number of robotic cases, up from 6.1% in 2015 to 6.6% of cases in 2016.
The was no external funding for the work, and the investigators had no relevant disclosures.
SOURCE: Alizadeh RF et al. SAGES 2018, Abstract S024.
SEATTLE – according to a review of 86,953 cases in the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database.
“Robotic sleeve gastrectomy increases [use of] hospital resources. ... These findings may explain the low utilization rate of the robotic approach to sleeve gastrectomy,” said lead investigator Reza Alizadeh, MD, a surgery resident at the University of California, Irvine.
Sleeve gastrectomy has eclipsed gastric bypass as the most common weight loss surgery in United States. While most are done laparoscopically, the use of robots is becoming more common, so the investigators wanted to compare outcomes in a large number of cases. They turned to the metabolic and bariatric surgery database, which is jointly maintained by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. Emergent, converted, and revision cases were excluded from the analysis to avoid confounding.
Almost 94% of the cases were done laparoscopically, with the rest done robotically. Mean operative time was 101 min in the robotic arm, and 1.5% of patients developed anastomotic leaks. Mean operative time in the laparoscopic group was 74 minutes, and 0.5% of patients developed leaks. After adjustment for potential confounders, leaks were 3.4 times more likely with the robotic approach (95% confidence interval, 2.47-4.0; P less than .01). It wasn’t possible to determine whether there were any differences in the type of stapling done in the two groups.
Meanwhile, 0.8% of robotic surgery patients developed surgical site infections versus 0.6% of the laparoscopic cases. After adjustment, infections were 38% more likely with the robot (95% CI, 1.01-1.89; P = 0.03). Dr. Alizadeh noted that the database only goes out to 30 days, so “the true complication rates may be underestimated.”
The findings are consistent with previous investigations. It’s unclear whether there’s something inherently riskier about robotic sleeve gastrectomy itself or whether surgeons haven’t quite got the knack of it yet. The higher leak rate with robotic surgery, “I believe, is mostly related to the small number of [robotic] cases being done. We are still in the beginning stages of utilizing the robotic approach. Maybe there’s a learning curve, and we need more experience and more practice,” Dr. Alizadeh said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
Indeed, others have reported that it takes more than two dozen cases to become proficient in another procedure, robotic esophagectomy.
The mean length of stay in the study was slightly, but not statistically significantly, longer in the robotic arm (1.8 vs. 1.7 days; P = 0.17). There was no statistically significant difference in in-hospital mortality.
The laparoscopic group had more men than did the robotic group (21.4% vs. 19.7%, respectively) and more chronic steroid use (1.7% vs. 1.3%), plus more patients were dependent on oxygen (0.7% vs. 0.3%). The robotic group had more obstructive sleep apnea than did the laparoscopic group (37.3% vs. 36% of cases) and a higher incidence of hypoalbuminemia (8.4% vs. 7%). The analysis adjusted for the differences.
The findings were pretty much the same when the team repeated their analysis with the 2016 database numbers, which were released while the SAGES presentation was being prepared. The only big difference was an increase in the number of robotic cases, up from 6.1% in 2015 to 6.6% of cases in 2016.
The was no external funding for the work, and the investigators had no relevant disclosures.
SOURCE: Alizadeh RF et al. SAGES 2018, Abstract S024.
SEATTLE – according to a review of 86,953 cases in the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database.
“Robotic sleeve gastrectomy increases [use of] hospital resources. ... These findings may explain the low utilization rate of the robotic approach to sleeve gastrectomy,” said lead investigator Reza Alizadeh, MD, a surgery resident at the University of California, Irvine.
Sleeve gastrectomy has eclipsed gastric bypass as the most common weight loss surgery in United States. While most are done laparoscopically, the use of robots is becoming more common, so the investigators wanted to compare outcomes in a large number of cases. They turned to the metabolic and bariatric surgery database, which is jointly maintained by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery. Emergent, converted, and revision cases were excluded from the analysis to avoid confounding.
Almost 94% of the cases were done laparoscopically, with the rest done robotically. Mean operative time was 101 min in the robotic arm, and 1.5% of patients developed anastomotic leaks. Mean operative time in the laparoscopic group was 74 minutes, and 0.5% of patients developed leaks. After adjustment for potential confounders, leaks were 3.4 times more likely with the robotic approach (95% confidence interval, 2.47-4.0; P less than .01). It wasn’t possible to determine whether there were any differences in the type of stapling done in the two groups.
Meanwhile, 0.8% of robotic surgery patients developed surgical site infections versus 0.6% of the laparoscopic cases. After adjustment, infections were 38% more likely with the robot (95% CI, 1.01-1.89; P = 0.03). Dr. Alizadeh noted that the database only goes out to 30 days, so “the true complication rates may be underestimated.”
The findings are consistent with previous investigations. It’s unclear whether there’s something inherently riskier about robotic sleeve gastrectomy itself or whether surgeons haven’t quite got the knack of it yet. The higher leak rate with robotic surgery, “I believe, is mostly related to the small number of [robotic] cases being done. We are still in the beginning stages of utilizing the robotic approach. Maybe there’s a learning curve, and we need more experience and more practice,” Dr. Alizadeh said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.
Indeed, others have reported that it takes more than two dozen cases to become proficient in another procedure, robotic esophagectomy.
The mean length of stay in the study was slightly, but not statistically significantly, longer in the robotic arm (1.8 vs. 1.7 days; P = 0.17). There was no statistically significant difference in in-hospital mortality.
The laparoscopic group had more men than did the robotic group (21.4% vs. 19.7%, respectively) and more chronic steroid use (1.7% vs. 1.3%), plus more patients were dependent on oxygen (0.7% vs. 0.3%). The robotic group had more obstructive sleep apnea than did the laparoscopic group (37.3% vs. 36% of cases) and a higher incidence of hypoalbuminemia (8.4% vs. 7%). The analysis adjusted for the differences.
The findings were pretty much the same when the team repeated their analysis with the 2016 database numbers, which were released while the SAGES presentation was being prepared. The only big difference was an increase in the number of robotic cases, up from 6.1% in 2015 to 6.6% of cases in 2016.
The was no external funding for the work, and the investigators had no relevant disclosures.
SOURCE: Alizadeh RF et al. SAGES 2018, Abstract S024.
REPORTING FROM SAGES 2018
Key clinical point: Operative times are longer, and leaks and surgical site infections more common, when surgeons opt for robotic instead of laparoscopic sleeve gastrectomy.
Major finding: Anastomotic leaks were 3.4 times more likely with the robotic approach (95% CI 2.47-4.0; P less than .01).
Study details: Review of 86,953 cases in the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database
Disclosures: The was no external funding for the project, and the investigators had no relevant disclosures.
Source: Alizadeh RF et al. SAGES 2018, Abstract S024