User login
Widespread lack of awareness of pancreatic insufficiency
Individuals experiencing chronic GI symptoms waited a mean of 3.7 years to see a health care professional, according to a recent survey.
Thus, for persons with chronic GI issues, inadequate communication may be a factor contributing to underdiagnosis. Fully 60% of patients surveyed cited embarrassment as the reason it was difficult to disclose GI symptoms to a doctor. Nearly half (47%) said they simply wanted to wait to see if their problems would go away. And 66% of patients interviewed had never heard of exocrine pancreatic insufficiency (EPI), while an additional 21% had heard of EPI but were not familiar with it.
Financial support for the survey came from AbbVie, which manufactures a Food and Drug Administration–approved pharmaceutical used to treat EPI.
EPI occurs when the production of pancreatic enzymes is insufficient and the digestion of food incomplete. Untreated EPI can lead to distressing symptoms and malnutrition, Phil Hart, MD, of the Ohio State University, Columbus, said in an interview.
Diagnosis can be challenging, but a high index of suspicion for EPI is appropriate for patients with unexplained weight loss and those with a personal or family history of pancreatic disease. An additional red flag is “a greasy, oily film in the toilet water, a sign indicating the malabsorption of nutrients, Dr. Hart pointed out.
Other symptoms may also be relevant to the diagnosis. “EPI is certainly not the most common reason for symptoms like diarrhea, flatulence, weight loss, etc. That being said, it is much more common than is appreciated,” Christopher E. Forsmark, MD, AGAF, of the University of Florida, Gainesville, said in an interview.
EPI should frequently be considered in the differential diagnosis of such conditions as functional bowel disease, irritable bowel disease, and lactose intolerance.
“We do not have accurate methods for diagnosis. Many patients with EPI, even those with underlying pancreatic disease who are at highest risk, are not diagnosed and therefore not treated,” said Dr. Forsmark.
The gold standard for diagnosis is a 72-hour stool collection and fecal fat analysis, which is both labor intensive, expensive, and rarely done. Other tests more-commonly done are fecal elastase and serum trypsin level or a mixed triglyceride breath test.
Dr. Hart and Dr. Forsmark were involved as AGA medical advisers in the development and drafting of the EPI Uncovered survey.
Of providers surveyed who had treated patient with EPI during the past 3 months, 70% of gastroenterologists reported that they had initiated discussion of EPI symptoms, prevention, diagnosis, or treatment; 24% of the time, it was the patient who had initiated that discussion. In contrast, primary care physicians reported that only 35% of the time had they initiated the discussion, while 43% of the time it was the patient who had done so. In 6% of the cases, gastroenterologists were unsure who had initiated the discussion or did not recall who had done so, while the corresponding figure for primary care physicians was 22%.
“Patients will usually respond honestly to direct questions but may not spontaneously volunteer to report their symptoms. This means that their physician must ask these questions, and not assume that the patient would let them know if GI symptoms were present,” Dr. Forsmark said.
Some patients might be gently and sensitively pushed to reveal information, Dr. Hart said. For example, he may ask patients if their symptoms are interfering with their work or their social interactions. Further, in his experience family members may prove to be better sources of relevant information than patients themselves.
The physicians surveyed revealed that approximately one-quarter of their patients (25% of primary care patients and 24% of patients of gastroenterologists) who are eventually diagnosed with EPI had previously been diagnosed with a different condition.
“There is a widespread lack of knowledge on the part of patients and even doctors about the pancreas and about EPI. There is also a widespread lack of knowledge on appropriate treatment of EPI. Patients often are not treated at all, or are treated with an inadequate dosage of pancreatic enzyme replacement therapy,” Dr. Forsmark said.
Further, while 63% of gastroenterologists said they considered the pancreas when diagnosing gastrointestinal symptoms, only 48% of primary care physicians reported considering the pancreas in these situations.
“In our culture, discussing GI symptoms is particularly embarrassing,” said Dr. Forsmark. “This is not uniform across these symptoms. For instance, patients will often report heartburn or GERD [gastroesophageal reflux disease] or difficulty swallowing but are more embarrassed to report bloating or flatulence or changes in bowel habits, or even abdominal pain.”
“In addition, as we have all had these types of symptoms during our lives and they often spontaneously improve, our tendency is to ignore them for prolonged periods,” Dr. Forsmark said.
“A recent patient of mine presented with some loose stools and severe weight loss. This patient reported that symptoms – in retrospect – had been present for more than 6 months. And noted that although he had lost more than 40 pounds, he had been ‘trying to lose weight.’ ” This patient seemed to ignore the fact that “all previous attempts at dieting had been ineffective, and his diet had not really changed. Only when a family member insisted did he agree to an evaluation, Dr. Forsmark said.
Of gastroenterologists surveyed, only 2% had not personally diagnosed at least one patient with EPI. In contrast, 57% of primary care physicians surveyed had never diagnosed a patient with EPI. Gastroenterologists should have all or most of the responsibility in educating patients about gastrointestinal symptoms, according to 78% of the primary care physicians and 92% of the gastroenterologists surveyed. And gastroenterologists should have all or most of the responsibility in treating EPI, said 84% of the primary care physicians and 93% of the gastroenterologists.
While 96% of gastroenterologists reported being either very or somewhat familiar with pancreatic enzyme replacement therapies, among primary care physicians surveyed only 52% expressed a similar level of familiarity with these drugs.
According to the National Institute for Diabetes and Digestive and Kidney Diseases 60-70 million Americans are affected by all digestive diseases. The exact prevalence of exocrine pancreatic insufficiency in not well defined, it is a symptom of a pancreatic disorder such as chronic pancreatitis.
Individuals experiencing chronic GI symptoms waited a mean of 3.7 years to see a health care professional, according to a recent survey.
Thus, for persons with chronic GI issues, inadequate communication may be a factor contributing to underdiagnosis. Fully 60% of patients surveyed cited embarrassment as the reason it was difficult to disclose GI symptoms to a doctor. Nearly half (47%) said they simply wanted to wait to see if their problems would go away. And 66% of patients interviewed had never heard of exocrine pancreatic insufficiency (EPI), while an additional 21% had heard of EPI but were not familiar with it.
Financial support for the survey came from AbbVie, which manufactures a Food and Drug Administration–approved pharmaceutical used to treat EPI.
EPI occurs when the production of pancreatic enzymes is insufficient and the digestion of food incomplete. Untreated EPI can lead to distressing symptoms and malnutrition, Phil Hart, MD, of the Ohio State University, Columbus, said in an interview.
Diagnosis can be challenging, but a high index of suspicion for EPI is appropriate for patients with unexplained weight loss and those with a personal or family history of pancreatic disease. An additional red flag is “a greasy, oily film in the toilet water, a sign indicating the malabsorption of nutrients, Dr. Hart pointed out.
Other symptoms may also be relevant to the diagnosis. “EPI is certainly not the most common reason for symptoms like diarrhea, flatulence, weight loss, etc. That being said, it is much more common than is appreciated,” Christopher E. Forsmark, MD, AGAF, of the University of Florida, Gainesville, said in an interview.
EPI should frequently be considered in the differential diagnosis of such conditions as functional bowel disease, irritable bowel disease, and lactose intolerance.
“We do not have accurate methods for diagnosis. Many patients with EPI, even those with underlying pancreatic disease who are at highest risk, are not diagnosed and therefore not treated,” said Dr. Forsmark.
The gold standard for diagnosis is a 72-hour stool collection and fecal fat analysis, which is both labor intensive, expensive, and rarely done. Other tests more-commonly done are fecal elastase and serum trypsin level or a mixed triglyceride breath test.
Dr. Hart and Dr. Forsmark were involved as AGA medical advisers in the development and drafting of the EPI Uncovered survey.
Of providers surveyed who had treated patient with EPI during the past 3 months, 70% of gastroenterologists reported that they had initiated discussion of EPI symptoms, prevention, diagnosis, or treatment; 24% of the time, it was the patient who had initiated that discussion. In contrast, primary care physicians reported that only 35% of the time had they initiated the discussion, while 43% of the time it was the patient who had done so. In 6% of the cases, gastroenterologists were unsure who had initiated the discussion or did not recall who had done so, while the corresponding figure for primary care physicians was 22%.
“Patients will usually respond honestly to direct questions but may not spontaneously volunteer to report their symptoms. This means that their physician must ask these questions, and not assume that the patient would let them know if GI symptoms were present,” Dr. Forsmark said.
Some patients might be gently and sensitively pushed to reveal information, Dr. Hart said. For example, he may ask patients if their symptoms are interfering with their work or their social interactions. Further, in his experience family members may prove to be better sources of relevant information than patients themselves.
The physicians surveyed revealed that approximately one-quarter of their patients (25% of primary care patients and 24% of patients of gastroenterologists) who are eventually diagnosed with EPI had previously been diagnosed with a different condition.
“There is a widespread lack of knowledge on the part of patients and even doctors about the pancreas and about EPI. There is also a widespread lack of knowledge on appropriate treatment of EPI. Patients often are not treated at all, or are treated with an inadequate dosage of pancreatic enzyme replacement therapy,” Dr. Forsmark said.
Further, while 63% of gastroenterologists said they considered the pancreas when diagnosing gastrointestinal symptoms, only 48% of primary care physicians reported considering the pancreas in these situations.
“In our culture, discussing GI symptoms is particularly embarrassing,” said Dr. Forsmark. “This is not uniform across these symptoms. For instance, patients will often report heartburn or GERD [gastroesophageal reflux disease] or difficulty swallowing but are more embarrassed to report bloating or flatulence or changes in bowel habits, or even abdominal pain.”
“In addition, as we have all had these types of symptoms during our lives and they often spontaneously improve, our tendency is to ignore them for prolonged periods,” Dr. Forsmark said.
“A recent patient of mine presented with some loose stools and severe weight loss. This patient reported that symptoms – in retrospect – had been present for more than 6 months. And noted that although he had lost more than 40 pounds, he had been ‘trying to lose weight.’ ” This patient seemed to ignore the fact that “all previous attempts at dieting had been ineffective, and his diet had not really changed. Only when a family member insisted did he agree to an evaluation, Dr. Forsmark said.
Of gastroenterologists surveyed, only 2% had not personally diagnosed at least one patient with EPI. In contrast, 57% of primary care physicians surveyed had never diagnosed a patient with EPI. Gastroenterologists should have all or most of the responsibility in educating patients about gastrointestinal symptoms, according to 78% of the primary care physicians and 92% of the gastroenterologists surveyed. And gastroenterologists should have all or most of the responsibility in treating EPI, said 84% of the primary care physicians and 93% of the gastroenterologists.
While 96% of gastroenterologists reported being either very or somewhat familiar with pancreatic enzyme replacement therapies, among primary care physicians surveyed only 52% expressed a similar level of familiarity with these drugs.
According to the National Institute for Diabetes and Digestive and Kidney Diseases 60-70 million Americans are affected by all digestive diseases. The exact prevalence of exocrine pancreatic insufficiency in not well defined, it is a symptom of a pancreatic disorder such as chronic pancreatitis.
Individuals experiencing chronic GI symptoms waited a mean of 3.7 years to see a health care professional, according to a recent survey.
Thus, for persons with chronic GI issues, inadequate communication may be a factor contributing to underdiagnosis. Fully 60% of patients surveyed cited embarrassment as the reason it was difficult to disclose GI symptoms to a doctor. Nearly half (47%) said they simply wanted to wait to see if their problems would go away. And 66% of patients interviewed had never heard of exocrine pancreatic insufficiency (EPI), while an additional 21% had heard of EPI but were not familiar with it.
Financial support for the survey came from AbbVie, which manufactures a Food and Drug Administration–approved pharmaceutical used to treat EPI.
EPI occurs when the production of pancreatic enzymes is insufficient and the digestion of food incomplete. Untreated EPI can lead to distressing symptoms and malnutrition, Phil Hart, MD, of the Ohio State University, Columbus, said in an interview.
Diagnosis can be challenging, but a high index of suspicion for EPI is appropriate for patients with unexplained weight loss and those with a personal or family history of pancreatic disease. An additional red flag is “a greasy, oily film in the toilet water, a sign indicating the malabsorption of nutrients, Dr. Hart pointed out.
Other symptoms may also be relevant to the diagnosis. “EPI is certainly not the most common reason for symptoms like diarrhea, flatulence, weight loss, etc. That being said, it is much more common than is appreciated,” Christopher E. Forsmark, MD, AGAF, of the University of Florida, Gainesville, said in an interview.
EPI should frequently be considered in the differential diagnosis of such conditions as functional bowel disease, irritable bowel disease, and lactose intolerance.
“We do not have accurate methods for diagnosis. Many patients with EPI, even those with underlying pancreatic disease who are at highest risk, are not diagnosed and therefore not treated,” said Dr. Forsmark.
The gold standard for diagnosis is a 72-hour stool collection and fecal fat analysis, which is both labor intensive, expensive, and rarely done. Other tests more-commonly done are fecal elastase and serum trypsin level or a mixed triglyceride breath test.
Dr. Hart and Dr. Forsmark were involved as AGA medical advisers in the development and drafting of the EPI Uncovered survey.
Of providers surveyed who had treated patient with EPI during the past 3 months, 70% of gastroenterologists reported that they had initiated discussion of EPI symptoms, prevention, diagnosis, or treatment; 24% of the time, it was the patient who had initiated that discussion. In contrast, primary care physicians reported that only 35% of the time had they initiated the discussion, while 43% of the time it was the patient who had done so. In 6% of the cases, gastroenterologists were unsure who had initiated the discussion or did not recall who had done so, while the corresponding figure for primary care physicians was 22%.
“Patients will usually respond honestly to direct questions but may not spontaneously volunteer to report their symptoms. This means that their physician must ask these questions, and not assume that the patient would let them know if GI symptoms were present,” Dr. Forsmark said.
Some patients might be gently and sensitively pushed to reveal information, Dr. Hart said. For example, he may ask patients if their symptoms are interfering with their work or their social interactions. Further, in his experience family members may prove to be better sources of relevant information than patients themselves.
The physicians surveyed revealed that approximately one-quarter of their patients (25% of primary care patients and 24% of patients of gastroenterologists) who are eventually diagnosed with EPI had previously been diagnosed with a different condition.
“There is a widespread lack of knowledge on the part of patients and even doctors about the pancreas and about EPI. There is also a widespread lack of knowledge on appropriate treatment of EPI. Patients often are not treated at all, or are treated with an inadequate dosage of pancreatic enzyme replacement therapy,” Dr. Forsmark said.
Further, while 63% of gastroenterologists said they considered the pancreas when diagnosing gastrointestinal symptoms, only 48% of primary care physicians reported considering the pancreas in these situations.
“In our culture, discussing GI symptoms is particularly embarrassing,” said Dr. Forsmark. “This is not uniform across these symptoms. For instance, patients will often report heartburn or GERD [gastroesophageal reflux disease] or difficulty swallowing but are more embarrassed to report bloating or flatulence or changes in bowel habits, or even abdominal pain.”
“In addition, as we have all had these types of symptoms during our lives and they often spontaneously improve, our tendency is to ignore them for prolonged periods,” Dr. Forsmark said.
“A recent patient of mine presented with some loose stools and severe weight loss. This patient reported that symptoms – in retrospect – had been present for more than 6 months. And noted that although he had lost more than 40 pounds, he had been ‘trying to lose weight.’ ” This patient seemed to ignore the fact that “all previous attempts at dieting had been ineffective, and his diet had not really changed. Only when a family member insisted did he agree to an evaluation, Dr. Forsmark said.
Of gastroenterologists surveyed, only 2% had not personally diagnosed at least one patient with EPI. In contrast, 57% of primary care physicians surveyed had never diagnosed a patient with EPI. Gastroenterologists should have all or most of the responsibility in educating patients about gastrointestinal symptoms, according to 78% of the primary care physicians and 92% of the gastroenterologists surveyed. And gastroenterologists should have all or most of the responsibility in treating EPI, said 84% of the primary care physicians and 93% of the gastroenterologists.
While 96% of gastroenterologists reported being either very or somewhat familiar with pancreatic enzyme replacement therapies, among primary care physicians surveyed only 52% expressed a similar level of familiarity with these drugs.
According to the National Institute for Diabetes and Digestive and Kidney Diseases 60-70 million Americans are affected by all digestive diseases. The exact prevalence of exocrine pancreatic insufficiency in not well defined, it is a symptom of a pancreatic disorder such as chronic pancreatitis.
Key clinical point: Embarrassment hinders diagnosis of lower GI conditions, including exocrine pancreatic insufficiency.
Major finding: Individuals experiencing chronic GI symptoms waited a mean of 3.7 years to see a health care professional.
Data source: An online survey of 1,001 patients, 250 gastroenterologists, and 250 primary care providers.
Disclosures: Financial support for the survey came from AbbVie, which manufactures an FDA-approved pharmaceutical used to treat EPI.
MARIANNE: Same PFS but TDM-1 more tolerable than trastuzumab + chemo
Trastuzumab emtansine (TDM-1) provided similar progression-free survival, compared with trastuzumab plus taxane for first-line treatment of human epidermal growth factor receptor 2–positive advanced breast cancer, but proved more tolerable to patients.
In the phase III MARIANNE study, 1,095 patients with HER2-positive advanced breast cancer were randomized 1:1:1 to trastuzumab plus taxane, T-DM1 plus placebo, or T-DM1 plus pertuzumab. Median duration of follow-up was approximately 35 months.
Incidence of adverse events equal to or greater than grade 3 were 54.1% for trastuzumab plus taxane, 45.4% for T-DM1, and 46.2% for T-DM1 plus pertuzumab, respectively. Adverse events led to discontinuation of treatment by a greater number of patients receiving trastuzumab plus taxane, compared with patients in other arms of the study.
Objective response rate and median response duration in those patients who achieved a response were 67.9% and 12.5 months for trastuzumab plus taxane, 59.7% and 20.7 months for T-DM1, and 64.2% and 21.2 months for T-DM1 plus pertuzumab, respectively.
Subgroup analysis demonstrated a numerical trend for an increased relative treatment effect for patients who, during early breast cancer treatment, had received either HER2-directed therapy or taxanes.
Time to clinically meaningful decrease in health-related quality of life was a median of 3.6 months for trastuzumab plus taxane, 7.7 months for T-DM1, and 9.0 months for T-DM1 plus pertuzumab.
A left ventricular ejection fraction of less than 50% accompanied by a greater than or equal to 15 percentage-point decease from baseline occurred in 0.8% of T-DM1 patients, compared with 4.5% with trastuzumab plus taxane and 2.5% with T-DM1 plus pertuzumab.
The authors note that the breast cancer guidelines of the National Comprehensive Cancer Network include T-DM1 as a first-line treatment option for patients with HER2-positive metastatic breast cancer who are not considered suitable for treatment with the preferred regimen of pertuzumab, trastuzumab, and a taxane.
Trastuzumab emtansine (TDM-1) provided similar progression-free survival, compared with trastuzumab plus taxane for first-line treatment of human epidermal growth factor receptor 2–positive advanced breast cancer, but proved more tolerable to patients.
In the phase III MARIANNE study, 1,095 patients with HER2-positive advanced breast cancer were randomized 1:1:1 to trastuzumab plus taxane, T-DM1 plus placebo, or T-DM1 plus pertuzumab. Median duration of follow-up was approximately 35 months.
Incidence of adverse events equal to or greater than grade 3 were 54.1% for trastuzumab plus taxane, 45.4% for T-DM1, and 46.2% for T-DM1 plus pertuzumab, respectively. Adverse events led to discontinuation of treatment by a greater number of patients receiving trastuzumab plus taxane, compared with patients in other arms of the study.
Objective response rate and median response duration in those patients who achieved a response were 67.9% and 12.5 months for trastuzumab plus taxane, 59.7% and 20.7 months for T-DM1, and 64.2% and 21.2 months for T-DM1 plus pertuzumab, respectively.
Subgroup analysis demonstrated a numerical trend for an increased relative treatment effect for patients who, during early breast cancer treatment, had received either HER2-directed therapy or taxanes.
Time to clinically meaningful decrease in health-related quality of life was a median of 3.6 months for trastuzumab plus taxane, 7.7 months for T-DM1, and 9.0 months for T-DM1 plus pertuzumab.
A left ventricular ejection fraction of less than 50% accompanied by a greater than or equal to 15 percentage-point decease from baseline occurred in 0.8% of T-DM1 patients, compared with 4.5% with trastuzumab plus taxane and 2.5% with T-DM1 plus pertuzumab.
The authors note that the breast cancer guidelines of the National Comprehensive Cancer Network include T-DM1 as a first-line treatment option for patients with HER2-positive metastatic breast cancer who are not considered suitable for treatment with the preferred regimen of pertuzumab, trastuzumab, and a taxane.
Trastuzumab emtansine (TDM-1) provided similar progression-free survival, compared with trastuzumab plus taxane for first-line treatment of human epidermal growth factor receptor 2–positive advanced breast cancer, but proved more tolerable to patients.
In the phase III MARIANNE study, 1,095 patients with HER2-positive advanced breast cancer were randomized 1:1:1 to trastuzumab plus taxane, T-DM1 plus placebo, or T-DM1 plus pertuzumab. Median duration of follow-up was approximately 35 months.
Incidence of adverse events equal to or greater than grade 3 were 54.1% for trastuzumab plus taxane, 45.4% for T-DM1, and 46.2% for T-DM1 plus pertuzumab, respectively. Adverse events led to discontinuation of treatment by a greater number of patients receiving trastuzumab plus taxane, compared with patients in other arms of the study.
Objective response rate and median response duration in those patients who achieved a response were 67.9% and 12.5 months for trastuzumab plus taxane, 59.7% and 20.7 months for T-DM1, and 64.2% and 21.2 months for T-DM1 plus pertuzumab, respectively.
Subgroup analysis demonstrated a numerical trend for an increased relative treatment effect for patients who, during early breast cancer treatment, had received either HER2-directed therapy or taxanes.
Time to clinically meaningful decrease in health-related quality of life was a median of 3.6 months for trastuzumab plus taxane, 7.7 months for T-DM1, and 9.0 months for T-DM1 plus pertuzumab.
A left ventricular ejection fraction of less than 50% accompanied by a greater than or equal to 15 percentage-point decease from baseline occurred in 0.8% of T-DM1 patients, compared with 4.5% with trastuzumab plus taxane and 2.5% with T-DM1 plus pertuzumab.
The authors note that the breast cancer guidelines of the National Comprehensive Cancer Network include T-DM1 as a first-line treatment option for patients with HER2-positive metastatic breast cancer who are not considered suitable for treatment with the preferred regimen of pertuzumab, trastuzumab, and a taxane.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point:
Major finding: Median progression-free survival for trastuzumab plus taxane was 13.7 months; for T-DM1, 14.1 months; and for T-DM1 plus pertuzumab, 15.2 months.
Data source: MARIANNE, a phase III trial of 1,095 patients with HER2-positive advanced breast cancer.
Disclosures: Dr. Perez disclosed employment with Genentech. Several other authors disclosed employment or other relationships with Genentech or Roche. The trial was sponsored by Genentech.
He/O2 does not reduce NIV failure in severe COPD exacerbations
Inhaling He/O2 did not result in a lower NIV failure rate than inhaling Air/O2 in COPD patients requiring noninvasive ventilation, in a randomized, controlled study.
In the study, known as the E.C.H.O.ICU trial, patients either received He/02 (a 78%/22% mixture blended with 100% O2) or a conventional Air/O2 mixture for up to 72 hours, during both noninvasive ventilation (NIV) and spontaneous breathing.
Previous research had demonstrated that during hypercapnic COPD exacerbations, the He/O2 mixture reduces airway resistance, partial pressure of carbon dioxide in arterial blood (PaCO2), intrinsic positive end-expiratory pressure, and work of breathing during both spontaneous breathing and NIV, compared with Air/O2, said Philippe Jolliet, MD, and his colleagues.
The two treatment groups in the E.C.H.O.ICU trial had similar NIV failure rates – defined as endotracheal intubation or death without intubation. The rates were 14.7% for the patients who received He/O2 and 14.5% for the patients who received Air/O2. The NIV failures for 31 the patients in the He/O2 group resulted in intubation; the remaining two patients who were classified as having NIV failure died. All 32 of the patients in the Air/O2 group who had NIV failures were intubated.
The length of ICU stay was also comparable between the two groups. In the subgroups of patients with severe acidosis (having a pH of less than 7.30) from both the He/O2 and Air/O2 groups, the NIV failure rates were again nearly identical (AJRCCM. 2016 Oct 13; doi: 10.1164/rccm.201601-0083OC).
The average times to NIV failure were 93 hours in the He/O2 group (N = 33) and 52 hours in the Air/O2 group (N = 32, P = .12). The He/O2 group achieved a significantly quicker improvement in respiratory acidosis, encephalopathy score, and respiratory rate.
Patients intubated following an NIV failure who had received He/O2 had a shorter ventilation duration and a shorter ICU stay than did the intubated patients who had received Air/O2 (7.4 days, vs. 13.6 days, P = .02, and 15.8 vs. 26.7 days, P = .01).
No significant differences appeared in the safety profile of the two groups, nor were significant differences seen in ICU, hospital, or 6-month mortality rates; or in 6-month hospital readmission rates.
“[The] study was stopped prematurely after a futility analysis due the low event rate identified by [an independent adjudication committee],” said Dr. Jolliet of the intensive care and burn unit at Le Centre Hospitalier Universitaire Vaudois (CHUV), in Lausanne, Switzerland, and his fellow researchers.
The study included 445 patients from ICUs or intermediate care units in six countries. The inclusion criteria were presenting with current COPD exacerbation with hypercapnic acute respiratory failure, a PaCO2 of at least 45 mm Hg, an arterial pH of less than or equal to 7.35, and at least one of the following: respiration rate of at least 25 breaths per minute, a PaO2 less than or equal to 50 mm Hg, and an arterial oxygen saturation of less than or equal to 90%.
Half of the patients in each group were already receiving NIV prior to enrollment in the study. Males constituted two thirds of all enrolled patients.
HeO2 administration was limited to 72 hours for each patient and about a third of NIV failures occurred after the end of the HeO2 administration, the researchers said.
“The main reason for the absence of observed benefit on outcome in the He/O2 probably lies in the very low NIV failure rate now observed in both groups. One possible mechanism explaining the low intubation rate could be that some patients had received uncontrolled oxygen therapy prior to ICU admission, thereby worsening initial hypercapnia and acidosis, a problem that can easily be corrected by adequate titration,” the researchers said. “The 14.5% failure rate in the Air/O2 group was much lower than the 25% rate used in designing the study,” which was based on previous research.
The trial’s sponsor, Air Liquide Healthcare, provided input into the design and conduct of the study; oversaw the collection, management, and statistical analysis of data; and contributed to the manuscript’s preparation and review.
Inhaling He/O2 did not result in a lower NIV failure rate than inhaling Air/O2 in COPD patients requiring noninvasive ventilation, in a randomized, controlled study.
In the study, known as the E.C.H.O.ICU trial, patients either received He/02 (a 78%/22% mixture blended with 100% O2) or a conventional Air/O2 mixture for up to 72 hours, during both noninvasive ventilation (NIV) and spontaneous breathing.
Previous research had demonstrated that during hypercapnic COPD exacerbations, the He/O2 mixture reduces airway resistance, partial pressure of carbon dioxide in arterial blood (PaCO2), intrinsic positive end-expiratory pressure, and work of breathing during both spontaneous breathing and NIV, compared with Air/O2, said Philippe Jolliet, MD, and his colleagues.
The two treatment groups in the E.C.H.O.ICU trial had similar NIV failure rates – defined as endotracheal intubation or death without intubation. The rates were 14.7% for the patients who received He/O2 and 14.5% for the patients who received Air/O2. The NIV failures for 31 the patients in the He/O2 group resulted in intubation; the remaining two patients who were classified as having NIV failure died. All 32 of the patients in the Air/O2 group who had NIV failures were intubated.
The length of ICU stay was also comparable between the two groups. In the subgroups of patients with severe acidosis (having a pH of less than 7.30) from both the He/O2 and Air/O2 groups, the NIV failure rates were again nearly identical (AJRCCM. 2016 Oct 13; doi: 10.1164/rccm.201601-0083OC).
The average times to NIV failure were 93 hours in the He/O2 group (N = 33) and 52 hours in the Air/O2 group (N = 32, P = .12). The He/O2 group achieved a significantly quicker improvement in respiratory acidosis, encephalopathy score, and respiratory rate.
Patients intubated following an NIV failure who had received He/O2 had a shorter ventilation duration and a shorter ICU stay than did the intubated patients who had received Air/O2 (7.4 days, vs. 13.6 days, P = .02, and 15.8 vs. 26.7 days, P = .01).
No significant differences appeared in the safety profile of the two groups, nor were significant differences seen in ICU, hospital, or 6-month mortality rates; or in 6-month hospital readmission rates.
“[The] study was stopped prematurely after a futility analysis due the low event rate identified by [an independent adjudication committee],” said Dr. Jolliet of the intensive care and burn unit at Le Centre Hospitalier Universitaire Vaudois (CHUV), in Lausanne, Switzerland, and his fellow researchers.
The study included 445 patients from ICUs or intermediate care units in six countries. The inclusion criteria were presenting with current COPD exacerbation with hypercapnic acute respiratory failure, a PaCO2 of at least 45 mm Hg, an arterial pH of less than or equal to 7.35, and at least one of the following: respiration rate of at least 25 breaths per minute, a PaO2 less than or equal to 50 mm Hg, and an arterial oxygen saturation of less than or equal to 90%.
Half of the patients in each group were already receiving NIV prior to enrollment in the study. Males constituted two thirds of all enrolled patients.
HeO2 administration was limited to 72 hours for each patient and about a third of NIV failures occurred after the end of the HeO2 administration, the researchers said.
“The main reason for the absence of observed benefit on outcome in the He/O2 probably lies in the very low NIV failure rate now observed in both groups. One possible mechanism explaining the low intubation rate could be that some patients had received uncontrolled oxygen therapy prior to ICU admission, thereby worsening initial hypercapnia and acidosis, a problem that can easily be corrected by adequate titration,” the researchers said. “The 14.5% failure rate in the Air/O2 group was much lower than the 25% rate used in designing the study,” which was based on previous research.
The trial’s sponsor, Air Liquide Healthcare, provided input into the design and conduct of the study; oversaw the collection, management, and statistical analysis of data; and contributed to the manuscript’s preparation and review.
Inhaling He/O2 did not result in a lower NIV failure rate than inhaling Air/O2 in COPD patients requiring noninvasive ventilation, in a randomized, controlled study.
In the study, known as the E.C.H.O.ICU trial, patients either received He/02 (a 78%/22% mixture blended with 100% O2) or a conventional Air/O2 mixture for up to 72 hours, during both noninvasive ventilation (NIV) and spontaneous breathing.
Previous research had demonstrated that during hypercapnic COPD exacerbations, the He/O2 mixture reduces airway resistance, partial pressure of carbon dioxide in arterial blood (PaCO2), intrinsic positive end-expiratory pressure, and work of breathing during both spontaneous breathing and NIV, compared with Air/O2, said Philippe Jolliet, MD, and his colleagues.
The two treatment groups in the E.C.H.O.ICU trial had similar NIV failure rates – defined as endotracheal intubation or death without intubation. The rates were 14.7% for the patients who received He/O2 and 14.5% for the patients who received Air/O2. The NIV failures for 31 the patients in the He/O2 group resulted in intubation; the remaining two patients who were classified as having NIV failure died. All 32 of the patients in the Air/O2 group who had NIV failures were intubated.
The length of ICU stay was also comparable between the two groups. In the subgroups of patients with severe acidosis (having a pH of less than 7.30) from both the He/O2 and Air/O2 groups, the NIV failure rates were again nearly identical (AJRCCM. 2016 Oct 13; doi: 10.1164/rccm.201601-0083OC).
The average times to NIV failure were 93 hours in the He/O2 group (N = 33) and 52 hours in the Air/O2 group (N = 32, P = .12). The He/O2 group achieved a significantly quicker improvement in respiratory acidosis, encephalopathy score, and respiratory rate.
Patients intubated following an NIV failure who had received He/O2 had a shorter ventilation duration and a shorter ICU stay than did the intubated patients who had received Air/O2 (7.4 days, vs. 13.6 days, P = .02, and 15.8 vs. 26.7 days, P = .01).
No significant differences appeared in the safety profile of the two groups, nor were significant differences seen in ICU, hospital, or 6-month mortality rates; or in 6-month hospital readmission rates.
“[The] study was stopped prematurely after a futility analysis due the low event rate identified by [an independent adjudication committee],” said Dr. Jolliet of the intensive care and burn unit at Le Centre Hospitalier Universitaire Vaudois (CHUV), in Lausanne, Switzerland, and his fellow researchers.
The study included 445 patients from ICUs or intermediate care units in six countries. The inclusion criteria were presenting with current COPD exacerbation with hypercapnic acute respiratory failure, a PaCO2 of at least 45 mm Hg, an arterial pH of less than or equal to 7.35, and at least one of the following: respiration rate of at least 25 breaths per minute, a PaO2 less than or equal to 50 mm Hg, and an arterial oxygen saturation of less than or equal to 90%.
Half of the patients in each group were already receiving NIV prior to enrollment in the study. Males constituted two thirds of all enrolled patients.
HeO2 administration was limited to 72 hours for each patient and about a third of NIV failures occurred after the end of the HeO2 administration, the researchers said.
“The main reason for the absence of observed benefit on outcome in the He/O2 probably lies in the very low NIV failure rate now observed in both groups. One possible mechanism explaining the low intubation rate could be that some patients had received uncontrolled oxygen therapy prior to ICU admission, thereby worsening initial hypercapnia and acidosis, a problem that can easily be corrected by adequate titration,” the researchers said. “The 14.5% failure rate in the Air/O2 group was much lower than the 25% rate used in designing the study,” which was based on previous research.
The trial’s sponsor, Air Liquide Healthcare, provided input into the design and conduct of the study; oversaw the collection, management, and statistical analysis of data; and contributed to the manuscript’s preparation and review.
FROM AJRCCM
Key clinical point: .
Major finding: The trial was stopped prematurely due to a low event rate. The NIV failure rates for patients who received Air/O2 and He/O2 were 14.5% (N = 32) and 14.7% ( N = 33, P = .97), respectively.
Data source: A prospective, open-label, randomized, controlled trial of 445 patients.
Disclosures: Air Liquide Healthcare sponsored and contributed to the study.