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Company discontinues phase 3 ADAPT for mRCC
A second interim analysis of
In ADAPT, 462 patients with previously untreated advanced or metastatic renal cell carcinoma (mRCC) were randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib versus sunitinib monotherapy, after undergoing cytoreductive nephrectomy.
In February 2017, the trial’s Independent Data Monitoring Committee had reviewed the data and concluded that the trial was unlikely to demonstrate a statistically significant improvement in median overall survival in the combination arm and recommended halting the trial. However, the principal investigators and the company, Argos Therapeutics, considered the data too immature to observe the delayed effects associated with immunotherapy and decided to continue the trial. They submitted a protocol amendment to the Food and Drug Administration adding additional co-primary endpoints, and in April of last year, met with the Food and Drug Administration, which accepted the amendment and agreed to continuation of the trial, according to a company press release issued in November.
In the latest interim analysis, which was conducted following an additional 51 deaths, median overall survival for the intent-to-treat patient population was 28.2 months for the combination arm (95% confidence interval, 23.4, 35.2) compared with 31.2 months (95% CI, 23.0, 44.5) for the control arm; this was one of four new co-primary endpoints. The hazard ratio was 1.10 (95% CI, 0.85, 1.42).
Other co-primary endpoints that were evaluated, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, did not demonstrate a favorable result, Argos Therapeutics said in a recent press release.
Rocapuldencel-T “consists of autologous dendritic cells programmed with amplified RNA from a patient’s primary tumor” and is “designed to overcome immunosuppression and induce broadly reactive, long-lasting anti-tumor memory T cells” according to the early interim analysis presented at the European Society for Medical Oncology (ESMO) 2017. The drug is also being evaluated in non–small cell lung cancer and bladder cancer.
A second interim analysis of
In ADAPT, 462 patients with previously untreated advanced or metastatic renal cell carcinoma (mRCC) were randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib versus sunitinib monotherapy, after undergoing cytoreductive nephrectomy.
In February 2017, the trial’s Independent Data Monitoring Committee had reviewed the data and concluded that the trial was unlikely to demonstrate a statistically significant improvement in median overall survival in the combination arm and recommended halting the trial. However, the principal investigators and the company, Argos Therapeutics, considered the data too immature to observe the delayed effects associated with immunotherapy and decided to continue the trial. They submitted a protocol amendment to the Food and Drug Administration adding additional co-primary endpoints, and in April of last year, met with the Food and Drug Administration, which accepted the amendment and agreed to continuation of the trial, according to a company press release issued in November.
In the latest interim analysis, which was conducted following an additional 51 deaths, median overall survival for the intent-to-treat patient population was 28.2 months for the combination arm (95% confidence interval, 23.4, 35.2) compared with 31.2 months (95% CI, 23.0, 44.5) for the control arm; this was one of four new co-primary endpoints. The hazard ratio was 1.10 (95% CI, 0.85, 1.42).
Other co-primary endpoints that were evaluated, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, did not demonstrate a favorable result, Argos Therapeutics said in a recent press release.
Rocapuldencel-T “consists of autologous dendritic cells programmed with amplified RNA from a patient’s primary tumor” and is “designed to overcome immunosuppression and induce broadly reactive, long-lasting anti-tumor memory T cells” according to the early interim analysis presented at the European Society for Medical Oncology (ESMO) 2017. The drug is also being evaluated in non–small cell lung cancer and bladder cancer.
A second interim analysis of
In ADAPT, 462 patients with previously untreated advanced or metastatic renal cell carcinoma (mRCC) were randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib versus sunitinib monotherapy, after undergoing cytoreductive nephrectomy.
In February 2017, the trial’s Independent Data Monitoring Committee had reviewed the data and concluded that the trial was unlikely to demonstrate a statistically significant improvement in median overall survival in the combination arm and recommended halting the trial. However, the principal investigators and the company, Argos Therapeutics, considered the data too immature to observe the delayed effects associated with immunotherapy and decided to continue the trial. They submitted a protocol amendment to the Food and Drug Administration adding additional co-primary endpoints, and in April of last year, met with the Food and Drug Administration, which accepted the amendment and agreed to continuation of the trial, according to a company press release issued in November.
In the latest interim analysis, which was conducted following an additional 51 deaths, median overall survival for the intent-to-treat patient population was 28.2 months for the combination arm (95% confidence interval, 23.4, 35.2) compared with 31.2 months (95% CI, 23.0, 44.5) for the control arm; this was one of four new co-primary endpoints. The hazard ratio was 1.10 (95% CI, 0.85, 1.42).
Other co-primary endpoints that were evaluated, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, did not demonstrate a favorable result, Argos Therapeutics said in a recent press release.
Rocapuldencel-T “consists of autologous dendritic cells programmed with amplified RNA from a patient’s primary tumor” and is “designed to overcome immunosuppression and induce broadly reactive, long-lasting anti-tumor memory T cells” according to the early interim analysis presented at the European Society for Medical Oncology (ESMO) 2017. The drug is also being evaluated in non–small cell lung cancer and bladder cancer.
Patient perspective improves dry eye syndrome research
WASHINGTON –
With dry eye found in over 85% of Sjogren’s patients, pinpointing important outcomes accurately can help researchers and physicians focus their efforts and be more cost effective when developing clinical trials, systematic reviews , practice guidelines, and evidence-based health care, according to presenter Ian J. Saldanha, MBBS, MPH, PhD, of the department of epidemiology at Johns Hopkins, Baltimore.
“When designing clinical trials, if you are trying to incorporate the views of patients, this can help more accurately depict what you should be measuring and in what time frame,“ Dr. Saldanha said to attendees. This can be important as agencies such as the Food and Drug Administration have absolved to be more committed to bringing the patient perspective to drug development, according to Dr. Saldanha.
Investigators surveyed 420 subscribers to KeratoScoop, a news source that specifically reports on dry eye, using a two-round survey process with participants ranking outcomes from 0 to 10, 0 being the least important and 10 being the most.
The majority of the patients were white American women, aged 50 years and older.
To start, Dr. Saldanha and his fellow investigators identified 109 outcomes commonly found in existing research. Of these, 28 were identified as important to survey takers.
The investigators noted that 39% of the outcomes identified were symptoms, compared with 25% for clinical testing, 14% related to quality of life, and the remainder split evenly between lab measures, safety, and others.
When ranked, the top 10 outcomes chosen were ocular burning, ocular discomfort, ocular pain, ocular dryness, visual acuity, overall assessment of surface symptoms, ocular foreign body sensation, tear film stability, artificial tear use, and adverse events.
Of the 28 outcomes deemed “important” by the surveyed population, 10 were found to be uncommon in current research.
When asked when patients would like these outcomes to be measured if they were to participate in a clinical trial, over 75% preferred a 3-month period for ocular burning, discomfort, pain, and foreign body sensations, as well as impact of dry eye in daily life, tear film stability, and costs of treatment. In comparison, a majority of patients agreed that outcomes such as satisfaction of treatment, ocular fatigue, and vision-related quality of life should be measured between 3 and 6 months.
With these data, according to Dr. Saldanha, researchers can maximize consistency across trials as well as contribute to better evidence-based medicine.
“This is useful for the next step, which would be to develop core outcome sets, which are an agreed upon minimum set of outcomes that should be examined in a given disease area,” Dr. Saldanha explained.
Dr. Saldanha reported no relevant financial disclosures. The meeting was sponsored by Johns Hopkins University and the National Institutes of Health.
SOURCE: Saldanha I et al. International Symposium on Sjogren’s Syndrome.
WASHINGTON –
With dry eye found in over 85% of Sjogren’s patients, pinpointing important outcomes accurately can help researchers and physicians focus their efforts and be more cost effective when developing clinical trials, systematic reviews , practice guidelines, and evidence-based health care, according to presenter Ian J. Saldanha, MBBS, MPH, PhD, of the department of epidemiology at Johns Hopkins, Baltimore.
“When designing clinical trials, if you are trying to incorporate the views of patients, this can help more accurately depict what you should be measuring and in what time frame,“ Dr. Saldanha said to attendees. This can be important as agencies such as the Food and Drug Administration have absolved to be more committed to bringing the patient perspective to drug development, according to Dr. Saldanha.
Investigators surveyed 420 subscribers to KeratoScoop, a news source that specifically reports on dry eye, using a two-round survey process with participants ranking outcomes from 0 to 10, 0 being the least important and 10 being the most.
The majority of the patients were white American women, aged 50 years and older.
To start, Dr. Saldanha and his fellow investigators identified 109 outcomes commonly found in existing research. Of these, 28 were identified as important to survey takers.
The investigators noted that 39% of the outcomes identified were symptoms, compared with 25% for clinical testing, 14% related to quality of life, and the remainder split evenly between lab measures, safety, and others.
When ranked, the top 10 outcomes chosen were ocular burning, ocular discomfort, ocular pain, ocular dryness, visual acuity, overall assessment of surface symptoms, ocular foreign body sensation, tear film stability, artificial tear use, and adverse events.
Of the 28 outcomes deemed “important” by the surveyed population, 10 were found to be uncommon in current research.
When asked when patients would like these outcomes to be measured if they were to participate in a clinical trial, over 75% preferred a 3-month period for ocular burning, discomfort, pain, and foreign body sensations, as well as impact of dry eye in daily life, tear film stability, and costs of treatment. In comparison, a majority of patients agreed that outcomes such as satisfaction of treatment, ocular fatigue, and vision-related quality of life should be measured between 3 and 6 months.
With these data, according to Dr. Saldanha, researchers can maximize consistency across trials as well as contribute to better evidence-based medicine.
“This is useful for the next step, which would be to develop core outcome sets, which are an agreed upon minimum set of outcomes that should be examined in a given disease area,” Dr. Saldanha explained.
Dr. Saldanha reported no relevant financial disclosures. The meeting was sponsored by Johns Hopkins University and the National Institutes of Health.
SOURCE: Saldanha I et al. International Symposium on Sjogren’s Syndrome.
WASHINGTON –
With dry eye found in over 85% of Sjogren’s patients, pinpointing important outcomes accurately can help researchers and physicians focus their efforts and be more cost effective when developing clinical trials, systematic reviews , practice guidelines, and evidence-based health care, according to presenter Ian J. Saldanha, MBBS, MPH, PhD, of the department of epidemiology at Johns Hopkins, Baltimore.
“When designing clinical trials, if you are trying to incorporate the views of patients, this can help more accurately depict what you should be measuring and in what time frame,“ Dr. Saldanha said to attendees. This can be important as agencies such as the Food and Drug Administration have absolved to be more committed to bringing the patient perspective to drug development, according to Dr. Saldanha.
Investigators surveyed 420 subscribers to KeratoScoop, a news source that specifically reports on dry eye, using a two-round survey process with participants ranking outcomes from 0 to 10, 0 being the least important and 10 being the most.
The majority of the patients were white American women, aged 50 years and older.
To start, Dr. Saldanha and his fellow investigators identified 109 outcomes commonly found in existing research. Of these, 28 were identified as important to survey takers.
The investigators noted that 39% of the outcomes identified were symptoms, compared with 25% for clinical testing, 14% related to quality of life, and the remainder split evenly between lab measures, safety, and others.
When ranked, the top 10 outcomes chosen were ocular burning, ocular discomfort, ocular pain, ocular dryness, visual acuity, overall assessment of surface symptoms, ocular foreign body sensation, tear film stability, artificial tear use, and adverse events.
Of the 28 outcomes deemed “important” by the surveyed population, 10 were found to be uncommon in current research.
When asked when patients would like these outcomes to be measured if they were to participate in a clinical trial, over 75% preferred a 3-month period for ocular burning, discomfort, pain, and foreign body sensations, as well as impact of dry eye in daily life, tear film stability, and costs of treatment. In comparison, a majority of patients agreed that outcomes such as satisfaction of treatment, ocular fatigue, and vision-related quality of life should be measured between 3 and 6 months.
With these data, according to Dr. Saldanha, researchers can maximize consistency across trials as well as contribute to better evidence-based medicine.
“This is useful for the next step, which would be to develop core outcome sets, which are an agreed upon minimum set of outcomes that should be examined in a given disease area,” Dr. Saldanha explained.
Dr. Saldanha reported no relevant financial disclosures. The meeting was sponsored by Johns Hopkins University and the National Institutes of Health.
SOURCE: Saldanha I et al. International Symposium on Sjogren’s Syndrome.
REPORTING FROM ISSS
Key clinical point: Investigators have identified core outcomes important to Sjogren’s patients with dry eye.
Major finding: Out of 28 outcomes identified, 39% were symptoms and 36% have not been commonly included in existing research.
Study details: An anonymous, two-round Delphi survey of 420 subscribers to KeratoScoop between November and December, 2017.
Disclosures: The presenter reported no relevant financial disclosures.
Source: Saldanha I et al. International Symposium on Sjogren’s Syndrome.
Calendar
For more information about upcoming events and award deadlines, please visit http://www.gastro.org/education and http://www.gastro.org/research-funding.
June 2-5, 2018
DIGESTIVE DISEASE WEEK® (DDW) 2018 – WASHINGTON, DC
DDW® is the premier meeting for the GI professional. Every year, it attracts approximately 15,000 physicians, researchers, and academics from around the world who desire to stay up to date in the field.
AGA Trainee and Early-Career GI Sessions
Join your colleagues at special sessions to meet the unique needs of physicians who are new to the field. Participants will learn about all aspects of starting a career in clinical practice or research, have the opportunity to network with mentors and peers, and review board material.
- June 2, 8:15 a.m.–5:30 p.m.; June 3, 8:30 a.m.–12:35 p.m.
AGA Postgraduate Course: From Abstract to Reality
Attend this multi-topic course to get practical, useful information to push your practice to the next level. The 2018 course will provide a comprehensive look at the latest medical, surgical, and technological advances over the past 12 months that aim to keep you up to date in a field that is rapidly changing. Each presenter will turn abstract ideas into concrete action items that you can immediately implement in your practice. AGA member trainees and early-career GIs receive discounted pricing for this course. - June 3, 4–5:30 p.m.
Difficult Conversations: Navigating People, Negotiations, Promotions, and Complications
During this session, attendees will obtain effective negotiation techniques and learn how to navigate difficult situations in clinical and research environments. - June 3, 6-7 p.m.
AGA Early Career Networking Hour
This event is open to all DDW trainee and early career GI attendees and provides a casual atmosphere to bond with your peers. Complimentary food and drinks will be available. - June 4, 4–5:30 p.m.
Advancing Clinical Practice: Gastroenterology Fellow–Directed Quality-Improvement Projects
This trainee-focused session will showcase selected abstracts from GI fellows based on quality improvement with a state-of-the-art lecture. Attendees will be provided with information that defines practical approaches to quality improvement from start to finish. A limited supply of coffee and tea will be provided during the session. - June 5, 1:30–5:30 p.m.
Board Review Course
This session, designed using content from DDSEP® 8, serves as a primer for third-year fellows preparing for the board exam as well as a review course for others wanting to test their knowledge. Session attendees will receive a $50 coupon to use at the AGA Store at DDW to purchase DDSEP 8.
UPCOMING EVENTS
June 4-8, 2018
Exosomes/Microvesicles: Heterogeneity, Biogenesis, Function, and Therapeutic Developments (E2)
Deepen your understanding of the structural and functional complexity of extracellular vesicles, their biogenesis and function in health and disease, cargo enrichment, potential as ideal biomarkers, and breakthroughs in their use as therapeutic targets/agents.
Breckenridge, CO
June 13-14; Aug. 15-16; Sept. 19-20; Oct. 10-11, 2018
Two-Day, In-Depth Coding and Billing Seminar
Become a certified GI coder with a two-day, in-depth training course provided by McVey Associates, Inc.
Nashville, TN (6/13-6/14); Baltimore, MD (8/15-8/16); Atlanta, GA (9/19-9/20); Las Vegas, NV (10/10-10/11)
Aug. 10–12, 2018
Principles of GI for the NP and PA
Hear from the experts as they provide you with critical updates on treating and managing patients with a variety of GI disorders.
Chicago, IL
Aug. 18-19, 2018
James W. Freston Conference: Obesity and Metabolic Disease – Integrating New Paradigms in Pathophysiology to Advance Treatment
Collaborate with researchers and clinicians to help advance obesity treatment and enhance the continuum of obesity care.
Arlington, VA
Feb. 7-9, 2019
Crohn’s & Colitis Congress™ (A Partnership of the Crohn’s & Colitis Foundation and American Gastroenterological Association)
Expand your knowledge, network with IBD leaders, spark innovative research and get inspired to improve patient care.
Las Vegas, NV
For more information about upcoming events and award deadlines, please visit http://www.gastro.org/education and http://www.gastro.org/research-funding.
June 2-5, 2018
DIGESTIVE DISEASE WEEK® (DDW) 2018 – WASHINGTON, DC
DDW® is the premier meeting for the GI professional. Every year, it attracts approximately 15,000 physicians, researchers, and academics from around the world who desire to stay up to date in the field.
AGA Trainee and Early-Career GI Sessions
Join your colleagues at special sessions to meet the unique needs of physicians who are new to the field. Participants will learn about all aspects of starting a career in clinical practice or research, have the opportunity to network with mentors and peers, and review board material.
- June 2, 8:15 a.m.–5:30 p.m.; June 3, 8:30 a.m.–12:35 p.m.
AGA Postgraduate Course: From Abstract to Reality
Attend this multi-topic course to get practical, useful information to push your practice to the next level. The 2018 course will provide a comprehensive look at the latest medical, surgical, and technological advances over the past 12 months that aim to keep you up to date in a field that is rapidly changing. Each presenter will turn abstract ideas into concrete action items that you can immediately implement in your practice. AGA member trainees and early-career GIs receive discounted pricing for this course. - June 3, 4–5:30 p.m.
Difficult Conversations: Navigating People, Negotiations, Promotions, and Complications
During this session, attendees will obtain effective negotiation techniques and learn how to navigate difficult situations in clinical and research environments. - June 3, 6-7 p.m.
AGA Early Career Networking Hour
This event is open to all DDW trainee and early career GI attendees and provides a casual atmosphere to bond with your peers. Complimentary food and drinks will be available. - June 4, 4–5:30 p.m.
Advancing Clinical Practice: Gastroenterology Fellow–Directed Quality-Improvement Projects
This trainee-focused session will showcase selected abstracts from GI fellows based on quality improvement with a state-of-the-art lecture. Attendees will be provided with information that defines practical approaches to quality improvement from start to finish. A limited supply of coffee and tea will be provided during the session. - June 5, 1:30–5:30 p.m.
Board Review Course
This session, designed using content from DDSEP® 8, serves as a primer for third-year fellows preparing for the board exam as well as a review course for others wanting to test their knowledge. Session attendees will receive a $50 coupon to use at the AGA Store at DDW to purchase DDSEP 8.
UPCOMING EVENTS
June 4-8, 2018
Exosomes/Microvesicles: Heterogeneity, Biogenesis, Function, and Therapeutic Developments (E2)
Deepen your understanding of the structural and functional complexity of extracellular vesicles, their biogenesis and function in health and disease, cargo enrichment, potential as ideal biomarkers, and breakthroughs in their use as therapeutic targets/agents.
Breckenridge, CO
June 13-14; Aug. 15-16; Sept. 19-20; Oct. 10-11, 2018
Two-Day, In-Depth Coding and Billing Seminar
Become a certified GI coder with a two-day, in-depth training course provided by McVey Associates, Inc.
Nashville, TN (6/13-6/14); Baltimore, MD (8/15-8/16); Atlanta, GA (9/19-9/20); Las Vegas, NV (10/10-10/11)
Aug. 10–12, 2018
Principles of GI for the NP and PA
Hear from the experts as they provide you with critical updates on treating and managing patients with a variety of GI disorders.
Chicago, IL
Aug. 18-19, 2018
James W. Freston Conference: Obesity and Metabolic Disease – Integrating New Paradigms in Pathophysiology to Advance Treatment
Collaborate with researchers and clinicians to help advance obesity treatment and enhance the continuum of obesity care.
Arlington, VA
Feb. 7-9, 2019
Crohn’s & Colitis Congress™ (A Partnership of the Crohn’s & Colitis Foundation and American Gastroenterological Association)
Expand your knowledge, network with IBD leaders, spark innovative research and get inspired to improve patient care.
Las Vegas, NV
For more information about upcoming events and award deadlines, please visit http://www.gastro.org/education and http://www.gastro.org/research-funding.
June 2-5, 2018
DIGESTIVE DISEASE WEEK® (DDW) 2018 – WASHINGTON, DC
DDW® is the premier meeting for the GI professional. Every year, it attracts approximately 15,000 physicians, researchers, and academics from around the world who desire to stay up to date in the field.
AGA Trainee and Early-Career GI Sessions
Join your colleagues at special sessions to meet the unique needs of physicians who are new to the field. Participants will learn about all aspects of starting a career in clinical practice or research, have the opportunity to network with mentors and peers, and review board material.
- June 2, 8:15 a.m.–5:30 p.m.; June 3, 8:30 a.m.–12:35 p.m.
AGA Postgraduate Course: From Abstract to Reality
Attend this multi-topic course to get practical, useful information to push your practice to the next level. The 2018 course will provide a comprehensive look at the latest medical, surgical, and technological advances over the past 12 months that aim to keep you up to date in a field that is rapidly changing. Each presenter will turn abstract ideas into concrete action items that you can immediately implement in your practice. AGA member trainees and early-career GIs receive discounted pricing for this course. - June 3, 4–5:30 p.m.
Difficult Conversations: Navigating People, Negotiations, Promotions, and Complications
During this session, attendees will obtain effective negotiation techniques and learn how to navigate difficult situations in clinical and research environments. - June 3, 6-7 p.m.
AGA Early Career Networking Hour
This event is open to all DDW trainee and early career GI attendees and provides a casual atmosphere to bond with your peers. Complimentary food and drinks will be available. - June 4, 4–5:30 p.m.
Advancing Clinical Practice: Gastroenterology Fellow–Directed Quality-Improvement Projects
This trainee-focused session will showcase selected abstracts from GI fellows based on quality improvement with a state-of-the-art lecture. Attendees will be provided with information that defines practical approaches to quality improvement from start to finish. A limited supply of coffee and tea will be provided during the session. - June 5, 1:30–5:30 p.m.
Board Review Course
This session, designed using content from DDSEP® 8, serves as a primer for third-year fellows preparing for the board exam as well as a review course for others wanting to test their knowledge. Session attendees will receive a $50 coupon to use at the AGA Store at DDW to purchase DDSEP 8.
UPCOMING EVENTS
June 4-8, 2018
Exosomes/Microvesicles: Heterogeneity, Biogenesis, Function, and Therapeutic Developments (E2)
Deepen your understanding of the structural and functional complexity of extracellular vesicles, their biogenesis and function in health and disease, cargo enrichment, potential as ideal biomarkers, and breakthroughs in their use as therapeutic targets/agents.
Breckenridge, CO
June 13-14; Aug. 15-16; Sept. 19-20; Oct. 10-11, 2018
Two-Day, In-Depth Coding and Billing Seminar
Become a certified GI coder with a two-day, in-depth training course provided by McVey Associates, Inc.
Nashville, TN (6/13-6/14); Baltimore, MD (8/15-8/16); Atlanta, GA (9/19-9/20); Las Vegas, NV (10/10-10/11)
Aug. 10–12, 2018
Principles of GI for the NP and PA
Hear from the experts as they provide you with critical updates on treating and managing patients with a variety of GI disorders.
Chicago, IL
Aug. 18-19, 2018
James W. Freston Conference: Obesity and Metabolic Disease – Integrating New Paradigms in Pathophysiology to Advance Treatment
Collaborate with researchers and clinicians to help advance obesity treatment and enhance the continuum of obesity care.
Arlington, VA
Feb. 7-9, 2019
Crohn’s & Colitis Congress™ (A Partnership of the Crohn’s & Colitis Foundation and American Gastroenterological Association)
Expand your knowledge, network with IBD leaders, spark innovative research and get inspired to improve patient care.
Las Vegas, NV
MDedge Daily News: Bridging medicine’s gender gap
Reshaping medicine’s mindset about gender roles, when to rechallenge for statin-associated muscle symptoms, how zip code (not gene code) influences health, and surgeries are driving hospital costs.
Listen to the MDedge Daily News podcast for all the details on today’s top news.
Reshaping medicine’s mindset about gender roles, when to rechallenge for statin-associated muscle symptoms, how zip code (not gene code) influences health, and surgeries are driving hospital costs.
Listen to the MDedge Daily News podcast for all the details on today’s top news.
Reshaping medicine’s mindset about gender roles, when to rechallenge for statin-associated muscle symptoms, how zip code (not gene code) influences health, and surgeries are driving hospital costs.
Listen to the MDedge Daily News podcast for all the details on today’s top news.
VIDEO: Encouraging results reported for novel Huntington’s disease therapy
LOS ANGELES – Results from the first-in-human trial of the investigational antisense oligonucleotide therapy IONIS-HTTRx showed strong dose-dependent reductions in the toxic huntingtin protein in Huntington’s disease patients’ cerebrospinal fluid when compared with placebo.
An exploratory analysis also showed signals of clinical improvement among patients receiving the therapy, the study’s lead author, Sarah Tabrizi, MD, PhD, of University College London, reported at the annual meeting of the American Academy of Neurology.
The findings represent a potential breakthrough in the way Huntington’s – and possibly other neurodegenerative diseases – are treated, said Dr. Tabrizi of University College London. The intrathecally-delivered drug binds to mutant huntingtin protein mRNA to reduce the level of the toxic protein being made.
In the phase 1/2a trial, Dr. Tabrizi and her colleagues enrolled 46 patients with early-stage Huntington’s disease and randomized them to four doses of IONIS-HTTRx or placebo. Patients received four monthly injections of the study drug into the cerebrospinal fluid followed by a 4-month untreated follow-up period. IONIS-HTTRx was delivered in five ascending-dose cohorts.
IONIS-HTTRx was safe and well tolerated and all patients completed the study, Dr. Tabrizi reported. “Our results show that we had significant lowering of the toxic mutant huntingtin protein in the spinal fluid of the patients,” she said, noting that patients receiving the highest doses saw 40%-60% lowering of the protein, which preclinical work suggests correlates to reductions of the protein in the brain.
Dr. Tabrizi stressed that the main outcome measures in the study were reduction of the mutant protein in the CSF and safety and tolerance of the study drug. The investigators did not expect to see clinical measures to change in such a short, small study, she said.
“But then when we looked more carefully at the data with exploratory analysis we found a link between lowering of CSF mutant huntingtin and improvement in total motor score, which is a measure of neurological function, and also, improvement in the Symbol Digit Modalities Test.”
The clinical results are exploratory and require confirmation in larger studies, Dr. Tabrizi stressed.
The study was supported by Ionis Pharmaceuticals. Roche will develop the drug in further clinical trials.
SOURCE: Tabrizi S et al. AAN 2018 abstract CT.002.
LOS ANGELES – Results from the first-in-human trial of the investigational antisense oligonucleotide therapy IONIS-HTTRx showed strong dose-dependent reductions in the toxic huntingtin protein in Huntington’s disease patients’ cerebrospinal fluid when compared with placebo.
An exploratory analysis also showed signals of clinical improvement among patients receiving the therapy, the study’s lead author, Sarah Tabrizi, MD, PhD, of University College London, reported at the annual meeting of the American Academy of Neurology.
The findings represent a potential breakthrough in the way Huntington’s – and possibly other neurodegenerative diseases – are treated, said Dr. Tabrizi of University College London. The intrathecally-delivered drug binds to mutant huntingtin protein mRNA to reduce the level of the toxic protein being made.
In the phase 1/2a trial, Dr. Tabrizi and her colleagues enrolled 46 patients with early-stage Huntington’s disease and randomized them to four doses of IONIS-HTTRx or placebo. Patients received four monthly injections of the study drug into the cerebrospinal fluid followed by a 4-month untreated follow-up period. IONIS-HTTRx was delivered in five ascending-dose cohorts.
IONIS-HTTRx was safe and well tolerated and all patients completed the study, Dr. Tabrizi reported. “Our results show that we had significant lowering of the toxic mutant huntingtin protein in the spinal fluid of the patients,” she said, noting that patients receiving the highest doses saw 40%-60% lowering of the protein, which preclinical work suggests correlates to reductions of the protein in the brain.
Dr. Tabrizi stressed that the main outcome measures in the study were reduction of the mutant protein in the CSF and safety and tolerance of the study drug. The investigators did not expect to see clinical measures to change in such a short, small study, she said.
“But then when we looked more carefully at the data with exploratory analysis we found a link between lowering of CSF mutant huntingtin and improvement in total motor score, which is a measure of neurological function, and also, improvement in the Symbol Digit Modalities Test.”
The clinical results are exploratory and require confirmation in larger studies, Dr. Tabrizi stressed.
The study was supported by Ionis Pharmaceuticals. Roche will develop the drug in further clinical trials.
SOURCE: Tabrizi S et al. AAN 2018 abstract CT.002.
LOS ANGELES – Results from the first-in-human trial of the investigational antisense oligonucleotide therapy IONIS-HTTRx showed strong dose-dependent reductions in the toxic huntingtin protein in Huntington’s disease patients’ cerebrospinal fluid when compared with placebo.
An exploratory analysis also showed signals of clinical improvement among patients receiving the therapy, the study’s lead author, Sarah Tabrizi, MD, PhD, of University College London, reported at the annual meeting of the American Academy of Neurology.
The findings represent a potential breakthrough in the way Huntington’s – and possibly other neurodegenerative diseases – are treated, said Dr. Tabrizi of University College London. The intrathecally-delivered drug binds to mutant huntingtin protein mRNA to reduce the level of the toxic protein being made.
In the phase 1/2a trial, Dr. Tabrizi and her colleagues enrolled 46 patients with early-stage Huntington’s disease and randomized them to four doses of IONIS-HTTRx or placebo. Patients received four monthly injections of the study drug into the cerebrospinal fluid followed by a 4-month untreated follow-up period. IONIS-HTTRx was delivered in five ascending-dose cohorts.
IONIS-HTTRx was safe and well tolerated and all patients completed the study, Dr. Tabrizi reported. “Our results show that we had significant lowering of the toxic mutant huntingtin protein in the spinal fluid of the patients,” she said, noting that patients receiving the highest doses saw 40%-60% lowering of the protein, which preclinical work suggests correlates to reductions of the protein in the brain.
Dr. Tabrizi stressed that the main outcome measures in the study were reduction of the mutant protein in the CSF and safety and tolerance of the study drug. The investigators did not expect to see clinical measures to change in such a short, small study, she said.
“But then when we looked more carefully at the data with exploratory analysis we found a link between lowering of CSF mutant huntingtin and improvement in total motor score, which is a measure of neurological function, and also, improvement in the Symbol Digit Modalities Test.”
The clinical results are exploratory and require confirmation in larger studies, Dr. Tabrizi stressed.
The study was supported by Ionis Pharmaceuticals. Roche will develop the drug in further clinical trials.
SOURCE: Tabrizi S et al. AAN 2018 abstract CT.002.
REPORTING FROM AAN 2018
VIDEO: Ubrogepant reduced pain, related symptoms of a migraine attack
LOS ANGELES – The investigational oral calcitonin gene-related peptide (CGRP) blocker ubrogepant proved superior to placebo in treating a single, acute, moderate to severe migraine attack in the phase 3 ACHIEVE I trial.
Blocking the function of CGRP when it is pathologically released during a migraine attack is the mechanism of a bevy of antagonists under development for treating migraine, and the ACHIEVE I trial results are the first to be reported from a phase 3 trial of an oral small molecule to treat single migraine attacks rather than prevent attacks with monoclonal antibodies targeting CGRP or its receptor, according to the lead author of ACHIEVE I, Joel M. Trugman, MD, director of clinical development for Allergan.
Dr. Trugman and his colleagues recruited 1,672 adult patients (88% female, mean age 41) with a history of migraine with or without aura, and randomized them to placebo, ubrogepant 50 mg, or ubrogepant 100 mg. Patients were instructed to treat a single migraine attack of moderate to severe pain intensity and record symptoms, such as pain, light sensitivity, and sound sensitivity, before and after taking the medication.
“The paradigm for this type of trial is to treat a single, well characterized migraine attack in a large population of patients,” Dr. Trugman said in a press conference at the annual meeting of the American Academy of Neurology.
At 2 hours after dosing, the percentage of ubrogepant-treated patients achieving freedom from pain was significantly greater than the percentage of those treated with placebo (50 mg: 19.2%, P = .0023; 100 mg: 21.2%, P = .0003; placebo: 11.8%).
The percentage of ubrogepant-treated patients achieving absence of their most bothersome symptom was also significantly greater than that of placebo (50 mg: 38.6%, P = .0023; 100 mg: 37.7%, P = .0023; placebo: 27.8%).
Adverse events in the ubrogepant groups were similar to those of placebo, the most reported to be nausea, somnolence, and dry mouth.
Several authors are employees of Allergan, which sponsored the study.
SOURCE: Trugman J et al. AAN 2018 emerging science abstract 008.
LOS ANGELES – The investigational oral calcitonin gene-related peptide (CGRP) blocker ubrogepant proved superior to placebo in treating a single, acute, moderate to severe migraine attack in the phase 3 ACHIEVE I trial.
Blocking the function of CGRP when it is pathologically released during a migraine attack is the mechanism of a bevy of antagonists under development for treating migraine, and the ACHIEVE I trial results are the first to be reported from a phase 3 trial of an oral small molecule to treat single migraine attacks rather than prevent attacks with monoclonal antibodies targeting CGRP or its receptor, according to the lead author of ACHIEVE I, Joel M. Trugman, MD, director of clinical development for Allergan.
Dr. Trugman and his colleagues recruited 1,672 adult patients (88% female, mean age 41) with a history of migraine with or without aura, and randomized them to placebo, ubrogepant 50 mg, or ubrogepant 100 mg. Patients were instructed to treat a single migraine attack of moderate to severe pain intensity and record symptoms, such as pain, light sensitivity, and sound sensitivity, before and after taking the medication.
“The paradigm for this type of trial is to treat a single, well characterized migraine attack in a large population of patients,” Dr. Trugman said in a press conference at the annual meeting of the American Academy of Neurology.
At 2 hours after dosing, the percentage of ubrogepant-treated patients achieving freedom from pain was significantly greater than the percentage of those treated with placebo (50 mg: 19.2%, P = .0023; 100 mg: 21.2%, P = .0003; placebo: 11.8%).
The percentage of ubrogepant-treated patients achieving absence of their most bothersome symptom was also significantly greater than that of placebo (50 mg: 38.6%, P = .0023; 100 mg: 37.7%, P = .0023; placebo: 27.8%).
Adverse events in the ubrogepant groups were similar to those of placebo, the most reported to be nausea, somnolence, and dry mouth.
Several authors are employees of Allergan, which sponsored the study.
SOURCE: Trugman J et al. AAN 2018 emerging science abstract 008.
LOS ANGELES – The investigational oral calcitonin gene-related peptide (CGRP) blocker ubrogepant proved superior to placebo in treating a single, acute, moderate to severe migraine attack in the phase 3 ACHIEVE I trial.
Blocking the function of CGRP when it is pathologically released during a migraine attack is the mechanism of a bevy of antagonists under development for treating migraine, and the ACHIEVE I trial results are the first to be reported from a phase 3 trial of an oral small molecule to treat single migraine attacks rather than prevent attacks with monoclonal antibodies targeting CGRP or its receptor, according to the lead author of ACHIEVE I, Joel M. Trugman, MD, director of clinical development for Allergan.
Dr. Trugman and his colleagues recruited 1,672 adult patients (88% female, mean age 41) with a history of migraine with or without aura, and randomized them to placebo, ubrogepant 50 mg, or ubrogepant 100 mg. Patients were instructed to treat a single migraine attack of moderate to severe pain intensity and record symptoms, such as pain, light sensitivity, and sound sensitivity, before and after taking the medication.
“The paradigm for this type of trial is to treat a single, well characterized migraine attack in a large population of patients,” Dr. Trugman said in a press conference at the annual meeting of the American Academy of Neurology.
At 2 hours after dosing, the percentage of ubrogepant-treated patients achieving freedom from pain was significantly greater than the percentage of those treated with placebo (50 mg: 19.2%, P = .0023; 100 mg: 21.2%, P = .0003; placebo: 11.8%).
The percentage of ubrogepant-treated patients achieving absence of their most bothersome symptom was also significantly greater than that of placebo (50 mg: 38.6%, P = .0023; 100 mg: 37.7%, P = .0023; placebo: 27.8%).
Adverse events in the ubrogepant groups were similar to those of placebo, the most reported to be nausea, somnolence, and dry mouth.
Several authors are employees of Allergan, which sponsored the study.
SOURCE: Trugman J et al. AAN 2018 emerging science abstract 008.
REPORTING FROM AAN 2018
Art education benefits blood cancer patients
New research suggests a bedside visual art intervention (BVAI) can reduce pain and anxiety in inpatients with hematologic malignancies, including those undergoing transplant.
The BVAI involved an educator teaching patients art technique one-on-one for approximately 30 minutes.
After a single session, patients had significant improvements in positive mood and pain scores, as well as decreases in negative mood and anxiety.
Alexandra P. Wolanskyj, MD, of Mayo Clinic in Rochester, Minnesota, and her colleagues reported these results in the European Journal of Cancer Care.
The study included 21 patients, 19 of them female. Their median age was 53.5 (range, 19-75). Six patients were undergoing hematopoietic stem cell transplant.
The patients had multiple myeloma (n=5), acute myeloid leukemia (n=5), non-Hodgkin lymphoma (n=3), Hodgkin lymphoma (n=2), acute lymphoblastic leukemia (n=1), chronic lymphocytic leukemia (n=1), amyloidosis (n=1), Gardner-Diamond syndrome (n=1), myelodysplastic syndrome (n=1), and Waldenstrom’s macroglobulinemia (n=1).
Nearly half of patients had relapsed disease (47.6%), 23.8% had active and new disease, 19.0% had active disease with primary resistance on chemotherapy, and 9.5% of patients were in remission.
Intervention
The researchers recruited an educator from a community art center to teach art at the patients’ bedsides. Sessions were intended to be about 30 minutes. However, patients could stop at any time or continue beyond 30 minutes.
Patients and their families could make art or just observe. Materials used included watercolors, oil pastels, colored pencils, and clay (all non-toxic and odorless). The materials were left with patients so they could continue to use them after the sessions.
Results
The researchers assessed patients’ pain, anxiety, and mood at baseline and after the patients had a session with the art educator.
After the BVAI, patients had a significant decrease in pain, according to the Visual Analog Scale (VAS). The 14 patients who reported any pain at baseline had a mean reduction in VAS score of 1.5, or a 35.1% reduction in pain (P=0.017).
Patients had a 21.6% reduction in anxiety after the BVAI. Among the 20 patients who completed this assessment, there was a mean 9.2-point decrease in State-Trait Anxiety Inventory (STAI) score (P=0.001).
In addition, patients had a significant increase in positive mood and a significant decrease in negative mood after the BVAI. Mood was assessed in 20 patients using the Positive and Negative Affect Schedule (PANAS) scale.
Positive mood increased 14.6% (P=0.003), and negative mood decreased 18.0% (P=0.015) after the BVAI. Patients’ mean PANAS scores increased 4.6 points for positive mood and decreased 3.3 points for negative mood.
All 21 patients completed a questionnaire on the BVAI. All but 1 patient (95%) said the intervention was positive overall, and 85% of patients (n=18) said they would be interested in participating in future art-based interventions.
The researchers said these results suggest experiences provided by artists in the community may be an adjunct to conventional treatments in patients with cancer-related mood symptoms and pain.
New research suggests a bedside visual art intervention (BVAI) can reduce pain and anxiety in inpatients with hematologic malignancies, including those undergoing transplant.
The BVAI involved an educator teaching patients art technique one-on-one for approximately 30 minutes.
After a single session, patients had significant improvements in positive mood and pain scores, as well as decreases in negative mood and anxiety.
Alexandra P. Wolanskyj, MD, of Mayo Clinic in Rochester, Minnesota, and her colleagues reported these results in the European Journal of Cancer Care.
The study included 21 patients, 19 of them female. Their median age was 53.5 (range, 19-75). Six patients were undergoing hematopoietic stem cell transplant.
The patients had multiple myeloma (n=5), acute myeloid leukemia (n=5), non-Hodgkin lymphoma (n=3), Hodgkin lymphoma (n=2), acute lymphoblastic leukemia (n=1), chronic lymphocytic leukemia (n=1), amyloidosis (n=1), Gardner-Diamond syndrome (n=1), myelodysplastic syndrome (n=1), and Waldenstrom’s macroglobulinemia (n=1).
Nearly half of patients had relapsed disease (47.6%), 23.8% had active and new disease, 19.0% had active disease with primary resistance on chemotherapy, and 9.5% of patients were in remission.
Intervention
The researchers recruited an educator from a community art center to teach art at the patients’ bedsides. Sessions were intended to be about 30 minutes. However, patients could stop at any time or continue beyond 30 minutes.
Patients and their families could make art or just observe. Materials used included watercolors, oil pastels, colored pencils, and clay (all non-toxic and odorless). The materials were left with patients so they could continue to use them after the sessions.
Results
The researchers assessed patients’ pain, anxiety, and mood at baseline and after the patients had a session with the art educator.
After the BVAI, patients had a significant decrease in pain, according to the Visual Analog Scale (VAS). The 14 patients who reported any pain at baseline had a mean reduction in VAS score of 1.5, or a 35.1% reduction in pain (P=0.017).
Patients had a 21.6% reduction in anxiety after the BVAI. Among the 20 patients who completed this assessment, there was a mean 9.2-point decrease in State-Trait Anxiety Inventory (STAI) score (P=0.001).
In addition, patients had a significant increase in positive mood and a significant decrease in negative mood after the BVAI. Mood was assessed in 20 patients using the Positive and Negative Affect Schedule (PANAS) scale.
Positive mood increased 14.6% (P=0.003), and negative mood decreased 18.0% (P=0.015) after the BVAI. Patients’ mean PANAS scores increased 4.6 points for positive mood and decreased 3.3 points for negative mood.
All 21 patients completed a questionnaire on the BVAI. All but 1 patient (95%) said the intervention was positive overall, and 85% of patients (n=18) said they would be interested in participating in future art-based interventions.
The researchers said these results suggest experiences provided by artists in the community may be an adjunct to conventional treatments in patients with cancer-related mood symptoms and pain.
New research suggests a bedside visual art intervention (BVAI) can reduce pain and anxiety in inpatients with hematologic malignancies, including those undergoing transplant.
The BVAI involved an educator teaching patients art technique one-on-one for approximately 30 minutes.
After a single session, patients had significant improvements in positive mood and pain scores, as well as decreases in negative mood and anxiety.
Alexandra P. Wolanskyj, MD, of Mayo Clinic in Rochester, Minnesota, and her colleagues reported these results in the European Journal of Cancer Care.
The study included 21 patients, 19 of them female. Their median age was 53.5 (range, 19-75). Six patients were undergoing hematopoietic stem cell transplant.
The patients had multiple myeloma (n=5), acute myeloid leukemia (n=5), non-Hodgkin lymphoma (n=3), Hodgkin lymphoma (n=2), acute lymphoblastic leukemia (n=1), chronic lymphocytic leukemia (n=1), amyloidosis (n=1), Gardner-Diamond syndrome (n=1), myelodysplastic syndrome (n=1), and Waldenstrom’s macroglobulinemia (n=1).
Nearly half of patients had relapsed disease (47.6%), 23.8% had active and new disease, 19.0% had active disease with primary resistance on chemotherapy, and 9.5% of patients were in remission.
Intervention
The researchers recruited an educator from a community art center to teach art at the patients’ bedsides. Sessions were intended to be about 30 minutes. However, patients could stop at any time or continue beyond 30 minutes.
Patients and their families could make art or just observe. Materials used included watercolors, oil pastels, colored pencils, and clay (all non-toxic and odorless). The materials were left with patients so they could continue to use them after the sessions.
Results
The researchers assessed patients’ pain, anxiety, and mood at baseline and after the patients had a session with the art educator.
After the BVAI, patients had a significant decrease in pain, according to the Visual Analog Scale (VAS). The 14 patients who reported any pain at baseline had a mean reduction in VAS score of 1.5, or a 35.1% reduction in pain (P=0.017).
Patients had a 21.6% reduction in anxiety after the BVAI. Among the 20 patients who completed this assessment, there was a mean 9.2-point decrease in State-Trait Anxiety Inventory (STAI) score (P=0.001).
In addition, patients had a significant increase in positive mood and a significant decrease in negative mood after the BVAI. Mood was assessed in 20 patients using the Positive and Negative Affect Schedule (PANAS) scale.
Positive mood increased 14.6% (P=0.003), and negative mood decreased 18.0% (P=0.015) after the BVAI. Patients’ mean PANAS scores increased 4.6 points for positive mood and decreased 3.3 points for negative mood.
All 21 patients completed a questionnaire on the BVAI. All but 1 patient (95%) said the intervention was positive overall, and 85% of patients (n=18) said they would be interested in participating in future art-based interventions.
The researchers said these results suggest experiences provided by artists in the community may be an adjunct to conventional treatments in patients with cancer-related mood symptoms and pain.
E-cigarette use in teens increases risk of cannabis use
, reported Hongying Dai, PhD, of Children’s Mercy Kansas City (Mo.), and her associates.
In an analysis of data from the Population Assessment of Tobacco and Health (PATH) survey, 11,996 participants aged 12-17 years completed both the wave 1 and wave 2 surveys. Researchers found one in four adolescents (26.6%) who used e-cigarettes at wave 1 reported marijuana use at wave 2, compared with 7.7% of adolescents who never used e-cigarettes at wave 1 (P less than .05). E-cigarette users at wave 1 were more likely to report marijuana use in the past 12 months at wave 2 (adjusted odds ratio = 1.9). In addition, 2.8% of participants who had never used marijuana at wave 1 reported heavy use of marijuana at wave 2.
“Our study revealed that e-cigarette use was associated with an increased risk of subsequent marijuana use among youth, with a stronger temporal association among younger adolescents,” the researchers concluded. “With these findings, we suggest that the widespread use of e-cigarettes among youth may have implications for the uptake of other drugs of abuse beyond nicotine and tobacco products.”
SOURCE: Dai H et al. Pediatrics. 2018;141(5):e20173787.
, reported Hongying Dai, PhD, of Children’s Mercy Kansas City (Mo.), and her associates.
In an analysis of data from the Population Assessment of Tobacco and Health (PATH) survey, 11,996 participants aged 12-17 years completed both the wave 1 and wave 2 surveys. Researchers found one in four adolescents (26.6%) who used e-cigarettes at wave 1 reported marijuana use at wave 2, compared with 7.7% of adolescents who never used e-cigarettes at wave 1 (P less than .05). E-cigarette users at wave 1 were more likely to report marijuana use in the past 12 months at wave 2 (adjusted odds ratio = 1.9). In addition, 2.8% of participants who had never used marijuana at wave 1 reported heavy use of marijuana at wave 2.
“Our study revealed that e-cigarette use was associated with an increased risk of subsequent marijuana use among youth, with a stronger temporal association among younger adolescents,” the researchers concluded. “With these findings, we suggest that the widespread use of e-cigarettes among youth may have implications for the uptake of other drugs of abuse beyond nicotine and tobacco products.”
SOURCE: Dai H et al. Pediatrics. 2018;141(5):e20173787.
, reported Hongying Dai, PhD, of Children’s Mercy Kansas City (Mo.), and her associates.
In an analysis of data from the Population Assessment of Tobacco and Health (PATH) survey, 11,996 participants aged 12-17 years completed both the wave 1 and wave 2 surveys. Researchers found one in four adolescents (26.6%) who used e-cigarettes at wave 1 reported marijuana use at wave 2, compared with 7.7% of adolescents who never used e-cigarettes at wave 1 (P less than .05). E-cigarette users at wave 1 were more likely to report marijuana use in the past 12 months at wave 2 (adjusted odds ratio = 1.9). In addition, 2.8% of participants who had never used marijuana at wave 1 reported heavy use of marijuana at wave 2.
“Our study revealed that e-cigarette use was associated with an increased risk of subsequent marijuana use among youth, with a stronger temporal association among younger adolescents,” the researchers concluded. “With these findings, we suggest that the widespread use of e-cigarettes among youth may have implications for the uptake of other drugs of abuse beyond nicotine and tobacco products.”
SOURCE: Dai H et al. Pediatrics. 2018;141(5):e20173787.
FROM PEDIATRICS
Nonopioids as effective as opioids in reducing acute pain in the ED
Clinical question: What is the most effective analgesic combination, opioid vs. nonopioid, for treating acute extremity pain in the emergency department?
Background: Patients often are prescribed opioids for acute pain in the ED while awaiting work-up. With the current opioid epidemic in the United States, it is important to examine the appropriate use of opioids and look for alternative medications for acute pain.
Setting: Two urban New York City emergency departments from July 2015 to August 2016.
Synopsis: 411 patients aged 21-65 years were randomized to four groups for treatment of acute extremity pain. Each received one oral analgesic combination: ibuprofen 400 mg and acetaminophen 1,000 mg; oxycodone 5 mg and acetaminophen 325 mg; hydrocodone 5 mg and acetaminophen 300 mg; or codeine 30 mg and acetaminophen 300 mg. Their pain was scored on presentation using a standard 0-10 numerical rating scale (NRS) and then at 2 hours after medication. The primary outcome was difference in NRS among groups. All patients had improvement in pain scores. Pain score improved by 4.4 in the oxycodone group, 4.3 in the ibuprofen group, 3.5 in the hydrocodone group, and 3.9 in the codeine group. There were no statistically significant differences among groups. Limitations to the study included short follow-up time, no reported data on adverse effects, and lack of uniform acetaminophen doses in each group.
Bottom line: There was no statistically significant difference in pain control among patients given a combination of acetaminophen and ibuprofen vs. three different opioids with acetaminophen when treating acute extremity pain in the ED.
Citation: Chang AK et al. Effect of a single dose of oral opioid and nonopioid analgesics on acute extremity pain in the emergency department: a randomized clinical trial. JAMA. 2017 Nov 7;318(17):1661-7.
Dr. Mathew is assistant professor of medicine, division of hospital medicine, University of Virginia.
Clinical question: What is the most effective analgesic combination, opioid vs. nonopioid, for treating acute extremity pain in the emergency department?
Background: Patients often are prescribed opioids for acute pain in the ED while awaiting work-up. With the current opioid epidemic in the United States, it is important to examine the appropriate use of opioids and look for alternative medications for acute pain.
Setting: Two urban New York City emergency departments from July 2015 to August 2016.
Synopsis: 411 patients aged 21-65 years were randomized to four groups for treatment of acute extremity pain. Each received one oral analgesic combination: ibuprofen 400 mg and acetaminophen 1,000 mg; oxycodone 5 mg and acetaminophen 325 mg; hydrocodone 5 mg and acetaminophen 300 mg; or codeine 30 mg and acetaminophen 300 mg. Their pain was scored on presentation using a standard 0-10 numerical rating scale (NRS) and then at 2 hours after medication. The primary outcome was difference in NRS among groups. All patients had improvement in pain scores. Pain score improved by 4.4 in the oxycodone group, 4.3 in the ibuprofen group, 3.5 in the hydrocodone group, and 3.9 in the codeine group. There were no statistically significant differences among groups. Limitations to the study included short follow-up time, no reported data on adverse effects, and lack of uniform acetaminophen doses in each group.
Bottom line: There was no statistically significant difference in pain control among patients given a combination of acetaminophen and ibuprofen vs. three different opioids with acetaminophen when treating acute extremity pain in the ED.
Citation: Chang AK et al. Effect of a single dose of oral opioid and nonopioid analgesics on acute extremity pain in the emergency department: a randomized clinical trial. JAMA. 2017 Nov 7;318(17):1661-7.
Dr. Mathew is assistant professor of medicine, division of hospital medicine, University of Virginia.
Clinical question: What is the most effective analgesic combination, opioid vs. nonopioid, for treating acute extremity pain in the emergency department?
Background: Patients often are prescribed opioids for acute pain in the ED while awaiting work-up. With the current opioid epidemic in the United States, it is important to examine the appropriate use of opioids and look for alternative medications for acute pain.
Setting: Two urban New York City emergency departments from July 2015 to August 2016.
Synopsis: 411 patients aged 21-65 years were randomized to four groups for treatment of acute extremity pain. Each received one oral analgesic combination: ibuprofen 400 mg and acetaminophen 1,000 mg; oxycodone 5 mg and acetaminophen 325 mg; hydrocodone 5 mg and acetaminophen 300 mg; or codeine 30 mg and acetaminophen 300 mg. Their pain was scored on presentation using a standard 0-10 numerical rating scale (NRS) and then at 2 hours after medication. The primary outcome was difference in NRS among groups. All patients had improvement in pain scores. Pain score improved by 4.4 in the oxycodone group, 4.3 in the ibuprofen group, 3.5 in the hydrocodone group, and 3.9 in the codeine group. There were no statistically significant differences among groups. Limitations to the study included short follow-up time, no reported data on adverse effects, and lack of uniform acetaminophen doses in each group.
Bottom line: There was no statistically significant difference in pain control among patients given a combination of acetaminophen and ibuprofen vs. three different opioids with acetaminophen when treating acute extremity pain in the ED.
Citation: Chang AK et al. Effect of a single dose of oral opioid and nonopioid analgesics on acute extremity pain in the emergency department: a randomized clinical trial. JAMA. 2017 Nov 7;318(17):1661-7.
Dr. Mathew is assistant professor of medicine, division of hospital medicine, University of Virginia.
Therapy targets ICU ‘teachable moment’ of suicide-attempt survivors
WASHINGTON – in a pair of controlled pilot studies with a total of 87 patients.
In the more recent study, the 32 patients who received this “teachable moment brief intervention” (TMBI) plus usual care tallied an overall satisfaction score of 3.88 on a 1-4 scale and showed a trend to higher motivation scores than patients managed with usual care alone, Stephen S. O’Connor, PhD, said at the annual conference of the American Association of Suicidology.
The TMBI was designed to help suicide-attempt survivors “wrap their head around what happened in a nonshaming way at a sensitive time. We try to help the patient understand what was the purpose of their attempt and what moving forward will look like,” Dr. O’Connor said in an interview.
The TMBI usually lasts about 30-45 minutes, and Dr. O’Connor described the general outline of the conversation: After the therapist establishes a rapport with the patient, the discussion moves to a functional analysis of what drove the patient to this action and why the suicide attempt seemed to make sense at the time. The therapist asks the patient what he or she sees as having been gained and lost by the event, and what the patient has gleaned from the experience. The goal is to help the patient understand what happened and its purpose, and also to discuss issues that need to be addressed going forward. “In a respectful, nonshaming way we get the patient to talk about what happened and how they got there,” he said.
The TMBI is a “drop in the ocean” of talk therapy that the patient will eventually receive, he said, but it is “all about the context.” In usual care, although the suicide attempter in the ICU may see a therapist, the conversation is generally about risk management and discharge planning.
In the initial test of the efficacy of this approach, Dr. O’Connor randomized 30 suicide survivors in the ICU to usual care or usual care plus the TMBI. The results showed a high level of patient satisfaction with the intervention and statistically significant improvements in readiness to change and in reasons for living, compared with controls (Gen Hosp Psychiatry. 2015 Sept-Oct;37[5]:427-33).
In a second pilot study that has not yet been published, Dr. O’Connor and his associates at Vanderbilt University in Nashville treated 32 patients with the TMBI and usual care and 25 with usual care only, with the study primarily designed to assess feasibility and acceptability to patients. Once again, patients who received the TMBI reported a high level of satisfaction with the encounter, including an average 3.96 rating (1-4 scale) of how likely they were to return to the service for future needs. Patients who received the extra intervention also showed trends toward a higher level of motivation after 3 months and less suicide ideation.
Further small-scale studies of the TMBI are now underway at two U.S. centers, and Dr. O’Connor said that a larger-scale test of the approach is now appropriate. One of the current limiting factors in dissemination is the training needed to perform a TMBI. One way to better leverage trained therapists might be to have the intervention occur remotely through telemedicine, with the patient encounter happening on a hand-held device.
The evidence collected so far on the TMBI has not yet proven its efficacy, Dr. O’Connor stressed. “We need to see to what degree this makes a difference. But there is clearly need for more engagement” with patients when they are in the ICU immediately after a suicide attempt. “Maybe it’s not the intervention, but just having someone being kind to the patient and sitting with them,” he suggested.
SOURCE: O’Connor S et al. American Association of Suicidology annual conference.
WASHINGTON – in a pair of controlled pilot studies with a total of 87 patients.
In the more recent study, the 32 patients who received this “teachable moment brief intervention” (TMBI) plus usual care tallied an overall satisfaction score of 3.88 on a 1-4 scale and showed a trend to higher motivation scores than patients managed with usual care alone, Stephen S. O’Connor, PhD, said at the annual conference of the American Association of Suicidology.
The TMBI was designed to help suicide-attempt survivors “wrap their head around what happened in a nonshaming way at a sensitive time. We try to help the patient understand what was the purpose of their attempt and what moving forward will look like,” Dr. O’Connor said in an interview.
The TMBI usually lasts about 30-45 minutes, and Dr. O’Connor described the general outline of the conversation: After the therapist establishes a rapport with the patient, the discussion moves to a functional analysis of what drove the patient to this action and why the suicide attempt seemed to make sense at the time. The therapist asks the patient what he or she sees as having been gained and lost by the event, and what the patient has gleaned from the experience. The goal is to help the patient understand what happened and its purpose, and also to discuss issues that need to be addressed going forward. “In a respectful, nonshaming way we get the patient to talk about what happened and how they got there,” he said.
The TMBI is a “drop in the ocean” of talk therapy that the patient will eventually receive, he said, but it is “all about the context.” In usual care, although the suicide attempter in the ICU may see a therapist, the conversation is generally about risk management and discharge planning.
In the initial test of the efficacy of this approach, Dr. O’Connor randomized 30 suicide survivors in the ICU to usual care or usual care plus the TMBI. The results showed a high level of patient satisfaction with the intervention and statistically significant improvements in readiness to change and in reasons for living, compared with controls (Gen Hosp Psychiatry. 2015 Sept-Oct;37[5]:427-33).
In a second pilot study that has not yet been published, Dr. O’Connor and his associates at Vanderbilt University in Nashville treated 32 patients with the TMBI and usual care and 25 with usual care only, with the study primarily designed to assess feasibility and acceptability to patients. Once again, patients who received the TMBI reported a high level of satisfaction with the encounter, including an average 3.96 rating (1-4 scale) of how likely they were to return to the service for future needs. Patients who received the extra intervention also showed trends toward a higher level of motivation after 3 months and less suicide ideation.
Further small-scale studies of the TMBI are now underway at two U.S. centers, and Dr. O’Connor said that a larger-scale test of the approach is now appropriate. One of the current limiting factors in dissemination is the training needed to perform a TMBI. One way to better leverage trained therapists might be to have the intervention occur remotely through telemedicine, with the patient encounter happening on a hand-held device.
The evidence collected so far on the TMBI has not yet proven its efficacy, Dr. O’Connor stressed. “We need to see to what degree this makes a difference. But there is clearly need for more engagement” with patients when they are in the ICU immediately after a suicide attempt. “Maybe it’s not the intervention, but just having someone being kind to the patient and sitting with them,” he suggested.
SOURCE: O’Connor S et al. American Association of Suicidology annual conference.
WASHINGTON – in a pair of controlled pilot studies with a total of 87 patients.
In the more recent study, the 32 patients who received this “teachable moment brief intervention” (TMBI) plus usual care tallied an overall satisfaction score of 3.88 on a 1-4 scale and showed a trend to higher motivation scores than patients managed with usual care alone, Stephen S. O’Connor, PhD, said at the annual conference of the American Association of Suicidology.
The TMBI was designed to help suicide-attempt survivors “wrap their head around what happened in a nonshaming way at a sensitive time. We try to help the patient understand what was the purpose of their attempt and what moving forward will look like,” Dr. O’Connor said in an interview.
The TMBI usually lasts about 30-45 minutes, and Dr. O’Connor described the general outline of the conversation: After the therapist establishes a rapport with the patient, the discussion moves to a functional analysis of what drove the patient to this action and why the suicide attempt seemed to make sense at the time. The therapist asks the patient what he or she sees as having been gained and lost by the event, and what the patient has gleaned from the experience. The goal is to help the patient understand what happened and its purpose, and also to discuss issues that need to be addressed going forward. “In a respectful, nonshaming way we get the patient to talk about what happened and how they got there,” he said.
The TMBI is a “drop in the ocean” of talk therapy that the patient will eventually receive, he said, but it is “all about the context.” In usual care, although the suicide attempter in the ICU may see a therapist, the conversation is generally about risk management and discharge planning.
In the initial test of the efficacy of this approach, Dr. O’Connor randomized 30 suicide survivors in the ICU to usual care or usual care plus the TMBI. The results showed a high level of patient satisfaction with the intervention and statistically significant improvements in readiness to change and in reasons for living, compared with controls (Gen Hosp Psychiatry. 2015 Sept-Oct;37[5]:427-33).
In a second pilot study that has not yet been published, Dr. O’Connor and his associates at Vanderbilt University in Nashville treated 32 patients with the TMBI and usual care and 25 with usual care only, with the study primarily designed to assess feasibility and acceptability to patients. Once again, patients who received the TMBI reported a high level of satisfaction with the encounter, including an average 3.96 rating (1-4 scale) of how likely they were to return to the service for future needs. Patients who received the extra intervention also showed trends toward a higher level of motivation after 3 months and less suicide ideation.
Further small-scale studies of the TMBI are now underway at two U.S. centers, and Dr. O’Connor said that a larger-scale test of the approach is now appropriate. One of the current limiting factors in dissemination is the training needed to perform a TMBI. One way to better leverage trained therapists might be to have the intervention occur remotely through telemedicine, with the patient encounter happening on a hand-held device.
The evidence collected so far on the TMBI has not yet proven its efficacy, Dr. O’Connor stressed. “We need to see to what degree this makes a difference. But there is clearly need for more engagement” with patients when they are in the ICU immediately after a suicide attempt. “Maybe it’s not the intervention, but just having someone being kind to the patient and sitting with them,” he suggested.
SOURCE: O’Connor S et al. American Association of Suicidology annual conference.
REPORTING FROM THE AAS ANNUAL CONFERENCE
Key clinical point: A 30- to 45-minute conversation was feasible and acceptable to suicide-attempt survivors in the ICU.
Major finding: Overall patient satisfaction with the intervention was rated 3.88 on a 1-4 scale.
Study details: Single-center randomized study with 57 patients.
Disclosures: Dr. O’Connor had no disclosures.
Source: O’Connor S et al. American Association of Suicidology annual conference.