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Readmissions after GI bleeds
Clinical question: What is the rate of hospital readmission within 30 days of nonvariceal upper GI hemorrhage, and what are its effects on mortality, morbidity, and health care use in the United States?
Background: Nonvariceal upper GI hemorrhage is the most common GI emergency that leads to hospital admission (approximately 300,000 admissions/year in the United States). Because of the advances in endoscopic therapy and overall medical care, associated in-hospital mortality has been steadily decreasing. As a result of Medicare and Medicaid shifts toward an alternative payment model, quantifying hospital readmission rate after an episode of nonvariceal upper GI hemorrhage and measuring its effects on patient outcomes and resource use have become a key step in both improving treatment outcomes and health care reimbursement.
Study design: Retrospective study.
Setting: The Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project Nationwide Readmission Database for the year 2014.
Synopsis: The study collected data on hospital readmissions for 203,220 adults who were hospitalized for urgent nonvariceal upper gastrointestinal hemorrhage and discharged. The primary outcome was rate of all-cause readmission within 30 days of discharge. Secondary outcomes were reasons for readmission, readmission mortality rate, morbidity (shock and prolonged mechanical ventilation), and resource use (length of stay and total hospitalization costs and charges).
The rate of readmission was determined to be 13%, with only 18% caused by recurrent nonvariceal upper gastrointestinal bleeding. The rate of death among readmissions was higher than that among index admissions, and a higher proportion of readmitted patients had morbidities requiring prolonged mechanical ventilation. The total economic in-hospital burden was $30.3 million in costs and $108 million in charges over the span of readmission-associated 133,368 hospital days. Independent predictors of readmission were having Medicaid insurance, having a higher comorbidity score, having a lower income, residence in a metropolitan area, hemorrhagic shock, and longer stays in the hospital.
Bottom line: Readmissions within 30 days of discharge for upper GI hemorrhage are associated with higher morbidity and mortality and lead to higher resource use.
Citation: Abougergi M et al. Thirty-day readmission among patients with nonvariceal upper gastrointestinal hemorrhage and effects on outcomes. Gastroenterology. 2018 Jul;155(1):38-46.
Dr. White is a hospitalist in the division of hospital medicine in the department of medicine at Loyola University Chicago, Maywood, Ill.
Clinical question: What is the rate of hospital readmission within 30 days of nonvariceal upper GI hemorrhage, and what are its effects on mortality, morbidity, and health care use in the United States?
Background: Nonvariceal upper GI hemorrhage is the most common GI emergency that leads to hospital admission (approximately 300,000 admissions/year in the United States). Because of the advances in endoscopic therapy and overall medical care, associated in-hospital mortality has been steadily decreasing. As a result of Medicare and Medicaid shifts toward an alternative payment model, quantifying hospital readmission rate after an episode of nonvariceal upper GI hemorrhage and measuring its effects on patient outcomes and resource use have become a key step in both improving treatment outcomes and health care reimbursement.
Study design: Retrospective study.
Setting: The Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project Nationwide Readmission Database for the year 2014.
Synopsis: The study collected data on hospital readmissions for 203,220 adults who were hospitalized for urgent nonvariceal upper gastrointestinal hemorrhage and discharged. The primary outcome was rate of all-cause readmission within 30 days of discharge. Secondary outcomes were reasons for readmission, readmission mortality rate, morbidity (shock and prolonged mechanical ventilation), and resource use (length of stay and total hospitalization costs and charges).
The rate of readmission was determined to be 13%, with only 18% caused by recurrent nonvariceal upper gastrointestinal bleeding. The rate of death among readmissions was higher than that among index admissions, and a higher proportion of readmitted patients had morbidities requiring prolonged mechanical ventilation. The total economic in-hospital burden was $30.3 million in costs and $108 million in charges over the span of readmission-associated 133,368 hospital days. Independent predictors of readmission were having Medicaid insurance, having a higher comorbidity score, having a lower income, residence in a metropolitan area, hemorrhagic shock, and longer stays in the hospital.
Bottom line: Readmissions within 30 days of discharge for upper GI hemorrhage are associated with higher morbidity and mortality and lead to higher resource use.
Citation: Abougergi M et al. Thirty-day readmission among patients with nonvariceal upper gastrointestinal hemorrhage and effects on outcomes. Gastroenterology. 2018 Jul;155(1):38-46.
Dr. White is a hospitalist in the division of hospital medicine in the department of medicine at Loyola University Chicago, Maywood, Ill.
Clinical question: What is the rate of hospital readmission within 30 days of nonvariceal upper GI hemorrhage, and what are its effects on mortality, morbidity, and health care use in the United States?
Background: Nonvariceal upper GI hemorrhage is the most common GI emergency that leads to hospital admission (approximately 300,000 admissions/year in the United States). Because of the advances in endoscopic therapy and overall medical care, associated in-hospital mortality has been steadily decreasing. As a result of Medicare and Medicaid shifts toward an alternative payment model, quantifying hospital readmission rate after an episode of nonvariceal upper GI hemorrhage and measuring its effects on patient outcomes and resource use have become a key step in both improving treatment outcomes and health care reimbursement.
Study design: Retrospective study.
Setting: The Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project Nationwide Readmission Database for the year 2014.
Synopsis: The study collected data on hospital readmissions for 203,220 adults who were hospitalized for urgent nonvariceal upper gastrointestinal hemorrhage and discharged. The primary outcome was rate of all-cause readmission within 30 days of discharge. Secondary outcomes were reasons for readmission, readmission mortality rate, morbidity (shock and prolonged mechanical ventilation), and resource use (length of stay and total hospitalization costs and charges).
The rate of readmission was determined to be 13%, with only 18% caused by recurrent nonvariceal upper gastrointestinal bleeding. The rate of death among readmissions was higher than that among index admissions, and a higher proportion of readmitted patients had morbidities requiring prolonged mechanical ventilation. The total economic in-hospital burden was $30.3 million in costs and $108 million in charges over the span of readmission-associated 133,368 hospital days. Independent predictors of readmission were having Medicaid insurance, having a higher comorbidity score, having a lower income, residence in a metropolitan area, hemorrhagic shock, and longer stays in the hospital.
Bottom line: Readmissions within 30 days of discharge for upper GI hemorrhage are associated with higher morbidity and mortality and lead to higher resource use.
Citation: Abougergi M et al. Thirty-day readmission among patients with nonvariceal upper gastrointestinal hemorrhage and effects on outcomes. Gastroenterology. 2018 Jul;155(1):38-46.
Dr. White is a hospitalist in the division of hospital medicine in the department of medicine at Loyola University Chicago, Maywood, Ill.
Smoking cessation drugs do not increase CV risk
Clinical question: Do pharmacotherapies used in tobacco cessation treatment significantly increase the risk of cardiovascular events?
Background: Although it is known that smoking cessation is the most beneficial enhancement of cardiovascular health, many clinicians may be hesitant to prescribe pharmacotherapies because of concerns regarding adverse events. This study reports the cardiovascular safety findings from EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) and its nontreatment extension trial.
Study design: Double-blind, randomized, triple-dummy, placebo- and active-controlled trial and its nontreatment extension trial.
Setting: Conducted by 140 multinational centers, EAGLES was a trial in cohorts of smokers with and without psychiatric disease that assessed the safety and efficacy of pharmacotherapies used for smoking cessation.
The EAGLES extension trial is a nontreatment extension of EAGLES. It began with the first dose of medication and included those who completed an additional 28 weeks of observation.
Synopsis: The study included approximately 8,000 participants aged 18-75 years who smoked 10 or more cigarettes per day and were interested in quitting. The study monitored the development of a major adverse cardiovascular event (MACE), such as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, during treatment with varenicline, bupropion hydrochloride, nicotine replacement therapy, and placebo therapy. Other end points included determining the occurrence of MACE along with other peripheral vascular disease that required either intervention, coronary revascularization, or hospitalization for unstable angina (MACE+).
There were no significant differences in time to MACE or MACE+ overall across all observation periods.
Possible limitations of the study were its exclusion criteria and baseline characteristics of participants. The study excluded participants with unstable psychiatric illness, active substance abuse, clinically significant cardiovascular disease in the 2 months prior to the study entry (MI or coronary artery bypass graft), clinically significant cerebrovascular disease in the 2 months prior to study entry (stroke or documented transient ischemic attack), or inadequate control of hypertension as judged by investigators at screening and baseline. Of the included participants, greater than 66% of the participants were in the low risk (less than 10%) cardiovascular risk category, less than 10% had diabetes, less than 5% had coronary heart disease, and less than 1% had carotid artery disease.
Bottom line: The findings provide evidence that, in a general population of smokers, smoking cessation medications do not increase the risk of serious cardiovascular events.
Citation: Benowitz N et al. Cardiovascular safety of varenicline, bupropion, and nicotine patch in smoker. JAMA Intern Med. 2018 May;178(5):622-31.
Dr. White is a hospitalist in the division of hospital medicine in the department of medicine at Loyola University Chicago, Maywood, Ill.
Clinical question: Do pharmacotherapies used in tobacco cessation treatment significantly increase the risk of cardiovascular events?
Background: Although it is known that smoking cessation is the most beneficial enhancement of cardiovascular health, many clinicians may be hesitant to prescribe pharmacotherapies because of concerns regarding adverse events. This study reports the cardiovascular safety findings from EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) and its nontreatment extension trial.
Study design: Double-blind, randomized, triple-dummy, placebo- and active-controlled trial and its nontreatment extension trial.
Setting: Conducted by 140 multinational centers, EAGLES was a trial in cohorts of smokers with and without psychiatric disease that assessed the safety and efficacy of pharmacotherapies used for smoking cessation.
The EAGLES extension trial is a nontreatment extension of EAGLES. It began with the first dose of medication and included those who completed an additional 28 weeks of observation.
Synopsis: The study included approximately 8,000 participants aged 18-75 years who smoked 10 or more cigarettes per day and were interested in quitting. The study monitored the development of a major adverse cardiovascular event (MACE), such as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, during treatment with varenicline, bupropion hydrochloride, nicotine replacement therapy, and placebo therapy. Other end points included determining the occurrence of MACE along with other peripheral vascular disease that required either intervention, coronary revascularization, or hospitalization for unstable angina (MACE+).
There were no significant differences in time to MACE or MACE+ overall across all observation periods.
Possible limitations of the study were its exclusion criteria and baseline characteristics of participants. The study excluded participants with unstable psychiatric illness, active substance abuse, clinically significant cardiovascular disease in the 2 months prior to the study entry (MI or coronary artery bypass graft), clinically significant cerebrovascular disease in the 2 months prior to study entry (stroke or documented transient ischemic attack), or inadequate control of hypertension as judged by investigators at screening and baseline. Of the included participants, greater than 66% of the participants were in the low risk (less than 10%) cardiovascular risk category, less than 10% had diabetes, less than 5% had coronary heart disease, and less than 1% had carotid artery disease.
Bottom line: The findings provide evidence that, in a general population of smokers, smoking cessation medications do not increase the risk of serious cardiovascular events.
Citation: Benowitz N et al. Cardiovascular safety of varenicline, bupropion, and nicotine patch in smoker. JAMA Intern Med. 2018 May;178(5):622-31.
Dr. White is a hospitalist in the division of hospital medicine in the department of medicine at Loyola University Chicago, Maywood, Ill.
Clinical question: Do pharmacotherapies used in tobacco cessation treatment significantly increase the risk of cardiovascular events?
Background: Although it is known that smoking cessation is the most beneficial enhancement of cardiovascular health, many clinicians may be hesitant to prescribe pharmacotherapies because of concerns regarding adverse events. This study reports the cardiovascular safety findings from EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) and its nontreatment extension trial.
Study design: Double-blind, randomized, triple-dummy, placebo- and active-controlled trial and its nontreatment extension trial.
Setting: Conducted by 140 multinational centers, EAGLES was a trial in cohorts of smokers with and without psychiatric disease that assessed the safety and efficacy of pharmacotherapies used for smoking cessation.
The EAGLES extension trial is a nontreatment extension of EAGLES. It began with the first dose of medication and included those who completed an additional 28 weeks of observation.
Synopsis: The study included approximately 8,000 participants aged 18-75 years who smoked 10 or more cigarettes per day and were interested in quitting. The study monitored the development of a major adverse cardiovascular event (MACE), such as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, during treatment with varenicline, bupropion hydrochloride, nicotine replacement therapy, and placebo therapy. Other end points included determining the occurrence of MACE along with other peripheral vascular disease that required either intervention, coronary revascularization, or hospitalization for unstable angina (MACE+).
There were no significant differences in time to MACE or MACE+ overall across all observation periods.
Possible limitations of the study were its exclusion criteria and baseline characteristics of participants. The study excluded participants with unstable psychiatric illness, active substance abuse, clinically significant cardiovascular disease in the 2 months prior to the study entry (MI or coronary artery bypass graft), clinically significant cerebrovascular disease in the 2 months prior to study entry (stroke or documented transient ischemic attack), or inadequate control of hypertension as judged by investigators at screening and baseline. Of the included participants, greater than 66% of the participants were in the low risk (less than 10%) cardiovascular risk category, less than 10% had diabetes, less than 5% had coronary heart disease, and less than 1% had carotid artery disease.
Bottom line: The findings provide evidence that, in a general population of smokers, smoking cessation medications do not increase the risk of serious cardiovascular events.
Citation: Benowitz N et al. Cardiovascular safety of varenicline, bupropion, and nicotine patch in smoker. JAMA Intern Med. 2018 May;178(5):622-31.
Dr. White is a hospitalist in the division of hospital medicine in the department of medicine at Loyola University Chicago, Maywood, Ill.
Bezlotoxumab for prevention of recurrent Clostridium difficile infection
Clinical question: Does administration of monoclonal antibodies to C. difficile toxins A and B, in addition to standard-of-care antibiotics, prevent recurrent infection?
Background: Currently, no therapy has been approved to prevent recurrent C. difficile infection. A new approach to the prevention of recurrent C. difficile infection is the administration of monoclonal antibodies against C. difficile toxins (in addition to antibiotic therapy) as a form of passive immunity. Actoxumab and bezlotoxumab are fully human monoclonal antibodies that bind and neutralize C. difficile toxins A and B, respectively. In humans, the level of circulating antibodies against toxin A or toxin B has been correlated with protection against primary and recurrent C. difficile infection.
Study design: Two (MODIFY [MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection] I and MODIFY II) double-blind, randomized, placebo-controlled, phase III trials.
Setting: 322 sites (~68% inpatient) in 30 countries from Nov. 1, 2011, through May 22, 2015.
Synopsis: Trials pooled data from 2,174 adults who were receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infections. Participants received an infusion of either bezlotoxumab, actoxumab plus bezlotoxumab, or placebo for MODIFY II; actoxumab alone was also given in MODIFY I. The primary endpoint was recurrent infection within 12 weeks.
The rate of recurrent C. difficile infection was significantly lower with bezlotoxumab alone than with placebo (MODIFY I: 17% vs. 28%; 95% CI, −15.9 to −4.3; P less than .001; MODIFY II: 16% vs. 26%; 95% CI, −15.5 to −4.3; P less than .001) and was significantly lower with actoxumab plus bezlotoxumab than with placebo (MODIFY I: 16% vs. 28%; 95% CI, −17.4 to −5.9; P less than .001; MODIFY II: 15% vs. 26%; 95% CI, −16.4 to −5.1; P less than .001).
The serious adverse events were similar with most groups, the exception being actoxumab alone. Given the higher rate of recurrent infection and deaths in the actoxumab group from interim analysis, the enrollment was discontinued in MODIFY I.
Investigators did admit that safety assessments were limited because of the relatively small number of patients who received bezlotoxumab, making it difficult to detect potentially serious but low-frequency toxic effects.
Bottom line: In patients receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection, a single intravenous infusion of bezlotoxumab was associated with a significantly lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo.
Citation: Wilcox MH, Gerding DN, Poxton IR, et al. “Bezlotoxumab for prevention of recurrent Clostridium difficile infection.” N Engl J Med. 2017 Jan 26;376(4):305-17.
Dr. White is an instructor in the Division of Hospital Medicine, Loyola University Chicago.
Clinical question: Does administration of monoclonal antibodies to C. difficile toxins A and B, in addition to standard-of-care antibiotics, prevent recurrent infection?
Background: Currently, no therapy has been approved to prevent recurrent C. difficile infection. A new approach to the prevention of recurrent C. difficile infection is the administration of monoclonal antibodies against C. difficile toxins (in addition to antibiotic therapy) as a form of passive immunity. Actoxumab and bezlotoxumab are fully human monoclonal antibodies that bind and neutralize C. difficile toxins A and B, respectively. In humans, the level of circulating antibodies against toxin A or toxin B has been correlated with protection against primary and recurrent C. difficile infection.
Study design: Two (MODIFY [MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection] I and MODIFY II) double-blind, randomized, placebo-controlled, phase III trials.
Setting: 322 sites (~68% inpatient) in 30 countries from Nov. 1, 2011, through May 22, 2015.
Synopsis: Trials pooled data from 2,174 adults who were receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infections. Participants received an infusion of either bezlotoxumab, actoxumab plus bezlotoxumab, or placebo for MODIFY II; actoxumab alone was also given in MODIFY I. The primary endpoint was recurrent infection within 12 weeks.
The rate of recurrent C. difficile infection was significantly lower with bezlotoxumab alone than with placebo (MODIFY I: 17% vs. 28%; 95% CI, −15.9 to −4.3; P less than .001; MODIFY II: 16% vs. 26%; 95% CI, −15.5 to −4.3; P less than .001) and was significantly lower with actoxumab plus bezlotoxumab than with placebo (MODIFY I: 16% vs. 28%; 95% CI, −17.4 to −5.9; P less than .001; MODIFY II: 15% vs. 26%; 95% CI, −16.4 to −5.1; P less than .001).
The serious adverse events were similar with most groups, the exception being actoxumab alone. Given the higher rate of recurrent infection and deaths in the actoxumab group from interim analysis, the enrollment was discontinued in MODIFY I.
Investigators did admit that safety assessments were limited because of the relatively small number of patients who received bezlotoxumab, making it difficult to detect potentially serious but low-frequency toxic effects.
Bottom line: In patients receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection, a single intravenous infusion of bezlotoxumab was associated with a significantly lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo.
Citation: Wilcox MH, Gerding DN, Poxton IR, et al. “Bezlotoxumab for prevention of recurrent Clostridium difficile infection.” N Engl J Med. 2017 Jan 26;376(4):305-17.
Dr. White is an instructor in the Division of Hospital Medicine, Loyola University Chicago.
Clinical question: Does administration of monoclonal antibodies to C. difficile toxins A and B, in addition to standard-of-care antibiotics, prevent recurrent infection?
Background: Currently, no therapy has been approved to prevent recurrent C. difficile infection. A new approach to the prevention of recurrent C. difficile infection is the administration of monoclonal antibodies against C. difficile toxins (in addition to antibiotic therapy) as a form of passive immunity. Actoxumab and bezlotoxumab are fully human monoclonal antibodies that bind and neutralize C. difficile toxins A and B, respectively. In humans, the level of circulating antibodies against toxin A or toxin B has been correlated with protection against primary and recurrent C. difficile infection.
Study design: Two (MODIFY [MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection] I and MODIFY II) double-blind, randomized, placebo-controlled, phase III trials.
Setting: 322 sites (~68% inpatient) in 30 countries from Nov. 1, 2011, through May 22, 2015.
Synopsis: Trials pooled data from 2,174 adults who were receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infections. Participants received an infusion of either bezlotoxumab, actoxumab plus bezlotoxumab, or placebo for MODIFY II; actoxumab alone was also given in MODIFY I. The primary endpoint was recurrent infection within 12 weeks.
The rate of recurrent C. difficile infection was significantly lower with bezlotoxumab alone than with placebo (MODIFY I: 17% vs. 28%; 95% CI, −15.9 to −4.3; P less than .001; MODIFY II: 16% vs. 26%; 95% CI, −15.5 to −4.3; P less than .001) and was significantly lower with actoxumab plus bezlotoxumab than with placebo (MODIFY I: 16% vs. 28%; 95% CI, −17.4 to −5.9; P less than .001; MODIFY II: 15% vs. 26%; 95% CI, −16.4 to −5.1; P less than .001).
The serious adverse events were similar with most groups, the exception being actoxumab alone. Given the higher rate of recurrent infection and deaths in the actoxumab group from interim analysis, the enrollment was discontinued in MODIFY I.
Investigators did admit that safety assessments were limited because of the relatively small number of patients who received bezlotoxumab, making it difficult to detect potentially serious but low-frequency toxic effects.
Bottom line: In patients receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection, a single intravenous infusion of bezlotoxumab was associated with a significantly lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo.
Citation: Wilcox MH, Gerding DN, Poxton IR, et al. “Bezlotoxumab for prevention of recurrent Clostridium difficile infection.” N Engl J Med. 2017 Jan 26;376(4):305-17.
Dr. White is an instructor in the Division of Hospital Medicine, Loyola University Chicago.