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Drug combo indicated for bacterial pneumonia
(Avycaz) to include hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.
Specifically, the approved indication is for infections caused by certain Gram-negative bacteria – some of which are increasingly resistant to available antibiotics – including, Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae.
There have not been new treatment options for HABP/VABP caused by Gram-negative bacteria in more than 15 years, according to Allergan, the drug’s manufacturer.
This is the third approved indication for ceftazidime/avibactam; the other two indications are for complicated intra-abdominal infections (in combination with metronidazole) and for complicated urinary tract infections.
(Avycaz) to include hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.
Specifically, the approved indication is for infections caused by certain Gram-negative bacteria – some of which are increasingly resistant to available antibiotics – including, Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae.
There have not been new treatment options for HABP/VABP caused by Gram-negative bacteria in more than 15 years, according to Allergan, the drug’s manufacturer.
This is the third approved indication for ceftazidime/avibactam; the other two indications are for complicated intra-abdominal infections (in combination with metronidazole) and for complicated urinary tract infections.
(Avycaz) to include hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.
Specifically, the approved indication is for infections caused by certain Gram-negative bacteria – some of which are increasingly resistant to available antibiotics – including, Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae.
There have not been new treatment options for HABP/VABP caused by Gram-negative bacteria in more than 15 years, according to Allergan, the drug’s manufacturer.
This is the third approved indication for ceftazidime/avibactam; the other two indications are for complicated intra-abdominal infections (in combination with metronidazole) and for complicated urinary tract infections.
Hospitals filling as flu season worsens
Through the last full week of January, the cumulative “hospitalization rate is the highest we’ve seen,” acting Centers for Disease Control and Prevention director Anne Schuchat, MD, said. For the current season so far, the hospitalization rate stands at 51.4 per 100,000 population, putting it on pace to top the total of 710,000 flu-related admissions that occurred during the 2014-2015 season, she said in a weekly briefing Feb. 2.
Flu-related pediatric deaths also took a big jump for the week as another 16 were reported, which brings the total for the season to 53. Of the children who have died so far, only 20% were vaccinated, said Dan Jernigan, MD, MPH, director of the influenza division at the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta. He also noted that half of the children who have been hospitalized did not had an underlying condition.
The one bit of good news for the week was that activity in the West seems to be easing up, Dr. Schuchat said. The geographic spread of ILI was reported as widespread in 48 states, which is down from 49 the previous week because Oregon dropped off the list. To go along with that, the ILI activity level in California has dropped 2 weeks in a row and now stands at level 7, the CDC data show.
Through the last full week of January, the cumulative “hospitalization rate is the highest we’ve seen,” acting Centers for Disease Control and Prevention director Anne Schuchat, MD, said. For the current season so far, the hospitalization rate stands at 51.4 per 100,000 population, putting it on pace to top the total of 710,000 flu-related admissions that occurred during the 2014-2015 season, she said in a weekly briefing Feb. 2.
Flu-related pediatric deaths also took a big jump for the week as another 16 were reported, which brings the total for the season to 53. Of the children who have died so far, only 20% were vaccinated, said Dan Jernigan, MD, MPH, director of the influenza division at the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta. He also noted that half of the children who have been hospitalized did not had an underlying condition.
The one bit of good news for the week was that activity in the West seems to be easing up, Dr. Schuchat said. The geographic spread of ILI was reported as widespread in 48 states, which is down from 49 the previous week because Oregon dropped off the list. To go along with that, the ILI activity level in California has dropped 2 weeks in a row and now stands at level 7, the CDC data show.
Through the last full week of January, the cumulative “hospitalization rate is the highest we’ve seen,” acting Centers for Disease Control and Prevention director Anne Schuchat, MD, said. For the current season so far, the hospitalization rate stands at 51.4 per 100,000 population, putting it on pace to top the total of 710,000 flu-related admissions that occurred during the 2014-2015 season, she said in a weekly briefing Feb. 2.
Flu-related pediatric deaths also took a big jump for the week as another 16 were reported, which brings the total for the season to 53. Of the children who have died so far, only 20% were vaccinated, said Dan Jernigan, MD, MPH, director of the influenza division at the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta. He also noted that half of the children who have been hospitalized did not had an underlying condition.
The one bit of good news for the week was that activity in the West seems to be easing up, Dr. Schuchat said. The geographic spread of ILI was reported as widespread in 48 states, which is down from 49 the previous week because Oregon dropped off the list. To go along with that, the ILI activity level in California has dropped 2 weeks in a row and now stands at level 7, the CDC data show.
Preoperative exercise lowers postoperative lung resection complications
with a systematic review suggesting it reduces postoperative complications and duration of hospital stay.
The review and meta-analysis, published in the February British Journal of Sports Medicine, looked at the impact of preoperative exercise in patients undergoing surgery for a range of cancers.
Their review of 13 interventional trials, involving 806 patients and six tumor types, found the postoperative benefits of exercise were evident only in patients undergoing lung resection.
Data from five randomized controlled trials and one quasirandomized trial in lung cancer patients showed a significant 48% reduction in postoperative complications, and a significant mean reduction of 2.86 days in hospital stay among patients undergoing lung resection, compared with controls.
“Postoperative complication is a major concern for patients undergoing oncological surgery,” wrote Dr. Daniel Steffens, from the Surgical Outcomes Research Centre at the Royal Prince Alfred Hospital, Sydney, and his coauthors. They suggested the benefits for patients undergoing lung resection were significant enough that exercise before surgery should be considered as standard preoperative care.
“Such findings may also [have impacts] on health care costs and on patients’ quality of life, and consequently, have important implications for patients, health care professionals and policy makers.”
The exercise regimens in the lung cancer studies mostly involved aerobic exercise, such as walking, and breathing exercises to train respiratory muscles, as well as use of an exercise bicycle. The exercises were undertaken in the 1-2 weeks before surgery, with a frequency ranging from three times a week to three times a day.
The authors noted that trials involving a higher frequency of exercise showed a larger effect size, which suggested there was a dose-response relationship.
There was little evidence of benefit in other tumor types. Two studies examined the benefits of preoperative pelvic floor muscle exercises in men undergoing radical prostatectomy and found significant benefits in quality of life, assessed using the International Continence Society Male Short form. However, the authors pointed out that the quality of evidence was very low.
One study investigated the effects of preoperative mouth-opening exercise training in patients undergoing surgery for oral cancer and found enhanced postoperative quality of life in these patients, but the researchers did not report estimates.
For patients undergoing surgery for colon cancer, colorectal liver metastases, and esophageal cancer, there was no benefit of exercise either in postoperative complications or duration of hospital stay. In all these studies, the authors rated the quality of evidence as “very low.”
“Despite the evidence suggesting that exercise improves physical and mental health in patients with cancer, there are only a limited number of trials investigating the effect of preoperative exercise on patients’ quality of life,” the authors wrote. “Therefore, the effect of preoperative exercise on quality of life at short-term and long-term postoperation should be explored in future trials.”
No conflicts of interest were declared.
chestphysician@frontlinemedcom.com
SOURCE: Steffens D et al. Br J Sports Med. 2018 Feb 1. doi: 10.1136/bjsports-2017-098032
with a systematic review suggesting it reduces postoperative complications and duration of hospital stay.
The review and meta-analysis, published in the February British Journal of Sports Medicine, looked at the impact of preoperative exercise in patients undergoing surgery for a range of cancers.
Their review of 13 interventional trials, involving 806 patients and six tumor types, found the postoperative benefits of exercise were evident only in patients undergoing lung resection.
Data from five randomized controlled trials and one quasirandomized trial in lung cancer patients showed a significant 48% reduction in postoperative complications, and a significant mean reduction of 2.86 days in hospital stay among patients undergoing lung resection, compared with controls.
“Postoperative complication is a major concern for patients undergoing oncological surgery,” wrote Dr. Daniel Steffens, from the Surgical Outcomes Research Centre at the Royal Prince Alfred Hospital, Sydney, and his coauthors. They suggested the benefits for patients undergoing lung resection were significant enough that exercise before surgery should be considered as standard preoperative care.
“Such findings may also [have impacts] on health care costs and on patients’ quality of life, and consequently, have important implications for patients, health care professionals and policy makers.”
The exercise regimens in the lung cancer studies mostly involved aerobic exercise, such as walking, and breathing exercises to train respiratory muscles, as well as use of an exercise bicycle. The exercises were undertaken in the 1-2 weeks before surgery, with a frequency ranging from three times a week to three times a day.
The authors noted that trials involving a higher frequency of exercise showed a larger effect size, which suggested there was a dose-response relationship.
There was little evidence of benefit in other tumor types. Two studies examined the benefits of preoperative pelvic floor muscle exercises in men undergoing radical prostatectomy and found significant benefits in quality of life, assessed using the International Continence Society Male Short form. However, the authors pointed out that the quality of evidence was very low.
One study investigated the effects of preoperative mouth-opening exercise training in patients undergoing surgery for oral cancer and found enhanced postoperative quality of life in these patients, but the researchers did not report estimates.
For patients undergoing surgery for colon cancer, colorectal liver metastases, and esophageal cancer, there was no benefit of exercise either in postoperative complications or duration of hospital stay. In all these studies, the authors rated the quality of evidence as “very low.”
“Despite the evidence suggesting that exercise improves physical and mental health in patients with cancer, there are only a limited number of trials investigating the effect of preoperative exercise on patients’ quality of life,” the authors wrote. “Therefore, the effect of preoperative exercise on quality of life at short-term and long-term postoperation should be explored in future trials.”
No conflicts of interest were declared.
chestphysician@frontlinemedcom.com
SOURCE: Steffens D et al. Br J Sports Med. 2018 Feb 1. doi: 10.1136/bjsports-2017-098032
with a systematic review suggesting it reduces postoperative complications and duration of hospital stay.
The review and meta-analysis, published in the February British Journal of Sports Medicine, looked at the impact of preoperative exercise in patients undergoing surgery for a range of cancers.
Their review of 13 interventional trials, involving 806 patients and six tumor types, found the postoperative benefits of exercise were evident only in patients undergoing lung resection.
Data from five randomized controlled trials and one quasirandomized trial in lung cancer patients showed a significant 48% reduction in postoperative complications, and a significant mean reduction of 2.86 days in hospital stay among patients undergoing lung resection, compared with controls.
“Postoperative complication is a major concern for patients undergoing oncological surgery,” wrote Dr. Daniel Steffens, from the Surgical Outcomes Research Centre at the Royal Prince Alfred Hospital, Sydney, and his coauthors. They suggested the benefits for patients undergoing lung resection were significant enough that exercise before surgery should be considered as standard preoperative care.
“Such findings may also [have impacts] on health care costs and on patients’ quality of life, and consequently, have important implications for patients, health care professionals and policy makers.”
The exercise regimens in the lung cancer studies mostly involved aerobic exercise, such as walking, and breathing exercises to train respiratory muscles, as well as use of an exercise bicycle. The exercises were undertaken in the 1-2 weeks before surgery, with a frequency ranging from three times a week to three times a day.
The authors noted that trials involving a higher frequency of exercise showed a larger effect size, which suggested there was a dose-response relationship.
There was little evidence of benefit in other tumor types. Two studies examined the benefits of preoperative pelvic floor muscle exercises in men undergoing radical prostatectomy and found significant benefits in quality of life, assessed using the International Continence Society Male Short form. However, the authors pointed out that the quality of evidence was very low.
One study investigated the effects of preoperative mouth-opening exercise training in patients undergoing surgery for oral cancer and found enhanced postoperative quality of life in these patients, but the researchers did not report estimates.
For patients undergoing surgery for colon cancer, colorectal liver metastases, and esophageal cancer, there was no benefit of exercise either in postoperative complications or duration of hospital stay. In all these studies, the authors rated the quality of evidence as “very low.”
“Despite the evidence suggesting that exercise improves physical and mental health in patients with cancer, there are only a limited number of trials investigating the effect of preoperative exercise on patients’ quality of life,” the authors wrote. “Therefore, the effect of preoperative exercise on quality of life at short-term and long-term postoperation should be explored in future trials.”
No conflicts of interest were declared.
chestphysician@frontlinemedcom.com
SOURCE: Steffens D et al. Br J Sports Med. 2018 Feb 1. doi: 10.1136/bjsports-2017-098032
FROM THE BRITISH JOURNAL OF SPORTS MEDICINE
Key clinical point: Exercising before oncologic surgery appears to lower the risk of postoperative complications and reduce hospital stay for lung cancer patients.
Major finding: Patients who participated in preoperative exercise before lung cancer surgery had a 48% reduction in postoperative complications, compared with controls.
Data source: Systematic review and meta-analysis of 13 interventional trials involving 806 patients.
Disclosures: No conflicts of interest were declared.
Source: Steffens D et al. Br J Sports Med. 2018, Feb 1. doi: 10.1136/bjsports-2017-098032
FDA approves implantable therapy for PAH
to treat adult patients with New York Heart Association (NYHA) Class I, II and III pulmonary arterial hypertension.
This infusion system is implanted into a patient for intravenous delivery of treprostinil (Remodulin) and is designed to help supply blood to the lungs and keep a patient’s blood pressure within a healthy range. The system comprises three parts: the pump, the programmer, and the catheter.
The implant should not be used for patients with NYHA Class IV heart failure, a known or suspected infection, bacteremia, or sepsis requiring antibiotics; vasculature that is inadequate for an 8 French introducer or catheter advancement without stylet guidance; implanted leads or catheters (active or abandoned) in the superior vena cava that cannot be removed prior to or at system implant; a body size not sufficient to accept the pump; or skin or soft tissue that would heal poorly or increase susceptibility to infections. Patients who are unable to tolerate a sudden cessation of treprostinil therapy also would not be able to receive the implantable device.
Read the full approval on the FDA’s website.
to treat adult patients with New York Heart Association (NYHA) Class I, II and III pulmonary arterial hypertension.
This infusion system is implanted into a patient for intravenous delivery of treprostinil (Remodulin) and is designed to help supply blood to the lungs and keep a patient’s blood pressure within a healthy range. The system comprises three parts: the pump, the programmer, and the catheter.
The implant should not be used for patients with NYHA Class IV heart failure, a known or suspected infection, bacteremia, or sepsis requiring antibiotics; vasculature that is inadequate for an 8 French introducer or catheter advancement without stylet guidance; implanted leads or catheters (active or abandoned) in the superior vena cava that cannot be removed prior to or at system implant; a body size not sufficient to accept the pump; or skin or soft tissue that would heal poorly or increase susceptibility to infections. Patients who are unable to tolerate a sudden cessation of treprostinil therapy also would not be able to receive the implantable device.
Read the full approval on the FDA’s website.
to treat adult patients with New York Heart Association (NYHA) Class I, II and III pulmonary arterial hypertension.
This infusion system is implanted into a patient for intravenous delivery of treprostinil (Remodulin) and is designed to help supply blood to the lungs and keep a patient’s blood pressure within a healthy range. The system comprises three parts: the pump, the programmer, and the catheter.
The implant should not be used for patients with NYHA Class IV heart failure, a known or suspected infection, bacteremia, or sepsis requiring antibiotics; vasculature that is inadequate for an 8 French introducer or catheter advancement without stylet guidance; implanted leads or catheters (active or abandoned) in the superior vena cava that cannot be removed prior to or at system implant; a body size not sufficient to accept the pump; or skin or soft tissue that would heal poorly or increase susceptibility to infections. Patients who are unable to tolerate a sudden cessation of treprostinil therapy also would not be able to receive the implantable device.
Read the full approval on the FDA’s website.
Joint Outpatient Experience Gets an A
The results are in: 93% of soldiers, retirees, and family members report very high overall satisfaction with their experience at Army medical treatment facilities.
Survey responses were for the DoD’s 2017 Joint Outpatient Experience Survey (JOES), which also asked about ease of access to Army providers (83% positive response) and overall experience with Army pharmacies (78% positive).
The results showed an increase in satisfaction of about 2% for those 3 questions compared with the results of 2016, the first time the Army participated in the survey, according to Melissa Gliner, senior health policy analyst with the Office of the Army Surgeon General, in an article for Defense.gov. The survey goes to about 10% of patients who have visited a military health facility.
Besides sharing the survey results with the facilities, Gliner advises them on how to improve the patient experience. For instance, she looks at civilian treatment facilities to see what works. One insight she culled was that it helps to have staff members circulate in the waiting area to chat with patients so they do not feel they are being ignored. Another was that facilities should retrain scheduling clerks to set up appointments without making the patient call back.
Gliner says the U.S. Army Medical Command also is working on a website that will help military health facilities share their ideas and “further elevate patient experience and survey scores.”
The results are in: 93% of soldiers, retirees, and family members report very high overall satisfaction with their experience at Army medical treatment facilities.
Survey responses were for the DoD’s 2017 Joint Outpatient Experience Survey (JOES), which also asked about ease of access to Army providers (83% positive response) and overall experience with Army pharmacies (78% positive).
The results showed an increase in satisfaction of about 2% for those 3 questions compared with the results of 2016, the first time the Army participated in the survey, according to Melissa Gliner, senior health policy analyst with the Office of the Army Surgeon General, in an article for Defense.gov. The survey goes to about 10% of patients who have visited a military health facility.
Besides sharing the survey results with the facilities, Gliner advises them on how to improve the patient experience. For instance, she looks at civilian treatment facilities to see what works. One insight she culled was that it helps to have staff members circulate in the waiting area to chat with patients so they do not feel they are being ignored. Another was that facilities should retrain scheduling clerks to set up appointments without making the patient call back.
Gliner says the U.S. Army Medical Command also is working on a website that will help military health facilities share their ideas and “further elevate patient experience and survey scores.”
The results are in: 93% of soldiers, retirees, and family members report very high overall satisfaction with their experience at Army medical treatment facilities.
Survey responses were for the DoD’s 2017 Joint Outpatient Experience Survey (JOES), which also asked about ease of access to Army providers (83% positive response) and overall experience with Army pharmacies (78% positive).
The results showed an increase in satisfaction of about 2% for those 3 questions compared with the results of 2016, the first time the Army participated in the survey, according to Melissa Gliner, senior health policy analyst with the Office of the Army Surgeon General, in an article for Defense.gov. The survey goes to about 10% of patients who have visited a military health facility.
Besides sharing the survey results with the facilities, Gliner advises them on how to improve the patient experience. For instance, she looks at civilian treatment facilities to see what works. One insight she culled was that it helps to have staff members circulate in the waiting area to chat with patients so they do not feel they are being ignored. Another was that facilities should retrain scheduling clerks to set up appointments without making the patient call back.
Gliner says the U.S. Army Medical Command also is working on a website that will help military health facilities share their ideas and “further elevate patient experience and survey scores.”
Preop physiotherapy training reduces risk of postop pulmonary complications
A single 30-minute coaching session with a physiotherapist within 6 weeks of major upper abdominal surgery significantly reduced postoperative pulmonary complications (PPC), according to the results of a prospective trial.
Ianthe Boden and her colleagues recruited 441 eligible adults scheduled for elective major upper abdominal surgery to participate in the prospective, multicenter, double-blinded, controlled superiority study to assess whether PPC outcomes were affected by preoperative physiotherapy. Consecutive participants were obtained from outpatient preadmission assessment clinics during June 2013 to August 2015; they were assigned randomly in a 1:1 ratio to the control (219) or intervention (222) groups. The median patient age was 68 years for the control and 63 for the intervention group, and each group was composed of 31% women.
Immediately after receiving the booklets, however, participants in the intervention group were also given an added 30-minute education and training session by preoperative physiotherapists. This instruction covered factors contributing to PPC occurrence, strategies to help prevention it, and three coached repetitions of breathing exercises. Emphasis was placed on initiating prescribed breathing exercises upon regaining postoperative consciousness and continuing them every hour until the patients were fully ambulatory.
The primary outcome was evaluated by masked assessors using the Melbourne group score criteria to determine PPC incidence within 14 postoperative days or by the time of hospital discharge, whichever was sooner. Nine participants, 4 from the intervention and 5 from the control group, withdrew from the study. Of the total remaining 432 participants, 85 (20%) had a documented PPC incident, including hospital acquired pneumonia, within the specified postoperative time frame, as reported in the BMJ.
Results showed that the physiotherapy group had significantly fewer PPC occurrences (27/218, 12%) than did the control group (58/214, 27%). The calculated absolute risk reduction was 15% (P less than .001). Adjustment for three of the prespecified covariates (age, respiratory comorbidity, and surgical procedure) showed PPC incidence remained halved (hazard ratio, 0.48; P = .001) for the intervention group with a number needed to treat of 7 (95% confidence interval, 5-14).
Secondary outcomes included incidence of hospital acquired pneumonia, hospital utilization, mobility, patient reported complications at 6 weeks, and mortality rates in hospital, at 6 weeks, and at 12 months. For secondary outcomes in the adjusted analysis, incidences of pneumonia were halved in the physiotherapy intervention group with a number needed to treat of 9 (95% CI, 6-21). No significant differences in secondary outcomes were detected between the control and treatment groups.
Sensitivity analysis that removed participants who had lower abdominal and laparoscopic surgery strengthened both primary and secondary outcome results to favor the preoperative physiotherapy intervention for reducing PPC. The researchers found that, in an adjusted analysis of subgroup effects, there was a gradient in reduction of PPCs according to surgical category.
Shorter lengths hospital stay and lower all-cause 12-month mortality were also associated with more experienced physiotherapists providing the preoperative education and training.
Ms. Boden and her colleagues proposed that the timing for patients to begin breathing exercises after major open upper abdominal surgery could be critical in reducing PPC incidence. Initiating breathing exercises within the first 24 hours after surgery – in contrast to the common practice of waiting 1-2 days to begin postoperative physiotherapy – could prevent general anesthesia-associated mild atelectasis from developing into severe atelectasis and PPCs.
The researchers concluded that “in a general population of patients listed for elective upper abdominal surgery, a 30-minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.”
The authors reported that they received grants from the Clifford Craig Foundation; the University of Tasmania (Hobart), Australia; and the Waitemata District Health Board in Auckland, New Zealand.
SOURCE: Boden I et al. BMJ. 2018. doi: 10.1136/bmj.j5916.
A single 30-minute coaching session with a physiotherapist within 6 weeks of major upper abdominal surgery significantly reduced postoperative pulmonary complications (PPC), according to the results of a prospective trial.
Ianthe Boden and her colleagues recruited 441 eligible adults scheduled for elective major upper abdominal surgery to participate in the prospective, multicenter, double-blinded, controlled superiority study to assess whether PPC outcomes were affected by preoperative physiotherapy. Consecutive participants were obtained from outpatient preadmission assessment clinics during June 2013 to August 2015; they were assigned randomly in a 1:1 ratio to the control (219) or intervention (222) groups. The median patient age was 68 years for the control and 63 for the intervention group, and each group was composed of 31% women.
Immediately after receiving the booklets, however, participants in the intervention group were also given an added 30-minute education and training session by preoperative physiotherapists. This instruction covered factors contributing to PPC occurrence, strategies to help prevention it, and three coached repetitions of breathing exercises. Emphasis was placed on initiating prescribed breathing exercises upon regaining postoperative consciousness and continuing them every hour until the patients were fully ambulatory.
The primary outcome was evaluated by masked assessors using the Melbourne group score criteria to determine PPC incidence within 14 postoperative days or by the time of hospital discharge, whichever was sooner. Nine participants, 4 from the intervention and 5 from the control group, withdrew from the study. Of the total remaining 432 participants, 85 (20%) had a documented PPC incident, including hospital acquired pneumonia, within the specified postoperative time frame, as reported in the BMJ.
Results showed that the physiotherapy group had significantly fewer PPC occurrences (27/218, 12%) than did the control group (58/214, 27%). The calculated absolute risk reduction was 15% (P less than .001). Adjustment for three of the prespecified covariates (age, respiratory comorbidity, and surgical procedure) showed PPC incidence remained halved (hazard ratio, 0.48; P = .001) for the intervention group with a number needed to treat of 7 (95% confidence interval, 5-14).
Secondary outcomes included incidence of hospital acquired pneumonia, hospital utilization, mobility, patient reported complications at 6 weeks, and mortality rates in hospital, at 6 weeks, and at 12 months. For secondary outcomes in the adjusted analysis, incidences of pneumonia were halved in the physiotherapy intervention group with a number needed to treat of 9 (95% CI, 6-21). No significant differences in secondary outcomes were detected between the control and treatment groups.
Sensitivity analysis that removed participants who had lower abdominal and laparoscopic surgery strengthened both primary and secondary outcome results to favor the preoperative physiotherapy intervention for reducing PPC. The researchers found that, in an adjusted analysis of subgroup effects, there was a gradient in reduction of PPCs according to surgical category.
Shorter lengths hospital stay and lower all-cause 12-month mortality were also associated with more experienced physiotherapists providing the preoperative education and training.
Ms. Boden and her colleagues proposed that the timing for patients to begin breathing exercises after major open upper abdominal surgery could be critical in reducing PPC incidence. Initiating breathing exercises within the first 24 hours after surgery – in contrast to the common practice of waiting 1-2 days to begin postoperative physiotherapy – could prevent general anesthesia-associated mild atelectasis from developing into severe atelectasis and PPCs.
The researchers concluded that “in a general population of patients listed for elective upper abdominal surgery, a 30-minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.”
The authors reported that they received grants from the Clifford Craig Foundation; the University of Tasmania (Hobart), Australia; and the Waitemata District Health Board in Auckland, New Zealand.
SOURCE: Boden I et al. BMJ. 2018. doi: 10.1136/bmj.j5916.
A single 30-minute coaching session with a physiotherapist within 6 weeks of major upper abdominal surgery significantly reduced postoperative pulmonary complications (PPC), according to the results of a prospective trial.
Ianthe Boden and her colleagues recruited 441 eligible adults scheduled for elective major upper abdominal surgery to participate in the prospective, multicenter, double-blinded, controlled superiority study to assess whether PPC outcomes were affected by preoperative physiotherapy. Consecutive participants were obtained from outpatient preadmission assessment clinics during June 2013 to August 2015; they were assigned randomly in a 1:1 ratio to the control (219) or intervention (222) groups. The median patient age was 68 years for the control and 63 for the intervention group, and each group was composed of 31% women.
Immediately after receiving the booklets, however, participants in the intervention group were also given an added 30-minute education and training session by preoperative physiotherapists. This instruction covered factors contributing to PPC occurrence, strategies to help prevention it, and three coached repetitions of breathing exercises. Emphasis was placed on initiating prescribed breathing exercises upon regaining postoperative consciousness and continuing them every hour until the patients were fully ambulatory.
The primary outcome was evaluated by masked assessors using the Melbourne group score criteria to determine PPC incidence within 14 postoperative days or by the time of hospital discharge, whichever was sooner. Nine participants, 4 from the intervention and 5 from the control group, withdrew from the study. Of the total remaining 432 participants, 85 (20%) had a documented PPC incident, including hospital acquired pneumonia, within the specified postoperative time frame, as reported in the BMJ.
Results showed that the physiotherapy group had significantly fewer PPC occurrences (27/218, 12%) than did the control group (58/214, 27%). The calculated absolute risk reduction was 15% (P less than .001). Adjustment for three of the prespecified covariates (age, respiratory comorbidity, and surgical procedure) showed PPC incidence remained halved (hazard ratio, 0.48; P = .001) for the intervention group with a number needed to treat of 7 (95% confidence interval, 5-14).
Secondary outcomes included incidence of hospital acquired pneumonia, hospital utilization, mobility, patient reported complications at 6 weeks, and mortality rates in hospital, at 6 weeks, and at 12 months. For secondary outcomes in the adjusted analysis, incidences of pneumonia were halved in the physiotherapy intervention group with a number needed to treat of 9 (95% CI, 6-21). No significant differences in secondary outcomes were detected between the control and treatment groups.
Sensitivity analysis that removed participants who had lower abdominal and laparoscopic surgery strengthened both primary and secondary outcome results to favor the preoperative physiotherapy intervention for reducing PPC. The researchers found that, in an adjusted analysis of subgroup effects, there was a gradient in reduction of PPCs according to surgical category.
Shorter lengths hospital stay and lower all-cause 12-month mortality were also associated with more experienced physiotherapists providing the preoperative education and training.
Ms. Boden and her colleagues proposed that the timing for patients to begin breathing exercises after major open upper abdominal surgery could be critical in reducing PPC incidence. Initiating breathing exercises within the first 24 hours after surgery – in contrast to the common practice of waiting 1-2 days to begin postoperative physiotherapy – could prevent general anesthesia-associated mild atelectasis from developing into severe atelectasis and PPCs.
The researchers concluded that “in a general population of patients listed for elective upper abdominal surgery, a 30-minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.”
The authors reported that they received grants from the Clifford Craig Foundation; the University of Tasmania (Hobart), Australia; and the Waitemata District Health Board in Auckland, New Zealand.
SOURCE: Boden I et al. BMJ. 2018. doi: 10.1136/bmj.j5916.
FROM THE BMJ
Key clinical point: Reduction in PPC incidences corresponded to physiotherapists providing preoperative education and coaching intervention.
Major finding: Compared with the control group, Absolute risk was reduced by 15%, and seven was determined as number needed to treat.
Study details: Prospective, blinded study of 441 adult participants randomly assigned in a 1:1 ratio, comparing PPC outcomes associated with preop practices for upper abdominal surgeries.
Disclosures: The authors reported that they received grants from the Clifford Craig Foundation; the University of Tasmania (Hobart), Australia; and the Waitemata District Health Board in Auckland, New Zealand.
Source: Boden I. et al. BMJ. 2018. doi: 10.1136/bmj.j5916.
Closer to a Vaccine For a ‘Pandemic in Progress’?
A series of National Institute of Health (NIH) clinical trials are bringing Zika virus vaccines closer to the public.
According to preliminary findings from 3 phase 1 clinical trials, an investigational Zika purified inactivated virus (ZPIV) vaccine was well tolerated and induced an immune response. Scientists from Walter Reed Army Institute of Research are developing the vaccine and leading 1 of the trials.
Of 67 adult participants, 55 received the investigational vaccine; 12 received placebo. All participants received 2 intramuscular injections 4 weeks apart. The researchers detected antibodies in > 90% of those who received the vaccine, 4 weeks after the last dose.
In phase 2 clinical trials, 2 versions of an experimental gene-based Zika vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases, were both found to be safe and to induce an immune response. One candidate showed “the most promise,” paving the way for an international phase 2/2b safety and efficacy trial, which began in 2017 and will last for 2 years.
“This trial marks a significant milestone in our efforts to develop countermeasures for a pandemic in progress,” said Anthony Fauci, MD, NIAID director
A series of National Institute of Health (NIH) clinical trials are bringing Zika virus vaccines closer to the public.
According to preliminary findings from 3 phase 1 clinical trials, an investigational Zika purified inactivated virus (ZPIV) vaccine was well tolerated and induced an immune response. Scientists from Walter Reed Army Institute of Research are developing the vaccine and leading 1 of the trials.
Of 67 adult participants, 55 received the investigational vaccine; 12 received placebo. All participants received 2 intramuscular injections 4 weeks apart. The researchers detected antibodies in > 90% of those who received the vaccine, 4 weeks after the last dose.
In phase 2 clinical trials, 2 versions of an experimental gene-based Zika vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases, were both found to be safe and to induce an immune response. One candidate showed “the most promise,” paving the way for an international phase 2/2b safety and efficacy trial, which began in 2017 and will last for 2 years.
“This trial marks a significant milestone in our efforts to develop countermeasures for a pandemic in progress,” said Anthony Fauci, MD, NIAID director
A series of National Institute of Health (NIH) clinical trials are bringing Zika virus vaccines closer to the public.
According to preliminary findings from 3 phase 1 clinical trials, an investigational Zika purified inactivated virus (ZPIV) vaccine was well tolerated and induced an immune response. Scientists from Walter Reed Army Institute of Research are developing the vaccine and leading 1 of the trials.
Of 67 adult participants, 55 received the investigational vaccine; 12 received placebo. All participants received 2 intramuscular injections 4 weeks apart. The researchers detected antibodies in > 90% of those who received the vaccine, 4 weeks after the last dose.
In phase 2 clinical trials, 2 versions of an experimental gene-based Zika vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases, were both found to be safe and to induce an immune response. One candidate showed “the most promise,” paving the way for an international phase 2/2b safety and efficacy trial, which began in 2017 and will last for 2 years.
“This trial marks a significant milestone in our efforts to develop countermeasures for a pandemic in progress,” said Anthony Fauci, MD, NIAID director
Birth cohort affected 2015-2016 flu vaccine effectiveness
The influenza vaccine introduced in 2009 showed reduced effectiveness during the 2015-2016 influenza season, but only in adults born between 1958 and 1979, according to an analysis published online in the Journal of Infectious Diseases.
Using the Influenza Vaccine Effectiveness Network, researchers analyzed data from 2,115 patients with medically attended acute respiratory illness who tested positive for A(H1N1)pdm09 influenza virus, and 14,696 patients who tested negative for the influenza virus, from 2010-2011 to 2015-2016 (excluding the 2014-2015 influenza season).
Overall, 48% of the influenza virus–negative patients and 28% of the virus-positive patients had received at least one dose of the seasonal inactivated influenza vaccine more than 2 weeks before they fell ill.
However, the vaccine, which was based on the A/California/07/2009 strain of the A(H1N1)pdm09 virus, was only 47% effective during the 2015-2016 season, compared with 61% effectiveness during the 2010-2011 season through to the 2013-2014 season.
When researchers looked at vaccine effectiveness by birth cohort, they found that one particular cohort – individuals born between 1958 and 1979 – showed a significantly reduced vaccine effectiveness (22%) during the 2015-2016 season. By comparison, vaccine effectiveness in this cohort was 61% during the 2010-2013 seasons, and 56% during the 2013-2014 season.
When this birth cohort was excluded from analysis of the 2015-2016 season, the overall vaccine effectiveness for that season was 61%.
While the vaccine was based on an early reference strain of A(H1N1)pdm09, the virus itself later acquired mutations in the hemagglutinin gene, leading to the emergence of new genetic clades, including 6B, which dominated in the 2013-2014 influenza season, and 6B.1, which dominated in 2015-2016.
“Limited serologic data suggest that some adults born during 1958-1979 (age range in 2015-2016, 36-57 years) have decreased antibody titers against A(H1N1)pdm09 group 6B and 6B.1 viruses,” wrote Brendan Flannery, PhD, from the Centers for Disease Control and Prevention, and his coauthors.
They suggested that individuals in this cohort may have been immunologically primed with A/USSR/90/1977-like viruses, which were the first group of A(H1N1) viruses that this cohort would have been exposed to. A(H1N1) strains didn’t circulate between 1958 and 1977. Vaccination with A(H1N1)pdm09 viruses may have induced antibodies against shared antigenic components found on early versions of A(H1N1)pdm09.
If these shared antigenic epitopes were then altered in the later 6B and 6B.1 viruses, that might account for decreased antibody titers in this age group.
“Replacement of the A/California/07/2009(H1N1)pdm09 vaccine reference strain with A/Michigan/45/2015 (group 6B.1) should lead to improved [vaccine effectiveness] against circulating A(H1N1)pdm09 viruses,” the investigators noted.
The study was supported by the Centers for Disease Control and Prevention, the National Institutes of Health, and the National Center for Advancing Translational Sciences. Eight authors declared funding, grants, and consultancies with the pharmaceutical industry, with five also declaring funding from the CDC.
SOURCE: Flannery B et al. J Infect Dis. 2018 Jan 18. doi: 10.1093/infdis/jix634.
This study proposes that influenza virus strains encountered early in life focus the immune response to later infection or vaccination on shared epitopes between the early and later strains. Supporting this hypothesis is evidence from other studies showing that 60% of the serological response to inactivated influenza vaccines is the result of boosting pre-existing antibodies, rather than the creation of new, vaccine-induced antibodies.
However there are also some flaws to this argument, and we should be careful to avoid confirmation bias. For example, the reduction in effectiveness of vaccines against A(H1N1) has been observed in North America, where this study is located, but to a lesser extent in studies conducted in other regions. Reductions in vaccine effectiveness have also been observed in other birth cohorts and during other influenza seasons.
That aside, accumulating evidence suggests that the vaccine strain be updated from A/California/7/2009 to A/Michigan/45/2015 (a clade 6B.1 strain) for the 2016-2017 influenza seasons.
Allen C. Cheng, PhD, is from the School of Public Health and Preventive Medicine at Monash University, Melbourne, and Kanta Subbarao, MBBS, is from the World Health Organization Collaborating Centre for Reference and Research on Influenza and the Peter Doherty Institute for Infection and Immunity, Australia. These comments are taken from an accompanying editorial (J Infect Dis. 2018, Jan 18. doi: 10.1093/infdis/jix635). The authors declared support from the Australian Department of Health and the Australian National Health and Medical Research Council. No conflicts of interest were declared.
This study proposes that influenza virus strains encountered early in life focus the immune response to later infection or vaccination on shared epitopes between the early and later strains. Supporting this hypothesis is evidence from other studies showing that 60% of the serological response to inactivated influenza vaccines is the result of boosting pre-existing antibodies, rather than the creation of new, vaccine-induced antibodies.
However there are also some flaws to this argument, and we should be careful to avoid confirmation bias. For example, the reduction in effectiveness of vaccines against A(H1N1) has been observed in North America, where this study is located, but to a lesser extent in studies conducted in other regions. Reductions in vaccine effectiveness have also been observed in other birth cohorts and during other influenza seasons.
That aside, accumulating evidence suggests that the vaccine strain be updated from A/California/7/2009 to A/Michigan/45/2015 (a clade 6B.1 strain) for the 2016-2017 influenza seasons.
Allen C. Cheng, PhD, is from the School of Public Health and Preventive Medicine at Monash University, Melbourne, and Kanta Subbarao, MBBS, is from the World Health Organization Collaborating Centre for Reference and Research on Influenza and the Peter Doherty Institute for Infection and Immunity, Australia. These comments are taken from an accompanying editorial (J Infect Dis. 2018, Jan 18. doi: 10.1093/infdis/jix635). The authors declared support from the Australian Department of Health and the Australian National Health and Medical Research Council. No conflicts of interest were declared.
This study proposes that influenza virus strains encountered early in life focus the immune response to later infection or vaccination on shared epitopes between the early and later strains. Supporting this hypothesis is evidence from other studies showing that 60% of the serological response to inactivated influenza vaccines is the result of boosting pre-existing antibodies, rather than the creation of new, vaccine-induced antibodies.
However there are also some flaws to this argument, and we should be careful to avoid confirmation bias. For example, the reduction in effectiveness of vaccines against A(H1N1) has been observed in North America, where this study is located, but to a lesser extent in studies conducted in other regions. Reductions in vaccine effectiveness have also been observed in other birth cohorts and during other influenza seasons.
That aside, accumulating evidence suggests that the vaccine strain be updated from A/California/7/2009 to A/Michigan/45/2015 (a clade 6B.1 strain) for the 2016-2017 influenza seasons.
Allen C. Cheng, PhD, is from the School of Public Health and Preventive Medicine at Monash University, Melbourne, and Kanta Subbarao, MBBS, is from the World Health Organization Collaborating Centre for Reference and Research on Influenza and the Peter Doherty Institute for Infection and Immunity, Australia. These comments are taken from an accompanying editorial (J Infect Dis. 2018, Jan 18. doi: 10.1093/infdis/jix635). The authors declared support from the Australian Department of Health and the Australian National Health and Medical Research Council. No conflicts of interest were declared.
The influenza vaccine introduced in 2009 showed reduced effectiveness during the 2015-2016 influenza season, but only in adults born between 1958 and 1979, according to an analysis published online in the Journal of Infectious Diseases.
Using the Influenza Vaccine Effectiveness Network, researchers analyzed data from 2,115 patients with medically attended acute respiratory illness who tested positive for A(H1N1)pdm09 influenza virus, and 14,696 patients who tested negative for the influenza virus, from 2010-2011 to 2015-2016 (excluding the 2014-2015 influenza season).
Overall, 48% of the influenza virus–negative patients and 28% of the virus-positive patients had received at least one dose of the seasonal inactivated influenza vaccine more than 2 weeks before they fell ill.
However, the vaccine, which was based on the A/California/07/2009 strain of the A(H1N1)pdm09 virus, was only 47% effective during the 2015-2016 season, compared with 61% effectiveness during the 2010-2011 season through to the 2013-2014 season.
When researchers looked at vaccine effectiveness by birth cohort, they found that one particular cohort – individuals born between 1958 and 1979 – showed a significantly reduced vaccine effectiveness (22%) during the 2015-2016 season. By comparison, vaccine effectiveness in this cohort was 61% during the 2010-2013 seasons, and 56% during the 2013-2014 season.
When this birth cohort was excluded from analysis of the 2015-2016 season, the overall vaccine effectiveness for that season was 61%.
While the vaccine was based on an early reference strain of A(H1N1)pdm09, the virus itself later acquired mutations in the hemagglutinin gene, leading to the emergence of new genetic clades, including 6B, which dominated in the 2013-2014 influenza season, and 6B.1, which dominated in 2015-2016.
“Limited serologic data suggest that some adults born during 1958-1979 (age range in 2015-2016, 36-57 years) have decreased antibody titers against A(H1N1)pdm09 group 6B and 6B.1 viruses,” wrote Brendan Flannery, PhD, from the Centers for Disease Control and Prevention, and his coauthors.
They suggested that individuals in this cohort may have been immunologically primed with A/USSR/90/1977-like viruses, which were the first group of A(H1N1) viruses that this cohort would have been exposed to. A(H1N1) strains didn’t circulate between 1958 and 1977. Vaccination with A(H1N1)pdm09 viruses may have induced antibodies against shared antigenic components found on early versions of A(H1N1)pdm09.
If these shared antigenic epitopes were then altered in the later 6B and 6B.1 viruses, that might account for decreased antibody titers in this age group.
“Replacement of the A/California/07/2009(H1N1)pdm09 vaccine reference strain with A/Michigan/45/2015 (group 6B.1) should lead to improved [vaccine effectiveness] against circulating A(H1N1)pdm09 viruses,” the investigators noted.
The study was supported by the Centers for Disease Control and Prevention, the National Institutes of Health, and the National Center for Advancing Translational Sciences. Eight authors declared funding, grants, and consultancies with the pharmaceutical industry, with five also declaring funding from the CDC.
SOURCE: Flannery B et al. J Infect Dis. 2018 Jan 18. doi: 10.1093/infdis/jix634.
The influenza vaccine introduced in 2009 showed reduced effectiveness during the 2015-2016 influenza season, but only in adults born between 1958 and 1979, according to an analysis published online in the Journal of Infectious Diseases.
Using the Influenza Vaccine Effectiveness Network, researchers analyzed data from 2,115 patients with medically attended acute respiratory illness who tested positive for A(H1N1)pdm09 influenza virus, and 14,696 patients who tested negative for the influenza virus, from 2010-2011 to 2015-2016 (excluding the 2014-2015 influenza season).
Overall, 48% of the influenza virus–negative patients and 28% of the virus-positive patients had received at least one dose of the seasonal inactivated influenza vaccine more than 2 weeks before they fell ill.
However, the vaccine, which was based on the A/California/07/2009 strain of the A(H1N1)pdm09 virus, was only 47% effective during the 2015-2016 season, compared with 61% effectiveness during the 2010-2011 season through to the 2013-2014 season.
When researchers looked at vaccine effectiveness by birth cohort, they found that one particular cohort – individuals born between 1958 and 1979 – showed a significantly reduced vaccine effectiveness (22%) during the 2015-2016 season. By comparison, vaccine effectiveness in this cohort was 61% during the 2010-2013 seasons, and 56% during the 2013-2014 season.
When this birth cohort was excluded from analysis of the 2015-2016 season, the overall vaccine effectiveness for that season was 61%.
While the vaccine was based on an early reference strain of A(H1N1)pdm09, the virus itself later acquired mutations in the hemagglutinin gene, leading to the emergence of new genetic clades, including 6B, which dominated in the 2013-2014 influenza season, and 6B.1, which dominated in 2015-2016.
“Limited serologic data suggest that some adults born during 1958-1979 (age range in 2015-2016, 36-57 years) have decreased antibody titers against A(H1N1)pdm09 group 6B and 6B.1 viruses,” wrote Brendan Flannery, PhD, from the Centers for Disease Control and Prevention, and his coauthors.
They suggested that individuals in this cohort may have been immunologically primed with A/USSR/90/1977-like viruses, which were the first group of A(H1N1) viruses that this cohort would have been exposed to. A(H1N1) strains didn’t circulate between 1958 and 1977. Vaccination with A(H1N1)pdm09 viruses may have induced antibodies against shared antigenic components found on early versions of A(H1N1)pdm09.
If these shared antigenic epitopes were then altered in the later 6B and 6B.1 viruses, that might account for decreased antibody titers in this age group.
“Replacement of the A/California/07/2009(H1N1)pdm09 vaccine reference strain with A/Michigan/45/2015 (group 6B.1) should lead to improved [vaccine effectiveness] against circulating A(H1N1)pdm09 viruses,” the investigators noted.
The study was supported by the Centers for Disease Control and Prevention, the National Institutes of Health, and the National Center for Advancing Translational Sciences. Eight authors declared funding, grants, and consultancies with the pharmaceutical industry, with five also declaring funding from the CDC.
SOURCE: Flannery B et al. J Infect Dis. 2018 Jan 18. doi: 10.1093/infdis/jix634.
FROM THE JOURNAL OF INFECTIOUS DISEASES
Key clinical point:
Major finding: The influenza vaccine effectiveness during the 2015-2016 season was just 22% in individuals born between 1958 and 1979.
Data source: A retrospective case-control study of 2,115 patients who tested positive for A(H1N1)pdm09 influenza virus, and 14,696 negative controls.
Disclosures: The study was supported by the Centers for Disease Control and Prevention, the National Institutes of Health, and the National Center for Advancing Translational Sciences. Eight authors declared funding, grants, and consultancies with the pharmaceutical industry, with five also declaring funding from the CDC.
Source: Flannery B et al. J Infect Dis. 2018 Jan 18. doi: 10.1093/infdis/jix634.
CDC: Flu levels highest since pandemic year 2009
according to data from the Centers for Disease Control and Prevention.
That season was dominated by influenza A (H3N2), and the 2017-2018 season seems to be going down that same path. For the week ending Jan. 20, the proportion of outpatient visits for influenza-like illness increased to 6.6%, which is, for the second consecutive week, the highest level reported since October of – you guessed it – 2009, when it hit 7.7%, the CDC said in its weekly flu surveillance report.
The level reported last week, 6.3%, has been revised downward and now stands at an even 6%.
It turns out that 2018 is something of a milestone for the H3N2 virus. The virus first emerged in 1968, so it has reached its 50th anniversary, Dan Jernigan, MD, director of the influenza division at the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta, said on Jan. 26 in a weekly briefing.
H3N2 must not be happy about hitting the big 5-0, however, because the map of influenza-like illness activity looks pretty red and angry. For the week ending Jan. 20, there were 30 states at the highest level of flu activity on the CDC’s 1-10 scale, with another nine in the “high” range at levels 8 and 9.
Dr. Jernigan did suggest that activity may have peaked in some areas of the country, with California among them.
There were seven pediatric deaths reported for the week ending Jan. 20, although six occurred in previous weeks. There have been 37 flu-related deaths among children so far during the 2017-2018 season, the CDC said.
according to data from the Centers for Disease Control and Prevention.
That season was dominated by influenza A (H3N2), and the 2017-2018 season seems to be going down that same path. For the week ending Jan. 20, the proportion of outpatient visits for influenza-like illness increased to 6.6%, which is, for the second consecutive week, the highest level reported since October of – you guessed it – 2009, when it hit 7.7%, the CDC said in its weekly flu surveillance report.
The level reported last week, 6.3%, has been revised downward and now stands at an even 6%.
It turns out that 2018 is something of a milestone for the H3N2 virus. The virus first emerged in 1968, so it has reached its 50th anniversary, Dan Jernigan, MD, director of the influenza division at the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta, said on Jan. 26 in a weekly briefing.
H3N2 must not be happy about hitting the big 5-0, however, because the map of influenza-like illness activity looks pretty red and angry. For the week ending Jan. 20, there were 30 states at the highest level of flu activity on the CDC’s 1-10 scale, with another nine in the “high” range at levels 8 and 9.
Dr. Jernigan did suggest that activity may have peaked in some areas of the country, with California among them.
There were seven pediatric deaths reported for the week ending Jan. 20, although six occurred in previous weeks. There have been 37 flu-related deaths among children so far during the 2017-2018 season, the CDC said.
according to data from the Centers for Disease Control and Prevention.
That season was dominated by influenza A (H3N2), and the 2017-2018 season seems to be going down that same path. For the week ending Jan. 20, the proportion of outpatient visits for influenza-like illness increased to 6.6%, which is, for the second consecutive week, the highest level reported since October of – you guessed it – 2009, when it hit 7.7%, the CDC said in its weekly flu surveillance report.
The level reported last week, 6.3%, has been revised downward and now stands at an even 6%.
It turns out that 2018 is something of a milestone for the H3N2 virus. The virus first emerged in 1968, so it has reached its 50th anniversary, Dan Jernigan, MD, director of the influenza division at the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta, said on Jan. 26 in a weekly briefing.
H3N2 must not be happy about hitting the big 5-0, however, because the map of influenza-like illness activity looks pretty red and angry. For the week ending Jan. 20, there were 30 states at the highest level of flu activity on the CDC’s 1-10 scale, with another nine in the “high” range at levels 8 and 9.
Dr. Jernigan did suggest that activity may have peaked in some areas of the country, with California among them.
There were seven pediatric deaths reported for the week ending Jan. 20, although six occurred in previous weeks. There have been 37 flu-related deaths among children so far during the 2017-2018 season, the CDC said.
FDA approves starting dose of roflumilast
The Food and Drug Administration has approved the use of a 250-mcg dose of roflumilast for patients with chronic obstructive pulmonary disease (COPD) for 4 weeks, followed by the use of 500-mcg therapeutic doses, according to a statement from the drug’s marketer, AstraZeneca.
The larger doses of roflumilast (Daliresp) are currently indicated for reducing the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations, according to the statement. The selective phosphodiesterase-4 inhibitor, roflumilast, was approved for this use in 500-mcg doses in 2011. The new smaller doses of the drug are being offered to help reduce the rate of treatment discontinuation with use of the higher therapeutic dosing. The 250-mcg doses of roflumilast are not to be used as treatment for COPD.
“As the only once-daily tablet to provide enhanced protection against COPD exacerbations when added to current bronchodilator therapy, this is an important new dosing option to help patients start and stay on treatment. Exacerbations are associated with hospitalizations and an accelerated decline in lung function, and these patients living with COPD need effective treatment options,” Tosh Butt, vice president, respiratory, at AstraZeneca, said in the press release.
The approval of use of the 250-mcg doses was based on data from the OPTIMIZE study (Evaluation of Tolerability and Pharmacokinetics of Roflumilast trial, 250 mcg and 500 mcg, as an add-on to Standard COPD Treatment to Treat Severe COPD), according to the statement.
Over 12 weeks, the percentage of patients stopping treatment was significantly lower in those first given 250 mcg of roflumilast daily for 4 weeks, followed by 500 mcg once a week for 8 weeks (18.4%), compared with those given 500 mcg of roflumilast daily for 12 weeks (24.6%; odds ratio, 0.66; 95% confidence interval, 0.47-0.93; P = .017).
In eight controlled clinical trials, the most common adverse effects were diarrhea, weight loss, nausea, headache, back pain, influenza, insomnia, dizziness, and decreased appetite.
The Food and Drug Administration has approved the use of a 250-mcg dose of roflumilast for patients with chronic obstructive pulmonary disease (COPD) for 4 weeks, followed by the use of 500-mcg therapeutic doses, according to a statement from the drug’s marketer, AstraZeneca.
The larger doses of roflumilast (Daliresp) are currently indicated for reducing the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations, according to the statement. The selective phosphodiesterase-4 inhibitor, roflumilast, was approved for this use in 500-mcg doses in 2011. The new smaller doses of the drug are being offered to help reduce the rate of treatment discontinuation with use of the higher therapeutic dosing. The 250-mcg doses of roflumilast are not to be used as treatment for COPD.
“As the only once-daily tablet to provide enhanced protection against COPD exacerbations when added to current bronchodilator therapy, this is an important new dosing option to help patients start and stay on treatment. Exacerbations are associated with hospitalizations and an accelerated decline in lung function, and these patients living with COPD need effective treatment options,” Tosh Butt, vice president, respiratory, at AstraZeneca, said in the press release.
The approval of use of the 250-mcg doses was based on data from the OPTIMIZE study (Evaluation of Tolerability and Pharmacokinetics of Roflumilast trial, 250 mcg and 500 mcg, as an add-on to Standard COPD Treatment to Treat Severe COPD), according to the statement.
Over 12 weeks, the percentage of patients stopping treatment was significantly lower in those first given 250 mcg of roflumilast daily for 4 weeks, followed by 500 mcg once a week for 8 weeks (18.4%), compared with those given 500 mcg of roflumilast daily for 12 weeks (24.6%; odds ratio, 0.66; 95% confidence interval, 0.47-0.93; P = .017).
In eight controlled clinical trials, the most common adverse effects were diarrhea, weight loss, nausea, headache, back pain, influenza, insomnia, dizziness, and decreased appetite.
The Food and Drug Administration has approved the use of a 250-mcg dose of roflumilast for patients with chronic obstructive pulmonary disease (COPD) for 4 weeks, followed by the use of 500-mcg therapeutic doses, according to a statement from the drug’s marketer, AstraZeneca.
The larger doses of roflumilast (Daliresp) are currently indicated for reducing the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations, according to the statement. The selective phosphodiesterase-4 inhibitor, roflumilast, was approved for this use in 500-mcg doses in 2011. The new smaller doses of the drug are being offered to help reduce the rate of treatment discontinuation with use of the higher therapeutic dosing. The 250-mcg doses of roflumilast are not to be used as treatment for COPD.
“As the only once-daily tablet to provide enhanced protection against COPD exacerbations when added to current bronchodilator therapy, this is an important new dosing option to help patients start and stay on treatment. Exacerbations are associated with hospitalizations and an accelerated decline in lung function, and these patients living with COPD need effective treatment options,” Tosh Butt, vice president, respiratory, at AstraZeneca, said in the press release.
The approval of use of the 250-mcg doses was based on data from the OPTIMIZE study (Evaluation of Tolerability and Pharmacokinetics of Roflumilast trial, 250 mcg and 500 mcg, as an add-on to Standard COPD Treatment to Treat Severe COPD), according to the statement.
Over 12 weeks, the percentage of patients stopping treatment was significantly lower in those first given 250 mcg of roflumilast daily for 4 weeks, followed by 500 mcg once a week for 8 weeks (18.4%), compared with those given 500 mcg of roflumilast daily for 12 weeks (24.6%; odds ratio, 0.66; 95% confidence interval, 0.47-0.93; P = .017).
In eight controlled clinical trials, the most common adverse effects were diarrhea, weight loss, nausea, headache, back pain, influenza, insomnia, dizziness, and decreased appetite.