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Simulation model favors hernia surgery over watchful waiting
WASHINGTON – Surgical repair of ventral hernias at time of diagnosis is a more cost-effective approach than watchful waiting, according to the results of a state-transition microsimulation model presented by Lindsey Wolf, MD, at the annual clinical congress of the American College of Surgeons.
The benefit of surgical intervention, compared with observation or watchful waiting for reducible ventral hernias is not well described, reported Dr. Wolf, a general surgery resident at Brigham and Women’s Hospital, Boston.
In the model, cost was represented in U.S. dollars and benefit was indicated by quality-adjusted life years (QALY). Both measures accumulated for individual patients over time and then were averaged and reported for an entire cohort of simulated patients, Dr. Wolf explained. Incremental cost effectiveness, a measure represented as a ratio of cost per QALY gained for each strategy, “provides context by allowing us to compare each strategy to the next best strategy,” explained Dr. Wolf.
Willingness to pay, a threshold set by the government that represents the maximum amount a payer is willing to spend for additional quality, was set at a threshold of $50,000 dollars per QALY, which is a “commonly accepted willingness-to pay-threshold,” she said.
The model’s primary outcomes were lifetime costs, QALYs from time of diagnosis, and incremental cost-effectiveness ratios.
“We built a state-transition microsimulation model which represents the different health states a patient can occupy at any point in time,” Dr. Wolf reported. “Using a yearly cycle, a cohort of patients were simulated through the model one at a time.”
All patients entered the model in an asymptomatic state. For each year there was a probability for a patient to transition from the current state to another state in the model.
Patients who underwent surgical repair at diagnosis were transitioned to the no-hernia state in the first year after undergoing surgery. Those in the watchful-waiting group stayed in the asymptotic state and each year there was a probability of becoming symptomatic. Of those who became symptomatic, there was a small probability that they would present with an incarcerated hernia and would require emergent surgery rather than elective surgery. Patients were subjected to perioperative mortality rates, as well as background yearly risk of death.
Cohort characteristics, hospital and other costs, perioperative mortality, and quality of life were derived from best available published studies and the Nationwide Inpatient Sample, the largest all-payer inpatient care database in the United States.
Overall, laparoscopic surgery at diagnosis was the optimal hernia repair strategy, reported Dr. Wolf.
Although laparoscopic surgery was the most expensive, it was also the most effective and, compared with watchful waiting – the least expensive and least effective strategy – the incremental cost-effectiveness ratio was about $14,800 per QALY.
Open repair at diagnosis fell between the watchful-waiting and laparoscopic-repair strategies in terms of cost and effectiveness.
To understand the conditions in which the optimal strategy changed, the researchers performed sensitivity analysis using the net monetary benefit metric, which represented both costs and benefits in a single unit at a given willingness to pay threshold.
“For a cohort of high-risk patients, once the perioperative risk of death exceeds 3.4%, watchful waiting becomes the preferred strategy,” Dr. Wolf said. Watchful waiting also was the preferred strategy when the yearly risk of recurrence exceeded 24%.
A sensitivity analysis comparing quality of life for elective open and laparoscopic repair revealed that, when quality-of-life measures were similar between the two surgical repair groups, the open repair became the preferred strategy.
Finally, researchers performed probabilistic sensitivity analysis by simulating the cohort of 100,000 patients 100 times and each time deriving results that were similar – an indication of robust results.
“In conclusion, we found that, for a typical cohort of patients with ventral hernia, laparoscopic repair at diagnosis is very cost effective. As long-term outcomes for open and laparoscopic repair were very similar in the model, the decision between laparoscopic and open surgery depends on surgeon experience and preference for one method over another,” said Dr. Wolf.
This study was funded by the Resident Research Scholarship awarded by the American College of Surgeons. Dr. Wolf reported having no disclosures.
jcraig@frontlinemedcom.com
On Twitter @jessnicolecraig
WASHINGTON – Surgical repair of ventral hernias at time of diagnosis is a more cost-effective approach than watchful waiting, according to the results of a state-transition microsimulation model presented by Lindsey Wolf, MD, at the annual clinical congress of the American College of Surgeons.
The benefit of surgical intervention, compared with observation or watchful waiting for reducible ventral hernias is not well described, reported Dr. Wolf, a general surgery resident at Brigham and Women’s Hospital, Boston.
In the model, cost was represented in U.S. dollars and benefit was indicated by quality-adjusted life years (QALY). Both measures accumulated for individual patients over time and then were averaged and reported for an entire cohort of simulated patients, Dr. Wolf explained. Incremental cost effectiveness, a measure represented as a ratio of cost per QALY gained for each strategy, “provides context by allowing us to compare each strategy to the next best strategy,” explained Dr. Wolf.
Willingness to pay, a threshold set by the government that represents the maximum amount a payer is willing to spend for additional quality, was set at a threshold of $50,000 dollars per QALY, which is a “commonly accepted willingness-to pay-threshold,” she said.
The model’s primary outcomes were lifetime costs, QALYs from time of diagnosis, and incremental cost-effectiveness ratios.
“We built a state-transition microsimulation model which represents the different health states a patient can occupy at any point in time,” Dr. Wolf reported. “Using a yearly cycle, a cohort of patients were simulated through the model one at a time.”
All patients entered the model in an asymptomatic state. For each year there was a probability for a patient to transition from the current state to another state in the model.
Patients who underwent surgical repair at diagnosis were transitioned to the no-hernia state in the first year after undergoing surgery. Those in the watchful-waiting group stayed in the asymptotic state and each year there was a probability of becoming symptomatic. Of those who became symptomatic, there was a small probability that they would present with an incarcerated hernia and would require emergent surgery rather than elective surgery. Patients were subjected to perioperative mortality rates, as well as background yearly risk of death.
Cohort characteristics, hospital and other costs, perioperative mortality, and quality of life were derived from best available published studies and the Nationwide Inpatient Sample, the largest all-payer inpatient care database in the United States.
Overall, laparoscopic surgery at diagnosis was the optimal hernia repair strategy, reported Dr. Wolf.
Although laparoscopic surgery was the most expensive, it was also the most effective and, compared with watchful waiting – the least expensive and least effective strategy – the incremental cost-effectiveness ratio was about $14,800 per QALY.
Open repair at diagnosis fell between the watchful-waiting and laparoscopic-repair strategies in terms of cost and effectiveness.
To understand the conditions in which the optimal strategy changed, the researchers performed sensitivity analysis using the net monetary benefit metric, which represented both costs and benefits in a single unit at a given willingness to pay threshold.
“For a cohort of high-risk patients, once the perioperative risk of death exceeds 3.4%, watchful waiting becomes the preferred strategy,” Dr. Wolf said. Watchful waiting also was the preferred strategy when the yearly risk of recurrence exceeded 24%.
A sensitivity analysis comparing quality of life for elective open and laparoscopic repair revealed that, when quality-of-life measures were similar between the two surgical repair groups, the open repair became the preferred strategy.
Finally, researchers performed probabilistic sensitivity analysis by simulating the cohort of 100,000 patients 100 times and each time deriving results that were similar – an indication of robust results.
“In conclusion, we found that, for a typical cohort of patients with ventral hernia, laparoscopic repair at diagnosis is very cost effective. As long-term outcomes for open and laparoscopic repair were very similar in the model, the decision between laparoscopic and open surgery depends on surgeon experience and preference for one method over another,” said Dr. Wolf.
This study was funded by the Resident Research Scholarship awarded by the American College of Surgeons. Dr. Wolf reported having no disclosures.
jcraig@frontlinemedcom.com
On Twitter @jessnicolecraig
WASHINGTON – Surgical repair of ventral hernias at time of diagnosis is a more cost-effective approach than watchful waiting, according to the results of a state-transition microsimulation model presented by Lindsey Wolf, MD, at the annual clinical congress of the American College of Surgeons.
The benefit of surgical intervention, compared with observation or watchful waiting for reducible ventral hernias is not well described, reported Dr. Wolf, a general surgery resident at Brigham and Women’s Hospital, Boston.
In the model, cost was represented in U.S. dollars and benefit was indicated by quality-adjusted life years (QALY). Both measures accumulated for individual patients over time and then were averaged and reported for an entire cohort of simulated patients, Dr. Wolf explained. Incremental cost effectiveness, a measure represented as a ratio of cost per QALY gained for each strategy, “provides context by allowing us to compare each strategy to the next best strategy,” explained Dr. Wolf.
Willingness to pay, a threshold set by the government that represents the maximum amount a payer is willing to spend for additional quality, was set at a threshold of $50,000 dollars per QALY, which is a “commonly accepted willingness-to pay-threshold,” she said.
The model’s primary outcomes were lifetime costs, QALYs from time of diagnosis, and incremental cost-effectiveness ratios.
“We built a state-transition microsimulation model which represents the different health states a patient can occupy at any point in time,” Dr. Wolf reported. “Using a yearly cycle, a cohort of patients were simulated through the model one at a time.”
All patients entered the model in an asymptomatic state. For each year there was a probability for a patient to transition from the current state to another state in the model.
Patients who underwent surgical repair at diagnosis were transitioned to the no-hernia state in the first year after undergoing surgery. Those in the watchful-waiting group stayed in the asymptotic state and each year there was a probability of becoming symptomatic. Of those who became symptomatic, there was a small probability that they would present with an incarcerated hernia and would require emergent surgery rather than elective surgery. Patients were subjected to perioperative mortality rates, as well as background yearly risk of death.
Cohort characteristics, hospital and other costs, perioperative mortality, and quality of life were derived from best available published studies and the Nationwide Inpatient Sample, the largest all-payer inpatient care database in the United States.
Overall, laparoscopic surgery at diagnosis was the optimal hernia repair strategy, reported Dr. Wolf.
Although laparoscopic surgery was the most expensive, it was also the most effective and, compared with watchful waiting – the least expensive and least effective strategy – the incremental cost-effectiveness ratio was about $14,800 per QALY.
Open repair at diagnosis fell between the watchful-waiting and laparoscopic-repair strategies in terms of cost and effectiveness.
To understand the conditions in which the optimal strategy changed, the researchers performed sensitivity analysis using the net monetary benefit metric, which represented both costs and benefits in a single unit at a given willingness to pay threshold.
“For a cohort of high-risk patients, once the perioperative risk of death exceeds 3.4%, watchful waiting becomes the preferred strategy,” Dr. Wolf said. Watchful waiting also was the preferred strategy when the yearly risk of recurrence exceeded 24%.
A sensitivity analysis comparing quality of life for elective open and laparoscopic repair revealed that, when quality-of-life measures were similar between the two surgical repair groups, the open repair became the preferred strategy.
Finally, researchers performed probabilistic sensitivity analysis by simulating the cohort of 100,000 patients 100 times and each time deriving results that were similar – an indication of robust results.
“In conclusion, we found that, for a typical cohort of patients with ventral hernia, laparoscopic repair at diagnosis is very cost effective. As long-term outcomes for open and laparoscopic repair were very similar in the model, the decision between laparoscopic and open surgery depends on surgeon experience and preference for one method over another,” said Dr. Wolf.
This study was funded by the Resident Research Scholarship awarded by the American College of Surgeons. Dr. Wolf reported having no disclosures.
jcraig@frontlinemedcom.com
On Twitter @jessnicolecraig
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: The incremental cost-effectiveness ratio for laparoscopic surgery, compared with watchful waiting, was about $14,800 per QALY.
Data source: A state-transition microsimulation model of 100,000 people.
Disclosures: This study was funded by the Resident Research Scholarship awarded by the American College of Surgeons. Dr. Wolf reported having no disclosures.
Lack of health literacy and normal routine implicated in hepatitis B virus treatment nonadherence
BOSTON – Lack of health literacy, lack of routine, and being a nonnative speaker of English were predictors of treatment nonadherence in one-quarter of adults with hepatitis B virus in Australia, according to a study.
“Clinicians don’t know this is happening. We overlook it. Because it’s just one tablet a day, we think it’s quite easy, but when I took up this project, I completely underestimated the complexity of adherence and how many different factors can play into why a patient does or doesn’t adhere,” Suzanne Sheppard-Law, RN, MPH, PhD, a senior research fellow at the University of Technology Sydney, said in an interview about her prize-winning poster presentation at this year’s annual meeting of the American Association for the Study of Liver Diseases.
The findings grew from Dr. Sheppard-Law’s clinical practice where she noticed a trend in some patients whose treatment regimen would lose efficacy over time. When switched to other therapies, the pattern would be repeated. Dr. Sheppard-Law interviewed 29 of these patients in person to see if there were commonalities she could address.
“The deeper I dug, the more it all unfolded before me,” she said. It turned out that patients who’d been endorsing adherence were not. In some cases, patients were skipping their medications for days at a time.
This informal study lead to a more formal one focused on a patient’s level of health literacy. Dr. Sheppard-Law and her colleagues examined factors the World Health Organization says are implicated in adherence, including ones that are social and economic, and others that are related to clinical worker interactions, health systems, individual therapy and condition, and patient considerations. They conducted in-person interviews and worked with the patients as they completed the Newest Vital Sign health literacy survey online.
Just over a fifth of respondents said they followed a regular routine when taking their medication, such as taking it at a certain time every day; however, three-quarters of those surveyed said they didn’t think having a routine made any difference (P less than .001). Half of respondents were prescribed at least one additional daily medication to their antiretroviral pill. A third had no idea what type of medication was prescribed for their hepatitis B.
Whether the person was proficient in English, and the impact this had on perceived communication between the patient and clinician was another factor, as most of the patients in the study were immigrants to Australia who’d been living there, on average, about 19 years. Only 27% of the study group reported that they spoke English at home as their primary language.
“It has to be individually focused, person-centered care, is the conclusion I came to,” Dr. Sheppard-Law said. Although her findings do not indicate a need for more resources in the clinic, she did say that clinicians could help patients by asking them to repeat back to them what they have heard.
“I don’t believe it has to be more resource intense; you just need to be sure the patient understands at the beginning what they need to do. Then you have a better chance [they will adhere],” she said. Because patients with poor health literacy are unlikely to tell their clinician that they do not fully grasp what they are being told about their condition and their treatment, Dr. Sheppard-Law suggested asking patients at the end of their consultation to detail what their routine will be, what they will do if they lose their prescription, what they will do if they run out of medication, and asking if they understand that their medication must be taken daily. “They need to understand it’s not okay to skip a day,” she said. “It’s our responsibility to ensure they know that.”
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
BOSTON – Lack of health literacy, lack of routine, and being a nonnative speaker of English were predictors of treatment nonadherence in one-quarter of adults with hepatitis B virus in Australia, according to a study.
“Clinicians don’t know this is happening. We overlook it. Because it’s just one tablet a day, we think it’s quite easy, but when I took up this project, I completely underestimated the complexity of adherence and how many different factors can play into why a patient does or doesn’t adhere,” Suzanne Sheppard-Law, RN, MPH, PhD, a senior research fellow at the University of Technology Sydney, said in an interview about her prize-winning poster presentation at this year’s annual meeting of the American Association for the Study of Liver Diseases.
The findings grew from Dr. Sheppard-Law’s clinical practice where she noticed a trend in some patients whose treatment regimen would lose efficacy over time. When switched to other therapies, the pattern would be repeated. Dr. Sheppard-Law interviewed 29 of these patients in person to see if there were commonalities she could address.
“The deeper I dug, the more it all unfolded before me,” she said. It turned out that patients who’d been endorsing adherence were not. In some cases, patients were skipping their medications for days at a time.
This informal study lead to a more formal one focused on a patient’s level of health literacy. Dr. Sheppard-Law and her colleagues examined factors the World Health Organization says are implicated in adherence, including ones that are social and economic, and others that are related to clinical worker interactions, health systems, individual therapy and condition, and patient considerations. They conducted in-person interviews and worked with the patients as they completed the Newest Vital Sign health literacy survey online.
Just over a fifth of respondents said they followed a regular routine when taking their medication, such as taking it at a certain time every day; however, three-quarters of those surveyed said they didn’t think having a routine made any difference (P less than .001). Half of respondents were prescribed at least one additional daily medication to their antiretroviral pill. A third had no idea what type of medication was prescribed for their hepatitis B.
Whether the person was proficient in English, and the impact this had on perceived communication between the patient and clinician was another factor, as most of the patients in the study were immigrants to Australia who’d been living there, on average, about 19 years. Only 27% of the study group reported that they spoke English at home as their primary language.
“It has to be individually focused, person-centered care, is the conclusion I came to,” Dr. Sheppard-Law said. Although her findings do not indicate a need for more resources in the clinic, she did say that clinicians could help patients by asking them to repeat back to them what they have heard.
“I don’t believe it has to be more resource intense; you just need to be sure the patient understands at the beginning what they need to do. Then you have a better chance [they will adhere],” she said. Because patients with poor health literacy are unlikely to tell their clinician that they do not fully grasp what they are being told about their condition and their treatment, Dr. Sheppard-Law suggested asking patients at the end of their consultation to detail what their routine will be, what they will do if they lose their prescription, what they will do if they run out of medication, and asking if they understand that their medication must be taken daily. “They need to understand it’s not okay to skip a day,” she said. “It’s our responsibility to ensure they know that.”
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
BOSTON – Lack of health literacy, lack of routine, and being a nonnative speaker of English were predictors of treatment nonadherence in one-quarter of adults with hepatitis B virus in Australia, according to a study.
“Clinicians don’t know this is happening. We overlook it. Because it’s just one tablet a day, we think it’s quite easy, but when I took up this project, I completely underestimated the complexity of adherence and how many different factors can play into why a patient does or doesn’t adhere,” Suzanne Sheppard-Law, RN, MPH, PhD, a senior research fellow at the University of Technology Sydney, said in an interview about her prize-winning poster presentation at this year’s annual meeting of the American Association for the Study of Liver Diseases.
The findings grew from Dr. Sheppard-Law’s clinical practice where she noticed a trend in some patients whose treatment regimen would lose efficacy over time. When switched to other therapies, the pattern would be repeated. Dr. Sheppard-Law interviewed 29 of these patients in person to see if there were commonalities she could address.
“The deeper I dug, the more it all unfolded before me,” she said. It turned out that patients who’d been endorsing adherence were not. In some cases, patients were skipping their medications for days at a time.
This informal study lead to a more formal one focused on a patient’s level of health literacy. Dr. Sheppard-Law and her colleagues examined factors the World Health Organization says are implicated in adherence, including ones that are social and economic, and others that are related to clinical worker interactions, health systems, individual therapy and condition, and patient considerations. They conducted in-person interviews and worked with the patients as they completed the Newest Vital Sign health literacy survey online.
Just over a fifth of respondents said they followed a regular routine when taking their medication, such as taking it at a certain time every day; however, three-quarters of those surveyed said they didn’t think having a routine made any difference (P less than .001). Half of respondents were prescribed at least one additional daily medication to their antiretroviral pill. A third had no idea what type of medication was prescribed for their hepatitis B.
Whether the person was proficient in English, and the impact this had on perceived communication between the patient and clinician was another factor, as most of the patients in the study were immigrants to Australia who’d been living there, on average, about 19 years. Only 27% of the study group reported that they spoke English at home as their primary language.
“It has to be individually focused, person-centered care, is the conclusion I came to,” Dr. Sheppard-Law said. Although her findings do not indicate a need for more resources in the clinic, she did say that clinicians could help patients by asking them to repeat back to them what they have heard.
“I don’t believe it has to be more resource intense; you just need to be sure the patient understands at the beginning what they need to do. Then you have a better chance [they will adhere],” she said. Because patients with poor health literacy are unlikely to tell their clinician that they do not fully grasp what they are being told about their condition and their treatment, Dr. Sheppard-Law suggested asking patients at the end of their consultation to detail what their routine will be, what they will do if they lose their prescription, what they will do if they run out of medication, and asking if they understand that their medication must be taken daily. “They need to understand it’s not okay to skip a day,” she said. “It’s our responsibility to ensure they know that.”
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
AT THE LIVER MEETING 2016
Key clinical point:
Major finding: A quarter of adults with hepatitis B virus were treatment noncompliant in the past 30 days.
Data source: In-person and online survey of 277 adults with hepatitis B virus.
Disclosures: Dr. Sheppard-Law did not have any relevant disclosures.
Urate-lowering therapy poses no harm to kidney function
WASHINGTON – Evidence supporting the renal benefits of urate-lowering therapy in patients with hyperuricemia and gout comes from two separate studies presented at the annual meeting of the American College of Rheumatology.
In the first study, allopurinol did not increase the risk of developing chronic kidney disease (CKD) in newly diagnosed patients with gout and normal or near-normal kidney function. The second study found that urate-lowering therapy (ULT) improved kidney function in patients who already had CKD.
Allopurinol in gout
The study was prompted by the recognition that gout patients are underdiagnosed and undertreated, and even when they have a diagnosis, both patients and primary care physicians who treat the majority of gout patients shy away from ULT.
“Further exacerbating the poor management of gout is the common practice of lowering the dose or stopping allopurinol when a patient with gout begins to have a decline in kidney function, which inevitably adds to the poor control of gout,” Dr. Vargas-Santos explained.
The study was based on electronic health records from the Health Improvement Network (THIN) database that includes patients treated by general practitioners in the United Kingdom. The study enrolled 13,608 patients with newly diagnosed gout and normal kidney function who initiated ULT with allopurinol; these patients were compared with 13,608 gout patients (matched by propensity score) in the THIN database who did not start ULT.
Patients were aged 18-89 years (mean age, 58 years) with incident gout diagnosed between 2000 and 2014 who had at least one contact with a general practitioner within a year of study enrollment. The investigators analyzed the relationship between allopurinol use by gout patients and the development of CKD stage 3 or higher.
At a mean follow-up of 4 years, there was no increased risk of developing CKD stage 3 or higher in the allopurinol users: 1,401 of the allopurinol initiators versus 1,319 of nonusers developed CKD stage 3 or higher. The relative risk of developing CKD stage 3 or higher on allopurinol was 1.05, which was not statistically significant. “Our study shows that there was no risk of harm to the kidney with allopurinol. This suggests that if a patient on gout presents with declining kidney function, it is better to look for other causes and keep the patient on allopurinol to lower serum urate. Accumulating evidence supports this. Doctors have to be less fearful of prescribing allopurinol. Gout patients deserve better,” Dr. Vargas-Santos said.
ULT in CKD
ULT improved kidney function in patients with CKD in a large retrospective study, with the greatest improvement observed in patients with CKD stage 3 and some improvement observed in patients with CKD stage 2. ULT had no benefit in patients with CKD stage 4, suggesting that these patients are too advanced to improve.
The study was conducted from 2008 to 2014 and included 12,751 patients with serum urate levels of greater than 7 mg/dL and CKD stages 2, 3, and 4 at the index date (the first time this test result was reported). Patients were drawn from the Kaiser Permanente database and treated by primary care physicians. Patients were followed for 1 year from the index date. The primary outcome measure was a 30% increase or a 30% decrease in glomerular filtration rate (GFR) from baseline to the last available result.
Of the 12,751 patients, 2,690 were on ULT and 10,061 were not. Goal serum urate (sUA) was achieved in 1,118 (42%) of patients on ULT. Among patients who achieved goal sUA, a 30% improvement in GFR was observed in 17.1% versus 10.4% of patients who did not achieve goal sUA, for an absolute difference of 6.7% (P less than .001).
For patients at goal versus those not at goal, the ratio of improvement was 3.4 and 3.8, respectively.
“This study suggests that patients with CKD should be tested for uric acid independent of whether they have gout or not. Getting to goal is important. Stage 3 CKD is the sweet spot where patients got the most pronounced benefit from urate-lowering therapy,” he said. “Stage 4 CDK is too late.”
The authors of both studies had no relevant financial disclosures to report.
WASHINGTON – Evidence supporting the renal benefits of urate-lowering therapy in patients with hyperuricemia and gout comes from two separate studies presented at the annual meeting of the American College of Rheumatology.
In the first study, allopurinol did not increase the risk of developing chronic kidney disease (CKD) in newly diagnosed patients with gout and normal or near-normal kidney function. The second study found that urate-lowering therapy (ULT) improved kidney function in patients who already had CKD.
Allopurinol in gout
The study was prompted by the recognition that gout patients are underdiagnosed and undertreated, and even when they have a diagnosis, both patients and primary care physicians who treat the majority of gout patients shy away from ULT.
“Further exacerbating the poor management of gout is the common practice of lowering the dose or stopping allopurinol when a patient with gout begins to have a decline in kidney function, which inevitably adds to the poor control of gout,” Dr. Vargas-Santos explained.
The study was based on electronic health records from the Health Improvement Network (THIN) database that includes patients treated by general practitioners in the United Kingdom. The study enrolled 13,608 patients with newly diagnosed gout and normal kidney function who initiated ULT with allopurinol; these patients were compared with 13,608 gout patients (matched by propensity score) in the THIN database who did not start ULT.
Patients were aged 18-89 years (mean age, 58 years) with incident gout diagnosed between 2000 and 2014 who had at least one contact with a general practitioner within a year of study enrollment. The investigators analyzed the relationship between allopurinol use by gout patients and the development of CKD stage 3 or higher.
At a mean follow-up of 4 years, there was no increased risk of developing CKD stage 3 or higher in the allopurinol users: 1,401 of the allopurinol initiators versus 1,319 of nonusers developed CKD stage 3 or higher. The relative risk of developing CKD stage 3 or higher on allopurinol was 1.05, which was not statistically significant. “Our study shows that there was no risk of harm to the kidney with allopurinol. This suggests that if a patient on gout presents with declining kidney function, it is better to look for other causes and keep the patient on allopurinol to lower serum urate. Accumulating evidence supports this. Doctors have to be less fearful of prescribing allopurinol. Gout patients deserve better,” Dr. Vargas-Santos said.
ULT in CKD
ULT improved kidney function in patients with CKD in a large retrospective study, with the greatest improvement observed in patients with CKD stage 3 and some improvement observed in patients with CKD stage 2. ULT had no benefit in patients with CKD stage 4, suggesting that these patients are too advanced to improve.
The study was conducted from 2008 to 2014 and included 12,751 patients with serum urate levels of greater than 7 mg/dL and CKD stages 2, 3, and 4 at the index date (the first time this test result was reported). Patients were drawn from the Kaiser Permanente database and treated by primary care physicians. Patients were followed for 1 year from the index date. The primary outcome measure was a 30% increase or a 30% decrease in glomerular filtration rate (GFR) from baseline to the last available result.
Of the 12,751 patients, 2,690 were on ULT and 10,061 were not. Goal serum urate (sUA) was achieved in 1,118 (42%) of patients on ULT. Among patients who achieved goal sUA, a 30% improvement in GFR was observed in 17.1% versus 10.4% of patients who did not achieve goal sUA, for an absolute difference of 6.7% (P less than .001).
For patients at goal versus those not at goal, the ratio of improvement was 3.4 and 3.8, respectively.
“This study suggests that patients with CKD should be tested for uric acid independent of whether they have gout or not. Getting to goal is important. Stage 3 CKD is the sweet spot where patients got the most pronounced benefit from urate-lowering therapy,” he said. “Stage 4 CDK is too late.”
The authors of both studies had no relevant financial disclosures to report.
WASHINGTON – Evidence supporting the renal benefits of urate-lowering therapy in patients with hyperuricemia and gout comes from two separate studies presented at the annual meeting of the American College of Rheumatology.
In the first study, allopurinol did not increase the risk of developing chronic kidney disease (CKD) in newly diagnosed patients with gout and normal or near-normal kidney function. The second study found that urate-lowering therapy (ULT) improved kidney function in patients who already had CKD.
Allopurinol in gout
The study was prompted by the recognition that gout patients are underdiagnosed and undertreated, and even when they have a diagnosis, both patients and primary care physicians who treat the majority of gout patients shy away from ULT.
“Further exacerbating the poor management of gout is the common practice of lowering the dose or stopping allopurinol when a patient with gout begins to have a decline in kidney function, which inevitably adds to the poor control of gout,” Dr. Vargas-Santos explained.
The study was based on electronic health records from the Health Improvement Network (THIN) database that includes patients treated by general practitioners in the United Kingdom. The study enrolled 13,608 patients with newly diagnosed gout and normal kidney function who initiated ULT with allopurinol; these patients were compared with 13,608 gout patients (matched by propensity score) in the THIN database who did not start ULT.
Patients were aged 18-89 years (mean age, 58 years) with incident gout diagnosed between 2000 and 2014 who had at least one contact with a general practitioner within a year of study enrollment. The investigators analyzed the relationship between allopurinol use by gout patients and the development of CKD stage 3 or higher.
At a mean follow-up of 4 years, there was no increased risk of developing CKD stage 3 or higher in the allopurinol users: 1,401 of the allopurinol initiators versus 1,319 of nonusers developed CKD stage 3 or higher. The relative risk of developing CKD stage 3 or higher on allopurinol was 1.05, which was not statistically significant. “Our study shows that there was no risk of harm to the kidney with allopurinol. This suggests that if a patient on gout presents with declining kidney function, it is better to look for other causes and keep the patient on allopurinol to lower serum urate. Accumulating evidence supports this. Doctors have to be less fearful of prescribing allopurinol. Gout patients deserve better,” Dr. Vargas-Santos said.
ULT in CKD
ULT improved kidney function in patients with CKD in a large retrospective study, with the greatest improvement observed in patients with CKD stage 3 and some improvement observed in patients with CKD stage 2. ULT had no benefit in patients with CKD stage 4, suggesting that these patients are too advanced to improve.
The study was conducted from 2008 to 2014 and included 12,751 patients with serum urate levels of greater than 7 mg/dL and CKD stages 2, 3, and 4 at the index date (the first time this test result was reported). Patients were drawn from the Kaiser Permanente database and treated by primary care physicians. Patients were followed for 1 year from the index date. The primary outcome measure was a 30% increase or a 30% decrease in glomerular filtration rate (GFR) from baseline to the last available result.
Of the 12,751 patients, 2,690 were on ULT and 10,061 were not. Goal serum urate (sUA) was achieved in 1,118 (42%) of patients on ULT. Among patients who achieved goal sUA, a 30% improvement in GFR was observed in 17.1% versus 10.4% of patients who did not achieve goal sUA, for an absolute difference of 6.7% (P less than .001).
For patients at goal versus those not at goal, the ratio of improvement was 3.4 and 3.8, respectively.
“This study suggests that patients with CKD should be tested for uric acid independent of whether they have gout or not. Getting to goal is important. Stage 3 CKD is the sweet spot where patients got the most pronounced benefit from urate-lowering therapy,” he said. “Stage 4 CDK is too late.”
The authors of both studies had no relevant financial disclosures to report.
AT THE ACR ANNUAL MEETING
Key clinical point:
Major finding: The first study found that allopurinol did not increase the risk of developing CKD stage 3 or higher in gout patients with normal or near-normal kidney function. The second study found that reaching goal with urate-lowering therapy led to improved kidney function, especially in patients with stage 3 CKD.
Data source: Two population-based studies based on the U.K.’s THIN database. The first included 13,608 patients and 13,608 matched controls. The second study included 12,751 patients with serum urate levels of greater than 7 mg/dL.
Disclosures: The authors of both studies had no relevant financial disclosures to report.
VIDEO: For CABG, double arterial grafts found no better than single
NEW ORLEANS – Patients undergoing coronary artery bypass graft (CABG) surgery do not see any 5-year survival advantage when their surgeon uses both internal mammary (thoracic) arteries for grafting rather than just one of them along with a vein, finds an interim analysis from the randomized Arterial Revascularization Trial (ART).
Overall, about 8.5% of the 3,102 patients randomized had died 5 years after surgery, with no significant difference between the bilateral graft and single graft groups, according to data reported at the American Heart Association scientific sessions and simultaneously published (N Engl J Med. 2016 Nov 14. doi: 10.1056/NEJMoa1610021). The former had roughly triple the rate of sternal reconstruction, mainly driven by complications in insulin-dependent diabetes patients having high body mass index.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
There is strong angiographic evidence that vein grafts have a high rate of failure over time because of atherosclerosis, but internal mammary artery grafts retain excellent patency, he elaborated. “People have speculated that this superior patency of internal mammary arteries will translate into a clinical survival benefit,” and observational data indeed suggest that the bilateral artery strategy reduces mortality by about one-fifth relative to the single artery strategy.
Yet uptake of the bilateral procedure has been low. It is used in fewer than 5% of patients undergoing CABG in the United States and fewer than 10% of those in Europe, reflecting concerns about its greater technical complexity, potentially increased mortality and morbidity, and – until now – lack of evidence from randomized trials.
“What I think we can conclude today is that there are excellent 5-year outcomes of CABG in both groups. This study confirms that it’s at least safe to use bilateral grafts over the medium term,” Dr. Taggart commented. He discussed the results in a video interview conducted at the meeting.
These interim ART data probably won’t sway practice one way or the other, he said. “People who believe in arterial grafts will continue to do them, and those who are not enthusiastic about the prospect of a slightly technically more difficult operation [can now] remain comfortable as to why they are not using both internal mammary arteries.”
Pointed questions
The lack of difference was possibly due to a very high level of guideline-based medical therapy in the trial (which may have especially protected the vein grafts) or to the fact that the annual failure rate of vein grafts is modest and steady up to 5 years but accelerates thereafter, Dr. Taggart proposed. The trial’s primary outcome of 10-year survival, expected in 2018, will likely differ, speculated Dr. Sellke, who is also program chair for the AHA scientific sessions.
“Do you think multiple arterial grafting is superior to single internal mammary artery grafting considering the lack of improvement in survival and other outcomes in the study, with the increase in sternal wound infections?” he asked.
“I personally, if I needed the operation, would insist on having bilateral internal mammary artery grafts done by an experienced operator because it is totally counterintuitive to believe that having more patent grafts in your heart at 10 to 20 years of follow-up is of no benefit,” Dr. Taggart maintained.
When data meet clinical practice
It may require time for the benefit of the bilateral artery graft to emerge, he agreed. “I’m undeterred from my belief that ... in patients who are getting CABG done in their 40s or 50s or early 60s, betting on a graft that’s going to outperform vein grafts is the better strategy.”
Until the trial’s 10-year results become available, physicians may wish to put these interim results in the context when counseling patients, according to Dr. Gardner.
“We have indisputable evidence that arterial grafts have better long-term patency than vein grafts,” he elaborated. “If we had a very sophisticated patient, we might tell them that we were a little surprised that this head-to-head trial of single versus double didn’t show any survival benefit at 5 years, but we still are persuaded by the data that shows the better patency, and we think in the situation that the patient’s in, that we would still recommend a double mammary, assuming that the patient doesn’t have comorbidities that would make that more dangerous.”
Trial details
ART enrolled patients from 28 cardiac surgical centers in seven countries. The patients, all of whom had multivessel coronary disease and were scheduled to undergo CABG, were randomized evenly to single or bilateral internal thoracic artery grafts.
The interim results showed differences in nonadherence to the randomized operation: 2.4% of patients in the single graft group ultimately underwent got bilateral grafts, whereas 14% of patients in the bilateral graft group ultimately got a single graft.
“This raises questions about how experienced some surgeons were with the use of bilateral internal mammary artery grafts,” Dr. Taggart commented.
At 5 years of follow-up, 8.7% of patients in the bilateral graft group and 8.4% of patients in the single graft group had died, a nonsignificant difference. “Those mortalities are similar to what has been observed in other contemporary trials of CABG,” he noted. There was no difference between diabetic and nondiabetic patients with respect to this outcome.
The rate of the composite outcome of death, myocardial infarction, or stroke was 12.2% in the bilateral graft group and 12.7% in the single graft group, also a nonsignificant difference.
On the other hand, patients in the bilateral graft group had higher rates of sternal wound complications (3.5% vs. 1.9%; P = .005) and sternal reconstruction (1.9% vs. 0.6%; P = .002).
The groups were statistically indistinguishable with respect to rates of mortality, major bleeding, or need for repeat revascularization, as well as angina status and quality of life measures, according to Dr. Taggart, who disclosed that he had no relevant conflicts of interest.
NEW ORLEANS – Patients undergoing coronary artery bypass graft (CABG) surgery do not see any 5-year survival advantage when their surgeon uses both internal mammary (thoracic) arteries for grafting rather than just one of them along with a vein, finds an interim analysis from the randomized Arterial Revascularization Trial (ART).
Overall, about 8.5% of the 3,102 patients randomized had died 5 years after surgery, with no significant difference between the bilateral graft and single graft groups, according to data reported at the American Heart Association scientific sessions and simultaneously published (N Engl J Med. 2016 Nov 14. doi: 10.1056/NEJMoa1610021). The former had roughly triple the rate of sternal reconstruction, mainly driven by complications in insulin-dependent diabetes patients having high body mass index.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
There is strong angiographic evidence that vein grafts have a high rate of failure over time because of atherosclerosis, but internal mammary artery grafts retain excellent patency, he elaborated. “People have speculated that this superior patency of internal mammary arteries will translate into a clinical survival benefit,” and observational data indeed suggest that the bilateral artery strategy reduces mortality by about one-fifth relative to the single artery strategy.
Yet uptake of the bilateral procedure has been low. It is used in fewer than 5% of patients undergoing CABG in the United States and fewer than 10% of those in Europe, reflecting concerns about its greater technical complexity, potentially increased mortality and morbidity, and – until now – lack of evidence from randomized trials.
“What I think we can conclude today is that there are excellent 5-year outcomes of CABG in both groups. This study confirms that it’s at least safe to use bilateral grafts over the medium term,” Dr. Taggart commented. He discussed the results in a video interview conducted at the meeting.
These interim ART data probably won’t sway practice one way or the other, he said. “People who believe in arterial grafts will continue to do them, and those who are not enthusiastic about the prospect of a slightly technically more difficult operation [can now] remain comfortable as to why they are not using both internal mammary arteries.”
Pointed questions
The lack of difference was possibly due to a very high level of guideline-based medical therapy in the trial (which may have especially protected the vein grafts) or to the fact that the annual failure rate of vein grafts is modest and steady up to 5 years but accelerates thereafter, Dr. Taggart proposed. The trial’s primary outcome of 10-year survival, expected in 2018, will likely differ, speculated Dr. Sellke, who is also program chair for the AHA scientific sessions.
“Do you think multiple arterial grafting is superior to single internal mammary artery grafting considering the lack of improvement in survival and other outcomes in the study, with the increase in sternal wound infections?” he asked.
“I personally, if I needed the operation, would insist on having bilateral internal mammary artery grafts done by an experienced operator because it is totally counterintuitive to believe that having more patent grafts in your heart at 10 to 20 years of follow-up is of no benefit,” Dr. Taggart maintained.
When data meet clinical practice
It may require time for the benefit of the bilateral artery graft to emerge, he agreed. “I’m undeterred from my belief that ... in patients who are getting CABG done in their 40s or 50s or early 60s, betting on a graft that’s going to outperform vein grafts is the better strategy.”
Until the trial’s 10-year results become available, physicians may wish to put these interim results in the context when counseling patients, according to Dr. Gardner.
“We have indisputable evidence that arterial grafts have better long-term patency than vein grafts,” he elaborated. “If we had a very sophisticated patient, we might tell them that we were a little surprised that this head-to-head trial of single versus double didn’t show any survival benefit at 5 years, but we still are persuaded by the data that shows the better patency, and we think in the situation that the patient’s in, that we would still recommend a double mammary, assuming that the patient doesn’t have comorbidities that would make that more dangerous.”
Trial details
ART enrolled patients from 28 cardiac surgical centers in seven countries. The patients, all of whom had multivessel coronary disease and were scheduled to undergo CABG, were randomized evenly to single or bilateral internal thoracic artery grafts.
The interim results showed differences in nonadherence to the randomized operation: 2.4% of patients in the single graft group ultimately underwent got bilateral grafts, whereas 14% of patients in the bilateral graft group ultimately got a single graft.
“This raises questions about how experienced some surgeons were with the use of bilateral internal mammary artery grafts,” Dr. Taggart commented.
At 5 years of follow-up, 8.7% of patients in the bilateral graft group and 8.4% of patients in the single graft group had died, a nonsignificant difference. “Those mortalities are similar to what has been observed in other contemporary trials of CABG,” he noted. There was no difference between diabetic and nondiabetic patients with respect to this outcome.
The rate of the composite outcome of death, myocardial infarction, or stroke was 12.2% in the bilateral graft group and 12.7% in the single graft group, also a nonsignificant difference.
On the other hand, patients in the bilateral graft group had higher rates of sternal wound complications (3.5% vs. 1.9%; P = .005) and sternal reconstruction (1.9% vs. 0.6%; P = .002).
The groups were statistically indistinguishable with respect to rates of mortality, major bleeding, or need for repeat revascularization, as well as angina status and quality of life measures, according to Dr. Taggart, who disclosed that he had no relevant conflicts of interest.
NEW ORLEANS – Patients undergoing coronary artery bypass graft (CABG) surgery do not see any 5-year survival advantage when their surgeon uses both internal mammary (thoracic) arteries for grafting rather than just one of them along with a vein, finds an interim analysis from the randomized Arterial Revascularization Trial (ART).
Overall, about 8.5% of the 3,102 patients randomized had died 5 years after surgery, with no significant difference between the bilateral graft and single graft groups, according to data reported at the American Heart Association scientific sessions and simultaneously published (N Engl J Med. 2016 Nov 14. doi: 10.1056/NEJMoa1610021). The former had roughly triple the rate of sternal reconstruction, mainly driven by complications in insulin-dependent diabetes patients having high body mass index.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
There is strong angiographic evidence that vein grafts have a high rate of failure over time because of atherosclerosis, but internal mammary artery grafts retain excellent patency, he elaborated. “People have speculated that this superior patency of internal mammary arteries will translate into a clinical survival benefit,” and observational data indeed suggest that the bilateral artery strategy reduces mortality by about one-fifth relative to the single artery strategy.
Yet uptake of the bilateral procedure has been low. It is used in fewer than 5% of patients undergoing CABG in the United States and fewer than 10% of those in Europe, reflecting concerns about its greater technical complexity, potentially increased mortality and morbidity, and – until now – lack of evidence from randomized trials.
“What I think we can conclude today is that there are excellent 5-year outcomes of CABG in both groups. This study confirms that it’s at least safe to use bilateral grafts over the medium term,” Dr. Taggart commented. He discussed the results in a video interview conducted at the meeting.
These interim ART data probably won’t sway practice one way or the other, he said. “People who believe in arterial grafts will continue to do them, and those who are not enthusiastic about the prospect of a slightly technically more difficult operation [can now] remain comfortable as to why they are not using both internal mammary arteries.”
Pointed questions
The lack of difference was possibly due to a very high level of guideline-based medical therapy in the trial (which may have especially protected the vein grafts) or to the fact that the annual failure rate of vein grafts is modest and steady up to 5 years but accelerates thereafter, Dr. Taggart proposed. The trial’s primary outcome of 10-year survival, expected in 2018, will likely differ, speculated Dr. Sellke, who is also program chair for the AHA scientific sessions.
“Do you think multiple arterial grafting is superior to single internal mammary artery grafting considering the lack of improvement in survival and other outcomes in the study, with the increase in sternal wound infections?” he asked.
“I personally, if I needed the operation, would insist on having bilateral internal mammary artery grafts done by an experienced operator because it is totally counterintuitive to believe that having more patent grafts in your heart at 10 to 20 years of follow-up is of no benefit,” Dr. Taggart maintained.
When data meet clinical practice
It may require time for the benefit of the bilateral artery graft to emerge, he agreed. “I’m undeterred from my belief that ... in patients who are getting CABG done in their 40s or 50s or early 60s, betting on a graft that’s going to outperform vein grafts is the better strategy.”
Until the trial’s 10-year results become available, physicians may wish to put these interim results in the context when counseling patients, according to Dr. Gardner.
“We have indisputable evidence that arterial grafts have better long-term patency than vein grafts,” he elaborated. “If we had a very sophisticated patient, we might tell them that we were a little surprised that this head-to-head trial of single versus double didn’t show any survival benefit at 5 years, but we still are persuaded by the data that shows the better patency, and we think in the situation that the patient’s in, that we would still recommend a double mammary, assuming that the patient doesn’t have comorbidities that would make that more dangerous.”
Trial details
ART enrolled patients from 28 cardiac surgical centers in seven countries. The patients, all of whom had multivessel coronary disease and were scheduled to undergo CABG, were randomized evenly to single or bilateral internal thoracic artery grafts.
The interim results showed differences in nonadherence to the randomized operation: 2.4% of patients in the single graft group ultimately underwent got bilateral grafts, whereas 14% of patients in the bilateral graft group ultimately got a single graft.
“This raises questions about how experienced some surgeons were with the use of bilateral internal mammary artery grafts,” Dr. Taggart commented.
At 5 years of follow-up, 8.7% of patients in the bilateral graft group and 8.4% of patients in the single graft group had died, a nonsignificant difference. “Those mortalities are similar to what has been observed in other contemporary trials of CABG,” he noted. There was no difference between diabetic and nondiabetic patients with respect to this outcome.
The rate of the composite outcome of death, myocardial infarction, or stroke was 12.2% in the bilateral graft group and 12.7% in the single graft group, also a nonsignificant difference.
On the other hand, patients in the bilateral graft group had higher rates of sternal wound complications (3.5% vs. 1.9%; P = .005) and sternal reconstruction (1.9% vs. 0.6%; P = .002).
The groups were statistically indistinguishable with respect to rates of mortality, major bleeding, or need for repeat revascularization, as well as angina status and quality of life measures, according to Dr. Taggart, who disclosed that he had no relevant conflicts of interest.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: At 5 years, the rate of all-cause mortality was 8.7% in the bilateral graft group and 8.4% in the single graft group, a nonsignificant difference.
Data source: ART, a randomized trial among 3,102 patients with multivessel coronary disease undergoing CABG.
Disclosures: Dr. Taggart had no relevant conflicts of interest. The trial was funded by the U.K. Medical Research Council, the British Heart Foundation, and the U.K. National Institute of Health Research Efficacy and Mechanistic Evaluation.
VIDEO: Celecoxib just as safe as naproxen or ibuprofen in OA and RA
WASHINGTON – Celecoxib conferred a 53% decreased risk of overall mortality upon patients with rheumatoid arthritis when compared with naproxen – a surprise finding in a subanalysis of the newly released PRECISION study of anti-inflammatory drugs in arthritis.
But it’s tough to know what to make of the difference, according to the investigators at the annual meeting of the American College of Rheumatology. Although statistically significant, the mortality finding was based on just 45 events: 30 among those taking naproxen and 15 among those taking celecoxib.
“While I would say we were surprised to see this, we really can’t say what it means – or if it means anything,” primary investigator Daniel Solomon, MD, said in an interview. “This is a finding we will continue to investigate and look at, but at this point it’s not enough to base any prescribing decisions on.”
PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen) enrolled more than 24,000 patients with osteoarthritis or rheumatoid arthritis. They were randomized to celecoxib, naproxen, or ibuprofen for a mean of 20 months, with an additional mean follow-up of 34 months.
The primary outcome was the first occurrence of an adverse event from the Antiplatelet Trialists Collaboration criteria (APTC; death from cardiovascular causes, nonfatal heart attack, or nonfatal stroke). Secondary outcomes included:
• Major cardiovascular events (heart attack, stroke, cardiovascular death, revascularization, and hospitalization for unstable angina or transient ischemic attack).
• Renal events (acute kidney injury, including hospitalization for renal failure).
• Gastrointestinal events (hemorrhage, perforation, gastroduodenal ulcer, anemia of gastrointestinal origin, and gastric outlet obstruction.
The main PRECISION findings were released Nov. 13 at the annual meeting of the American Heart Association and simultaneously published in the New England Journal of Medicine (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1611593).
Overall, celecoxib was just as safe as were the other drugs on the APTC endpoint, which occurred in about 2% of each groups. The study found significantly decreased risks of both GI and renal events with celecoxib, compared with either naproxen or ibuprofen. Celecoxib and naproxen were equivalent with regard to GI and renal events.
The subanalysis, released at the ACR meeting, adds important disease-specific context to the overall PRECISION results.
“We wanted to really delve into the subtle differences in how these two patient groups responded to these medications,” said PRECISION coinvestigator Elaine Husni, MD, vice chair of the department of rheumatic and immunologic diseases at the Cleveland Clinic.
“We learned that each of these NSAIDs has a unique safety profile that can be different in different groups. And in general, celecoxib seems less risky than the others.”
The cohort subanalysis broke down these endpoints among 21,600 patients with osteoarthritis and 2,400 with rheumatoid arthritis.
Among patients with osteoarthritis, celecoxib was also associated with a 16% decreased risk of a major adverse cardiovascular event, compared with ibuprofen. GI events were also less likely in this group: Celecoxib was associated with a 32% decreased risk, compared with ibuprofen, and a 27% decreased risk, compared with naproxen.
Renal outcomes were almost identical in all of the medications in both groups, Dr. Husni said.
In addition to the adverse event outcomes, the subanalysis examined how well patients responded to their assigned NSAID. There were also some subtle differences seen here, Dr. Solomon and Dr. Husni said.
For patients with RA, ibuprofen was slightly, but significantly, more effective than either celecoxib or ibuprofen at controlling pain as measured by a visual analog pain scale. Patients with osteoarthritis responded equally well to all of the drugs.
RA patients also responded best to ibuprofen as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Again, patients with osteoarthritis responded equally well to all of the medications.
The overall findings, as well as the subanalysis, should be reassuring to both physicians and patients, said Dr. Solomon, chief of the section of clinical sciences in the divisions of rheumatology and pharmacoepidemiology at Brigham and Women’s Hospital, Boston.
“I can now stand in front of patients and say with confidence, ‘Each of these drugs is fairly safe, and together we can choose the one that will be best for you, based on your own individual history and your own individual risk factors.’ I feel good about that.”
Pfizer funded the trial. Dr. Husni has research grants from Genzyme/Sanofi on a knee osteoarthritis trial related to hyaluronic acid injections. Dr. Solomon has research grants from Pfizer on non-NSAID related topics. He also receives royalties from UpToDate on chapters related to NSAIDs and selective COX-2 inhibitors.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
msullivan@frontlinemedcom.com
On Twitter @alz_gal
WASHINGTON – Celecoxib conferred a 53% decreased risk of overall mortality upon patients with rheumatoid arthritis when compared with naproxen – a surprise finding in a subanalysis of the newly released PRECISION study of anti-inflammatory drugs in arthritis.
But it’s tough to know what to make of the difference, according to the investigators at the annual meeting of the American College of Rheumatology. Although statistically significant, the mortality finding was based on just 45 events: 30 among those taking naproxen and 15 among those taking celecoxib.
“While I would say we were surprised to see this, we really can’t say what it means – or if it means anything,” primary investigator Daniel Solomon, MD, said in an interview. “This is a finding we will continue to investigate and look at, but at this point it’s not enough to base any prescribing decisions on.”
PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen) enrolled more than 24,000 patients with osteoarthritis or rheumatoid arthritis. They were randomized to celecoxib, naproxen, or ibuprofen for a mean of 20 months, with an additional mean follow-up of 34 months.
The primary outcome was the first occurrence of an adverse event from the Antiplatelet Trialists Collaboration criteria (APTC; death from cardiovascular causes, nonfatal heart attack, or nonfatal stroke). Secondary outcomes included:
• Major cardiovascular events (heart attack, stroke, cardiovascular death, revascularization, and hospitalization for unstable angina or transient ischemic attack).
• Renal events (acute kidney injury, including hospitalization for renal failure).
• Gastrointestinal events (hemorrhage, perforation, gastroduodenal ulcer, anemia of gastrointestinal origin, and gastric outlet obstruction.
The main PRECISION findings were released Nov. 13 at the annual meeting of the American Heart Association and simultaneously published in the New England Journal of Medicine (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1611593).
Overall, celecoxib was just as safe as were the other drugs on the APTC endpoint, which occurred in about 2% of each groups. The study found significantly decreased risks of both GI and renal events with celecoxib, compared with either naproxen or ibuprofen. Celecoxib and naproxen were equivalent with regard to GI and renal events.
The subanalysis, released at the ACR meeting, adds important disease-specific context to the overall PRECISION results.
“We wanted to really delve into the subtle differences in how these two patient groups responded to these medications,” said PRECISION coinvestigator Elaine Husni, MD, vice chair of the department of rheumatic and immunologic diseases at the Cleveland Clinic.
“We learned that each of these NSAIDs has a unique safety profile that can be different in different groups. And in general, celecoxib seems less risky than the others.”
The cohort subanalysis broke down these endpoints among 21,600 patients with osteoarthritis and 2,400 with rheumatoid arthritis.
Among patients with osteoarthritis, celecoxib was also associated with a 16% decreased risk of a major adverse cardiovascular event, compared with ibuprofen. GI events were also less likely in this group: Celecoxib was associated with a 32% decreased risk, compared with ibuprofen, and a 27% decreased risk, compared with naproxen.
Renal outcomes were almost identical in all of the medications in both groups, Dr. Husni said.
In addition to the adverse event outcomes, the subanalysis examined how well patients responded to their assigned NSAID. There were also some subtle differences seen here, Dr. Solomon and Dr. Husni said.
For patients with RA, ibuprofen was slightly, but significantly, more effective than either celecoxib or ibuprofen at controlling pain as measured by a visual analog pain scale. Patients with osteoarthritis responded equally well to all of the drugs.
RA patients also responded best to ibuprofen as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Again, patients with osteoarthritis responded equally well to all of the medications.
The overall findings, as well as the subanalysis, should be reassuring to both physicians and patients, said Dr. Solomon, chief of the section of clinical sciences in the divisions of rheumatology and pharmacoepidemiology at Brigham and Women’s Hospital, Boston.
“I can now stand in front of patients and say with confidence, ‘Each of these drugs is fairly safe, and together we can choose the one that will be best for you, based on your own individual history and your own individual risk factors.’ I feel good about that.”
Pfizer funded the trial. Dr. Husni has research grants from Genzyme/Sanofi on a knee osteoarthritis trial related to hyaluronic acid injections. Dr. Solomon has research grants from Pfizer on non-NSAID related topics. He also receives royalties from UpToDate on chapters related to NSAIDs and selective COX-2 inhibitors.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
msullivan@frontlinemedcom.com
On Twitter @alz_gal
WASHINGTON – Celecoxib conferred a 53% decreased risk of overall mortality upon patients with rheumatoid arthritis when compared with naproxen – a surprise finding in a subanalysis of the newly released PRECISION study of anti-inflammatory drugs in arthritis.
But it’s tough to know what to make of the difference, according to the investigators at the annual meeting of the American College of Rheumatology. Although statistically significant, the mortality finding was based on just 45 events: 30 among those taking naproxen and 15 among those taking celecoxib.
“While I would say we were surprised to see this, we really can’t say what it means – or if it means anything,” primary investigator Daniel Solomon, MD, said in an interview. “This is a finding we will continue to investigate and look at, but at this point it’s not enough to base any prescribing decisions on.”
PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen) enrolled more than 24,000 patients with osteoarthritis or rheumatoid arthritis. They were randomized to celecoxib, naproxen, or ibuprofen for a mean of 20 months, with an additional mean follow-up of 34 months.
The primary outcome was the first occurrence of an adverse event from the Antiplatelet Trialists Collaboration criteria (APTC; death from cardiovascular causes, nonfatal heart attack, or nonfatal stroke). Secondary outcomes included:
• Major cardiovascular events (heart attack, stroke, cardiovascular death, revascularization, and hospitalization for unstable angina or transient ischemic attack).
• Renal events (acute kidney injury, including hospitalization for renal failure).
• Gastrointestinal events (hemorrhage, perforation, gastroduodenal ulcer, anemia of gastrointestinal origin, and gastric outlet obstruction.
The main PRECISION findings were released Nov. 13 at the annual meeting of the American Heart Association and simultaneously published in the New England Journal of Medicine (N Engl J Med. 2016 Nov 13. doi: 10.1056/NEJMoa1611593).
Overall, celecoxib was just as safe as were the other drugs on the APTC endpoint, which occurred in about 2% of each groups. The study found significantly decreased risks of both GI and renal events with celecoxib, compared with either naproxen or ibuprofen. Celecoxib and naproxen were equivalent with regard to GI and renal events.
The subanalysis, released at the ACR meeting, adds important disease-specific context to the overall PRECISION results.
“We wanted to really delve into the subtle differences in how these two patient groups responded to these medications,” said PRECISION coinvestigator Elaine Husni, MD, vice chair of the department of rheumatic and immunologic diseases at the Cleveland Clinic.
“We learned that each of these NSAIDs has a unique safety profile that can be different in different groups. And in general, celecoxib seems less risky than the others.”
The cohort subanalysis broke down these endpoints among 21,600 patients with osteoarthritis and 2,400 with rheumatoid arthritis.
Among patients with osteoarthritis, celecoxib was also associated with a 16% decreased risk of a major adverse cardiovascular event, compared with ibuprofen. GI events were also less likely in this group: Celecoxib was associated with a 32% decreased risk, compared with ibuprofen, and a 27% decreased risk, compared with naproxen.
Renal outcomes were almost identical in all of the medications in both groups, Dr. Husni said.
In addition to the adverse event outcomes, the subanalysis examined how well patients responded to their assigned NSAID. There were also some subtle differences seen here, Dr. Solomon and Dr. Husni said.
For patients with RA, ibuprofen was slightly, but significantly, more effective than either celecoxib or ibuprofen at controlling pain as measured by a visual analog pain scale. Patients with osteoarthritis responded equally well to all of the drugs.
RA patients also responded best to ibuprofen as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Again, patients with osteoarthritis responded equally well to all of the medications.
The overall findings, as well as the subanalysis, should be reassuring to both physicians and patients, said Dr. Solomon, chief of the section of clinical sciences in the divisions of rheumatology and pharmacoepidemiology at Brigham and Women’s Hospital, Boston.
“I can now stand in front of patients and say with confidence, ‘Each of these drugs is fairly safe, and together we can choose the one that will be best for you, based on your own individual history and your own individual risk factors.’ I feel good about that.”
Pfizer funded the trial. Dr. Husni has research grants from Genzyme/Sanofi on a knee osteoarthritis trial related to hyaluronic acid injections. Dr. Solomon has research grants from Pfizer on non-NSAID related topics. He also receives royalties from UpToDate on chapters related to NSAIDs and selective COX-2 inhibitors.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
msullivan@frontlinemedcom.com
On Twitter @alz_gal
AT THE ACR ANNUAL MEETING
Key clinical point:
Major finding: Compared with naproxen, celecoxib was associated with a 53% lower risk of overall mortality, although the clinical impact of that finding remains unknown.
Data source: PRECISION, which randomized more than 24,000 patients to celecoxib, ibuprofen, or naproxen.
Disclosures: Pfizer funded the trial. Dr. Husni has research grants from Genzyme/Sanofi on a knee osteoarthritis trial related to hyaluronic acid injections. Dr. Solomon has research grants from Pfizer on non-NSAID related topics. He also receives royalties from UpToDate on chapters related to NSAIDs and selective COX-2 inhibitors.
No primary prevention gains from low-dose aspirin in diabetes
Low-dose aspirin does not appear to reduce the risk of cardiovascular events in individuals with type 2 diabetes but without preexisting cardiovascular disease, according to a study presented at the American Heart Association scientific sessions and published simultaneously in the Nov. 15 edition of Circulation.
In the long-term follow-up of participants in an open-label controlled trial, Japanese researchers followed 2,539 patients with type 2 diabetes who were randomized to daily aspirin (81 mg or 100 mg) or no aspirin, for a median of 10.3 years to see the impact on the incidence of cardiovascular events.
In their study, they found that a daily regimen of low-dose aspirin was not associated with a significant change in the risk of cardiovascular events including sudden death, fatal or nonfatal coronary artery disease, fatal or nonfatal stroke, and peripheral vascular disease (hazard ratio, 1.14; 95% confidence interval, 0.91-1.42). They also found no significant difference between the two groups in secondary outcomes, which were a composite of coronary artery, cerebrovascular, and vascular events.
This lack of impact persisted even after age, sex, glycemic control, kidney function, smoking status, hypertension, and dyslipidemia were accounted for, and it was also seen in sensitivity analyses on the intention-to-treat cohort.
However, the investigators did find a significantly higher rate of gastrointestinal bleeding in patients taking aspirin, compared with the control group (2% vs. 0.9%, P = .03) but no difference in the rate of hemorrhagic stroke.
“Meta-analyses in patients with diabetes have reported that aspirin has a smaller benefit for primary prevention than in general populations, although patients with diabetes are at high risk for cardiovascular events,” the authors wrote. “It seems there are differential effects of low-dose aspirin therapy on preventing cardiovascular events in patients with and without diabetes.”
The study was supported by the Ministry of Health, Labour, and Welfare of Japan and the Japan Heart Foundation. Eight authors declared funding, grants, honoraria, and other support from the pharmaceutical industry. No other conflicts of interest were declared.
Low-dose aspirin does not appear to reduce the risk of cardiovascular events in individuals with type 2 diabetes but without preexisting cardiovascular disease, according to a study presented at the American Heart Association scientific sessions and published simultaneously in the Nov. 15 edition of Circulation.
In the long-term follow-up of participants in an open-label controlled trial, Japanese researchers followed 2,539 patients with type 2 diabetes who were randomized to daily aspirin (81 mg or 100 mg) or no aspirin, for a median of 10.3 years to see the impact on the incidence of cardiovascular events.
In their study, they found that a daily regimen of low-dose aspirin was not associated with a significant change in the risk of cardiovascular events including sudden death, fatal or nonfatal coronary artery disease, fatal or nonfatal stroke, and peripheral vascular disease (hazard ratio, 1.14; 95% confidence interval, 0.91-1.42). They also found no significant difference between the two groups in secondary outcomes, which were a composite of coronary artery, cerebrovascular, and vascular events.
This lack of impact persisted even after age, sex, glycemic control, kidney function, smoking status, hypertension, and dyslipidemia were accounted for, and it was also seen in sensitivity analyses on the intention-to-treat cohort.
However, the investigators did find a significantly higher rate of gastrointestinal bleeding in patients taking aspirin, compared with the control group (2% vs. 0.9%, P = .03) but no difference in the rate of hemorrhagic stroke.
“Meta-analyses in patients with diabetes have reported that aspirin has a smaller benefit for primary prevention than in general populations, although patients with diabetes are at high risk for cardiovascular events,” the authors wrote. “It seems there are differential effects of low-dose aspirin therapy on preventing cardiovascular events in patients with and without diabetes.”
The study was supported by the Ministry of Health, Labour, and Welfare of Japan and the Japan Heart Foundation. Eight authors declared funding, grants, honoraria, and other support from the pharmaceutical industry. No other conflicts of interest were declared.
Low-dose aspirin does not appear to reduce the risk of cardiovascular events in individuals with type 2 diabetes but without preexisting cardiovascular disease, according to a study presented at the American Heart Association scientific sessions and published simultaneously in the Nov. 15 edition of Circulation.
In the long-term follow-up of participants in an open-label controlled trial, Japanese researchers followed 2,539 patients with type 2 diabetes who were randomized to daily aspirin (81 mg or 100 mg) or no aspirin, for a median of 10.3 years to see the impact on the incidence of cardiovascular events.
In their study, they found that a daily regimen of low-dose aspirin was not associated with a significant change in the risk of cardiovascular events including sudden death, fatal or nonfatal coronary artery disease, fatal or nonfatal stroke, and peripheral vascular disease (hazard ratio, 1.14; 95% confidence interval, 0.91-1.42). They also found no significant difference between the two groups in secondary outcomes, which were a composite of coronary artery, cerebrovascular, and vascular events.
This lack of impact persisted even after age, sex, glycemic control, kidney function, smoking status, hypertension, and dyslipidemia were accounted for, and it was also seen in sensitivity analyses on the intention-to-treat cohort.
However, the investigators did find a significantly higher rate of gastrointestinal bleeding in patients taking aspirin, compared with the control group (2% vs. 0.9%, P = .03) but no difference in the rate of hemorrhagic stroke.
“Meta-analyses in patients with diabetes have reported that aspirin has a smaller benefit for primary prevention than in general populations, although patients with diabetes are at high risk for cardiovascular events,” the authors wrote. “It seems there are differential effects of low-dose aspirin therapy on preventing cardiovascular events in patients with and without diabetes.”
The study was supported by the Ministry of Health, Labour, and Welfare of Japan and the Japan Heart Foundation. Eight authors declared funding, grants, honoraria, and other support from the pharmaceutical industry. No other conflicts of interest were declared.
FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Patients with type 2 diabetes taking daily low-dose aspirin showed no significant reductions in cardiovascular events, compared with a control group not taking aspirin.
Data source: Long-term follow-up in a randomized controlled trial in 2,539 patients with type 2 diabetes in the absence of preexisting cardiovascular disease.
Disclosures: The study was supported by the Ministry of Health, Labour, and Welfare of Japan and the Japan Heart Foundation. Eight authors declared funding, grants, honoraria, and other support from the pharmaceutical industry. No other conflicts of interest were declared.
Moises Auron, MD, SFHM, leverages his SHM membership to engage students in hospital medicine
Editor’s note: As SHM celebrates the “Year of the Hospitalist,” we’re putting the spotlight on some of our most active members who are making substantial contributions to hospital medicine. Log on to www.hospitalmedicine.org/yoth for more information on how you can join the yearlong celebration and help SHM improve the care of hospitalized patients.
This month, The Hospitalist spotlights Moises Auron, MD, SFHM, a dual internal medicine/pediatrics hospitalist at the Cleveland Clinic. He is board certified in internal medicine and pediatrics and serves as associate professor of medicine and pediatrics at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.
Question: What inspired you to begin working in hospital medicine and later join SHM?
Answer: I joined SHM as a third-year med-peds resident, influenced by my mentor and teacher, Dr. James C. Pile. I completed my medicine and perioperative consult rotation with him, and it was the first time in ages that anybody had served as such a motivating role model. He gave me a collection of The Hospitalist newsmagazines focused on perioperative medicine as well as a pack of articles around pertinent subjects for an internal medicine consultation service. It was a breath of fresh air; I found an entirely new niche in medicine. And in addition, he demonstrated to me how being a hospitalist was a fundamental pillar of patient care within the healthcare system. He showed me the elements of a thorough and pertinent system-based practice.
I met SHM CEO Dr. Larry Wellikson and the SHM team during a meeting in Philadelphia about 10 years ago and became even more acquainted with the society and its goals. I became a member on the spot. As a resident, I loved receiving both The Hospitalist and the Journal of Hospital Medicine. Both helped me also in my initial job search during my senior year of residency as well as with familiarizing myself with the latest hospital medicine literature. In short, being a member of SHM helped me cement my professional career path to hospital medicine.
Q: How has SHM provided you with resources to improve patient care and further your career?
I had the privilege of attending the Academic Hospitalist Academy and the Quality and Safety Educators Academy as well; both have helped me foster further goals in my career as well as achieve substantial professional and personal satisfaction.
The most important aspect of my membership has been becoming acquainted with a tremendous group of talented human beings, including both the SHM staff as well as hospitalist colleagues. The strength of SHM is its people: passionate providers and administrators who aim to make a better world for patients and doctors.
Q: What is your proudest moment working in hospital medicine?
A: Every single day of my job. As an academic hospitalist and a quality officer at my institution, I take tremendous pride in my job. I define ourselves as the super-internists; we are a quaternary medical center that cares for patients referred from all over the nation, and we need to elucidate obscure diagnoses and aim to offer a treatment and hope.
To me, what is more important is when I witness my residents being actively mindful about preventing harm: when they hardwire best practices such as good hand hygiene, precautions for prevention of falls, risk mitigation associated with any medical intervention … The list goes on. When I appreciate that behavior that becomes my proudest moment because I know that they will ensure the best outcomes for our patients and that I have made an impact.
Q: What do you see as the biggest opportunity for hospitalists as healthcare continues to evolve, and how can hospitalists rise to the challenge?
A: As the saying goes, “One of the tests of leadership is the ability to recognize a problem before it becomes an emergency.” We need to anticipate the way American healthcare is being delivered. The business model is changing, and the payment system is transitioning. Quality is being leveraged as a tool to decrease costs of care.
Hospitalists need to be creative in capitalizing on each individual patient encounter to maximize communication with other members of the healthcare team and use the patient’s hospitalization time strategically. We need to be the savings experts. We can recognize areas where unnecessary expenditure is used by having a lean mind and focusing on removing waste that will not impact our patients. We are the experts on the front line—we need to share the feedback to the leadership.
Q: What advice would you give to future providers considering a career in hospital medicine?
A: Become an SHM member early in your residency, aim to present a poster, participate at an SHM meeting, and engage in the networking process. SHM offers educational initiatives (e.g., Leadership Academy, Academic Hospitalist Academy, Quality and Safety Educators Academy), quality improvement programs (e.g., BOOST and Glycemic Control), and educational content to ensure your success in the Focused Practice in Hospital Medicine exam via the SHM SPARK tool.
Why so early? Because all of these resources help to build a sense of purpose and help to answer the question, “Where do I want to be five years from now?” Networking is fundamental, especially as it gives the opportunity to develop potential mentorship relationships and create teams for future collaboration endeavors.
Editor’s note: As SHM celebrates the “Year of the Hospitalist,” we’re putting the spotlight on some of our most active members who are making substantial contributions to hospital medicine. Log on to www.hospitalmedicine.org/yoth for more information on how you can join the yearlong celebration and help SHM improve the care of hospitalized patients.
This month, The Hospitalist spotlights Moises Auron, MD, SFHM, a dual internal medicine/pediatrics hospitalist at the Cleveland Clinic. He is board certified in internal medicine and pediatrics and serves as associate professor of medicine and pediatrics at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.
Question: What inspired you to begin working in hospital medicine and later join SHM?
Answer: I joined SHM as a third-year med-peds resident, influenced by my mentor and teacher, Dr. James C. Pile. I completed my medicine and perioperative consult rotation with him, and it was the first time in ages that anybody had served as such a motivating role model. He gave me a collection of The Hospitalist newsmagazines focused on perioperative medicine as well as a pack of articles around pertinent subjects for an internal medicine consultation service. It was a breath of fresh air; I found an entirely new niche in medicine. And in addition, he demonstrated to me how being a hospitalist was a fundamental pillar of patient care within the healthcare system. He showed me the elements of a thorough and pertinent system-based practice.
I met SHM CEO Dr. Larry Wellikson and the SHM team during a meeting in Philadelphia about 10 years ago and became even more acquainted with the society and its goals. I became a member on the spot. As a resident, I loved receiving both The Hospitalist and the Journal of Hospital Medicine. Both helped me also in my initial job search during my senior year of residency as well as with familiarizing myself with the latest hospital medicine literature. In short, being a member of SHM helped me cement my professional career path to hospital medicine.
Q: How has SHM provided you with resources to improve patient care and further your career?
I had the privilege of attending the Academic Hospitalist Academy and the Quality and Safety Educators Academy as well; both have helped me foster further goals in my career as well as achieve substantial professional and personal satisfaction.
The most important aspect of my membership has been becoming acquainted with a tremendous group of talented human beings, including both the SHM staff as well as hospitalist colleagues. The strength of SHM is its people: passionate providers and administrators who aim to make a better world for patients and doctors.
Q: What is your proudest moment working in hospital medicine?
A: Every single day of my job. As an academic hospitalist and a quality officer at my institution, I take tremendous pride in my job. I define ourselves as the super-internists; we are a quaternary medical center that cares for patients referred from all over the nation, and we need to elucidate obscure diagnoses and aim to offer a treatment and hope.
To me, what is more important is when I witness my residents being actively mindful about preventing harm: when they hardwire best practices such as good hand hygiene, precautions for prevention of falls, risk mitigation associated with any medical intervention … The list goes on. When I appreciate that behavior that becomes my proudest moment because I know that they will ensure the best outcomes for our patients and that I have made an impact.
Q: What do you see as the biggest opportunity for hospitalists as healthcare continues to evolve, and how can hospitalists rise to the challenge?
A: As the saying goes, “One of the tests of leadership is the ability to recognize a problem before it becomes an emergency.” We need to anticipate the way American healthcare is being delivered. The business model is changing, and the payment system is transitioning. Quality is being leveraged as a tool to decrease costs of care.
Hospitalists need to be creative in capitalizing on each individual patient encounter to maximize communication with other members of the healthcare team and use the patient’s hospitalization time strategically. We need to be the savings experts. We can recognize areas where unnecessary expenditure is used by having a lean mind and focusing on removing waste that will not impact our patients. We are the experts on the front line—we need to share the feedback to the leadership.
Q: What advice would you give to future providers considering a career in hospital medicine?
A: Become an SHM member early in your residency, aim to present a poster, participate at an SHM meeting, and engage in the networking process. SHM offers educational initiatives (e.g., Leadership Academy, Academic Hospitalist Academy, Quality and Safety Educators Academy), quality improvement programs (e.g., BOOST and Glycemic Control), and educational content to ensure your success in the Focused Practice in Hospital Medicine exam via the SHM SPARK tool.
Why so early? Because all of these resources help to build a sense of purpose and help to answer the question, “Where do I want to be five years from now?” Networking is fundamental, especially as it gives the opportunity to develop potential mentorship relationships and create teams for future collaboration endeavors.
Editor’s note: As SHM celebrates the “Year of the Hospitalist,” we’re putting the spotlight on some of our most active members who are making substantial contributions to hospital medicine. Log on to www.hospitalmedicine.org/yoth for more information on how you can join the yearlong celebration and help SHM improve the care of hospitalized patients.
This month, The Hospitalist spotlights Moises Auron, MD, SFHM, a dual internal medicine/pediatrics hospitalist at the Cleveland Clinic. He is board certified in internal medicine and pediatrics and serves as associate professor of medicine and pediatrics at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.
Question: What inspired you to begin working in hospital medicine and later join SHM?
Answer: I joined SHM as a third-year med-peds resident, influenced by my mentor and teacher, Dr. James C. Pile. I completed my medicine and perioperative consult rotation with him, and it was the first time in ages that anybody had served as such a motivating role model. He gave me a collection of The Hospitalist newsmagazines focused on perioperative medicine as well as a pack of articles around pertinent subjects for an internal medicine consultation service. It was a breath of fresh air; I found an entirely new niche in medicine. And in addition, he demonstrated to me how being a hospitalist was a fundamental pillar of patient care within the healthcare system. He showed me the elements of a thorough and pertinent system-based practice.
I met SHM CEO Dr. Larry Wellikson and the SHM team during a meeting in Philadelphia about 10 years ago and became even more acquainted with the society and its goals. I became a member on the spot. As a resident, I loved receiving both The Hospitalist and the Journal of Hospital Medicine. Both helped me also in my initial job search during my senior year of residency as well as with familiarizing myself with the latest hospital medicine literature. In short, being a member of SHM helped me cement my professional career path to hospital medicine.
Q: How has SHM provided you with resources to improve patient care and further your career?
I had the privilege of attending the Academic Hospitalist Academy and the Quality and Safety Educators Academy as well; both have helped me foster further goals in my career as well as achieve substantial professional and personal satisfaction.
The most important aspect of my membership has been becoming acquainted with a tremendous group of talented human beings, including both the SHM staff as well as hospitalist colleagues. The strength of SHM is its people: passionate providers and administrators who aim to make a better world for patients and doctors.
Q: What is your proudest moment working in hospital medicine?
A: Every single day of my job. As an academic hospitalist and a quality officer at my institution, I take tremendous pride in my job. I define ourselves as the super-internists; we are a quaternary medical center that cares for patients referred from all over the nation, and we need to elucidate obscure diagnoses and aim to offer a treatment and hope.
To me, what is more important is when I witness my residents being actively mindful about preventing harm: when they hardwire best practices such as good hand hygiene, precautions for prevention of falls, risk mitigation associated with any medical intervention … The list goes on. When I appreciate that behavior that becomes my proudest moment because I know that they will ensure the best outcomes for our patients and that I have made an impact.
Q: What do you see as the biggest opportunity for hospitalists as healthcare continues to evolve, and how can hospitalists rise to the challenge?
A: As the saying goes, “One of the tests of leadership is the ability to recognize a problem before it becomes an emergency.” We need to anticipate the way American healthcare is being delivered. The business model is changing, and the payment system is transitioning. Quality is being leveraged as a tool to decrease costs of care.
Hospitalists need to be creative in capitalizing on each individual patient encounter to maximize communication with other members of the healthcare team and use the patient’s hospitalization time strategically. We need to be the savings experts. We can recognize areas where unnecessary expenditure is used by having a lean mind and focusing on removing waste that will not impact our patients. We are the experts on the front line—we need to share the feedback to the leadership.
Q: What advice would you give to future providers considering a career in hospital medicine?
A: Become an SHM member early in your residency, aim to present a poster, participate at an SHM meeting, and engage in the networking process. SHM offers educational initiatives (e.g., Leadership Academy, Academic Hospitalist Academy, Quality and Safety Educators Academy), quality improvement programs (e.g., BOOST and Glycemic Control), and educational content to ensure your success in the Focused Practice in Hospital Medicine exam via the SHM SPARK tool.
Why so early? Because all of these resources help to build a sense of purpose and help to answer the question, “Where do I want to be five years from now?” Networking is fundamental, especially as it gives the opportunity to develop potential mentorship relationships and create teams for future collaboration endeavors.
Six Open Clinical Trials That Are Expanding Our Understanding of Immunotherapies
Using the immune system to help fight cancer is one of newest and most promising directions in cancer research. While many of the findings so far remain preliminary, a number of new studies are being developed or are already underway. Not surprisingly, federal oncologists and hematologists are leading the way with ground-breaking research. Importantly, a number of trials are recruiting patients at VA facilities. Here are a few of the studies already underway:
Study: Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
Sponsor: National Cancer Institute
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
Federal Study Locations (7 total): Kansas City VAMC
Study: Nivolumab and Ipilimumab With or Without Sargramostim in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
Sponsor: National Cancer Institute
This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well these drugs work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
Federal Study Locations (311 total): Little Rock (Arkansas) VAMC
Study: Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma (NCT01169337)
Sponsor: National Cancer Institute
This randomized phase II/III trial studies how well lenalidomide works in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.
Federal Study Locations (600 total): Kansas City VAMC, VA New Jersey Health Care System, East Orange
Study: Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (NCT02143414)
Sponsor: National Cancer Institute
This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, find cancer cells and help kill them. Drugs used in chemotherapy, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or halting the cells’ ability to spread. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.
Federal Study Locations (180 total): Little Rock (Arkansas) VAMC
Study: Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma (NCT01415752)
Sponsor: Eastern Cooperative Oncology Group
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.
Federal Study Locations (426 total): Kansas City VAMC, VA New Jersey Health Care System, East Orange
Study: Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma (NCT01856192)
This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.
Federal Study Locations (511 total): Little Rock (Arkansas) VAMC
Using the immune system to help fight cancer is one of newest and most promising directions in cancer research. While many of the findings so far remain preliminary, a number of new studies are being developed or are already underway. Not surprisingly, federal oncologists and hematologists are leading the way with ground-breaking research. Importantly, a number of trials are recruiting patients at VA facilities. Here are a few of the studies already underway:
Study: Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
Sponsor: National Cancer Institute
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
Federal Study Locations (7 total): Kansas City VAMC
Study: Nivolumab and Ipilimumab With or Without Sargramostim in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
Sponsor: National Cancer Institute
This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well these drugs work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
Federal Study Locations (311 total): Little Rock (Arkansas) VAMC
Study: Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma (NCT01169337)
Sponsor: National Cancer Institute
This randomized phase II/III trial studies how well lenalidomide works in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.
Federal Study Locations (600 total): Kansas City VAMC, VA New Jersey Health Care System, East Orange
Study: Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (NCT02143414)
Sponsor: National Cancer Institute
This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, find cancer cells and help kill them. Drugs used in chemotherapy, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or halting the cells’ ability to spread. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.
Federal Study Locations (180 total): Little Rock (Arkansas) VAMC
Study: Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma (NCT01415752)
Sponsor: Eastern Cooperative Oncology Group
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.
Federal Study Locations (426 total): Kansas City VAMC, VA New Jersey Health Care System, East Orange
Study: Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma (NCT01856192)
This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.
Federal Study Locations (511 total): Little Rock (Arkansas) VAMC
Using the immune system to help fight cancer is one of newest and most promising directions in cancer research. While many of the findings so far remain preliminary, a number of new studies are being developed or are already underway. Not surprisingly, federal oncologists and hematologists are leading the way with ground-breaking research. Importantly, a number of trials are recruiting patients at VA facilities. Here are a few of the studies already underway:
Study: Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
Sponsor: National Cancer Institute
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
Federal Study Locations (7 total): Kansas City VAMC
Study: Nivolumab and Ipilimumab With or Without Sargramostim in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
Sponsor: National Cancer Institute
This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well these drugs work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
Federal Study Locations (311 total): Little Rock (Arkansas) VAMC
Study: Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma (NCT01169337)
Sponsor: National Cancer Institute
This randomized phase II/III trial studies how well lenalidomide works in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.
Federal Study Locations (600 total): Kansas City VAMC, VA New Jersey Health Care System, East Orange
Study: Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (NCT02143414)
Sponsor: National Cancer Institute
This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, find cancer cells and help kill them. Drugs used in chemotherapy, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or halting the cells’ ability to spread. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.
Federal Study Locations (180 total): Little Rock (Arkansas) VAMC
Study: Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma (NCT01415752)
Sponsor: Eastern Cooperative Oncology Group
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.
Federal Study Locations (426 total): Kansas City VAMC, VA New Jersey Health Care System, East Orange
Study: Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma (NCT01856192)
This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.
Federal Study Locations (511 total): Little Rock (Arkansas) VAMC
MRI detects early stages of MF in mice
Magnetic resonance imaging (MRI) can effectively detect myelofibrosis (MF) in a mouse model, according to research published in the journal Blood Cancer.
In fact, researchers found that MRI could detect early and late stages of primary MF.
The researchers believe this discovery could potentially change the way MF is diagnosed, as MRI might be used to help physicians decide if or where to biopsy.
Katya Ravid, PhD, of Boston University School of Medicine in Massachusetts, and her colleagues conducted this research, aiming to determine whether T2-weighted MRI could detect bone marrow fibrosis in a mouse model of primary MF.
The team looked specifically at how effectively MRI could detect MF during the pre-fibrotic stage (when mice were less than 16 weeks old), when the mice had early MF (16 to 36 weeks old), and once the mice had overt MF (older than 36 weeks).
The researchers found that MRI could detect MF at the pre-fibrotic stage as well as detecting progressive MF.
The team said they observed a clear, bright signal that allowed them to differentiate mice with MF from healthy control mice.
The researchers proposed that the abundance of large megakaryocytes contributed to the bright signal they observed, since, in T2-weighted MR images, increased water/proton content, as in increased cellularity, yields high MR-signal intensity.
The team said this study provides proof of concept that T2-weighted MRI can detect primary MF in the early and late stages. 
Magnetic resonance imaging (MRI) can effectively detect myelofibrosis (MF) in a mouse model, according to research published in the journal Blood Cancer.
In fact, researchers found that MRI could detect early and late stages of primary MF.
The researchers believe this discovery could potentially change the way MF is diagnosed, as MRI might be used to help physicians decide if or where to biopsy.
Katya Ravid, PhD, of Boston University School of Medicine in Massachusetts, and her colleagues conducted this research, aiming to determine whether T2-weighted MRI could detect bone marrow fibrosis in a mouse model of primary MF.
The team looked specifically at how effectively MRI could detect MF during the pre-fibrotic stage (when mice were less than 16 weeks old), when the mice had early MF (16 to 36 weeks old), and once the mice had overt MF (older than 36 weeks).
The researchers found that MRI could detect MF at the pre-fibrotic stage as well as detecting progressive MF.
The team said they observed a clear, bright signal that allowed them to differentiate mice with MF from healthy control mice.
The researchers proposed that the abundance of large megakaryocytes contributed to the bright signal they observed, since, in T2-weighted MR images, increased water/proton content, as in increased cellularity, yields high MR-signal intensity.
The team said this study provides proof of concept that T2-weighted MRI can detect primary MF in the early and late stages.
Magnetic resonance imaging (MRI) can effectively detect myelofibrosis (MF) in a mouse model, according to research published in the journal Blood Cancer.
In fact, researchers found that MRI could detect early and late stages of primary MF.
The researchers believe this discovery could potentially change the way MF is diagnosed, as MRI might be used to help physicians decide if or where to biopsy.
Katya Ravid, PhD, of Boston University School of Medicine in Massachusetts, and her colleagues conducted this research, aiming to determine whether T2-weighted MRI could detect bone marrow fibrosis in a mouse model of primary MF.
The team looked specifically at how effectively MRI could detect MF during the pre-fibrotic stage (when mice were less than 16 weeks old), when the mice had early MF (16 to 36 weeks old), and once the mice had overt MF (older than 36 weeks).
The researchers found that MRI could detect MF at the pre-fibrotic stage as well as detecting progressive MF.
The team said they observed a clear, bright signal that allowed them to differentiate mice with MF from healthy control mice.
The researchers proposed that the abundance of large megakaryocytes contributed to the bright signal they observed, since, in T2-weighted MR images, increased water/proton content, as in increased cellularity, yields high MR-signal intensity.
The team said this study provides proof of concept that T2-weighted MRI can detect primary MF in the early and late stages.
Antiplatelet drugs produce similar results in PAD
Photo from AstraZeneca
NEW ORLEANS—Results of the EUCLID trial suggest ticagrelor does not a provide a benefit over clopidogrel in patients with symptomatic peripheral artery disease (PAD).
The incidence of atherothrombotic events was similar in patients who received ticagrelor and those who received clopidogrel.
Likewise, there was no significant difference between the treatment arms with regard to major bleeding.
Manesh R. Patel, MD, of Duke University Medical Center in Durham, North Carolina, presented results from the EUCLID trial at the American Heart Association Scientific Sessions.
Results were also published in NEJM. The trial was supported by AstraZeneca.
EUCLID included 13,885 patients with symptomatic PAD. They had median age of 66, and 72% were male.
The patients were randomized to receive ticagrelor at 90 mg twice daily or clopidogrel at 75 mg once daily.
The study’s primary efficacy endpoint was a composite of adjudicated cardiovascular death, myocardial infarction, and ischemic stroke.
At a median follow-up of 30 months, the primary efficacy endpoint had occurred in 10.8% (751/6930) of patients in the ticagrelor arm and 10.6% (740/6955) in the clopidogrel arm (P=0.65).
When the researchers assessed each of the components of the primary endpoint alone, they found a significant difference between the treatment groups in the incidence of ischemic stroke but not cardiovascular death or myocardial infarction.
Cardiovascular death occurred in 5.2% of patients in the ticagrelor arm and 4.9% of those in the clopidogrel arm (P=0.40). Myocardial infarction occurred in 5% and 4.8%, respectively (P=0.48). And ischemic stroke occurred in 1.9% and 2.4%, respectively (P=0.03).
The study’s primary safety endpoint was major bleeding, which occurred in 1.6% of patients in both treatment arms (P=0.49).
Fatal bleeding occurred in 0.1% of patients in the ticagrelor arm and 0.3% of patients in the clopidogrel arm (P=0.10). And intracranial bleeding occurred in 0.5% of patients in both arms (P=0.82).
However, significantly more patients discontinued ticagrelor due to bleeding—2.4%, compared to 1.6% of patients who discontinued clopidogrel due to bleeding (P<0.001).
Significantly more patients discontinued ticagrelor due to dyspnea as well—4.8% vs 0.8% (P<0.001).
In all, 30.1% of patients in the ticagrelor arm and 25.9% of those in the clopidogrel arm prematurely discontinued treatment. This includes patients who discontinued due to adverse events, meeting the primary efficacy endpoint, and death.
Photo from AstraZeneca
NEW ORLEANS—Results of the EUCLID trial suggest ticagrelor does not a provide a benefit over clopidogrel in patients with symptomatic peripheral artery disease (PAD).
The incidence of atherothrombotic events was similar in patients who received ticagrelor and those who received clopidogrel.
Likewise, there was no significant difference between the treatment arms with regard to major bleeding.
Manesh R. Patel, MD, of Duke University Medical Center in Durham, North Carolina, presented results from the EUCLID trial at the American Heart Association Scientific Sessions.
Results were also published in NEJM. The trial was supported by AstraZeneca.
EUCLID included 13,885 patients with symptomatic PAD. They had median age of 66, and 72% were male.
The patients were randomized to receive ticagrelor at 90 mg twice daily or clopidogrel at 75 mg once daily.
The study’s primary efficacy endpoint was a composite of adjudicated cardiovascular death, myocardial infarction, and ischemic stroke.
At a median follow-up of 30 months, the primary efficacy endpoint had occurred in 10.8% (751/6930) of patients in the ticagrelor arm and 10.6% (740/6955) in the clopidogrel arm (P=0.65).
When the researchers assessed each of the components of the primary endpoint alone, they found a significant difference between the treatment groups in the incidence of ischemic stroke but not cardiovascular death or myocardial infarction.
Cardiovascular death occurred in 5.2% of patients in the ticagrelor arm and 4.9% of those in the clopidogrel arm (P=0.40). Myocardial infarction occurred in 5% and 4.8%, respectively (P=0.48). And ischemic stroke occurred in 1.9% and 2.4%, respectively (P=0.03).
The study’s primary safety endpoint was major bleeding, which occurred in 1.6% of patients in both treatment arms (P=0.49).
Fatal bleeding occurred in 0.1% of patients in the ticagrelor arm and 0.3% of patients in the clopidogrel arm (P=0.10). And intracranial bleeding occurred in 0.5% of patients in both arms (P=0.82).
However, significantly more patients discontinued ticagrelor due to bleeding—2.4%, compared to 1.6% of patients who discontinued clopidogrel due to bleeding (P<0.001).
Significantly more patients discontinued ticagrelor due to dyspnea as well—4.8% vs 0.8% (P<0.001).
In all, 30.1% of patients in the ticagrelor arm and 25.9% of those in the clopidogrel arm prematurely discontinued treatment. This includes patients who discontinued due to adverse events, meeting the primary efficacy endpoint, and death.
Photo from AstraZeneca
NEW ORLEANS—Results of the EUCLID trial suggest ticagrelor does not a provide a benefit over clopidogrel in patients with symptomatic peripheral artery disease (PAD).
The incidence of atherothrombotic events was similar in patients who received ticagrelor and those who received clopidogrel.
Likewise, there was no significant difference between the treatment arms with regard to major bleeding.
Manesh R. Patel, MD, of Duke University Medical Center in Durham, North Carolina, presented results from the EUCLID trial at the American Heart Association Scientific Sessions.
Results were also published in NEJM. The trial was supported by AstraZeneca.
EUCLID included 13,885 patients with symptomatic PAD. They had median age of 66, and 72% were male.
The patients were randomized to receive ticagrelor at 90 mg twice daily or clopidogrel at 75 mg once daily.
The study’s primary efficacy endpoint was a composite of adjudicated cardiovascular death, myocardial infarction, and ischemic stroke.
At a median follow-up of 30 months, the primary efficacy endpoint had occurred in 10.8% (751/6930) of patients in the ticagrelor arm and 10.6% (740/6955) in the clopidogrel arm (P=0.65).
When the researchers assessed each of the components of the primary endpoint alone, they found a significant difference between the treatment groups in the incidence of ischemic stroke but not cardiovascular death or myocardial infarction.
Cardiovascular death occurred in 5.2% of patients in the ticagrelor arm and 4.9% of those in the clopidogrel arm (P=0.40). Myocardial infarction occurred in 5% and 4.8%, respectively (P=0.48). And ischemic stroke occurred in 1.9% and 2.4%, respectively (P=0.03).
The study’s primary safety endpoint was major bleeding, which occurred in 1.6% of patients in both treatment arms (P=0.49).
Fatal bleeding occurred in 0.1% of patients in the ticagrelor arm and 0.3% of patients in the clopidogrel arm (P=0.10). And intracranial bleeding occurred in 0.5% of patients in both arms (P=0.82).
However, significantly more patients discontinued ticagrelor due to bleeding—2.4%, compared to 1.6% of patients who discontinued clopidogrel due to bleeding (P<0.001).
Significantly more patients discontinued ticagrelor due to dyspnea as well—4.8% vs 0.8% (P<0.001).
In all, 30.1% of patients in the ticagrelor arm and 25.9% of those in the clopidogrel arm prematurely discontinued treatment. This includes patients who discontinued due to adverse events, meeting the primary efficacy endpoint, and death.