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Evaluation of the diagnostic accuracy of point-of-care ultrasound for pediatric distal forearm fractures

According to a recent study, clinician-performed point-of-care ultrasound proved to be more precise in diagnosing clinically nondeformed distal forearm injuries in children and adolescents compared to clinician-interpreted radiographic imaging. The findings of this study were published in the journal, Annals of emergency medicine.

This was an open-label, multicenter, diagnostic randomized controlled trial where 270 participants were enrolled. Eligible patients were randomly assigned to undergo initial imaging either through point-of-care ultrasound conducted by an emergency department (ED) clinician or through radiography (135 randomized to each imaging group). The primary outcome was the treating clinician's diagnostic accuracy in comparison to the reference standard diagnosis. The reference standard diagnosis was determined retrospectively by a panel of experts, which included an emergency physician, pediatric orthopedic surgeon, and pediatric radiologist. This panel thoroughly reviewed all imaging and follow-up data.

At the end of the study, it was observed that in the point-of-care ultrasound group, 132 (97.8%) participants were accurately diagnosed by ED clinicians, while in the radiograph group, 112 (83.0%) participants received correct diagnoses. Point-of-care ultrasound demonstrated superior accuracy in detecting "buckle" fractures (AD=18.5%) and "other" fractures (AD=17.1%).

Thus, it can be concluded that clinician-performed point-of-care ultrasound demonstrated superior accuracy in diagnosing clinically nondeformed distal forearm injuries in children and adolescents compared to clinician-interpreted radiographic imaging in the ED.

26 Apr 2024

Evaluation of the diagnostic accuracy of point-of-care ultrasound for pediatric distal forearm fractures

According to a recent study, clinician-performed point-of-care ultrasound proved to be more precise in diagnosing clinically nondeformed distal forearm injuries in children and adolescents compared to clinician-interpreted radiographic imaging. The findings of this study were published in the journal, Annals of emergency medicine.

This was an open-label, multicenter, diagnostic randomized controlled trial where 270 participants were enrolled. Eligible patients were randomly assigned to undergo initial imaging either through point-of-care ultrasound conducted by an emergency department (ED) clinician or through radiography (135 randomized to each imaging group). The primary outcome was the treating clinician's diagnostic accuracy in comparison to the reference standard diagnosis. The reference standard diagnosis was determined retrospectively by a panel of experts, which included an emergency physician, pediatric orthopedic surgeon, and pediatric radiologist. This panel thoroughly reviewed all imaging and follow-up data.

At the end of the study, it was observed that in the point-of-care ultrasound group, 132 (97.8%) participants were accurately diagnosed by ED clinicians, while in the radiograph group, 112 (83.0%) participants received correct diagnoses. Point-of-care ultrasound demonstrated superior accuracy in detecting "buckle" fractures (AD=18.5%) and "other" fractures (AD=17.1%).

Thus, it can be concluded that clinician-performed point-of-care ultrasound demonstrated superior accuracy in diagnosing clinically nondeformed distal forearm injuries in children and adolescents compared to clinician-interpreted radiographic imaging in the ED.

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Evaluation of the diagnostic accuracy of point-of-care ultrasound for pediatric distal forearm fractures

According to a recent study, clinician-performed point-of-care ultrasound proved to be more precise in diagnosing clinically nondeformed distal forearm injuries in children and adolescents compared to clinician-interpreted radiographic imaging. The findings of this study were published in the journal, Annals of emergency medicine.

This was an open-label, multicenter, diagnostic randomized controlled trial where 270 participants were enrolled. Eligible patients were randomly assigned to undergo initial imaging either through point-of-care ultrasound conducted by an emergency department (ED) clinician or through radiography (135 randomized to each imaging group). The primary outcome was the treating clinician's diagnostic accuracy in comparison to the reference standard diagnosis. The reference standard diagnosis was determined retrospectively by a panel of experts, which included an emergency physician, pediatric orthopedic surgeon, and pediatric radiologist. This panel thoroughly reviewed all imaging and follow-up data.

At the end of the study, it was observed that in the point-of-care ultrasound group, 132 (97.8%) participants were accurately diagnosed by ED clinicians, while in the radiograph group, 112 (83.0%) participants received correct diagnoses. Point-of-care ultrasound demonstrated superior accuracy in detecting "buckle" fractures (AD=18.5%) and "other" fractures (AD=17.1%).

Thus, it can be concluded that clinician-performed point-of-care ultrasound demonstrated superior accuracy in diagnosing clinically nondeformed distal forearm injuries in children and adolescents compared to clinician-interpreted radiographic imaging in the ED.

26 Apr 2024
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2Min Read

Efficacy and safety of dupilumab with concomitant topical corticosteroids for severe atopic dermatitis in children

According to a recent study, dupilumab demonstrated notable improvements in the quality of life of young children who suffer from severe atopic dermatitis (AD), while maintaining an acceptable level of safety. The study’s findings were published in the journal, Advances in therapy.

In this pre-specified subgroup analysis, data of 125 patients aged 6 months to 5 years with severe AD at baseline (Investigator's Global Assessment [IGA] = 4) from a randomized, double-blind, placebo-controlled, phase III trial of dupilumab was examined. Patients were assigned randomly to receive either subcutaneous dupilumab (200/300 mg) [n=63] or a placebo [n=62] every 4 weeks, in addition to low-potency topical corticosteroids for a duration of 16 weeks. The study’s co-primary endpoints at week 16 included the proportion of patients displaying a ≥ 75% improvement from the baseline in Eczema Area and Severity Index (EASI-75) and the proportion of patients achieving IGA ≤ 1 (representing clear or almost clear skin). Secondary endpoints at week 16 included pruritis, mean changes in EASI, sleep loss, skin pain, and quality of life.

At week 16, a significantly higher percentage of patients who were given dupilumab compared to those who were given a placebo had achieved IGA ≤ 1 (14.3% vs. 1.6%) and EASI-75 (46.0% vs. 6.6%). Notable enhancements with dupilumab were seen in all secondary endpoints measured, with a least squares mean reduction of 48.9% in pruritus. The overall occurrence of adverse events (AEs) was comparable in both the dupilumab group (66.7%) and the placebo group (73.8%). No AEs related to dupilumab were severe or led to treatment discontinuation.

Based on the above results, it can be concluded that dupilumab may lead to significant improvement in the signs, symptoms, and overall quality of life for children between the ages of 6 months and 5 years with severe AD. Furthermore, the dupilumab treatment exhibited an acceptable level of safety.

23 Apr 2024

Efficacy and safety of dupilumab with concomitant topical corticosteroids for severe atopic dermatitis in children

According to a recent study, dupilumab demonstrated notable improvements in the quality of life of young children who suffer from severe atopic dermatitis (AD), while maintaining an acceptable level of safety. The study’s findings were published in the journal, Advances in therapy.

In this pre-specified subgroup analysis, data of 125 patients aged 6 months to 5 years with severe AD at baseline (Investigator's Global Assessment [IGA] = 4) from a randomized, double-blind, placebo-controlled, phase III trial of dupilumab was examined. Patients were assigned randomly to receive either subcutaneous dupilumab (200/300 mg) [n=63] or a placebo [n=62] every 4 weeks, in addition to low-potency topical corticosteroids for a duration of 16 weeks. The study’s co-primary endpoints at week 16 included the proportion of patients displaying a ≥ 75% improvement from the baseline in Eczema Area and Severity Index (EASI-75) and the proportion of patients achieving IGA ≤ 1 (representing clear or almost clear skin). Secondary endpoints at week 16 included pruritis, mean changes in EASI, sleep loss, skin pain, and quality of life.

At week 16, a significantly higher percentage of patients who were given dupilumab compared to those who were given a placebo had achieved IGA ≤ 1 (14.3% vs. 1.6%) and EASI-75 (46.0% vs. 6.6%). Notable enhancements with dupilumab were seen in all secondary endpoints measured, with a least squares mean reduction of 48.9% in pruritus. The overall occurrence of adverse events (AEs) was comparable in both the dupilumab group (66.7%) and the placebo group (73.8%). No AEs related to dupilumab were severe or led to treatment discontinuation.

Based on the above results, it can be concluded that dupilumab may lead to significant improvement in the signs, symptoms, and overall quality of life for children between the ages of 6 months and 5 years with severe AD. Furthermore, the dupilumab treatment exhibited an acceptable level of safety.

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Efficacy and safety of dupilumab with concomitant topical corticosteroids for severe atopic dermatitis in children

According to a recent study, dupilumab demonstrated notable improvements in the quality of life of young children who suffer from severe atopic dermatitis (AD), while maintaining an acceptable level of safety. The study’s findings were published in the journal, Advances in therapy.

In this pre-specified subgroup analysis, data of 125 patients aged 6 months to 5 years with severe AD at baseline (Investigator's Global Assessment [IGA] = 4) from a randomized, double-blind, placebo-controlled, phase III trial of dupilumab was examined. Patients were assigned randomly to receive either subcutaneous dupilumab (200/300 mg) [n=63] or a placebo [n=62] every 4 weeks, in addition to low-potency topical corticosteroids for a duration of 16 weeks. The study’s co-primary endpoints at week 16 included the proportion of patients displaying a ≥ 75% improvement from the baseline in Eczema Area and Severity Index (EASI-75) and the proportion of patients achieving IGA ≤ 1 (representing clear or almost clear skin). Secondary endpoints at week 16 included pruritis, mean changes in EASI, sleep loss, skin pain, and quality of life.

At week 16, a significantly higher percentage of patients who were given dupilumab compared to those who were given a placebo had achieved IGA ≤ 1 (14.3% vs. 1.6%) and EASI-75 (46.0% vs. 6.6%). Notable enhancements with dupilumab were seen in all secondary endpoints measured, with a least squares mean reduction of 48.9% in pruritus. The overall occurrence of adverse events (AEs) was comparable in both the dupilumab group (66.7%) and the placebo group (73.8%). No AEs related to dupilumab were severe or led to treatment discontinuation.

Based on the above results, it can be concluded that dupilumab may lead to significant improvement in the signs, symptoms, and overall quality of life for children between the ages of 6 months and 5 years with severe AD. Furthermore, the dupilumab treatment exhibited an acceptable level of safety.

23 Apr 2024
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2Min Read

Effectiveness of alirocumab in treating pediatric patients with heterozygous familial hypercholesterolemia

According to a recent study, alirocumab may reduce low-density lipoprotein cholesterol (LDL-C) and other lipid parameters in pediatric patients with heterozygous familial hypercholesterolemia (HeFH) who have not achieved sufficient control with statins. This study’s findings were published in the journal, JAMA pediatrics.

In this phase 3, randomized clinical trial, 153 pediatric patients aged 8-17 years with HeFH, LDL-C levels of 130 mg/dL or higher, and undergoing statin or other lipid-lowering therapy (LLT) were randomly assigned to receive subcutaneous alirocumab or a placebo and dosed every 2 weeks (Q2W) or every 4 weeks (Q4W). The dosage depended on weight (if <50 kg then 40 mg for Q2W or 150 mg for Q4W; if ≥50 kg then 75 mg for Q2W or 300 mg for Q4W) and was adjusted at week 12 if LDL-C was 110 mg/dL or higher at week 8. Following the 24-week double-blind phase, patients could continue alirocumab treatment in an 80-week open-label phase. The primary endpoint of the study was the percentage change in LDL-C from baseline to week 24 in each group.

Alirocumab demonstrated statistically significant decreases in LDL-C compared to the placebo in both groups at week 24. The least squares mean difference in percentage change from baseline was -43.3% for the Q2W group and -33.8% for the Q4W group. A hierarchical analysis of secondary efficacy endpoints revealed notable enhancements in other lipid parameters at weeks 12 and 24 with alirocumab. The findings from the open-label period were consistent with those from the double-blind period.

Based on the above results, it can be concluded that alirocumab dosed every two weeks or every four weeks may lower LDL-C levels and improve other lipid parameters in pediatric patients with HeFH who have not achieved adequate control with statins.

16 Apr 2024

Effectiveness of alirocumab in treating pediatric patients with heterozygous familial hypercholesterolemia

According to a recent study, alirocumab may reduce low-density lipoprotein cholesterol (LDL-C) and other lipid parameters in pediatric patients with heterozygous familial hypercholesterolemia (HeFH) who have not achieved sufficient control with statins. This study’s findings were published in the journal, JAMA pediatrics.

In this phase 3, randomized clinical trial, 153 pediatric patients aged 8-17 years with HeFH, LDL-C levels of 130 mg/dL or higher, and undergoing statin or other lipid-lowering therapy (LLT) were randomly assigned to receive subcutaneous alirocumab or a placebo and dosed every 2 weeks (Q2W) or every 4 weeks (Q4W). The dosage depended on weight (if <50 kg then 40 mg for Q2W or 150 mg for Q4W; if ≥50 kg then 75 mg for Q2W or 300 mg for Q4W) and was adjusted at week 12 if LDL-C was 110 mg/dL or higher at week 8. Following the 24-week double-blind phase, patients could continue alirocumab treatment in an 80-week open-label phase. The primary endpoint of the study was the percentage change in LDL-C from baseline to week 24 in each group.

Alirocumab demonstrated statistically significant decreases in LDL-C compared to the placebo in both groups at week 24. The least squares mean difference in percentage change from baseline was -43.3% for the Q2W group and -33.8% for the Q4W group. A hierarchical analysis of secondary efficacy endpoints revealed notable enhancements in other lipid parameters at weeks 12 and 24 with alirocumab. The findings from the open-label period were consistent with those from the double-blind period.

Based on the above results, it can be concluded that alirocumab dosed every two weeks or every four weeks may lower LDL-C levels and improve other lipid parameters in pediatric patients with HeFH who have not achieved adequate control with statins.

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Effectiveness of alirocumab in treating pediatric patients with heterozygous familial hypercholesterolemia

According to a recent study, alirocumab may reduce low-density lipoprotein cholesterol (LDL-C) and other lipid parameters in pediatric patients with heterozygous familial hypercholesterolemia (HeFH) who have not achieved sufficient control with statins. This study’s findings were published in the journal, JAMA pediatrics.

In this phase 3, randomized clinical trial, 153 pediatric patients aged 8-17 years with HeFH, LDL-C levels of 130 mg/dL or higher, and undergoing statin or other lipid-lowering therapy (LLT) were randomly assigned to receive subcutaneous alirocumab or a placebo and dosed every 2 weeks (Q2W) or every 4 weeks (Q4W). The dosage depended on weight (if <50 kg then 40 mg for Q2W or 150 mg for Q4W; if ≥50 kg then 75 mg for Q2W or 300 mg for Q4W) and was adjusted at week 12 if LDL-C was 110 mg/dL or higher at week 8. Following the 24-week double-blind phase, patients could continue alirocumab treatment in an 80-week open-label phase. The primary endpoint of the study was the percentage change in LDL-C from baseline to week 24 in each group.

Alirocumab demonstrated statistically significant decreases in LDL-C compared to the placebo in both groups at week 24. The least squares mean difference in percentage change from baseline was -43.3% for the Q2W group and -33.8% for the Q4W group. A hierarchical analysis of secondary efficacy endpoints revealed notable enhancements in other lipid parameters at weeks 12 and 24 with alirocumab. The findings from the open-label period were consistent with those from the double-blind period.

Based on the above results, it can be concluded that alirocumab dosed every two weeks or every four weeks may lower LDL-C levels and improve other lipid parameters in pediatric patients with HeFH who have not achieved adequate control with statins.

16 Apr 2024
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2Min Read

MenACYW-TT booster vaccine immunogenic and well-tolerated in adults aged ≥59 years

According to a recent study, quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) booster dose was found to be immunogenic and well tolerated in participants aged ≥59 years, irrespective of previously received quadrivalent meningococcal vaccine. This study was published in the journal, Human vaccines & immunotherapeutics.

This 2-stage phase III randomized study included 401 older adults (≥59 years) who were primed with either MenACYW-TT or a quadrivalent meningococcal polysaccharide vaccine (MPSV4). During Stage I, the participants who had received either MPSV4 (n = 165) or MenACYW-TT (n = 236) 3 years before, were randomized in a 9:2 ratio to receive either the booster (MenACYW-TT) or to have blood drawn for persistence only. Those participants who were primed 6-7 years earlier with MPSV4 or MenACYW-TT, had blood drawn for antibody persistence only. Functional antibodies against each serogroup were measured at baseline and for those participants receiving a booster, it was measured 30 days post-vaccination (D30).

For all serogroups, the seroresponse rates at D30 ranged from 49.2% to 60.8% and 79.3 to 93.1% in the MPSV4-primed and MenACYW-TT-primed groups, respectively. It was found that MenACYW-TT induced adequate seroresponses in each primed group. After primary vaccination, geometric mean titers (GMTs) for serogroups C, W, and Y trended higher than pre-vaccination levels at both 3 and 6-7 years.

Based on the above results, it can be concluded that MenACYW-TT booster may be immunogenic and well tolerated in participants aged ≥59 years, who may elicit the greatest immune responses.

28 Mar 2024

MenACYW-TT booster vaccine immunogenic and well-tolerated in adults aged ≥59 years

According to a recent study, quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) booster dose was found to be immunogenic and well tolerated in participants aged ≥59 years, irrespective of previously received quadrivalent meningococcal vaccine. This study was published in the journal, Human vaccines & immunotherapeutics.

This 2-stage phase III randomized study included 401 older adults (≥59 years) who were primed with either MenACYW-TT or a quadrivalent meningococcal polysaccharide vaccine (MPSV4). During Stage I, the participants who had received either MPSV4 (n = 165) or MenACYW-TT (n = 236) 3 years before, were randomized in a 9:2 ratio to receive either the booster (MenACYW-TT) or to have blood drawn for persistence only. Those participants who were primed 6-7 years earlier with MPSV4 or MenACYW-TT, had blood drawn for antibody persistence only. Functional antibodies against each serogroup were measured at baseline and for those participants receiving a booster, it was measured 30 days post-vaccination (D30).

For all serogroups, the seroresponse rates at D30 ranged from 49.2% to 60.8% and 79.3 to 93.1% in the MPSV4-primed and MenACYW-TT-primed groups, respectively. It was found that MenACYW-TT induced adequate seroresponses in each primed group. After primary vaccination, geometric mean titers (GMTs) for serogroups C, W, and Y trended higher than pre-vaccination levels at both 3 and 6-7 years.

Based on the above results, it can be concluded that MenACYW-TT booster may be immunogenic and well tolerated in participants aged ≥59 years, who may elicit the greatest immune responses.

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MenACYW-TT booster vaccine immunogenic and well-tolerated in adults aged ≥59 years

According to a recent study, quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) booster dose was found to be immunogenic and well tolerated in participants aged ≥59 years, irrespective of previously received quadrivalent meningococcal vaccine. This study was published in the journal, Human vaccines & immunotherapeutics.

This 2-stage phase III randomized study included 401 older adults (≥59 years) who were primed with either MenACYW-TT or a quadrivalent meningococcal polysaccharide vaccine (MPSV4). During Stage I, the participants who had received either MPSV4 (n = 165) or MenACYW-TT (n = 236) 3 years before, were randomized in a 9:2 ratio to receive either the booster (MenACYW-TT) or to have blood drawn for persistence only. Those participants who were primed 6-7 years earlier with MPSV4 or MenACYW-TT, had blood drawn for antibody persistence only. Functional antibodies against each serogroup were measured at baseline and for those participants receiving a booster, it was measured 30 days post-vaccination (D30).

For all serogroups, the seroresponse rates at D30 ranged from 49.2% to 60.8% and 79.3 to 93.1% in the MPSV4-primed and MenACYW-TT-primed groups, respectively. It was found that MenACYW-TT induced adequate seroresponses in each primed group. After primary vaccination, geometric mean titers (GMTs) for serogroups C, W, and Y trended higher than pre-vaccination levels at both 3 and 6-7 years.

Based on the above results, it can be concluded that MenACYW-TT booster may be immunogenic and well tolerated in participants aged ≥59 years, who may elicit the greatest immune responses.

28 Mar 2024
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