Dactylitis, enthesitis, anterior uveitis less frequent in IBD-SpA

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Thu, 12/06/2018 - 11:36

 

In patients with inflammatory bowel disease and spondyloarthritis (IBD-SpA), dactylitis, enthesitis, and anterior uveitis (AU) are significantly less frequent than in patients with other types of SpA, according to Fabrizio Cantini, MD, and his associates.

In a 12-month, case-control study, 88 patients with IBD-SpA, 29 with ulcerative colitis (UC), and 59 with Crohn’s disease (CD) were examined along with the 176 patients with SpA in the control group. Results showed a significantly lower occurrence of dactylitis in case patients, with 4 episodes (4.5%) in IBD-SpA patients and 30 (17.4%) in controls (P = .008). The comparison of the frequency of dactylitis in patients with UC-SpA and in patients with CD-SpA found no significant differences between the two (3.4% and 5.08%, respectively; P = .843). Enthesitis was significantly lower in IBD-SpA, occurring in 16 out of 88 patients (18.1%), compared with in 78 out of 176 controls (44.3%; P less than .001). AU was also recorded in 3 (3.4%) of the patients with IBD-SpA and in 26 controls (14.7%; P = .010), and B27 positivity was recorded in 10 (11.3%) of patients with IBD-SpA and in 70 (39.8%) of patients with SpA (P less than .001).

There was a significantly lower occurrence of dactylitis reported in IBD-SpA patients without psoriasis (1 case in 74 patients; P = .001) compared with the control group, while dactylitis occurrence was not significantly different in 3 out of 14 patients (21.4%) with coexistent psoriasis (P = .960). Enthesitis was significantly higher in 14 IBD-SpA patients with associated psoriasis (50%), compared with the remaining 74 cases (12.1%; P = .003). It was noted that enthesitis occurrence was not different in patients with UC and in those with CD (P = .103).

“The results of our case-control study show that dactylitis, enthesitis, and AU are significantly less frequent in IBD-SpA, compared with other types of SpA,” researchers concluded. “Owing to the frequent association of psoriasis with IBD, and especially with CD, the coexistence of skin disease should be taken into account when evaluating the prevalence of dactylitis and enthesitis in patients with IBD-SpA.”

Find the full study in the Journal of Rheumatology (doi: 10.3899/jrheum.161518).

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In patients with inflammatory bowel disease and spondyloarthritis (IBD-SpA), dactylitis, enthesitis, and anterior uveitis (AU) are significantly less frequent than in patients with other types of SpA, according to Fabrizio Cantini, MD, and his associates.

In a 12-month, case-control study, 88 patients with IBD-SpA, 29 with ulcerative colitis (UC), and 59 with Crohn’s disease (CD) were examined along with the 176 patients with SpA in the control group. Results showed a significantly lower occurrence of dactylitis in case patients, with 4 episodes (4.5%) in IBD-SpA patients and 30 (17.4%) in controls (P = .008). The comparison of the frequency of dactylitis in patients with UC-SpA and in patients with CD-SpA found no significant differences between the two (3.4% and 5.08%, respectively; P = .843). Enthesitis was significantly lower in IBD-SpA, occurring in 16 out of 88 patients (18.1%), compared with in 78 out of 176 controls (44.3%; P less than .001). AU was also recorded in 3 (3.4%) of the patients with IBD-SpA and in 26 controls (14.7%; P = .010), and B27 positivity was recorded in 10 (11.3%) of patients with IBD-SpA and in 70 (39.8%) of patients with SpA (P less than .001).

There was a significantly lower occurrence of dactylitis reported in IBD-SpA patients without psoriasis (1 case in 74 patients; P = .001) compared with the control group, while dactylitis occurrence was not significantly different in 3 out of 14 patients (21.4%) with coexistent psoriasis (P = .960). Enthesitis was significantly higher in 14 IBD-SpA patients with associated psoriasis (50%), compared with the remaining 74 cases (12.1%; P = .003). It was noted that enthesitis occurrence was not different in patients with UC and in those with CD (P = .103).

“The results of our case-control study show that dactylitis, enthesitis, and AU are significantly less frequent in IBD-SpA, compared with other types of SpA,” researchers concluded. “Owing to the frequent association of psoriasis with IBD, and especially with CD, the coexistence of skin disease should be taken into account when evaluating the prevalence of dactylitis and enthesitis in patients with IBD-SpA.”

Find the full study in the Journal of Rheumatology (doi: 10.3899/jrheum.161518).

 

In patients with inflammatory bowel disease and spondyloarthritis (IBD-SpA), dactylitis, enthesitis, and anterior uveitis (AU) are significantly less frequent than in patients with other types of SpA, according to Fabrizio Cantini, MD, and his associates.

In a 12-month, case-control study, 88 patients with IBD-SpA, 29 with ulcerative colitis (UC), and 59 with Crohn’s disease (CD) were examined along with the 176 patients with SpA in the control group. Results showed a significantly lower occurrence of dactylitis in case patients, with 4 episodes (4.5%) in IBD-SpA patients and 30 (17.4%) in controls (P = .008). The comparison of the frequency of dactylitis in patients with UC-SpA and in patients with CD-SpA found no significant differences between the two (3.4% and 5.08%, respectively; P = .843). Enthesitis was significantly lower in IBD-SpA, occurring in 16 out of 88 patients (18.1%), compared with in 78 out of 176 controls (44.3%; P less than .001). AU was also recorded in 3 (3.4%) of the patients with IBD-SpA and in 26 controls (14.7%; P = .010), and B27 positivity was recorded in 10 (11.3%) of patients with IBD-SpA and in 70 (39.8%) of patients with SpA (P less than .001).

There was a significantly lower occurrence of dactylitis reported in IBD-SpA patients without psoriasis (1 case in 74 patients; P = .001) compared with the control group, while dactylitis occurrence was not significantly different in 3 out of 14 patients (21.4%) with coexistent psoriasis (P = .960). Enthesitis was significantly higher in 14 IBD-SpA patients with associated psoriasis (50%), compared with the remaining 74 cases (12.1%; P = .003). It was noted that enthesitis occurrence was not different in patients with UC and in those with CD (P = .103).

“The results of our case-control study show that dactylitis, enthesitis, and AU are significantly less frequent in IBD-SpA, compared with other types of SpA,” researchers concluded. “Owing to the frequent association of psoriasis with IBD, and especially with CD, the coexistence of skin disease should be taken into account when evaluating the prevalence of dactylitis and enthesitis in patients with IBD-SpA.”

Find the full study in the Journal of Rheumatology (doi: 10.3899/jrheum.161518).

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Study finds psoriasis link to melanoma and hematologic cancers

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Mon, 07/01/2019 - 11:13

 

Patients with psoriasis may be at a greater risk of melanoma and hematologic cancers, compared with the general population, but treatments do not appear to increase risk, according to Shivani P. Reddy of the University of Illinois at Chicago, and associates.

In a retrospective cohort study, they identified 815,765 patients at Kaiser Permanente Southern California who had at least one medical encounter from January 2004 through December 2013. Of these patients, 8,161 (1%) met the diagnostic and inclusion criteria for psoriasis, and there were 7,167 (0.89%) cases of melanoma and 5,399 (0.66%) cases of lymphoma or leukemia.

Among the patients with psoriasis, there were 62 (0.87%) melanoma cases and 47 (0.87%) cases of lymphoma or leukemia.

Of the 109 patients with psoriasis who went on to develop melanoma or lymphoma, the time to diagnosis of melanoma or hematologic cancers was significantly less for patients with psoriasis than for patients without psoriasis (P = .01). The patients with psoriasis had a 1.53 times higher risk of developing a malignancy compared with patients without psoriasis (P less than .01) in the multivariable Cox proportional hazards model.

“There were no differences between patients with melanoma and hematologic cancer by treatment type,” which were phototherapy, tumor necrosis factor inhibitor therapy, and topical medications, they wrote.

“Our study demonstrates that the risk of hematologic cancer and melanoma is increased in patients with psoriasis over time, although this risk is not impacted by psoriasis therapies,” the researchers concluded. “Defining the risk of malignancy in these patients is important for proper workup and management.”

Read the study in the Journal of the American Academy of Dermatology (doi: 10.1016/j.jaad.2016.09.047).
 

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Patients with psoriasis may be at a greater risk of melanoma and hematologic cancers, compared with the general population, but treatments do not appear to increase risk, according to Shivani P. Reddy of the University of Illinois at Chicago, and associates.

In a retrospective cohort study, they identified 815,765 patients at Kaiser Permanente Southern California who had at least one medical encounter from January 2004 through December 2013. Of these patients, 8,161 (1%) met the diagnostic and inclusion criteria for psoriasis, and there were 7,167 (0.89%) cases of melanoma and 5,399 (0.66%) cases of lymphoma or leukemia.

Among the patients with psoriasis, there were 62 (0.87%) melanoma cases and 47 (0.87%) cases of lymphoma or leukemia.

Of the 109 patients with psoriasis who went on to develop melanoma or lymphoma, the time to diagnosis of melanoma or hematologic cancers was significantly less for patients with psoriasis than for patients without psoriasis (P = .01). The patients with psoriasis had a 1.53 times higher risk of developing a malignancy compared with patients without psoriasis (P less than .01) in the multivariable Cox proportional hazards model.

“There were no differences between patients with melanoma and hematologic cancer by treatment type,” which were phototherapy, tumor necrosis factor inhibitor therapy, and topical medications, they wrote.

“Our study demonstrates that the risk of hematologic cancer and melanoma is increased in patients with psoriasis over time, although this risk is not impacted by psoriasis therapies,” the researchers concluded. “Defining the risk of malignancy in these patients is important for proper workup and management.”

Read the study in the Journal of the American Academy of Dermatology (doi: 10.1016/j.jaad.2016.09.047).
 

 

Patients with psoriasis may be at a greater risk of melanoma and hematologic cancers, compared with the general population, but treatments do not appear to increase risk, according to Shivani P. Reddy of the University of Illinois at Chicago, and associates.

In a retrospective cohort study, they identified 815,765 patients at Kaiser Permanente Southern California who had at least one medical encounter from January 2004 through December 2013. Of these patients, 8,161 (1%) met the diagnostic and inclusion criteria for psoriasis, and there were 7,167 (0.89%) cases of melanoma and 5,399 (0.66%) cases of lymphoma or leukemia.

Among the patients with psoriasis, there were 62 (0.87%) melanoma cases and 47 (0.87%) cases of lymphoma or leukemia.

Of the 109 patients with psoriasis who went on to develop melanoma or lymphoma, the time to diagnosis of melanoma or hematologic cancers was significantly less for patients with psoriasis than for patients without psoriasis (P = .01). The patients with psoriasis had a 1.53 times higher risk of developing a malignancy compared with patients without psoriasis (P less than .01) in the multivariable Cox proportional hazards model.

“There were no differences between patients with melanoma and hematologic cancer by treatment type,” which were phototherapy, tumor necrosis factor inhibitor therapy, and topical medications, they wrote.

“Our study demonstrates that the risk of hematologic cancer and melanoma is increased in patients with psoriasis over time, although this risk is not impacted by psoriasis therapies,” the researchers concluded. “Defining the risk of malignancy in these patients is important for proper workup and management.”

Read the study in the Journal of the American Academy of Dermatology (doi: 10.1016/j.jaad.2016.09.047).
 

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FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

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FDA approves new treatment for episodic cluster headaches in adults

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Fri, 01/18/2019 - 16:41

 

The Food and Drug Administration announced April 18 the approval of the gammaCore device to treat pain associated with episodic cluster headache in adult patients.

The agency based its approval of the noninvasive vagus nerve stimulator device on subgroup analyses of episodic cluster headache patients in the ACT1 and ACT2 trials, which were double-blind, placebo-controlled, randomized studies.

In the ACT1 trial of 85 patients, 34.2% experienced a reduction in pain (defined as the percentage of patients who reported mild or no pain 15 minutes after treatment initiation with gammaCore), compared with 10.6% of patients treated with placebo (P = .008). Of 27 patients in the ACT2 trial, 47.5% of patients using the device were pain free at 15 minutes after the onset of pain from cluster headache, with no use of rescue medication through the 30-minute treatment period, which was significantly greater than for placebo (6.2%; P = .003).

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In both trials, gammaCore was found to be safe and well tolerated, and the majority of adverse events were mild and transient and occurring during the time of active treatment.

“Cluster headache is a rare, debilitating, and difficult to treat disorder with few effective acute therapies,” Stephen Silberstein, MD, director of the Headache Center at Jefferson University, Philadelphia, said in a statement from the manufacturer, electroCore. “The FDA release of gammaCore is an important advance in the treatment of the pain associated with cluster headache. It is a way for patients to treat their symptoms as often as they need to use the device. It does not have the side effects or dose limitations of commonly prescribed treatments or the need for invasive implantation procedures, which can be inconvenient, costly, and high-risk.”

The gammaCore device works by transmitting a mild electrical stimulation to the vagus nerve through the skin, resulting in a reduction of pain. Currently, gammaCore is in use only outside of the United States, including in the European Union. Commercial availability of gammaCore in the United States is expected to begin early in the third quarter of 2017, the company said.

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The Food and Drug Administration announced April 18 the approval of the gammaCore device to treat pain associated with episodic cluster headache in adult patients.

The agency based its approval of the noninvasive vagus nerve stimulator device on subgroup analyses of episodic cluster headache patients in the ACT1 and ACT2 trials, which were double-blind, placebo-controlled, randomized studies.

In the ACT1 trial of 85 patients, 34.2% experienced a reduction in pain (defined as the percentage of patients who reported mild or no pain 15 minutes after treatment initiation with gammaCore), compared with 10.6% of patients treated with placebo (P = .008). Of 27 patients in the ACT2 trial, 47.5% of patients using the device were pain free at 15 minutes after the onset of pain from cluster headache, with no use of rescue medication through the 30-minute treatment period, which was significantly greater than for placebo (6.2%; P = .003).

FDA icon
In both trials, gammaCore was found to be safe and well tolerated, and the majority of adverse events were mild and transient and occurring during the time of active treatment.

“Cluster headache is a rare, debilitating, and difficult to treat disorder with few effective acute therapies,” Stephen Silberstein, MD, director of the Headache Center at Jefferson University, Philadelphia, said in a statement from the manufacturer, electroCore. “The FDA release of gammaCore is an important advance in the treatment of the pain associated with cluster headache. It is a way for patients to treat their symptoms as often as they need to use the device. It does not have the side effects or dose limitations of commonly prescribed treatments or the need for invasive implantation procedures, which can be inconvenient, costly, and high-risk.”

The gammaCore device works by transmitting a mild electrical stimulation to the vagus nerve through the skin, resulting in a reduction of pain. Currently, gammaCore is in use only outside of the United States, including in the European Union. Commercial availability of gammaCore in the United States is expected to begin early in the third quarter of 2017, the company said.

 

The Food and Drug Administration announced April 18 the approval of the gammaCore device to treat pain associated with episodic cluster headache in adult patients.

The agency based its approval of the noninvasive vagus nerve stimulator device on subgroup analyses of episodic cluster headache patients in the ACT1 and ACT2 trials, which were double-blind, placebo-controlled, randomized studies.

In the ACT1 trial of 85 patients, 34.2% experienced a reduction in pain (defined as the percentage of patients who reported mild or no pain 15 minutes after treatment initiation with gammaCore), compared with 10.6% of patients treated with placebo (P = .008). Of 27 patients in the ACT2 trial, 47.5% of patients using the device were pain free at 15 minutes after the onset of pain from cluster headache, with no use of rescue medication through the 30-minute treatment period, which was significantly greater than for placebo (6.2%; P = .003).

FDA icon
In both trials, gammaCore was found to be safe and well tolerated, and the majority of adverse events were mild and transient and occurring during the time of active treatment.

“Cluster headache is a rare, debilitating, and difficult to treat disorder with few effective acute therapies,” Stephen Silberstein, MD, director of the Headache Center at Jefferson University, Philadelphia, said in a statement from the manufacturer, electroCore. “The FDA release of gammaCore is an important advance in the treatment of the pain associated with cluster headache. It is a way for patients to treat their symptoms as often as they need to use the device. It does not have the side effects or dose limitations of commonly prescribed treatments or the need for invasive implantation procedures, which can be inconvenient, costly, and high-risk.”

The gammaCore device works by transmitting a mild electrical stimulation to the vagus nerve through the skin, resulting in a reduction of pain. Currently, gammaCore is in use only outside of the United States, including in the European Union. Commercial availability of gammaCore in the United States is expected to begin early in the third quarter of 2017, the company said.

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FDA approves safinamide to treat Parkinson’s disease

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Fri, 01/18/2019 - 16:38

 

The U.S. Food and Drug Administration approved safinamide tablets on March 21 as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.

Newron Pharmaceuticals will market safinamide under the brand name Xadago.

FDA icon
Part of the evidence base for approving safinamide came from two clinical trials with 645 and 549 participants who were also taking levodopa and were experiencing “off” time. Patients who were receiving safinamide experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without dyskinesia, compared with those receiving a placebo. An “off” episode is when a patient’s medications are not working sufficiently, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. The increase in “on” time occurred with a reduction in “off” time and better scores on a measure of motor function during “on” time.

The most common adverse reactions observed in patients taking safinamide were uncontrolled involuntary movement, falls, nausea, and insomnia.

In its announcement of the approval, the FDA noted that patients should not take safinamide if they have severe liver problems, take dextromethorphan, or take a monoamine oxidase inhibitor, because the two together may cause a sudden severe increase in blood pressure. Safinamide also should not be taken by patients who use a opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.

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The U.S. Food and Drug Administration approved safinamide tablets on March 21 as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.

Newron Pharmaceuticals will market safinamide under the brand name Xadago.

FDA icon
Part of the evidence base for approving safinamide came from two clinical trials with 645 and 549 participants who were also taking levodopa and were experiencing “off” time. Patients who were receiving safinamide experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without dyskinesia, compared with those receiving a placebo. An “off” episode is when a patient’s medications are not working sufficiently, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. The increase in “on” time occurred with a reduction in “off” time and better scores on a measure of motor function during “on” time.

The most common adverse reactions observed in patients taking safinamide were uncontrolled involuntary movement, falls, nausea, and insomnia.

In its announcement of the approval, the FDA noted that patients should not take safinamide if they have severe liver problems, take dextromethorphan, or take a monoamine oxidase inhibitor, because the two together may cause a sudden severe increase in blood pressure. Safinamide also should not be taken by patients who use a opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.

 

The U.S. Food and Drug Administration approved safinamide tablets on March 21 as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.

Newron Pharmaceuticals will market safinamide under the brand name Xadago.

FDA icon
Part of the evidence base for approving safinamide came from two clinical trials with 645 and 549 participants who were also taking levodopa and were experiencing “off” time. Patients who were receiving safinamide experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without dyskinesia, compared with those receiving a placebo. An “off” episode is when a patient’s medications are not working sufficiently, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. The increase in “on” time occurred with a reduction in “off” time and better scores on a measure of motor function during “on” time.

The most common adverse reactions observed in patients taking safinamide were uncontrolled involuntary movement, falls, nausea, and insomnia.

In its announcement of the approval, the FDA noted that patients should not take safinamide if they have severe liver problems, take dextromethorphan, or take a monoamine oxidase inhibitor, because the two together may cause a sudden severe increase in blood pressure. Safinamide also should not be taken by patients who use a opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.

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FDA approves first dedicated bifurcation device to treat coronary bifurcation lesions

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Wed, 01/02/2019 - 09:49

 

Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.

In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.

FDA icon
It is noted that the confirmatory study met its pre-specified primary endpoint, periprocedural myocardial infarction, which was within its noninferiority margin (primary endpoint, P = .01).

“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”

There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.

Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.

Read more on Tryton Side Branch Stent on Tryton’s website.

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Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.

In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.

FDA icon
It is noted that the confirmatory study met its pre-specified primary endpoint, periprocedural myocardial infarction, which was within its noninferiority margin (primary endpoint, P = .01).

“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”

There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.

Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.

Read more on Tryton Side Branch Stent on Tryton’s website.

 

Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.

In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.

FDA icon
It is noted that the confirmatory study met its pre-specified primary endpoint, periprocedural myocardial infarction, which was within its noninferiority margin (primary endpoint, P = .01).

“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”

There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.

Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.

Read more on Tryton Side Branch Stent on Tryton’s website.

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Primary prophylaxis of bleeding in portal hypertension safe in cirrhosis with high-risk varices

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Tue, 02/14/2023 - 13:06

 

Primary prophylaxis of bleeding in children with portal hypertension is safe for treatment of cirrhosis associated with high-risk varices, according to Mathieu Duché, MD, of Hôpital Bicêtre in France, and his associates.

In a study from July 1989 to June 2014, researchers examined 1,300 children with various causes of liver disease, based on the presence of palpable splenomegaly and/or ultrasonographic signs of portal hypertension. During the study, a high-risk pattern – including grade 3 esophageal varices, grade 2 varices with red markings and/or gastric varices along the cardia, or gastric varices with or without esophageal varices – was present in 96% of the 246 children who bled spontaneously and in 11% of the 872 children who did not bleed. Of the 246 children who bled spontaneously, 170 children with high-risk varices underwent primary prophylaxis of bleeding with portal surgery, endoscopic banding/sclerotherapy of varices, or interventional radiology.

In 50 children with noncirrhotic causes of portal hypertension and the high risk varices, those with portal vein obstruction underwent portal surgery (Rex bypass or portosystemic shunt) as primary prophylaxis. Endoscopic banding or sclerotherapy was performed instead in younger children or when angiograms did not favor the surgery. One child who had a severe stenosis of the portal trunk underwent successful interventional radiology. After a mean follow-up of 5.5 years after primary prophylaxis, all these patients are alive.

Of the 120 children with cirrhosis with high risk varices, 10 children with well compensated cirrhosis received a portosystemic shunt; thrombosis of the shunt occurred in 1 child who later underwent liver transplantation, and 1 child with a patent shunt developed portosystemic encephalopathy and underwent liver transplantation. No gastrointestinal bleeding was recorded in these 10 children who were alive at the last follow-up.

Of 110 children who underwent endoscopic banding or sclerotherapy, in 76 children there was eradication of varices; there was a relapse of high-risk varices in 20 children, so further endoscopic was needed. In two children who initially underwent endoscopic treatment and achieved eradication of varices, a protein-losing enteropathy and bleeding from ectopic varices, respectively, required subsequent treatment by a surgical portosystemic shunt. Of the 34 children in whom no eradication was obtained with this primary prophylaxis, 3 died and 29 underwent liver transplantation before eradication could be obtained; 1 was lost to follow-up and 1 received a transjugular intrahepatic portosystemic shunt. After a mean follow-up of 5 years, 8 of the 120 children with cirrhosis who underwent primary prophylaxis have died: 4 children died before transplantation, 2 of septic shock unrelated to endoscopic treatment, and 1 of atrioventricular block during variceal injection of aethoxysklerol. Four other children died after transplantation.

It was noted that no esophageal or gastric perforation was observed as a consequence of endoscopic primary prophylaxis in the pre- or posttransplantation period.

“Although no statistical analysis was performed because this was not a controlled study, the results suggest that, compared with liver transplantation performed directly or with care after a spontaneous bleed, primary prophylaxis of bleeding has a fairly good safety record for the management of children with cirrhosis and high-risk varices,” researchers concluded.

Read the full study in the Journal of Hepatology (doi: 10.1016/j.jhep.2016.09.006).

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Primary prophylaxis of bleeding in children with portal hypertension is safe for treatment of cirrhosis associated with high-risk varices, according to Mathieu Duché, MD, of Hôpital Bicêtre in France, and his associates.

In a study from July 1989 to June 2014, researchers examined 1,300 children with various causes of liver disease, based on the presence of palpable splenomegaly and/or ultrasonographic signs of portal hypertension. During the study, a high-risk pattern – including grade 3 esophageal varices, grade 2 varices with red markings and/or gastric varices along the cardia, or gastric varices with or without esophageal varices – was present in 96% of the 246 children who bled spontaneously and in 11% of the 872 children who did not bleed. Of the 246 children who bled spontaneously, 170 children with high-risk varices underwent primary prophylaxis of bleeding with portal surgery, endoscopic banding/sclerotherapy of varices, or interventional radiology.

In 50 children with noncirrhotic causes of portal hypertension and the high risk varices, those with portal vein obstruction underwent portal surgery (Rex bypass or portosystemic shunt) as primary prophylaxis. Endoscopic banding or sclerotherapy was performed instead in younger children or when angiograms did not favor the surgery. One child who had a severe stenosis of the portal trunk underwent successful interventional radiology. After a mean follow-up of 5.5 years after primary prophylaxis, all these patients are alive.

Of the 120 children with cirrhosis with high risk varices, 10 children with well compensated cirrhosis received a portosystemic shunt; thrombosis of the shunt occurred in 1 child who later underwent liver transplantation, and 1 child with a patent shunt developed portosystemic encephalopathy and underwent liver transplantation. No gastrointestinal bleeding was recorded in these 10 children who were alive at the last follow-up.

Of 110 children who underwent endoscopic banding or sclerotherapy, in 76 children there was eradication of varices; there was a relapse of high-risk varices in 20 children, so further endoscopic was needed. In two children who initially underwent endoscopic treatment and achieved eradication of varices, a protein-losing enteropathy and bleeding from ectopic varices, respectively, required subsequent treatment by a surgical portosystemic shunt. Of the 34 children in whom no eradication was obtained with this primary prophylaxis, 3 died and 29 underwent liver transplantation before eradication could be obtained; 1 was lost to follow-up and 1 received a transjugular intrahepatic portosystemic shunt. After a mean follow-up of 5 years, 8 of the 120 children with cirrhosis who underwent primary prophylaxis have died: 4 children died before transplantation, 2 of septic shock unrelated to endoscopic treatment, and 1 of atrioventricular block during variceal injection of aethoxysklerol. Four other children died after transplantation.

It was noted that no esophageal or gastric perforation was observed as a consequence of endoscopic primary prophylaxis in the pre- or posttransplantation period.

“Although no statistical analysis was performed because this was not a controlled study, the results suggest that, compared with liver transplantation performed directly or with care after a spontaneous bleed, primary prophylaxis of bleeding has a fairly good safety record for the management of children with cirrhosis and high-risk varices,” researchers concluded.

Read the full study in the Journal of Hepatology (doi: 10.1016/j.jhep.2016.09.006).

 

Primary prophylaxis of bleeding in children with portal hypertension is safe for treatment of cirrhosis associated with high-risk varices, according to Mathieu Duché, MD, of Hôpital Bicêtre in France, and his associates.

In a study from July 1989 to June 2014, researchers examined 1,300 children with various causes of liver disease, based on the presence of palpable splenomegaly and/or ultrasonographic signs of portal hypertension. During the study, a high-risk pattern – including grade 3 esophageal varices, grade 2 varices with red markings and/or gastric varices along the cardia, or gastric varices with or without esophageal varices – was present in 96% of the 246 children who bled spontaneously and in 11% of the 872 children who did not bleed. Of the 246 children who bled spontaneously, 170 children with high-risk varices underwent primary prophylaxis of bleeding with portal surgery, endoscopic banding/sclerotherapy of varices, or interventional radiology.

In 50 children with noncirrhotic causes of portal hypertension and the high risk varices, those with portal vein obstruction underwent portal surgery (Rex bypass or portosystemic shunt) as primary prophylaxis. Endoscopic banding or sclerotherapy was performed instead in younger children or when angiograms did not favor the surgery. One child who had a severe stenosis of the portal trunk underwent successful interventional radiology. After a mean follow-up of 5.5 years after primary prophylaxis, all these patients are alive.

Of the 120 children with cirrhosis with high risk varices, 10 children with well compensated cirrhosis received a portosystemic shunt; thrombosis of the shunt occurred in 1 child who later underwent liver transplantation, and 1 child with a patent shunt developed portosystemic encephalopathy and underwent liver transplantation. No gastrointestinal bleeding was recorded in these 10 children who were alive at the last follow-up.

Of 110 children who underwent endoscopic banding or sclerotherapy, in 76 children there was eradication of varices; there was a relapse of high-risk varices in 20 children, so further endoscopic was needed. In two children who initially underwent endoscopic treatment and achieved eradication of varices, a protein-losing enteropathy and bleeding from ectopic varices, respectively, required subsequent treatment by a surgical portosystemic shunt. Of the 34 children in whom no eradication was obtained with this primary prophylaxis, 3 died and 29 underwent liver transplantation before eradication could be obtained; 1 was lost to follow-up and 1 received a transjugular intrahepatic portosystemic shunt. After a mean follow-up of 5 years, 8 of the 120 children with cirrhosis who underwent primary prophylaxis have died: 4 children died before transplantation, 2 of septic shock unrelated to endoscopic treatment, and 1 of atrioventricular block during variceal injection of aethoxysklerol. Four other children died after transplantation.

It was noted that no esophageal or gastric perforation was observed as a consequence of endoscopic primary prophylaxis in the pre- or posttransplantation period.

“Although no statistical analysis was performed because this was not a controlled study, the results suggest that, compared with liver transplantation performed directly or with care after a spontaneous bleed, primary prophylaxis of bleeding has a fairly good safety record for the management of children with cirrhosis and high-risk varices,” researchers concluded.

Read the full study in the Journal of Hepatology (doi: 10.1016/j.jhep.2016.09.006).

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Bronchiolitis pathway adherence tied to shorter LOS, lower costs

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High adherence to bronchiolitis clinical pathway recommendations in health care settings is associated with shorter length of stay (LOS) and lower health care costs, according to Mersine A. Bryan, MD, of the University of Washington, Seattle and her associates.

In a retrospective cohort study, researchers looked at 267 patients less than 24 months old diagnosed with bronchiolitis from December 2009 to July 2012. Levels of adherence were then categorized into low, middle, and high tertiles. Results show that adherence was highest for the inpatient quality indicators (mean score, 95) and lowest for the emergency department (ED) quality indicators (mean score, 79). The mean ED LOS was significantly shorter for cases with ED adherence scores in the highest versus the lowest tertile (90 vs. 140 minutes; P less than .05). There were no significant differences in mean inpatient LOS by inpatient adherence score tertiles. “However, the mean inpatient LOS was approximately 17 hours shorter for cases with combined ED/inpatient adherence scores in the highest, compared with the lowest tertile,” they said.

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The mean ED costs for cases with ED adherence scores in the highest tertile were significantly lower than cases with scores in the lowest tertile (–$84; P less than .05). It is noted there were no significant differences in mean total costs by inpatient adherence score tertile, but “for cases where the combined ED/inpatient adherence scores were in the highest tertile, the mean total costs were significantly lower than for cases with combined adherence scores in the lowest tertile, the researchers noted. Also, cases with ED adherence scores in the highest tertile had lower odds of inpatient admission, compared with those with scores in the lowest tertile (odds ratio, 0.38). There were no significant differences in the odds of return ED visits or readmissions by adherence score tertile.

“Our study demonstrates that high adherence to evidence-based recommendations within a clinical pathway across the entire continuum of care, from the ED to the inpatient setting, is associated with lower costs and shorter LOS,” Dr. Bryan and associates concluded. “By improving adherence to evidence-based recommendations within a clinical pathway, we may be able to provide higher-value care by optimizing the quality of bronchiolitis care at lower costs and with shorter LOS.”

Read the full study in Pediatrics (doi: 10.1542/peds.2016-3432).

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High adherence to bronchiolitis clinical pathway recommendations in health care settings is associated with shorter length of stay (LOS) and lower health care costs, according to Mersine A. Bryan, MD, of the University of Washington, Seattle and her associates.

In a retrospective cohort study, researchers looked at 267 patients less than 24 months old diagnosed with bronchiolitis from December 2009 to July 2012. Levels of adherence were then categorized into low, middle, and high tertiles. Results show that adherence was highest for the inpatient quality indicators (mean score, 95) and lowest for the emergency department (ED) quality indicators (mean score, 79). The mean ED LOS was significantly shorter for cases with ED adherence scores in the highest versus the lowest tertile (90 vs. 140 minutes; P less than .05). There were no significant differences in mean inpatient LOS by inpatient adherence score tertiles. “However, the mean inpatient LOS was approximately 17 hours shorter for cases with combined ED/inpatient adherence scores in the highest, compared with the lowest tertile,” they said.

hospital
peterspiro/Thinkstock
The mean ED costs for cases with ED adherence scores in the highest tertile were significantly lower than cases with scores in the lowest tertile (–$84; P less than .05). It is noted there were no significant differences in mean total costs by inpatient adherence score tertile, but “for cases where the combined ED/inpatient adherence scores were in the highest tertile, the mean total costs were significantly lower than for cases with combined adherence scores in the lowest tertile, the researchers noted. Also, cases with ED adherence scores in the highest tertile had lower odds of inpatient admission, compared with those with scores in the lowest tertile (odds ratio, 0.38). There were no significant differences in the odds of return ED visits or readmissions by adherence score tertile.

“Our study demonstrates that high adherence to evidence-based recommendations within a clinical pathway across the entire continuum of care, from the ED to the inpatient setting, is associated with lower costs and shorter LOS,” Dr. Bryan and associates concluded. “By improving adherence to evidence-based recommendations within a clinical pathway, we may be able to provide higher-value care by optimizing the quality of bronchiolitis care at lower costs and with shorter LOS.”

Read the full study in Pediatrics (doi: 10.1542/peds.2016-3432).

 

High adherence to bronchiolitis clinical pathway recommendations in health care settings is associated with shorter length of stay (LOS) and lower health care costs, according to Mersine A. Bryan, MD, of the University of Washington, Seattle and her associates.

In a retrospective cohort study, researchers looked at 267 patients less than 24 months old diagnosed with bronchiolitis from December 2009 to July 2012. Levels of adherence were then categorized into low, middle, and high tertiles. Results show that adherence was highest for the inpatient quality indicators (mean score, 95) and lowest for the emergency department (ED) quality indicators (mean score, 79). The mean ED LOS was significantly shorter for cases with ED adherence scores in the highest versus the lowest tertile (90 vs. 140 minutes; P less than .05). There were no significant differences in mean inpatient LOS by inpatient adherence score tertiles. “However, the mean inpatient LOS was approximately 17 hours shorter for cases with combined ED/inpatient adherence scores in the highest, compared with the lowest tertile,” they said.

hospital
peterspiro/Thinkstock
The mean ED costs for cases with ED adherence scores in the highest tertile were significantly lower than cases with scores in the lowest tertile (–$84; P less than .05). It is noted there were no significant differences in mean total costs by inpatient adherence score tertile, but “for cases where the combined ED/inpatient adherence scores were in the highest tertile, the mean total costs were significantly lower than for cases with combined adherence scores in the lowest tertile, the researchers noted. Also, cases with ED adherence scores in the highest tertile had lower odds of inpatient admission, compared with those with scores in the lowest tertile (odds ratio, 0.38). There were no significant differences in the odds of return ED visits or readmissions by adherence score tertile.

“Our study demonstrates that high adherence to evidence-based recommendations within a clinical pathway across the entire continuum of care, from the ED to the inpatient setting, is associated with lower costs and shorter LOS,” Dr. Bryan and associates concluded. “By improving adherence to evidence-based recommendations within a clinical pathway, we may be able to provide higher-value care by optimizing the quality of bronchiolitis care at lower costs and with shorter LOS.”

Read the full study in Pediatrics (doi: 10.1542/peds.2016-3432).

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Postpartum depression risk 20 times greater among women with depression history

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Women with a history of depression have a risk of postpartum depression that is more than 20 times greater than women without such a history, according to Michael E. Silverman, PhD, and his associates. In addition, pre- and perinatal risk factors also raise the postpartum depression risk, they reported.

In a nationwide prospective cohort study, Dr. Silverman and his associates identified 707,701 women with live singleton births in Sweden from 1997-2008. Results showed that, compared with women without a history of depression, there was a statistically increased risk for postpartum depression in women with a history of depression (relative risk, 21.03; 95% confidence interval, 19.72-22.42).

Woman with postpartum depression holding her baby.
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The investigators also found that, among women aged 35-39 with a history of depression, the risk of postpartum depression was higher (RR, 1.29; 95% CI, 1.10-1.50), compared with women in that age cohort without a depression history (RR, 1.21; 95% CI, 1.08-1.36).

Pregnancy length and depression history also proved significant in the mothers’ development of postpartum depression. The risk of postpartum depression, for example, was higher among women with a history of depression who gave birth before week 32 (RR, 1.12; 95% CI, 0.73-1.74), compared with women who gave birth before the 32nd week without a depression history (RR, 1.53; 95% CI, 1.12-2.10).

The existence of diabetic disease was another significant factor. Among women with gestational diabetes with a history of depression, the risk of postpartum depression was slightly higher (RR, 1.69; 95% CI, 1.18-2.43) than it was for women in that group without a depression history (RR, 1.67; 95% CI, 1.25-2.23). The differences were more dramatic among women with pregestational diabetes. Those with pregestational diabetes with a history of depression had a far greater risk of developing postpartum depression (RR, 1.49; 95% CI, 1.01-2.21) than did women with pregestational diabetes without a history of depression (RR, 1.16; 95% CI, 0.73-1.83), reported Dr. Silverman, of the department of psychiatry at the Icahn Medicine at Mount Sinai, New York, and his associates.

“For the first time, we show how maternal and obstetric risk factors for [postpartum depression] may differ between new mothers with and without a history of depression,” the investigators wrote. “Never shown before, some of the risks associated with obstetric and perinatal factors are modified by a history of depression, suggesting differences in the etiology of [postpartum depression] between women with and without a personal history of depression.”

Read the full study in Depression and Anxiety (doi: 10.1002/da.22597).

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Women with a history of depression have a risk of postpartum depression that is more than 20 times greater than women without such a history, according to Michael E. Silverman, PhD, and his associates. In addition, pre- and perinatal risk factors also raise the postpartum depression risk, they reported.

In a nationwide prospective cohort study, Dr. Silverman and his associates identified 707,701 women with live singleton births in Sweden from 1997-2008. Results showed that, compared with women without a history of depression, there was a statistically increased risk for postpartum depression in women with a history of depression (relative risk, 21.03; 95% confidence interval, 19.72-22.42).

Woman with postpartum depression holding her baby.
monkeybusinessimages/Thinkstock
The investigators also found that, among women aged 35-39 with a history of depression, the risk of postpartum depression was higher (RR, 1.29; 95% CI, 1.10-1.50), compared with women in that age cohort without a depression history (RR, 1.21; 95% CI, 1.08-1.36).

Pregnancy length and depression history also proved significant in the mothers’ development of postpartum depression. The risk of postpartum depression, for example, was higher among women with a history of depression who gave birth before week 32 (RR, 1.12; 95% CI, 0.73-1.74), compared with women who gave birth before the 32nd week without a depression history (RR, 1.53; 95% CI, 1.12-2.10).

The existence of diabetic disease was another significant factor. Among women with gestational diabetes with a history of depression, the risk of postpartum depression was slightly higher (RR, 1.69; 95% CI, 1.18-2.43) than it was for women in that group without a depression history (RR, 1.67; 95% CI, 1.25-2.23). The differences were more dramatic among women with pregestational diabetes. Those with pregestational diabetes with a history of depression had a far greater risk of developing postpartum depression (RR, 1.49; 95% CI, 1.01-2.21) than did women with pregestational diabetes without a history of depression (RR, 1.16; 95% CI, 0.73-1.83), reported Dr. Silverman, of the department of psychiatry at the Icahn Medicine at Mount Sinai, New York, and his associates.

“For the first time, we show how maternal and obstetric risk factors for [postpartum depression] may differ between new mothers with and without a history of depression,” the investigators wrote. “Never shown before, some of the risks associated with obstetric and perinatal factors are modified by a history of depression, suggesting differences in the etiology of [postpartum depression] between women with and without a personal history of depression.”

Read the full study in Depression and Anxiety (doi: 10.1002/da.22597).

 

Women with a history of depression have a risk of postpartum depression that is more than 20 times greater than women without such a history, according to Michael E. Silverman, PhD, and his associates. In addition, pre- and perinatal risk factors also raise the postpartum depression risk, they reported.

In a nationwide prospective cohort study, Dr. Silverman and his associates identified 707,701 women with live singleton births in Sweden from 1997-2008. Results showed that, compared with women without a history of depression, there was a statistically increased risk for postpartum depression in women with a history of depression (relative risk, 21.03; 95% confidence interval, 19.72-22.42).

Woman with postpartum depression holding her baby.
monkeybusinessimages/Thinkstock
The investigators also found that, among women aged 35-39 with a history of depression, the risk of postpartum depression was higher (RR, 1.29; 95% CI, 1.10-1.50), compared with women in that age cohort without a depression history (RR, 1.21; 95% CI, 1.08-1.36).

Pregnancy length and depression history also proved significant in the mothers’ development of postpartum depression. The risk of postpartum depression, for example, was higher among women with a history of depression who gave birth before week 32 (RR, 1.12; 95% CI, 0.73-1.74), compared with women who gave birth before the 32nd week without a depression history (RR, 1.53; 95% CI, 1.12-2.10).

The existence of diabetic disease was another significant factor. Among women with gestational diabetes with a history of depression, the risk of postpartum depression was slightly higher (RR, 1.69; 95% CI, 1.18-2.43) than it was for women in that group without a depression history (RR, 1.67; 95% CI, 1.25-2.23). The differences were more dramatic among women with pregestational diabetes. Those with pregestational diabetes with a history of depression had a far greater risk of developing postpartum depression (RR, 1.49; 95% CI, 1.01-2.21) than did women with pregestational diabetes without a history of depression (RR, 1.16; 95% CI, 0.73-1.83), reported Dr. Silverman, of the department of psychiatry at the Icahn Medicine at Mount Sinai, New York, and his associates.

“For the first time, we show how maternal and obstetric risk factors for [postpartum depression] may differ between new mothers with and without a history of depression,” the investigators wrote. “Never shown before, some of the risks associated with obstetric and perinatal factors are modified by a history of depression, suggesting differences in the etiology of [postpartum depression] between women with and without a personal history of depression.”

Read the full study in Depression and Anxiety (doi: 10.1002/da.22597).

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PCV effective against HNIs, pHNIs that require hospitalization in immunized children

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Fri, 01/18/2019 - 16:28

 

Pneumococcal conjugate vaccines (PCV) in immunized children show effectiveness against head and neck infections (HNIs), especially against pneumococcal HNIs (pHNIs) that require hospitalization, according to Tal Marom, MD, of Tel Aviv University, Zerifin, Israel, and associates.

In a retrospective study, researchers identified children aged 0-16 years who were hospitalized with HNIs between Jan. 1, 2007 and Dec. 31, 2014. HNIs accounted for 2.5%-4.7% of admissions to the pediatric department, and there was a downward trend in the incidence in the post-PCV years, compared with previous years. Of the 820 children admitted with HNIs, 11% children were identified with pHNIs, 5% with acute otitis media, 4% with acute mastoiditis, and 2% with meningitis; there were no cases of pneumococcal acute bacterial sinusitis or pneumococcal head and neck abscesses. In 2009-2010 (considered as the “transition years,” in which both PCV7 and PCV13 were implemented in Israel), pHNIs incidence sharply decreased, from 7/1,000 to 1.74/1,000 hospitalized children per year, because of a 55% reduction of pneumococcal acute otitis media episodes. There also was an additional decrease observed in the post-PCV years of 2012-2014 (1.62/1,000 hospitalized children per year).

It was noted that unimmunized children were more likely to suffer from pneumococcal infections than immunized children (P = .001). There were no significant differences in the clinical presentation of these two groups, except for the need for surgery, which was significantly greater in immunized children (P = .042).

“The findings of the current study provide further evidence of PCV effectiveness against HNIs in PCV immunized children, and particularly against pHNI which required hospitalization,” Dr. Marom and associates concluded. “A substantial reduction in the all-cause HNIs incidence, and more specifically in pHNIs, in PCV immunized children who required hospitalization, was evident in the present study. This was also followed by a significant reduction in [acute otitis media] rates and to a much lesser extent, in [acute mastoiditis] and meningitis rates.”

Find the full study in the Pediatric Infectious Disease Journal (2016. doi: 10.1097/INF.0000000000001425).

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Pneumococcal conjugate vaccines (PCV) in immunized children show effectiveness against head and neck infections (HNIs), especially against pneumococcal HNIs (pHNIs) that require hospitalization, according to Tal Marom, MD, of Tel Aviv University, Zerifin, Israel, and associates.

In a retrospective study, researchers identified children aged 0-16 years who were hospitalized with HNIs between Jan. 1, 2007 and Dec. 31, 2014. HNIs accounted for 2.5%-4.7% of admissions to the pediatric department, and there was a downward trend in the incidence in the post-PCV years, compared with previous years. Of the 820 children admitted with HNIs, 11% children were identified with pHNIs, 5% with acute otitis media, 4% with acute mastoiditis, and 2% with meningitis; there were no cases of pneumococcal acute bacterial sinusitis or pneumococcal head and neck abscesses. In 2009-2010 (considered as the “transition years,” in which both PCV7 and PCV13 were implemented in Israel), pHNIs incidence sharply decreased, from 7/1,000 to 1.74/1,000 hospitalized children per year, because of a 55% reduction of pneumococcal acute otitis media episodes. There also was an additional decrease observed in the post-PCV years of 2012-2014 (1.62/1,000 hospitalized children per year).

It was noted that unimmunized children were more likely to suffer from pneumococcal infections than immunized children (P = .001). There were no significant differences in the clinical presentation of these two groups, except for the need for surgery, which was significantly greater in immunized children (P = .042).

“The findings of the current study provide further evidence of PCV effectiveness against HNIs in PCV immunized children, and particularly against pHNI which required hospitalization,” Dr. Marom and associates concluded. “A substantial reduction in the all-cause HNIs incidence, and more specifically in pHNIs, in PCV immunized children who required hospitalization, was evident in the present study. This was also followed by a significant reduction in [acute otitis media] rates and to a much lesser extent, in [acute mastoiditis] and meningitis rates.”

Find the full study in the Pediatric Infectious Disease Journal (2016. doi: 10.1097/INF.0000000000001425).

 

Pneumococcal conjugate vaccines (PCV) in immunized children show effectiveness against head and neck infections (HNIs), especially against pneumococcal HNIs (pHNIs) that require hospitalization, according to Tal Marom, MD, of Tel Aviv University, Zerifin, Israel, and associates.

In a retrospective study, researchers identified children aged 0-16 years who were hospitalized with HNIs between Jan. 1, 2007 and Dec. 31, 2014. HNIs accounted for 2.5%-4.7% of admissions to the pediatric department, and there was a downward trend in the incidence in the post-PCV years, compared with previous years. Of the 820 children admitted with HNIs, 11% children were identified with pHNIs, 5% with acute otitis media, 4% with acute mastoiditis, and 2% with meningitis; there were no cases of pneumococcal acute bacterial sinusitis or pneumococcal head and neck abscesses. In 2009-2010 (considered as the “transition years,” in which both PCV7 and PCV13 were implemented in Israel), pHNIs incidence sharply decreased, from 7/1,000 to 1.74/1,000 hospitalized children per year, because of a 55% reduction of pneumococcal acute otitis media episodes. There also was an additional decrease observed in the post-PCV years of 2012-2014 (1.62/1,000 hospitalized children per year).

It was noted that unimmunized children were more likely to suffer from pneumococcal infections than immunized children (P = .001). There were no significant differences in the clinical presentation of these two groups, except for the need for surgery, which was significantly greater in immunized children (P = .042).

“The findings of the current study provide further evidence of PCV effectiveness against HNIs in PCV immunized children, and particularly against pHNI which required hospitalization,” Dr. Marom and associates concluded. “A substantial reduction in the all-cause HNIs incidence, and more specifically in pHNIs, in PCV immunized children who required hospitalization, was evident in the present study. This was also followed by a significant reduction in [acute otitis media] rates and to a much lesser extent, in [acute mastoiditis] and meningitis rates.”

Find the full study in the Pediatric Infectious Disease Journal (2016. doi: 10.1097/INF.0000000000001425).

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NAS linked to poor and deteriorating school performance

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A neonatal diagnostic code of neonatal abstinence syndrome (NAS) is strongly associated with poor and deteriorating school performance, according to Ju Lee Oei, MD, of the University of New South Wales, Sydney, and her associates.

In a study of 604,829 children born in 2000-2006 in New South Wales, linkage rates were similar between matched controls (77.6% of 4,330) and other NSW children (77.4% of 598,265; P = .83) but were significantly lower in children with NAS (75.6% of 2,234; P = .03). The controls were matched for gender,gestation, and socioeconomic status.

The children with NAS had significantly lower scores than the controls and other NSW children in every grade and every domain of testing (reading, writing, numeracy, spelling, and grammar/punctuation). By grade 7, 38% of children with NAS did not meet National Minimum Standard (NMS) in one or more domains (versus 18.4% of controls and 14.5% of other NSW children). The mean serial composite scores also were lower in children with NAS from grades 3 to 7, compared with the other two groups; the difference was progressive, the investigators said. And by grade 7, the scores for children with NAS were lower than other children’s scores in grade 5.

It was noted that children with NAS, indigenous status (adjusted odds ratio, 1.7), male gender (aOR, 1.3), and having a primary parent without a grade 9 education (aOR, 1.3) increased the risk of failure to meet NMS. Overall, NAS (aOR, 2.5), indigenous status (aOR, 2.2), male gender (aOR, 1.3), and prematurity (less than 37 weeks’ gestation [aOR, 1.2]) increased the risk of failure to meet NMS.

“To date these are the only data demonstrating long-term school outcomes for children with a history of NAS. Similar data for children born from the current opioid epidemic gripping much of the Northern Hemisphere, assuming linkage is possible, will be available only in 7-10 years,” researchers concluded. “Although this study was conducted in Australia, the high risk of poor academic performance in this vulnerable group of children is applicable to all countries, and strategies to address this risk and prevent poor adult outcomes and intergenerational vulnerability must be urgently addressed.”

Read the full study in Pediatrics (doi: 10.1542/peds.2016-2651).

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A neonatal diagnostic code of neonatal abstinence syndrome (NAS) is strongly associated with poor and deteriorating school performance, according to Ju Lee Oei, MD, of the University of New South Wales, Sydney, and her associates.

In a study of 604,829 children born in 2000-2006 in New South Wales, linkage rates were similar between matched controls (77.6% of 4,330) and other NSW children (77.4% of 598,265; P = .83) but were significantly lower in children with NAS (75.6% of 2,234; P = .03). The controls were matched for gender,gestation, and socioeconomic status.

The children with NAS had significantly lower scores than the controls and other NSW children in every grade and every domain of testing (reading, writing, numeracy, spelling, and grammar/punctuation). By grade 7, 38% of children with NAS did not meet National Minimum Standard (NMS) in one or more domains (versus 18.4% of controls and 14.5% of other NSW children). The mean serial composite scores also were lower in children with NAS from grades 3 to 7, compared with the other two groups; the difference was progressive, the investigators said. And by grade 7, the scores for children with NAS were lower than other children’s scores in grade 5.

It was noted that children with NAS, indigenous status (adjusted odds ratio, 1.7), male gender (aOR, 1.3), and having a primary parent without a grade 9 education (aOR, 1.3) increased the risk of failure to meet NMS. Overall, NAS (aOR, 2.5), indigenous status (aOR, 2.2), male gender (aOR, 1.3), and prematurity (less than 37 weeks’ gestation [aOR, 1.2]) increased the risk of failure to meet NMS.

“To date these are the only data demonstrating long-term school outcomes for children with a history of NAS. Similar data for children born from the current opioid epidemic gripping much of the Northern Hemisphere, assuming linkage is possible, will be available only in 7-10 years,” researchers concluded. “Although this study was conducted in Australia, the high risk of poor academic performance in this vulnerable group of children is applicable to all countries, and strategies to address this risk and prevent poor adult outcomes and intergenerational vulnerability must be urgently addressed.”

Read the full study in Pediatrics (doi: 10.1542/peds.2016-2651).

 

A neonatal diagnostic code of neonatal abstinence syndrome (NAS) is strongly associated with poor and deteriorating school performance, according to Ju Lee Oei, MD, of the University of New South Wales, Sydney, and her associates.

In a study of 604,829 children born in 2000-2006 in New South Wales, linkage rates were similar between matched controls (77.6% of 4,330) and other NSW children (77.4% of 598,265; P = .83) but were significantly lower in children with NAS (75.6% of 2,234; P = .03). The controls were matched for gender,gestation, and socioeconomic status.

The children with NAS had significantly lower scores than the controls and other NSW children in every grade and every domain of testing (reading, writing, numeracy, spelling, and grammar/punctuation). By grade 7, 38% of children with NAS did not meet National Minimum Standard (NMS) in one or more domains (versus 18.4% of controls and 14.5% of other NSW children). The mean serial composite scores also were lower in children with NAS from grades 3 to 7, compared with the other two groups; the difference was progressive, the investigators said. And by grade 7, the scores for children with NAS were lower than other children’s scores in grade 5.

It was noted that children with NAS, indigenous status (adjusted odds ratio, 1.7), male gender (aOR, 1.3), and having a primary parent without a grade 9 education (aOR, 1.3) increased the risk of failure to meet NMS. Overall, NAS (aOR, 2.5), indigenous status (aOR, 2.2), male gender (aOR, 1.3), and prematurity (less than 37 weeks’ gestation [aOR, 1.2]) increased the risk of failure to meet NMS.

“To date these are the only data demonstrating long-term school outcomes for children with a history of NAS. Similar data for children born from the current opioid epidemic gripping much of the Northern Hemisphere, assuming linkage is possible, will be available only in 7-10 years,” researchers concluded. “Although this study was conducted in Australia, the high risk of poor academic performance in this vulnerable group of children is applicable to all countries, and strategies to address this risk and prevent poor adult outcomes and intergenerational vulnerability must be urgently addressed.”

Read the full study in Pediatrics (doi: 10.1542/peds.2016-2651).

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