Chronic obstructive pulmonary disease and a new phenotype of lung function impairment predicted progression of frailty in older adults, based on data from more than 5,000 individuals.

COPD has been associated with frailty, but longitudinal data on the association of COPD with progression of frailty are limited, as are data on the potential association of preserved ratio impaired spirometry (PRISm) with frailty progression, wrote Di He, BS, of Zhejiang University, China, and colleagues. 

PRISm has been defined in recent studies as “proportional impairments in FEV1 and FVC, resulting in the normal ratio of FEV1 and FVC.” Individuals with PRISm may transition to normal spirometry or COPD over time, the researchers wrote.

In a study published in the journal Chest, the researchers reviewed data from 5,901 adults aged 50 years and older who were participating on the English Longitudinal Study of Ageing (ELSA), a prospective cohort study. Of these, 3,765 were included in an additional analysis of the association between transitions from normal spirometry to PRISm and the progression of frailty. The mean age of the participants was 65.5 years; 54.9% were women.

The median follow-up period for analysis with frailty progression was 9.5 years for PRISm and COPD and 5.8 years for PRISm transitions. Lung function data were collected at baseline. Based on spirometry data, participants were divided into three lung function groups – normal spirometry, PRISm, and COPD – and each of these was classified based on severity. Frailty was assessed using the frailty index (FI) during the follow-up period.

Frailty progression based on FI was significantly accelerated in patients with PRISm and COPD, compared with individuals with normal spirometry, with additional annual increases of 0.301 and 0.172, respectively (P < .001 for both). 

When stratified by severity, individuals with more severe PRISm and with more COPD had higher baseline FI and faster FI progression, compared with those with mild PRISm and COPD. 

PRISm transitions were assessed over a 4-year interval at the start of the ELSA. Individuals with normal spirometry who transitioned to PRISm during the study had accelerated progression of frailty, as did those with COPD who transitioned to PRISm. However, no significant frailty progression occurred in those who changed from PRISm to normal spirometry. 

The mechanisms behind the associations of PRISm and COPD with frailty remain unclear, but the results were consistent after controlling for multiple confounders, “suggesting PRISm and COPD had independent pathophysiological mechanisms for frailty,” the researchers write in their discussion. Other recent studies have identified sarcopenia as a complication for individuals with lung function impairment, they noted. “Therefore, another plausible explanation could be that PRISm and COPD caused sarcopenia, which accelerated frailty progression,” they say.

The findings were limited by several factors, including the observational design and the potential underestimation of lung function in participants with reversible airflow obstruction because of the use of prebronchodilator spirometry in the cohort study, the researchers noted. 

However, the results were strengthened by the large sample size and high-quality data from the ELSA, as well as by the repeat measures of FI and lung function. The results were consistent after controlling for multiple confounders, and support the need for more research to explore the causality behind the association of PRISm and COPD with frailty, the researchers concluded. 

The study was supported by the Zhejiang Provincial Basic Public Welfare Research Project, the Zhoushan Science and Technology Project, and the Key Laboratory of Intelligent Preventive Medicine of Zhejiang Province. The researchers report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Chronic obstructive pulmonary disease and a new phenotype of lung function impairment predicted progression of frailty in older adults, based on data from more than 5,000 individuals.

COPD has been associated with frailty, but longitudinal data on the association of COPD with progression of frailty are limited, as are data on the potential association of preserved ratio impaired spirometry (PRISm) with frailty progression, wrote Di He, BS, of Zhejiang University, China, and colleagues. 

PRISm has been defined in recent studies as “proportional impairments in FEV1 and FVC, resulting in the normal ratio of FEV1 and FVC.” Individuals with PRISm may transition to normal spirometry or COPD over time, the researchers wrote.

In a study published in the journal Chest, the researchers reviewed data from 5,901 adults aged 50 years and older who were participating on the English Longitudinal Study of Ageing (ELSA), a prospective cohort study. Of these, 3,765 were included in an additional analysis of the association between transitions from normal spirometry to PRISm and the progression of frailty. The mean age of the participants was 65.5 years; 54.9% were women.

The median follow-up period for analysis with frailty progression was 9.5 years for PRISm and COPD and 5.8 years for PRISm transitions. Lung function data were collected at baseline. Based on spirometry data, participants were divided into three lung function groups – normal spirometry, PRISm, and COPD – and each of these was classified based on severity. Frailty was assessed using the frailty index (FI) during the follow-up period.

Frailty progression based on FI was significantly accelerated in patients with PRISm and COPD, compared with individuals with normal spirometry, with additional annual increases of 0.301 and 0.172, respectively (P < .001 for both). 

When stratified by severity, individuals with more severe PRISm and with more COPD had higher baseline FI and faster FI progression, compared with those with mild PRISm and COPD. 

PRISm transitions were assessed over a 4-year interval at the start of the ELSA. Individuals with normal spirometry who transitioned to PRISm during the study had accelerated progression of frailty, as did those with COPD who transitioned to PRISm. However, no significant frailty progression occurred in those who changed from PRISm to normal spirometry. 

The mechanisms behind the associations of PRISm and COPD with frailty remain unclear, but the results were consistent after controlling for multiple confounders, “suggesting PRISm and COPD had independent pathophysiological mechanisms for frailty,” the researchers write in their discussion. Other recent studies have identified sarcopenia as a complication for individuals with lung function impairment, they noted. “Therefore, another plausible explanation could be that PRISm and COPD caused sarcopenia, which accelerated frailty progression,” they say.

The findings were limited by several factors, including the observational design and the potential underestimation of lung function in participants with reversible airflow obstruction because of the use of prebronchodilator spirometry in the cohort study, the researchers noted. 

However, the results were strengthened by the large sample size and high-quality data from the ELSA, as well as by the repeat measures of FI and lung function. The results were consistent after controlling for multiple confounders, and support the need for more research to explore the causality behind the association of PRISm and COPD with frailty, the researchers concluded. 

The study was supported by the Zhejiang Provincial Basic Public Welfare Research Project, the Zhoushan Science and Technology Project, and the Key Laboratory of Intelligent Preventive Medicine of Zhejiang Province. The researchers report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Chronic obstructive pulmonary disease and a new phenotype of lung function impairment predicted progression of frailty in older adults, based on data from more than 5,000 individuals.

COPD has been associated with frailty, but longitudinal data on the association of COPD with progression of frailty are limited, as are data on the potential association of preserved ratio impaired spirometry (PRISm) with frailty progression, wrote Di He, BS, of Zhejiang University, China, and colleagues. 

PRISm has been defined in recent studies as “proportional impairments in FEV1 and FVC, resulting in the normal ratio of FEV1 and FVC.” Individuals with PRISm may transition to normal spirometry or COPD over time, the researchers wrote.

In a study published in the journal Chest, the researchers reviewed data from 5,901 adults aged 50 years and older who were participating on the English Longitudinal Study of Ageing (ELSA), a prospective cohort study. Of these, 3,765 were included in an additional analysis of the association between transitions from normal spirometry to PRISm and the progression of frailty. The mean age of the participants was 65.5 years; 54.9% were women.

The median follow-up period for analysis with frailty progression was 9.5 years for PRISm and COPD and 5.8 years for PRISm transitions. Lung function data were collected at baseline. Based on spirometry data, participants were divided into three lung function groups – normal spirometry, PRISm, and COPD – and each of these was classified based on severity. Frailty was assessed using the frailty index (FI) during the follow-up period.

Frailty progression based on FI was significantly accelerated in patients with PRISm and COPD, compared with individuals with normal spirometry, with additional annual increases of 0.301 and 0.172, respectively (P < .001 for both). 

When stratified by severity, individuals with more severe PRISm and with more COPD had higher baseline FI and faster FI progression, compared with those with mild PRISm and COPD. 

PRISm transitions were assessed over a 4-year interval at the start of the ELSA. Individuals with normal spirometry who transitioned to PRISm during the study had accelerated progression of frailty, as did those with COPD who transitioned to PRISm. However, no significant frailty progression occurred in those who changed from PRISm to normal spirometry. 

The mechanisms behind the associations of PRISm and COPD with frailty remain unclear, but the results were consistent after controlling for multiple confounders, “suggesting PRISm and COPD had independent pathophysiological mechanisms for frailty,” the researchers write in their discussion. Other recent studies have identified sarcopenia as a complication for individuals with lung function impairment, they noted. “Therefore, another plausible explanation could be that PRISm and COPD caused sarcopenia, which accelerated frailty progression,” they say.

The findings were limited by several factors, including the observational design and the potential underestimation of lung function in participants with reversible airflow obstruction because of the use of prebronchodilator spirometry in the cohort study, the researchers noted. 

However, the results were strengthened by the large sample size and high-quality data from the ELSA, as well as by the repeat measures of FI and lung function. The results were consistent after controlling for multiple confounders, and support the need for more research to explore the causality behind the association of PRISm and COPD with frailty, the researchers concluded. 

The study was supported by the Zhejiang Provincial Basic Public Welfare Research Project, the Zhoushan Science and Technology Project, and the Key Laboratory of Intelligent Preventive Medicine of Zhejiang Province. The researchers report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In a specialty dermatology clinic, pediatric lichen sclerosus (LS) was difficult to differentiate from vitiligo, especially in patients with medium to dark skin tones, according to a retrospective review of cases.

Researchers who tallied symptoms and physical exam findings observed fewer statistically significant differences between LS and vitiligo patients than expected, and LS and vitiligo were sometimes misdiagnosed as each other.

“LS must be treated aggressively to prevent long-term sequelae such as permanent scarring and vulvar squamous cell carcinoma, making an accurate diagnosis crucial,” the authors write in a poster they presented at the annual meeting of the Society for Pediatric Dermatology.

The researchers found that pruritus, constipation, and dysuria were the most common symptoms experienced by both LS and vitiligo patients. All were experienced more frequently by LS patients, but only pruritus reached statistical significance (P = .040). Other symptoms experienced only by LS patients included vulvar pain, bleeding, and pain with defecation.

Meanwhile, apart from hypopigmentation and erythema, all physical exam findings were more frequent in LS patients, compared with vitiligo patients, including fissures and purpura/petechiae, but only epidermal atrophy and figure-of-8 distribution of hypopigmentation reached statistical significance (P values of .047 and .036, respectively).

In other findings, LS and vitiligo were misdiagnosed as each other 15 times. Nearly half of the misdiagnoses (46.7%) were made in Black patients, who composed 38.8% of all patients in the study.

“I suspect that some vitiligo cases that were previously ‘misdiagnosed’ as LS were actually LS that just didn’t repigment and then were labeled as vitiligo in the chart,” Dr. Habeshian said.

“And some of those LS cases that previously were misdiagnosed as vitiligo likely had other more subtle LS findings that were missed (shininess and wrinkling of the skin, small fissures, constipation) or that were attributed to comorbid irritant contact dermatitis or another condition,” she said. “It was interesting to see that even in a vulvar dermatology clinic there can be confusion between these diagnoses because the literature on pediatric LS in darker skin tones is so sparse.”

She emphasized that a close exam and detailed history are needed to properly diagnose patients with anogenital skin conditions.

“Don’t forget to ask about constipation and urinary symptoms as well as psychosocial and, in the appropriate patient, sexual and reproductive function,” Dr. Habeshian said. “Based on my experience, pediatric LS is much more common in our community than the literature would suggest. Its psychosocial impact is tremendous but not well documented, particularly in pediatric patients. In my experience, the longer LS is misdiagnosed or mistreated, the more challenging it becomes to manage. You don’t want to miss LS.”

She acknowledged certain limitations of the study, including the fact that photographs were not available for review for many of the earlier years of the clinic. “Therefore, we had to depend on the diagnosis given at the time of the visit,” she said. “This likely accounts in part for the smaller number than expected of significant exam and history findings between LS and vitiligo. We need further studies utilizing a standardized approach to accurate diagnosis.”

Her coauthors were Nikita Menta, Aneka Khilnani, MS, and Tazim Dowlut-McElroy, MD. The researchers reported having no financial disclosures.

 

In a specialty dermatology clinic, pediatric lichen sclerosus (LS) was difficult to differentiate from vitiligo, especially in patients with medium to dark skin tones, according to a retrospective review of cases.

Researchers who tallied symptoms and physical exam findings observed fewer statistically significant differences between LS and vitiligo patients than expected, and LS and vitiligo were sometimes misdiagnosed as each other.

“LS must be treated aggressively to prevent long-term sequelae such as permanent scarring and vulvar squamous cell carcinoma, making an accurate diagnosis crucial,” the authors write in a poster they presented at the annual meeting of the Society for Pediatric Dermatology.

The researchers found that pruritus, constipation, and dysuria were the most common symptoms experienced by both LS and vitiligo patients. All were experienced more frequently by LS patients, but only pruritus reached statistical significance (P = .040). Other symptoms experienced only by LS patients included vulvar pain, bleeding, and pain with defecation.

Meanwhile, apart from hypopigmentation and erythema, all physical exam findings were more frequent in LS patients, compared with vitiligo patients, including fissures and purpura/petechiae, but only epidermal atrophy and figure-of-8 distribution of hypopigmentation reached statistical significance (P values of .047 and .036, respectively).

In other findings, LS and vitiligo were misdiagnosed as each other 15 times. Nearly half of the misdiagnoses (46.7%) were made in Black patients, who composed 38.8% of all patients in the study.

“I suspect that some vitiligo cases that were previously ‘misdiagnosed’ as LS were actually LS that just didn’t repigment and then were labeled as vitiligo in the chart,” Dr. Habeshian said.

“And some of those LS cases that previously were misdiagnosed as vitiligo likely had other more subtle LS findings that were missed (shininess and wrinkling of the skin, small fissures, constipation) or that were attributed to comorbid irritant contact dermatitis or another condition,” she said. “It was interesting to see that even in a vulvar dermatology clinic there can be confusion between these diagnoses because the literature on pediatric LS in darker skin tones is so sparse.”

She emphasized that a close exam and detailed history are needed to properly diagnose patients with anogenital skin conditions.

“Don’t forget to ask about constipation and urinary symptoms as well as psychosocial and, in the appropriate patient, sexual and reproductive function,” Dr. Habeshian said. “Based on my experience, pediatric LS is much more common in our community than the literature would suggest. Its psychosocial impact is tremendous but not well documented, particularly in pediatric patients. In my experience, the longer LS is misdiagnosed or mistreated, the more challenging it becomes to manage. You don’t want to miss LS.”

She acknowledged certain limitations of the study, including the fact that photographs were not available for review for many of the earlier years of the clinic. “Therefore, we had to depend on the diagnosis given at the time of the visit,” she said. “This likely accounts in part for the smaller number than expected of significant exam and history findings between LS and vitiligo. We need further studies utilizing a standardized approach to accurate diagnosis.”

Her coauthors were Nikita Menta, Aneka Khilnani, MS, and Tazim Dowlut-McElroy, MD. The researchers reported having no financial disclosures.

 

In a specialty dermatology clinic, pediatric lichen sclerosus (LS) was difficult to differentiate from vitiligo, especially in patients with medium to dark skin tones, according to a retrospective review of cases.

Researchers who tallied symptoms and physical exam findings observed fewer statistically significant differences between LS and vitiligo patients than expected, and LS and vitiligo were sometimes misdiagnosed as each other.

“LS must be treated aggressively to prevent long-term sequelae such as permanent scarring and vulvar squamous cell carcinoma, making an accurate diagnosis crucial,” the authors write in a poster they presented at the annual meeting of the Society for Pediatric Dermatology.

The researchers found that pruritus, constipation, and dysuria were the most common symptoms experienced by both LS and vitiligo patients. All were experienced more frequently by LS patients, but only pruritus reached statistical significance (P = .040). Other symptoms experienced only by LS patients included vulvar pain, bleeding, and pain with defecation.

Meanwhile, apart from hypopigmentation and erythema, all physical exam findings were more frequent in LS patients, compared with vitiligo patients, including fissures and purpura/petechiae, but only epidermal atrophy and figure-of-8 distribution of hypopigmentation reached statistical significance (P values of .047 and .036, respectively).

In other findings, LS and vitiligo were misdiagnosed as each other 15 times. Nearly half of the misdiagnoses (46.7%) were made in Black patients, who composed 38.8% of all patients in the study.

“I suspect that some vitiligo cases that were previously ‘misdiagnosed’ as LS were actually LS that just didn’t repigment and then were labeled as vitiligo in the chart,” Dr. Habeshian said.

“And some of those LS cases that previously were misdiagnosed as vitiligo likely had other more subtle LS findings that were missed (shininess and wrinkling of the skin, small fissures, constipation) or that were attributed to comorbid irritant contact dermatitis or another condition,” she said. “It was interesting to see that even in a vulvar dermatology clinic there can be confusion between these diagnoses because the literature on pediatric LS in darker skin tones is so sparse.”

She emphasized that a close exam and detailed history are needed to properly diagnose patients with anogenital skin conditions.

“Don’t forget to ask about constipation and urinary symptoms as well as psychosocial and, in the appropriate patient, sexual and reproductive function,” Dr. Habeshian said. “Based on my experience, pediatric LS is much more common in our community than the literature would suggest. Its psychosocial impact is tremendous but not well documented, particularly in pediatric patients. In my experience, the longer LS is misdiagnosed or mistreated, the more challenging it becomes to manage. You don’t want to miss LS.”

She acknowledged certain limitations of the study, including the fact that photographs were not available for review for many of the earlier years of the clinic. “Therefore, we had to depend on the diagnosis given at the time of the visit,” she said. “This likely accounts in part for the smaller number than expected of significant exam and history findings between LS and vitiligo. We need further studies utilizing a standardized approach to accurate diagnosis.”

Her coauthors were Nikita Menta, Aneka Khilnani, MS, and Tazim Dowlut-McElroy, MD. The researchers reported having no financial disclosures.

 

Ancestry was a significant predictor of response to lithium by adults with bipolar disorder (BPD), based on data from 172 individuals.

Lithium remains the first-line treatment for BPD, but clinical improvement occurs in less than one-third of patients, and factors that might affect response, especially genetic factors, have not been well studied, wrote Ana M. Díaz-Zuluaga, MD, of University of Antioquia, Medellín, Colombia, and colleagues.

Previous genetic research identified four linked single nucleotide polymorphisms (SNPs) in a single locus on chromosome 21 that were associated with lithium response, but the study was limited to individuals with European and Asian ancestry, the researchers said.

In a study published in the Journal of Affective Disorders, the researchers identified 172 adults aged 18 and older with a diagnosis of BPD I or II based on the DSM-IV-TR criteria. Participants had been taking lithium continuously for at least 6 months. Lithium response was defined using the Retrospective Criteria of Long-Term Treatment Response in Research Subjects with BD, also known as the Alda scale. Total Alda scale scores of 7 or higher indicated a responder phenotype; scores less than 7 were considered nonresponders.

Ancestry was determined using DNA samples and the software Structure Version 2.2, and participants were classified as Amerindian, African, or European.

The overall response rate to lithium was 15.11% (26 of 172 patients). In a univariate analysis, no significant differences emerged between responders and nonresponders in demographics or clinical characteristics. However, patients responsive to lithium were significantly less likely of African ancestry, compared with nonresponders (0.1 vs. 0.2, P = .005) and more likely of European ancestry (0.5 vs. 0.3, P = .024), and had fewer depressive episodes (2 vs. 3.9, P = .002). The difference in responders vs. nonresponders of Amerindian ancestry was not statistically significant (0.4 vs. 0.5, P = .204).

The researchers then used machine learning based on Advanced Recursive Partitioning Approaches (ARPAs) to create classification trees with and without ancestry components for predicting response to lithium. “Variable importance analysis shows that the most important predictor is the probability of Amerindian ancestry component, followed by the Amerindian and European ancestral components individual variances, and then by the African and European ancestry components,” the researchers wrote.

Without the ancestry component, the sensitivity and specificity for predicting a treatment response to lithium were 50% and 94.5% respectively, with an area under the curve of 72.2%.

“However, when ancestral components are included in the model, the sensitivity and specificity are 93 % and 84 %, respectively,” with an AUC of 89.2%, the researchers said.

Clinical predictors of treatment response included disease duration, number of depressive episodes, total number of affective episodes, and number of manic episodes.

The findings were limited by several factors including the cross-sectional design and potential impact of other psychotropic drugs, the researchers noted. A replication of the study in an independent dataset is needed to validate the findings, they said.

However, the study is the first known to explore the effect of ancestry on bipolar patients’ response to lithium, and suggests that ancestry components have potential predictive value in the clinical setting that could support a more personalized approach to treatment, the researchers said.

The study was supported by PRISMA U.T., Colciencias, Invitación 990 del 3 de Agosto de 2017, Código 111577757629, Contrato 781 de 2017; Convocatoria Programática Ciencias de la Salud 2014-2015 CODI-UdeA, and Convocatoria N.727-2015 Doctorados Nacionales, Colciencias, 2015. The researchers had no financial conflicts to disclose.

Ancestry was a significant predictor of response to lithium by adults with bipolar disorder (BPD), based on data from 172 individuals.

Lithium remains the first-line treatment for BPD, but clinical improvement occurs in less than one-third of patients, and factors that might affect response, especially genetic factors, have not been well studied, wrote Ana M. Díaz-Zuluaga, MD, of University of Antioquia, Medellín, Colombia, and colleagues.

Previous genetic research identified four linked single nucleotide polymorphisms (SNPs) in a single locus on chromosome 21 that were associated with lithium response, but the study was limited to individuals with European and Asian ancestry, the researchers said.

In a study published in the Journal of Affective Disorders, the researchers identified 172 adults aged 18 and older with a diagnosis of BPD I or II based on the DSM-IV-TR criteria. Participants had been taking lithium continuously for at least 6 months. Lithium response was defined using the Retrospective Criteria of Long-Term Treatment Response in Research Subjects with BD, also known as the Alda scale. Total Alda scale scores of 7 or higher indicated a responder phenotype; scores less than 7 were considered nonresponders.

Ancestry was determined using DNA samples and the software Structure Version 2.2, and participants were classified as Amerindian, African, or European.

The overall response rate to lithium was 15.11% (26 of 172 patients). In a univariate analysis, no significant differences emerged between responders and nonresponders in demographics or clinical characteristics. However, patients responsive to lithium were significantly less likely of African ancestry, compared with nonresponders (0.1 vs. 0.2, P = .005) and more likely of European ancestry (0.5 vs. 0.3, P = .024), and had fewer depressive episodes (2 vs. 3.9, P = .002). The difference in responders vs. nonresponders of Amerindian ancestry was not statistically significant (0.4 vs. 0.5, P = .204).

The researchers then used machine learning based on Advanced Recursive Partitioning Approaches (ARPAs) to create classification trees with and without ancestry components for predicting response to lithium. “Variable importance analysis shows that the most important predictor is the probability of Amerindian ancestry component, followed by the Amerindian and European ancestral components individual variances, and then by the African and European ancestry components,” the researchers wrote.

Without the ancestry component, the sensitivity and specificity for predicting a treatment response to lithium were 50% and 94.5% respectively, with an area under the curve of 72.2%.

“However, when ancestral components are included in the model, the sensitivity and specificity are 93 % and 84 %, respectively,” with an AUC of 89.2%, the researchers said.

Clinical predictors of treatment response included disease duration, number of depressive episodes, total number of affective episodes, and number of manic episodes.

The findings were limited by several factors including the cross-sectional design and potential impact of other psychotropic drugs, the researchers noted. A replication of the study in an independent dataset is needed to validate the findings, they said.

However, the study is the first known to explore the effect of ancestry on bipolar patients’ response to lithium, and suggests that ancestry components have potential predictive value in the clinical setting that could support a more personalized approach to treatment, the researchers said.

The study was supported by PRISMA U.T., Colciencias, Invitación 990 del 3 de Agosto de 2017, Código 111577757629, Contrato 781 de 2017; Convocatoria Programática Ciencias de la Salud 2014-2015 CODI-UdeA, and Convocatoria N.727-2015 Doctorados Nacionales, Colciencias, 2015. The researchers had no financial conflicts to disclose.

Ancestry was a significant predictor of response to lithium by adults with bipolar disorder (BPD), based on data from 172 individuals.

Lithium remains the first-line treatment for BPD, but clinical improvement occurs in less than one-third of patients, and factors that might affect response, especially genetic factors, have not been well studied, wrote Ana M. Díaz-Zuluaga, MD, of University of Antioquia, Medellín, Colombia, and colleagues.

Previous genetic research identified four linked single nucleotide polymorphisms (SNPs) in a single locus on chromosome 21 that were associated with lithium response, but the study was limited to individuals with European and Asian ancestry, the researchers said.

In a study published in the Journal of Affective Disorders, the researchers identified 172 adults aged 18 and older with a diagnosis of BPD I or II based on the DSM-IV-TR criteria. Participants had been taking lithium continuously for at least 6 months. Lithium response was defined using the Retrospective Criteria of Long-Term Treatment Response in Research Subjects with BD, also known as the Alda scale. Total Alda scale scores of 7 or higher indicated a responder phenotype; scores less than 7 were considered nonresponders.

Ancestry was determined using DNA samples and the software Structure Version 2.2, and participants were classified as Amerindian, African, or European.

The overall response rate to lithium was 15.11% (26 of 172 patients). In a univariate analysis, no significant differences emerged between responders and nonresponders in demographics or clinical characteristics. However, patients responsive to lithium were significantly less likely of African ancestry, compared with nonresponders (0.1 vs. 0.2, P = .005) and more likely of European ancestry (0.5 vs. 0.3, P = .024), and had fewer depressive episodes (2 vs. 3.9, P = .002). The difference in responders vs. nonresponders of Amerindian ancestry was not statistically significant (0.4 vs. 0.5, P = .204).

The researchers then used machine learning based on Advanced Recursive Partitioning Approaches (ARPAs) to create classification trees with and without ancestry components for predicting response to lithium. “Variable importance analysis shows that the most important predictor is the probability of Amerindian ancestry component, followed by the Amerindian and European ancestral components individual variances, and then by the African and European ancestry components,” the researchers wrote.

Without the ancestry component, the sensitivity and specificity for predicting a treatment response to lithium were 50% and 94.5% respectively, with an area under the curve of 72.2%.

“However, when ancestral components are included in the model, the sensitivity and specificity are 93 % and 84 %, respectively,” with an AUC of 89.2%, the researchers said.

Clinical predictors of treatment response included disease duration, number of depressive episodes, total number of affective episodes, and number of manic episodes.

The findings were limited by several factors including the cross-sectional design and potential impact of other psychotropic drugs, the researchers noted. A replication of the study in an independent dataset is needed to validate the findings, they said.

However, the study is the first known to explore the effect of ancestry on bipolar patients’ response to lithium, and suggests that ancestry components have potential predictive value in the clinical setting that could support a more personalized approach to treatment, the researchers said.

The study was supported by PRISMA U.T., Colciencias, Invitación 990 del 3 de Agosto de 2017, Código 111577757629, Contrato 781 de 2017; Convocatoria Programática Ciencias de la Salud 2014-2015 CODI-UdeA, and Convocatoria N.727-2015 Doctorados Nacionales, Colciencias, 2015. The researchers had no financial conflicts to disclose.

As we navigate the ever-evolving landscape of diabetic foot disease management, I’d like to discuss the updated 2023 International Working Group on the Diabetic Foot guidelines and their implications for our practice. The goal is to create a common language of risk that is easily related from clinician to clinician to patient.

Whatever language we use, though, the problem we face is vast:

• Diabetic foot ulcers affect approximately 18.6 million people worldwide and 1.6 million in the United States each year.
• They are associated with high rates of premature death, with a 5-year mortality rate of 30%. This rate is greater than 70% for those with above-foot amputations, worse than all but the most aggressive cancers.
• The direct costs of treating diabetic foot ulcers in the United States is estimated at $9 billion-$13 billion annually.
• Over 550 million people worldwide have diabetes, with 18.6 million developing foot ulcers annually. Up to 34% of those with diabetes will develop a foot ulcer.
• About 20% of those with a diabetic foot ulcer will undergo amputation, a major cause of which is infection, which affects 50% of foot ulcers.
• Up to 20% of those with a foot ulcer require hospitalization, with 15%-20% undergoing amputation. Inequities exist in diabetes-related foot complications:
• –Rates of major amputation are higher in non-Hispanic Black, Hispanic, and Native American populations, compared with non-Hispanic White populations.
• –Non-Hispanic Black and Hispanic populations present with more advanced ulcers and peripheral artery disease, and are more likely to undergo amputation without revascularization attempt.

The IWGDF, a multidisciplinary team of international experts, has recently updated its guidelines. This team, comprising endocrinologists, internal medicine physicians, physiatrists, podiatrists, and vascular surgeons from across the globe, has worked tirelessly to provide us with a comprehensive guide to managing diabetes-related foot ulcers.

The updated guidelines address five critical clinical questions, each with up to 13 important outcomes. The systematic review that underpins these guidelines identified 149 eligible studies, assessing 28 different systems. This exhaustive research has led to the development of seven key recommendations that address the clinical questions and consider the existence of different clinical settings.

One of the significant updates in the 2023 guidelines is the recommendation of SINBAD – site, ischemia, neuropathy, bacterial infection, area, and depth – as the priority wound classification system for people with diabetes and a foot ulcer. This system is particularly useful for interprofessional communication, describing each composite variable, and conducting clinical audits using the full score. However, the guidelines also recommend the use of other, more specific assessment systems for infection and peripheral artery disease from the Infectious Diseases Society of America/IWGDF when resources and an appropriate level of expertise exist.

The introduction of the Wound, Ischemia and Foot Infection (WIfI) classification system in the guidelines is also a noteworthy development. This system is crucial in assessing perfusion and the likely benefit of revascularization in a person with diabetes and a foot ulcer. By assessing the level of wound ischemia and infection, we can make informed decisions about the need for vascular intervention, which can significantly affect the patient’s outcome. This can be done simply by classifying each of the three categories of wound, ischemia, or foot infection as none, mild, moderate, or severe. By simplifying the very dynamic comorbidities of tissue loss, ischemia, and infection into a usable and predictive scale, it helps us to communicate risk across disciplines. This has been found to be highly predictive of healing, amputation, and mortality.

We use WIfI every day across our system. An example might include a patient we recently treated:

A 76-year-old woman presented with a wound to her left foot. Her past medical history revealed type 2 diabetes, peripheral neuropathy, and documented peripheral artery disease with prior bilateral femoral-popliteal bypass conducted at an external facility. In addition to gangrenous changes to her fourth toe, she displayed erythema and lymphangitic streaking up her dorsal foot. While she was afebrile, her white cell count was 13,000/mcL. Radiographic examinations did not show signs of osteomyelitis. Noninvasive vascular evaluations revealed an ankle brachial index of 0.4 and a toe pressure of 10 mm Hg. An aortogram with a lower-extremity runoff arteriogram confirmed the obstruction of her left femoral-popliteal bypass.

Taking these results into account, her WIfI score was determined as: wound 2 (moderate), ischemia 3 (severe), foot infection 2 (moderate, no sepsis), translating to a clinical stage 4. This denotes a high risk for major amputation.

Following a team discussion, she was taken to the operating room for an initial debridement of her infection which consisted of a partial fourth ray resection to the level of the mid-metatarsal. Following control of the infection, she received a vascular assessment which ultimately constituted a femoral to distal anterior tibial bypass. Following both of these, she was discharged on a negative-pressure wound therapy device, receiving a split-thickness skin graft 4 weeks later.

The guidelines also emphasize the need for specific training, skills, and experience to ensure the accuracy of the recommended systems for characterizing foot ulcers. The person applying these systems should be appropriately trained and, according to their national or regional standards, should have the knowledge, expertise, and skills necessary to manage people with a diabetes-related foot ulcer.

As we continue to navigate the complexities of diabetes-related foot disease, these guidelines serve as a valuable compass, guiding our decisions and actions. They remind us of the importance of continuous learning, collaboration, and the application of evidence-based practice in our work.

I encourage you to delve into these guidelines. Let’s use them to improve our practice, enhance our communication, and, ultimately, provide better care for our patients.

Dr. Armstrong is professor of surgery, director of limb preservation, University of Southern California, Los Angeles. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

As we navigate the ever-evolving landscape of diabetic foot disease management, I’d like to discuss the updated 2023 International Working Group on the Diabetic Foot guidelines and their implications for our practice. The goal is to create a common language of risk that is easily related from clinician to clinician to patient.

Whatever language we use, though, the problem we face is vast:

• Diabetic foot ulcers affect approximately 18.6 million people worldwide and 1.6 million in the United States each year.
• They are associated with high rates of premature death, with a 5-year mortality rate of 30%. This rate is greater than 70% for those with above-foot amputations, worse than all but the most aggressive cancers.
• The direct costs of treating diabetic foot ulcers in the United States is estimated at $9 billion-$13 billion annually.
• Over 550 million people worldwide have diabetes, with 18.6 million developing foot ulcers annually. Up to 34% of those with diabetes will develop a foot ulcer.
• About 20% of those with a diabetic foot ulcer will undergo amputation, a major cause of which is infection, which affects 50% of foot ulcers.
• Up to 20% of those with a foot ulcer require hospitalization, with 15%-20% undergoing amputation. Inequities exist in diabetes-related foot complications:
• –Rates of major amputation are higher in non-Hispanic Black, Hispanic, and Native American populations, compared with non-Hispanic White populations.
• –Non-Hispanic Black and Hispanic populations present with more advanced ulcers and peripheral artery disease, and are more likely to undergo amputation without revascularization attempt.

The IWGDF, a multidisciplinary team of international experts, has recently updated its guidelines. This team, comprising endocrinologists, internal medicine physicians, physiatrists, podiatrists, and vascular surgeons from across the globe, has worked tirelessly to provide us with a comprehensive guide to managing diabetes-related foot ulcers.

The updated guidelines address five critical clinical questions, each with up to 13 important outcomes. The systematic review that underpins these guidelines identified 149 eligible studies, assessing 28 different systems. This exhaustive research has led to the development of seven key recommendations that address the clinical questions and consider the existence of different clinical settings.

One of the significant updates in the 2023 guidelines is the recommendation of SINBAD – site, ischemia, neuropathy, bacterial infection, area, and depth – as the priority wound classification system for people with diabetes and a foot ulcer. This system is particularly useful for interprofessional communication, describing each composite variable, and conducting clinical audits using the full score. However, the guidelines also recommend the use of other, more specific assessment systems for infection and peripheral artery disease from the Infectious Diseases Society of America/IWGDF when resources and an appropriate level of expertise exist.

The introduction of the Wound, Ischemia and Foot Infection (WIfI) classification system in the guidelines is also a noteworthy development. This system is crucial in assessing perfusion and the likely benefit of revascularization in a person with diabetes and a foot ulcer. By assessing the level of wound ischemia and infection, we can make informed decisions about the need for vascular intervention, which can significantly affect the patient’s outcome. This can be done simply by classifying each of the three categories of wound, ischemia, or foot infection as none, mild, moderate, or severe. By simplifying the very dynamic comorbidities of tissue loss, ischemia, and infection into a usable and predictive scale, it helps us to communicate risk across disciplines. This has been found to be highly predictive of healing, amputation, and mortality.

We use WIfI every day across our system. An example might include a patient we recently treated:

A 76-year-old woman presented with a wound to her left foot. Her past medical history revealed type 2 diabetes, peripheral neuropathy, and documented peripheral artery disease with prior bilateral femoral-popliteal bypass conducted at an external facility. In addition to gangrenous changes to her fourth toe, she displayed erythema and lymphangitic streaking up her dorsal foot. While she was afebrile, her white cell count was 13,000/mcL. Radiographic examinations did not show signs of osteomyelitis. Noninvasive vascular evaluations revealed an ankle brachial index of 0.4 and a toe pressure of 10 mm Hg. An aortogram with a lower-extremity runoff arteriogram confirmed the obstruction of her left femoral-popliteal bypass.

Taking these results into account, her WIfI score was determined as: wound 2 (moderate), ischemia 3 (severe), foot infection 2 (moderate, no sepsis), translating to a clinical stage 4. This denotes a high risk for major amputation.

Following a team discussion, she was taken to the operating room for an initial debridement of her infection which consisted of a partial fourth ray resection to the level of the mid-metatarsal. Following control of the infection, she received a vascular assessment which ultimately constituted a femoral to distal anterior tibial bypass. Following both of these, she was discharged on a negative-pressure wound therapy device, receiving a split-thickness skin graft 4 weeks later.

The guidelines also emphasize the need for specific training, skills, and experience to ensure the accuracy of the recommended systems for characterizing foot ulcers. The person applying these systems should be appropriately trained and, according to their national or regional standards, should have the knowledge, expertise, and skills necessary to manage people with a diabetes-related foot ulcer.

As we continue to navigate the complexities of diabetes-related foot disease, these guidelines serve as a valuable compass, guiding our decisions and actions. They remind us of the importance of continuous learning, collaboration, and the application of evidence-based practice in our work.

I encourage you to delve into these guidelines. Let’s use them to improve our practice, enhance our communication, and, ultimately, provide better care for our patients.

Dr. Armstrong is professor of surgery, director of limb preservation, University of Southern California, Los Angeles. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

As we navigate the ever-evolving landscape of diabetic foot disease management, I’d like to discuss the updated 2023 International Working Group on the Diabetic Foot guidelines and their implications for our practice. The goal is to create a common language of risk that is easily related from clinician to clinician to patient.

Whatever language we use, though, the problem we face is vast:

• Diabetic foot ulcers affect approximately 18.6 million people worldwide and 1.6 million in the United States each year.
• They are associated with high rates of premature death, with a 5-year mortality rate of 30%. This rate is greater than 70% for those with above-foot amputations, worse than all but the most aggressive cancers.
• The direct costs of treating diabetic foot ulcers in the United States is estimated at $9 billion-$13 billion annually.
• Over 550 million people worldwide have diabetes, with 18.6 million developing foot ulcers annually. Up to 34% of those with diabetes will develop a foot ulcer.
• About 20% of those with a diabetic foot ulcer will undergo amputation, a major cause of which is infection, which affects 50% of foot ulcers.
• Up to 20% of those with a foot ulcer require hospitalization, with 15%-20% undergoing amputation. Inequities exist in diabetes-related foot complications:
• –Rates of major amputation are higher in non-Hispanic Black, Hispanic, and Native American populations, compared with non-Hispanic White populations.
• –Non-Hispanic Black and Hispanic populations present with more advanced ulcers and peripheral artery disease, and are more likely to undergo amputation without revascularization attempt.

The IWGDF, a multidisciplinary team of international experts, has recently updated its guidelines. This team, comprising endocrinologists, internal medicine physicians, physiatrists, podiatrists, and vascular surgeons from across the globe, has worked tirelessly to provide us with a comprehensive guide to managing diabetes-related foot ulcers.

The updated guidelines address five critical clinical questions, each with up to 13 important outcomes. The systematic review that underpins these guidelines identified 149 eligible studies, assessing 28 different systems. This exhaustive research has led to the development of seven key recommendations that address the clinical questions and consider the existence of different clinical settings.

One of the significant updates in the 2023 guidelines is the recommendation of SINBAD – site, ischemia, neuropathy, bacterial infection, area, and depth – as the priority wound classification system for people with diabetes and a foot ulcer. This system is particularly useful for interprofessional communication, describing each composite variable, and conducting clinical audits using the full score. However, the guidelines also recommend the use of other, more specific assessment systems for infection and peripheral artery disease from the Infectious Diseases Society of America/IWGDF when resources and an appropriate level of expertise exist.

The introduction of the Wound, Ischemia and Foot Infection (WIfI) classification system in the guidelines is also a noteworthy development. This system is crucial in assessing perfusion and the likely benefit of revascularization in a person with diabetes and a foot ulcer. By assessing the level of wound ischemia and infection, we can make informed decisions about the need for vascular intervention, which can significantly affect the patient’s outcome. This can be done simply by classifying each of the three categories of wound, ischemia, or foot infection as none, mild, moderate, or severe. By simplifying the very dynamic comorbidities of tissue loss, ischemia, and infection into a usable and predictive scale, it helps us to communicate risk across disciplines. This has been found to be highly predictive of healing, amputation, and mortality.

We use WIfI every day across our system. An example might include a patient we recently treated:

A 76-year-old woman presented with a wound to her left foot. Her past medical history revealed type 2 diabetes, peripheral neuropathy, and documented peripheral artery disease with prior bilateral femoral-popliteal bypass conducted at an external facility. In addition to gangrenous changes to her fourth toe, she displayed erythema and lymphangitic streaking up her dorsal foot. While she was afebrile, her white cell count was 13,000/mcL. Radiographic examinations did not show signs of osteomyelitis. Noninvasive vascular evaluations revealed an ankle brachial index of 0.4 and a toe pressure of 10 mm Hg. An aortogram with a lower-extremity runoff arteriogram confirmed the obstruction of her left femoral-popliteal bypass.

Taking these results into account, her WIfI score was determined as: wound 2 (moderate), ischemia 3 (severe), foot infection 2 (moderate, no sepsis), translating to a clinical stage 4. This denotes a high risk for major amputation.

Following a team discussion, she was taken to the operating room for an initial debridement of her infection which consisted of a partial fourth ray resection to the level of the mid-metatarsal. Following control of the infection, she received a vascular assessment which ultimately constituted a femoral to distal anterior tibial bypass. Following both of these, she was discharged on a negative-pressure wound therapy device, receiving a split-thickness skin graft 4 weeks later.

The guidelines also emphasize the need for specific training, skills, and experience to ensure the accuracy of the recommended systems for characterizing foot ulcers. The person applying these systems should be appropriately trained and, according to their national or regional standards, should have the knowledge, expertise, and skills necessary to manage people with a diabetes-related foot ulcer.

As we continue to navigate the complexities of diabetes-related foot disease, these guidelines serve as a valuable compass, guiding our decisions and actions. They remind us of the importance of continuous learning, collaboration, and the application of evidence-based practice in our work.

I encourage you to delve into these guidelines. Let’s use them to improve our practice, enhance our communication, and, ultimately, provide better care for our patients.

Dr. Armstrong is professor of surgery, director of limb preservation, University of Southern California, Los Angeles. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

The popular but expensive weight loss drug semaglutide (Wegovy, significantly reduced major adverse cardiovascular events (MACE) by 20% when given to patients, compared with those receiving placebo, in the pivotal SELECT trial, with more than 17,000 enrolled people with overweight or obesity and established cardiovascular disease (CVD), but no diabetes.

The finding should fuel improved patient access to this glucagon-like peptide-1 (GLP-1) agonist weight-loss agent that has historically been hindered by skepticism among U.S. payers, many of whom have criticized the health benefits and cost effectiveness of this drug in people whose only indication for treatment is overweight or obesity.

According to top-line results from SELECT released by Novo Nordisk on Aug. 8, the people randomly assigned to receive weekly 2.4-mg subcutaneous injections of semaglutide showed a significant 20% reduction in their incidence of the combined endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. The announcement added that semaglutide treatment also significantly linked with a drop in the incidence of each of these individual three endpoints; the magnitude of these reductions, however, wasn’t specified, nor was the duration of treatment and follow-up.

The results also showed a level of safety and patient tolerance for weekly 2.4-mg injections of semaglutide that were consistent with prior reports on the agent. Semaglutide as Wegovy received marketing approval from the U.S. Food and Drug Administration in 2021 for weight loss, and in 2017 for glucose control in people with type 2 diabetes, at a weekly maximum dose of 2.0 mg (for which it’s marketed as Ozempic).

SELECT began in 2018 and randomly assigned 17,604 adults aged 45 years and older at more than 800 sites in 41 countries. The company’s announcement noted that the trial had accrued a total of 1,270 study participants with a first MACE event but did not break this total down based on treatment received.
 

‘A good result for patients’

“The topline results from SELECT are exciting, as preventing heart attacks and stroke with a drug that also lowers weight is very important for many patients, especially if the data also show – as I suspect they will – a meaningful improvement of quality of life for patients due to associated weight loss,” commented Naveed Sattar, PhD, a professor of metabolic medicine at the University of Glasgow who was not involved with the study.

Changing how obesity is regarded

“To date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke, or cardiovascular death,” said Martin Holst Lange, executive vice president for development at Novo Nordisk, in the company’s press release.

“SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated.”

Several of the early medical options for aiding weight loss had substantial adverse effects, including increased MACE rates, a history that led to pervasive wariness among physicians over the safety of antiobesity agents and the wisdom of using medically aided weight loss to produce health benefits.

This attitude also helped dampen health insurance coverage of weight-loss treatments. For example, Medicare has a long-standing policy against reimbursing the cost for medications that are used for the indication of weight loss, and a 2003 U.S. law prohibited part D plans from providing this coverage.

Semaglutide belongs to the class of agents that mimic the action of the incretin GLP-1. The introduction of this class of GLP-1 agonists for weight loss began in 2014 with the FDA’s approval of liraglutide (Saxenda), a daily subcutaneous injection that marked the first step toward establishing the class as safe and effective for weight loss and launching a new era in weight-loss treatment.

According to the Novo Nordisk announcement, a full report on results from SELECT will occur “at a scientific meeting later in 2023.”

SELECT is sponsored by Novo Nordisk, the company that markets semaglutide (Wegovy). Dr. Sattar is a consultant to several companies that market GLP-1 receptor agonists, including Novo Nordisk and Lilly, but has had no involvement in SELECT.

A version of this article first appeared on Medscape.com.

The popular but expensive weight loss drug semaglutide (Wegovy, significantly reduced major adverse cardiovascular events (MACE) by 20% when given to patients, compared with those receiving placebo, in the pivotal SELECT trial, with more than 17,000 enrolled people with overweight or obesity and established cardiovascular disease (CVD), but no diabetes.

The finding should fuel improved patient access to this glucagon-like peptide-1 (GLP-1) agonist weight-loss agent that has historically been hindered by skepticism among U.S. payers, many of whom have criticized the health benefits and cost effectiveness of this drug in people whose only indication for treatment is overweight or obesity.

According to top-line results from SELECT released by Novo Nordisk on Aug. 8, the people randomly assigned to receive weekly 2.4-mg subcutaneous injections of semaglutide showed a significant 20% reduction in their incidence of the combined endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. The announcement added that semaglutide treatment also significantly linked with a drop in the incidence of each of these individual three endpoints; the magnitude of these reductions, however, wasn’t specified, nor was the duration of treatment and follow-up.

The results also showed a level of safety and patient tolerance for weekly 2.4-mg injections of semaglutide that were consistent with prior reports on the agent. Semaglutide as Wegovy received marketing approval from the U.S. Food and Drug Administration in 2021 for weight loss, and in 2017 for glucose control in people with type 2 diabetes, at a weekly maximum dose of 2.0 mg (for which it’s marketed as Ozempic).

SELECT began in 2018 and randomly assigned 17,604 adults aged 45 years and older at more than 800 sites in 41 countries. The company’s announcement noted that the trial had accrued a total of 1,270 study participants with a first MACE event but did not break this total down based on treatment received.
 

‘A good result for patients’

“The topline results from SELECT are exciting, as preventing heart attacks and stroke with a drug that also lowers weight is very important for many patients, especially if the data also show – as I suspect they will – a meaningful improvement of quality of life for patients due to associated weight loss,” commented Naveed Sattar, PhD, a professor of metabolic medicine at the University of Glasgow who was not involved with the study.

Changing how obesity is regarded

“To date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke, or cardiovascular death,” said Martin Holst Lange, executive vice president for development at Novo Nordisk, in the company’s press release.

“SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated.”

Several of the early medical options for aiding weight loss had substantial adverse effects, including increased MACE rates, a history that led to pervasive wariness among physicians over the safety of antiobesity agents and the wisdom of using medically aided weight loss to produce health benefits.

This attitude also helped dampen health insurance coverage of weight-loss treatments. For example, Medicare has a long-standing policy against reimbursing the cost for medications that are used for the indication of weight loss, and a 2003 U.S. law prohibited part D plans from providing this coverage.

Semaglutide belongs to the class of agents that mimic the action of the incretin GLP-1. The introduction of this class of GLP-1 agonists for weight loss began in 2014 with the FDA’s approval of liraglutide (Saxenda), a daily subcutaneous injection that marked the first step toward establishing the class as safe and effective for weight loss and launching a new era in weight-loss treatment.

According to the Novo Nordisk announcement, a full report on results from SELECT will occur “at a scientific meeting later in 2023.”

SELECT is sponsored by Novo Nordisk, the company that markets semaglutide (Wegovy). Dr. Sattar is a consultant to several companies that market GLP-1 receptor agonists, including Novo Nordisk and Lilly, but has had no involvement in SELECT.

A version of this article first appeared on Medscape.com.

The popular but expensive weight loss drug semaglutide (Wegovy, significantly reduced major adverse cardiovascular events (MACE) by 20% when given to patients, compared with those receiving placebo, in the pivotal SELECT trial, with more than 17,000 enrolled people with overweight or obesity and established cardiovascular disease (CVD), but no diabetes.

The finding should fuel improved patient access to this glucagon-like peptide-1 (GLP-1) agonist weight-loss agent that has historically been hindered by skepticism among U.S. payers, many of whom have criticized the health benefits and cost effectiveness of this drug in people whose only indication for treatment is overweight or obesity.

According to top-line results from SELECT released by Novo Nordisk on Aug. 8, the people randomly assigned to receive weekly 2.4-mg subcutaneous injections of semaglutide showed a significant 20% reduction in their incidence of the combined endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. The announcement added that semaglutide treatment also significantly linked with a drop in the incidence of each of these individual three endpoints; the magnitude of these reductions, however, wasn’t specified, nor was the duration of treatment and follow-up.

The results also showed a level of safety and patient tolerance for weekly 2.4-mg injections of semaglutide that were consistent with prior reports on the agent. Semaglutide as Wegovy received marketing approval from the U.S. Food and Drug Administration in 2021 for weight loss, and in 2017 for glucose control in people with type 2 diabetes, at a weekly maximum dose of 2.0 mg (for which it’s marketed as Ozempic).

SELECT began in 2018 and randomly assigned 17,604 adults aged 45 years and older at more than 800 sites in 41 countries. The company’s announcement noted that the trial had accrued a total of 1,270 study participants with a first MACE event but did not break this total down based on treatment received.
 

‘A good result for patients’

“The topline results from SELECT are exciting, as preventing heart attacks and stroke with a drug that also lowers weight is very important for many patients, especially if the data also show – as I suspect they will – a meaningful improvement of quality of life for patients due to associated weight loss,” commented Naveed Sattar, PhD, a professor of metabolic medicine at the University of Glasgow who was not involved with the study.

Changing how obesity is regarded

“To date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke, or cardiovascular death,” said Martin Holst Lange, executive vice president for development at Novo Nordisk, in the company’s press release.

“SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated.”

Several of the early medical options for aiding weight loss had substantial adverse effects, including increased MACE rates, a history that led to pervasive wariness among physicians over the safety of antiobesity agents and the wisdom of using medically aided weight loss to produce health benefits.

This attitude also helped dampen health insurance coverage of weight-loss treatments. For example, Medicare has a long-standing policy against reimbursing the cost for medications that are used for the indication of weight loss, and a 2003 U.S. law prohibited part D plans from providing this coverage.

Semaglutide belongs to the class of agents that mimic the action of the incretin GLP-1. The introduction of this class of GLP-1 agonists for weight loss began in 2014 with the FDA’s approval of liraglutide (Saxenda), a daily subcutaneous injection that marked the first step toward establishing the class as safe and effective for weight loss and launching a new era in weight-loss treatment.

According to the Novo Nordisk announcement, a full report on results from SELECT will occur “at a scientific meeting later in 2023.”

SELECT is sponsored by Novo Nordisk, the company that markets semaglutide (Wegovy). Dr. Sattar is a consultant to several companies that market GLP-1 receptor agonists, including Novo Nordisk and Lilly, but has had no involvement in SELECT.

A version of this article first appeared on Medscape.com.

Until the 19th century there was nothing even resembling our current conception of the medical record. A few physicians may have kept personal notes, observations, and some sketches of their patients primarily to be used in teaching medical students or as part of their own curiosity-driven research. However, around 1800 the Governor Council of the State of New York adopted a proposition that all home doctors should register their medical cases again to be used as an educational tool. By 1830 these registries became annual reporting requirements that included admissions and discharges, treatment results, and expenditures. It shouldn’t surprise you learn that a review of these entries could be linked to a doctor’s prospects for promotion.

In 1919 the American College of Surgeons attempted to standardize its members’ “treatment diaries” to look something more like our current medical records with a history, lab tests, diagnosis, treatment plan, and something akin to daily progress notes. However, as late as the 1970s, when I began primary care practice, there were very few dictates on what our office notes should contain. A few (not including myself) had been trained to use a S.O.A.P. format (Subjective, Objective, Assessment, and Plan) to organize their observations. Back then I viewed my office records as primarily a mnemonic device and only because I had a partner did I make any passing attempt at legibility.

With AI staring us in the face and threatening to expand what has become an already bloated medical record, it may be time to reconsider the purpose of the medical record.

Although there was a time when a doctor’s notes simply functioned as a mnemonic, few physicians today practice in isolation and their records must now serve as a vehicle to communicate with covering physicians and consultants.

How detailed do those notes need to be? Do we need more than the hard data – the numbers, the prescriptions, the biometrics, the chronology of the patient’s procedures? As a covering physician or consultant, I’m not really that interested in your subjective observations. It’s not that I don’t trust you, but like any good physician I’m going to take my own history directly from the patient and do my own physical exam. You may have missed something and I owe the patient a fresh look and listen before I render an opinion or prescribe a management plan.

The medical record has become a detailed invoice to be attached to your bill to third-party payers. You need to prove to them that your service has some value. It’s not that the third-party payers don’t trust you ... well maybe that’s the issue. They don’t. So you have to prove to them that you really did something. Since they weren’t in the exam room, you must document that you asked the patient questions, did a thorough exam, and spent a specified amount of time at it. Of course that assumes that there is a direct correlation between the amount of time you spent with the patient and the quality of care. Which isn’t always the case. One sentence merely stating that you are a well-trained professional and did a thorough job doesn’t seem to be good enough. It works for the plumber and the electrician. But again, it’s that trust thing.

Of course there are the licensing and certification organizations that have a legitimate interest in the quality of your work. Because having an observer following you around for a day or two is impractical (which I still think is a good idea), you need to include evidence in your chart that you practice the standard of care by following accepted screening measures and treating according to standard guidelines.

And finally, while we are talking about trust, there is the whole risk management thing – maybe the most potent inflater of medical records. The lawyer-promoted myth “if you didn’t document it, it didn’t happen” encourages doctors to use voluminous verbiage merely to give your lawyer ammunition when you find yourself in a he-said/she-said situation.

Of course all of this needs to be carefully worded because the patient now has and deserves the right to review his or her medical records. And this might be the only good news. AI can be taught to create a medical record that is complete and more easily read and digested by the patient. This could make the records even more voluminous and as more patients become familiar with their own health records they may begin to demand that they become more concise and actually reflect what went on in the visit.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Until the 19th century there was nothing even resembling our current conception of the medical record. A few physicians may have kept personal notes, observations, and some sketches of their patients primarily to be used in teaching medical students or as part of their own curiosity-driven research. However, around 1800 the Governor Council of the State of New York adopted a proposition that all home doctors should register their medical cases again to be used as an educational tool. By 1830 these registries became annual reporting requirements that included admissions and discharges, treatment results, and expenditures. It shouldn’t surprise you learn that a review of these entries could be linked to a doctor’s prospects for promotion.

In 1919 the American College of Surgeons attempted to standardize its members’ “treatment diaries” to look something more like our current medical records with a history, lab tests, diagnosis, treatment plan, and something akin to daily progress notes. However, as late as the 1970s, when I began primary care practice, there were very few dictates on what our office notes should contain. A few (not including myself) had been trained to use a S.O.A.P. format (Subjective, Objective, Assessment, and Plan) to organize their observations. Back then I viewed my office records as primarily a mnemonic device and only because I had a partner did I make any passing attempt at legibility.

With AI staring us in the face and threatening to expand what has become an already bloated medical record, it may be time to reconsider the purpose of the medical record.

Although there was a time when a doctor’s notes simply functioned as a mnemonic, few physicians today practice in isolation and their records must now serve as a vehicle to communicate with covering physicians and consultants.

How detailed do those notes need to be? Do we need more than the hard data – the numbers, the prescriptions, the biometrics, the chronology of the patient’s procedures? As a covering physician or consultant, I’m not really that interested in your subjective observations. It’s not that I don’t trust you, but like any good physician I’m going to take my own history directly from the patient and do my own physical exam. You may have missed something and I owe the patient a fresh look and listen before I render an opinion or prescribe a management plan.

The medical record has become a detailed invoice to be attached to your bill to third-party payers. You need to prove to them that your service has some value. It’s not that the third-party payers don’t trust you ... well maybe that’s the issue. They don’t. So you have to prove to them that you really did something. Since they weren’t in the exam room, you must document that you asked the patient questions, did a thorough exam, and spent a specified amount of time at it. Of course that assumes that there is a direct correlation between the amount of time you spent with the patient and the quality of care. Which isn’t always the case. One sentence merely stating that you are a well-trained professional and did a thorough job doesn’t seem to be good enough. It works for the plumber and the electrician. But again, it’s that trust thing.

Of course there are the licensing and certification organizations that have a legitimate interest in the quality of your work. Because having an observer following you around for a day or two is impractical (which I still think is a good idea), you need to include evidence in your chart that you practice the standard of care by following accepted screening measures and treating according to standard guidelines.

And finally, while we are talking about trust, there is the whole risk management thing – maybe the most potent inflater of medical records. The lawyer-promoted myth “if you didn’t document it, it didn’t happen” encourages doctors to use voluminous verbiage merely to give your lawyer ammunition when you find yourself in a he-said/she-said situation.

Of course all of this needs to be carefully worded because the patient now has and deserves the right to review his or her medical records. And this might be the only good news. AI can be taught to create a medical record that is complete and more easily read and digested by the patient. This could make the records even more voluminous and as more patients become familiar with their own health records they may begin to demand that they become more concise and actually reflect what went on in the visit.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Until the 19th century there was nothing even resembling our current conception of the medical record. A few physicians may have kept personal notes, observations, and some sketches of their patients primarily to be used in teaching medical students or as part of their own curiosity-driven research. However, around 1800 the Governor Council of the State of New York adopted a proposition that all home doctors should register their medical cases again to be used as an educational tool. By 1830 these registries became annual reporting requirements that included admissions and discharges, treatment results, and expenditures. It shouldn’t surprise you learn that a review of these entries could be linked to a doctor’s prospects for promotion.

In 1919 the American College of Surgeons attempted to standardize its members’ “treatment diaries” to look something more like our current medical records with a history, lab tests, diagnosis, treatment plan, and something akin to daily progress notes. However, as late as the 1970s, when I began primary care practice, there were very few dictates on what our office notes should contain. A few (not including myself) had been trained to use a S.O.A.P. format (Subjective, Objective, Assessment, and Plan) to organize their observations. Back then I viewed my office records as primarily a mnemonic device and only because I had a partner did I make any passing attempt at legibility.

With AI staring us in the face and threatening to expand what has become an already bloated medical record, it may be time to reconsider the purpose of the medical record.

Although there was a time when a doctor’s notes simply functioned as a mnemonic, few physicians today practice in isolation and their records must now serve as a vehicle to communicate with covering physicians and consultants.

How detailed do those notes need to be? Do we need more than the hard data – the numbers, the prescriptions, the biometrics, the chronology of the patient’s procedures? As a covering physician or consultant, I’m not really that interested in your subjective observations. It’s not that I don’t trust you, but like any good physician I’m going to take my own history directly from the patient and do my own physical exam. You may have missed something and I owe the patient a fresh look and listen before I render an opinion or prescribe a management plan.

The medical record has become a detailed invoice to be attached to your bill to third-party payers. You need to prove to them that your service has some value. It’s not that the third-party payers don’t trust you ... well maybe that’s the issue. They don’t. So you have to prove to them that you really did something. Since they weren’t in the exam room, you must document that you asked the patient questions, did a thorough exam, and spent a specified amount of time at it. Of course that assumes that there is a direct correlation between the amount of time you spent with the patient and the quality of care. Which isn’t always the case. One sentence merely stating that you are a well-trained professional and did a thorough job doesn’t seem to be good enough. It works for the plumber and the electrician. But again, it’s that trust thing.

Of course there are the licensing and certification organizations that have a legitimate interest in the quality of your work. Because having an observer following you around for a day or two is impractical (which I still think is a good idea), you need to include evidence in your chart that you practice the standard of care by following accepted screening measures and treating according to standard guidelines.

And finally, while we are talking about trust, there is the whole risk management thing – maybe the most potent inflater of medical records. The lawyer-promoted myth “if you didn’t document it, it didn’t happen” encourages doctors to use voluminous verbiage merely to give your lawyer ammunition when you find yourself in a he-said/she-said situation.

Of course all of this needs to be carefully worded because the patient now has and deserves the right to review his or her medical records. And this might be the only good news. AI can be taught to create a medical record that is complete and more easily read and digested by the patient. This could make the records even more voluminous and as more patients become familiar with their own health records they may begin to demand that they become more concise and actually reflect what went on in the visit.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Antigephyrin autoantibodies have been tied to lower gastrointestinal dysfunction, such as severe constipation and distention, in patients with systemic sclerosis (SSc), new research suggests. Researchers also found that gephyrin is expressed in the patient’s enteric nervous system (ENS), which regulates gut motility.

University of Texas Health Science Center at Houston

“While there are many antibodies that are helpful in identifying patients at risk for extraintestinal complications of this disease, markers that identify patients at higher risk for gastrointestinal complications are limited. Furthermore, the biological mechanisms that cause and perpetuate the progression of gastrointestinal disease in scleroderma are not well understood, making it challenging to distinguish between patients whose gastrointestinal disease will progress from those whose GI disease will remain stable/mild,” Zsuzsanna H. McMahan, MD, MHS, told this news organization in an email. Dr. McMahan is co–first author on the study along with Subhash Kulkarni, PhD. They conducted the research with colleagues when they both worked at Johns Hopkins University in Baltimore, Md.

Hospital for Special Surgery

When asked for comment, Kimberly Lakin, MD, MS, assistant professor of medicine at Weill Cornell Medicine and a rheumatologist at Hospital for Special Surgery, New York, called the study “interesting and novel.”

“Not only did [antigephyrin antibodies] correlate with the presence of lower GI symptoms, but also higher levels of antibodies correlated with worse lower GI symptoms. This suggests that not only could this antibody be used to predict who may have constipation and potentially need more aggressive GI interventions, but it may also be useful in quantifying GI severity in systemic sclerosis, although more research is still needed,” said Dr. Lakin, who was not involved with the research.

The study was published online in Arthritis & Rheumatology.

In the cross-sectional study, researchers identified gephyrin as an autoantigen in sera from a single patient with SSc by isolating it from immunoprecipitations performed with murine myenteric plexus neuron lysates, and then characterizing it by mass spectrometry and validating it in further assays. That patient had GI dysfunction but no defined SSc-associated autoantibodies.

Dr. McMahan and colleagues then investigated the prevalence of the autoantibody by screening the sera of 188 patients with SSc who presented consecutively to the Johns Hopkins Scleroderma Center between April 2016 and August 2017, as well as 40 controls, and compared GI symptom severity between antibody-positive and antibody-negative patients with SSc.

A total of 16 (8.5%) of the 188 patients with SSc had antigephyrin antibodies, compared with none of the controls. Of these 16 patients, 4 had no other defined SSc antibodies. In the SSc cohort, severe constipation was more common in antigephyrin antibody–positive patients, compared with antibody-negative patients (46% vs. 15%). Antibody-positive patients also had higher constipation scores, and severe distension and bloating occurred in the antibody-positive group more than twice as often (54% vs. 25%).

Patients with severe constipation, distention, and bloating had higher antigephyrin antibody levels. After adjusting for confounders such as disease duration, patients with severe constipation were nearly five times as likely (odds ratio, 4.74; P = .010) to be antigephyrin antibody–positive, and patients with severe distention and bloating were nearly four times as likely (OR, 3.71; P = .027) to be antibody-positive.

Last, the authors showed via immunohistochemistry that gephyrin is expressed in the myenteric ganglia of human GI tissue.

“Gastrointestinal function is highly regulated by the ENS, so it is interesting that antibodies that target a protein expressed by ENS cells (gephyrin) were identified in patients with scleroderma who have severe lower bowel dysfunction,” said Dr. McMahan, who is associate professor in the division of rheumatology and codirector of the scleroderma program at the University of Texas Health Science Center at Houston. “Gephyrin is a key mediator of normal communications between nerves in the gut, so it is tantalizing to speculate that autoimmune-mediated disruption (e.g., an inhibitory or blocking antibody) in neural (ENS) communications in the gut might lead to impaired bowel transit and prominent constipation.”

The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and other NIH grants, as well as the Scleroderma Research Foundation, Rheumatology Research Foundation, Jerome L. Greene Foundation, Martha McCrory Professorship, and Chresanthe Stauraluakis Memorial Discovery Fund. The study authors and Dr. Lakin report no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Antigephyrin autoantibodies have been tied to lower gastrointestinal dysfunction, such as severe constipation and distention, in patients with systemic sclerosis (SSc), new research suggests. Researchers also found that gephyrin is expressed in the patient’s enteric nervous system (ENS), which regulates gut motility.

University of Texas Health Science Center at Houston

“While there are many antibodies that are helpful in identifying patients at risk for extraintestinal complications of this disease, markers that identify patients at higher risk for gastrointestinal complications are limited. Furthermore, the biological mechanisms that cause and perpetuate the progression of gastrointestinal disease in scleroderma are not well understood, making it challenging to distinguish between patients whose gastrointestinal disease will progress from those whose GI disease will remain stable/mild,” Zsuzsanna H. McMahan, MD, MHS, told this news organization in an email. Dr. McMahan is co–first author on the study along with Subhash Kulkarni, PhD. They conducted the research with colleagues when they both worked at Johns Hopkins University in Baltimore, Md.

Hospital for Special Surgery

When asked for comment, Kimberly Lakin, MD, MS, assistant professor of medicine at Weill Cornell Medicine and a rheumatologist at Hospital for Special Surgery, New York, called the study “interesting and novel.”

“Not only did [antigephyrin antibodies] correlate with the presence of lower GI symptoms, but also higher levels of antibodies correlated with worse lower GI symptoms. This suggests that not only could this antibody be used to predict who may have constipation and potentially need more aggressive GI interventions, but it may also be useful in quantifying GI severity in systemic sclerosis, although more research is still needed,” said Dr. Lakin, who was not involved with the research.

The study was published online in Arthritis & Rheumatology.

In the cross-sectional study, researchers identified gephyrin as an autoantigen in sera from a single patient with SSc by isolating it from immunoprecipitations performed with murine myenteric plexus neuron lysates, and then characterizing it by mass spectrometry and validating it in further assays. That patient had GI dysfunction but no defined SSc-associated autoantibodies.

Dr. McMahan and colleagues then investigated the prevalence of the autoantibody by screening the sera of 188 patients with SSc who presented consecutively to the Johns Hopkins Scleroderma Center between April 2016 and August 2017, as well as 40 controls, and compared GI symptom severity between antibody-positive and antibody-negative patients with SSc.

A total of 16 (8.5%) of the 188 patients with SSc had antigephyrin antibodies, compared with none of the controls. Of these 16 patients, 4 had no other defined SSc antibodies. In the SSc cohort, severe constipation was more common in antigephyrin antibody–positive patients, compared with antibody-negative patients (46% vs. 15%). Antibody-positive patients also had higher constipation scores, and severe distension and bloating occurred in the antibody-positive group more than twice as often (54% vs. 25%).

Patients with severe constipation, distention, and bloating had higher antigephyrin antibody levels. After adjusting for confounders such as disease duration, patients with severe constipation were nearly five times as likely (odds ratio, 4.74; P = .010) to be antigephyrin antibody–positive, and patients with severe distention and bloating were nearly four times as likely (OR, 3.71; P = .027) to be antibody-positive.

Last, the authors showed via immunohistochemistry that gephyrin is expressed in the myenteric ganglia of human GI tissue.

“Gastrointestinal function is highly regulated by the ENS, so it is interesting that antibodies that target a protein expressed by ENS cells (gephyrin) were identified in patients with scleroderma who have severe lower bowel dysfunction,” said Dr. McMahan, who is associate professor in the division of rheumatology and codirector of the scleroderma program at the University of Texas Health Science Center at Houston. “Gephyrin is a key mediator of normal communications between nerves in the gut, so it is tantalizing to speculate that autoimmune-mediated disruption (e.g., an inhibitory or blocking antibody) in neural (ENS) communications in the gut might lead to impaired bowel transit and prominent constipation.”

The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and other NIH grants, as well as the Scleroderma Research Foundation, Rheumatology Research Foundation, Jerome L. Greene Foundation, Martha McCrory Professorship, and Chresanthe Stauraluakis Memorial Discovery Fund. The study authors and Dr. Lakin report no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Antigephyrin autoantibodies have been tied to lower gastrointestinal dysfunction, such as severe constipation and distention, in patients with systemic sclerosis (SSc), new research suggests. Researchers also found that gephyrin is expressed in the patient’s enteric nervous system (ENS), which regulates gut motility.

University of Texas Health Science Center at Houston

“While there are many antibodies that are helpful in identifying patients at risk for extraintestinal complications of this disease, markers that identify patients at higher risk for gastrointestinal complications are limited. Furthermore, the biological mechanisms that cause and perpetuate the progression of gastrointestinal disease in scleroderma are not well understood, making it challenging to distinguish between patients whose gastrointestinal disease will progress from those whose GI disease will remain stable/mild,” Zsuzsanna H. McMahan, MD, MHS, told this news organization in an email. Dr. McMahan is co–first author on the study along with Subhash Kulkarni, PhD. They conducted the research with colleagues when they both worked at Johns Hopkins University in Baltimore, Md.

Hospital for Special Surgery

When asked for comment, Kimberly Lakin, MD, MS, assistant professor of medicine at Weill Cornell Medicine and a rheumatologist at Hospital for Special Surgery, New York, called the study “interesting and novel.”

“Not only did [antigephyrin antibodies] correlate with the presence of lower GI symptoms, but also higher levels of antibodies correlated with worse lower GI symptoms. This suggests that not only could this antibody be used to predict who may have constipation and potentially need more aggressive GI interventions, but it may also be useful in quantifying GI severity in systemic sclerosis, although more research is still needed,” said Dr. Lakin, who was not involved with the research.

The study was published online in Arthritis & Rheumatology.

In the cross-sectional study, researchers identified gephyrin as an autoantigen in sera from a single patient with SSc by isolating it from immunoprecipitations performed with murine myenteric plexus neuron lysates, and then characterizing it by mass spectrometry and validating it in further assays. That patient had GI dysfunction but no defined SSc-associated autoantibodies.

Dr. McMahan and colleagues then investigated the prevalence of the autoantibody by screening the sera of 188 patients with SSc who presented consecutively to the Johns Hopkins Scleroderma Center between April 2016 and August 2017, as well as 40 controls, and compared GI symptom severity between antibody-positive and antibody-negative patients with SSc.

A total of 16 (8.5%) of the 188 patients with SSc had antigephyrin antibodies, compared with none of the controls. Of these 16 patients, 4 had no other defined SSc antibodies. In the SSc cohort, severe constipation was more common in antigephyrin antibody–positive patients, compared with antibody-negative patients (46% vs. 15%). Antibody-positive patients also had higher constipation scores, and severe distension and bloating occurred in the antibody-positive group more than twice as often (54% vs. 25%).

Patients with severe constipation, distention, and bloating had higher antigephyrin antibody levels. After adjusting for confounders such as disease duration, patients with severe constipation were nearly five times as likely (odds ratio, 4.74; P = .010) to be antigephyrin antibody–positive, and patients with severe distention and bloating were nearly four times as likely (OR, 3.71; P = .027) to be antibody-positive.

Last, the authors showed via immunohistochemistry that gephyrin is expressed in the myenteric ganglia of human GI tissue.

“Gastrointestinal function is highly regulated by the ENS, so it is interesting that antibodies that target a protein expressed by ENS cells (gephyrin) were identified in patients with scleroderma who have severe lower bowel dysfunction,” said Dr. McMahan, who is associate professor in the division of rheumatology and codirector of the scleroderma program at the University of Texas Health Science Center at Houston. “Gephyrin is a key mediator of normal communications between nerves in the gut, so it is tantalizing to speculate that autoimmune-mediated disruption (e.g., an inhibitory or blocking antibody) in neural (ENS) communications in the gut might lead to impaired bowel transit and prominent constipation.”

The study was supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and other NIH grants, as well as the Scleroderma Research Foundation, Rheumatology Research Foundation, Jerome L. Greene Foundation, Martha McCrory Professorship, and Chresanthe Stauraluakis Memorial Discovery Fund. The study authors and Dr. Lakin report no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Adults with exacerbations of chronic obstructive pulmonary disease (ECOPD) whose condition was classified as severe using the Rome criteria had a higher risk of death at 1 year than those who were classified as having moderate or mild disease, as determined from data from more than 300 individuals.

Patients hospitalized with severe exacerbations of ECOPD are at increased risk for worse clinical outcomes and death, so early identification is important, Ernesto Crisafulli, MD, of the University of Verona (Italy) and Azienda Ospedaliera Universitaria Integrata of Verona, and colleagues wrote.

To help predict prognosis for patients with ECOPD, an expert opinion group updated the definition of ECOPD using a new severity classification known as the Rome definition, which grades ECOPD as mild, moderate, or severe on the basis of more objective and disease-related aspects. However, data on the clinical usefulness of the Rome criteria are limited.

In a study published in the journal Chest, the researchers retrospectively categorized 347 adults hospitalized with ECOPD using the Rome severity classifications of mild, moderate, and severe.

Classifications were made using baseline, clinical and microbiological factors, as well as gas analysis and laboratory variables. The researchers also reviewed data on the length of hospital stay and mortality (in-hospital and over a follow-up of 6 months to 3 years).

Approximately one-third of the patients (39%) were classified as having mild disease, 31% as having moderate disease, and 30% as having severe illness. Overall, hospital stay was significantly longer for the patients with severe disease, although in-hospital mortality was similar across all three groups.

Patients classified as having severe disease also had a worse prognosis at all follow-up time points, and severe classification was significantly associated with worse cumulative survival at 1 year and 3 years (Gehan-Breslow-Wilson test, P = .032 and P = .004, respectively).

In a multivariate analysis, the risk of death at 1 year was significantly higher among patients classified as severe or moderate (hazard ratio, 1.99 and 1.47, respectively), compared with those classified as mild.

Mortality risk also was higher among patients aged 80 years and older and among those requiring long-term oxygen therapy or with a history of ECOPD episodes, the researchers noted. Body mass index in the range of 25-29 kg/m² was associated with lower risk.

The study was limited by several factors, including the replacement of dyspnea perception in the Rome classification with other objective measures, the researchers wrote. Other limitations include the retrospective design, small sample size, use of data from a single center, and lack of data on causes of mortality. Women were underrepresented in the study, and so additional research involving women is needed.

The results suggest that the Rome classification allows for the effective identification of patients with ECOPD who have a worse prognosis. The Rome classification may help guide disease management through targeted interventions and personalized care programs for this population, the researchers concluded.

The study received no outside funding. The researchers disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Adults with exacerbations of chronic obstructive pulmonary disease (ECOPD) whose condition was classified as severe using the Rome criteria had a higher risk of death at 1 year than those who were classified as having moderate or mild disease, as determined from data from more than 300 individuals.

Patients hospitalized with severe exacerbations of ECOPD are at increased risk for worse clinical outcomes and death, so early identification is important, Ernesto Crisafulli, MD, of the University of Verona (Italy) and Azienda Ospedaliera Universitaria Integrata of Verona, and colleagues wrote.

To help predict prognosis for patients with ECOPD, an expert opinion group updated the definition of ECOPD using a new severity classification known as the Rome definition, which grades ECOPD as mild, moderate, or severe on the basis of more objective and disease-related aspects. However, data on the clinical usefulness of the Rome criteria are limited.

In a study published in the journal Chest, the researchers retrospectively categorized 347 adults hospitalized with ECOPD using the Rome severity classifications of mild, moderate, and severe.

Classifications were made using baseline, clinical and microbiological factors, as well as gas analysis and laboratory variables. The researchers also reviewed data on the length of hospital stay and mortality (in-hospital and over a follow-up of 6 months to 3 years).

Approximately one-third of the patients (39%) were classified as having mild disease, 31% as having moderate disease, and 30% as having severe illness. Overall, hospital stay was significantly longer for the patients with severe disease, although in-hospital mortality was similar across all three groups.

Patients classified as having severe disease also had a worse prognosis at all follow-up time points, and severe classification was significantly associated with worse cumulative survival at 1 year and 3 years (Gehan-Breslow-Wilson test, P = .032 and P = .004, respectively).

In a multivariate analysis, the risk of death at 1 year was significantly higher among patients classified as severe or moderate (hazard ratio, 1.99 and 1.47, respectively), compared with those classified as mild.

Mortality risk also was higher among patients aged 80 years and older and among those requiring long-term oxygen therapy or with a history of ECOPD episodes, the researchers noted. Body mass index in the range of 25-29 kg/m² was associated with lower risk.

The study was limited by several factors, including the replacement of dyspnea perception in the Rome classification with other objective measures, the researchers wrote. Other limitations include the retrospective design, small sample size, use of data from a single center, and lack of data on causes of mortality. Women were underrepresented in the study, and so additional research involving women is needed.

The results suggest that the Rome classification allows for the effective identification of patients with ECOPD who have a worse prognosis. The Rome classification may help guide disease management through targeted interventions and personalized care programs for this population, the researchers concluded.

The study received no outside funding. The researchers disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Adults with exacerbations of chronic obstructive pulmonary disease (ECOPD) whose condition was classified as severe using the Rome criteria had a higher risk of death at 1 year than those who were classified as having moderate or mild disease, as determined from data from more than 300 individuals.

Patients hospitalized with severe exacerbations of ECOPD are at increased risk for worse clinical outcomes and death, so early identification is important, Ernesto Crisafulli, MD, of the University of Verona (Italy) and Azienda Ospedaliera Universitaria Integrata of Verona, and colleagues wrote.

To help predict prognosis for patients with ECOPD, an expert opinion group updated the definition of ECOPD using a new severity classification known as the Rome definition, which grades ECOPD as mild, moderate, or severe on the basis of more objective and disease-related aspects. However, data on the clinical usefulness of the Rome criteria are limited.

In a study published in the journal Chest, the researchers retrospectively categorized 347 adults hospitalized with ECOPD using the Rome severity classifications of mild, moderate, and severe.

Classifications were made using baseline, clinical and microbiological factors, as well as gas analysis and laboratory variables. The researchers also reviewed data on the length of hospital stay and mortality (in-hospital and over a follow-up of 6 months to 3 years).

Approximately one-third of the patients (39%) were classified as having mild disease, 31% as having moderate disease, and 30% as having severe illness. Overall, hospital stay was significantly longer for the patients with severe disease, although in-hospital mortality was similar across all three groups.

Patients classified as having severe disease also had a worse prognosis at all follow-up time points, and severe classification was significantly associated with worse cumulative survival at 1 year and 3 years (Gehan-Breslow-Wilson test, P = .032 and P = .004, respectively).

In a multivariate analysis, the risk of death at 1 year was significantly higher among patients classified as severe or moderate (hazard ratio, 1.99 and 1.47, respectively), compared with those classified as mild.

Mortality risk also was higher among patients aged 80 years and older and among those requiring long-term oxygen therapy or with a history of ECOPD episodes, the researchers noted. Body mass index in the range of 25-29 kg/m² was associated with lower risk.

The study was limited by several factors, including the replacement of dyspnea perception in the Rome classification with other objective measures, the researchers wrote. Other limitations include the retrospective design, small sample size, use of data from a single center, and lack of data on causes of mortality. Women were underrepresented in the study, and so additional research involving women is needed.

The results suggest that the Rome classification allows for the effective identification of patients with ECOPD who have a worse prognosis. The Rome classification may help guide disease management through targeted interventions and personalized care programs for this population, the researchers concluded.

The study received no outside funding. The researchers disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression.
 

Those are just 4 of the more than 80 pairs of drug names that the Institute for Safe Medication Practices recently added to its list of confusing drug names. The aim is to increase awareness about the potential for a serious medication mistake when the wrong drug is given because of drug names that look and sound similar.

Awareness of these drug names, however, is just the first step in preventing medication mistakes. Health care providers should take a number of other steps as well, experts said.

ISMP launched its confusing drug names list, previously called look-alike, sound-alike (LASA) drugs, in 2008. The new list is an update of the 2019 version, said Michael J. Gaunt, PharmD, senior manager of error reporting programs for the ISMP, which focuses on the prevention of medication mistakes. The new entries were chosen on the basis of a number of factors, including ISMP’s analysis of recent medication mishap reports that were submitted to it.

The ISMP list now includes about 528 drug pairs, Dr. Gaunt said. The list is long, he said, partly because each pair is listed twice, so readers can cross reference. For instance, hydralazine and hydroxyzine are listed in one entry in the list, and hydroxyzine and hydralazine are listed in another.

Brand Institute in Miami has named, among other drugs, Entresto, Rybelsus, and Lunesta. The regulatory arm of the company, the Drug Safety Institute, “considers drug names that have been confused as an important part of our comprehensive drug name assessments,” Todd Bridges, global president of the institute, said in an emailed statement. Information on the confusing drug names are incorporated into the company’s proprietary algorithm and is used when developing brand names for drugs. “We continually update this algorithm as new drug names that are often confused are identified,” Mr. Bridges said.
 

Confusing drug names: Ongoing issue

The length of the list, as well as the latest additions, are not surprising, said Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists, a membership organization of about 60,000 pharmacists who practice in inpatient and outpatient settings.

“I’ve been in practice over 45 years,” she said, “and this has been a problem ever since I have been in practice.” The sheer volume of new drugs is one reason, she said. From 2013 through 2022, the U.S. Food and Drug Administration approved an average of 43 novel drugs per year, according to a report from its Center for Drug Evaluation and Research. “Since the 90s, this [confusion about similar drug names] has happened,” Dr. Kliethermes said.

According to a 2023 report, about 7,000-9,000 people die each year in the United States as the result of a medication error. However, it’s impossible to say for sure what percentage of those errors involve name confusion, Dr. Gaunt said.

Not all the mistakes are reported. Some that are reported are dramatic and deadly. In 2022, a Tennessee nurse was convicted of gross neglect and negligent homicide. She was sentenced to 3 years’ probation after she mistakenly gave vercuronium, an anesthetic agent, instead of the sedative Versed to a patient, and the woman died.
 

Updated list: A closer look

Many of the new drug pairs that are listed in the update are cephalosporins, said Dr. Kliethermes, who reviewed the new list for this news organization. In all, 20 of the latest 82 additions are cephalosporins. These include drugs such as cefazolin, which can be confused with cefotetan, and vice versa. These drugs have been around since the 1980s, she said, but “they needed to be on there.” Even in the 1980s, it was becoming difficult to differentiate them, and there were fewer drugs in that class then, she said.

Influenza vaccines made the new list, too. Fluzone High-Dose Quadrivalent can be confused with fluzone quadrivalent. Other new additions: hydrochlorothiazide and hydroxychloroquine, Lasik and Wakix, Pitressin and Pitocin, Remeron and Rozerem.
 

Beyond the list

While it’s not possible to pinpoint how big a problem name confusion is in causing medication mistakes, “it is certainly still an issue,” Dr. Gaunt said. A variety of practices can reduce that risk substantially, Dr. Gaunt and Dr. Kliethermes agreed.

Tall-man lettering. Both the FDA and the ISMP recommend the use of so-called tall-man lettering (TML), which involves the use of uppercase letters, sometimes in boldface, to distinguish similar names on product labels and elsewhere. Examples include vinBLAStine and vinCRIStine.

Electronic prescribing. “It eliminates the risk of handwriting confusion,” Dr. Gaunt said. However, electronic prescribing can have a downside, Dr. Kliethermes said. When ordering medication, a person may type in a few letters and may then be presented with a prompt that lists several drug names, and it can be easy to click the wrong one. For that reason, ISMP and other experts recommend typing at least five letters when searching for a medication in an electronic system.

Use both brand and generic names on labels and prescriptions.

Write the indication. That can serve as a double check. If a prescription for Ambien says “For sleep,” there’s probably less risk of filling a prescription for ambrisentan, the vasodilator.

Smart formulary additions. When hospitals add medications to their formularies, “part of that formulary assessment should include looking at the potential risk for errors,” Dr. Gaunt said. This involves keeping an eye out for confusing names and similar packaging. “Do that analysis up front and put in strategies to minimize that. Maybe you look for a different drug [for the same use] that has a different name.” Or choose a different manufacturer, so the medication would at least have a different container.

Use bar code scanning. Suppose a pharmacist goes to the shelf and pulls the wrong drug. “Bar code scanning provides the opportunity to catch the error,” Dr. Gaunt said. Many community pharmacies now have bar code scanning. ISMP just issued best practices for community pharmacies, Dr. Gaunt said, and these include the use of bar code scanning and other measures.

Educate consumers. Health care providers can educate consumers on how to minimize the risk of getting the wrong drug, Dr. Gaunt said. When patients are picking up a prescription, suggest they look at the container label; if it looks different from previous prescriptions of the same medicine, ask the pharmacist for an explanation. Some patients just pass it off, Dr. Gaunt said, figuring the pharmacist or health plan switched manufacturers of their medication.

Access the list. The entire list is on the ISMP site and is accessible after free registration.
 

Goal: Preventing confusion

The FDA has provided guidance for industry on naming drugs not yet approved so that the proposed names are not too similar in sound or appearance to those already on the market. Included in the lengthy document are checklists, such as, “Across a range of dialects, are the names consistently pronounced differently?” and “Are the lengths of the names dissimilar when scripted?” (Lengths are considered different if they differ by two or more letters.)

The FDA also offers the phonetic and orthographic computer analysis (POCA) program, a software tool that employs an advanced algorithm to evaluate similarities between two drug names. The data sources are updated regularly as new drugs are approved.
 

Liability update

The problem may be decreasing. In a 2020 report, researchers used pharmacists’ professional liability claim data from the Healthcare Providers Service Organization. They compared 2018 data on claims with 2013 data. The percentage of claims associated with wrong drug dispensing errors declined from 43.8% in 2013 to 36.8% in 2018. Wrong dose claims also declined, from 31.5% to 15.3%.

These researchers concluded that technology and automation have contributed to the prevention of medication errors caused by the use of the wrong drug and the wrong dose, but mistakes continue, owing to system and human errors.

A version of this article first appeared on Medscape.com.

Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression.
 

Those are just 4 of the more than 80 pairs of drug names that the Institute for Safe Medication Practices recently added to its list of confusing drug names. The aim is to increase awareness about the potential for a serious medication mistake when the wrong drug is given because of drug names that look and sound similar.

Awareness of these drug names, however, is just the first step in preventing medication mistakes. Health care providers should take a number of other steps as well, experts said.

ISMP launched its confusing drug names list, previously called look-alike, sound-alike (LASA) drugs, in 2008. The new list is an update of the 2019 version, said Michael J. Gaunt, PharmD, senior manager of error reporting programs for the ISMP, which focuses on the prevention of medication mistakes. The new entries were chosen on the basis of a number of factors, including ISMP’s analysis of recent medication mishap reports that were submitted to it.

The ISMP list now includes about 528 drug pairs, Dr. Gaunt said. The list is long, he said, partly because each pair is listed twice, so readers can cross reference. For instance, hydralazine and hydroxyzine are listed in one entry in the list, and hydroxyzine and hydralazine are listed in another.

Brand Institute in Miami has named, among other drugs, Entresto, Rybelsus, and Lunesta. The regulatory arm of the company, the Drug Safety Institute, “considers drug names that have been confused as an important part of our comprehensive drug name assessments,” Todd Bridges, global president of the institute, said in an emailed statement. Information on the confusing drug names are incorporated into the company’s proprietary algorithm and is used when developing brand names for drugs. “We continually update this algorithm as new drug names that are often confused are identified,” Mr. Bridges said.
 

Confusing drug names: Ongoing issue

The length of the list, as well as the latest additions, are not surprising, said Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists, a membership organization of about 60,000 pharmacists who practice in inpatient and outpatient settings.

“I’ve been in practice over 45 years,” she said, “and this has been a problem ever since I have been in practice.” The sheer volume of new drugs is one reason, she said. From 2013 through 2022, the U.S. Food and Drug Administration approved an average of 43 novel drugs per year, according to a report from its Center for Drug Evaluation and Research. “Since the 90s, this [confusion about similar drug names] has happened,” Dr. Kliethermes said.

According to a 2023 report, about 7,000-9,000 people die each year in the United States as the result of a medication error. However, it’s impossible to say for sure what percentage of those errors involve name confusion, Dr. Gaunt said.

Not all the mistakes are reported. Some that are reported are dramatic and deadly. In 2022, a Tennessee nurse was convicted of gross neglect and negligent homicide. She was sentenced to 3 years’ probation after she mistakenly gave vercuronium, an anesthetic agent, instead of the sedative Versed to a patient, and the woman died.
 

Updated list: A closer look

Many of the new drug pairs that are listed in the update are cephalosporins, said Dr. Kliethermes, who reviewed the new list for this news organization. In all, 20 of the latest 82 additions are cephalosporins. These include drugs such as cefazolin, which can be confused with cefotetan, and vice versa. These drugs have been around since the 1980s, she said, but “they needed to be on there.” Even in the 1980s, it was becoming difficult to differentiate them, and there were fewer drugs in that class then, she said.

Influenza vaccines made the new list, too. Fluzone High-Dose Quadrivalent can be confused with fluzone quadrivalent. Other new additions: hydrochlorothiazide and hydroxychloroquine, Lasik and Wakix, Pitressin and Pitocin, Remeron and Rozerem.
 

Beyond the list

While it’s not possible to pinpoint how big a problem name confusion is in causing medication mistakes, “it is certainly still an issue,” Dr. Gaunt said. A variety of practices can reduce that risk substantially, Dr. Gaunt and Dr. Kliethermes agreed.

Tall-man lettering. Both the FDA and the ISMP recommend the use of so-called tall-man lettering (TML), which involves the use of uppercase letters, sometimes in boldface, to distinguish similar names on product labels and elsewhere. Examples include vinBLAStine and vinCRIStine.

Electronic prescribing. “It eliminates the risk of handwriting confusion,” Dr. Gaunt said. However, electronic prescribing can have a downside, Dr. Kliethermes said. When ordering medication, a person may type in a few letters and may then be presented with a prompt that lists several drug names, and it can be easy to click the wrong one. For that reason, ISMP and other experts recommend typing at least five letters when searching for a medication in an electronic system.

Use both brand and generic names on labels and prescriptions.

Write the indication. That can serve as a double check. If a prescription for Ambien says “For sleep,” there’s probably less risk of filling a prescription for ambrisentan, the vasodilator.

Smart formulary additions. When hospitals add medications to their formularies, “part of that formulary assessment should include looking at the potential risk for errors,” Dr. Gaunt said. This involves keeping an eye out for confusing names and similar packaging. “Do that analysis up front and put in strategies to minimize that. Maybe you look for a different drug [for the same use] that has a different name.” Or choose a different manufacturer, so the medication would at least have a different container.

Use bar code scanning. Suppose a pharmacist goes to the shelf and pulls the wrong drug. “Bar code scanning provides the opportunity to catch the error,” Dr. Gaunt said. Many community pharmacies now have bar code scanning. ISMP just issued best practices for community pharmacies, Dr. Gaunt said, and these include the use of bar code scanning and other measures.

Educate consumers. Health care providers can educate consumers on how to minimize the risk of getting the wrong drug, Dr. Gaunt said. When patients are picking up a prescription, suggest they look at the container label; if it looks different from previous prescriptions of the same medicine, ask the pharmacist for an explanation. Some patients just pass it off, Dr. Gaunt said, figuring the pharmacist or health plan switched manufacturers of their medication.

Access the list. The entire list is on the ISMP site and is accessible after free registration.
 

Goal: Preventing confusion

The FDA has provided guidance for industry on naming drugs not yet approved so that the proposed names are not too similar in sound or appearance to those already on the market. Included in the lengthy document are checklists, such as, “Across a range of dialects, are the names consistently pronounced differently?” and “Are the lengths of the names dissimilar when scripted?” (Lengths are considered different if they differ by two or more letters.)

The FDA also offers the phonetic and orthographic computer analysis (POCA) program, a software tool that employs an advanced algorithm to evaluate similarities between two drug names. The data sources are updated regularly as new drugs are approved.
 

Liability update

The problem may be decreasing. In a 2020 report, researchers used pharmacists’ professional liability claim data from the Healthcare Providers Service Organization. They compared 2018 data on claims with 2013 data. The percentage of claims associated with wrong drug dispensing errors declined from 43.8% in 2013 to 36.8% in 2018. Wrong dose claims also declined, from 31.5% to 15.3%.

These researchers concluded that technology and automation have contributed to the prevention of medication errors caused by the use of the wrong drug and the wrong dose, but mistakes continue, owing to system and human errors.

A version of this article first appeared on Medscape.com.

Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression.
 

Those are just 4 of the more than 80 pairs of drug names that the Institute for Safe Medication Practices recently added to its list of confusing drug names. The aim is to increase awareness about the potential for a serious medication mistake when the wrong drug is given because of drug names that look and sound similar.

Awareness of these drug names, however, is just the first step in preventing medication mistakes. Health care providers should take a number of other steps as well, experts said.

ISMP launched its confusing drug names list, previously called look-alike, sound-alike (LASA) drugs, in 2008. The new list is an update of the 2019 version, said Michael J. Gaunt, PharmD, senior manager of error reporting programs for the ISMP, which focuses on the prevention of medication mistakes. The new entries were chosen on the basis of a number of factors, including ISMP’s analysis of recent medication mishap reports that were submitted to it.

The ISMP list now includes about 528 drug pairs, Dr. Gaunt said. The list is long, he said, partly because each pair is listed twice, so readers can cross reference. For instance, hydralazine and hydroxyzine are listed in one entry in the list, and hydroxyzine and hydralazine are listed in another.

Brand Institute in Miami has named, among other drugs, Entresto, Rybelsus, and Lunesta. The regulatory arm of the company, the Drug Safety Institute, “considers drug names that have been confused as an important part of our comprehensive drug name assessments,” Todd Bridges, global president of the institute, said in an emailed statement. Information on the confusing drug names are incorporated into the company’s proprietary algorithm and is used when developing brand names for drugs. “We continually update this algorithm as new drug names that are often confused are identified,” Mr. Bridges said.
 

Confusing drug names: Ongoing issue

The length of the list, as well as the latest additions, are not surprising, said Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists, a membership organization of about 60,000 pharmacists who practice in inpatient and outpatient settings.

“I’ve been in practice over 45 years,” she said, “and this has been a problem ever since I have been in practice.” The sheer volume of new drugs is one reason, she said. From 2013 through 2022, the U.S. Food and Drug Administration approved an average of 43 novel drugs per year, according to a report from its Center for Drug Evaluation and Research. “Since the 90s, this [confusion about similar drug names] has happened,” Dr. Kliethermes said.

According to a 2023 report, about 7,000-9,000 people die each year in the United States as the result of a medication error. However, it’s impossible to say for sure what percentage of those errors involve name confusion, Dr. Gaunt said.

Not all the mistakes are reported. Some that are reported are dramatic and deadly. In 2022, a Tennessee nurse was convicted of gross neglect and negligent homicide. She was sentenced to 3 years’ probation after she mistakenly gave vercuronium, an anesthetic agent, instead of the sedative Versed to a patient, and the woman died.
 

Updated list: A closer look

Many of the new drug pairs that are listed in the update are cephalosporins, said Dr. Kliethermes, who reviewed the new list for this news organization. In all, 20 of the latest 82 additions are cephalosporins. These include drugs such as cefazolin, which can be confused with cefotetan, and vice versa. These drugs have been around since the 1980s, she said, but “they needed to be on there.” Even in the 1980s, it was becoming difficult to differentiate them, and there were fewer drugs in that class then, she said.

Influenza vaccines made the new list, too. Fluzone High-Dose Quadrivalent can be confused with fluzone quadrivalent. Other new additions: hydrochlorothiazide and hydroxychloroquine, Lasik and Wakix, Pitressin and Pitocin, Remeron and Rozerem.
 

Beyond the list

While it’s not possible to pinpoint how big a problem name confusion is in causing medication mistakes, “it is certainly still an issue,” Dr. Gaunt said. A variety of practices can reduce that risk substantially, Dr. Gaunt and Dr. Kliethermes agreed.

Tall-man lettering. Both the FDA and the ISMP recommend the use of so-called tall-man lettering (TML), which involves the use of uppercase letters, sometimes in boldface, to distinguish similar names on product labels and elsewhere. Examples include vinBLAStine and vinCRIStine.

Electronic prescribing. “It eliminates the risk of handwriting confusion,” Dr. Gaunt said. However, electronic prescribing can have a downside, Dr. Kliethermes said. When ordering medication, a person may type in a few letters and may then be presented with a prompt that lists several drug names, and it can be easy to click the wrong one. For that reason, ISMP and other experts recommend typing at least five letters when searching for a medication in an electronic system.

Use both brand and generic names on labels and prescriptions.

Write the indication. That can serve as a double check. If a prescription for Ambien says “For sleep,” there’s probably less risk of filling a prescription for ambrisentan, the vasodilator.

Smart formulary additions. When hospitals add medications to their formularies, “part of that formulary assessment should include looking at the potential risk for errors,” Dr. Gaunt said. This involves keeping an eye out for confusing names and similar packaging. “Do that analysis up front and put in strategies to minimize that. Maybe you look for a different drug [for the same use] that has a different name.” Or choose a different manufacturer, so the medication would at least have a different container.

Use bar code scanning. Suppose a pharmacist goes to the shelf and pulls the wrong drug. “Bar code scanning provides the opportunity to catch the error,” Dr. Gaunt said. Many community pharmacies now have bar code scanning. ISMP just issued best practices for community pharmacies, Dr. Gaunt said, and these include the use of bar code scanning and other measures.

Educate consumers. Health care providers can educate consumers on how to minimize the risk of getting the wrong drug, Dr. Gaunt said. When patients are picking up a prescription, suggest they look at the container label; if it looks different from previous prescriptions of the same medicine, ask the pharmacist for an explanation. Some patients just pass it off, Dr. Gaunt said, figuring the pharmacist or health plan switched manufacturers of their medication.

Access the list. The entire list is on the ISMP site and is accessible after free registration.
 

Goal: Preventing confusion

The FDA has provided guidance for industry on naming drugs not yet approved so that the proposed names are not too similar in sound or appearance to those already on the market. Included in the lengthy document are checklists, such as, “Across a range of dialects, are the names consistently pronounced differently?” and “Are the lengths of the names dissimilar when scripted?” (Lengths are considered different if they differ by two or more letters.)

The FDA also offers the phonetic and orthographic computer analysis (POCA) program, a software tool that employs an advanced algorithm to evaluate similarities between two drug names. The data sources are updated regularly as new drugs are approved.
 

Liability update

The problem may be decreasing. In a 2020 report, researchers used pharmacists’ professional liability claim data from the Healthcare Providers Service Organization. They compared 2018 data on claims with 2013 data. The percentage of claims associated with wrong drug dispensing errors declined from 43.8% in 2013 to 36.8% in 2018. Wrong dose claims also declined, from 31.5% to 15.3%.

These researchers concluded that technology and automation have contributed to the prevention of medication errors caused by the use of the wrong drug and the wrong dose, but mistakes continue, owing to system and human errors.

A version of this article first appeared on Medscape.com.

As with porridge, so with blood pressure: Just right makes all the difference.

Ill-fitting blood pressure measurement cuffs produce erroneous readings that impair hypertension treatment, according to research published in JAMA Internal Medicine.

People whose mid-upper arm circumference exceeds 32 cm require larger cuffs than the standard size, but in many cases the regular-sized cuff is used on everyone. As a result, patients with larger arms may be falsely diagnosed with high blood pressure because of a too-small cuff, leading to overprescribing of medications that could make their health worse, according to the researchers.  

“A person whose blood pressure is 120/80, which is normal – if they’re using the wrong cuff, they could get a measurement that says 140/90, let’s say,” said study author Tammy M. Brady, MD, PhD, vice chair for clinical research in the department of pediatrics at Johns Hopkins University, Baltimore. “They might think they not only have hypertension, but stage 2 hypertension. Providers might give one or even two medicines to lower this, which could lead to hypotension,” Dr. Brady said.

Conversely, someone with smaller arms whose cuff is too big may present with an artificially low blood pressure. The implications of using ill-fitting cuffs are well known. Dr. Brady, among others, has studied the topic extensively. Even so, she said the measurement errors in the latest study were larger than expected.
 

The Goldilocks test

People with an arm circumference of 20-25 cm should use a smaller cuff than the regular size, Dr. Brady and colleagues reported. Circumferences of 25.1-32 cm require a regular-sized cuff; large cuffs are for circumferences of 32.1-40 cm; and extra-large cuffs should be used at 40.1-55 cm.

The study included 195 residents of Baltimore (128 women, 67 men; 132 Black, 58 White, 5 Hispanic) with an average age of 54 years. The researchers measured every participant’s blood pressure using an automated device on four occasions, taking three measurements each time.

The first three sets of measurements used, respectively, an appropriate cuff size for each person’s arm circumference; a cuff that was too big; and a cuff that was too small. This study design ensured that a regular-sized cuff would be used during one of the three measurements – sometimes that cuff was too small, sometimes it was appropriate, and other times it was too big.

The final set of three measurements used the appropriate cuff size for a person’s arm every time. Dr. Brady and colleagues then compared people’s blood pressure measurements when using the right-sized cuff to measurements with a regular-sized cuff that was not suited for them.

They found that using a cuff that was too large for the patient’s arm (i.e., using a regular cuff when a small cuff was the right choice) led to understating systolic blood pressure by –3.6 mm Hg (95% confidence interval [CI], –5.6 to –1.7). A cuff that was one size too small – using regular instead of a large – overestimated systolic blood pressure by 4.8 (3.0-6.6) mm Hg. And a cuff that was two sizes too small – someone who should have received an extra-large cuff but received the regular size – overestimated systolic blood pressure by 19.5 (16.1-22.9) mm Hg. All differences were statistically significant, the researchers reported.

“To our knowledge, this is the first randomized cross-over trial to examine the effect of miscuffing on automated blood pressure readings,” Mathias Lalika, MD, MPH, of the Mayo Clinic in Rochester, Minn.; Stephen P. Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston; and LaPrincess C. Brewer, MD, MPH, of the Mayo Clinic, wrote in an editorial accompanying the journal article.

“Interestingly, the degree of underestimation or overestimation increased as the appropriate cuff size progressed from the regular to extra-large BP cuff. More importantly, the effect of miscuffing did not vary with BP or obesity status,” they wrote.

“This was more of a pragmatic trial to see real world, all comers,” Dr. Brady said, when regular-sized cuffs are used whether or not that made sense.

“This study reaffirms findings of previous studies and highlights a major source of error in blood pressure measurement,” Raj Padwal, MD, director of the University of Alberta Hypertension Clinic, Edmonton, Alta., said in an interview. Dr. Padwal, who was not involved in the study, said the findings highlight the importance of ensuring that technicians who typically measure blood pressure understand the value of using the right-sized cuff.

Dr. Brady noted that measuring arm circumference takes about 15 seconds. He advised health organizations and clinics to carry multiple cuffs sizes to avoid a scramble to find a right-sized cuff. In the editorial, Dr. Lalika, Dr. Juraschek, and Dr. Brewer call for particular attention to providing the right-sized cuffs to facilities that work with underserved populations, such as federally qualified health centers.

Dr. Padwal added that even a perfectly measured blood pressure test at a clinic indicates pressure at a moment in time. Ten minutes later the story could be different. For this reason, he and other clinicians recommend frequent home blood pressure measurements rather than relying solely on the sparse number of readings collected in the clinic setting.

“A properly educated patient can give many readings that are separated in space and time and, when averaged, can give a much better picture of overall blood pressure and future risk,” Dr. Padwal said. 

Dr. Brady agreed with the value of home readings but said home-based readings also can be erroneous if the patient uses a cuff that is the wrong size. She cochairs a committee for the American Medical Association that recommends validated home blood pressure measurement devices on a periodically updated website called Validate BP. The details for each device listing show the cuff sizes available per device. Many devices provide only the standard cuff, Dr. Brady noted, but some offer multiple cuff sizes.

“One of the things that would be great if it came out of this paper is if patients were empowered to ask physicians to measure their arm” and then use that information to select the appropriate cuff for their home device, she said.

Dr. Brady and Dr. Padwal reported no relevant financial relationships. This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.

A version of this article appeared on Medscape.com.

As with porridge, so with blood pressure: Just right makes all the difference.

Ill-fitting blood pressure measurement cuffs produce erroneous readings that impair hypertension treatment, according to research published in JAMA Internal Medicine.

People whose mid-upper arm circumference exceeds 32 cm require larger cuffs than the standard size, but in many cases the regular-sized cuff is used on everyone. As a result, patients with larger arms may be falsely diagnosed with high blood pressure because of a too-small cuff, leading to overprescribing of medications that could make their health worse, according to the researchers.  

“A person whose blood pressure is 120/80, which is normal – if they’re using the wrong cuff, they could get a measurement that says 140/90, let’s say,” said study author Tammy M. Brady, MD, PhD, vice chair for clinical research in the department of pediatrics at Johns Hopkins University, Baltimore. “They might think they not only have hypertension, but stage 2 hypertension. Providers might give one or even two medicines to lower this, which could lead to hypotension,” Dr. Brady said.

Conversely, someone with smaller arms whose cuff is too big may present with an artificially low blood pressure. The implications of using ill-fitting cuffs are well known. Dr. Brady, among others, has studied the topic extensively. Even so, she said the measurement errors in the latest study were larger than expected.
 

The Goldilocks test

People with an arm circumference of 20-25 cm should use a smaller cuff than the regular size, Dr. Brady and colleagues reported. Circumferences of 25.1-32 cm require a regular-sized cuff; large cuffs are for circumferences of 32.1-40 cm; and extra-large cuffs should be used at 40.1-55 cm.

The study included 195 residents of Baltimore (128 women, 67 men; 132 Black, 58 White, 5 Hispanic) with an average age of 54 years. The researchers measured every participant’s blood pressure using an automated device on four occasions, taking three measurements each time.

The first three sets of measurements used, respectively, an appropriate cuff size for each person’s arm circumference; a cuff that was too big; and a cuff that was too small. This study design ensured that a regular-sized cuff would be used during one of the three measurements – sometimes that cuff was too small, sometimes it was appropriate, and other times it was too big.

The final set of three measurements used the appropriate cuff size for a person’s arm every time. Dr. Brady and colleagues then compared people’s blood pressure measurements when using the right-sized cuff to measurements with a regular-sized cuff that was not suited for them.

They found that using a cuff that was too large for the patient’s arm (i.e., using a regular cuff when a small cuff was the right choice) led to understating systolic blood pressure by –3.6 mm Hg (95% confidence interval [CI], –5.6 to –1.7). A cuff that was one size too small – using regular instead of a large – overestimated systolic blood pressure by 4.8 (3.0-6.6) mm Hg. And a cuff that was two sizes too small – someone who should have received an extra-large cuff but received the regular size – overestimated systolic blood pressure by 19.5 (16.1-22.9) mm Hg. All differences were statistically significant, the researchers reported.

“To our knowledge, this is the first randomized cross-over trial to examine the effect of miscuffing on automated blood pressure readings,” Mathias Lalika, MD, MPH, of the Mayo Clinic in Rochester, Minn.; Stephen P. Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston; and LaPrincess C. Brewer, MD, MPH, of the Mayo Clinic, wrote in an editorial accompanying the journal article.

“Interestingly, the degree of underestimation or overestimation increased as the appropriate cuff size progressed from the regular to extra-large BP cuff. More importantly, the effect of miscuffing did not vary with BP or obesity status,” they wrote.

“This was more of a pragmatic trial to see real world, all comers,” Dr. Brady said, when regular-sized cuffs are used whether or not that made sense.

“This study reaffirms findings of previous studies and highlights a major source of error in blood pressure measurement,” Raj Padwal, MD, director of the University of Alberta Hypertension Clinic, Edmonton, Alta., said in an interview. Dr. Padwal, who was not involved in the study, said the findings highlight the importance of ensuring that technicians who typically measure blood pressure understand the value of using the right-sized cuff.

Dr. Brady noted that measuring arm circumference takes about 15 seconds. He advised health organizations and clinics to carry multiple cuffs sizes to avoid a scramble to find a right-sized cuff. In the editorial, Dr. Lalika, Dr. Juraschek, and Dr. Brewer call for particular attention to providing the right-sized cuffs to facilities that work with underserved populations, such as federally qualified health centers.

Dr. Padwal added that even a perfectly measured blood pressure test at a clinic indicates pressure at a moment in time. Ten minutes later the story could be different. For this reason, he and other clinicians recommend frequent home blood pressure measurements rather than relying solely on the sparse number of readings collected in the clinic setting.

“A properly educated patient can give many readings that are separated in space and time and, when averaged, can give a much better picture of overall blood pressure and future risk,” Dr. Padwal said. 

Dr. Brady agreed with the value of home readings but said home-based readings also can be erroneous if the patient uses a cuff that is the wrong size. She cochairs a committee for the American Medical Association that recommends validated home blood pressure measurement devices on a periodically updated website called Validate BP. The details for each device listing show the cuff sizes available per device. Many devices provide only the standard cuff, Dr. Brady noted, but some offer multiple cuff sizes.

“One of the things that would be great if it came out of this paper is if patients were empowered to ask physicians to measure their arm” and then use that information to select the appropriate cuff for their home device, she said.

Dr. Brady and Dr. Padwal reported no relevant financial relationships. This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.

A version of this article appeared on Medscape.com.

As with porridge, so with blood pressure: Just right makes all the difference.

Ill-fitting blood pressure measurement cuffs produce erroneous readings that impair hypertension treatment, according to research published in JAMA Internal Medicine.

People whose mid-upper arm circumference exceeds 32 cm require larger cuffs than the standard size, but in many cases the regular-sized cuff is used on everyone. As a result, patients with larger arms may be falsely diagnosed with high blood pressure because of a too-small cuff, leading to overprescribing of medications that could make their health worse, according to the researchers.  

“A person whose blood pressure is 120/80, which is normal – if they’re using the wrong cuff, they could get a measurement that says 140/90, let’s say,” said study author Tammy M. Brady, MD, PhD, vice chair for clinical research in the department of pediatrics at Johns Hopkins University, Baltimore. “They might think they not only have hypertension, but stage 2 hypertension. Providers might give one or even two medicines to lower this, which could lead to hypotension,” Dr. Brady said.

Conversely, someone with smaller arms whose cuff is too big may present with an artificially low blood pressure. The implications of using ill-fitting cuffs are well known. Dr. Brady, among others, has studied the topic extensively. Even so, she said the measurement errors in the latest study were larger than expected.
 

The Goldilocks test

People with an arm circumference of 20-25 cm should use a smaller cuff than the regular size, Dr. Brady and colleagues reported. Circumferences of 25.1-32 cm require a regular-sized cuff; large cuffs are for circumferences of 32.1-40 cm; and extra-large cuffs should be used at 40.1-55 cm.

The study included 195 residents of Baltimore (128 women, 67 men; 132 Black, 58 White, 5 Hispanic) with an average age of 54 years. The researchers measured every participant’s blood pressure using an automated device on four occasions, taking three measurements each time.

The first three sets of measurements used, respectively, an appropriate cuff size for each person’s arm circumference; a cuff that was too big; and a cuff that was too small. This study design ensured that a regular-sized cuff would be used during one of the three measurements – sometimes that cuff was too small, sometimes it was appropriate, and other times it was too big.

The final set of three measurements used the appropriate cuff size for a person’s arm every time. Dr. Brady and colleagues then compared people’s blood pressure measurements when using the right-sized cuff to measurements with a regular-sized cuff that was not suited for them.

They found that using a cuff that was too large for the patient’s arm (i.e., using a regular cuff when a small cuff was the right choice) led to understating systolic blood pressure by –3.6 mm Hg (95% confidence interval [CI], –5.6 to –1.7). A cuff that was one size too small – using regular instead of a large – overestimated systolic blood pressure by 4.8 (3.0-6.6) mm Hg. And a cuff that was two sizes too small – someone who should have received an extra-large cuff but received the regular size – overestimated systolic blood pressure by 19.5 (16.1-22.9) mm Hg. All differences were statistically significant, the researchers reported.

“To our knowledge, this is the first randomized cross-over trial to examine the effect of miscuffing on automated blood pressure readings,” Mathias Lalika, MD, MPH, of the Mayo Clinic in Rochester, Minn.; Stephen P. Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston; and LaPrincess C. Brewer, MD, MPH, of the Mayo Clinic, wrote in an editorial accompanying the journal article.

“Interestingly, the degree of underestimation or overestimation increased as the appropriate cuff size progressed from the regular to extra-large BP cuff. More importantly, the effect of miscuffing did not vary with BP or obesity status,” they wrote.

“This was more of a pragmatic trial to see real world, all comers,” Dr. Brady said, when regular-sized cuffs are used whether or not that made sense.

“This study reaffirms findings of previous studies and highlights a major source of error in blood pressure measurement,” Raj Padwal, MD, director of the University of Alberta Hypertension Clinic, Edmonton, Alta., said in an interview. Dr. Padwal, who was not involved in the study, said the findings highlight the importance of ensuring that technicians who typically measure blood pressure understand the value of using the right-sized cuff.

Dr. Brady noted that measuring arm circumference takes about 15 seconds. He advised health organizations and clinics to carry multiple cuffs sizes to avoid a scramble to find a right-sized cuff. In the editorial, Dr. Lalika, Dr. Juraschek, and Dr. Brewer call for particular attention to providing the right-sized cuffs to facilities that work with underserved populations, such as federally qualified health centers.

Dr. Padwal added that even a perfectly measured blood pressure test at a clinic indicates pressure at a moment in time. Ten minutes later the story could be different. For this reason, he and other clinicians recommend frequent home blood pressure measurements rather than relying solely on the sparse number of readings collected in the clinic setting.

“A properly educated patient can give many readings that are separated in space and time and, when averaged, can give a much better picture of overall blood pressure and future risk,” Dr. Padwal said. 

Dr. Brady agreed with the value of home readings but said home-based readings also can be erroneous if the patient uses a cuff that is the wrong size. She cochairs a committee for the American Medical Association that recommends validated home blood pressure measurement devices on a periodically updated website called Validate BP. The details for each device listing show the cuff sizes available per device. Many devices provide only the standard cuff, Dr. Brady noted, but some offer multiple cuff sizes.

“One of the things that would be great if it came out of this paper is if patients were empowered to ask physicians to measure their arm” and then use that information to select the appropriate cuff for their home device, she said.

Dr. Brady and Dr. Padwal reported no relevant financial relationships. This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.

A version of this article appeared on Medscape.com.