Expert Panel Weighs NSAID Treatment Options

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Expert Panel Weighs NSAID Treatment Options

A panel of 18 experts from 10 European countries had some difficulty in defining when the benefits sufficiently outweighed the potential adverse effects of various nonsteroidal anti-inflammatory drugs – with and without a proton pump inhibitor – for 144 profiles of patients with chronic rheumatic diseases.

Panelists generally gave patients with low gastrointestinal or cardiovascular risks the full range of NSAID options. Approximately one-third of the patient-drug matches labeled "inappropriate" by panelists applied to the use of a nonselective NSAID without a PPI, the panelists wrote in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011;70:818-22).

When scoring patient profiles, panelists took into account seven clinical variables: age of 65 years or older, history of upper gastrointestinal problems, use of anticoagulants, use of systemic corticosteroids, intermittent or continuous treatment pattern, cardiovascular risk, and the use of low-dose aspirin (for those patients with cardiovascular risk). Against these variables, panelists considered 10 treatment options: ibuprofen, diclofenac, naproxen, celecoxib, etoricoxib, and each of these drugs plus a PPI. They did not consider costs when making their treatment recommendations, according to Dr. G.R. Burmester of the department of rheumatology and clinical immunology, Charité Medical University Berlin, and his coauthors.

For patients with the lowest gastrointestinal and cardiovascular risks, a nonselective NSAID (ibuprofen, diclofenac, or naproxen) was deemed appropriate. As gastrointestinal risks increased, the cyclooxygenase-2 (COX-2) inhibitors celecoxib and etoricoxib alone or a nonselective NSAID plus PPI were considered appropriate. In cases of high gastrointestinal risk and low to average cardiovascular risk, panelists rated ibuprofen/diclofenac plus PPI, or a COX-2 inhibitor plus PPI, as the most appropriate options. For patients with both high gastrointestinal and cardiovascular risks, avoidance of all NSAIDs was recommended, with the use of diclofenac, naproxen, celecoxib, or etoricoxib plus PPI deemed acceptable if necessary.

In January 2008, the panel established the appropriateness rating of treatment options on a 1-9 scale, with 1 as "inappropriate" and 9 as "appropriate." As defined by the RAND/UCLA appropriateness method, a "treatment had to be considered appropriate if the expected benefits exceeded the potential negative consequences by a sufficient margin." However, the panel did not define "sufficient," which led to most of the disagreement on scoring.

In June 2008, after the panel evaluated the first-round practice ratings and revised the evaluation measures, the second round of rating began with the 144 patient profiles and 10 treatment choices. A treatment with a median score of 7-9 was categorized as appropriate, whereas treatments with a median score of 1-3 were labeled inappropriate and those scoring 4-6 were categorized as uncertain.

An online tool (www.e-hims.com/Sensar) shows the corresponding panel treatment recommendation for various patient data.

Panelists were experts in the fields of rheumatology, orthopedics, cardiology, clinical pharmacology, gastroenterology, family medicine, and geriatrics.

All panelists disclosed receiving honoraria from Pfizer, which supported the study with an unrestricted educational grant. Eleven panelists disclosed other relationships with pharmaceutical companies, including Pfizer.

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A panel of 18 experts from 10 European countries had some difficulty in defining when the benefits sufficiently outweighed the potential adverse effects of various nonsteroidal anti-inflammatory drugs – with and without a proton pump inhibitor – for 144 profiles of patients with chronic rheumatic diseases.

Panelists generally gave patients with low gastrointestinal or cardiovascular risks the full range of NSAID options. Approximately one-third of the patient-drug matches labeled "inappropriate" by panelists applied to the use of a nonselective NSAID without a PPI, the panelists wrote in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011;70:818-22).

When scoring patient profiles, panelists took into account seven clinical variables: age of 65 years or older, history of upper gastrointestinal problems, use of anticoagulants, use of systemic corticosteroids, intermittent or continuous treatment pattern, cardiovascular risk, and the use of low-dose aspirin (for those patients with cardiovascular risk). Against these variables, panelists considered 10 treatment options: ibuprofen, diclofenac, naproxen, celecoxib, etoricoxib, and each of these drugs plus a PPI. They did not consider costs when making their treatment recommendations, according to Dr. G.R. Burmester of the department of rheumatology and clinical immunology, Charité Medical University Berlin, and his coauthors.

For patients with the lowest gastrointestinal and cardiovascular risks, a nonselective NSAID (ibuprofen, diclofenac, or naproxen) was deemed appropriate. As gastrointestinal risks increased, the cyclooxygenase-2 (COX-2) inhibitors celecoxib and etoricoxib alone or a nonselective NSAID plus PPI were considered appropriate. In cases of high gastrointestinal risk and low to average cardiovascular risk, panelists rated ibuprofen/diclofenac plus PPI, or a COX-2 inhibitor plus PPI, as the most appropriate options. For patients with both high gastrointestinal and cardiovascular risks, avoidance of all NSAIDs was recommended, with the use of diclofenac, naproxen, celecoxib, or etoricoxib plus PPI deemed acceptable if necessary.

In January 2008, the panel established the appropriateness rating of treatment options on a 1-9 scale, with 1 as "inappropriate" and 9 as "appropriate." As defined by the RAND/UCLA appropriateness method, a "treatment had to be considered appropriate if the expected benefits exceeded the potential negative consequences by a sufficient margin." However, the panel did not define "sufficient," which led to most of the disagreement on scoring.

In June 2008, after the panel evaluated the first-round practice ratings and revised the evaluation measures, the second round of rating began with the 144 patient profiles and 10 treatment choices. A treatment with a median score of 7-9 was categorized as appropriate, whereas treatments with a median score of 1-3 were labeled inappropriate and those scoring 4-6 were categorized as uncertain.

An online tool (www.e-hims.com/Sensar) shows the corresponding panel treatment recommendation for various patient data.

Panelists were experts in the fields of rheumatology, orthopedics, cardiology, clinical pharmacology, gastroenterology, family medicine, and geriatrics.

All panelists disclosed receiving honoraria from Pfizer, which supported the study with an unrestricted educational grant. Eleven panelists disclosed other relationships with pharmaceutical companies, including Pfizer.

A panel of 18 experts from 10 European countries had some difficulty in defining when the benefits sufficiently outweighed the potential adverse effects of various nonsteroidal anti-inflammatory drugs – with and without a proton pump inhibitor – for 144 profiles of patients with chronic rheumatic diseases.

Panelists generally gave patients with low gastrointestinal or cardiovascular risks the full range of NSAID options. Approximately one-third of the patient-drug matches labeled "inappropriate" by panelists applied to the use of a nonselective NSAID without a PPI, the panelists wrote in Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2011;70:818-22).

When scoring patient profiles, panelists took into account seven clinical variables: age of 65 years or older, history of upper gastrointestinal problems, use of anticoagulants, use of systemic corticosteroids, intermittent or continuous treatment pattern, cardiovascular risk, and the use of low-dose aspirin (for those patients with cardiovascular risk). Against these variables, panelists considered 10 treatment options: ibuprofen, diclofenac, naproxen, celecoxib, etoricoxib, and each of these drugs plus a PPI. They did not consider costs when making their treatment recommendations, according to Dr. G.R. Burmester of the department of rheumatology and clinical immunology, Charité Medical University Berlin, and his coauthors.

For patients with the lowest gastrointestinal and cardiovascular risks, a nonselective NSAID (ibuprofen, diclofenac, or naproxen) was deemed appropriate. As gastrointestinal risks increased, the cyclooxygenase-2 (COX-2) inhibitors celecoxib and etoricoxib alone or a nonselective NSAID plus PPI were considered appropriate. In cases of high gastrointestinal risk and low to average cardiovascular risk, panelists rated ibuprofen/diclofenac plus PPI, or a COX-2 inhibitor plus PPI, as the most appropriate options. For patients with both high gastrointestinal and cardiovascular risks, avoidance of all NSAIDs was recommended, with the use of diclofenac, naproxen, celecoxib, or etoricoxib plus PPI deemed acceptable if necessary.

In January 2008, the panel established the appropriateness rating of treatment options on a 1-9 scale, with 1 as "inappropriate" and 9 as "appropriate." As defined by the RAND/UCLA appropriateness method, a "treatment had to be considered appropriate if the expected benefits exceeded the potential negative consequences by a sufficient margin." However, the panel did not define "sufficient," which led to most of the disagreement on scoring.

In June 2008, after the panel evaluated the first-round practice ratings and revised the evaluation measures, the second round of rating began with the 144 patient profiles and 10 treatment choices. A treatment with a median score of 7-9 was categorized as appropriate, whereas treatments with a median score of 1-3 were labeled inappropriate and those scoring 4-6 were categorized as uncertain.

An online tool (www.e-hims.com/Sensar) shows the corresponding panel treatment recommendation for various patient data.

Panelists were experts in the fields of rheumatology, orthopedics, cardiology, clinical pharmacology, gastroenterology, family medicine, and geriatrics.

All panelists disclosed receiving honoraria from Pfizer, which supported the study with an unrestricted educational grant. Eleven panelists disclosed other relationships with pharmaceutical companies, including Pfizer.

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Medication Adherence in Epileptic Children Follows Socioeconomic Status

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Medication Adherence in Epileptic Children Follows Socioeconomic Status

Higher socioeconomic status was associated with better adherence to antiepileptic medication during a 6-month, single-center study of 124 children with newly diagnosed epilepsy.

Avani C. Modi, Ph.D., and her colleagues at Cincinnati Children’s Hospital Medical Center reported that five adherence trajectories characterized the children’s adherence levels for twice-daily medication: "severe early nonadherence" for 13% of patients, "severe delayed nonadherence" for 7% of patients, "moderate nonadherence" for 13%, "mild nonadherence" for 26%, and "near-perfect adherence" for 42%. The authors described the study as the first to examine adherence trajectories for children with epilepsy.

According to this group-based trajectory modeling, almost 60% of the patients were nonadherent for the first 6 months of treatment. This was a "surprising" figure, given the results of the investigators’ previous study, which found a nonadherence rate of 20% in the first month of treatment, they wrote in a report published online April 27 in JAMA.

Prior cross-sectional studies of children with epilepsy have described self-reported nonadherence rates of 12%-35%, but they had "major methodological problems," according to the authors.

They advised that "clinicians should consider routinely assessing adherence to antiepileptic drug therapy in all children with epilepsy. Self-report measures of adherence have recently been developed for children with epilepsy and could be used in routine clinical care."

The children had a mean age of 7.2 years (range of 2-12 years) and 64% of them were male. The cohort was 76% white, 17% black, 7% biracial or multiracial, and 1% Asian; 3% were Hispanic. Nearly half of the cohort had idiopathic localization-related epilepsy (48%), and others had idiopathic generalized epilepsy (19%), idiopathic unclassified epilepsy (15%), cryptogenic localization-related epilepsy (8%), cryptogenic generalized epilepsy (5%), symptomatic localization-related epilepsy (5%), or symptomatic generalized epilepsy (1%). (Percentages do not equal 100% because of rounding.)

A majority of the patients (60%) received carbamazepine, and others received valproic acid.

To measure socioeconomic status, the investigators calculated occupation-based Duncan scores for each family. The mean score was 52, reflecting "occupations such as office supervisor, mail carrier, firefighter, and police officer." An electronic monitoring system measured adherence rates by recording when the medicine bottle was opened or closed.

During follow-up appointments at 1 month post diagnosis and every 3 months thereafter, a pediatric epileptologist or pediatric epilepsy nurse practitioner recorded seizure frequency, adverse events, and any change in medication for controlling seizures or reducing intolerable adverse events.

Dr. Modi and her associates found no effect on adherence rates by other variables such as age, sex, caregiver marital status, seizure type and frequency, initial and total number of antiepileptic medications, frequency of adverse events, and who first observed the child’s seizure (JAMA 2011;305:1669-76).

The five adherence groups exhibited significant intra- and interpatient variability, according to the investigators. Children who had severe early nonadherence "took between one-quarter and one-half of their antiepileptic drug doses in the first month of therapy and then became completely nonadherent over time, suggesting ‘volitional’ nonadherence, wherein parents may have actively decided that their children should not take antiepileptic drugs based on reasoned decisions."

Children in the severe delayed nonadherence group initially had about 90% adherence, but that gradually declined to about 20% after 6 months. This decline "may reflect caregivers who occasionally missed giving antiepileptic drug doses with no major health consequence (e.g., seizure) and, thus, made decisions to discontinue antiepileptic drugs."

Dr. Modi and her coauthors described those two groups as the children and families who are in greatest need of "adherence interventions focused on discussing the family’s beliefs regarding epilepsy and antiepileptic drugs and providing education about treatment misconceptions."

Children in the moderate nonadherence group, which averaged taking about 70% of their doses, may have missed taking their medication in blocked periods of time such as on vacations and during weekend sports, and "would benefit from problem-solving regarding barriers to adherence and instituting general behavioral and organizational strategies."

Although children in the mild nonadherence group had a stable adherence rate of 85%, the authors noted that it is unknown if this rate is "sufficient to maintain the therapeutic benefit of antiepileptic drugs for this period."

The investigators wrote that the "often intrinsic link between socioeconomic status and education" makes it plausible that the limited financial resources of many of the families of children that fell into groups with mild or worse rates of nonadherence affect tangible aspects of poor adherence, such as the inability to pay for medications, as well as the intangible aspects, such as parental supervision. "Proactive adherence promotion efforts are particularly salient for families who are economically disadvantaged," they wrote.

 

 

The investigators limited their focus to sociodemographic and medical factors. In addition, they did not study whether adherence trajectories affected health outcomes. However, this study is part of a longitudinal study, and the investigators noted that they are "currently examining psychosocial factors that contribute to adherence trajectories."

The study was funded by a grant from the National Institutes of Health. Dr. Modi disclosed that she has been a consultant for Novartis Pharmaceuticals Inc. Another study author disclosed speaker and adviser relationships with companies that manufacture antiepileptic drugs.

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Higher socioeconomic status was associated with better adherence to antiepileptic medication during a 6-month, single-center study of 124 children with newly diagnosed epilepsy.

Avani C. Modi, Ph.D., and her colleagues at Cincinnati Children’s Hospital Medical Center reported that five adherence trajectories characterized the children’s adherence levels for twice-daily medication: "severe early nonadherence" for 13% of patients, "severe delayed nonadherence" for 7% of patients, "moderate nonadherence" for 13%, "mild nonadherence" for 26%, and "near-perfect adherence" for 42%. The authors described the study as the first to examine adherence trajectories for children with epilepsy.

According to this group-based trajectory modeling, almost 60% of the patients were nonadherent for the first 6 months of treatment. This was a "surprising" figure, given the results of the investigators’ previous study, which found a nonadherence rate of 20% in the first month of treatment, they wrote in a report published online April 27 in JAMA.

Prior cross-sectional studies of children with epilepsy have described self-reported nonadherence rates of 12%-35%, but they had "major methodological problems," according to the authors.

They advised that "clinicians should consider routinely assessing adherence to antiepileptic drug therapy in all children with epilepsy. Self-report measures of adherence have recently been developed for children with epilepsy and could be used in routine clinical care."

The children had a mean age of 7.2 years (range of 2-12 years) and 64% of them were male. The cohort was 76% white, 17% black, 7% biracial or multiracial, and 1% Asian; 3% were Hispanic. Nearly half of the cohort had idiopathic localization-related epilepsy (48%), and others had idiopathic generalized epilepsy (19%), idiopathic unclassified epilepsy (15%), cryptogenic localization-related epilepsy (8%), cryptogenic generalized epilepsy (5%), symptomatic localization-related epilepsy (5%), or symptomatic generalized epilepsy (1%). (Percentages do not equal 100% because of rounding.)

A majority of the patients (60%) received carbamazepine, and others received valproic acid.

To measure socioeconomic status, the investigators calculated occupation-based Duncan scores for each family. The mean score was 52, reflecting "occupations such as office supervisor, mail carrier, firefighter, and police officer." An electronic monitoring system measured adherence rates by recording when the medicine bottle was opened or closed.

During follow-up appointments at 1 month post diagnosis and every 3 months thereafter, a pediatric epileptologist or pediatric epilepsy nurse practitioner recorded seizure frequency, adverse events, and any change in medication for controlling seizures or reducing intolerable adverse events.

Dr. Modi and her associates found no effect on adherence rates by other variables such as age, sex, caregiver marital status, seizure type and frequency, initial and total number of antiepileptic medications, frequency of adverse events, and who first observed the child’s seizure (JAMA 2011;305:1669-76).

The five adherence groups exhibited significant intra- and interpatient variability, according to the investigators. Children who had severe early nonadherence "took between one-quarter and one-half of their antiepileptic drug doses in the first month of therapy and then became completely nonadherent over time, suggesting ‘volitional’ nonadherence, wherein parents may have actively decided that their children should not take antiepileptic drugs based on reasoned decisions."

Children in the severe delayed nonadherence group initially had about 90% adherence, but that gradually declined to about 20% after 6 months. This decline "may reflect caregivers who occasionally missed giving antiepileptic drug doses with no major health consequence (e.g., seizure) and, thus, made decisions to discontinue antiepileptic drugs."

Dr. Modi and her coauthors described those two groups as the children and families who are in greatest need of "adherence interventions focused on discussing the family’s beliefs regarding epilepsy and antiepileptic drugs and providing education about treatment misconceptions."

Children in the moderate nonadherence group, which averaged taking about 70% of their doses, may have missed taking their medication in blocked periods of time such as on vacations and during weekend sports, and "would benefit from problem-solving regarding barriers to adherence and instituting general behavioral and organizational strategies."

Although children in the mild nonadherence group had a stable adherence rate of 85%, the authors noted that it is unknown if this rate is "sufficient to maintain the therapeutic benefit of antiepileptic drugs for this period."

The investigators wrote that the "often intrinsic link between socioeconomic status and education" makes it plausible that the limited financial resources of many of the families of children that fell into groups with mild or worse rates of nonadherence affect tangible aspects of poor adherence, such as the inability to pay for medications, as well as the intangible aspects, such as parental supervision. "Proactive adherence promotion efforts are particularly salient for families who are economically disadvantaged," they wrote.

 

 

The investigators limited their focus to sociodemographic and medical factors. In addition, they did not study whether adherence trajectories affected health outcomes. However, this study is part of a longitudinal study, and the investigators noted that they are "currently examining psychosocial factors that contribute to adherence trajectories."

The study was funded by a grant from the National Institutes of Health. Dr. Modi disclosed that she has been a consultant for Novartis Pharmaceuticals Inc. Another study author disclosed speaker and adviser relationships with companies that manufacture antiepileptic drugs.

Higher socioeconomic status was associated with better adherence to antiepileptic medication during a 6-month, single-center study of 124 children with newly diagnosed epilepsy.

Avani C. Modi, Ph.D., and her colleagues at Cincinnati Children’s Hospital Medical Center reported that five adherence trajectories characterized the children’s adherence levels for twice-daily medication: "severe early nonadherence" for 13% of patients, "severe delayed nonadherence" for 7% of patients, "moderate nonadherence" for 13%, "mild nonadherence" for 26%, and "near-perfect adherence" for 42%. The authors described the study as the first to examine adherence trajectories for children with epilepsy.

According to this group-based trajectory modeling, almost 60% of the patients were nonadherent for the first 6 months of treatment. This was a "surprising" figure, given the results of the investigators’ previous study, which found a nonadherence rate of 20% in the first month of treatment, they wrote in a report published online April 27 in JAMA.

Prior cross-sectional studies of children with epilepsy have described self-reported nonadherence rates of 12%-35%, but they had "major methodological problems," according to the authors.

They advised that "clinicians should consider routinely assessing adherence to antiepileptic drug therapy in all children with epilepsy. Self-report measures of adherence have recently been developed for children with epilepsy and could be used in routine clinical care."

The children had a mean age of 7.2 years (range of 2-12 years) and 64% of them were male. The cohort was 76% white, 17% black, 7% biracial or multiracial, and 1% Asian; 3% were Hispanic. Nearly half of the cohort had idiopathic localization-related epilepsy (48%), and others had idiopathic generalized epilepsy (19%), idiopathic unclassified epilepsy (15%), cryptogenic localization-related epilepsy (8%), cryptogenic generalized epilepsy (5%), symptomatic localization-related epilepsy (5%), or symptomatic generalized epilepsy (1%). (Percentages do not equal 100% because of rounding.)

A majority of the patients (60%) received carbamazepine, and others received valproic acid.

To measure socioeconomic status, the investigators calculated occupation-based Duncan scores for each family. The mean score was 52, reflecting "occupations such as office supervisor, mail carrier, firefighter, and police officer." An electronic monitoring system measured adherence rates by recording when the medicine bottle was opened or closed.

During follow-up appointments at 1 month post diagnosis and every 3 months thereafter, a pediatric epileptologist or pediatric epilepsy nurse practitioner recorded seizure frequency, adverse events, and any change in medication for controlling seizures or reducing intolerable adverse events.

Dr. Modi and her associates found no effect on adherence rates by other variables such as age, sex, caregiver marital status, seizure type and frequency, initial and total number of antiepileptic medications, frequency of adverse events, and who first observed the child’s seizure (JAMA 2011;305:1669-76).

The five adherence groups exhibited significant intra- and interpatient variability, according to the investigators. Children who had severe early nonadherence "took between one-quarter and one-half of their antiepileptic drug doses in the first month of therapy and then became completely nonadherent over time, suggesting ‘volitional’ nonadherence, wherein parents may have actively decided that their children should not take antiepileptic drugs based on reasoned decisions."

Children in the severe delayed nonadherence group initially had about 90% adherence, but that gradually declined to about 20% after 6 months. This decline "may reflect caregivers who occasionally missed giving antiepileptic drug doses with no major health consequence (e.g., seizure) and, thus, made decisions to discontinue antiepileptic drugs."

Dr. Modi and her coauthors described those two groups as the children and families who are in greatest need of "adherence interventions focused on discussing the family’s beliefs regarding epilepsy and antiepileptic drugs and providing education about treatment misconceptions."

Children in the moderate nonadherence group, which averaged taking about 70% of their doses, may have missed taking their medication in blocked periods of time such as on vacations and during weekend sports, and "would benefit from problem-solving regarding barriers to adherence and instituting general behavioral and organizational strategies."

Although children in the mild nonadherence group had a stable adherence rate of 85%, the authors noted that it is unknown if this rate is "sufficient to maintain the therapeutic benefit of antiepileptic drugs for this period."

The investigators wrote that the "often intrinsic link between socioeconomic status and education" makes it plausible that the limited financial resources of many of the families of children that fell into groups with mild or worse rates of nonadherence affect tangible aspects of poor adherence, such as the inability to pay for medications, as well as the intangible aspects, such as parental supervision. "Proactive adherence promotion efforts are particularly salient for families who are economically disadvantaged," they wrote.

 

 

The investigators limited their focus to sociodemographic and medical factors. In addition, they did not study whether adherence trajectories affected health outcomes. However, this study is part of a longitudinal study, and the investigators noted that they are "currently examining psychosocial factors that contribute to adherence trajectories."

The study was funded by a grant from the National Institutes of Health. Dr. Modi disclosed that she has been a consultant for Novartis Pharmaceuticals Inc. Another study author disclosed speaker and adviser relationships with companies that manufacture antiepileptic drugs.

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Major Finding: Nonadherence rates for antiepileptic medication reached 58% in the first 6 months after epilepsy diagnosis.

Data Source: A 6-month, single-center study of 124 children with newly diagnosed epilepsy.

Disclosures: The study was funded by a grant from the National Institutes of Health. Dr. Modi disclosed that she has been a consultant for Novartis Pharmaceuticals Inc. Another study author disclosed speaker and adviser relationships with companies that manufacture antiepileptic drugs.

Medication Adherence in Epileptic Children Follows Socioeconomic Status

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Medication Adherence in Epileptic Children Follows Socioeconomic Status

Higher socioeconomic status was associated with better adherence to antiepileptic medication during a 6-month, single-center study of 124 children with newly diagnosed epilepsy.

Avani C. Modi, Ph.D., and her colleagues at Cincinnati Children’s Hospital Medical Center reported that five adherence trajectories characterized the children’s adherence levels for twice-daily medication: "severe early nonadherence" for 13% of patients, "severe delayed nonadherence" for 7% of patients, "moderate nonadherence" for 13%, "mild nonadherence" for 26%, and "near-perfect adherence" for 42%. The authors described the study as the first to examine adherence trajectories for children with epilepsy.

According to this group-based trajectory modeling, almost 60% of the patients were nonadherent for the first 6 months of treatment. This was a "surprising" figure, given the results of the investigators’ previous study, which found a nonadherence rate of 20% in the first month of treatment, they wrote in a report published online April 27 in JAMA.

Prior cross-sectional studies of children with epilepsy have described self-reported nonadherence rates of 12%-35%, but they had "major methodological problems," according to the authors.

They advised that "clinicians should consider routinely assessing adherence to antiepileptic drug therapy in all children with epilepsy. Self-report measures of adherence have recently been developed for children with epilepsy and could be used in routine clinical care."

The children had a mean age of 7.2 years (range of 2-12 years) and 64% of them were male. The cohort was 76% white, 17% black, 7% biracial or multiracial, and 1% Asian; 3% were Hispanic. Nearly half of the cohort had idiopathic localization-related epilepsy (48%), and others had idiopathic generalized epilepsy (19%), idiopathic unclassified epilepsy (15%), cryptogenic localization-related epilepsy (8%), cryptogenic generalized epilepsy (5%), symptomatic localization-related epilepsy (5%), or symptomatic generalized epilepsy (1%). (Percentages do not equal 100% because of rounding.)

A majority of the patients (60%) received carbamazepine, and others received valproic acid.

To measure socioeconomic status, the investigators calculated occupation-based Duncan scores for each family. The mean score was 52, reflecting "occupations such as office supervisor, mail carrier, firefighter, and police officer." An electronic monitoring system measured adherence rates by recording when the medicine bottle was opened or closed.

During follow-up appointments at 1 month post diagnosis and every 3 months thereafter, a pediatric epileptologist or pediatric epilepsy nurse practitioner recorded seizure frequency, adverse events, and any change in medication for controlling seizures or reducing intolerable adverse events.

Dr. Modi and her associates found no effect on adherence rates by other variables such as age, sex, caregiver marital status, seizure type and frequency, initial and total number of antiepileptic medications, frequency of adverse events, and who first observed the child’s seizure (JAMA 2011;305:1669-76).

The five adherence groups exhibited significant intra- and interpatient variability, according to the investigators. Children who had severe early nonadherence "took between one-quarter and one-half of their antiepileptic drug doses in the first month of therapy and then became completely nonadherent over time, suggesting ‘volitional’ nonadherence, wherein parents may have actively decided that their children should not take antiepileptic drugs based on reasoned decisions."

Children in the severe delayed nonadherence group initially had about 90% adherence, but that gradually declined to about 20% after 6 months. This decline "may reflect caregivers who occasionally missed giving antiepileptic drug doses with no major health consequence (e.g., seizure) and, thus, made decisions to discontinue antiepileptic drugs."

Dr. Modi and her coauthors described those two groups as the children and families who are in greatest need of "adherence interventions focused on discussing the family’s beliefs regarding epilepsy and antiepileptic drugs and providing education about treatment misconceptions."

Children in the moderate nonadherence group, which averaged taking about 70% of their doses, may have missed taking their medication in blocked periods of time such as on vacations and during weekend sports, and "would benefit from problem-solving regarding barriers to adherence and instituting general behavioral and organizational strategies."

Although children in the mild nonadherence group had a stable adherence rate of 85%, the authors noted that it is unknown if this rate is "sufficient to maintain the therapeutic benefit of antiepileptic drugs for this period."

The investigators wrote that the "often intrinsic link between socioeconomic status and education" makes it plausible that the limited financial resources of many of the families of children that fell into groups with mild or worse rates of nonadherence affect tangible aspects of poor adherence, such as the inability to pay for medications, as well as the intangible aspects, such as parental supervision. "Proactive adherence promotion efforts are particularly salient for families who are economically disadvantaged," they wrote.

 

 

The investigators limited their focus to sociodemographic and medical factors. In addition, they did not study whether adherence trajectories affected health outcomes. However, this study is part of a longitudinal study, and the investigators noted that they are "currently examining psychosocial factors that contribute to adherence trajectories."

The study was funded by a grant from the National Institutes of Health. Dr. Modi disclosed that she has been a consultant for Novartis Pharmaceuticals Inc. Another study author disclosed speaker and adviser relationships with companies that manufacture antiepileptic drugs.

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Higher socioeconomic status was associated with better adherence to antiepileptic medication during a 6-month, single-center study of 124 children with newly diagnosed epilepsy.

Avani C. Modi, Ph.D., and her colleagues at Cincinnati Children’s Hospital Medical Center reported that five adherence trajectories characterized the children’s adherence levels for twice-daily medication: "severe early nonadherence" for 13% of patients, "severe delayed nonadherence" for 7% of patients, "moderate nonadherence" for 13%, "mild nonadherence" for 26%, and "near-perfect adherence" for 42%. The authors described the study as the first to examine adherence trajectories for children with epilepsy.

According to this group-based trajectory modeling, almost 60% of the patients were nonadherent for the first 6 months of treatment. This was a "surprising" figure, given the results of the investigators’ previous study, which found a nonadherence rate of 20% in the first month of treatment, they wrote in a report published online April 27 in JAMA.

Prior cross-sectional studies of children with epilepsy have described self-reported nonadherence rates of 12%-35%, but they had "major methodological problems," according to the authors.

They advised that "clinicians should consider routinely assessing adherence to antiepileptic drug therapy in all children with epilepsy. Self-report measures of adherence have recently been developed for children with epilepsy and could be used in routine clinical care."

The children had a mean age of 7.2 years (range of 2-12 years) and 64% of them were male. The cohort was 76% white, 17% black, 7% biracial or multiracial, and 1% Asian; 3% were Hispanic. Nearly half of the cohort had idiopathic localization-related epilepsy (48%), and others had idiopathic generalized epilepsy (19%), idiopathic unclassified epilepsy (15%), cryptogenic localization-related epilepsy (8%), cryptogenic generalized epilepsy (5%), symptomatic localization-related epilepsy (5%), or symptomatic generalized epilepsy (1%). (Percentages do not equal 100% because of rounding.)

A majority of the patients (60%) received carbamazepine, and others received valproic acid.

To measure socioeconomic status, the investigators calculated occupation-based Duncan scores for each family. The mean score was 52, reflecting "occupations such as office supervisor, mail carrier, firefighter, and police officer." An electronic monitoring system measured adherence rates by recording when the medicine bottle was opened or closed.

During follow-up appointments at 1 month post diagnosis and every 3 months thereafter, a pediatric epileptologist or pediatric epilepsy nurse practitioner recorded seizure frequency, adverse events, and any change in medication for controlling seizures or reducing intolerable adverse events.

Dr. Modi and her associates found no effect on adherence rates by other variables such as age, sex, caregiver marital status, seizure type and frequency, initial and total number of antiepileptic medications, frequency of adverse events, and who first observed the child’s seizure (JAMA 2011;305:1669-76).

The five adherence groups exhibited significant intra- and interpatient variability, according to the investigators. Children who had severe early nonadherence "took between one-quarter and one-half of their antiepileptic drug doses in the first month of therapy and then became completely nonadherent over time, suggesting ‘volitional’ nonadherence, wherein parents may have actively decided that their children should not take antiepileptic drugs based on reasoned decisions."

Children in the severe delayed nonadherence group initially had about 90% adherence, but that gradually declined to about 20% after 6 months. This decline "may reflect caregivers who occasionally missed giving antiepileptic drug doses with no major health consequence (e.g., seizure) and, thus, made decisions to discontinue antiepileptic drugs."

Dr. Modi and her coauthors described those two groups as the children and families who are in greatest need of "adherence interventions focused on discussing the family’s beliefs regarding epilepsy and antiepileptic drugs and providing education about treatment misconceptions."

Children in the moderate nonadherence group, which averaged taking about 70% of their doses, may have missed taking their medication in blocked periods of time such as on vacations and during weekend sports, and "would benefit from problem-solving regarding barriers to adherence and instituting general behavioral and organizational strategies."

Although children in the mild nonadherence group had a stable adherence rate of 85%, the authors noted that it is unknown if this rate is "sufficient to maintain the therapeutic benefit of antiepileptic drugs for this period."

The investigators wrote that the "often intrinsic link between socioeconomic status and education" makes it plausible that the limited financial resources of many of the families of children that fell into groups with mild or worse rates of nonadherence affect tangible aspects of poor adherence, such as the inability to pay for medications, as well as the intangible aspects, such as parental supervision. "Proactive adherence promotion efforts are particularly salient for families who are economically disadvantaged," they wrote.

 

 

The investigators limited their focus to sociodemographic and medical factors. In addition, they did not study whether adherence trajectories affected health outcomes. However, this study is part of a longitudinal study, and the investigators noted that they are "currently examining psychosocial factors that contribute to adherence trajectories."

The study was funded by a grant from the National Institutes of Health. Dr. Modi disclosed that she has been a consultant for Novartis Pharmaceuticals Inc. Another study author disclosed speaker and adviser relationships with companies that manufacture antiepileptic drugs.

Higher socioeconomic status was associated with better adherence to antiepileptic medication during a 6-month, single-center study of 124 children with newly diagnosed epilepsy.

Avani C. Modi, Ph.D., and her colleagues at Cincinnati Children’s Hospital Medical Center reported that five adherence trajectories characterized the children’s adherence levels for twice-daily medication: "severe early nonadherence" for 13% of patients, "severe delayed nonadherence" for 7% of patients, "moderate nonadherence" for 13%, "mild nonadherence" for 26%, and "near-perfect adherence" for 42%. The authors described the study as the first to examine adherence trajectories for children with epilepsy.

According to this group-based trajectory modeling, almost 60% of the patients were nonadherent for the first 6 months of treatment. This was a "surprising" figure, given the results of the investigators’ previous study, which found a nonadherence rate of 20% in the first month of treatment, they wrote in a report published online April 27 in JAMA.

Prior cross-sectional studies of children with epilepsy have described self-reported nonadherence rates of 12%-35%, but they had "major methodological problems," according to the authors.

They advised that "clinicians should consider routinely assessing adherence to antiepileptic drug therapy in all children with epilepsy. Self-report measures of adherence have recently been developed for children with epilepsy and could be used in routine clinical care."

The children had a mean age of 7.2 years (range of 2-12 years) and 64% of them were male. The cohort was 76% white, 17% black, 7% biracial or multiracial, and 1% Asian; 3% were Hispanic. Nearly half of the cohort had idiopathic localization-related epilepsy (48%), and others had idiopathic generalized epilepsy (19%), idiopathic unclassified epilepsy (15%), cryptogenic localization-related epilepsy (8%), cryptogenic generalized epilepsy (5%), symptomatic localization-related epilepsy (5%), or symptomatic generalized epilepsy (1%). (Percentages do not equal 100% because of rounding.)

A majority of the patients (60%) received carbamazepine, and others received valproic acid.

To measure socioeconomic status, the investigators calculated occupation-based Duncan scores for each family. The mean score was 52, reflecting "occupations such as office supervisor, mail carrier, firefighter, and police officer." An electronic monitoring system measured adherence rates by recording when the medicine bottle was opened or closed.

During follow-up appointments at 1 month post diagnosis and every 3 months thereafter, a pediatric epileptologist or pediatric epilepsy nurse practitioner recorded seizure frequency, adverse events, and any change in medication for controlling seizures or reducing intolerable adverse events.

Dr. Modi and her associates found no effect on adherence rates by other variables such as age, sex, caregiver marital status, seizure type and frequency, initial and total number of antiepileptic medications, frequency of adverse events, and who first observed the child’s seizure (JAMA 2011;305:1669-76).

The five adherence groups exhibited significant intra- and interpatient variability, according to the investigators. Children who had severe early nonadherence "took between one-quarter and one-half of their antiepileptic drug doses in the first month of therapy and then became completely nonadherent over time, suggesting ‘volitional’ nonadherence, wherein parents may have actively decided that their children should not take antiepileptic drugs based on reasoned decisions."

Children in the severe delayed nonadherence group initially had about 90% adherence, but that gradually declined to about 20% after 6 months. This decline "may reflect caregivers who occasionally missed giving antiepileptic drug doses with no major health consequence (e.g., seizure) and, thus, made decisions to discontinue antiepileptic drugs."

Dr. Modi and her coauthors described those two groups as the children and families who are in greatest need of "adherence interventions focused on discussing the family’s beliefs regarding epilepsy and antiepileptic drugs and providing education about treatment misconceptions."

Children in the moderate nonadherence group, which averaged taking about 70% of their doses, may have missed taking their medication in blocked periods of time such as on vacations and during weekend sports, and "would benefit from problem-solving regarding barriers to adherence and instituting general behavioral and organizational strategies."

Although children in the mild nonadherence group had a stable adherence rate of 85%, the authors noted that it is unknown if this rate is "sufficient to maintain the therapeutic benefit of antiepileptic drugs for this period."

The investigators wrote that the "often intrinsic link between socioeconomic status and education" makes it plausible that the limited financial resources of many of the families of children that fell into groups with mild or worse rates of nonadherence affect tangible aspects of poor adherence, such as the inability to pay for medications, as well as the intangible aspects, such as parental supervision. "Proactive adherence promotion efforts are particularly salient for families who are economically disadvantaged," they wrote.

 

 

The investigators limited their focus to sociodemographic and medical factors. In addition, they did not study whether adherence trajectories affected health outcomes. However, this study is part of a longitudinal study, and the investigators noted that they are "currently examining psychosocial factors that contribute to adherence trajectories."

The study was funded by a grant from the National Institutes of Health. Dr. Modi disclosed that she has been a consultant for Novartis Pharmaceuticals Inc. Another study author disclosed speaker and adviser relationships with companies that manufacture antiepileptic drugs.

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Medication Adherence in Epileptic Children Follows Socioeconomic Status

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Medication Adherence in Epileptic Children Follows Socioeconomic Status

Higher socioeconomic status was associated with better adherence to antiepileptic medication during a 6-month, single-center study of 124 children with newly diagnosed epilepsy.

Avani C. Modi, Ph.D., and her colleagues at Cincinnati Children’s Hospital Medical Center reported that five adherence trajectories characterized the children’s adherence levels for twice-daily medication: "severe early nonadherence" for 13% of patients, "severe delayed nonadherence" for 7% of patients, "moderate nonadherence" for 13%, "mild nonadherence" for 26%, and "near-perfect adherence" for 42%. The authors described the study as the first to examine adherence trajectories for children with epilepsy.

According to this group-based trajectory modeling, almost 60% of the patients were nonadherent for the first 6 months of treatment. This was a "surprising" figure, given the results of the investigators’ previous study, which found a nonadherence rate of 20% in the first month of treatment, they wrote in a report published online April 27 in JAMA.

Prior cross-sectional studies of children with epilepsy have described self-reported nonadherence rates of 12%-35%, but they had "major methodological problems," according to the authors.

They advised that "clinicians should consider routinely assessing adherence to antiepileptic drug therapy in all children with epilepsy. Self-report measures of adherence have recently been developed for children with epilepsy and could be used in routine clinical care."

The children had a mean age of 7.2 years (range of 2-12 years) and 64% of them were male. The cohort was 76% white, 17% black, 7% biracial or multiracial, and 1% Asian; 3% were Hispanic. Nearly half of the cohort had idiopathic localization-related epilepsy (48%), and others had idiopathic generalized epilepsy (19%), idiopathic unclassified epilepsy (15%), cryptogenic localization-related epilepsy (8%), cryptogenic generalized epilepsy (5%), symptomatic localization-related epilepsy (5%), or symptomatic generalized epilepsy (1%). (Percentages do not equal 100% because of rounding.)

A majority of the patients (60%) received carbamazepine, and others received valproic acid.

To measure socioeconomic status, the investigators calculated occupation-based Duncan scores for each family. The mean score was 52, reflecting "occupations such as office supervisor, mail carrier, firefighter, and police officer." An electronic monitoring system measured adherence rates by recording when the medicine bottle was opened or closed.

During follow-up appointments at 1 month post diagnosis and every 3 months thereafter, a pediatric epileptologist or pediatric epilepsy nurse practitioner recorded seizure frequency, adverse events, and any change in medication for controlling seizures or reducing intolerable adverse events.

Dr. Modi and her associates found no effect on adherence rates by other variables such as age, sex, caregiver marital status, seizure type and frequency, initial and total number of antiepileptic medications, frequency of adverse events, and who first observed the child’s seizure (JAMA 2011;305:1669-76).

The five adherence groups exhibited significant intra- and interpatient variability, according to the investigators. Children who had severe early nonadherence "took between one-quarter and one-half of their antiepileptic drug doses in the first month of therapy and then became completely nonadherent over time, suggesting ‘volitional’ nonadherence, wherein parents may have actively decided that their children should not take antiepileptic drugs based on reasoned decisions."

Children in the severe delayed nonadherence group initially had about 90% adherence, but that gradually declined to about 20% after 6 months. This decline "may reflect caregivers who occasionally missed giving antiepileptic drug doses with no major health consequence (e.g., seizure) and, thus, made decisions to discontinue antiepileptic drugs."

Dr. Modi and her coauthors described those two groups as the children and families who are in greatest need of "adherence interventions focused on discussing the family’s beliefs regarding epilepsy and antiepileptic drugs and providing education about treatment misconceptions."

Children in the moderate nonadherence group, which averaged taking about 70% of their doses, may have missed taking their medication in blocked periods of time such as on vacations and during weekend sports, and "would benefit from problem-solving regarding barriers to adherence and instituting general behavioral and organizational strategies."

Although children in the mild nonadherence group had a stable adherence rate of 85%, the authors noted that it is unknown if this rate is "sufficient to maintain the therapeutic benefit of antiepileptic drugs for this period."

The investigators wrote that the "often intrinsic link between socioeconomic status and education" makes it plausible that the limited financial resources of many of the families of children that fell into groups with mild or worse rates of nonadherence affect tangible aspects of poor adherence, such as the inability to pay for medications, as well as the intangible aspects, such as parental supervision. "Proactive adherence promotion efforts are particularly salient for families who are economically disadvantaged," they wrote.

 

 

The investigators limited their focus to sociodemographic and medical factors. In addition, they did not study whether adherence trajectories affected health outcomes. However, this study is part of a longitudinal study, and the investigators noted that they are "currently examining psychosocial factors that contribute to adherence trajectories."

The study was funded by a grant from the National Institutes of Health. Dr. Modi disclosed that she has been a consultant for Novartis Pharmaceuticals Inc. Another study author disclosed speaker and adviser relationships with companies that manufacture antiepileptic drugs.

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Higher socioeconomic status was associated with better adherence to antiepileptic medication during a 6-month, single-center study of 124 children with newly diagnosed epilepsy.

Avani C. Modi, Ph.D., and her colleagues at Cincinnati Children’s Hospital Medical Center reported that five adherence trajectories characterized the children’s adherence levels for twice-daily medication: "severe early nonadherence" for 13% of patients, "severe delayed nonadherence" for 7% of patients, "moderate nonadherence" for 13%, "mild nonadherence" for 26%, and "near-perfect adherence" for 42%. The authors described the study as the first to examine adherence trajectories for children with epilepsy.

According to this group-based trajectory modeling, almost 60% of the patients were nonadherent for the first 6 months of treatment. This was a "surprising" figure, given the results of the investigators’ previous study, which found a nonadherence rate of 20% in the first month of treatment, they wrote in a report published online April 27 in JAMA.

Prior cross-sectional studies of children with epilepsy have described self-reported nonadherence rates of 12%-35%, but they had "major methodological problems," according to the authors.

They advised that "clinicians should consider routinely assessing adherence to antiepileptic drug therapy in all children with epilepsy. Self-report measures of adherence have recently been developed for children with epilepsy and could be used in routine clinical care."

The children had a mean age of 7.2 years (range of 2-12 years) and 64% of them were male. The cohort was 76% white, 17% black, 7% biracial or multiracial, and 1% Asian; 3% were Hispanic. Nearly half of the cohort had idiopathic localization-related epilepsy (48%), and others had idiopathic generalized epilepsy (19%), idiopathic unclassified epilepsy (15%), cryptogenic localization-related epilepsy (8%), cryptogenic generalized epilepsy (5%), symptomatic localization-related epilepsy (5%), or symptomatic generalized epilepsy (1%). (Percentages do not equal 100% because of rounding.)

A majority of the patients (60%) received carbamazepine, and others received valproic acid.

To measure socioeconomic status, the investigators calculated occupation-based Duncan scores for each family. The mean score was 52, reflecting "occupations such as office supervisor, mail carrier, firefighter, and police officer." An electronic monitoring system measured adherence rates by recording when the medicine bottle was opened or closed.

During follow-up appointments at 1 month post diagnosis and every 3 months thereafter, a pediatric epileptologist or pediatric epilepsy nurse practitioner recorded seizure frequency, adverse events, and any change in medication for controlling seizures or reducing intolerable adverse events.

Dr. Modi and her associates found no effect on adherence rates by other variables such as age, sex, caregiver marital status, seizure type and frequency, initial and total number of antiepileptic medications, frequency of adverse events, and who first observed the child’s seizure (JAMA 2011;305:1669-76).

The five adherence groups exhibited significant intra- and interpatient variability, according to the investigators. Children who had severe early nonadherence "took between one-quarter and one-half of their antiepileptic drug doses in the first month of therapy and then became completely nonadherent over time, suggesting ‘volitional’ nonadherence, wherein parents may have actively decided that their children should not take antiepileptic drugs based on reasoned decisions."

Children in the severe delayed nonadherence group initially had about 90% adherence, but that gradually declined to about 20% after 6 months. This decline "may reflect caregivers who occasionally missed giving antiepileptic drug doses with no major health consequence (e.g., seizure) and, thus, made decisions to discontinue antiepileptic drugs."

Dr. Modi and her coauthors described those two groups as the children and families who are in greatest need of "adherence interventions focused on discussing the family’s beliefs regarding epilepsy and antiepileptic drugs and providing education about treatment misconceptions."

Children in the moderate nonadherence group, which averaged taking about 70% of their doses, may have missed taking their medication in blocked periods of time such as on vacations and during weekend sports, and "would benefit from problem-solving regarding barriers to adherence and instituting general behavioral and organizational strategies."

Although children in the mild nonadherence group had a stable adherence rate of 85%, the authors noted that it is unknown if this rate is "sufficient to maintain the therapeutic benefit of antiepileptic drugs for this period."

The investigators wrote that the "often intrinsic link between socioeconomic status and education" makes it plausible that the limited financial resources of many of the families of children that fell into groups with mild or worse rates of nonadherence affect tangible aspects of poor adherence, such as the inability to pay for medications, as well as the intangible aspects, such as parental supervision. "Proactive adherence promotion efforts are particularly salient for families who are economically disadvantaged," they wrote.

 

 

The investigators limited their focus to sociodemographic and medical factors. In addition, they did not study whether adherence trajectories affected health outcomes. However, this study is part of a longitudinal study, and the investigators noted that they are "currently examining psychosocial factors that contribute to adherence trajectories."

The study was funded by a grant from the National Institutes of Health. Dr. Modi disclosed that she has been a consultant for Novartis Pharmaceuticals Inc. Another study author disclosed speaker and adviser relationships with companies that manufacture antiepileptic drugs.

Higher socioeconomic status was associated with better adherence to antiepileptic medication during a 6-month, single-center study of 124 children with newly diagnosed epilepsy.

Avani C. Modi, Ph.D., and her colleagues at Cincinnati Children’s Hospital Medical Center reported that five adherence trajectories characterized the children’s adherence levels for twice-daily medication: "severe early nonadherence" for 13% of patients, "severe delayed nonadherence" for 7% of patients, "moderate nonadherence" for 13%, "mild nonadherence" for 26%, and "near-perfect adherence" for 42%. The authors described the study as the first to examine adherence trajectories for children with epilepsy.

According to this group-based trajectory modeling, almost 60% of the patients were nonadherent for the first 6 months of treatment. This was a "surprising" figure, given the results of the investigators’ previous study, which found a nonadherence rate of 20% in the first month of treatment, they wrote in a report published online April 27 in JAMA.

Prior cross-sectional studies of children with epilepsy have described self-reported nonadherence rates of 12%-35%, but they had "major methodological problems," according to the authors.

They advised that "clinicians should consider routinely assessing adherence to antiepileptic drug therapy in all children with epilepsy. Self-report measures of adherence have recently been developed for children with epilepsy and could be used in routine clinical care."

The children had a mean age of 7.2 years (range of 2-12 years) and 64% of them were male. The cohort was 76% white, 17% black, 7% biracial or multiracial, and 1% Asian; 3% were Hispanic. Nearly half of the cohort had idiopathic localization-related epilepsy (48%), and others had idiopathic generalized epilepsy (19%), idiopathic unclassified epilepsy (15%), cryptogenic localization-related epilepsy (8%), cryptogenic generalized epilepsy (5%), symptomatic localization-related epilepsy (5%), or symptomatic generalized epilepsy (1%). (Percentages do not equal 100% because of rounding.)

A majority of the patients (60%) received carbamazepine, and others received valproic acid.

To measure socioeconomic status, the investigators calculated occupation-based Duncan scores for each family. The mean score was 52, reflecting "occupations such as office supervisor, mail carrier, firefighter, and police officer." An electronic monitoring system measured adherence rates by recording when the medicine bottle was opened or closed.

During follow-up appointments at 1 month post diagnosis and every 3 months thereafter, a pediatric epileptologist or pediatric epilepsy nurse practitioner recorded seizure frequency, adverse events, and any change in medication for controlling seizures or reducing intolerable adverse events.

Dr. Modi and her associates found no effect on adherence rates by other variables such as age, sex, caregiver marital status, seizure type and frequency, initial and total number of antiepileptic medications, frequency of adverse events, and who first observed the child’s seizure (JAMA 2011;305:1669-76).

The five adherence groups exhibited significant intra- and interpatient variability, according to the investigators. Children who had severe early nonadherence "took between one-quarter and one-half of their antiepileptic drug doses in the first month of therapy and then became completely nonadherent over time, suggesting ‘volitional’ nonadherence, wherein parents may have actively decided that their children should not take antiepileptic drugs based on reasoned decisions."

Children in the severe delayed nonadherence group initially had about 90% adherence, but that gradually declined to about 20% after 6 months. This decline "may reflect caregivers who occasionally missed giving antiepileptic drug doses with no major health consequence (e.g., seizure) and, thus, made decisions to discontinue antiepileptic drugs."

Dr. Modi and her coauthors described those two groups as the children and families who are in greatest need of "adherence interventions focused on discussing the family’s beliefs regarding epilepsy and antiepileptic drugs and providing education about treatment misconceptions."

Children in the moderate nonadherence group, which averaged taking about 70% of their doses, may have missed taking their medication in blocked periods of time such as on vacations and during weekend sports, and "would benefit from problem-solving regarding barriers to adherence and instituting general behavioral and organizational strategies."

Although children in the mild nonadherence group had a stable adherence rate of 85%, the authors noted that it is unknown if this rate is "sufficient to maintain the therapeutic benefit of antiepileptic drugs for this period."

The investigators wrote that the "often intrinsic link between socioeconomic status and education" makes it plausible that the limited financial resources of many of the families of children that fell into groups with mild or worse rates of nonadherence affect tangible aspects of poor adherence, such as the inability to pay for medications, as well as the intangible aspects, such as parental supervision. "Proactive adherence promotion efforts are particularly salient for families who are economically disadvantaged," they wrote.

 

 

The investigators limited their focus to sociodemographic and medical factors. In addition, they did not study whether adherence trajectories affected health outcomes. However, this study is part of a longitudinal study, and the investigators noted that they are "currently examining psychosocial factors that contribute to adherence trajectories."

The study was funded by a grant from the National Institutes of Health. Dr. Modi disclosed that she has been a consultant for Novartis Pharmaceuticals Inc. Another study author disclosed speaker and adviser relationships with companies that manufacture antiepileptic drugs.

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Major Finding: Nonadherence rates for antiepileptic medication reached 58% in the first 6 months after epilepsy diagnosis.

Data Source: A 6-month, single-center study of 124 children with newly diagnosed epilepsy.

Disclosures: The study was funded by a grant from the National Institutes of Health. Dr. Modi disclosed that she has been a consultant for Novartis Pharmaceuticals Inc. Another study author disclosed speaker and adviser relationships with companies that manufacture antiepileptic drugs.

Adapalene-Benzoyl Peroxide Improves Even Severe Acne

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Adapalene-Benzoyl Peroxide Improves Even Severe Acne

Combination adapalene-benzoyl peroxide for acne vulgaris is more effective than either therapy alone, according to the results of a new analysis.

The therapy reduced total lesion count after 12 weeks, regardless of a patient’s initial number of lesions, according to Dr. Steven R. Feldman of the department of dermatology at Wake Forest University, Winston-Salem, N.C., and his colleagues.

    Dr. Steven R. Feldman

The investigators pooled data from three multicenter, randomized clinical trials of similar design, totaling 3,853 patients. The three studies had four treatment groups (combination, adapalene only, benzoyl peroxide [BPO] only, and a gel vehicle).

The study investigators defined three subgroups based on lesion count: lowest 25%, middle 50%, and highest 25%. They found that efficacy of adapalene-benzoyl relative to its gel vehicle increased with number of lesions (J. Amer. Acad. Dermatol. 2011 [doi:10.1016/j.jaad.2010.03.036]).

Also, "adapalene-BPO was significantly more efficacious, compared with the monotherapies and vehicle in percent reduction of inflammatory, noninflammatory, and total lesions," the investigators wrote. "The superior efficacy of adapalene-BPO was also confirmed in all lesion count subgroups."

Total lesion counts in the three subgroups treated with combination therapy were reduced by 19%, 26%, and 29%, respectively.

The patients were aged 12 years or older and had 20-50 inflammatory lesions and 30-100 noninflammatory lesions on their face. Although 495 patients dropped out of the study, they were proportionally distributed among the three subgroups.

As for adverse events, tolerability was similar across all lesion count subgroups, with events being highest at week 1. The most common side effect was dry sin.

Dr. Feldman said in an interview that by subtracting the effect of the gel vehicle, he could more clearly determine the effect of the drug itself, since the study did not incorporate a placebo. However, he added, in clinical practice what is important is the full effect of the drug for the patient, aided by the gel vehicle.

He concluded that because the combination therapy showed similar overall improvement in the low- and high-lesion count groups, topical drugs are a viable first option even for severe acne cases. In addition, studies show that combination therapies simplify treatment for the patient and increase likelihood of adherence.

The study received funding from Galderma. Dr. Feldman disclosed receiving grant funding from Galderma, as well as serving as a speaker, investigator, and consultant for the pharmaceutical company. All of the other investigators for this study also disclosed relationships with Galderma.

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Combination adapalene-benzoyl peroxide for acne vulgaris is more effective than either therapy alone, according to the results of a new analysis.

The therapy reduced total lesion count after 12 weeks, regardless of a patient’s initial number of lesions, according to Dr. Steven R. Feldman of the department of dermatology at Wake Forest University, Winston-Salem, N.C., and his colleagues.

    Dr. Steven R. Feldman

The investigators pooled data from three multicenter, randomized clinical trials of similar design, totaling 3,853 patients. The three studies had four treatment groups (combination, adapalene only, benzoyl peroxide [BPO] only, and a gel vehicle).

The study investigators defined three subgroups based on lesion count: lowest 25%, middle 50%, and highest 25%. They found that efficacy of adapalene-benzoyl relative to its gel vehicle increased with number of lesions (J. Amer. Acad. Dermatol. 2011 [doi:10.1016/j.jaad.2010.03.036]).

Also, "adapalene-BPO was significantly more efficacious, compared with the monotherapies and vehicle in percent reduction of inflammatory, noninflammatory, and total lesions," the investigators wrote. "The superior efficacy of adapalene-BPO was also confirmed in all lesion count subgroups."

Total lesion counts in the three subgroups treated with combination therapy were reduced by 19%, 26%, and 29%, respectively.

The patients were aged 12 years or older and had 20-50 inflammatory lesions and 30-100 noninflammatory lesions on their face. Although 495 patients dropped out of the study, they were proportionally distributed among the three subgroups.

As for adverse events, tolerability was similar across all lesion count subgroups, with events being highest at week 1. The most common side effect was dry sin.

Dr. Feldman said in an interview that by subtracting the effect of the gel vehicle, he could more clearly determine the effect of the drug itself, since the study did not incorporate a placebo. However, he added, in clinical practice what is important is the full effect of the drug for the patient, aided by the gel vehicle.

He concluded that because the combination therapy showed similar overall improvement in the low- and high-lesion count groups, topical drugs are a viable first option even for severe acne cases. In addition, studies show that combination therapies simplify treatment for the patient and increase likelihood of adherence.

The study received funding from Galderma. Dr. Feldman disclosed receiving grant funding from Galderma, as well as serving as a speaker, investigator, and consultant for the pharmaceutical company. All of the other investigators for this study also disclosed relationships with Galderma.

Combination adapalene-benzoyl peroxide for acne vulgaris is more effective than either therapy alone, according to the results of a new analysis.

The therapy reduced total lesion count after 12 weeks, regardless of a patient’s initial number of lesions, according to Dr. Steven R. Feldman of the department of dermatology at Wake Forest University, Winston-Salem, N.C., and his colleagues.

    Dr. Steven R. Feldman

The investigators pooled data from three multicenter, randomized clinical trials of similar design, totaling 3,853 patients. The three studies had four treatment groups (combination, adapalene only, benzoyl peroxide [BPO] only, and a gel vehicle).

The study investigators defined three subgroups based on lesion count: lowest 25%, middle 50%, and highest 25%. They found that efficacy of adapalene-benzoyl relative to its gel vehicle increased with number of lesions (J. Amer. Acad. Dermatol. 2011 [doi:10.1016/j.jaad.2010.03.036]).

Also, "adapalene-BPO was significantly more efficacious, compared with the monotherapies and vehicle in percent reduction of inflammatory, noninflammatory, and total lesions," the investigators wrote. "The superior efficacy of adapalene-BPO was also confirmed in all lesion count subgroups."

Total lesion counts in the three subgroups treated with combination therapy were reduced by 19%, 26%, and 29%, respectively.

The patients were aged 12 years or older and had 20-50 inflammatory lesions and 30-100 noninflammatory lesions on their face. Although 495 patients dropped out of the study, they were proportionally distributed among the three subgroups.

As for adverse events, tolerability was similar across all lesion count subgroups, with events being highest at week 1. The most common side effect was dry sin.

Dr. Feldman said in an interview that by subtracting the effect of the gel vehicle, he could more clearly determine the effect of the drug itself, since the study did not incorporate a placebo. However, he added, in clinical practice what is important is the full effect of the drug for the patient, aided by the gel vehicle.

He concluded that because the combination therapy showed similar overall improvement in the low- and high-lesion count groups, topical drugs are a viable first option even for severe acne cases. In addition, studies show that combination therapies simplify treatment for the patient and increase likelihood of adherence.

The study received funding from Galderma. Dr. Feldman disclosed receiving grant funding from Galderma, as well as serving as a speaker, investigator, and consultant for the pharmaceutical company. All of the other investigators for this study also disclosed relationships with Galderma.

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Adapalene-Benzoyl Peroxide Improves Even Severe Acne
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JAAD: Adapalene-Benzoyl Peroxide Improves Even Severe Acne

Study Limited, Not Convincing
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JAAD: Adapalene-Benzoyl Peroxide Improves Even Severe Acne

Combination adapalene-benzoyl peroxide for acne vulgaris is more effective than either therapy alone, according to the results of a new analysis.

The therapy reduced total lesion count after 12 weeks, regardless of a patient's initial number of lesions, according to Dr. Steven R. Feldman of the department of dermatology at Wake Forest University, Winston-Salem, N.C., and his colleagues.

    Dr. Steven R. Feldman

The investigators pooled data from three multicenter, randomized clinical trials of similar design, totaling 3,853 patients. The three studies had four treatment groups (combination, adapalene only, benzoyl peroxide [BPO] only, and a gel vehicle).

The study investigators defined three subgroups based on lesion count: lowest 25%, middle 50%, and highest 25%. They found that efficacy of adapalene-benzoyl relative to its gel vehicle increased with number of lesions (J. Amer. Acad. Dermatol. 2011 [doi:10.1016/j.jaad.2010.03.036]).

Also, "adapalene-BPO was significantly more efficacious, compared with the monotherapies and vehicle in percent reduction of inflammatory, noninflammatory, and total lesions," the investigators wrote. "The superior efficacy of adapalene-BPO was also confirmed in all lesion count subgroups."

Total lesion counts in the three subgroups treated with combination therapy were reduced by 19%, 26%, and 29%, respectively.

The patients were aged 12 years or older and had 20-50 inflammatory lesions and 30-100 noninflammatory lesions on their face. Although 495 patients dropped out of the study, they were proportionally distributed among the three subgroups.

As for adverse events, tolerability was similar across all lesion count subgroups, with events being highest at week 1. The most common side effect was dry sin.

Dr. Feldman said in an interview that by subtracting the effect of the gel vehicle, he could more clearly determine the effect of the drug itself, since the study did not incorporate a placebo. However, he added, in clinical practice what is important is the full effect of the drug for the patient, aided by the gel vehicle.

He concluded that because the combination therapy showed similar overall improvement in the low- and high-lesion count groups, topical drugs are a viable first option even for severe acne cases. In addition, studies show that combination therapies simplify treatment for the patient and increase likelihood of adherence.

The study received funding from Galderma. Dr. Feldman disclosed receiving grant funding from Galderma, as well as serving as a speaker, investigator, and consultant for the pharmaceutical company. All of the other investigators for this study also disclosed relationships with Galderma.

Body

    



This study makes no dent

in the practice of deciding on a case-by-case basis whether to begin with

topical or systemic treatments for acne, according to Dr. Neil S. Goldberg. None

of the patients included in the study showed a severe enough level of acne from

the study's description to warrant bypassing the conventional first step of

topical treatment. Therefore, the study authors, in asserting that the study

makes the case for considering topical treatments as a first option even for

patients with severe acne, based their argument on a limited clinical spectrum.

Dr. Goldberg is a member of the editorial advisory

board of Skin & Allergy News and practices dermatology in Bronxville, N.Y.

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Body

    



This study makes no dent

in the practice of deciding on a case-by-case basis whether to begin with

topical or systemic treatments for acne, according to Dr. Neil S. Goldberg. None

of the patients included in the study showed a severe enough level of acne from

the study's description to warrant bypassing the conventional first step of

topical treatment. Therefore, the study authors, in asserting that the study

makes the case for considering topical treatments as a first option even for

patients with severe acne, based their argument on a limited clinical spectrum.

Dr. Goldberg is a member of the editorial advisory

board of Skin & Allergy News and practices dermatology in Bronxville, N.Y.

Body

    



This study makes no dent

in the practice of deciding on a case-by-case basis whether to begin with

topical or systemic treatments for acne, according to Dr. Neil S. Goldberg. None

of the patients included in the study showed a severe enough level of acne from

the study's description to warrant bypassing the conventional first step of

topical treatment. Therefore, the study authors, in asserting that the study

makes the case for considering topical treatments as a first option even for

patients with severe acne, based their argument on a limited clinical spectrum.

Dr. Goldberg is a member of the editorial advisory

board of Skin & Allergy News and practices dermatology in Bronxville, N.Y.

Title
Study Limited, Not Convincing
Study Limited, Not Convincing

Combination adapalene-benzoyl peroxide for acne vulgaris is more effective than either therapy alone, according to the results of a new analysis.

The therapy reduced total lesion count after 12 weeks, regardless of a patient's initial number of lesions, according to Dr. Steven R. Feldman of the department of dermatology at Wake Forest University, Winston-Salem, N.C., and his colleagues.

    Dr. Steven R. Feldman

The investigators pooled data from three multicenter, randomized clinical trials of similar design, totaling 3,853 patients. The three studies had four treatment groups (combination, adapalene only, benzoyl peroxide [BPO] only, and a gel vehicle).

The study investigators defined three subgroups based on lesion count: lowest 25%, middle 50%, and highest 25%. They found that efficacy of adapalene-benzoyl relative to its gel vehicle increased with number of lesions (J. Amer. Acad. Dermatol. 2011 [doi:10.1016/j.jaad.2010.03.036]).

Also, "adapalene-BPO was significantly more efficacious, compared with the monotherapies and vehicle in percent reduction of inflammatory, noninflammatory, and total lesions," the investigators wrote. "The superior efficacy of adapalene-BPO was also confirmed in all lesion count subgroups."

Total lesion counts in the three subgroups treated with combination therapy were reduced by 19%, 26%, and 29%, respectively.

The patients were aged 12 years or older and had 20-50 inflammatory lesions and 30-100 noninflammatory lesions on their face. Although 495 patients dropped out of the study, they were proportionally distributed among the three subgroups.

As for adverse events, tolerability was similar across all lesion count subgroups, with events being highest at week 1. The most common side effect was dry sin.

Dr. Feldman said in an interview that by subtracting the effect of the gel vehicle, he could more clearly determine the effect of the drug itself, since the study did not incorporate a placebo. However, he added, in clinical practice what is important is the full effect of the drug for the patient, aided by the gel vehicle.

He concluded that because the combination therapy showed similar overall improvement in the low- and high-lesion count groups, topical drugs are a viable first option even for severe acne cases. In addition, studies show that combination therapies simplify treatment for the patient and increase likelihood of adherence.

The study received funding from Galderma. Dr. Feldman disclosed receiving grant funding from Galderma, as well as serving as a speaker, investigator, and consultant for the pharmaceutical company. All of the other investigators for this study also disclosed relationships with Galderma.

Combination adapalene-benzoyl peroxide for acne vulgaris is more effective than either therapy alone, according to the results of a new analysis.

The therapy reduced total lesion count after 12 weeks, regardless of a patient's initial number of lesions, according to Dr. Steven R. Feldman of the department of dermatology at Wake Forest University, Winston-Salem, N.C., and his colleagues.

    Dr. Steven R. Feldman

The investigators pooled data from three multicenter, randomized clinical trials of similar design, totaling 3,853 patients. The three studies had four treatment groups (combination, adapalene only, benzoyl peroxide [BPO] only, and a gel vehicle).

The study investigators defined three subgroups based on lesion count: lowest 25%, middle 50%, and highest 25%. They found that efficacy of adapalene-benzoyl relative to its gel vehicle increased with number of lesions (J. Amer. Acad. Dermatol. 2011 [doi:10.1016/j.jaad.2010.03.036]).

Also, "adapalene-BPO was significantly more efficacious, compared with the monotherapies and vehicle in percent reduction of inflammatory, noninflammatory, and total lesions," the investigators wrote. "The superior efficacy of adapalene-BPO was also confirmed in all lesion count subgroups."

Total lesion counts in the three subgroups treated with combination therapy were reduced by 19%, 26%, and 29%, respectively.

The patients were aged 12 years or older and had 20-50 inflammatory lesions and 30-100 noninflammatory lesions on their face. Although 495 patients dropped out of the study, they were proportionally distributed among the three subgroups.

As for adverse events, tolerability was similar across all lesion count subgroups, with events being highest at week 1. The most common side effect was dry sin.

Dr. Feldman said in an interview that by subtracting the effect of the gel vehicle, he could more clearly determine the effect of the drug itself, since the study did not incorporate a placebo. However, he added, in clinical practice what is important is the full effect of the drug for the patient, aided by the gel vehicle.

He concluded that because the combination therapy showed similar overall improvement in the low- and high-lesion count groups, topical drugs are a viable first option even for severe acne cases. In addition, studies show that combination therapies simplify treatment for the patient and increase likelihood of adherence.

The study received funding from Galderma. Dr. Feldman disclosed receiving grant funding from Galderma, as well as serving as a speaker, investigator, and consultant for the pharmaceutical company. All of the other investigators for this study also disclosed relationships with Galderma.

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JAAD: Adapalene-Benzoyl Peroxide Improves Even Severe Acne
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FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

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Vitals

Major Finding: Total lesion counts with combination

therapy were reduced by 19% for patients with the lowest lesion count, 26% for patients

with a medium lesion count, and 29% for patients with the highest lesion count.

Data Source: Pooled

data from three multicenter, randomized clinical trials of similar design,

totaling 3,853 patients.

Disclosures: The

study received funding from Galderma. Dr. Feldman disclosed receiving grant

funding from Galderma, as well as serving as a speaker, investigator, and

consultant for the pharmaceutical company. All of the other investigators for

this study also disclosed relationships with Galderma.

Adapalene-Benzoyl Peroxide Improves Even Severe Acne

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Adapalene-Benzoyl Peroxide Improves Even Severe Acne

Combination adapalene-benzoyl peroxide for acne vulgaris is more effective than either therapy alone, according to the results of a new analysis.

The therapy reduced total lesion count after 12 weeks, regardless of a patient’s initial number of lesions, according to Dr. Steven R. Feldman of the department of dermatology at Wake Forest University, Winston-Salem, N.C., and his colleagues.

    Dr. Steven R. Feldman

The investigators pooled data from three multicenter, randomized clinical trials of similar design, totaling 3,853 patients. The three studies had four treatment groups (combination, adapalene only, benzoyl peroxide [BPO] only, and a gel vehicle).

The study investigators defined three subgroups based on lesion count: lowest 25%, middle 50%, and highest 25%. They found that efficacy of adapalene-benzoyl relative to its gel vehicle increased with number of lesions (J. Amer. Acad. Dermatol. 2011 [doi:10.1016/j.jaad.2010.03.036]).

Also, "adapalene-BPO was significantly more efficacious, compared with the monotherapies and vehicle in percent reduction of inflammatory, noninflammatory, and total lesions," the investigators wrote. "The superior efficacy of adapalene-BPO was also confirmed in all lesion count subgroups."

Total lesion counts in the three subgroups treated with combination therapy were reduced by 19%, 26%, and 29%, respectively.

The patients were aged 12 years or older and had 20-50 inflammatory lesions and 30-100 noninflammatory lesions on their face. Although 495 patients dropped out of the study, they were proportionally distributed among the three subgroups.

As for adverse events, tolerability was similar across all lesion count subgroups, with events being highest at week 1. The most common side effect was dry sin.

Dr. Feldman said in an interview that by subtracting the effect of the gel vehicle, he could more clearly determine the effect of the drug itself, since the study did not incorporate a placebo. However, he added, in clinical practice what is important is the full effect of the drug for the patient, aided by the gel vehicle.

He concluded that because the combination therapy showed similar overall improvement in the low- and high-lesion count groups, topical drugs are a viable first option even for severe acne cases. In addition, studies show that combination therapies simplify treatment for the patient and increase likelihood of adherence.

The study received funding from Galderma. Dr. Feldman disclosed receiving grant funding from Galderma, as well as serving as a speaker, investigator, and consultant for the pharmaceutical company. All of the other investigators for this study also disclosed relationships with Galderma.

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Combination adapalene-benzoyl peroxide for acne vulgaris is more effective than either therapy alone, according to the results of a new analysis.

The therapy reduced total lesion count after 12 weeks, regardless of a patient’s initial number of lesions, according to Dr. Steven R. Feldman of the department of dermatology at Wake Forest University, Winston-Salem, N.C., and his colleagues.

    Dr. Steven R. Feldman

The investigators pooled data from three multicenter, randomized clinical trials of similar design, totaling 3,853 patients. The three studies had four treatment groups (combination, adapalene only, benzoyl peroxide [BPO] only, and a gel vehicle).

The study investigators defined three subgroups based on lesion count: lowest 25%, middle 50%, and highest 25%. They found that efficacy of adapalene-benzoyl relative to its gel vehicle increased with number of lesions (J. Amer. Acad. Dermatol. 2011 [doi:10.1016/j.jaad.2010.03.036]).

Also, "adapalene-BPO was significantly more efficacious, compared with the monotherapies and vehicle in percent reduction of inflammatory, noninflammatory, and total lesions," the investigators wrote. "The superior efficacy of adapalene-BPO was also confirmed in all lesion count subgroups."

Total lesion counts in the three subgroups treated with combination therapy were reduced by 19%, 26%, and 29%, respectively.

The patients were aged 12 years or older and had 20-50 inflammatory lesions and 30-100 noninflammatory lesions on their face. Although 495 patients dropped out of the study, they were proportionally distributed among the three subgroups.

As for adverse events, tolerability was similar across all lesion count subgroups, with events being highest at week 1. The most common side effect was dry sin.

Dr. Feldman said in an interview that by subtracting the effect of the gel vehicle, he could more clearly determine the effect of the drug itself, since the study did not incorporate a placebo. However, he added, in clinical practice what is important is the full effect of the drug for the patient, aided by the gel vehicle.

He concluded that because the combination therapy showed similar overall improvement in the low- and high-lesion count groups, topical drugs are a viable first option even for severe acne cases. In addition, studies show that combination therapies simplify treatment for the patient and increase likelihood of adherence.

The study received funding from Galderma. Dr. Feldman disclosed receiving grant funding from Galderma, as well as serving as a speaker, investigator, and consultant for the pharmaceutical company. All of the other investigators for this study also disclosed relationships with Galderma.

Combination adapalene-benzoyl peroxide for acne vulgaris is more effective than either therapy alone, according to the results of a new analysis.

The therapy reduced total lesion count after 12 weeks, regardless of a patient’s initial number of lesions, according to Dr. Steven R. Feldman of the department of dermatology at Wake Forest University, Winston-Salem, N.C., and his colleagues.

    Dr. Steven R. Feldman

The investigators pooled data from three multicenter, randomized clinical trials of similar design, totaling 3,853 patients. The three studies had four treatment groups (combination, adapalene only, benzoyl peroxide [BPO] only, and a gel vehicle).

The study investigators defined three subgroups based on lesion count: lowest 25%, middle 50%, and highest 25%. They found that efficacy of adapalene-benzoyl relative to its gel vehicle increased with number of lesions (J. Amer. Acad. Dermatol. 2011 [doi:10.1016/j.jaad.2010.03.036]).

Also, "adapalene-BPO was significantly more efficacious, compared with the monotherapies and vehicle in percent reduction of inflammatory, noninflammatory, and total lesions," the investigators wrote. "The superior efficacy of adapalene-BPO was also confirmed in all lesion count subgroups."

Total lesion counts in the three subgroups treated with combination therapy were reduced by 19%, 26%, and 29%, respectively.

The patients were aged 12 years or older and had 20-50 inflammatory lesions and 30-100 noninflammatory lesions on their face. Although 495 patients dropped out of the study, they were proportionally distributed among the three subgroups.

As for adverse events, tolerability was similar across all lesion count subgroups, with events being highest at week 1. The most common side effect was dry sin.

Dr. Feldman said in an interview that by subtracting the effect of the gel vehicle, he could more clearly determine the effect of the drug itself, since the study did not incorporate a placebo. However, he added, in clinical practice what is important is the full effect of the drug for the patient, aided by the gel vehicle.

He concluded that because the combination therapy showed similar overall improvement in the low- and high-lesion count groups, topical drugs are a viable first option even for severe acne cases. In addition, studies show that combination therapies simplify treatment for the patient and increase likelihood of adherence.

The study received funding from Galderma. Dr. Feldman disclosed receiving grant funding from Galderma, as well as serving as a speaker, investigator, and consultant for the pharmaceutical company. All of the other investigators for this study also disclosed relationships with Galderma.

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Depression From Pregnancy Loss Lingers

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Depression From Pregnancy Loss Lingers

Women who have lost a baby in a miscarriage or stillbirth can experience persistent depression during a later pregnancy that continues even after the birth of a healthy baby.

In a study of 13,133 women who gave birth in the early 1990s in southwest England and 21% had experienced miscarriages or stillbirths, “previous prenatal loss showed a persisting prediction of depressive and anxiety symptoms well after what would conventionally be defined as the postnatal period,” reported Emma Robertson Blackmore, Ph.D., of the University of Rochester Medical Center, New York, and her associates (Br. J. Psychiatry 2011 March 7 [doi:10.1192/bjp.bp.110.083105]).

The study builds on previous findings about increased anxiety and depression in pregnant women who had previously lost a baby in a miscarriage or stillbirth “by showing that the impact persists well past the subsequent pregnancy and despite the birth of a healthy child.” Because depression is very treatable, Dr. Blackmore emphasized in an interview the need for a heightened focus on identifying women with a previous prenatal loss and routinely screening them for depression.

The study, which drew its large sample from the Avon Longitudinal Study of Parents and Children (ALSPAC), measured data from six assessments, two prenatal (at 18 and 32 weeks) and four post partum (at 8 weeks and 8, 21, and 33 months). In the first assessment, the women self-reported any previous miscarriages and stillbirths. At each assessment stage, the women self-reported maternal anxiety using the Crown–Crisp Experiential Index (CCEI) and depression using the Edinburgh Postnatal Depression Scale (EPDS).

Covariates included “maternal age at initial interview, currently living with husband or partner, number of living children, education level, ethnicity, and use of tobacco and alcohol during the first 3 months of pregnancy,” previous depressive episodes, birth weight and gestational age, and a household crowding index. The investigators combined stillbirths and miscarriages after finding no significant difference in results.

Dr. Blackmore, who is in the department of psychiatry, said that she has done extensive work in postpartum depression, but she “was actually quite surprised by the findings” because it never crossed her mind before to ask women about previous loss. She had focused instead on factors such as any history of depression.

She explained how women who had a previous loss can “get incredibly anxious leading up to the gestational point” during which they lost the baby, which is when an ob.gyn. can step in and alleviate anxiety about physical symptoms.

The investigators did not report any relevant financial disclosures. The U.K. Medical Research Council, the Wellcome Trust, and the University of Bristol currently provide core support for ALSPAC. This particular study received funding from the National Institutes of Health.

View on the News

Miscarriages Require More Sensitivity

Dr. Nada Stotland sees this study as an important reminder for physicians not to trivialize miscarriages. “Sometimes medical professionals don't know what to say,” she said, and they may unintentionally hurt the patient by saying “You didn't even know the baby” or “Have another one.”

Because miscarriage is so common, Dr. Stotland thinks that physicians should be screening every woman for depression, whether or not she has risk factors.

The absence of cultural rituals for miscarriages can prevent the patient from getting closure in a time of grief. Dr. Stotland noted how Americans place importance on retrieving the bodies of fallen soldiers, but “we have nothing for miscarriage.” A physician's sensitivity to a patient's desire to name the child or hold a memorial service can help formalize this loss.

“It's just a matter of not saying something dismissive,” she said in an interview.

DR. STOTLAND is a professor of psychiatry and obstetrics and gynecology at Rush Medical College in Chicago. She did not report any relevant financial disclosures.

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Women who have lost a baby in a miscarriage or stillbirth can experience persistent depression during a later pregnancy that continues even after the birth of a healthy baby.

In a study of 13,133 women who gave birth in the early 1990s in southwest England and 21% had experienced miscarriages or stillbirths, “previous prenatal loss showed a persisting prediction of depressive and anxiety symptoms well after what would conventionally be defined as the postnatal period,” reported Emma Robertson Blackmore, Ph.D., of the University of Rochester Medical Center, New York, and her associates (Br. J. Psychiatry 2011 March 7 [doi:10.1192/bjp.bp.110.083105]).

The study builds on previous findings about increased anxiety and depression in pregnant women who had previously lost a baby in a miscarriage or stillbirth “by showing that the impact persists well past the subsequent pregnancy and despite the birth of a healthy child.” Because depression is very treatable, Dr. Blackmore emphasized in an interview the need for a heightened focus on identifying women with a previous prenatal loss and routinely screening them for depression.

The study, which drew its large sample from the Avon Longitudinal Study of Parents and Children (ALSPAC), measured data from six assessments, two prenatal (at 18 and 32 weeks) and four post partum (at 8 weeks and 8, 21, and 33 months). In the first assessment, the women self-reported any previous miscarriages and stillbirths. At each assessment stage, the women self-reported maternal anxiety using the Crown–Crisp Experiential Index (CCEI) and depression using the Edinburgh Postnatal Depression Scale (EPDS).

Covariates included “maternal age at initial interview, currently living with husband or partner, number of living children, education level, ethnicity, and use of tobacco and alcohol during the first 3 months of pregnancy,” previous depressive episodes, birth weight and gestational age, and a household crowding index. The investigators combined stillbirths and miscarriages after finding no significant difference in results.

Dr. Blackmore, who is in the department of psychiatry, said that she has done extensive work in postpartum depression, but she “was actually quite surprised by the findings” because it never crossed her mind before to ask women about previous loss. She had focused instead on factors such as any history of depression.

She explained how women who had a previous loss can “get incredibly anxious leading up to the gestational point” during which they lost the baby, which is when an ob.gyn. can step in and alleviate anxiety about physical symptoms.

The investigators did not report any relevant financial disclosures. The U.K. Medical Research Council, the Wellcome Trust, and the University of Bristol currently provide core support for ALSPAC. This particular study received funding from the National Institutes of Health.

View on the News

Miscarriages Require More Sensitivity

Dr. Nada Stotland sees this study as an important reminder for physicians not to trivialize miscarriages. “Sometimes medical professionals don't know what to say,” she said, and they may unintentionally hurt the patient by saying “You didn't even know the baby” or “Have another one.”

Because miscarriage is so common, Dr. Stotland thinks that physicians should be screening every woman for depression, whether or not she has risk factors.

The absence of cultural rituals for miscarriages can prevent the patient from getting closure in a time of grief. Dr. Stotland noted how Americans place importance on retrieving the bodies of fallen soldiers, but “we have nothing for miscarriage.” A physician's sensitivity to a patient's desire to name the child or hold a memorial service can help formalize this loss.

“It's just a matter of not saying something dismissive,” she said in an interview.

DR. STOTLAND is a professor of psychiatry and obstetrics and gynecology at Rush Medical College in Chicago. She did not report any relevant financial disclosures.

Women who have lost a baby in a miscarriage or stillbirth can experience persistent depression during a later pregnancy that continues even after the birth of a healthy baby.

In a study of 13,133 women who gave birth in the early 1990s in southwest England and 21% had experienced miscarriages or stillbirths, “previous prenatal loss showed a persisting prediction of depressive and anxiety symptoms well after what would conventionally be defined as the postnatal period,” reported Emma Robertson Blackmore, Ph.D., of the University of Rochester Medical Center, New York, and her associates (Br. J. Psychiatry 2011 March 7 [doi:10.1192/bjp.bp.110.083105]).

The study builds on previous findings about increased anxiety and depression in pregnant women who had previously lost a baby in a miscarriage or stillbirth “by showing that the impact persists well past the subsequent pregnancy and despite the birth of a healthy child.” Because depression is very treatable, Dr. Blackmore emphasized in an interview the need for a heightened focus on identifying women with a previous prenatal loss and routinely screening them for depression.

The study, which drew its large sample from the Avon Longitudinal Study of Parents and Children (ALSPAC), measured data from six assessments, two prenatal (at 18 and 32 weeks) and four post partum (at 8 weeks and 8, 21, and 33 months). In the first assessment, the women self-reported any previous miscarriages and stillbirths. At each assessment stage, the women self-reported maternal anxiety using the Crown–Crisp Experiential Index (CCEI) and depression using the Edinburgh Postnatal Depression Scale (EPDS).

Covariates included “maternal age at initial interview, currently living with husband or partner, number of living children, education level, ethnicity, and use of tobacco and alcohol during the first 3 months of pregnancy,” previous depressive episodes, birth weight and gestational age, and a household crowding index. The investigators combined stillbirths and miscarriages after finding no significant difference in results.

Dr. Blackmore, who is in the department of psychiatry, said that she has done extensive work in postpartum depression, but she “was actually quite surprised by the findings” because it never crossed her mind before to ask women about previous loss. She had focused instead on factors such as any history of depression.

She explained how women who had a previous loss can “get incredibly anxious leading up to the gestational point” during which they lost the baby, which is when an ob.gyn. can step in and alleviate anxiety about physical symptoms.

The investigators did not report any relevant financial disclosures. The U.K. Medical Research Council, the Wellcome Trust, and the University of Bristol currently provide core support for ALSPAC. This particular study received funding from the National Institutes of Health.

View on the News

Miscarriages Require More Sensitivity

Dr. Nada Stotland sees this study as an important reminder for physicians not to trivialize miscarriages. “Sometimes medical professionals don't know what to say,” she said, and they may unintentionally hurt the patient by saying “You didn't even know the baby” or “Have another one.”

Because miscarriage is so common, Dr. Stotland thinks that physicians should be screening every woman for depression, whether or not she has risk factors.

The absence of cultural rituals for miscarriages can prevent the patient from getting closure in a time of grief. Dr. Stotland noted how Americans place importance on retrieving the bodies of fallen soldiers, but “we have nothing for miscarriage.” A physician's sensitivity to a patient's desire to name the child or hold a memorial service can help formalize this loss.

“It's just a matter of not saying something dismissive,” she said in an interview.

DR. STOTLAND is a professor of psychiatry and obstetrics and gynecology at Rush Medical College in Chicago. She did not report any relevant financial disclosures.

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Video Report: How Patients View Chronic Disease

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Out of sight, out of mind: If patients don't observe disease symptoms, they may think continuing treatment is unnecessary. Dr. Ethan A. Halm explains how physicians can understand and correct erroneous patient perceptions about chronic disease.

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Out of sight, out of mind: If patients don't observe disease symptoms, they may think continuing treatment is unnecessary. Dr. Ethan A. Halm explains how physicians can understand and correct erroneous patient perceptions about chronic disease.

Out of sight, out of mind: If patients don't observe disease symptoms, they may think continuing treatment is unnecessary. Dr. Ethan A. Halm explains how physicians can understand and correct erroneous patient perceptions about chronic disease.

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