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FDA requires labeling changes to metformin-containing drugs
Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function, according to the FDA’s recent review of several medical studies.
These findings have prompted the FDA to require manufacturers to change the labeling for metformin-containing drugs. These drugs’ labels now must include the results of the medical studies and new measures of kidney function for determining if a patient can use metformin, says a written statement from the FDA.
Metformin’s current labeling strongly recommends against its use in some patients with kidneys that do not work normally. The FDA is specifically requiring that new labels include the recommendation that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (that is, the glomerular filtration rate estimating equation, eGFR).
The full labeling recommendations are available in the FDA’s written statement.
Additional information including a data summary and a list of metformin-containing drugs is available in the FDA Drug Safety Communication.
The FDA asks that healthcare professionals and patients report adverse events or side effects related to the use of metformin-containing drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function, according to the FDA’s recent review of several medical studies.
These findings have prompted the FDA to require manufacturers to change the labeling for metformin-containing drugs. These drugs’ labels now must include the results of the medical studies and new measures of kidney function for determining if a patient can use metformin, says a written statement from the FDA.
Metformin’s current labeling strongly recommends against its use in some patients with kidneys that do not work normally. The FDA is specifically requiring that new labels include the recommendation that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (that is, the glomerular filtration rate estimating equation, eGFR).
The full labeling recommendations are available in the FDA’s written statement.
Additional information including a data summary and a list of metformin-containing drugs is available in the FDA Drug Safety Communication.
The FDA asks that healthcare professionals and patients report adverse events or side effects related to the use of metformin-containing drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function, according to the FDA’s recent review of several medical studies.
These findings have prompted the FDA to require manufacturers to change the labeling for metformin-containing drugs. These drugs’ labels now must include the results of the medical studies and new measures of kidney function for determining if a patient can use metformin, says a written statement from the FDA.
Metformin’s current labeling strongly recommends against its use in some patients with kidneys that do not work normally. The FDA is specifically requiring that new labels include the recommendation that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (that is, the glomerular filtration rate estimating equation, eGFR).
The full labeling recommendations are available in the FDA’s written statement.
Additional information including a data summary and a list of metformin-containing drugs is available in the FDA Drug Safety Communication.
The FDA asks that healthcare professionals and patients report adverse events or side effects related to the use of metformin-containing drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
FDA: CT scans safe for patients with electronic medical devices
There’s no need to let fear of electronic interference between computed tomography and electronic medical devices preclude the ordering of such scans for patients with insulin pumps, cardiac implantable electronic devices, or neurostimulators, the Food and Drug Administration said in a written notification.
“The probability of an adverse event being caused by exposing these devices to CT irradiation is extremely low, and it is greatly outweighed by the clinical benefit of a medically indicated CT examination,” according to the new notification, which updates and replaces a preliminary health notification released on July 14, 2008.
The preliminary notification said there was a “possibility that the x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction.” It also included recommendations to reduce the potential risk of such events from occurring and cited adverse events experienced by a few patients with medical devices who had undergone CT scanning, including unintended shocks from neurostimulators, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate.
The new notification says there is an extremely low probability that a CT scanner directly irradiating the circuitry of certain implantable or wearable electronic medical devices can cause sufficient electronic interference to affect the function and operation of the medical device, and this probability is even lower when the radiation dose and the radiation dose rate are reduced. The FDA also notes that the interference is completely avoided when the medical device is outside of the primary x-ray beam of the CT scanner.
The update, which provides additional reports of adverse events by patients with electronic medical devices who had CT scans, states that the number of such events was small, compared with the number of patients with insulin pumps, cardiac implantable electronic devices, and neurostimulators who were scanned without adverse effects.
The FDA encourages health care providers and patients who suspect a problem with a medical imaging device to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
There’s no need to let fear of electronic interference between computed tomography and electronic medical devices preclude the ordering of such scans for patients with insulin pumps, cardiac implantable electronic devices, or neurostimulators, the Food and Drug Administration said in a written notification.
“The probability of an adverse event being caused by exposing these devices to CT irradiation is extremely low, and it is greatly outweighed by the clinical benefit of a medically indicated CT examination,” according to the new notification, which updates and replaces a preliminary health notification released on July 14, 2008.
The preliminary notification said there was a “possibility that the x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction.” It also included recommendations to reduce the potential risk of such events from occurring and cited adverse events experienced by a few patients with medical devices who had undergone CT scanning, including unintended shocks from neurostimulators, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate.
The new notification says there is an extremely low probability that a CT scanner directly irradiating the circuitry of certain implantable or wearable electronic medical devices can cause sufficient electronic interference to affect the function and operation of the medical device, and this probability is even lower when the radiation dose and the radiation dose rate are reduced. The FDA also notes that the interference is completely avoided when the medical device is outside of the primary x-ray beam of the CT scanner.
The update, which provides additional reports of adverse events by patients with electronic medical devices who had CT scans, states that the number of such events was small, compared with the number of patients with insulin pumps, cardiac implantable electronic devices, and neurostimulators who were scanned without adverse effects.
The FDA encourages health care providers and patients who suspect a problem with a medical imaging device to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
There’s no need to let fear of electronic interference between computed tomography and electronic medical devices preclude the ordering of such scans for patients with insulin pumps, cardiac implantable electronic devices, or neurostimulators, the Food and Drug Administration said in a written notification.
“The probability of an adverse event being caused by exposing these devices to CT irradiation is extremely low, and it is greatly outweighed by the clinical benefit of a medically indicated CT examination,” according to the new notification, which updates and replaces a preliminary health notification released on July 14, 2008.
The preliminary notification said there was a “possibility that the x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction.” It also included recommendations to reduce the potential risk of such events from occurring and cited adverse events experienced by a few patients with medical devices who had undergone CT scanning, including unintended shocks from neurostimulators, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate.
The new notification says there is an extremely low probability that a CT scanner directly irradiating the circuitry of certain implantable or wearable electronic medical devices can cause sufficient electronic interference to affect the function and operation of the medical device, and this probability is even lower when the radiation dose and the radiation dose rate are reduced. The FDA also notes that the interference is completely avoided when the medical device is outside of the primary x-ray beam of the CT scanner.
The update, which provides additional reports of adverse events by patients with electronic medical devices who had CT scans, states that the number of such events was small, compared with the number of patients with insulin pumps, cardiac implantable electronic devices, and neurostimulators who were scanned without adverse effects.
The FDA encourages health care providers and patients who suspect a problem with a medical imaging device to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
Drug for conditioning AML patients for transplant gets orphan drug designation
A radioimmunotherapeutic drug for conditioning relapsed and refractory acute myeloid leukemia (AML) patients for a hematopoietic stem cell transplant has been granted orphan drug designation by the Food and Drug Administration.
Iomab-B is a radioimmunoconjugate consisting of the murine monoclonal antibody BC8 and an iodine-131 radioisotope. The Fred Hutchinson Cancer Research Center developed BC8 to target CD45, a panleukocytic antigen widely expressed on white blood cells. “When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues,” says a statement from Actinium Pharmaceuticals, which would market the drug.
Iomab-B will be tested in a multicenter trial that will include 150 patients over age 55 with refractory and relapsed AML. “There has not been a new drug approved for relapsed and refractory AML patients over the age of 55 in decades and with Iomab-B being the only therapy of its kind, we are pleased to have achieved this important milestone,” Sandesh Seth, executive chairman of Actinium, said in the statement.
A radioimmunotherapeutic drug for conditioning relapsed and refractory acute myeloid leukemia (AML) patients for a hematopoietic stem cell transplant has been granted orphan drug designation by the Food and Drug Administration.
Iomab-B is a radioimmunoconjugate consisting of the murine monoclonal antibody BC8 and an iodine-131 radioisotope. The Fred Hutchinson Cancer Research Center developed BC8 to target CD45, a panleukocytic antigen widely expressed on white blood cells. “When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues,” says a statement from Actinium Pharmaceuticals, which would market the drug.
Iomab-B will be tested in a multicenter trial that will include 150 patients over age 55 with refractory and relapsed AML. “There has not been a new drug approved for relapsed and refractory AML patients over the age of 55 in decades and with Iomab-B being the only therapy of its kind, we are pleased to have achieved this important milestone,” Sandesh Seth, executive chairman of Actinium, said in the statement.
A radioimmunotherapeutic drug for conditioning relapsed and refractory acute myeloid leukemia (AML) patients for a hematopoietic stem cell transplant has been granted orphan drug designation by the Food and Drug Administration.
Iomab-B is a radioimmunoconjugate consisting of the murine monoclonal antibody BC8 and an iodine-131 radioisotope. The Fred Hutchinson Cancer Research Center developed BC8 to target CD45, a panleukocytic antigen widely expressed on white blood cells. “When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues,” says a statement from Actinium Pharmaceuticals, which would market the drug.
Iomab-B will be tested in a multicenter trial that will include 150 patients over age 55 with refractory and relapsed AML. “There has not been a new drug approved for relapsed and refractory AML patients over the age of 55 in decades and with Iomab-B being the only therapy of its kind, we are pleased to have achieved this important milestone,” Sandesh Seth, executive chairman of Actinium, said in the statement.
New drug approved for hepatic veno-occlusive disease
Defibrotide sodium has been approved to treat hepatic veno-occlusive disease (VOD) in patients with renal or pulmonary dysfunction following a hematopoietic stem cell transplantation, the Food and Drug Administration has announced.
The drug, which will be marketed as Defitelio by Jazz Pharmaceuticals, was tested in two prospective clinical trials and an expanded access study that included a total of 528 patients with hepatic VOD and multiorgan dysfunction following a transplantation. All patients received 6.25 mg/kg doses of the drug intravenously, every 6 hours until resolution of VOD. The percentages of patients surviving more than 100 days after receiving a stem cell transplantation in each of the studies were 38%, 44%, and 45%, respectively, according to a statement from the FDA.
Contraindications for taking the drug are concurrent use of anticoagulants or fibrinolytic therapies.
Hypotension, diarrhea, vomiting, nausea, and epistaxis are the most common adverse reactions to the drug.
Full prescribing information is available at the FDA website.
Defibrotide sodium has been approved to treat hepatic veno-occlusive disease (VOD) in patients with renal or pulmonary dysfunction following a hematopoietic stem cell transplantation, the Food and Drug Administration has announced.
The drug, which will be marketed as Defitelio by Jazz Pharmaceuticals, was tested in two prospective clinical trials and an expanded access study that included a total of 528 patients with hepatic VOD and multiorgan dysfunction following a transplantation. All patients received 6.25 mg/kg doses of the drug intravenously, every 6 hours until resolution of VOD. The percentages of patients surviving more than 100 days after receiving a stem cell transplantation in each of the studies were 38%, 44%, and 45%, respectively, according to a statement from the FDA.
Contraindications for taking the drug are concurrent use of anticoagulants or fibrinolytic therapies.
Hypotension, diarrhea, vomiting, nausea, and epistaxis are the most common adverse reactions to the drug.
Full prescribing information is available at the FDA website.
Defibrotide sodium has been approved to treat hepatic veno-occlusive disease (VOD) in patients with renal or pulmonary dysfunction following a hematopoietic stem cell transplantation, the Food and Drug Administration has announced.
The drug, which will be marketed as Defitelio by Jazz Pharmaceuticals, was tested in two prospective clinical trials and an expanded access study that included a total of 528 patients with hepatic VOD and multiorgan dysfunction following a transplantation. All patients received 6.25 mg/kg doses of the drug intravenously, every 6 hours until resolution of VOD. The percentages of patients surviving more than 100 days after receiving a stem cell transplantation in each of the studies were 38%, 44%, and 45%, respectively, according to a statement from the FDA.
Contraindications for taking the drug are concurrent use of anticoagulants or fibrinolytic therapies.
Hypotension, diarrhea, vomiting, nausea, and epistaxis are the most common adverse reactions to the drug.
Full prescribing information is available at the FDA website.
FDA approves reslizumab as add-on drug for adults with severe asthma
The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.
The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.
In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.
The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.
Teva Pharmaceuticals is marketing the drug as Cinqair.
The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.
The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.
In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.
The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.
Teva Pharmaceuticals is marketing the drug as Cinqair.
The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.
The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.
In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.
The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.
Teva Pharmaceuticals is marketing the drug as Cinqair.
Decline in depression symptoms followed less than standard number of ketamine doses
Ketamine was 80% effective at decreasing depression symptoms, in a study of 100 depression patients who received less frequent and lower total doses of ketamine than are typically administered to treat depression.
Each study participant received no more than one ketamine intravenous infusion per week, with 4.3 having been the average total number of ketamine infusions received by a patient during the study. The frequency with which an infusion was received and the total number of infusions received by a patient were tailored to each patient’s responses to the therapy, according to the study’s author, Dr. Theodore Henderson. This study used a schedule of treatments for patients that differed from the established protocol for ketamine usage as an antidepressant, which is 3 times per week.
Prior to receiving the intravenous ketamine infusions, study participant’s Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) score was 17.87 plus or minus 2.8 points, which corresponds to being severely depressed. The QIDS-SR score for each of the 80 study participants who responded to the therapy decreased by 10.8 plus or minus 3.5 points. The QIDS-SR of each of the 20 non-responders to the therapy changed by 0.8 plus or minus 1.8 points.
This study showed “clinical improvement with much fewer infusions for most patients. From a mechanistic standpoint, this can only be possible if ketamine is inducing increased BDNF [brain-derived neurotrophic factor] which leads to lasting changes in synapses, dendrites, and neuronal circuits,” Dr. Henderson said.
The study participants comprised 80 patients with recurrent unipolar depression and 20 patients with recurrent bipolar depression from Neuro-Luminance Ketamine Infusion Centers. Side effects experienced by the patients included elevated blood pressure, nausea, and dizziness, which was very common.
“Further controlled studies of the best clinical methods for ketamine infusion therapy are encouraged.” Dr. Henderson said.
Read the study in Neural Regeneration Research (doi: 10.4103/1673-5374.177708).
Ketamine was 80% effective at decreasing depression symptoms, in a study of 100 depression patients who received less frequent and lower total doses of ketamine than are typically administered to treat depression.
Each study participant received no more than one ketamine intravenous infusion per week, with 4.3 having been the average total number of ketamine infusions received by a patient during the study. The frequency with which an infusion was received and the total number of infusions received by a patient were tailored to each patient’s responses to the therapy, according to the study’s author, Dr. Theodore Henderson. This study used a schedule of treatments for patients that differed from the established protocol for ketamine usage as an antidepressant, which is 3 times per week.
Prior to receiving the intravenous ketamine infusions, study participant’s Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) score was 17.87 plus or minus 2.8 points, which corresponds to being severely depressed. The QIDS-SR score for each of the 80 study participants who responded to the therapy decreased by 10.8 plus or minus 3.5 points. The QIDS-SR of each of the 20 non-responders to the therapy changed by 0.8 plus or minus 1.8 points.
This study showed “clinical improvement with much fewer infusions for most patients. From a mechanistic standpoint, this can only be possible if ketamine is inducing increased BDNF [brain-derived neurotrophic factor] which leads to lasting changes in synapses, dendrites, and neuronal circuits,” Dr. Henderson said.
The study participants comprised 80 patients with recurrent unipolar depression and 20 patients with recurrent bipolar depression from Neuro-Luminance Ketamine Infusion Centers. Side effects experienced by the patients included elevated blood pressure, nausea, and dizziness, which was very common.
“Further controlled studies of the best clinical methods for ketamine infusion therapy are encouraged.” Dr. Henderson said.
Read the study in Neural Regeneration Research (doi: 10.4103/1673-5374.177708).
Ketamine was 80% effective at decreasing depression symptoms, in a study of 100 depression patients who received less frequent and lower total doses of ketamine than are typically administered to treat depression.
Each study participant received no more than one ketamine intravenous infusion per week, with 4.3 having been the average total number of ketamine infusions received by a patient during the study. The frequency with which an infusion was received and the total number of infusions received by a patient were tailored to each patient’s responses to the therapy, according to the study’s author, Dr. Theodore Henderson. This study used a schedule of treatments for patients that differed from the established protocol for ketamine usage as an antidepressant, which is 3 times per week.
Prior to receiving the intravenous ketamine infusions, study participant’s Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) score was 17.87 plus or minus 2.8 points, which corresponds to being severely depressed. The QIDS-SR score for each of the 80 study participants who responded to the therapy decreased by 10.8 plus or minus 3.5 points. The QIDS-SR of each of the 20 non-responders to the therapy changed by 0.8 plus or minus 1.8 points.
This study showed “clinical improvement with much fewer infusions for most patients. From a mechanistic standpoint, this can only be possible if ketamine is inducing increased BDNF [brain-derived neurotrophic factor] which leads to lasting changes in synapses, dendrites, and neuronal circuits,” Dr. Henderson said.
The study participants comprised 80 patients with recurrent unipolar depression and 20 patients with recurrent bipolar depression from Neuro-Luminance Ketamine Infusion Centers. Side effects experienced by the patients included elevated blood pressure, nausea, and dizziness, which was very common.
“Further controlled studies of the best clinical methods for ketamine infusion therapy are encouraged.” Dr. Henderson said.
Read the study in Neural Regeneration Research (doi: 10.4103/1673-5374.177708).
FROM NEURAL REGENERATION RESEARCH
Better control of asymptomatic C. difficile needed in communities
Clostridium difficile is transmitted at higher rates in hospitals or long-term care facilities than in community settings, but more efforts need to be directed at reducing community transmission of the infection, report David P. Durham, Ph.D., and his associates.
Hospitalized symptomatic patients transmit C. difficile at a rate 15 times that of patients who are asymptomatic, according to a model created from U.S. national databases described in the paper. Long-term care facility (LTCF) residents transmit C. difficile at a rate of 27% that of hospitalized patients, while people in the community transmit the infection at a rate of less than 0.1% that of hospitalized patients, the model found.
“Despite the lower community transmission rate, we found that because of the much larger pool of colonized persons in the community, interventions that reduce community transmission hold substantial potential to reduce hospital-onset C. difficile infection by reducing the number of patients entering the hospital with asymptomatic colonization,” reported Dr. Durham, associate research scientist in epidemiology at Yale University, New Haven, Conn., and his associates.
The researchers also estimated the effect of transmission-control interventions on C. difficile incidence by computing the percentage reduction in hospital-onset C. difficile, community-onset C. difficile, and LTCF C. difficile per percentage in improvement in hospital C. difficile diagnosis rate, effectiveness of isolation protocols, overall hospital hygiene, transmission in the community, and transmission in an LTCF.
“We found that C. difficile infection diagnosis rate, effectiveness of isolation, overall hospital hygiene, and transmission in the community, but not transmission in an LTCF, affected hospital-onset C. difficile infection,” the researchers wrote. “In addition, community-onset C. difficile infection and LTCF C. difficile infection were not affected by hospital-based transmission interventions.”
Additionally, as the relative risk for antimicrobial drug class prescribed increased in each of the three settings, the C. difficile incidence increased within the respective setting.
The researchers suggested that the use of vaccines and other toxin-targeting treatments, nontoxigenic C. difficile, and monoclonal antibodies could lead to reductions in primary C. difficile cases and transmission of the infection.
“These results underscore the need for empirical quantification of community-associated transmission and the need of understanding transmission dynamics in all settings when evaluating C. difficile interventions and control strategies,” researchers said.
Read the study in Emerging Infectious Diseases (doi: 10.3201.eid2204.1540455).
Clostridium difficile is transmitted at higher rates in hospitals or long-term care facilities than in community settings, but more efforts need to be directed at reducing community transmission of the infection, report David P. Durham, Ph.D., and his associates.
Hospitalized symptomatic patients transmit C. difficile at a rate 15 times that of patients who are asymptomatic, according to a model created from U.S. national databases described in the paper. Long-term care facility (LTCF) residents transmit C. difficile at a rate of 27% that of hospitalized patients, while people in the community transmit the infection at a rate of less than 0.1% that of hospitalized patients, the model found.
“Despite the lower community transmission rate, we found that because of the much larger pool of colonized persons in the community, interventions that reduce community transmission hold substantial potential to reduce hospital-onset C. difficile infection by reducing the number of patients entering the hospital with asymptomatic colonization,” reported Dr. Durham, associate research scientist in epidemiology at Yale University, New Haven, Conn., and his associates.
The researchers also estimated the effect of transmission-control interventions on C. difficile incidence by computing the percentage reduction in hospital-onset C. difficile, community-onset C. difficile, and LTCF C. difficile per percentage in improvement in hospital C. difficile diagnosis rate, effectiveness of isolation protocols, overall hospital hygiene, transmission in the community, and transmission in an LTCF.
“We found that C. difficile infection diagnosis rate, effectiveness of isolation, overall hospital hygiene, and transmission in the community, but not transmission in an LTCF, affected hospital-onset C. difficile infection,” the researchers wrote. “In addition, community-onset C. difficile infection and LTCF C. difficile infection were not affected by hospital-based transmission interventions.”
Additionally, as the relative risk for antimicrobial drug class prescribed increased in each of the three settings, the C. difficile incidence increased within the respective setting.
The researchers suggested that the use of vaccines and other toxin-targeting treatments, nontoxigenic C. difficile, and monoclonal antibodies could lead to reductions in primary C. difficile cases and transmission of the infection.
“These results underscore the need for empirical quantification of community-associated transmission and the need of understanding transmission dynamics in all settings when evaluating C. difficile interventions and control strategies,” researchers said.
Read the study in Emerging Infectious Diseases (doi: 10.3201.eid2204.1540455).
Clostridium difficile is transmitted at higher rates in hospitals or long-term care facilities than in community settings, but more efforts need to be directed at reducing community transmission of the infection, report David P. Durham, Ph.D., and his associates.
Hospitalized symptomatic patients transmit C. difficile at a rate 15 times that of patients who are asymptomatic, according to a model created from U.S. national databases described in the paper. Long-term care facility (LTCF) residents transmit C. difficile at a rate of 27% that of hospitalized patients, while people in the community transmit the infection at a rate of less than 0.1% that of hospitalized patients, the model found.
“Despite the lower community transmission rate, we found that because of the much larger pool of colonized persons in the community, interventions that reduce community transmission hold substantial potential to reduce hospital-onset C. difficile infection by reducing the number of patients entering the hospital with asymptomatic colonization,” reported Dr. Durham, associate research scientist in epidemiology at Yale University, New Haven, Conn., and his associates.
The researchers also estimated the effect of transmission-control interventions on C. difficile incidence by computing the percentage reduction in hospital-onset C. difficile, community-onset C. difficile, and LTCF C. difficile per percentage in improvement in hospital C. difficile diagnosis rate, effectiveness of isolation protocols, overall hospital hygiene, transmission in the community, and transmission in an LTCF.
“We found that C. difficile infection diagnosis rate, effectiveness of isolation, overall hospital hygiene, and transmission in the community, but not transmission in an LTCF, affected hospital-onset C. difficile infection,” the researchers wrote. “In addition, community-onset C. difficile infection and LTCF C. difficile infection were not affected by hospital-based transmission interventions.”
Additionally, as the relative risk for antimicrobial drug class prescribed increased in each of the three settings, the C. difficile incidence increased within the respective setting.
The researchers suggested that the use of vaccines and other toxin-targeting treatments, nontoxigenic C. difficile, and monoclonal antibodies could lead to reductions in primary C. difficile cases and transmission of the infection.
“These results underscore the need for empirical quantification of community-associated transmission and the need of understanding transmission dynamics in all settings when evaluating C. difficile interventions and control strategies,” researchers said.
Read the study in Emerging Infectious Diseases (doi: 10.3201.eid2204.1540455).
FROM EMERGING INFECTIOUS DISEASES
Pilot study shows potential of transcranial direct current stimulation in poststroke motor recovery
Anodal transcranial direct current stimulation (tDCS) combined with motor training in stroke patients led to greater improvements in motor function, compared with motor training alone, in a double-blind randomized trial that was controlled with a sham intervention.
“We report long-term improvements in upper limb ability in patients receiving repeated sessions of anodal tDCS to the ipsilesional motor cortex compared to the sham-treated group when tDCS was paired with motor training. We also found that these clinical improvements were associated with increased activation of ipsilesional motor cortical areas,” said Claire Allman of the University of Oxford (England) and her colleagues.
Participants in the U.K. study included 24 individuals, who had had a single unilateral ischemic or hemorrhagic stroke affecting motor function in the contralesional hand at least 6 months prior to the start of the study. All patients participated in nine daily, supervised, 1-hour weekday sessions of the motor training program, the Graded Repetitive Arm Supplementary Program. For the first 20 minutes of each session, brain stimulations via tDCS electrodes were delivered to 11 patients comprising the experimental group. The 13 patients in the control group received a sham treatment, while electrodes were positioned on their scalps, during the first 20 minutes of each session. The researchers used the Upper Extremity Fugl-Meyer Assessment, the Action Research Arm Test, and the Wolf Motor Function Test to assess upper limb function before and after each patient’s sessions. Neuroimaging analyses were performed using MRI on 11 participants in the experimental group and 11 participants in the control group, both before and after the interventions, as well.
Patients who received the anodal tDCS earned greater scores in the Action Research Arm Test (P = .045) and the Wolf Motor Function Test (P = .001) than did patients in the control group, at 3 months following the intervention. The differences between the Extremity Fugl-Meyer Assessment scores of participants in the two groups at the same point in time were not statistically significant.
There were also “greater increases in [functional MRI] activation and gray matter volume in ipsilesional motor cortical areas in the anodal tDCS group compared to the sham group,” the investigators reported.
Among the researchers’ suggestions for future research on the effects of tDCS on stroke patients were for such studies to include more patients, a less intensive motor training regimen, and a group of patients who receive tDCS without undergoing motor training.
The authors reported that they have no competing interests.
Read the study in Science Translational Medicine (doi: 10.1126/scitranslmed.aad5651).
Anodal transcranial direct current stimulation (tDCS) combined with motor training in stroke patients led to greater improvements in motor function, compared with motor training alone, in a double-blind randomized trial that was controlled with a sham intervention.
“We report long-term improvements in upper limb ability in patients receiving repeated sessions of anodal tDCS to the ipsilesional motor cortex compared to the sham-treated group when tDCS was paired with motor training. We also found that these clinical improvements were associated with increased activation of ipsilesional motor cortical areas,” said Claire Allman of the University of Oxford (England) and her colleagues.
Participants in the U.K. study included 24 individuals, who had had a single unilateral ischemic or hemorrhagic stroke affecting motor function in the contralesional hand at least 6 months prior to the start of the study. All patients participated in nine daily, supervised, 1-hour weekday sessions of the motor training program, the Graded Repetitive Arm Supplementary Program. For the first 20 minutes of each session, brain stimulations via tDCS electrodes were delivered to 11 patients comprising the experimental group. The 13 patients in the control group received a sham treatment, while electrodes were positioned on their scalps, during the first 20 minutes of each session. The researchers used the Upper Extremity Fugl-Meyer Assessment, the Action Research Arm Test, and the Wolf Motor Function Test to assess upper limb function before and after each patient’s sessions. Neuroimaging analyses were performed using MRI on 11 participants in the experimental group and 11 participants in the control group, both before and after the interventions, as well.
Patients who received the anodal tDCS earned greater scores in the Action Research Arm Test (P = .045) and the Wolf Motor Function Test (P = .001) than did patients in the control group, at 3 months following the intervention. The differences between the Extremity Fugl-Meyer Assessment scores of participants in the two groups at the same point in time were not statistically significant.
There were also “greater increases in [functional MRI] activation and gray matter volume in ipsilesional motor cortical areas in the anodal tDCS group compared to the sham group,” the investigators reported.
Among the researchers’ suggestions for future research on the effects of tDCS on stroke patients were for such studies to include more patients, a less intensive motor training regimen, and a group of patients who receive tDCS without undergoing motor training.
The authors reported that they have no competing interests.
Read the study in Science Translational Medicine (doi: 10.1126/scitranslmed.aad5651).
Anodal transcranial direct current stimulation (tDCS) combined with motor training in stroke patients led to greater improvements in motor function, compared with motor training alone, in a double-blind randomized trial that was controlled with a sham intervention.
“We report long-term improvements in upper limb ability in patients receiving repeated sessions of anodal tDCS to the ipsilesional motor cortex compared to the sham-treated group when tDCS was paired with motor training. We also found that these clinical improvements were associated with increased activation of ipsilesional motor cortical areas,” said Claire Allman of the University of Oxford (England) and her colleagues.
Participants in the U.K. study included 24 individuals, who had had a single unilateral ischemic or hemorrhagic stroke affecting motor function in the contralesional hand at least 6 months prior to the start of the study. All patients participated in nine daily, supervised, 1-hour weekday sessions of the motor training program, the Graded Repetitive Arm Supplementary Program. For the first 20 minutes of each session, brain stimulations via tDCS electrodes were delivered to 11 patients comprising the experimental group. The 13 patients in the control group received a sham treatment, while electrodes were positioned on their scalps, during the first 20 minutes of each session. The researchers used the Upper Extremity Fugl-Meyer Assessment, the Action Research Arm Test, and the Wolf Motor Function Test to assess upper limb function before and after each patient’s sessions. Neuroimaging analyses were performed using MRI on 11 participants in the experimental group and 11 participants in the control group, both before and after the interventions, as well.
Patients who received the anodal tDCS earned greater scores in the Action Research Arm Test (P = .045) and the Wolf Motor Function Test (P = .001) than did patients in the control group, at 3 months following the intervention. The differences between the Extremity Fugl-Meyer Assessment scores of participants in the two groups at the same point in time were not statistically significant.
There were also “greater increases in [functional MRI] activation and gray matter volume in ipsilesional motor cortical areas in the anodal tDCS group compared to the sham group,” the investigators reported.
Among the researchers’ suggestions for future research on the effects of tDCS on stroke patients were for such studies to include more patients, a less intensive motor training regimen, and a group of patients who receive tDCS without undergoing motor training.
The authors reported that they have no competing interests.
Read the study in Science Translational Medicine (doi: 10.1126/scitranslmed.aad5651).
FROM SCIENCE TRANSLATIONAL MEDICINE
Study: Two Varicella Vaccination Doses More Effective Than One
Two-dose varicella vaccinations were more effective and resulted in decreased risk of varicella severity and some disease characteristics than did one-dose varicella vaccinations, in a case-control study of children living in two communities in the United States.
Two doses of the vaccine were 93.6% effective against all clinically diagnosed varicella and 97.9% effective against moderate to severe varicella, compared with children receiving no vaccine, among subjects aged 4 years and older. A single dose of the vaccine was 75.6% effective against all clinically diagnosed varicella and 78.1% effective against moderate or severe disease, compared with no vaccine.
Cases of varicella in patients who had two doses of the vaccine were more likely to involve rashes that resolved in less than 1 week (P = .01) and were less likely to involve vesicular rashes (P = .01), among breakthrough cases in patients aged 4 years and older, reported Dana Perella of the Philadelphia Department of Public Health, and her colleagues. They investigated 125 clinically diagnosed cases of varicella and 408 matched controls from May 2009 through June 2011. The study participants, aged 1-18 years, were residents of West Philadelphia and the Antelope Valley are of Northern Los Angeles.
“With superior protection provided by the two-dose varicella vaccination, compared with the one-dose regimen as demonstrated in our study and others, it will be important to expand school immunization requirements to include two-dose varicella vaccination,” the researchers wrote.
Read the study in Pediatrics (doi: 10.1542/peds.2015-2802).
Two-dose varicella vaccinations were more effective and resulted in decreased risk of varicella severity and some disease characteristics than did one-dose varicella vaccinations, in a case-control study of children living in two communities in the United States.
Two doses of the vaccine were 93.6% effective against all clinically diagnosed varicella and 97.9% effective against moderate to severe varicella, compared with children receiving no vaccine, among subjects aged 4 years and older. A single dose of the vaccine was 75.6% effective against all clinically diagnosed varicella and 78.1% effective against moderate or severe disease, compared with no vaccine.
Cases of varicella in patients who had two doses of the vaccine were more likely to involve rashes that resolved in less than 1 week (P = .01) and were less likely to involve vesicular rashes (P = .01), among breakthrough cases in patients aged 4 years and older, reported Dana Perella of the Philadelphia Department of Public Health, and her colleagues. They investigated 125 clinically diagnosed cases of varicella and 408 matched controls from May 2009 through June 2011. The study participants, aged 1-18 years, were residents of West Philadelphia and the Antelope Valley are of Northern Los Angeles.
“With superior protection provided by the two-dose varicella vaccination, compared with the one-dose regimen as demonstrated in our study and others, it will be important to expand school immunization requirements to include two-dose varicella vaccination,” the researchers wrote.
Read the study in Pediatrics (doi: 10.1542/peds.2015-2802).
Two-dose varicella vaccinations were more effective and resulted in decreased risk of varicella severity and some disease characteristics than did one-dose varicella vaccinations, in a case-control study of children living in two communities in the United States.
Two doses of the vaccine were 93.6% effective against all clinically diagnosed varicella and 97.9% effective against moderate to severe varicella, compared with children receiving no vaccine, among subjects aged 4 years and older. A single dose of the vaccine was 75.6% effective against all clinically diagnosed varicella and 78.1% effective against moderate or severe disease, compared with no vaccine.
Cases of varicella in patients who had two doses of the vaccine were more likely to involve rashes that resolved in less than 1 week (P = .01) and were less likely to involve vesicular rashes (P = .01), among breakthrough cases in patients aged 4 years and older, reported Dana Perella of the Philadelphia Department of Public Health, and her colleagues. They investigated 125 clinically diagnosed cases of varicella and 408 matched controls from May 2009 through June 2011. The study participants, aged 1-18 years, were residents of West Philadelphia and the Antelope Valley are of Northern Los Angeles.
“With superior protection provided by the two-dose varicella vaccination, compared with the one-dose regimen as demonstrated in our study and others, it will be important to expand school immunization requirements to include two-dose varicella vaccination,” the researchers wrote.
Read the study in Pediatrics (doi: 10.1542/peds.2015-2802).
FROM PEDIATRICS
Study: Two varicella vaccination doses more effective than one
Two-dose varicella vaccinations were more effective and resulted in decreased risk of varicella severity and some disease characteristics than did one-dose varicella vaccinations, in a case-control study of children living in two communities in the United States.
Two doses of the vaccine were 93.6% effective against all clinically diagnosed varicella and 97.9% effective against moderate to severe varicella, compared with children receiving no vaccine, among subjects aged 4 years and older. A single dose of the vaccine was 75.6% effective against all clinically diagnosed varicella and 78.1% effective against moderate or severe disease, compared with no vaccine.
Cases of varicella in patients who had two doses of the vaccine were more likely to involve rashes that resolved in less than 1 week (P = .01) and were less likely to involve vesicular rashes (P = .01), among breakthrough cases in patients aged 4 years and older, reported Dana Perella of the Philadelphia Department of Public Health, and her colleagues. They investigated 125 clinically diagnosed cases of varicella and 408 matched controls from May 2009 through June 2011. The study participants, aged 1-18 years, were residents of West Philadelphia and the Antelope Valley are of Northern Los Angeles.
“With superior protection provided by the two-dose varicella vaccination, compared with the one-dose regimen as demonstrated in our study and others, it will be important to expand school immunization requirements to include two-dose varicella vaccination,” the researchers wrote.
Read the study in Pediatrics (doi: 10.1542/peds.2015-2802).
Two-dose varicella vaccinations were more effective and resulted in decreased risk of varicella severity and some disease characteristics than did one-dose varicella vaccinations, in a case-control study of children living in two communities in the United States.
Two doses of the vaccine were 93.6% effective against all clinically diagnosed varicella and 97.9% effective against moderate to severe varicella, compared with children receiving no vaccine, among subjects aged 4 years and older. A single dose of the vaccine was 75.6% effective against all clinically diagnosed varicella and 78.1% effective against moderate or severe disease, compared with no vaccine.
Cases of varicella in patients who had two doses of the vaccine were more likely to involve rashes that resolved in less than 1 week (P = .01) and were less likely to involve vesicular rashes (P = .01), among breakthrough cases in patients aged 4 years and older, reported Dana Perella of the Philadelphia Department of Public Health, and her colleagues. They investigated 125 clinically diagnosed cases of varicella and 408 matched controls from May 2009 through June 2011. The study participants, aged 1-18 years, were residents of West Philadelphia and the Antelope Valley are of Northern Los Angeles.
“With superior protection provided by the two-dose varicella vaccination, compared with the one-dose regimen as demonstrated in our study and others, it will be important to expand school immunization requirements to include two-dose varicella vaccination,” the researchers wrote.
Read the study in Pediatrics (doi: 10.1542/peds.2015-2802).
Two-dose varicella vaccinations were more effective and resulted in decreased risk of varicella severity and some disease characteristics than did one-dose varicella vaccinations, in a case-control study of children living in two communities in the United States.
Two doses of the vaccine were 93.6% effective against all clinically diagnosed varicella and 97.9% effective against moderate to severe varicella, compared with children receiving no vaccine, among subjects aged 4 years and older. A single dose of the vaccine was 75.6% effective against all clinically diagnosed varicella and 78.1% effective against moderate or severe disease, compared with no vaccine.
Cases of varicella in patients who had two doses of the vaccine were more likely to involve rashes that resolved in less than 1 week (P = .01) and were less likely to involve vesicular rashes (P = .01), among breakthrough cases in patients aged 4 years and older, reported Dana Perella of the Philadelphia Department of Public Health, and her colleagues. They investigated 125 clinically diagnosed cases of varicella and 408 matched controls from May 2009 through June 2011. The study participants, aged 1-18 years, were residents of West Philadelphia and the Antelope Valley are of Northern Los Angeles.
“With superior protection provided by the two-dose varicella vaccination, compared with the one-dose regimen as demonstrated in our study and others, it will be important to expand school immunization requirements to include two-dose varicella vaccination,” the researchers wrote.
Read the study in Pediatrics (doi: 10.1542/peds.2015-2802).
FROM PEDIATRICS
