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Lenvima Gets the FDA’s Nod for Differentiated Thyroid Cancer
The Food and Drug Administration has approved the kinase inhibitor lenvatinib (Lenvima) for the treatment of differentiated thyroid cancer, the agency announced Feb. 13. The drug is approved for use in patients in whom disease progressed despite receiving radioactive iodine therapy.
A trial of 392 patients with progressive, radioactive iodine–refractory differentiated thyroid cancer (DTC) found a median progression-free survival time of 18.3 months in participants treated with Lenvima, compared with a median of 3.6 months in those who received a placebo, the FDA said in a statement. In addition, 65% of lenvatinib-treated patients saw a reduction in tumor size, compared with just 2% of patients who received placebo.
DTC is the most common type of thyroid cancer. The National Cancer Institute has estimated that nearly 63,000 Americans were diagnosed with thyroid cancer, and nearly 1,900 died from the disease in 2014, the FDA said.
Lenvatinib was approved early upon expedited review under the FDA’s priority review program, which allows for the accelerated evaluation of promising drugs that would significantly benefit patients with serious illness.
Common side effects from the drug included hypertension, fatigue, diarrhea, joint and muscle pain, decreased appetite, weight loss, and nausea, among others.
Lenvatinib is marketed by Eisai, based in Woodcliff Lake, N.J.
The Food and Drug Administration has approved the kinase inhibitor lenvatinib (Lenvima) for the treatment of differentiated thyroid cancer, the agency announced Feb. 13. The drug is approved for use in patients in whom disease progressed despite receiving radioactive iodine therapy.
A trial of 392 patients with progressive, radioactive iodine–refractory differentiated thyroid cancer (DTC) found a median progression-free survival time of 18.3 months in participants treated with Lenvima, compared with a median of 3.6 months in those who received a placebo, the FDA said in a statement. In addition, 65% of lenvatinib-treated patients saw a reduction in tumor size, compared with just 2% of patients who received placebo.
DTC is the most common type of thyroid cancer. The National Cancer Institute has estimated that nearly 63,000 Americans were diagnosed with thyroid cancer, and nearly 1,900 died from the disease in 2014, the FDA said.
Lenvatinib was approved early upon expedited review under the FDA’s priority review program, which allows for the accelerated evaluation of promising drugs that would significantly benefit patients with serious illness.
Common side effects from the drug included hypertension, fatigue, diarrhea, joint and muscle pain, decreased appetite, weight loss, and nausea, among others.
Lenvatinib is marketed by Eisai, based in Woodcliff Lake, N.J.
The Food and Drug Administration has approved the kinase inhibitor lenvatinib (Lenvima) for the treatment of differentiated thyroid cancer, the agency announced Feb. 13. The drug is approved for use in patients in whom disease progressed despite receiving radioactive iodine therapy.
A trial of 392 patients with progressive, radioactive iodine–refractory differentiated thyroid cancer (DTC) found a median progression-free survival time of 18.3 months in participants treated with Lenvima, compared with a median of 3.6 months in those who received a placebo, the FDA said in a statement. In addition, 65% of lenvatinib-treated patients saw a reduction in tumor size, compared with just 2% of patients who received placebo.
DTC is the most common type of thyroid cancer. The National Cancer Institute has estimated that nearly 63,000 Americans were diagnosed with thyroid cancer, and nearly 1,900 died from the disease in 2014, the FDA said.
Lenvatinib was approved early upon expedited review under the FDA’s priority review program, which allows for the accelerated evaluation of promising drugs that would significantly benefit patients with serious illness.
Common side effects from the drug included hypertension, fatigue, diarrhea, joint and muscle pain, decreased appetite, weight loss, and nausea, among others.
Lenvatinib is marketed by Eisai, based in Woodcliff Lake, N.J.
Lenvima gets the FDA’s nod for differentiated thyroid cancer
The Food and Drug Administration has approved the kinase inhibitor lenvatinib (Lenvima) for the treatment of differentiated thyroid cancer, the agency announced Feb. 13. The drug is approved for use in patients in whom disease progressed despite receiving radioactive iodine therapy.
A trial of 392 patients with progressive, radioactive iodine–refractory differentiated thyroid cancer (DTC) found a median progression-free survival time of 18.3 months in participants treated with Lenvima, compared with a median of 3.6 months in those who received a placebo, the FDA said in a statement. In addition, 65% of lenvatinib-treated patients saw a reduction in tumor size, compared with just 2% of patients who received placebo.
DTC is the most common type of thyroid cancer. The National Cancer Institute has estimated that nearly 63,000 Americans were diagnosed with thyroid cancer, and nearly 1,900 died from the disease in 2014, the FDA said.
Lenvatinib was approved early upon expedited review under the FDA’s priority review program, which allows for the accelerated evaluation of promising drugs that would significantly benefit patients with serious illness.
Common side effects from the drug included hypertension, fatigue, diarrhea, joint and muscle pain, decreased appetite, weight loss, and nausea, among others.
Lenvatinib is marketed by Eisai, based in Woodcliff Lake, N.J.
The Food and Drug Administration has approved the kinase inhibitor lenvatinib (Lenvima) for the treatment of differentiated thyroid cancer, the agency announced Feb. 13. The drug is approved for use in patients in whom disease progressed despite receiving radioactive iodine therapy.
A trial of 392 patients with progressive, radioactive iodine–refractory differentiated thyroid cancer (DTC) found a median progression-free survival time of 18.3 months in participants treated with Lenvima, compared with a median of 3.6 months in those who received a placebo, the FDA said in a statement. In addition, 65% of lenvatinib-treated patients saw a reduction in tumor size, compared with just 2% of patients who received placebo.
DTC is the most common type of thyroid cancer. The National Cancer Institute has estimated that nearly 63,000 Americans were diagnosed with thyroid cancer, and nearly 1,900 died from the disease in 2014, the FDA said.
Lenvatinib was approved early upon expedited review under the FDA’s priority review program, which allows for the accelerated evaluation of promising drugs that would significantly benefit patients with serious illness.
Common side effects from the drug included hypertension, fatigue, diarrhea, joint and muscle pain, decreased appetite, weight loss, and nausea, among others.
Lenvatinib is marketed by Eisai, based in Woodcliff Lake, N.J.
The Food and Drug Administration has approved the kinase inhibitor lenvatinib (Lenvima) for the treatment of differentiated thyroid cancer, the agency announced Feb. 13. The drug is approved for use in patients in whom disease progressed despite receiving radioactive iodine therapy.
A trial of 392 patients with progressive, radioactive iodine–refractory differentiated thyroid cancer (DTC) found a median progression-free survival time of 18.3 months in participants treated with Lenvima, compared with a median of 3.6 months in those who received a placebo, the FDA said in a statement. In addition, 65% of lenvatinib-treated patients saw a reduction in tumor size, compared with just 2% of patients who received placebo.
DTC is the most common type of thyroid cancer. The National Cancer Institute has estimated that nearly 63,000 Americans were diagnosed with thyroid cancer, and nearly 1,900 died from the disease in 2014, the FDA said.
Lenvatinib was approved early upon expedited review under the FDA’s priority review program, which allows for the accelerated evaluation of promising drugs that would significantly benefit patients with serious illness.
Common side effects from the drug included hypertension, fatigue, diarrhea, joint and muscle pain, decreased appetite, weight loss, and nausea, among others.
Lenvatinib is marketed by Eisai, based in Woodcliff Lake, N.J.
Furosemide stress test predicted acute kidney injury progression
A furosemide stress test may help predict progression to stage 3 acute kidney injury, according to findings published online Feb. 5 in the Journal of the American Society of Nephrology.
In a cohort of 77 patients with early acute kidney injury (AKI), 32.5% of patients progressed to stage 3 AKI, reported Dr. Jay L. Koyner of the University of Chicago and his colleagues (J. Am. Soc. Nephrol. 2015 Feb. 5 [doi: 110.1681/ASN.2014060535]).
Patients included in the study had either stage 1 or stage 2 AKI according to Acute Kidney Injury Network (AKIN) criteria, and had a furosemide stress test (FST) at either George Washington University, in Washington, or the University of Chicago between June 2009 and December 2012. The standardized dose for FST is 1 mg/kg of furosemide in naive patients and 1.5 mg/kg in patients with prior exposure.
Two-hour urine output (UOP) after FST predicted progression to stage 3 AKI significantly better than did several urinary biomarkers, with an area under the curve (AUC) of 0.87 (P < .001), the investigators said in the report. Of the biomarkers tested, plasma neutrophil gelatinase-associated lipocalin (NGAL) performed best, with an AUC of 0.75 (P = .007).
UOP also outperformed all biomarkers for predicting receipt of renal replacement therapy, with an AUC value of 0.86 (P < .001). Renal replacement therapy was administered to 14.2% of patients following FST.
A total of 20.7% of patients died in the hospital, with an AUC value of 0.70 (P = .02) for prediction of inpatient death following UOP, Dr. Koyner and his associates reported.
The results of this study “demonstrate the promise of FST in improving risk stratification of patients with early AKI,” the investigators wrote.
Although FST may be a “promising tool” for evaluating AKI severity, the study was limited by the small size of the cohort and limited number of patient events, the authors cautioned. Future studies should focus on “larger prospective validations” of FST with biomarkers, they added.
“Improving risk prediction in those with early AKI is likely to alter patient care and clinical decision making, as well as facilitate enrollment into future therapeutic AKI trials,” the researchers said.
Dr. Koyner and his associates reported receiving consulting fees from Abbott, Alere Medical, and Astute Medical.
The results presented in this paper need to be confirmed in studies with more patients and settings, wrote Dr. T. Clark Powell and Dr. David G. Warnock, of the University of Alabama at Birmingham, in an accompanying editorial (J. Am. Soc. Nephrol. 2015 Feb. 5 [doi: 10.1681/ASN.2014121160]).
Because the furosemide stress test (FST) is designed to be predictive of future outcomes, it is essential to test it in a cohort of patients with less-severe disease and in noncritical care settings, they said.
“It will be important to see if the predictive power of FST remains informative for patients who are not in the critical care setting and critically ill patients,” they concluded.
Dr. Powell and Dr. Warnock had no relevant disclosures.
The results presented in this paper need to be confirmed in studies with more patients and settings, wrote Dr. T. Clark Powell and Dr. David G. Warnock, of the University of Alabama at Birmingham, in an accompanying editorial (J. Am. Soc. Nephrol. 2015 Feb. 5 [doi: 10.1681/ASN.2014121160]).
Because the furosemide stress test (FST) is designed to be predictive of future outcomes, it is essential to test it in a cohort of patients with less-severe disease and in noncritical care settings, they said.
“It will be important to see if the predictive power of FST remains informative for patients who are not in the critical care setting and critically ill patients,” they concluded.
Dr. Powell and Dr. Warnock had no relevant disclosures.
The results presented in this paper need to be confirmed in studies with more patients and settings, wrote Dr. T. Clark Powell and Dr. David G. Warnock, of the University of Alabama at Birmingham, in an accompanying editorial (J. Am. Soc. Nephrol. 2015 Feb. 5 [doi: 10.1681/ASN.2014121160]).
Because the furosemide stress test (FST) is designed to be predictive of future outcomes, it is essential to test it in a cohort of patients with less-severe disease and in noncritical care settings, they said.
“It will be important to see if the predictive power of FST remains informative for patients who are not in the critical care setting and critically ill patients,” they concluded.
Dr. Powell and Dr. Warnock had no relevant disclosures.
A furosemide stress test may help predict progression to stage 3 acute kidney injury, according to findings published online Feb. 5 in the Journal of the American Society of Nephrology.
In a cohort of 77 patients with early acute kidney injury (AKI), 32.5% of patients progressed to stage 3 AKI, reported Dr. Jay L. Koyner of the University of Chicago and his colleagues (J. Am. Soc. Nephrol. 2015 Feb. 5 [doi: 110.1681/ASN.2014060535]).
Patients included in the study had either stage 1 or stage 2 AKI according to Acute Kidney Injury Network (AKIN) criteria, and had a furosemide stress test (FST) at either George Washington University, in Washington, or the University of Chicago between June 2009 and December 2012. The standardized dose for FST is 1 mg/kg of furosemide in naive patients and 1.5 mg/kg in patients with prior exposure.
Two-hour urine output (UOP) after FST predicted progression to stage 3 AKI significantly better than did several urinary biomarkers, with an area under the curve (AUC) of 0.87 (P < .001), the investigators said in the report. Of the biomarkers tested, plasma neutrophil gelatinase-associated lipocalin (NGAL) performed best, with an AUC of 0.75 (P = .007).
UOP also outperformed all biomarkers for predicting receipt of renal replacement therapy, with an AUC value of 0.86 (P < .001). Renal replacement therapy was administered to 14.2% of patients following FST.
A total of 20.7% of patients died in the hospital, with an AUC value of 0.70 (P = .02) for prediction of inpatient death following UOP, Dr. Koyner and his associates reported.
The results of this study “demonstrate the promise of FST in improving risk stratification of patients with early AKI,” the investigators wrote.
Although FST may be a “promising tool” for evaluating AKI severity, the study was limited by the small size of the cohort and limited number of patient events, the authors cautioned. Future studies should focus on “larger prospective validations” of FST with biomarkers, they added.
“Improving risk prediction in those with early AKI is likely to alter patient care and clinical decision making, as well as facilitate enrollment into future therapeutic AKI trials,” the researchers said.
Dr. Koyner and his associates reported receiving consulting fees from Abbott, Alere Medical, and Astute Medical.
A furosemide stress test may help predict progression to stage 3 acute kidney injury, according to findings published online Feb. 5 in the Journal of the American Society of Nephrology.
In a cohort of 77 patients with early acute kidney injury (AKI), 32.5% of patients progressed to stage 3 AKI, reported Dr. Jay L. Koyner of the University of Chicago and his colleagues (J. Am. Soc. Nephrol. 2015 Feb. 5 [doi: 110.1681/ASN.2014060535]).
Patients included in the study had either stage 1 or stage 2 AKI according to Acute Kidney Injury Network (AKIN) criteria, and had a furosemide stress test (FST) at either George Washington University, in Washington, or the University of Chicago between June 2009 and December 2012. The standardized dose for FST is 1 mg/kg of furosemide in naive patients and 1.5 mg/kg in patients with prior exposure.
Two-hour urine output (UOP) after FST predicted progression to stage 3 AKI significantly better than did several urinary biomarkers, with an area under the curve (AUC) of 0.87 (P < .001), the investigators said in the report. Of the biomarkers tested, plasma neutrophil gelatinase-associated lipocalin (NGAL) performed best, with an AUC of 0.75 (P = .007).
UOP also outperformed all biomarkers for predicting receipt of renal replacement therapy, with an AUC value of 0.86 (P < .001). Renal replacement therapy was administered to 14.2% of patients following FST.
A total of 20.7% of patients died in the hospital, with an AUC value of 0.70 (P = .02) for prediction of inpatient death following UOP, Dr. Koyner and his associates reported.
The results of this study “demonstrate the promise of FST in improving risk stratification of patients with early AKI,” the investigators wrote.
Although FST may be a “promising tool” for evaluating AKI severity, the study was limited by the small size of the cohort and limited number of patient events, the authors cautioned. Future studies should focus on “larger prospective validations” of FST with biomarkers, they added.
“Improving risk prediction in those with early AKI is likely to alter patient care and clinical decision making, as well as facilitate enrollment into future therapeutic AKI trials,” the researchers said.
Dr. Koyner and his associates reported receiving consulting fees from Abbott, Alere Medical, and Astute Medical.
FROM THE JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY
Key clinical point: A furosemide stress test may help predict progression to stage 3 acute kidney injury.
Major finding: Two-hour urine output after FST predicted progression to stage 3 acute kidney injury significantly better than did several urinary biomarkers, with an area under the curve of 0.87 (P < .001).
Data source: A study of 77 patients with early acute kidney injury who had a standardized high-dose furosemide stress test between June 2009 and December 2012.
Disclosures: The study authors reported receiving consulting fees from Abbott, Alere Medical, and Astute Medical.
Developmental trajectories vary in children with autism spectrum disorder
Developmental trajectories in preschool children with autism spectrum disorder are highly heterogeneous, according to findings published Jan. 28 in JAMA Psychiatry.
In a longitudinal study of 421 preschool children recently diagnosed with autism spectrum disorder (ASD), two distinct trajectory groups were found in the domain of symptom severity, and three distinct groups were found for adaptive functioning, reported Dr. Peter Szatmari and colleagues at the University of Toronto’s Hospital for Sick Children.
For symptom severity, 11.4% of children had less severe symptoms and an improving trajectory (P < .05), and 88.6% of children had severe symptoms and a stable trajectory. For adaptive functioning, 29.2% of children had lower functioning and a worsening trajectory, 49.9% had moderate functioning and a stable trajectory, and 20.9% had higher functioning and an improving trajectory (P < .05), Dr. Szatmari and his associates reported (JAMA Psychiatry 2015 [doi:10.1001/jamapsychiatry.2014.2463]).
Children were 39.87 months of age on average at baseline, and were enrolled in the longitudinal, multisite Pathways in ASD Study across multiple sites in Canada. Eligibility criteria were age between 2 years and 4 years 11 months, a clinical ASD diagnosis within the last 4 months confirmed by the Autism Diagnostic Observation Schedule (ADOS) and the Autism Diagnostic Interview-Revised, and a DSM-IV diagnosis.
Adaptive functioning trajectory was assessed using composite scores from the Vineland Adaptive Behavior Scales, Second Edition. Symptom severity was assessed using the ADOS calibrated severity score. Data for adaptive functioning was collected at baseline, after 6 months, after 12 months, and at 6 years. Symptom severity data was collected at all points except for the 12-month mark.
Sex was a significant predictor of autistic symptom trajectory, with boys more likely to belong to the group with severe symptoms and a stable trajectory (P = 0.03), the investigators reported. Earlier age at diagnosis was associated with membership in the improving and higher functioning groups (P = 0.02).
“These findings have important implications for surveillance and early identification efforts,” the authors said, and improving a child’s trajectory may need to begin before official diagnosis, “when children manifest behavioral or functional concerns during an at-risk or prodromal phase,” they added.
Once ASD is diagnosed, “It is imperative that a flexible suite of interventions should then be implemented and tailored to each child’s strengths and difficulties,” the investigators said.
The study was funded by the Canadian Institutes of Health Research, NeuroDevNet, Autism Speaks, the Government of British Columbia, the Alberta Innovates Health Solutions, and the Sinneave Family Foundation. The investigators reported no conflict of interest disclosures.
Developmental trajectories in preschool children with autism spectrum disorder are highly heterogeneous, according to findings published Jan. 28 in JAMA Psychiatry.
In a longitudinal study of 421 preschool children recently diagnosed with autism spectrum disorder (ASD), two distinct trajectory groups were found in the domain of symptom severity, and three distinct groups were found for adaptive functioning, reported Dr. Peter Szatmari and colleagues at the University of Toronto’s Hospital for Sick Children.
For symptom severity, 11.4% of children had less severe symptoms and an improving trajectory (P < .05), and 88.6% of children had severe symptoms and a stable trajectory. For adaptive functioning, 29.2% of children had lower functioning and a worsening trajectory, 49.9% had moderate functioning and a stable trajectory, and 20.9% had higher functioning and an improving trajectory (P < .05), Dr. Szatmari and his associates reported (JAMA Psychiatry 2015 [doi:10.1001/jamapsychiatry.2014.2463]).
Children were 39.87 months of age on average at baseline, and were enrolled in the longitudinal, multisite Pathways in ASD Study across multiple sites in Canada. Eligibility criteria were age between 2 years and 4 years 11 months, a clinical ASD diagnosis within the last 4 months confirmed by the Autism Diagnostic Observation Schedule (ADOS) and the Autism Diagnostic Interview-Revised, and a DSM-IV diagnosis.
Adaptive functioning trajectory was assessed using composite scores from the Vineland Adaptive Behavior Scales, Second Edition. Symptom severity was assessed using the ADOS calibrated severity score. Data for adaptive functioning was collected at baseline, after 6 months, after 12 months, and at 6 years. Symptom severity data was collected at all points except for the 12-month mark.
Sex was a significant predictor of autistic symptom trajectory, with boys more likely to belong to the group with severe symptoms and a stable trajectory (P = 0.03), the investigators reported. Earlier age at diagnosis was associated with membership in the improving and higher functioning groups (P = 0.02).
“These findings have important implications for surveillance and early identification efforts,” the authors said, and improving a child’s trajectory may need to begin before official diagnosis, “when children manifest behavioral or functional concerns during an at-risk or prodromal phase,” they added.
Once ASD is diagnosed, “It is imperative that a flexible suite of interventions should then be implemented and tailored to each child’s strengths and difficulties,” the investigators said.
The study was funded by the Canadian Institutes of Health Research, NeuroDevNet, Autism Speaks, the Government of British Columbia, the Alberta Innovates Health Solutions, and the Sinneave Family Foundation. The investigators reported no conflict of interest disclosures.
Developmental trajectories in preschool children with autism spectrum disorder are highly heterogeneous, according to findings published Jan. 28 in JAMA Psychiatry.
In a longitudinal study of 421 preschool children recently diagnosed with autism spectrum disorder (ASD), two distinct trajectory groups were found in the domain of symptom severity, and three distinct groups were found for adaptive functioning, reported Dr. Peter Szatmari and colleagues at the University of Toronto’s Hospital for Sick Children.
For symptom severity, 11.4% of children had less severe symptoms and an improving trajectory (P < .05), and 88.6% of children had severe symptoms and a stable trajectory. For adaptive functioning, 29.2% of children had lower functioning and a worsening trajectory, 49.9% had moderate functioning and a stable trajectory, and 20.9% had higher functioning and an improving trajectory (P < .05), Dr. Szatmari and his associates reported (JAMA Psychiatry 2015 [doi:10.1001/jamapsychiatry.2014.2463]).
Children were 39.87 months of age on average at baseline, and were enrolled in the longitudinal, multisite Pathways in ASD Study across multiple sites in Canada. Eligibility criteria were age between 2 years and 4 years 11 months, a clinical ASD diagnosis within the last 4 months confirmed by the Autism Diagnostic Observation Schedule (ADOS) and the Autism Diagnostic Interview-Revised, and a DSM-IV diagnosis.
Adaptive functioning trajectory was assessed using composite scores from the Vineland Adaptive Behavior Scales, Second Edition. Symptom severity was assessed using the ADOS calibrated severity score. Data for adaptive functioning was collected at baseline, after 6 months, after 12 months, and at 6 years. Symptom severity data was collected at all points except for the 12-month mark.
Sex was a significant predictor of autistic symptom trajectory, with boys more likely to belong to the group with severe symptoms and a stable trajectory (P = 0.03), the investigators reported. Earlier age at diagnosis was associated with membership in the improving and higher functioning groups (P = 0.02).
“These findings have important implications for surveillance and early identification efforts,” the authors said, and improving a child’s trajectory may need to begin before official diagnosis, “when children manifest behavioral or functional concerns during an at-risk or prodromal phase,” they added.
Once ASD is diagnosed, “It is imperative that a flexible suite of interventions should then be implemented and tailored to each child’s strengths and difficulties,” the investigators said.
The study was funded by the Canadian Institutes of Health Research, NeuroDevNet, Autism Speaks, the Government of British Columbia, the Alberta Innovates Health Solutions, and the Sinneave Family Foundation. The investigators reported no conflict of interest disclosures.
FROM JAMA PSYCHIATRY
Key clinical point: The developmental trajectory of symptom severity and adaptive functioning varies in preschool children with autism spectrum disorder.
Major finding: For symptom severity, 11.4% of children had less severe symptoms and an improving trajectory (P < .05), whereas 88.6% of children had severe symptoms and a stable trajectory. For adaptive functioning, 29.2% of children had lower functioning and a worsening trajectory, 49.9% had moderate functioning and a stable trajectory, and 20.9% had higher functioning and an improving trajectory (P < .05).
Data source: An analysis of symptom severity and adaptive functioning in 421 Canadian preschool children diagnosed with autism spectrum disorder.
Disclosures: The study was funded by the Canadian Institutes of Health Research, NeuroDevNet, Autism Speaks, the Government of British Columbia, the Alberta Innovates Health Solutions, and the Sinneave Family Foundation. The investigators reported no conflict of interest disclosures.
Almost a quarter of schizophrenia patients show obsessive-compulsive symptoms
Nearly a quarter of schizophrenia patients also have symptoms of obsessive compulsive disorder, according to a recently published study in the journal Comprehensive Psychiatry.
Dr. Sugnyani Devi and colleagues at the National Institute of Mental Health and Neurosciences (NIMHANS) Department of Psychiatry in Bangalore, India, evaluated 200 patients admitted to the institute’s inpatient services unit between September 2010 and September 2011. Patients met DSM-IV criteria for schizophrenia, with a mean age of 33 years, and a mean age at illness onset of 25 years. The mean duration of illness was 8 years (Compr. Psychiatry 2015;56:141-8.
Symptoms were assessed via the Structured Clinical Interview for DSM-IV Axis I and II disorders (SCID I and II), the Positive and Negative Symptom Scale (PANSS), and the Yale Brown Obsessive-Compulsive Scale (Y-BOCS). Obsessive-compulsive disorder (OCD) was defined as a score of 16 or greater on the Y-BOCS assessment. Patients who showed OCD symptoms but scored less than 16 on the Y-BOCS test and did not meet DSM-IV criteria for OCD were considered as having obsessive-compulsive symptoms (OCS).
The prevalence of OCD/OCS in schizophrenia patients was 24% (n = 48). A total of 18.5% of patients had OCD (n = 37), and 5.5% (n = 11) had OCS, reported Dr. Devi and associates.
Of the 48 patients with OCD or OCS, 46 had both obsessions and compulsions. The mean total score on the Y-BOCS test was 22.25, with a mean of 10.93 for obsessions and 11.33 for compulsions, the authors reported. The most prevalent obsessions were contamination-related (n = 33, 68.8%), and cleaning was the most common compulsive behavior (n = 31, 64.6%).
The mean age at onset for schizophrenia was 19.95 years, and the mean age at onset for OCS was 19.88 years. A total of 64.6% of patients developed obsessive-compulsive symptoms before the use of atypical antipsychotics, the investigators noted.
Schizophrenia patients with OCD/OCS were significantly younger, with a mean age of 27.48 years (P < 0.001), and lived in urban areas (87.5%, P = 0.001). On post hoc analysis with the Mann-Whitney U test, patients in the OCD/OCS group also had significantly younger age at onset of schizophrenia (U = 1242; z = 5.26; P < 0.001), lower PANSS positive scores (U = 2046; z = 2.57; P = 0.001), and better environmental quality of life (U = 1745; z = 3.59; P < 0.001), the investigators said in the report.
“The prevalence of OCS/OCD in our study is consistent with the results of most previous studies but higher than that reported in some studies,” the authors wrote.
Although a higher prevalence of OCD/OCS in schizophrenia has been established, the effect of these symptoms on schizophrenia is inconclusive, and further study is needed to establish a separate diagnostic category of “schizo-obsessive disorder,” they added.
The results of this study “further highlight the importance of assessing OC symptoms in schizophrenia patients owing to high prevalence of OCS and OCD in subjects with schizophrenia,” they added.
The investigators did not report any disclosures or conflicts of interest.
Nearly a quarter of schizophrenia patients also have symptoms of obsessive compulsive disorder, according to a recently published study in the journal Comprehensive Psychiatry.
Dr. Sugnyani Devi and colleagues at the National Institute of Mental Health and Neurosciences (NIMHANS) Department of Psychiatry in Bangalore, India, evaluated 200 patients admitted to the institute’s inpatient services unit between September 2010 and September 2011. Patients met DSM-IV criteria for schizophrenia, with a mean age of 33 years, and a mean age at illness onset of 25 years. The mean duration of illness was 8 years (Compr. Psychiatry 2015;56:141-8.
Symptoms were assessed via the Structured Clinical Interview for DSM-IV Axis I and II disorders (SCID I and II), the Positive and Negative Symptom Scale (PANSS), and the Yale Brown Obsessive-Compulsive Scale (Y-BOCS). Obsessive-compulsive disorder (OCD) was defined as a score of 16 or greater on the Y-BOCS assessment. Patients who showed OCD symptoms but scored less than 16 on the Y-BOCS test and did not meet DSM-IV criteria for OCD were considered as having obsessive-compulsive symptoms (OCS).
The prevalence of OCD/OCS in schizophrenia patients was 24% (n = 48). A total of 18.5% of patients had OCD (n = 37), and 5.5% (n = 11) had OCS, reported Dr. Devi and associates.
Of the 48 patients with OCD or OCS, 46 had both obsessions and compulsions. The mean total score on the Y-BOCS test was 22.25, with a mean of 10.93 for obsessions and 11.33 for compulsions, the authors reported. The most prevalent obsessions were contamination-related (n = 33, 68.8%), and cleaning was the most common compulsive behavior (n = 31, 64.6%).
The mean age at onset for schizophrenia was 19.95 years, and the mean age at onset for OCS was 19.88 years. A total of 64.6% of patients developed obsessive-compulsive symptoms before the use of atypical antipsychotics, the investigators noted.
Schizophrenia patients with OCD/OCS were significantly younger, with a mean age of 27.48 years (P < 0.001), and lived in urban areas (87.5%, P = 0.001). On post hoc analysis with the Mann-Whitney U test, patients in the OCD/OCS group also had significantly younger age at onset of schizophrenia (U = 1242; z = 5.26; P < 0.001), lower PANSS positive scores (U = 2046; z = 2.57; P = 0.001), and better environmental quality of life (U = 1745; z = 3.59; P < 0.001), the investigators said in the report.
“The prevalence of OCS/OCD in our study is consistent with the results of most previous studies but higher than that reported in some studies,” the authors wrote.
Although a higher prevalence of OCD/OCS in schizophrenia has been established, the effect of these symptoms on schizophrenia is inconclusive, and further study is needed to establish a separate diagnostic category of “schizo-obsessive disorder,” they added.
The results of this study “further highlight the importance of assessing OC symptoms in schizophrenia patients owing to high prevalence of OCS and OCD in subjects with schizophrenia,” they added.
The investigators did not report any disclosures or conflicts of interest.
Nearly a quarter of schizophrenia patients also have symptoms of obsessive compulsive disorder, according to a recently published study in the journal Comprehensive Psychiatry.
Dr. Sugnyani Devi and colleagues at the National Institute of Mental Health and Neurosciences (NIMHANS) Department of Psychiatry in Bangalore, India, evaluated 200 patients admitted to the institute’s inpatient services unit between September 2010 and September 2011. Patients met DSM-IV criteria for schizophrenia, with a mean age of 33 years, and a mean age at illness onset of 25 years. The mean duration of illness was 8 years (Compr. Psychiatry 2015;56:141-8.
Symptoms were assessed via the Structured Clinical Interview for DSM-IV Axis I and II disorders (SCID I and II), the Positive and Negative Symptom Scale (PANSS), and the Yale Brown Obsessive-Compulsive Scale (Y-BOCS). Obsessive-compulsive disorder (OCD) was defined as a score of 16 or greater on the Y-BOCS assessment. Patients who showed OCD symptoms but scored less than 16 on the Y-BOCS test and did not meet DSM-IV criteria for OCD were considered as having obsessive-compulsive symptoms (OCS).
The prevalence of OCD/OCS in schizophrenia patients was 24% (n = 48). A total of 18.5% of patients had OCD (n = 37), and 5.5% (n = 11) had OCS, reported Dr. Devi and associates.
Of the 48 patients with OCD or OCS, 46 had both obsessions and compulsions. The mean total score on the Y-BOCS test was 22.25, with a mean of 10.93 for obsessions and 11.33 for compulsions, the authors reported. The most prevalent obsessions were contamination-related (n = 33, 68.8%), and cleaning was the most common compulsive behavior (n = 31, 64.6%).
The mean age at onset for schizophrenia was 19.95 years, and the mean age at onset for OCS was 19.88 years. A total of 64.6% of patients developed obsessive-compulsive symptoms before the use of atypical antipsychotics, the investigators noted.
Schizophrenia patients with OCD/OCS were significantly younger, with a mean age of 27.48 years (P < 0.001), and lived in urban areas (87.5%, P = 0.001). On post hoc analysis with the Mann-Whitney U test, patients in the OCD/OCS group also had significantly younger age at onset of schizophrenia (U = 1242; z = 5.26; P < 0.001), lower PANSS positive scores (U = 2046; z = 2.57; P = 0.001), and better environmental quality of life (U = 1745; z = 3.59; P < 0.001), the investigators said in the report.
“The prevalence of OCS/OCD in our study is consistent with the results of most previous studies but higher than that reported in some studies,” the authors wrote.
Although a higher prevalence of OCD/OCS in schizophrenia has been established, the effect of these symptoms on schizophrenia is inconclusive, and further study is needed to establish a separate diagnostic category of “schizo-obsessive disorder,” they added.
The results of this study “further highlight the importance of assessing OC symptoms in schizophrenia patients owing to high prevalence of OCS and OCD in subjects with schizophrenia,” they added.
The investigators did not report any disclosures or conflicts of interest.
FROM COMPREHENSIVE PSYCHIATRY
Key clinical point: It is important to assess obsessive-compulsive symptoms in patients with schizophrenia.
Major finding: The prevalence of OCD/OCS in schizophrenia patients was 24% (n = 48); 18.5% of patients had OCD (n = 37) and 5.5% (n = 11) had OCS.
Data source: A study of 200 schizophrenia patients admitted to the National Institute of Mental Health and Neurosciences in Bangalore, India, between September 2010 and September 2011.
Disclosures: The investigators did not report any disclosures or conflicts of interest.
Inappropriate aspirin use for CVD prevention high and varies by practice
More than 1 in 10 heart patients are inappropriately prescribed aspirin therapy for the prevention of cardiovascular disease, and there’s wide variation by practice in that proportion, according to a registry analysis published Jan. 12 in the Journal of the American College of Cardiology.
In a study of patients in the National Cardiovascular Data Registry’s Practice Innovation and Clinical Excellence (PINNACLE) registry, 11.6% of heart patients were prescribed aspirin even though they did not meet American Heart Association guidelines for the use of aspirin in cardiovascular disease (CVD) prevention.
Dr. Ravi S. Hira and colleagues of the Baylor College of Medicine in Houston collected data from 68,808 patients in the PINNACLE registry who received aspirin between January 2008 and June 2013. Participants were excluded if they were taking aspirin for secondary prevention (such as a history of MI, stroke, or other cardiovascular events) or if they were also taking warfarin, clopidogrel, ticlopidine, or an aspirin/dipyridamole combination (JACC 2015 [doi:10.1016/j.jacc.2014.10.035]).
The investigators defined “inappropriate aspirin use” as aspirin therapy in patients with a 10-year risk of a cardiovascular event of less than 6%. The AHA recommends aspirin use only in patients with a 10-year CVD risk of at least 6%, mainly because the risk of gastrointestinal bleeding and hemorrhagic stroke outweighs any potential benefit in low-risk CVD patients, the authors reported.
A total of 7,972 patients had a 10-year CVD risk of less than 6% and therefore were prescribed aspirin inappropriately. About 80% of them were women, and the frequency of inappropriate aspirin use was 16.6% in women and 5.3% in men. The authors explained that guidelines recommend aspirin use for postmenopausal women because participants of the Women’s Health Initiative who took aspirin had reduced major cardiovascular events, and those over age 65 in particular had reduced ischemic stroke. They performed a sensitivity analysis to adjust for this, and found similar results.
However, during the 5-year study period, inappropriate use declined from 14.5% to 9.1%.
Patients who received aspirin inappropriately were younger, with a mean age of 58 years, versus a mean age of 66 years in patients who received aspirin appropriately. Those who received appropriate aspirin therapy were mostly male; had diabetes, hypertension, or dyslipidemia; and were smokers.
There was wide variation in inappropriate aspirin therapy depending on practice characteristics. Overall, the likelihood that two randomly chosen practices would differ in treatment of “identical” patients was 1.63. Specifically, larger practices (with median 13 physicians vs. 8), and those that participated in PINNACLE longer (24 months vs. 16 months), were significantly more likely to promote inappropriate aspirin use.
“Our results provide an important benchmark for inappropriate aspirin use for primary CVD prevention in contemporary outpatient U.S. practices,” Dr. Hira and his associates wrote. Although the benefits of aspirin may outweigh bleeding risk in high-risk patients because of the presence of several cardiovascular risk factors, “patients who are at low risk for cardiovascular events could be harmed by aspirin use due to an increased risk of major bleeding,” they said.
The results of this study underscore the need to improve evidence-based aspirin use for cardiovascular disease prevention, the authors added.
The investigators disclosed financial relationships with Anthera, GE, Tomtec, AstraZeneca, and numerous other companies.
Major coronary events, such as coronary heart disease and nonfatal myocardial infarction, are reduced by 18% with the use of aspirin, but at the expense of a 54% increased bleeding risk. Aspirin therapy is commonly used not just for cardiovascular protection, but also for chemoprotection against cancer, he said.
Because most clinical trials have examined prevention with aspirin in general practice but not cardiology clinic practice, Dr. Hira and colleagues’ study is unique and important in defining the role of practicing cardiologists in administering appropriate therapy in both patients with heart disease who are beyond prevention, and in patients without heart disease who present with complaints such as chest pain, arrhythmia, and heart failure. Additionally, the use of other preventive methods, such as statins, should also be considered, wrote Dr. Verheugt.
Freek W.A. Verheugt, M.D., is affiliated with the Nijmegen Medical Centre in Amsterdam. These remarks were taken from an accompanying editorial (JACC 2015 [doi:10.1016/j. jacc.2014.10.036]). He reported receiving grants from Bayer Healthcare.
Major coronary events, such as coronary heart disease and nonfatal myocardial infarction, are reduced by 18% with the use of aspirin, but at the expense of a 54% increased bleeding risk. Aspirin therapy is commonly used not just for cardiovascular protection, but also for chemoprotection against cancer, he said.
Because most clinical trials have examined prevention with aspirin in general practice but not cardiology clinic practice, Dr. Hira and colleagues’ study is unique and important in defining the role of practicing cardiologists in administering appropriate therapy in both patients with heart disease who are beyond prevention, and in patients without heart disease who present with complaints such as chest pain, arrhythmia, and heart failure. Additionally, the use of other preventive methods, such as statins, should also be considered, wrote Dr. Verheugt.
Freek W.A. Verheugt, M.D., is affiliated with the Nijmegen Medical Centre in Amsterdam. These remarks were taken from an accompanying editorial (JACC 2015 [doi:10.1016/j. jacc.2014.10.036]). He reported receiving grants from Bayer Healthcare.
Major coronary events, such as coronary heart disease and nonfatal myocardial infarction, are reduced by 18% with the use of aspirin, but at the expense of a 54% increased bleeding risk. Aspirin therapy is commonly used not just for cardiovascular protection, but also for chemoprotection against cancer, he said.
Because most clinical trials have examined prevention with aspirin in general practice but not cardiology clinic practice, Dr. Hira and colleagues’ study is unique and important in defining the role of practicing cardiologists in administering appropriate therapy in both patients with heart disease who are beyond prevention, and in patients without heart disease who present with complaints such as chest pain, arrhythmia, and heart failure. Additionally, the use of other preventive methods, such as statins, should also be considered, wrote Dr. Verheugt.
Freek W.A. Verheugt, M.D., is affiliated with the Nijmegen Medical Centre in Amsterdam. These remarks were taken from an accompanying editorial (JACC 2015 [doi:10.1016/j. jacc.2014.10.036]). He reported receiving grants from Bayer Healthcare.
More than 1 in 10 heart patients are inappropriately prescribed aspirin therapy for the prevention of cardiovascular disease, and there’s wide variation by practice in that proportion, according to a registry analysis published Jan. 12 in the Journal of the American College of Cardiology.
In a study of patients in the National Cardiovascular Data Registry’s Practice Innovation and Clinical Excellence (PINNACLE) registry, 11.6% of heart patients were prescribed aspirin even though they did not meet American Heart Association guidelines for the use of aspirin in cardiovascular disease (CVD) prevention.
Dr. Ravi S. Hira and colleagues of the Baylor College of Medicine in Houston collected data from 68,808 patients in the PINNACLE registry who received aspirin between January 2008 and June 2013. Participants were excluded if they were taking aspirin for secondary prevention (such as a history of MI, stroke, or other cardiovascular events) or if they were also taking warfarin, clopidogrel, ticlopidine, or an aspirin/dipyridamole combination (JACC 2015 [doi:10.1016/j.jacc.2014.10.035]).
The investigators defined “inappropriate aspirin use” as aspirin therapy in patients with a 10-year risk of a cardiovascular event of less than 6%. The AHA recommends aspirin use only in patients with a 10-year CVD risk of at least 6%, mainly because the risk of gastrointestinal bleeding and hemorrhagic stroke outweighs any potential benefit in low-risk CVD patients, the authors reported.
A total of 7,972 patients had a 10-year CVD risk of less than 6% and therefore were prescribed aspirin inappropriately. About 80% of them were women, and the frequency of inappropriate aspirin use was 16.6% in women and 5.3% in men. The authors explained that guidelines recommend aspirin use for postmenopausal women because participants of the Women’s Health Initiative who took aspirin had reduced major cardiovascular events, and those over age 65 in particular had reduced ischemic stroke. They performed a sensitivity analysis to adjust for this, and found similar results.
However, during the 5-year study period, inappropriate use declined from 14.5% to 9.1%.
Patients who received aspirin inappropriately were younger, with a mean age of 58 years, versus a mean age of 66 years in patients who received aspirin appropriately. Those who received appropriate aspirin therapy were mostly male; had diabetes, hypertension, or dyslipidemia; and were smokers.
There was wide variation in inappropriate aspirin therapy depending on practice characteristics. Overall, the likelihood that two randomly chosen practices would differ in treatment of “identical” patients was 1.63. Specifically, larger practices (with median 13 physicians vs. 8), and those that participated in PINNACLE longer (24 months vs. 16 months), were significantly more likely to promote inappropriate aspirin use.
“Our results provide an important benchmark for inappropriate aspirin use for primary CVD prevention in contemporary outpatient U.S. practices,” Dr. Hira and his associates wrote. Although the benefits of aspirin may outweigh bleeding risk in high-risk patients because of the presence of several cardiovascular risk factors, “patients who are at low risk for cardiovascular events could be harmed by aspirin use due to an increased risk of major bleeding,” they said.
The results of this study underscore the need to improve evidence-based aspirin use for cardiovascular disease prevention, the authors added.
The investigators disclosed financial relationships with Anthera, GE, Tomtec, AstraZeneca, and numerous other companies.
More than 1 in 10 heart patients are inappropriately prescribed aspirin therapy for the prevention of cardiovascular disease, and there’s wide variation by practice in that proportion, according to a registry analysis published Jan. 12 in the Journal of the American College of Cardiology.
In a study of patients in the National Cardiovascular Data Registry’s Practice Innovation and Clinical Excellence (PINNACLE) registry, 11.6% of heart patients were prescribed aspirin even though they did not meet American Heart Association guidelines for the use of aspirin in cardiovascular disease (CVD) prevention.
Dr. Ravi S. Hira and colleagues of the Baylor College of Medicine in Houston collected data from 68,808 patients in the PINNACLE registry who received aspirin between January 2008 and June 2013. Participants were excluded if they were taking aspirin for secondary prevention (such as a history of MI, stroke, or other cardiovascular events) or if they were also taking warfarin, clopidogrel, ticlopidine, or an aspirin/dipyridamole combination (JACC 2015 [doi:10.1016/j.jacc.2014.10.035]).
The investigators defined “inappropriate aspirin use” as aspirin therapy in patients with a 10-year risk of a cardiovascular event of less than 6%. The AHA recommends aspirin use only in patients with a 10-year CVD risk of at least 6%, mainly because the risk of gastrointestinal bleeding and hemorrhagic stroke outweighs any potential benefit in low-risk CVD patients, the authors reported.
A total of 7,972 patients had a 10-year CVD risk of less than 6% and therefore were prescribed aspirin inappropriately. About 80% of them were women, and the frequency of inappropriate aspirin use was 16.6% in women and 5.3% in men. The authors explained that guidelines recommend aspirin use for postmenopausal women because participants of the Women’s Health Initiative who took aspirin had reduced major cardiovascular events, and those over age 65 in particular had reduced ischemic stroke. They performed a sensitivity analysis to adjust for this, and found similar results.
However, during the 5-year study period, inappropriate use declined from 14.5% to 9.1%.
Patients who received aspirin inappropriately were younger, with a mean age of 58 years, versus a mean age of 66 years in patients who received aspirin appropriately. Those who received appropriate aspirin therapy were mostly male; had diabetes, hypertension, or dyslipidemia; and were smokers.
There was wide variation in inappropriate aspirin therapy depending on practice characteristics. Overall, the likelihood that two randomly chosen practices would differ in treatment of “identical” patients was 1.63. Specifically, larger practices (with median 13 physicians vs. 8), and those that participated in PINNACLE longer (24 months vs. 16 months), were significantly more likely to promote inappropriate aspirin use.
“Our results provide an important benchmark for inappropriate aspirin use for primary CVD prevention in contemporary outpatient U.S. practices,” Dr. Hira and his associates wrote. Although the benefits of aspirin may outweigh bleeding risk in high-risk patients because of the presence of several cardiovascular risk factors, “patients who are at low risk for cardiovascular events could be harmed by aspirin use due to an increased risk of major bleeding,” they said.
The results of this study underscore the need to improve evidence-based aspirin use for cardiovascular disease prevention, the authors added.
The investigators disclosed financial relationships with Anthera, GE, Tomtec, AstraZeneca, and numerous other companies.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point: More than 10% of heart patients are inappropriately prescribed aspirin for CVD prevention.
Major finding: 11.6% of patients were inappropriately prescribed aspirin for the prevention of CVD, despite bleeding risks outweighing any potential benefits of aspirin use.
Data source: An analysis of 68,808 patients in the National Cardiovascular Data Registry’s PINNACLE registry.
Disclosures: The investigators disclosed financial relationships with Anthera, GE, Tomtec, AstraZeneca, and numerous other companies.
Symptom severity predicts remission in first-episode schizophrenia
Severity of symptoms in the first episode of schizophrenia might be an indicator of whether patients will achieve remission, recently published findings suggest.
Dr. Carlo Marchesi and associates at the University of Parma (Italy) studied 48 first-episode schizophrenia patients admitted to the university’s psychiatric clinic between January 1995 and December 1999. Patients were 17 years of age and older, hospitalized for the first time for a psychotic episode, and were discharged with a DSM-IV diagnosis of schizophrenia (Psychiatry Res. 2015;225:129-32).
Symptom severity was assessed using the Positive and Negative Syndrome Scale (PANSS), with the eight core symptoms being delusions, hallucinations, unusual thoughts, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity. Exclusion criteria included drug abuse, delirium, mental retardation, previous treatment with psychotropic medication, and discontinuation of treatment after discharge.
Patients attended monthly mental health visits following discharge, with a follow-up re-evaluation in 2010, the authors reported. During monthly visits, data were collected about patients’ psychiatric state, treatment adherence, medications, and illicit drug use.
At follow-up, 18 of the 48 patients had achieved remission (R) and 30 had not achieved remission (NR). Duration of illness was similar in both groups (16.0 ± 4.8 years in the R group; 16.3 ± 5.1 years in the NR group). The number of psychotic episodes requiring hospitalization was higher in patients who did not achieve remission (3.6 ± 1.0 in the NR group; 2.2 ± 0.6 in the R group; P < 0.001), Dr. Marchesi and his colleagues reported.
Severity of core symptoms at baseline was lower in R patients than in NR patients, with 61% of patients in remission meeting symptom severity criteria in five of the eight core symptoms, compared with 10% of patients who did not achieve remission (P < 0.001).
These findings confirm results from previous studies suggesting that, at the time of a first episode, “lesser symptom severity, particularly a lesser degree of negative symptoms, predict long-term remission in schizophrenic patients,” the investigators wrote.
Additionally, the results might provide evidence supporting a proposal from the Remission in Schizophrenia Working Group to define a subgroup of schizophrenia patients with milder symptoms at baseline who might have a higher chance of achieving long-term remission.
The investigators noted two limitations to the study. First, since schizophrenia is not a stable disorder, remission might be time limited, making it impossible to rule out the possibility of relapse. Second, it is important to consider that some patients might have been nonadherent to medications between monthly visits, they added.
Dr. Marchesi and his coauthors did not report any relevant financial disclosures.
Severity of symptoms in the first episode of schizophrenia might be an indicator of whether patients will achieve remission, recently published findings suggest.
Dr. Carlo Marchesi and associates at the University of Parma (Italy) studied 48 first-episode schizophrenia patients admitted to the university’s psychiatric clinic between January 1995 and December 1999. Patients were 17 years of age and older, hospitalized for the first time for a psychotic episode, and were discharged with a DSM-IV diagnosis of schizophrenia (Psychiatry Res. 2015;225:129-32).
Symptom severity was assessed using the Positive and Negative Syndrome Scale (PANSS), with the eight core symptoms being delusions, hallucinations, unusual thoughts, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity. Exclusion criteria included drug abuse, delirium, mental retardation, previous treatment with psychotropic medication, and discontinuation of treatment after discharge.
Patients attended monthly mental health visits following discharge, with a follow-up re-evaluation in 2010, the authors reported. During monthly visits, data were collected about patients’ psychiatric state, treatment adherence, medications, and illicit drug use.
At follow-up, 18 of the 48 patients had achieved remission (R) and 30 had not achieved remission (NR). Duration of illness was similar in both groups (16.0 ± 4.8 years in the R group; 16.3 ± 5.1 years in the NR group). The number of psychotic episodes requiring hospitalization was higher in patients who did not achieve remission (3.6 ± 1.0 in the NR group; 2.2 ± 0.6 in the R group; P < 0.001), Dr. Marchesi and his colleagues reported.
Severity of core symptoms at baseline was lower in R patients than in NR patients, with 61% of patients in remission meeting symptom severity criteria in five of the eight core symptoms, compared with 10% of patients who did not achieve remission (P < 0.001).
These findings confirm results from previous studies suggesting that, at the time of a first episode, “lesser symptom severity, particularly a lesser degree of negative symptoms, predict long-term remission in schizophrenic patients,” the investigators wrote.
Additionally, the results might provide evidence supporting a proposal from the Remission in Schizophrenia Working Group to define a subgroup of schizophrenia patients with milder symptoms at baseline who might have a higher chance of achieving long-term remission.
The investigators noted two limitations to the study. First, since schizophrenia is not a stable disorder, remission might be time limited, making it impossible to rule out the possibility of relapse. Second, it is important to consider that some patients might have been nonadherent to medications between monthly visits, they added.
Dr. Marchesi and his coauthors did not report any relevant financial disclosures.
Severity of symptoms in the first episode of schizophrenia might be an indicator of whether patients will achieve remission, recently published findings suggest.
Dr. Carlo Marchesi and associates at the University of Parma (Italy) studied 48 first-episode schizophrenia patients admitted to the university’s psychiatric clinic between January 1995 and December 1999. Patients were 17 years of age and older, hospitalized for the first time for a psychotic episode, and were discharged with a DSM-IV diagnosis of schizophrenia (Psychiatry Res. 2015;225:129-32).
Symptom severity was assessed using the Positive and Negative Syndrome Scale (PANSS), with the eight core symptoms being delusions, hallucinations, unusual thoughts, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity. Exclusion criteria included drug abuse, delirium, mental retardation, previous treatment with psychotropic medication, and discontinuation of treatment after discharge.
Patients attended monthly mental health visits following discharge, with a follow-up re-evaluation in 2010, the authors reported. During monthly visits, data were collected about patients’ psychiatric state, treatment adherence, medications, and illicit drug use.
At follow-up, 18 of the 48 patients had achieved remission (R) and 30 had not achieved remission (NR). Duration of illness was similar in both groups (16.0 ± 4.8 years in the R group; 16.3 ± 5.1 years in the NR group). The number of psychotic episodes requiring hospitalization was higher in patients who did not achieve remission (3.6 ± 1.0 in the NR group; 2.2 ± 0.6 in the R group; P < 0.001), Dr. Marchesi and his colleagues reported.
Severity of core symptoms at baseline was lower in R patients than in NR patients, with 61% of patients in remission meeting symptom severity criteria in five of the eight core symptoms, compared with 10% of patients who did not achieve remission (P < 0.001).
These findings confirm results from previous studies suggesting that, at the time of a first episode, “lesser symptom severity, particularly a lesser degree of negative symptoms, predict long-term remission in schizophrenic patients,” the investigators wrote.
Additionally, the results might provide evidence supporting a proposal from the Remission in Schizophrenia Working Group to define a subgroup of schizophrenia patients with milder symptoms at baseline who might have a higher chance of achieving long-term remission.
The investigators noted two limitations to the study. First, since schizophrenia is not a stable disorder, remission might be time limited, making it impossible to rule out the possibility of relapse. Second, it is important to consider that some patients might have been nonadherent to medications between monthly visits, they added.
Dr. Marchesi and his coauthors did not report any relevant financial disclosures.
FROM PSYCHIATRY RESEARCH
Key clinical point: Schizophrenia patients with milder symptoms at baseline might have a higher chance of achieving remission.
Major finding: Lower symptom severity at baseline was associated with a higher likelihood of achieving remission, with 61% of patients in remission meeting symptom severity criteria in five of eight core symptoms, compared with 10% of patients who did not achieve remission (P < 0.001).
Data source: An analysis of 48 first-episode schizophrenia patients admitted to the psychiatric clinic of the University of Parma (Italy) between January 1995 and December 1999, with follow-up evaluation in 2010.
Disclosures: The authors did not report any relevant financial disclosures.
Late-onset Schizophrenia Fosters Better Social Cognition
Older age of illness onset in schizophrenia patients is associated with better social competence, according to results of a recent study.
In an analysis of schizophrenia patients in a Warsaw mental health clinic, older age was associated with better performance on measures of social cognition, though it also was associated with slower performance in processing speed, problem solving, and attention, wrote Magdalena Linke and her colleagues at the Institute of Psychiatry and Neurology in Warsaw (Psychiatry Res. 2015;225:197-201).
The investigators studied 151 patients, aged 18 to 59 years, who met ICD-10 diagnostic criteria for schizophrenia at the Institute of Psychiatry and Neurology’s mental health clinic in Warsaw. Participants did not meet criteria for other psychiatric ICD-10 diagnoses, neurologic disorders that could affect cognitive function, history of head injury, or substance abuse. Patients were on stable doses of antipsychotic medications for at least 4 weeks at baseline.
Patient demographic and disease data were collected via interviews, and the Positive and Negative Syndrome Scale (PANSS) was completed for participants. Age at illness onset ranged from 12.5 years to 50.4 years, with a mean onset age of 23.1 years.
After assessment of participants’ cognitive function and psychiatric symptoms, cognition was evaluated using a Polish translation of the MATRICS Consensus Cognitive Battery (MCCB), which measures cognitive function in the areas of processing speed, working memory, problem solving, visual and verbal learning, social cognition, and attention.
Older age was associated with better scores in social cognition (r = 0.20; P = .016), as measured by the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) component of the MCCB, reported Ms. Linke, a PhD student, and her associates.
Older patients had slower performance on tests of processing speed (r = 0.21; P = .011), reasoning and problem solving (r = –0.28; P = .001), visual learning (r = –0.27; P = .001), and attention and vigilance (r = –0.20; P = .016), the authors said. Younger age was associated with better problem-solving performance and lower social cognition scores.
The results of this study “demonstrate that age at onset of schizophrenia might be an important factor altering social cognition in individuals with schizophrenia,” the authors said in the report. In light of these findings, cognitive remediation programs should be available to schizophrenia patients to help prevent cognitive decline, particularly in those at high risk for psychosis, they added.
The primary limitation of this study is a lack of healthy controls, which means conclusions cannot be made about whether age-related cognitive decline is accelerated in schizophrenia patients, the investigators said.
The study was funded by the National Science Center, Poland. The authors did not report any additional disclosures.
Older age of illness onset in schizophrenia patients is associated with better social competence, according to results of a recent study.
In an analysis of schizophrenia patients in a Warsaw mental health clinic, older age was associated with better performance on measures of social cognition, though it also was associated with slower performance in processing speed, problem solving, and attention, wrote Magdalena Linke and her colleagues at the Institute of Psychiatry and Neurology in Warsaw (Psychiatry Res. 2015;225:197-201).
The investigators studied 151 patients, aged 18 to 59 years, who met ICD-10 diagnostic criteria for schizophrenia at the Institute of Psychiatry and Neurology’s mental health clinic in Warsaw. Participants did not meet criteria for other psychiatric ICD-10 diagnoses, neurologic disorders that could affect cognitive function, history of head injury, or substance abuse. Patients were on stable doses of antipsychotic medications for at least 4 weeks at baseline.
Patient demographic and disease data were collected via interviews, and the Positive and Negative Syndrome Scale (PANSS) was completed for participants. Age at illness onset ranged from 12.5 years to 50.4 years, with a mean onset age of 23.1 years.
After assessment of participants’ cognitive function and psychiatric symptoms, cognition was evaluated using a Polish translation of the MATRICS Consensus Cognitive Battery (MCCB), which measures cognitive function in the areas of processing speed, working memory, problem solving, visual and verbal learning, social cognition, and attention.
Older age was associated with better scores in social cognition (r = 0.20; P = .016), as measured by the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) component of the MCCB, reported Ms. Linke, a PhD student, and her associates.
Older patients had slower performance on tests of processing speed (r = 0.21; P = .011), reasoning and problem solving (r = –0.28; P = .001), visual learning (r = –0.27; P = .001), and attention and vigilance (r = –0.20; P = .016), the authors said. Younger age was associated with better problem-solving performance and lower social cognition scores.
The results of this study “demonstrate that age at onset of schizophrenia might be an important factor altering social cognition in individuals with schizophrenia,” the authors said in the report. In light of these findings, cognitive remediation programs should be available to schizophrenia patients to help prevent cognitive decline, particularly in those at high risk for psychosis, they added.
The primary limitation of this study is a lack of healthy controls, which means conclusions cannot be made about whether age-related cognitive decline is accelerated in schizophrenia patients, the investigators said.
The study was funded by the National Science Center, Poland. The authors did not report any additional disclosures.
Older age of illness onset in schizophrenia patients is associated with better social competence, according to results of a recent study.
In an analysis of schizophrenia patients in a Warsaw mental health clinic, older age was associated with better performance on measures of social cognition, though it also was associated with slower performance in processing speed, problem solving, and attention, wrote Magdalena Linke and her colleagues at the Institute of Psychiatry and Neurology in Warsaw (Psychiatry Res. 2015;225:197-201).
The investigators studied 151 patients, aged 18 to 59 years, who met ICD-10 diagnostic criteria for schizophrenia at the Institute of Psychiatry and Neurology’s mental health clinic in Warsaw. Participants did not meet criteria for other psychiatric ICD-10 diagnoses, neurologic disorders that could affect cognitive function, history of head injury, or substance abuse. Patients were on stable doses of antipsychotic medications for at least 4 weeks at baseline.
Patient demographic and disease data were collected via interviews, and the Positive and Negative Syndrome Scale (PANSS) was completed for participants. Age at illness onset ranged from 12.5 years to 50.4 years, with a mean onset age of 23.1 years.
After assessment of participants’ cognitive function and psychiatric symptoms, cognition was evaluated using a Polish translation of the MATRICS Consensus Cognitive Battery (MCCB), which measures cognitive function in the areas of processing speed, working memory, problem solving, visual and verbal learning, social cognition, and attention.
Older age was associated with better scores in social cognition (r = 0.20; P = .016), as measured by the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) component of the MCCB, reported Ms. Linke, a PhD student, and her associates.
Older patients had slower performance on tests of processing speed (r = 0.21; P = .011), reasoning and problem solving (r = –0.28; P = .001), visual learning (r = –0.27; P = .001), and attention and vigilance (r = –0.20; P = .016), the authors said. Younger age was associated with better problem-solving performance and lower social cognition scores.
The results of this study “demonstrate that age at onset of schizophrenia might be an important factor altering social cognition in individuals with schizophrenia,” the authors said in the report. In light of these findings, cognitive remediation programs should be available to schizophrenia patients to help prevent cognitive decline, particularly in those at high risk for psychosis, they added.
The primary limitation of this study is a lack of healthy controls, which means conclusions cannot be made about whether age-related cognitive decline is accelerated in schizophrenia patients, the investigators said.
The study was funded by the National Science Center, Poland. The authors did not report any additional disclosures.
FROM PSYCHIATRY RESEARCH
Late-onset schizophrenia fosters better social cognition
Older age of illness onset in schizophrenia patients is associated with better social competence, according to results of a recent study.
In an analysis of schizophrenia patients in a Warsaw mental health clinic, older age was associated with better performance on measures of social cognition, though it also was associated with slower performance in processing speed, problem solving, and attention, wrote Magdalena Linke and her colleagues at the Institute of Psychiatry and Neurology in Warsaw (Psychiatry Res. 2015;225:197-201).
The investigators studied 151 patients, aged 18 to 59 years, who met ICD-10 diagnostic criteria for schizophrenia at the Institute of Psychiatry and Neurology’s mental health clinic in Warsaw. Participants did not meet criteria for other psychiatric ICD-10 diagnoses, neurologic disorders that could affect cognitive function, history of head injury, or substance abuse. Patients were on stable doses of antipsychotic medications for at least 4 weeks at baseline.
Patient demographic and disease data were collected via interviews, and the Positive and Negative Syndrome Scale (PANSS) was completed for participants. Age at illness onset ranged from 12.5 years to 50.4 years, with a mean onset age of 23.1 years.
After assessment of participants’ cognitive function and psychiatric symptoms, cognition was evaluated using a Polish translation of the MATRICS Consensus Cognitive Battery (MCCB), which measures cognitive function in the areas of processing speed, working memory, problem solving, visual and verbal learning, social cognition, and attention.
Older age was associated with better scores in social cognition (r = 0.20; P = .016), as measured by the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) component of the MCCB, reported Ms. Linke, a PhD student, and her associates.
Older patients had slower performance on tests of processing speed (r = 0.21; P = .011), reasoning and problem solving (r = –0.28; P = .001), visual learning (r = –0.27; P = .001), and attention and vigilance (r = –0.20; P = .016), the authors said. Younger age was associated with better problem-solving performance and lower social cognition scores.
The results of this study “demonstrate that age at onset of schizophrenia might be an important factor altering social cognition in individuals with schizophrenia,” the authors said in the report. In light of these findings, cognitive remediation programs should be available to schizophrenia patients to help prevent cognitive decline, particularly in those at high risk for psychosis, they added.
The primary limitation of this study is a lack of healthy controls, which means conclusions cannot be made about whether age-related cognitive decline is accelerated in schizophrenia patients, the investigators said.
The study was funded by the National Science Center, Poland. The authors did not report any additional disclosures.
Older age of illness onset in schizophrenia patients is associated with better social competence, according to results of a recent study.
In an analysis of schizophrenia patients in a Warsaw mental health clinic, older age was associated with better performance on measures of social cognition, though it also was associated with slower performance in processing speed, problem solving, and attention, wrote Magdalena Linke and her colleagues at the Institute of Psychiatry and Neurology in Warsaw (Psychiatry Res. 2015;225:197-201).
The investigators studied 151 patients, aged 18 to 59 years, who met ICD-10 diagnostic criteria for schizophrenia at the Institute of Psychiatry and Neurology’s mental health clinic in Warsaw. Participants did not meet criteria for other psychiatric ICD-10 diagnoses, neurologic disorders that could affect cognitive function, history of head injury, or substance abuse. Patients were on stable doses of antipsychotic medications for at least 4 weeks at baseline.
Patient demographic and disease data were collected via interviews, and the Positive and Negative Syndrome Scale (PANSS) was completed for participants. Age at illness onset ranged from 12.5 years to 50.4 years, with a mean onset age of 23.1 years.
After assessment of participants’ cognitive function and psychiatric symptoms, cognition was evaluated using a Polish translation of the MATRICS Consensus Cognitive Battery (MCCB), which measures cognitive function in the areas of processing speed, working memory, problem solving, visual and verbal learning, social cognition, and attention.
Older age was associated with better scores in social cognition (r = 0.20; P = .016), as measured by the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) component of the MCCB, reported Ms. Linke, a PhD student, and her associates.
Older patients had slower performance on tests of processing speed (r = 0.21; P = .011), reasoning and problem solving (r = –0.28; P = .001), visual learning (r = –0.27; P = .001), and attention and vigilance (r = –0.20; P = .016), the authors said. Younger age was associated with better problem-solving performance and lower social cognition scores.
The results of this study “demonstrate that age at onset of schizophrenia might be an important factor altering social cognition in individuals with schizophrenia,” the authors said in the report. In light of these findings, cognitive remediation programs should be available to schizophrenia patients to help prevent cognitive decline, particularly in those at high risk for psychosis, they added.
The primary limitation of this study is a lack of healthy controls, which means conclusions cannot be made about whether age-related cognitive decline is accelerated in schizophrenia patients, the investigators said.
The study was funded by the National Science Center, Poland. The authors did not report any additional disclosures.
Older age of illness onset in schizophrenia patients is associated with better social competence, according to results of a recent study.
In an analysis of schizophrenia patients in a Warsaw mental health clinic, older age was associated with better performance on measures of social cognition, though it also was associated with slower performance in processing speed, problem solving, and attention, wrote Magdalena Linke and her colleagues at the Institute of Psychiatry and Neurology in Warsaw (Psychiatry Res. 2015;225:197-201).
The investigators studied 151 patients, aged 18 to 59 years, who met ICD-10 diagnostic criteria for schizophrenia at the Institute of Psychiatry and Neurology’s mental health clinic in Warsaw. Participants did not meet criteria for other psychiatric ICD-10 diagnoses, neurologic disorders that could affect cognitive function, history of head injury, or substance abuse. Patients were on stable doses of antipsychotic medications for at least 4 weeks at baseline.
Patient demographic and disease data were collected via interviews, and the Positive and Negative Syndrome Scale (PANSS) was completed for participants. Age at illness onset ranged from 12.5 years to 50.4 years, with a mean onset age of 23.1 years.
After assessment of participants’ cognitive function and psychiatric symptoms, cognition was evaluated using a Polish translation of the MATRICS Consensus Cognitive Battery (MCCB), which measures cognitive function in the areas of processing speed, working memory, problem solving, visual and verbal learning, social cognition, and attention.
Older age was associated with better scores in social cognition (r = 0.20; P = .016), as measured by the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) component of the MCCB, reported Ms. Linke, a PhD student, and her associates.
Older patients had slower performance on tests of processing speed (r = 0.21; P = .011), reasoning and problem solving (r = –0.28; P = .001), visual learning (r = –0.27; P = .001), and attention and vigilance (r = –0.20; P = .016), the authors said. Younger age was associated with better problem-solving performance and lower social cognition scores.
The results of this study “demonstrate that age at onset of schizophrenia might be an important factor altering social cognition in individuals with schizophrenia,” the authors said in the report. In light of these findings, cognitive remediation programs should be available to schizophrenia patients to help prevent cognitive decline, particularly in those at high risk for psychosis, they added.
The primary limitation of this study is a lack of healthy controls, which means conclusions cannot be made about whether age-related cognitive decline is accelerated in schizophrenia patients, the investigators said.
The study was funded by the National Science Center, Poland. The authors did not report any additional disclosures.
FROM PSYCHIATRY RESEARCH
Key clinical point: Older age at onset of schizophrenia was associated with better social cognition.
Major finding: Older patients showed better scores on measures of social cognition than did those with early-onset illness (r = 0.20; P < .016).
Data source: An analysis of 151 clinically stable schizophrenia patients from the mental health clinic at the Institute of Psychiatry and Neurology in Warsaw, Poland.
Disclosures: The study was sponsored by the National Science Center, Poland.
Experimental Ebola and Marburg vaccines safe, well-tolerated in Ugandan adults
Experimental vaccines to prevent the Ebola and Marburg viruses were safe, well-tolerated, and produced similar results in Ugandan adults as in U.S. adults, according to findings published Dec. 22 in the Lancet.
In a randomized, phase I trial designed to evaluate the safety and immune response of two investigational vaccines, only one severe adverse event (neutropenia) was reported and was believed to be unrelated to the vaccine.
Dr. Julie E. Ledgerwood and colleagues at the National Institutes of Health studied 108 healthy adults aged 18-50 years in Kampala, Uganda from November 2009 to April 2010. Participants were randomized to receive either the Ebola (EBO) vaccine, the Marburg (MAR) vaccine, both vaccines, or placebo at the start of the study, and again after 4 and 8 weeks (Lancet 2014 [doi:10.1016/S0140-6736(14)62385-0].
Positive T-cell antibody responses were seen for the Ebola Sudan (SUDV) glycoprotein antigen in 43% of patients in the EBO vaccine group (95% confidence interval, 25-63), 3% of patients in the MAR vaccine–only group (95% CI, 0-18), and 33% of those in the group receiving both vaccines (95% CI, 17-53). T-cell responses for the Ebola Zaire (EBOV) glycoprotein were positive in 63% of patients in the EBO vaccine group (95% CI, 44-80), 3% of patients in the MAR vaccine–only group (95% CI, 0-18), and 33% of those in the group receiving both vaccines (95% CI, 17-53). Positive T-cell antibody responses were seen for the MARV glycoprotein antigen in 10% of patients in the EBO vaccine group (95% CI, 2-27), 52% of patients in the MAR vaccine–only group (95% CI, 33-71), and 43% of those in the group receiving both vaccines (95% CI, 25-63).
“This is the first clinical trial to assess an Ebola virus vaccine and a Marburg virus vaccine in an African population,” the authors said in the report.
Additionally, “safety and immunogenicity were similar in U.S. and Ugandan populations, which is important especially for a filovirus vaccine since the people at greatest risk of the disease reside mainly in Africa,” they added.
In an editorial accompanying the study, Dr. Saranya Sridhar of the Oxford University Centre for Clinical Vaccinology and Tropical Medicine comments that this trial could “provide some insight into what might be expected from the ongoing trials of virus-vectored Ebola virus vaccines in Africa.”
The similarity of the safety profile to that of a similar U.S. trial is encouraging in its possible implications for trials currently underway in Mali, he added (Lancet 2014 [doi:10.1016/S0140-6736(14)62445-4]).
“The international response to the present Ebola outbreak is an exemplar of the speed and purpose with which clinical vaccine development can progress and has set the benchmark against which future vaccine development must be judged,” he said.
The study was funded by the U.S. Department of Defense Infectious Disease Clinical Research Program and the U.S. National Institutes of Health Intramural Research Program. The authors did not disclose any conflicts of interest.
Experimental vaccines to prevent the Ebola and Marburg viruses were safe, well-tolerated, and produced similar results in Ugandan adults as in U.S. adults, according to findings published Dec. 22 in the Lancet.
In a randomized, phase I trial designed to evaluate the safety and immune response of two investigational vaccines, only one severe adverse event (neutropenia) was reported and was believed to be unrelated to the vaccine.
Dr. Julie E. Ledgerwood and colleagues at the National Institutes of Health studied 108 healthy adults aged 18-50 years in Kampala, Uganda from November 2009 to April 2010. Participants were randomized to receive either the Ebola (EBO) vaccine, the Marburg (MAR) vaccine, both vaccines, or placebo at the start of the study, and again after 4 and 8 weeks (Lancet 2014 [doi:10.1016/S0140-6736(14)62385-0].
Positive T-cell antibody responses were seen for the Ebola Sudan (SUDV) glycoprotein antigen in 43% of patients in the EBO vaccine group (95% confidence interval, 25-63), 3% of patients in the MAR vaccine–only group (95% CI, 0-18), and 33% of those in the group receiving both vaccines (95% CI, 17-53). T-cell responses for the Ebola Zaire (EBOV) glycoprotein were positive in 63% of patients in the EBO vaccine group (95% CI, 44-80), 3% of patients in the MAR vaccine–only group (95% CI, 0-18), and 33% of those in the group receiving both vaccines (95% CI, 17-53). Positive T-cell antibody responses were seen for the MARV glycoprotein antigen in 10% of patients in the EBO vaccine group (95% CI, 2-27), 52% of patients in the MAR vaccine–only group (95% CI, 33-71), and 43% of those in the group receiving both vaccines (95% CI, 25-63).
“This is the first clinical trial to assess an Ebola virus vaccine and a Marburg virus vaccine in an African population,” the authors said in the report.
Additionally, “safety and immunogenicity were similar in U.S. and Ugandan populations, which is important especially for a filovirus vaccine since the people at greatest risk of the disease reside mainly in Africa,” they added.
In an editorial accompanying the study, Dr. Saranya Sridhar of the Oxford University Centre for Clinical Vaccinology and Tropical Medicine comments that this trial could “provide some insight into what might be expected from the ongoing trials of virus-vectored Ebola virus vaccines in Africa.”
The similarity of the safety profile to that of a similar U.S. trial is encouraging in its possible implications for trials currently underway in Mali, he added (Lancet 2014 [doi:10.1016/S0140-6736(14)62445-4]).
“The international response to the present Ebola outbreak is an exemplar of the speed and purpose with which clinical vaccine development can progress and has set the benchmark against which future vaccine development must be judged,” he said.
The study was funded by the U.S. Department of Defense Infectious Disease Clinical Research Program and the U.S. National Institutes of Health Intramural Research Program. The authors did not disclose any conflicts of interest.
Experimental vaccines to prevent the Ebola and Marburg viruses were safe, well-tolerated, and produced similar results in Ugandan adults as in U.S. adults, according to findings published Dec. 22 in the Lancet.
In a randomized, phase I trial designed to evaluate the safety and immune response of two investigational vaccines, only one severe adverse event (neutropenia) was reported and was believed to be unrelated to the vaccine.
Dr. Julie E. Ledgerwood and colleagues at the National Institutes of Health studied 108 healthy adults aged 18-50 years in Kampala, Uganda from November 2009 to April 2010. Participants were randomized to receive either the Ebola (EBO) vaccine, the Marburg (MAR) vaccine, both vaccines, or placebo at the start of the study, and again after 4 and 8 weeks (Lancet 2014 [doi:10.1016/S0140-6736(14)62385-0].
Positive T-cell antibody responses were seen for the Ebola Sudan (SUDV) glycoprotein antigen in 43% of patients in the EBO vaccine group (95% confidence interval, 25-63), 3% of patients in the MAR vaccine–only group (95% CI, 0-18), and 33% of those in the group receiving both vaccines (95% CI, 17-53). T-cell responses for the Ebola Zaire (EBOV) glycoprotein were positive in 63% of patients in the EBO vaccine group (95% CI, 44-80), 3% of patients in the MAR vaccine–only group (95% CI, 0-18), and 33% of those in the group receiving both vaccines (95% CI, 17-53). Positive T-cell antibody responses were seen for the MARV glycoprotein antigen in 10% of patients in the EBO vaccine group (95% CI, 2-27), 52% of patients in the MAR vaccine–only group (95% CI, 33-71), and 43% of those in the group receiving both vaccines (95% CI, 25-63).
“This is the first clinical trial to assess an Ebola virus vaccine and a Marburg virus vaccine in an African population,” the authors said in the report.
Additionally, “safety and immunogenicity were similar in U.S. and Ugandan populations, which is important especially for a filovirus vaccine since the people at greatest risk of the disease reside mainly in Africa,” they added.
In an editorial accompanying the study, Dr. Saranya Sridhar of the Oxford University Centre for Clinical Vaccinology and Tropical Medicine comments that this trial could “provide some insight into what might be expected from the ongoing trials of virus-vectored Ebola virus vaccines in Africa.”
The similarity of the safety profile to that of a similar U.S. trial is encouraging in its possible implications for trials currently underway in Mali, he added (Lancet 2014 [doi:10.1016/S0140-6736(14)62445-4]).
“The international response to the present Ebola outbreak is an exemplar of the speed and purpose with which clinical vaccine development can progress and has set the benchmark against which future vaccine development must be judged,” he said.
The study was funded by the U.S. Department of Defense Infectious Disease Clinical Research Program and the U.S. National Institutes of Health Intramural Research Program. The authors did not disclose any conflicts of interest.
FROM THE LANCET
Key clinical point: Two experimental vaccines for the Ebola and Marburg virus are safe and produced a similar immune response in Ugandan adults as in U.S. adults.
Major finding: Both the EBO and MAR vaccines were well-tolerated with only one grade 4 adverse event reported (neutropenia); 57% of participants in the EBO group had an antibody response to the Ebola Zaire glycoprotein.
Data source: A phase I, randomized trial of 108 healthy adults in Kampala, Uganda, who received three installments of either Ebola vaccine only, Marburg vaccine only, both vaccines, or placebo.
Disclosures: The study was funded by the Department of Defense and the National Institutes of Health.