Nicola Garrett

Adults with type 2 diabetes or prediabetes in midlife had greater cognitive decline over the next 20 years than did people without diabetes, according to the findings from a large prospective cohort study.

The Atherosclerosis Risk in Communities (ARIC) study of 13,351 adults aged 48-67 years found those with diabetes in midlife had a 19% greater cognitive decline over a 20-year period than did people without diabetes (adjusted global z-score difference, –0.15 (95% confidence interval, –0.22 to –0.08]), according to the findings published online today in Annals of Internal Medicine (doi:10.7326/M14-0737).

The investigators used three neuropsychological tests to assess cognitive function: the delayed word recall test, the digit symbol substitution test of the Wechsler Adult Intelligence Scale–Revised, and the word fluency test.

Cognitive decline was significantly greater in people with prediabetes (HbA_1c level of 5.7%-6.4%), compared with those with an HbA_1c level lower than 5.7%, reported the study authors led by Andreea M. Rawlings of the Johns Hopkins Bloomberg School of Public Health in Baltimore.

People with poorly controlled diabetes (HbA_1c≥7%) had greater cognitive decline than did people with better-controlled disease (adjusted global z-score difference, –0.16; P = .071). The association with cognitive decline was stronger for longer-duration diabetes (P<.001), and the findings were similar for black and white adults (P = .44). Maintaining cognitive function is a critical aspect of successful aging and ensuring a high quality of life, the study authors said.

“Diabetes and glucose control are potentially modifiable and may offer an important opportunity for the prevention of cognitive decline, thus delaying progression to dementia,” they wrote. At the population level, delaying the onset of dementia by even a couple of years could reduce its prevalence by more than 20% over the next 30 years, according to the investigators. Diabetes was assessed at baseline, and cognitive function was assessed at baseline and periodically during the 20-year follow-up.

The study was supported by the National Heart, Lung, and Blood Institute.

Adults with type 2 diabetes or prediabetes in midlife had greater cognitive decline over the next 20 years than did people without diabetes, according to the findings from a large prospective cohort study.

The Atherosclerosis Risk in Communities (ARIC) study of 13,351 adults aged 48-67 years found those with diabetes in midlife had a 19% greater cognitive decline over a 20-year period than did people without diabetes (adjusted global z-score difference, –0.15 (95% confidence interval, –0.22 to –0.08]), according to the findings published online today in Annals of Internal Medicine (doi:10.7326/M14-0737).

The investigators used three neuropsychological tests to assess cognitive function: the delayed word recall test, the digit symbol substitution test of the Wechsler Adult Intelligence Scale–Revised, and the word fluency test.

Cognitive decline was significantly greater in people with prediabetes (HbA_1c level of 5.7%-6.4%), compared with those with an HbA_1c level lower than 5.7%, reported the study authors led by Andreea M. Rawlings of the Johns Hopkins Bloomberg School of Public Health in Baltimore.

People with poorly controlled diabetes (HbA_1c≥7%) had greater cognitive decline than did people with better-controlled disease (adjusted global z-score difference, –0.16; P = .071). The association with cognitive decline was stronger for longer-duration diabetes (P<.001), and the findings were similar for black and white adults (P = .44). Maintaining cognitive function is a critical aspect of successful aging and ensuring a high quality of life, the study authors said.

“Diabetes and glucose control are potentially modifiable and may offer an important opportunity for the prevention of cognitive decline, thus delaying progression to dementia,” they wrote. At the population level, delaying the onset of dementia by even a couple of years could reduce its prevalence by more than 20% over the next 30 years, according to the investigators. Diabetes was assessed at baseline, and cognitive function was assessed at baseline and periodically during the 20-year follow-up.

The study was supported by the National Heart, Lung, and Blood Institute.

Adults with type 2 diabetes or prediabetes in midlife had greater cognitive decline over the next 20 years than did people without diabetes, according to the findings from a large prospective cohort study.

The Atherosclerosis Risk in Communities (ARIC) study of 13,351 adults aged 48-67 years found those with diabetes in midlife had a 19% greater cognitive decline over a 20-year period than did people without diabetes (adjusted global z-score difference, –0.15 (95% confidence interval, –0.22 to –0.08]), according to the findings published online today in Annals of Internal Medicine (doi:10.7326/M14-0737).

The investigators used three neuropsychological tests to assess cognitive function: the delayed word recall test, the digit symbol substitution test of the Wechsler Adult Intelligence Scale–Revised, and the word fluency test.

Cognitive decline was significantly greater in people with prediabetes (HbA_1c level of 5.7%-6.4%), compared with those with an HbA_1c level lower than 5.7%, reported the study authors led by Andreea M. Rawlings of the Johns Hopkins Bloomberg School of Public Health in Baltimore.

People with poorly controlled diabetes (HbA_1c≥7%) had greater cognitive decline than did people with better-controlled disease (adjusted global z-score difference, –0.16; P = .071). The association with cognitive decline was stronger for longer-duration diabetes (P<.001), and the findings were similar for black and white adults (P = .44). Maintaining cognitive function is a critical aspect of successful aging and ensuring a high quality of life, the study authors said.

“Diabetes and glucose control are potentially modifiable and may offer an important opportunity for the prevention of cognitive decline, thus delaying progression to dementia,” they wrote. At the population level, delaying the onset of dementia by even a couple of years could reduce its prevalence by more than 20% over the next 30 years, according to the investigators. Diabetes was assessed at baseline, and cognitive function was assessed at baseline and periodically during the 20-year follow-up.

The study was supported by the National Heart, Lung, and Blood Institute.

Hyperbaric oxygen is no better than a sham procedure for treating persistent postconcussion symptoms in military personnel, according to results from the randomized HOPPS trial.

Both hyperbaric oxygen (HBO) and a sham treatment were associated with significant improvements in postconcussion symptoms and secondary outcomes, including posttraumatic stress disorder, depression, and sleep quality compared to routine post-concussion care, reported Dr. R. Scott Miller of the Uniformed Services University of the Health Sciences, Bethesda, Md., and his associates.

The results suggested that improvements in the chamber intervention groups were tied to placebo effects or the potential benefit of daily interactions with medical staff, the researchers said in the paper published Nov. 17 (JAMA Intern. Med. 2014; [doi:10.1001/jamainternmed.2014.5479]).

The Hyperbaric Oxygen Therapy for Persistent Postconcussive Symptoms After Mild Traumatic Brain Injury (HOPPS) double-blind study randomized 72 military service members who had persistent postconcussion symptoms for more than 4 months to 40 hyperbaric oxygen treatments, 40 sham treatments in an air-filled chamber, or routine postconcussion care.

No differences were seen between the groups for improvement of at least two points (defined as clinically significant) on the Rivermead Post Concussion Symptoms Questionnaire (RPQ) symptoms subscale (RPQ-3) (25% in the no intervention group, 52% in the HBO group, and 33% in the sham group; P = .24). Compared with the no intervention group (average change score, 0.5; P = .91), the HBO and sham groups showed improvement in symptoms on the RPQ total score (average change score, 5.4; P = .008 in the HBO group and 7.0; P = .02 in the sham group).

The results suggest that the improvements seen in the HBO and sham groups were not oxygen mediated but may reflect “nonspecific improvements related to placebo effects.

“Taken with results from other concurrent investigations our study does not support phase III trials of HBO for the treatment of PCS at this time,” the researchers concluded.

Hyperbaric oxygen 100% was administered at a dose of 1.5 atmospheres absolute for 60 minutes at a time. The sham treatment followed the same procedures but the chamber was pressurized to 1.2 atmospheres absolute.

The study sponsor is the U.S. Army Office of the Surgeon General who holds the investigational new drug application for hyperbaric oxygen to treat traumatic brain injury.

Hyperbaric oxygen is no better than a sham procedure for treating persistent postconcussion symptoms in military personnel, according to results from the randomized HOPPS trial.

Both hyperbaric oxygen (HBO) and a sham treatment were associated with significant improvements in postconcussion symptoms and secondary outcomes, including posttraumatic stress disorder, depression, and sleep quality compared to routine post-concussion care, reported Dr. R. Scott Miller of the Uniformed Services University of the Health Sciences, Bethesda, Md., and his associates.

The results suggested that improvements in the chamber intervention groups were tied to placebo effects or the potential benefit of daily interactions with medical staff, the researchers said in the paper published Nov. 17 (JAMA Intern. Med. 2014; [doi:10.1001/jamainternmed.2014.5479]).

The Hyperbaric Oxygen Therapy for Persistent Postconcussive Symptoms After Mild Traumatic Brain Injury (HOPPS) double-blind study randomized 72 military service members who had persistent postconcussion symptoms for more than 4 months to 40 hyperbaric oxygen treatments, 40 sham treatments in an air-filled chamber, or routine postconcussion care.

No differences were seen between the groups for improvement of at least two points (defined as clinically significant) on the Rivermead Post Concussion Symptoms Questionnaire (RPQ) symptoms subscale (RPQ-3) (25% in the no intervention group, 52% in the HBO group, and 33% in the sham group; P = .24). Compared with the no intervention group (average change score, 0.5; P = .91), the HBO and sham groups showed improvement in symptoms on the RPQ total score (average change score, 5.4; P = .008 in the HBO group and 7.0; P = .02 in the sham group).

The results suggest that the improvements seen in the HBO and sham groups were not oxygen mediated but may reflect “nonspecific improvements related to placebo effects.

“Taken with results from other concurrent investigations our study does not support phase III trials of HBO for the treatment of PCS at this time,” the researchers concluded.

Hyperbaric oxygen 100% was administered at a dose of 1.5 atmospheres absolute for 60 minutes at a time. The sham treatment followed the same procedures but the chamber was pressurized to 1.2 atmospheres absolute.

The study sponsor is the U.S. Army Office of the Surgeon General who holds the investigational new drug application for hyperbaric oxygen to treat traumatic brain injury.

Hyperbaric oxygen is no better than a sham procedure for treating persistent postconcussion symptoms in military personnel, according to results from the randomized HOPPS trial.

Both hyperbaric oxygen (HBO) and a sham treatment were associated with significant improvements in postconcussion symptoms and secondary outcomes, including posttraumatic stress disorder, depression, and sleep quality compared to routine post-concussion care, reported Dr. R. Scott Miller of the Uniformed Services University of the Health Sciences, Bethesda, Md., and his associates.

The results suggested that improvements in the chamber intervention groups were tied to placebo effects or the potential benefit of daily interactions with medical staff, the researchers said in the paper published Nov. 17 (JAMA Intern. Med. 2014; [doi:10.1001/jamainternmed.2014.5479]).

The Hyperbaric Oxygen Therapy for Persistent Postconcussive Symptoms After Mild Traumatic Brain Injury (HOPPS) double-blind study randomized 72 military service members who had persistent postconcussion symptoms for more than 4 months to 40 hyperbaric oxygen treatments, 40 sham treatments in an air-filled chamber, or routine postconcussion care.

No differences were seen between the groups for improvement of at least two points (defined as clinically significant) on the Rivermead Post Concussion Symptoms Questionnaire (RPQ) symptoms subscale (RPQ-3) (25% in the no intervention group, 52% in the HBO group, and 33% in the sham group; P = .24). Compared with the no intervention group (average change score, 0.5; P = .91), the HBO and sham groups showed improvement in symptoms on the RPQ total score (average change score, 5.4; P = .008 in the HBO group and 7.0; P = .02 in the sham group).

The results suggest that the improvements seen in the HBO and sham groups were not oxygen mediated but may reflect “nonspecific improvements related to placebo effects.

“Taken with results from other concurrent investigations our study does not support phase III trials of HBO for the treatment of PCS at this time,” the researchers concluded.

Hyperbaric oxygen 100% was administered at a dose of 1.5 atmospheres absolute for 60 minutes at a time. The sham treatment followed the same procedures but the chamber was pressurized to 1.2 atmospheres absolute.

The study sponsor is the U.S. Army Office of the Surgeon General who holds the investigational new drug application for hyperbaric oxygen to treat traumatic brain injury.

The oral drug sodium zirconium cyclosilicate may offer an effective new treatment option for outpatients with mild hyperkalemia, according to results of the phase III, open-label, randomized HARMONIZE trial presented at the American Heart Association scientific sessions.

The sodium-potassium cation exchanger zirconium cyclosilicate reduced potassium levels in 258 patients with mild hyperkalemia to normal levels within 48 hours, compared with placebo, and effectively maintained potassium levels for up to 4 weeks. The findings were published simultaneously in JAMA (JAMA 2014 Nov. 17 [doi: 10.1001/jama.2014.15688]). However, more long-term studies are needed to assess the efficacy and safety of the drug beyond 4 weeks and in patients with more severe hyperkalemia, reported Dr. Mikhail Kosiborod of Saint Luke’s Mid America Heart Institute in Kansas City, Mo., and his colleagues.

In the open-label phase of the study, 258 outpatients with hyperkalemia (serum potassium ≥5.1 mEq/L) were given 10 g of zirconium cyclosilicate three times a day for 48 hours. Mean serum potassium levels significantly declined by 0.2 mEq/L 1 hour after the initial dose and decreased an average 1.1 mEq/L at 48 hours, with 98% (n = 237) of patients achieving normokalemia (3.5-5.0 mEq/L). These patients were then randomized to receive 5 g (n = 45), 10 g (n = 51), or 15 g (n = 56) of zirconium cyclosilicate or placebo (n = 85) daily, and were followed for 28 days.

Zirconium cyclosilicate lowered serum potassium to 4.8, 4.5, and 4.4 mEq/L at 5, 10, and 15 g, respectively, compared with 5.1 mEq/L for placebo. Adverse events were comparable between the treatment and placebo groups, but edema was more common in the 15-g group. Hyperkalemia developed in 10% of the 10-g group and 11% of the 15-g group, compared with no patients in the 5-g or placebo groups.

In an accompanying editorial, Dr. Bradley S. Dixon of the University of Iowa, Iowa City, said the findings suggest that zirconium cyclosilicate may offer an important new treatment for the acute and short-term treatment of outpatients with mild hyperkalemia. “Longer-term studies are needed to assess the clinical benefits and risks that may be related to more extended use of this product, especially among hospitalized patients, as well as those with more severe hyperkalemia, other medical conditions, and other medications that affect potassium homeostasis,” he wrote.

The study was sponsored and funded by ZS Pharma, maker of sodium zirconium cyclosilicate. Dr. Kosiborod reported serving as a consultant for ZS Pharma and as an investigator on the HARMONIZE study. Several coauthors also declared financial interests with ZS Pharma. Dr. Dixon reported financial relationships with multiple companies, but not with ZS Pharma.

The oral drug sodium zirconium cyclosilicate may offer an effective new treatment option for outpatients with mild hyperkalemia, according to results of the phase III, open-label, randomized HARMONIZE trial presented at the American Heart Association scientific sessions.

The sodium-potassium cation exchanger zirconium cyclosilicate reduced potassium levels in 258 patients with mild hyperkalemia to normal levels within 48 hours, compared with placebo, and effectively maintained potassium levels for up to 4 weeks. The findings were published simultaneously in JAMA (JAMA 2014 Nov. 17 [doi: 10.1001/jama.2014.15688]). However, more long-term studies are needed to assess the efficacy and safety of the drug beyond 4 weeks and in patients with more severe hyperkalemia, reported Dr. Mikhail Kosiborod of Saint Luke’s Mid America Heart Institute in Kansas City, Mo., and his colleagues.

In the open-label phase of the study, 258 outpatients with hyperkalemia (serum potassium ≥5.1 mEq/L) were given 10 g of zirconium cyclosilicate three times a day for 48 hours. Mean serum potassium levels significantly declined by 0.2 mEq/L 1 hour after the initial dose and decreased an average 1.1 mEq/L at 48 hours, with 98% (n = 237) of patients achieving normokalemia (3.5-5.0 mEq/L). These patients were then randomized to receive 5 g (n = 45), 10 g (n = 51), or 15 g (n = 56) of zirconium cyclosilicate or placebo (n = 85) daily, and were followed for 28 days.

Zirconium cyclosilicate lowered serum potassium to 4.8, 4.5, and 4.4 mEq/L at 5, 10, and 15 g, respectively, compared with 5.1 mEq/L for placebo. Adverse events were comparable between the treatment and placebo groups, but edema was more common in the 15-g group. Hyperkalemia developed in 10% of the 10-g group and 11% of the 15-g group, compared with no patients in the 5-g or placebo groups.

In an accompanying editorial, Dr. Bradley S. Dixon of the University of Iowa, Iowa City, said the findings suggest that zirconium cyclosilicate may offer an important new treatment for the acute and short-term treatment of outpatients with mild hyperkalemia. “Longer-term studies are needed to assess the clinical benefits and risks that may be related to more extended use of this product, especially among hospitalized patients, as well as those with more severe hyperkalemia, other medical conditions, and other medications that affect potassium homeostasis,” he wrote.

The study was sponsored and funded by ZS Pharma, maker of sodium zirconium cyclosilicate. Dr. Kosiborod reported serving as a consultant for ZS Pharma and as an investigator on the HARMONIZE study. Several coauthors also declared financial interests with ZS Pharma. Dr. Dixon reported financial relationships with multiple companies, but not with ZS Pharma.

The oral drug sodium zirconium cyclosilicate may offer an effective new treatment option for outpatients with mild hyperkalemia, according to results of the phase III, open-label, randomized HARMONIZE trial presented at the American Heart Association scientific sessions.

The sodium-potassium cation exchanger zirconium cyclosilicate reduced potassium levels in 258 patients with mild hyperkalemia to normal levels within 48 hours, compared with placebo, and effectively maintained potassium levels for up to 4 weeks. The findings were published simultaneously in JAMA (JAMA 2014 Nov. 17 [doi: 10.1001/jama.2014.15688]). However, more long-term studies are needed to assess the efficacy and safety of the drug beyond 4 weeks and in patients with more severe hyperkalemia, reported Dr. Mikhail Kosiborod of Saint Luke’s Mid America Heart Institute in Kansas City, Mo., and his colleagues.

In the open-label phase of the study, 258 outpatients with hyperkalemia (serum potassium ≥5.1 mEq/L) were given 10 g of zirconium cyclosilicate three times a day for 48 hours. Mean serum potassium levels significantly declined by 0.2 mEq/L 1 hour after the initial dose and decreased an average 1.1 mEq/L at 48 hours, with 98% (n = 237) of patients achieving normokalemia (3.5-5.0 mEq/L). These patients were then randomized to receive 5 g (n = 45), 10 g (n = 51), or 15 g (n = 56) of zirconium cyclosilicate or placebo (n = 85) daily, and were followed for 28 days.

Zirconium cyclosilicate lowered serum potassium to 4.8, 4.5, and 4.4 mEq/L at 5, 10, and 15 g, respectively, compared with 5.1 mEq/L for placebo. Adverse events were comparable between the treatment and placebo groups, but edema was more common in the 15-g group. Hyperkalemia developed in 10% of the 10-g group and 11% of the 15-g group, compared with no patients in the 5-g or placebo groups.

In an accompanying editorial, Dr. Bradley S. Dixon of the University of Iowa, Iowa City, said the findings suggest that zirconium cyclosilicate may offer an important new treatment for the acute and short-term treatment of outpatients with mild hyperkalemia. “Longer-term studies are needed to assess the clinical benefits and risks that may be related to more extended use of this product, especially among hospitalized patients, as well as those with more severe hyperkalemia, other medical conditions, and other medications that affect potassium homeostasis,” he wrote.

The study was sponsored and funded by ZS Pharma, maker of sodium zirconium cyclosilicate. Dr. Kosiborod reported serving as a consultant for ZS Pharma and as an investigator on the HARMONIZE study. Several coauthors also declared financial interests with ZS Pharma. Dr. Dixon reported financial relationships with multiple companies, but not with ZS Pharma.

Topical efinaconazole’s ability to permeate the nail to the infection in onychomycosis is not hampered by the presence of infection or nail thickness, according to data from a multicenter, open-label study.

Adult patients with onychomycosis treated with efinaconazole 10% solution for 4 weeks had drug concentrations in both big and second toenails much higher than minimum inhibitory concentration (MIC) values for common onychomycosis pathogens, the researchers reported in the Journal of Drugs in Dermatology (J. Drugs Dermatol. 2014;13:1388-92).

© istockphoto / thinkstockphotos.com

The topical triazole efinaconazole has a broad spectrum of activity that is particularly potent against the common onychomycosis pathogens Trichophyton rubrum,T. mentagrophytes, and Candida albicans, the investigators, led by Misao Sakamoto of Kaken Pharmaceutical in Tokyo, noted. The treatment is an alternative to oral antifungal therapy, which can have systemic side effects or drug interactions. However, transungual delivery of effective topical treatments has been hampered by low permeation rates. The goal of this study was to assess the transungual delivery of efinaconazole in onychomycosis and its fungicidal activity in the toenail.

A total of 40 patients treated their toenails with efinaconazole 5% or 10% topical solution once daily before bedtime for 28 days. Patients applied two drops of solution to both great toes and one drop to all other toenails. Nail samples were taken from the big toenails at weeks 2, 4, and 6. Fungicidal activity against T. rubrum in the ventral layer of the nails was assessed by using an in vitro human nail infection model. Concentrations of the antifungal in the toenail were similar at weeks 2 and 4 with 10% solution, whereas they were lower at week 2 than at week 4 with 5% treatment. For both doses, efinaconazole concentrations peaked at the end of week 4 and declined at week 6. Great-toenail concentrations at week 4 for the 5% and 10% solutions were 5.6 and 6.0 mg/g, respectively.

This finding might be explained by the drug diffusing into the nail bed, the study authors said. No differences in the concentrations were seen in normal or affected nails, suggesting that transungual delivery of efinaconazole was not influenced by the presence of disease.

Concentrations of the antifungal were similar in the great and second toenails, suggesting nail thickness did not affect drug accumulation. In the in vitro nail model, efinaconazole was effective in reducing fungal viability, which suggested that sufficient amounts of the antifungal were being delivered to the ventral layer of the nail plate, the researchers noted.

“The high efinaconazole concentrations in patients’ toenails and fungicidal activity in vitro potentially contribute to the clinical efficacy reported in phase III studies,” they concluded.

All authors work for Kaken Pharmaceutical or Dow Pharmaceutical Sciences (a division of Valeant Pharmaceuticals, manufacturer of efinaconazole). The study was funded by Kaken and Valeant.

[email protected]

Topical efinaconazole’s ability to permeate the nail to the infection in onychomycosis is not hampered by the presence of infection or nail thickness, according to data from a multicenter, open-label study.

Adult patients with onychomycosis treated with efinaconazole 10% solution for 4 weeks had drug concentrations in both big and second toenails much higher than minimum inhibitory concentration (MIC) values for common onychomycosis pathogens, the researchers reported in the Journal of Drugs in Dermatology (J. Drugs Dermatol. 2014;13:1388-92).

© istockphoto / thinkstockphotos.com

The topical triazole efinaconazole has a broad spectrum of activity that is particularly potent against the common onychomycosis pathogens Trichophyton rubrum,T. mentagrophytes, and Candida albicans, the investigators, led by Misao Sakamoto of Kaken Pharmaceutical in Tokyo, noted. The treatment is an alternative to oral antifungal therapy, which can have systemic side effects or drug interactions. However, transungual delivery of effective topical treatments has been hampered by low permeation rates. The goal of this study was to assess the transungual delivery of efinaconazole in onychomycosis and its fungicidal activity in the toenail.

A total of 40 patients treated their toenails with efinaconazole 5% or 10% topical solution once daily before bedtime for 28 days. Patients applied two drops of solution to both great toes and one drop to all other toenails. Nail samples were taken from the big toenails at weeks 2, 4, and 6. Fungicidal activity against T. rubrum in the ventral layer of the nails was assessed by using an in vitro human nail infection model. Concentrations of the antifungal in the toenail were similar at weeks 2 and 4 with 10% solution, whereas they were lower at week 2 than at week 4 with 5% treatment. For both doses, efinaconazole concentrations peaked at the end of week 4 and declined at week 6. Great-toenail concentrations at week 4 for the 5% and 10% solutions were 5.6 and 6.0 mg/g, respectively.

This finding might be explained by the drug diffusing into the nail bed, the study authors said. No differences in the concentrations were seen in normal or affected nails, suggesting that transungual delivery of efinaconazole was not influenced by the presence of disease.

Concentrations of the antifungal were similar in the great and second toenails, suggesting nail thickness did not affect drug accumulation. In the in vitro nail model, efinaconazole was effective in reducing fungal viability, which suggested that sufficient amounts of the antifungal were being delivered to the ventral layer of the nail plate, the researchers noted.

“The high efinaconazole concentrations in patients’ toenails and fungicidal activity in vitro potentially contribute to the clinical efficacy reported in phase III studies,” they concluded.

All authors work for Kaken Pharmaceutical or Dow Pharmaceutical Sciences (a division of Valeant Pharmaceuticals, manufacturer of efinaconazole). The study was funded by Kaken and Valeant.

[email protected]

Topical efinaconazole’s ability to permeate the nail to the infection in onychomycosis is not hampered by the presence of infection or nail thickness, according to data from a multicenter, open-label study.

Adult patients with onychomycosis treated with efinaconazole 10% solution for 4 weeks had drug concentrations in both big and second toenails much higher than minimum inhibitory concentration (MIC) values for common onychomycosis pathogens, the researchers reported in the Journal of Drugs in Dermatology (J. Drugs Dermatol. 2014;13:1388-92).

© istockphoto / thinkstockphotos.com

The topical triazole efinaconazole has a broad spectrum of activity that is particularly potent against the common onychomycosis pathogens Trichophyton rubrum,T. mentagrophytes, and Candida albicans, the investigators, led by Misao Sakamoto of Kaken Pharmaceutical in Tokyo, noted. The treatment is an alternative to oral antifungal therapy, which can have systemic side effects or drug interactions. However, transungual delivery of effective topical treatments has been hampered by low permeation rates. The goal of this study was to assess the transungual delivery of efinaconazole in onychomycosis and its fungicidal activity in the toenail.

A total of 40 patients treated their toenails with efinaconazole 5% or 10% topical solution once daily before bedtime for 28 days. Patients applied two drops of solution to both great toes and one drop to all other toenails. Nail samples were taken from the big toenails at weeks 2, 4, and 6. Fungicidal activity against T. rubrum in the ventral layer of the nails was assessed by using an in vitro human nail infection model. Concentrations of the antifungal in the toenail were similar at weeks 2 and 4 with 10% solution, whereas they were lower at week 2 than at week 4 with 5% treatment. For both doses, efinaconazole concentrations peaked at the end of week 4 and declined at week 6. Great-toenail concentrations at week 4 for the 5% and 10% solutions were 5.6 and 6.0 mg/g, respectively.

This finding might be explained by the drug diffusing into the nail bed, the study authors said. No differences in the concentrations were seen in normal or affected nails, suggesting that transungual delivery of efinaconazole was not influenced by the presence of disease.

Concentrations of the antifungal were similar in the great and second toenails, suggesting nail thickness did not affect drug accumulation. In the in vitro nail model, efinaconazole was effective in reducing fungal viability, which suggested that sufficient amounts of the antifungal were being delivered to the ventral layer of the nail plate, the researchers noted.

“The high efinaconazole concentrations in patients’ toenails and fungicidal activity in vitro potentially contribute to the clinical efficacy reported in phase III studies,” they concluded.

All authors work for Kaken Pharmaceutical or Dow Pharmaceutical Sciences (a division of Valeant Pharmaceuticals, manufacturer of efinaconazole). The study was funded by Kaken and Valeant.

[email protected]

The vehicle used in the topical antifungal efinaconazole 10% spread into the subungual space between the nail bed and nail plate, reaching the site of infection in patients with toenail onychomycosis, according to results from a small study.

Efinaconazole topical solution 10% has a broad spectrum of antifungal activity against the organisms most associated with toenail onychomycosis and has shown efficacy in two phase III trials, reported Dr. Boni E. Elweski of the University of Alabama, Birmingham, and her colleagues in the Journal of Drugs in Dermatology (J. Drugs Dermatol. 2014;13:1394-98). The vehicle for the topical solution was developed with low surface tension to create a greater probability of nail plate permeation and access through the subungual space, the study authors wrote.

To assess the effectiveness of the solution in reaching the site of infection, the researchers applied the vehicle to the toenails of 11 adult patients with moderate to severe onychomycosis. Two drops of test material (saturated fluorescein 0.6% in vehicle solution) were applied to the distal end of the toenail, and a brush was used to spread the solution below the surface of the nail and distal skin area in contact with the nail. Standard and UV pictures of the toenails were taken after 20-30 minutes, and the process was repeated 40-45 minutes later. Approximately 1-2 mm of the affected toenail was clipped, photographed, and clipped again.

The findings showed that the vehicle had spread into the subungual space, with deposition of fluorescein seen wherever the vehicle had reached, including the nail bed. Nail clippings also showed deposition to the underside of the nail plate. The data support the instructions for the use of efinaconazole topical solution 10%, which specifically state that the solution be brushed on the skin around the nail as well as the nail plate, the authors said. However, they noted that the study was performed without the active drug, and that results could differ if efinaconazole were included.

All of the study authors are either advisers for, or employees of, Valeant Pharmaceuticals, manufacturer of topical 10% efinaconazole.

The vehicle used in the topical antifungal efinaconazole 10% spread into the subungual space between the nail bed and nail plate, reaching the site of infection in patients with toenail onychomycosis, according to results from a small study.

Efinaconazole topical solution 10% has a broad spectrum of antifungal activity against the organisms most associated with toenail onychomycosis and has shown efficacy in two phase III trials, reported Dr. Boni E. Elweski of the University of Alabama, Birmingham, and her colleagues in the Journal of Drugs in Dermatology (J. Drugs Dermatol. 2014;13:1394-98). The vehicle for the topical solution was developed with low surface tension to create a greater probability of nail plate permeation and access through the subungual space, the study authors wrote.

To assess the effectiveness of the solution in reaching the site of infection, the researchers applied the vehicle to the toenails of 11 adult patients with moderate to severe onychomycosis. Two drops of test material (saturated fluorescein 0.6% in vehicle solution) were applied to the distal end of the toenail, and a brush was used to spread the solution below the surface of the nail and distal skin area in contact with the nail. Standard and UV pictures of the toenails were taken after 20-30 minutes, and the process was repeated 40-45 minutes later. Approximately 1-2 mm of the affected toenail was clipped, photographed, and clipped again.

The findings showed that the vehicle had spread into the subungual space, with deposition of fluorescein seen wherever the vehicle had reached, including the nail bed. Nail clippings also showed deposition to the underside of the nail plate. The data support the instructions for the use of efinaconazole topical solution 10%, which specifically state that the solution be brushed on the skin around the nail as well as the nail plate, the authors said. However, they noted that the study was performed without the active drug, and that results could differ if efinaconazole were included.

All of the study authors are either advisers for, or employees of, Valeant Pharmaceuticals, manufacturer of topical 10% efinaconazole.

The vehicle used in the topical antifungal efinaconazole 10% spread into the subungual space between the nail bed and nail plate, reaching the site of infection in patients with toenail onychomycosis, according to results from a small study.

Efinaconazole topical solution 10% has a broad spectrum of antifungal activity against the organisms most associated with toenail onychomycosis and has shown efficacy in two phase III trials, reported Dr. Boni E. Elweski of the University of Alabama, Birmingham, and her colleagues in the Journal of Drugs in Dermatology (J. Drugs Dermatol. 2014;13:1394-98). The vehicle for the topical solution was developed with low surface tension to create a greater probability of nail plate permeation and access through the subungual space, the study authors wrote.

To assess the effectiveness of the solution in reaching the site of infection, the researchers applied the vehicle to the toenails of 11 adult patients with moderate to severe onychomycosis. Two drops of test material (saturated fluorescein 0.6% in vehicle solution) were applied to the distal end of the toenail, and a brush was used to spread the solution below the surface of the nail and distal skin area in contact with the nail. Standard and UV pictures of the toenails were taken after 20-30 minutes, and the process was repeated 40-45 minutes later. Approximately 1-2 mm of the affected toenail was clipped, photographed, and clipped again.

The findings showed that the vehicle had spread into the subungual space, with deposition of fluorescein seen wherever the vehicle had reached, including the nail bed. Nail clippings also showed deposition to the underside of the nail plate. The data support the instructions for the use of efinaconazole topical solution 10%, which specifically state that the solution be brushed on the skin around the nail as well as the nail plate, the authors said. However, they noted that the study was performed without the active drug, and that results could differ if efinaconazole were included.

All of the study authors are either advisers for, or employees of, Valeant Pharmaceuticals, manufacturer of topical 10% efinaconazole.

Children born to mothers with rheumatoid arthritis are more likely to be born prematurely and have a lower birth weight than are those born to mothers without the condition, according to a Danish nationwide cohort study.

The reduction in fetal growth, however, is small – a mean difference of 87 g – and unlikely to have any impact on the well being of the child, Ane Rom of Copenhagen University Hospital and her colleagues reported in Arthritis & Rheumatology.

Of 1,917,723 children born in Denmark during 1977-2008, 13,556 children were exposed to either maternal or preclinical RA. Children with mothers who had rheumatoid arthritis (RA) were almost one and half times more likely (odds ratio, 1.48; 95% confidence interval, 1.20-1.84) to be born preterm. The odds of preterm birth were slightly lower, but still elevated, in children with mothers who had preclinical signs of disease, compared with children not exposed to RA (OR, 1.32; 95% CI, 1.07-1.64).

Children exposed to RA had a similar length and head and abdominal circumference at birth, compared with children of mothers without RA, but their birth weight was, on average, 87 g lower (95% CI, –111.23 to –62.84) and their placenta weight was 14 g lower (95% CI, –21.46 to –5.43). The investigators found similar results for children exposed to preclinical RA (Arthritis Rheumatol. 2014 Nov. 13 [doi:10.1002/art.38874]).

Paternal RA was not associated with reduced fetal growth or preterm birth. Maternal RA may affect fetal growth either through fetal programming related to the effect that RA may have on the intrauterine environment, through genetic factors, or through medications taken in pregnancy. “For women with RA, it is reassuring that only a small reduction in fetal growth was found for most of their children, which will have little, if any, impact on perinatal conditions for the child,” Ms. Rom and her associates wrote.

“Clinicians should be aware of the increased risk of preterm birth not only in women diagnosed with RA but also in women with signs of preclinical RA,” they concluded.

Ms. Rom’s work on the study was supported by grants from the National Institutes of Health, the Danish Council for Independent Research, and the Augustinus Foundation. No conflicts of interest were reported.

Children born to mothers with rheumatoid arthritis are more likely to be born prematurely and have a lower birth weight than are those born to mothers without the condition, according to a Danish nationwide cohort study.

The reduction in fetal growth, however, is small – a mean difference of 87 g – and unlikely to have any impact on the well being of the child, Ane Rom of Copenhagen University Hospital and her colleagues reported in Arthritis & Rheumatology.

Of 1,917,723 children born in Denmark during 1977-2008, 13,556 children were exposed to either maternal or preclinical RA. Children with mothers who had rheumatoid arthritis (RA) were almost one and half times more likely (odds ratio, 1.48; 95% confidence interval, 1.20-1.84) to be born preterm. The odds of preterm birth were slightly lower, but still elevated, in children with mothers who had preclinical signs of disease, compared with children not exposed to RA (OR, 1.32; 95% CI, 1.07-1.64).

Children exposed to RA had a similar length and head and abdominal circumference at birth, compared with children of mothers without RA, but their birth weight was, on average, 87 g lower (95% CI, –111.23 to –62.84) and their placenta weight was 14 g lower (95% CI, –21.46 to –5.43). The investigators found similar results for children exposed to preclinical RA (Arthritis Rheumatol. 2014 Nov. 13 [doi:10.1002/art.38874]).

Paternal RA was not associated with reduced fetal growth or preterm birth. Maternal RA may affect fetal growth either through fetal programming related to the effect that RA may have on the intrauterine environment, through genetic factors, or through medications taken in pregnancy. “For women with RA, it is reassuring that only a small reduction in fetal growth was found for most of their children, which will have little, if any, impact on perinatal conditions for the child,” Ms. Rom and her associates wrote.

“Clinicians should be aware of the increased risk of preterm birth not only in women diagnosed with RA but also in women with signs of preclinical RA,” they concluded.

Ms. Rom’s work on the study was supported by grants from the National Institutes of Health, the Danish Council for Independent Research, and the Augustinus Foundation. No conflicts of interest were reported.

Children born to mothers with rheumatoid arthritis are more likely to be born prematurely and have a lower birth weight than are those born to mothers without the condition, according to a Danish nationwide cohort study.

The reduction in fetal growth, however, is small – a mean difference of 87 g – and unlikely to have any impact on the well being of the child, Ane Rom of Copenhagen University Hospital and her colleagues reported in Arthritis & Rheumatology.

Of 1,917,723 children born in Denmark during 1977-2008, 13,556 children were exposed to either maternal or preclinical RA. Children with mothers who had rheumatoid arthritis (RA) were almost one and half times more likely (odds ratio, 1.48; 95% confidence interval, 1.20-1.84) to be born preterm. The odds of preterm birth were slightly lower, but still elevated, in children with mothers who had preclinical signs of disease, compared with children not exposed to RA (OR, 1.32; 95% CI, 1.07-1.64).

Children exposed to RA had a similar length and head and abdominal circumference at birth, compared with children of mothers without RA, but their birth weight was, on average, 87 g lower (95% CI, –111.23 to –62.84) and their placenta weight was 14 g lower (95% CI, –21.46 to –5.43). The investigators found similar results for children exposed to preclinical RA (Arthritis Rheumatol. 2014 Nov. 13 [doi:10.1002/art.38874]).

Paternal RA was not associated with reduced fetal growth or preterm birth. Maternal RA may affect fetal growth either through fetal programming related to the effect that RA may have on the intrauterine environment, through genetic factors, or through medications taken in pregnancy. “For women with RA, it is reassuring that only a small reduction in fetal growth was found for most of their children, which will have little, if any, impact on perinatal conditions for the child,” Ms. Rom and her associates wrote.

“Clinicians should be aware of the increased risk of preterm birth not only in women diagnosed with RA but also in women with signs of preclinical RA,” they concluded.

Ms. Rom’s work on the study was supported by grants from the National Institutes of Health, the Danish Council for Independent Research, and the Augustinus Foundation. No conflicts of interest were reported.

People with schizophrenia have decreased cognitive empathy that contributes to poor social functioning, according to a study using a contemporary self-report model of empathy.

Past research indicates that people with schizophrenia self-report diminished cognitive empathy – the ability to understand the emotional states of others as well as distinguish between one’s own and someone else’s emotional states. Findings have been mixed for affective empathy – the vicarious sharing of emotions experienced by others that are automatically mirrored through social cues. These inconsistent findings might be attributable to the use of suboptimal assessment tools that fail to recognize empathy as a multidimensional construct, reported Tania M. Michaels and her colleagues at Northwestern University in Chicago (Psychiatry Res. 2014 doi: 10.1016/j.psychres.2014.08.054]).

The Interpersonal Reactivity Index (IRI), developed more than 3 decades ago, has been used in many studies. However, concerns have been raised about the compatibility of its subscales with updated models of empathy. In 2011, the Questionnaire of Cognitive and Affective Empathy (QCAE) was developed as a more comprehensive measure of cognitive and affective empathy.

To assess the reliability of the QCAE subscales and how they compare to the IRI, 52 people with schizophrenia and 37 healthy controls completed both self-report questionnaires.

After accounting for symptoms and neurocognitive functioning, the researchers then examined whether cognitive and affective empathy had an effect on social functioning. The results showed that people with schizophrenia had significantly lower total QCAE cognitive empathy scores than did healthy controls.

This finding primarily was driven by a significantly lower online simulation subscale score, which focused more on others’ in-the-moment emotions. A higher total cognitive empathy score significantly correlated with better social attainment. Higher online simulation correlated with better social competence and social attainment, as well as fewer disorganized symptoms.

For affective empathy, the researchers observed a variable pattern of intact and abnormal scores. According to the authors, the findings bolster support for the presence and functional significance of decreased cognitive empathy in schizophrenia.

The findings also contribute to emerging evidence that in people with schizophrenia, some processes related to affective empathy might be intact or hyperresponsive.

“Efforts to target cognitive empathy in social cognitive training programs for schizophrenia may be a useful way to enhance the generalizability of these interventions,” they concluded.

The authors declared no relevant financial conflicts.

People with schizophrenia have decreased cognitive empathy that contributes to poor social functioning, according to a study using a contemporary self-report model of empathy.

Past research indicates that people with schizophrenia self-report diminished cognitive empathy – the ability to understand the emotional states of others as well as distinguish between one’s own and someone else’s emotional states. Findings have been mixed for affective empathy – the vicarious sharing of emotions experienced by others that are automatically mirrored through social cues. These inconsistent findings might be attributable to the use of suboptimal assessment tools that fail to recognize empathy as a multidimensional construct, reported Tania M. Michaels and her colleagues at Northwestern University in Chicago (Psychiatry Res. 2014 doi: 10.1016/j.psychres.2014.08.054]).

The Interpersonal Reactivity Index (IRI), developed more than 3 decades ago, has been used in many studies. However, concerns have been raised about the compatibility of its subscales with updated models of empathy. In 2011, the Questionnaire of Cognitive and Affective Empathy (QCAE) was developed as a more comprehensive measure of cognitive and affective empathy.

To assess the reliability of the QCAE subscales and how they compare to the IRI, 52 people with schizophrenia and 37 healthy controls completed both self-report questionnaires.

After accounting for symptoms and neurocognitive functioning, the researchers then examined whether cognitive and affective empathy had an effect on social functioning. The results showed that people with schizophrenia had significantly lower total QCAE cognitive empathy scores than did healthy controls.

This finding primarily was driven by a significantly lower online simulation subscale score, which focused more on others’ in-the-moment emotions. A higher total cognitive empathy score significantly correlated with better social attainment. Higher online simulation correlated with better social competence and social attainment, as well as fewer disorganized symptoms.

For affective empathy, the researchers observed a variable pattern of intact and abnormal scores. According to the authors, the findings bolster support for the presence and functional significance of decreased cognitive empathy in schizophrenia.

The findings also contribute to emerging evidence that in people with schizophrenia, some processes related to affective empathy might be intact or hyperresponsive.

“Efforts to target cognitive empathy in social cognitive training programs for schizophrenia may be a useful way to enhance the generalizability of these interventions,” they concluded.

The authors declared no relevant financial conflicts.

People with schizophrenia have decreased cognitive empathy that contributes to poor social functioning, according to a study using a contemporary self-report model of empathy.

Past research indicates that people with schizophrenia self-report diminished cognitive empathy – the ability to understand the emotional states of others as well as distinguish between one’s own and someone else’s emotional states. Findings have been mixed for affective empathy – the vicarious sharing of emotions experienced by others that are automatically mirrored through social cues. These inconsistent findings might be attributable to the use of suboptimal assessment tools that fail to recognize empathy as a multidimensional construct, reported Tania M. Michaels and her colleagues at Northwestern University in Chicago (Psychiatry Res. 2014 doi: 10.1016/j.psychres.2014.08.054]).

The Interpersonal Reactivity Index (IRI), developed more than 3 decades ago, has been used in many studies. However, concerns have been raised about the compatibility of its subscales with updated models of empathy. In 2011, the Questionnaire of Cognitive and Affective Empathy (QCAE) was developed as a more comprehensive measure of cognitive and affective empathy.

To assess the reliability of the QCAE subscales and how they compare to the IRI, 52 people with schizophrenia and 37 healthy controls completed both self-report questionnaires.

After accounting for symptoms and neurocognitive functioning, the researchers then examined whether cognitive and affective empathy had an effect on social functioning. The results showed that people with schizophrenia had significantly lower total QCAE cognitive empathy scores than did healthy controls.

This finding primarily was driven by a significantly lower online simulation subscale score, which focused more on others’ in-the-moment emotions. A higher total cognitive empathy score significantly correlated with better social attainment. Higher online simulation correlated with better social competence and social attainment, as well as fewer disorganized symptoms.

For affective empathy, the researchers observed a variable pattern of intact and abnormal scores. According to the authors, the findings bolster support for the presence and functional significance of decreased cognitive empathy in schizophrenia.

The findings also contribute to emerging evidence that in people with schizophrenia, some processes related to affective empathy might be intact or hyperresponsive.

“Efforts to target cognitive empathy in social cognitive training programs for schizophrenia may be a useful way to enhance the generalizability of these interventions,” they concluded.

The authors declared no relevant financial conflicts.

People with schizophrenia experience the same level of positive emotion and enjoyment as people without the disease but have a higher level of negative emotion, investigators have found.

In the study, Amy H. Sanchez and her colleagues gave people with schizophrenia (n = 47) and without schizophrenia (n = 41) a cell phone. People with active substance dependence were not included.

Participants were telephoned four times a day for 1 week, asked about their current emotional state, and how much they were enjoying their current activity. No significant differences were seen in positive emotion (P = .53) or how enjoyable activities (P = .23) were experienced between people with and without schizophrenia, reported Ms. Sanchez, from the psychology department at the San Francisco State University (Psychiatry Res. 2014;220:89-95).

However, people with schizophrenia reported significantly more negative emotion (P = .003) and a weaker relationship between current enjoyment and negative emotion, compared to people without the disease (P = .04). Lower neurocognition predicted this relationship (P = .02); people with schizophrenia and poor cognitive function reported negative emotions that were more independent of how they had rated their enjoyment of activities. “An increase in activity enjoyment is connected to a decrease in negative emotion for people without schizophrenia, while there was less of a connection between appraisals of the environment and negative emotion for people with schizophrenia,” the reported the investigators, who used a methodology developed to measures experiences in-the-moment called ecological momentary assessment (EMA).

Their findings suggested that schizophrenia is not characterized by a disconnect between positive emotion and pleasurable experiences but rather is limited specifically to the elevation and dysregulation of negative emotion. “This finding highlights the importance of negative emotion as a target for research and treatment in schizophrenia,” they said.

Ms. Sanchez and her colleagues reported several limitations. One is that symptoms were assessed while the study participants were in lab assessments with clinicians rather than during the EMA assessments. “Relatedly, our measure of substance use relied on self-report during the in-lab session rather than by a more objective measure or during the EMA interview,” they wrote.

The National Institute of Mental Health funded the study. The authors declared no conflicts of interest.

People with schizophrenia experience the same level of positive emotion and enjoyment as people without the disease but have a higher level of negative emotion, investigators have found.

In the study, Amy H. Sanchez and her colleagues gave people with schizophrenia (n = 47) and without schizophrenia (n = 41) a cell phone. People with active substance dependence were not included.

Participants were telephoned four times a day for 1 week, asked about their current emotional state, and how much they were enjoying their current activity. No significant differences were seen in positive emotion (P = .53) or how enjoyable activities (P = .23) were experienced between people with and without schizophrenia, reported Ms. Sanchez, from the psychology department at the San Francisco State University (Psychiatry Res. 2014;220:89-95).

However, people with schizophrenia reported significantly more negative emotion (P = .003) and a weaker relationship between current enjoyment and negative emotion, compared to people without the disease (P = .04). Lower neurocognition predicted this relationship (P = .02); people with schizophrenia and poor cognitive function reported negative emotions that were more independent of how they had rated their enjoyment of activities. “An increase in activity enjoyment is connected to a decrease in negative emotion for people without schizophrenia, while there was less of a connection between appraisals of the environment and negative emotion for people with schizophrenia,” the reported the investigators, who used a methodology developed to measures experiences in-the-moment called ecological momentary assessment (EMA).

Their findings suggested that schizophrenia is not characterized by a disconnect between positive emotion and pleasurable experiences but rather is limited specifically to the elevation and dysregulation of negative emotion. “This finding highlights the importance of negative emotion as a target for research and treatment in schizophrenia,” they said.

Ms. Sanchez and her colleagues reported several limitations. One is that symptoms were assessed while the study participants were in lab assessments with clinicians rather than during the EMA assessments. “Relatedly, our measure of substance use relied on self-report during the in-lab session rather than by a more objective measure or during the EMA interview,” they wrote.

The National Institute of Mental Health funded the study. The authors declared no conflicts of interest.

People with schizophrenia experience the same level of positive emotion and enjoyment as people without the disease but have a higher level of negative emotion, investigators have found.

In the study, Amy H. Sanchez and her colleagues gave people with schizophrenia (n = 47) and without schizophrenia (n = 41) a cell phone. People with active substance dependence were not included.

Participants were telephoned four times a day for 1 week, asked about their current emotional state, and how much they were enjoying their current activity. No significant differences were seen in positive emotion (P = .53) or how enjoyable activities (P = .23) were experienced between people with and without schizophrenia, reported Ms. Sanchez, from the psychology department at the San Francisco State University (Psychiatry Res. 2014;220:89-95).

However, people with schizophrenia reported significantly more negative emotion (P = .003) and a weaker relationship between current enjoyment and negative emotion, compared to people without the disease (P = .04). Lower neurocognition predicted this relationship (P = .02); people with schizophrenia and poor cognitive function reported negative emotions that were more independent of how they had rated their enjoyment of activities. “An increase in activity enjoyment is connected to a decrease in negative emotion for people without schizophrenia, while there was less of a connection between appraisals of the environment and negative emotion for people with schizophrenia,” the reported the investigators, who used a methodology developed to measures experiences in-the-moment called ecological momentary assessment (EMA).

Their findings suggested that schizophrenia is not characterized by a disconnect between positive emotion and pleasurable experiences but rather is limited specifically to the elevation and dysregulation of negative emotion. “This finding highlights the importance of negative emotion as a target for research and treatment in schizophrenia,” they said.

Ms. Sanchez and her colleagues reported several limitations. One is that symptoms were assessed while the study participants were in lab assessments with clinicians rather than during the EMA assessments. “Relatedly, our measure of substance use relied on self-report during the in-lab session rather than by a more objective measure or during the EMA interview,” they wrote.

The National Institute of Mental Health funded the study. The authors declared no conflicts of interest.

Patients with rheumatoid arthritis, psoriatic arthritis, or psoriasis are at an increased risk of major adverse cardiovascular events when compared with the general population, according to findings from a large cohort study.

All three diseases had statistically similar risks for major adverse cardiovascular events (MACE) after adjustment for age, gender, and traditional CV risk factors, Dr. Alexis Ogdie-Beatty of the University of Pennsylvania, Philadelphia, and her colleagues reported (Ann. Rheum. Dis. 2014 Oct. 30 [doi: 10.1136/annrheumdis-2014-205675]).

The investigators noted that most studies of CV risk in psoriatic arthritis (PsA) patients have been cross-sectional and that three previous population-based cohort studies have evaluated CV risk in psoriasis patients, with PsA patients as a subgroup; however, these three psoriasis studies did not include incident MACE and matched internal control patients with adjustments for traditional CV risk factors.

The investigators used data from the Health Improvement Network, a U.K. primary care medical record database, and compared the number of MACE (myocardial infarction, cerebrovascular accident, and CV death) that occurred during a mean 5 years of follow-up in 41,752 patients with rheumatoid arthritis (RA), 8,706 with PsA, 138,424 with psoriasis, and 81,573 matched controls. There was significant interaction between disease-modifying antirheumatic drug (DMARD) use and disease group (P < .001 for MACE and two components, CV death and cerebrovascular accident; and P = .01 for MI).

The risk of MACE was higher in patients with PsA not prescribed a DMARD (hazard ratio, 1.24; 95% confidence interval, 1.03-1.49). This risk was elevated in RA patients both with DMARD prescriptions (HR, 1.58; 95% CI, 1.46-1.70) and without (HR, 1.39; 95% CI, 1.28-1.50). Patients with severe psoriasis who were prescribed a DMARD had an HR of 1.42 (95% CI, 1.17-1.73), whereas psoriasis patients not prescribed a DMARD had an HR of 1.08 (95% CI, 1.02-1.15).

The results highlight a need for improved screening and management of traditional CV risk factors in patients with inflammatory diseases, the researchers said.

Study limitations included not being able to measure disease severity or the use of over-the-counter NSAIDs, as well as having few records on biologic medications and possibly missing DMARD prescriptions.

The researchers were supported by various grants from the Rheumatology Research Foundation, the National Institutes of Health, the Doris Duke Charitable Foundation, and the Icelandic Research Fund. Several authors reported financial relationships with companies that market drugs for chronic inflammatory diseases.

Patients with rheumatoid arthritis, psoriatic arthritis, or psoriasis are at an increased risk of major adverse cardiovascular events when compared with the general population, according to findings from a large cohort study.

All three diseases had statistically similar risks for major adverse cardiovascular events (MACE) after adjustment for age, gender, and traditional CV risk factors, Dr. Alexis Ogdie-Beatty of the University of Pennsylvania, Philadelphia, and her colleagues reported (Ann. Rheum. Dis. 2014 Oct. 30 [doi: 10.1136/annrheumdis-2014-205675]).

The investigators noted that most studies of CV risk in psoriatic arthritis (PsA) patients have been cross-sectional and that three previous population-based cohort studies have evaluated CV risk in psoriasis patients, with PsA patients as a subgroup; however, these three psoriasis studies did not include incident MACE and matched internal control patients with adjustments for traditional CV risk factors.

The investigators used data from the Health Improvement Network, a U.K. primary care medical record database, and compared the number of MACE (myocardial infarction, cerebrovascular accident, and CV death) that occurred during a mean 5 years of follow-up in 41,752 patients with rheumatoid arthritis (RA), 8,706 with PsA, 138,424 with psoriasis, and 81,573 matched controls. There was significant interaction between disease-modifying antirheumatic drug (DMARD) use and disease group (P < .001 for MACE and two components, CV death and cerebrovascular accident; and P = .01 for MI).

The risk of MACE was higher in patients with PsA not prescribed a DMARD (hazard ratio, 1.24; 95% confidence interval, 1.03-1.49). This risk was elevated in RA patients both with DMARD prescriptions (HR, 1.58; 95% CI, 1.46-1.70) and without (HR, 1.39; 95% CI, 1.28-1.50). Patients with severe psoriasis who were prescribed a DMARD had an HR of 1.42 (95% CI, 1.17-1.73), whereas psoriasis patients not prescribed a DMARD had an HR of 1.08 (95% CI, 1.02-1.15).

The results highlight a need for improved screening and management of traditional CV risk factors in patients with inflammatory diseases, the researchers said.

Study limitations included not being able to measure disease severity or the use of over-the-counter NSAIDs, as well as having few records on biologic medications and possibly missing DMARD prescriptions.

The researchers were supported by various grants from the Rheumatology Research Foundation, the National Institutes of Health, the Doris Duke Charitable Foundation, and the Icelandic Research Fund. Several authors reported financial relationships with companies that market drugs for chronic inflammatory diseases.

Patients with rheumatoid arthritis, psoriatic arthritis, or psoriasis are at an increased risk of major adverse cardiovascular events when compared with the general population, according to findings from a large cohort study.

All three diseases had statistically similar risks for major adverse cardiovascular events (MACE) after adjustment for age, gender, and traditional CV risk factors, Dr. Alexis Ogdie-Beatty of the University of Pennsylvania, Philadelphia, and her colleagues reported (Ann. Rheum. Dis. 2014 Oct. 30 [doi: 10.1136/annrheumdis-2014-205675]).

The investigators noted that most studies of CV risk in psoriatic arthritis (PsA) patients have been cross-sectional and that three previous population-based cohort studies have evaluated CV risk in psoriasis patients, with PsA patients as a subgroup; however, these three psoriasis studies did not include incident MACE and matched internal control patients with adjustments for traditional CV risk factors.

The investigators used data from the Health Improvement Network, a U.K. primary care medical record database, and compared the number of MACE (myocardial infarction, cerebrovascular accident, and CV death) that occurred during a mean 5 years of follow-up in 41,752 patients with rheumatoid arthritis (RA), 8,706 with PsA, 138,424 with psoriasis, and 81,573 matched controls. There was significant interaction between disease-modifying antirheumatic drug (DMARD) use and disease group (P < .001 for MACE and two components, CV death and cerebrovascular accident; and P = .01 for MI).

The risk of MACE was higher in patients with PsA not prescribed a DMARD (hazard ratio, 1.24; 95% confidence interval, 1.03-1.49). This risk was elevated in RA patients both with DMARD prescriptions (HR, 1.58; 95% CI, 1.46-1.70) and without (HR, 1.39; 95% CI, 1.28-1.50). Patients with severe psoriasis who were prescribed a DMARD had an HR of 1.42 (95% CI, 1.17-1.73), whereas psoriasis patients not prescribed a DMARD had an HR of 1.08 (95% CI, 1.02-1.15).

The results highlight a need for improved screening and management of traditional CV risk factors in patients with inflammatory diseases, the researchers said.

Study limitations included not being able to measure disease severity or the use of over-the-counter NSAIDs, as well as having few records on biologic medications and possibly missing DMARD prescriptions.

The researchers were supported by various grants from the Rheumatology Research Foundation, the National Institutes of Health, the Doris Duke Charitable Foundation, and the Icelandic Research Fund. Several authors reported financial relationships with companies that market drugs for chronic inflammatory diseases.