Michele G. Sullivan

WASHINGTON – Patients with hidradenitis suppurativa (HS) face an increased risk of also developing inflammatory bowel disease (IBD), Ahuva Cices said at the annual meeting of the American Academy of Dermatology.

In a case-control study, Ms. Cices found that those with a new diagnosis of HS were twice as likely as controls to also be diagnosed with inflammatory bowel disease, either concurrently or shortly afterward.

“Our findings support a comorbid relationship between these two disorders, and suggest that hidradenitis suppurativa should be considered a risk factor for IBD and impart increased clinical suspicion for undiagnosed IBD,” said Ms. Cices of Northwestern University, Chicago.

She and her coinvestigators at Northwestern searched a large academic medical center database for patients with a diagnosis of HS from 2005 to 2015. These 1,332 patients were matched with about 2,600 control subjects. Of the individuals with HS, 20 were also concurrently or subsequently diagnosed with IBD. The mean lag time to an IBD diagnosis was 9 months.

The mean age of the patients with both conditions was almost 40 years. Most (75%) were female – significantly more than in the control group (42%). About half of the patients (45%) were black – also significantly more than in the control group (10%).

In a multivariate analysis, a diagnosis of HS conferred a doubling in the risk of a concurrent or subsequent diagnosis of IBD (odds ratio, 2.11), which was statistically significant.

The pathophysiologic link between the two diseases has been theorized but not confirmed, Ms. Cices said.

“The multifactorial pathways of HS and IBD are complicated, but they both involve inflammatory responses to normal flora, immune dysfunction, and dysregulation of Notch, the sulfotransferase enzyme, [tumor necrosis factor–]alpha, and T-helper 17 cells.”

She had no relevant financial disclosures.

[email protected]

WASHINGTON – Patients with hidradenitis suppurativa (HS) face an increased risk of also developing inflammatory bowel disease (IBD), Ahuva Cices said at the annual meeting of the American Academy of Dermatology.

In a case-control study, Ms. Cices found that those with a new diagnosis of HS were twice as likely as controls to also be diagnosed with inflammatory bowel disease, either concurrently or shortly afterward.

“Our findings support a comorbid relationship between these two disorders, and suggest that hidradenitis suppurativa should be considered a risk factor for IBD and impart increased clinical suspicion for undiagnosed IBD,” said Ms. Cices of Northwestern University, Chicago.

She and her coinvestigators at Northwestern searched a large academic medical center database for patients with a diagnosis of HS from 2005 to 2015. These 1,332 patients were matched with about 2,600 control subjects. Of the individuals with HS, 20 were also concurrently or subsequently diagnosed with IBD. The mean lag time to an IBD diagnosis was 9 months.

The mean age of the patients with both conditions was almost 40 years. Most (75%) were female – significantly more than in the control group (42%). About half of the patients (45%) were black – also significantly more than in the control group (10%).

In a multivariate analysis, a diagnosis of HS conferred a doubling in the risk of a concurrent or subsequent diagnosis of IBD (odds ratio, 2.11), which was statistically significant.

The pathophysiologic link between the two diseases has been theorized but not confirmed, Ms. Cices said.

“The multifactorial pathways of HS and IBD are complicated, but they both involve inflammatory responses to normal flora, immune dysfunction, and dysregulation of Notch, the sulfotransferase enzyme, [tumor necrosis factor–]alpha, and T-helper 17 cells.”

She had no relevant financial disclosures.

[email protected]

WASHINGTON – Patients with hidradenitis suppurativa (HS) face an increased risk of also developing inflammatory bowel disease (IBD), Ahuva Cices said at the annual meeting of the American Academy of Dermatology.

In a case-control study, Ms. Cices found that those with a new diagnosis of HS were twice as likely as controls to also be diagnosed with inflammatory bowel disease, either concurrently or shortly afterward.

“Our findings support a comorbid relationship between these two disorders, and suggest that hidradenitis suppurativa should be considered a risk factor for IBD and impart increased clinical suspicion for undiagnosed IBD,” said Ms. Cices of Northwestern University, Chicago.

She and her coinvestigators at Northwestern searched a large academic medical center database for patients with a diagnosis of HS from 2005 to 2015. These 1,332 patients were matched with about 2,600 control subjects. Of the individuals with HS, 20 were also concurrently or subsequently diagnosed with IBD. The mean lag time to an IBD diagnosis was 9 months.

The mean age of the patients with both conditions was almost 40 years. Most (75%) were female – significantly more than in the control group (42%). About half of the patients (45%) were black – also significantly more than in the control group (10%).

In a multivariate analysis, a diagnosis of HS conferred a doubling in the risk of a concurrent or subsequent diagnosis of IBD (odds ratio, 2.11), which was statistically significant.

The pathophysiologic link between the two diseases has been theorized but not confirmed, Ms. Cices said.

“The multifactorial pathways of HS and IBD are complicated, but they both involve inflammatory responses to normal flora, immune dysfunction, and dysregulation of Notch, the sulfotransferase enzyme, [tumor necrosis factor–]alpha, and T-helper 17 cells.”

She had no relevant financial disclosures.

[email protected]

WASHINGTON – A 6% allantoin cream has shown good results in healing wounds caused by epidermolysis bullosa (EB), with 82% of patients getting a complete closure by 2 months, in a phase IIb study.

The results of the 3 month study were good enough to propel that dose into both an open label and a phase III study, Dr. Amy Paller said at the annual meeting of the American Academy of Dermatology.

Bruce Jancin/Frontline Medical News

SD-101 (Zorblisa) may not be a “game-changer” in terms of disease modification, but it’s an enormous step forward in symptomatic treatment, Dr. Paller said in an interview. The active ingredient, allantoin – used for years at low concentrations in cosmetics and emollients – imparts virtually no adverse effects, and may, at this higher dosage, actually be working on a cellular level, she added.

Although its mechanism has not been fully elucidated, allantoin seems to help reduce inflammation, loosen protein bonds, and promote collagen formation. It also has some bactericidal effects, she noted.

“We see that healing is improved and inflammation is decreased. Many patients also report less itching and pain, which can speed dressing changes, and that is a huge quality of life issue for families. Although these results are still early stage, and in a small number of patients, they were enough for us to move forward,” said Dr. Paller, professor and chair of the department of dermatology and professor of pediatrics at Northwestern University, Chicago.

At the meeting, she discussed the phase IIb study, which compared allantoin 6%, allantoin 3%, and a vehicle cream, in 48 patients aged 6 months to 44 years old. Most had the recessive dystrophic form of EB, which is associated with skin and mucosal blistering; orofacial and esophageal narrowing; anemia; and growth restriction. Older patients have a high risk of aggressive skin cancers.

The less severe EB simplex form was present in 11 patients; 8 had the most severe junctional form. The median size of the target lesion was about 8 cm²; the largest was 39 cm². The baseline body surface area of lesional skin was 19%, with the largest area encompassing 48%. The target wounds were a median of 182 days in age, although this varied widely, from 21 to 1,600 days.

The cream was applied to the target lesion once a day. The study’s primary endpoint was target wound healing at 1 month; secondary endpoints included time to wound closure and the change in total body surface area of lesional skin. Assessments were conducted at baseline and at 14, 30, 60, and 90 days.

In the evaluable population of 45 patients, the 6% cream was most successful in effecting complete target wound closure at 1 month: 67%, compared with 38% for allantoin 3% and 41% for the vehicle (P = .165 for allantoin 6% vs. placebo).

And at 2 months, complete closure of the target wound occurred in 82% of the high dose group, compared with 44% of the low dose group and 41% of the vehicle group (P = .04 for allantoin 6% vs. placebo).

Results were similar at 3 months (82% for the high dose group, vs. 56% and 53% for the 3% and vehicle groups, respectively); this difference was not statistically significant (P = .124 for allantoin 6% vs. placebo).

These results equated to a significantly faster time to total wound closure in the allantoin 6% group (a median of 30 days vs. 86 days in the low dose group and 91 days for placebo).

Treatment emergent adverse events were low and were similar between the groups. Itching occurred in 13% of those in each active group and in 6% of those in the placebo group. Fever was most common in the high dose group (33% vs. 19% of the low dose group, and 12% of the placebo group.) However, those in the placebo group experienced more rash, erythematous rash, and oropharyngeal pain.

There were no deaths or severe adverse events in any group, according to Dr. Paller.

The study has evolved into an open label extension study that includes 42 patients in the original cohort. To date, 28 patients have completed 12 months of treatment. The time line shows a steady decrease in the body surface area of lesional skin, with a mean 3.4% decline from baseline to 1 year, she noted. Patient baselines were reset at 0, so these improvements were measured on top of any that may have occurred during the IIb study, she pointed out.

Scioderm has started a phase III double-blind, randomized placebo-controlled trial evaluating the 6% concentration, which is being conducted in the United States and Europe and is still recruiting participants. Endpoints are similar to the phase IIb study.

Although not a disease modifying agent, allantoin 6% cream is the biggest treatment advance so far for these patients, Dr. Paller commented. “There is lots of research going on,” including stem cell therapy leading to fibroblast differentiation, grafting cultured keratinocytes onto skin, and intravenous collagen, she said.

But these approaches are in the early stages of research, she added, “and so far we either don’t know their effect or [if] they offer minimal assistance. The concept of using something that has virtually no risk, even if it simply helps make someone more comfortable with less itching and pain, or which starts to enable some healing, is really important to a child with one of these devastating disorders.”

Dr. Paller is also excited about the possibility that starting the treatment earlier, or continuing for a longer time, could even have a better result. While she cautioned that this is a “very small study of patients with mixed EB types,” she said, “still, it’s the best thing we have ever seen with anything topically.”

Dr. Paller is a consultant for Scioderm, which is developing Zorblisa and sponsoring the studies. Northwestern was one of the study sites for the phase IIb study.

[email protected]

WASHINGTON – A 6% allantoin cream has shown good results in healing wounds caused by epidermolysis bullosa (EB), with 82% of patients getting a complete closure by 2 months, in a phase IIb study.

The results of the 3 month study were good enough to propel that dose into both an open label and a phase III study, Dr. Amy Paller said at the annual meeting of the American Academy of Dermatology.

Bruce Jancin/Frontline Medical News

SD-101 (Zorblisa) may not be a “game-changer” in terms of disease modification, but it’s an enormous step forward in symptomatic treatment, Dr. Paller said in an interview. The active ingredient, allantoin – used for years at low concentrations in cosmetics and emollients – imparts virtually no adverse effects, and may, at this higher dosage, actually be working on a cellular level, she added.

Although its mechanism has not been fully elucidated, allantoin seems to help reduce inflammation, loosen protein bonds, and promote collagen formation. It also has some bactericidal effects, she noted.

“We see that healing is improved and inflammation is decreased. Many patients also report less itching and pain, which can speed dressing changes, and that is a huge quality of life issue for families. Although these results are still early stage, and in a small number of patients, they were enough for us to move forward,” said Dr. Paller, professor and chair of the department of dermatology and professor of pediatrics at Northwestern University, Chicago.

At the meeting, she discussed the phase IIb study, which compared allantoin 6%, allantoin 3%, and a vehicle cream, in 48 patients aged 6 months to 44 years old. Most had the recessive dystrophic form of EB, which is associated with skin and mucosal blistering; orofacial and esophageal narrowing; anemia; and growth restriction. Older patients have a high risk of aggressive skin cancers.

The less severe EB simplex form was present in 11 patients; 8 had the most severe junctional form. The median size of the target lesion was about 8 cm²; the largest was 39 cm². The baseline body surface area of lesional skin was 19%, with the largest area encompassing 48%. The target wounds were a median of 182 days in age, although this varied widely, from 21 to 1,600 days.

The cream was applied to the target lesion once a day. The study’s primary endpoint was target wound healing at 1 month; secondary endpoints included time to wound closure and the change in total body surface area of lesional skin. Assessments were conducted at baseline and at 14, 30, 60, and 90 days.

In the evaluable population of 45 patients, the 6% cream was most successful in effecting complete target wound closure at 1 month: 67%, compared with 38% for allantoin 3% and 41% for the vehicle (P = .165 for allantoin 6% vs. placebo).

And at 2 months, complete closure of the target wound occurred in 82% of the high dose group, compared with 44% of the low dose group and 41% of the vehicle group (P = .04 for allantoin 6% vs. placebo).

Results were similar at 3 months (82% for the high dose group, vs. 56% and 53% for the 3% and vehicle groups, respectively); this difference was not statistically significant (P = .124 for allantoin 6% vs. placebo).

These results equated to a significantly faster time to total wound closure in the allantoin 6% group (a median of 30 days vs. 86 days in the low dose group and 91 days for placebo).

Treatment emergent adverse events were low and were similar between the groups. Itching occurred in 13% of those in each active group and in 6% of those in the placebo group. Fever was most common in the high dose group (33% vs. 19% of the low dose group, and 12% of the placebo group.) However, those in the placebo group experienced more rash, erythematous rash, and oropharyngeal pain.

There were no deaths or severe adverse events in any group, according to Dr. Paller.

The study has evolved into an open label extension study that includes 42 patients in the original cohort. To date, 28 patients have completed 12 months of treatment. The time line shows a steady decrease in the body surface area of lesional skin, with a mean 3.4% decline from baseline to 1 year, she noted. Patient baselines were reset at 0, so these improvements were measured on top of any that may have occurred during the IIb study, she pointed out.

Scioderm has started a phase III double-blind, randomized placebo-controlled trial evaluating the 6% concentration, which is being conducted in the United States and Europe and is still recruiting participants. Endpoints are similar to the phase IIb study.

Although not a disease modifying agent, allantoin 6% cream is the biggest treatment advance so far for these patients, Dr. Paller commented. “There is lots of research going on,” including stem cell therapy leading to fibroblast differentiation, grafting cultured keratinocytes onto skin, and intravenous collagen, she said.

But these approaches are in the early stages of research, she added, “and so far we either don’t know their effect or [if] they offer minimal assistance. The concept of using something that has virtually no risk, even if it simply helps make someone more comfortable with less itching and pain, or which starts to enable some healing, is really important to a child with one of these devastating disorders.”

Dr. Paller is also excited about the possibility that starting the treatment earlier, or continuing for a longer time, could even have a better result. While she cautioned that this is a “very small study of patients with mixed EB types,” she said, “still, it’s the best thing we have ever seen with anything topically.”

Dr. Paller is a consultant for Scioderm, which is developing Zorblisa and sponsoring the studies. Northwestern was one of the study sites for the phase IIb study.

[email protected]

WASHINGTON – A 6% allantoin cream has shown good results in healing wounds caused by epidermolysis bullosa (EB), with 82% of patients getting a complete closure by 2 months, in a phase IIb study.

The results of the 3 month study were good enough to propel that dose into both an open label and a phase III study, Dr. Amy Paller said at the annual meeting of the American Academy of Dermatology.

Bruce Jancin/Frontline Medical News

SD-101 (Zorblisa) may not be a “game-changer” in terms of disease modification, but it’s an enormous step forward in symptomatic treatment, Dr. Paller said in an interview. The active ingredient, allantoin – used for years at low concentrations in cosmetics and emollients – imparts virtually no adverse effects, and may, at this higher dosage, actually be working on a cellular level, she added.

Although its mechanism has not been fully elucidated, allantoin seems to help reduce inflammation, loosen protein bonds, and promote collagen formation. It also has some bactericidal effects, she noted.

“We see that healing is improved and inflammation is decreased. Many patients also report less itching and pain, which can speed dressing changes, and that is a huge quality of life issue for families. Although these results are still early stage, and in a small number of patients, they were enough for us to move forward,” said Dr. Paller, professor and chair of the department of dermatology and professor of pediatrics at Northwestern University, Chicago.

At the meeting, she discussed the phase IIb study, which compared allantoin 6%, allantoin 3%, and a vehicle cream, in 48 patients aged 6 months to 44 years old. Most had the recessive dystrophic form of EB, which is associated with skin and mucosal blistering; orofacial and esophageal narrowing; anemia; and growth restriction. Older patients have a high risk of aggressive skin cancers.

The less severe EB simplex form was present in 11 patients; 8 had the most severe junctional form. The median size of the target lesion was about 8 cm²; the largest was 39 cm². The baseline body surface area of lesional skin was 19%, with the largest area encompassing 48%. The target wounds were a median of 182 days in age, although this varied widely, from 21 to 1,600 days.

The cream was applied to the target lesion once a day. The study’s primary endpoint was target wound healing at 1 month; secondary endpoints included time to wound closure and the change in total body surface area of lesional skin. Assessments were conducted at baseline and at 14, 30, 60, and 90 days.

In the evaluable population of 45 patients, the 6% cream was most successful in effecting complete target wound closure at 1 month: 67%, compared with 38% for allantoin 3% and 41% for the vehicle (P = .165 for allantoin 6% vs. placebo).

And at 2 months, complete closure of the target wound occurred in 82% of the high dose group, compared with 44% of the low dose group and 41% of the vehicle group (P = .04 for allantoin 6% vs. placebo).

Results were similar at 3 months (82% for the high dose group, vs. 56% and 53% for the 3% and vehicle groups, respectively); this difference was not statistically significant (P = .124 for allantoin 6% vs. placebo).

These results equated to a significantly faster time to total wound closure in the allantoin 6% group (a median of 30 days vs. 86 days in the low dose group and 91 days for placebo).

Treatment emergent adverse events were low and were similar between the groups. Itching occurred in 13% of those in each active group and in 6% of those in the placebo group. Fever was most common in the high dose group (33% vs. 19% of the low dose group, and 12% of the placebo group.) However, those in the placebo group experienced more rash, erythematous rash, and oropharyngeal pain.

There were no deaths or severe adverse events in any group, according to Dr. Paller.

The study has evolved into an open label extension study that includes 42 patients in the original cohort. To date, 28 patients have completed 12 months of treatment. The time line shows a steady decrease in the body surface area of lesional skin, with a mean 3.4% decline from baseline to 1 year, she noted. Patient baselines were reset at 0, so these improvements were measured on top of any that may have occurred during the IIb study, she pointed out.

Scioderm has started a phase III double-blind, randomized placebo-controlled trial evaluating the 6% concentration, which is being conducted in the United States and Europe and is still recruiting participants. Endpoints are similar to the phase IIb study.

Although not a disease modifying agent, allantoin 6% cream is the biggest treatment advance so far for these patients, Dr. Paller commented. “There is lots of research going on,” including stem cell therapy leading to fibroblast differentiation, grafting cultured keratinocytes onto skin, and intravenous collagen, she said.

But these approaches are in the early stages of research, she added, “and so far we either don’t know their effect or [if] they offer minimal assistance. The concept of using something that has virtually no risk, even if it simply helps make someone more comfortable with less itching and pain, or which starts to enable some healing, is really important to a child with one of these devastating disorders.”

Dr. Paller is also excited about the possibility that starting the treatment earlier, or continuing for a longer time, could even have a better result. While she cautioned that this is a “very small study of patients with mixed EB types,” she said, “still, it’s the best thing we have ever seen with anything topically.”

Dr. Paller is a consultant for Scioderm, which is developing Zorblisa and sponsoring the studies. Northwestern was one of the study sites for the phase IIb study.

[email protected]

WASHINGTON – Sofpironium bromide, a newly developed “soft” anticholinergic gel, improved clinical outcomes and quality of life in patients with severe hyperhidrosis.

The drug is designed to work as an effective anticholinergic, but is metabolized and excreted much more quickly. This limits the possibility of troublesome systemic anticholinergic side effects, Dr. David M. Pariser said at the annual meeting of the American Academy of Dermatology.

“The main one we saw was vision issues, which occurred in about 8% of the patients,” who participated in a phase IIb randomized study, said Dr. Pariser, a dermatologist in Norfolk, Va. “We also saw urinary hesitancy, dry eyes, and dry lips. But these were nothing unexpected, and didn’t occur at an unexpected rate,” he added.

Sofpironium bromide (BBI-4000; BrickellBiotech) is a new molecular entity designed to bind to the M3 AC (acetylcholine) receptor on sweat glands – inhibiting sweat production – but to incompletely bind to systemic AC receptors. Thus, it exerts most of its effects locally, is rapidly metabolized, and exhibits very low systemic absorption, according to the company website.

The phase IIb study randomized 189 subjects to BBI-4000 in 5%, 10%, and 15% concentrations, or a placebo gel. All of the subjects had axillary hyperhidrosis scores of 3 or 4 on the Hyperhidrosis Disease Severity Scale (HDSS) – a 1-4 scale – and/or sweat at least 50 mg per 5 minutes per axilla.

Subjects applied the gel to underarms once daily for 28 days. Key endpoints were significant changes on the HDSS scale and the Hyperhidrosis Disease Severity Measure Axillary (HDSM-Ax), an axillary-specific scale developed by the company.

Positive results occurred in a dose-dependent outcome, with the 15% gel being the most effective. At that concentration, 38% of subjects achieved at least a 2 point improvement on the HDSS scale vs. 12% of those using the placebo (P less than .01).

On the HDSM-Ax, almost 45% of the high dose group and 19.5% of the placebo group achieved at least a 2 point improvement (P = .01). Those in the high dose group also produced significantly less sweat by day 29 than those in the placebo group.

All of these results were considered clinically significant, Dr. Pariser said.

About 10% of subjects in both groups experienced an application site reaction. Another 10% experienced a systemic anticholinergic adverse event.

Based on the positive results, BrickellBiotech intends to evaluate the 15% gel in a phase III study, Dr. Pariser said.

He is a consultant for the company. BrickellBiotech sponsored the study.

[email protected]

WASHINGTON – Sofpironium bromide, a newly developed “soft” anticholinergic gel, improved clinical outcomes and quality of life in patients with severe hyperhidrosis.

The drug is designed to work as an effective anticholinergic, but is metabolized and excreted much more quickly. This limits the possibility of troublesome systemic anticholinergic side effects, Dr. David M. Pariser said at the annual meeting of the American Academy of Dermatology.

“The main one we saw was vision issues, which occurred in about 8% of the patients,” who participated in a phase IIb randomized study, said Dr. Pariser, a dermatologist in Norfolk, Va. “We also saw urinary hesitancy, dry eyes, and dry lips. But these were nothing unexpected, and didn’t occur at an unexpected rate,” he added.

Sofpironium bromide (BBI-4000; BrickellBiotech) is a new molecular entity designed to bind to the M3 AC (acetylcholine) receptor on sweat glands – inhibiting sweat production – but to incompletely bind to systemic AC receptors. Thus, it exerts most of its effects locally, is rapidly metabolized, and exhibits very low systemic absorption, according to the company website.

The phase IIb study randomized 189 subjects to BBI-4000 in 5%, 10%, and 15% concentrations, or a placebo gel. All of the subjects had axillary hyperhidrosis scores of 3 or 4 on the Hyperhidrosis Disease Severity Scale (HDSS) – a 1-4 scale – and/or sweat at least 50 mg per 5 minutes per axilla.

Subjects applied the gel to underarms once daily for 28 days. Key endpoints were significant changes on the HDSS scale and the Hyperhidrosis Disease Severity Measure Axillary (HDSM-Ax), an axillary-specific scale developed by the company.

Positive results occurred in a dose-dependent outcome, with the 15% gel being the most effective. At that concentration, 38% of subjects achieved at least a 2 point improvement on the HDSS scale vs. 12% of those using the placebo (P less than .01).

On the HDSM-Ax, almost 45% of the high dose group and 19.5% of the placebo group achieved at least a 2 point improvement (P = .01). Those in the high dose group also produced significantly less sweat by day 29 than those in the placebo group.

All of these results were considered clinically significant, Dr. Pariser said.

About 10% of subjects in both groups experienced an application site reaction. Another 10% experienced a systemic anticholinergic adverse event.

Based on the positive results, BrickellBiotech intends to evaluate the 15% gel in a phase III study, Dr. Pariser said.

He is a consultant for the company. BrickellBiotech sponsored the study.

[email protected]

WASHINGTON – Sofpironium bromide, a newly developed “soft” anticholinergic gel, improved clinical outcomes and quality of life in patients with severe hyperhidrosis.

The drug is designed to work as an effective anticholinergic, but is metabolized and excreted much more quickly. This limits the possibility of troublesome systemic anticholinergic side effects, Dr. David M. Pariser said at the annual meeting of the American Academy of Dermatology.

“The main one we saw was vision issues, which occurred in about 8% of the patients,” who participated in a phase IIb randomized study, said Dr. Pariser, a dermatologist in Norfolk, Va. “We also saw urinary hesitancy, dry eyes, and dry lips. But these were nothing unexpected, and didn’t occur at an unexpected rate,” he added.

Sofpironium bromide (BBI-4000; BrickellBiotech) is a new molecular entity designed to bind to the M3 AC (acetylcholine) receptor on sweat glands – inhibiting sweat production – but to incompletely bind to systemic AC receptors. Thus, it exerts most of its effects locally, is rapidly metabolized, and exhibits very low systemic absorption, according to the company website.

The phase IIb study randomized 189 subjects to BBI-4000 in 5%, 10%, and 15% concentrations, or a placebo gel. All of the subjects had axillary hyperhidrosis scores of 3 or 4 on the Hyperhidrosis Disease Severity Scale (HDSS) – a 1-4 scale – and/or sweat at least 50 mg per 5 minutes per axilla.

Subjects applied the gel to underarms once daily for 28 days. Key endpoints were significant changes on the HDSS scale and the Hyperhidrosis Disease Severity Measure Axillary (HDSM-Ax), an axillary-specific scale developed by the company.

Positive results occurred in a dose-dependent outcome, with the 15% gel being the most effective. At that concentration, 38% of subjects achieved at least a 2 point improvement on the HDSS scale vs. 12% of those using the placebo (P less than .01).

On the HDSM-Ax, almost 45% of the high dose group and 19.5% of the placebo group achieved at least a 2 point improvement (P = .01). Those in the high dose group also produced significantly less sweat by day 29 than those in the placebo group.

All of these results were considered clinically significant, Dr. Pariser said.

About 10% of subjects in both groups experienced an application site reaction. Another 10% experienced a systemic anticholinergic adverse event.

Based on the positive results, BrickellBiotech intends to evaluate the 15% gel in a phase III study, Dr. Pariser said.

He is a consultant for the company. BrickellBiotech sponsored the study.

[email protected]

WASHINGTON – Adding a topical steroid to tretinoin may be useful in reducing some of the retinoid-induced dermal irritation commonly seen with this treatment in patients with acne.

The reduction in dryness and peeling could, potentially, increase compliance with tretinoin treatment, especially in the first few weeks when retinoid reactions are most likely to occur, Dr. Garrett Coman said at the annual meeting of the American Academy of Dermatology.

“Patients definitely preferred adding the topical steroid to tretinoin-alone treatment,” said Dr. Coman, a clinical research fellow in the department of dermatology at the Virginia Tech Carilion School of Medicine and Research Institute, Roanoke. “At week 2, 64% already exhibited a strong preference, and that had increased to 86% by week 4.”

He and his colleagues conducted the 8-week, randomized, split-face trial of 20 patients who were treated with tretinoin for acne. In addition to 0.05% tretinoin, they applied 0.025% triamcinolone to one side of the face and a vehicle emollient to the other side.

Patients were a typical acne treatment population, with a mean age of 18 years and most were female. They had already tried a number of acne treatments, including benzoyl peroxide, topical and oral antibiotics, and tretinoin.

They were assessed at baseline and at weeks 1, 2, 4, and 8. The outcome measures were acne severity; dryness, peeling, and erythema; and overall irritation.

Patients said that irritation increased significantly on the tretinoin-only (control) side by the end of week 1, while dryness did not change on the steroid combination side. By week 4 those scores were converging; by week 8 they were similar.

Physicians scored three categories of irritation: dryness, peeling, and erythema. They felt that dryness was significantly worse on the control side, peaked at week 2, and then slowly decreased, while dryness on the steroid side slowly increased and the scores converged by week 8. Peeling followed a similar pattern. Erythema was not significantly different at any time point.

Overall, acne severity decreased more quickly and dramatically on the steroid side, according to physicians. This finding, combined with the early decreases in symptoms of irritation, might improve compliance. “We have all noticed that the early irritation can be a significant inhibitor of compliance. Our results suggest that topical corticosteroids reduce peeling and dryness early in treatment. We think this could increase compliance and boost outcomes in patients starting topical retinoids,” Dr. Coman commented.

He had no disclosures. The Carilion Clinic funded the study.

WASHINGTON – Adding a topical steroid to tretinoin may be useful in reducing some of the retinoid-induced dermal irritation commonly seen with this treatment in patients with acne.

The reduction in dryness and peeling could, potentially, increase compliance with tretinoin treatment, especially in the first few weeks when retinoid reactions are most likely to occur, Dr. Garrett Coman said at the annual meeting of the American Academy of Dermatology.

“Patients definitely preferred adding the topical steroid to tretinoin-alone treatment,” said Dr. Coman, a clinical research fellow in the department of dermatology at the Virginia Tech Carilion School of Medicine and Research Institute, Roanoke. “At week 2, 64% already exhibited a strong preference, and that had increased to 86% by week 4.”

He and his colleagues conducted the 8-week, randomized, split-face trial of 20 patients who were treated with tretinoin for acne. In addition to 0.05% tretinoin, they applied 0.025% triamcinolone to one side of the face and a vehicle emollient to the other side.

Patients were a typical acne treatment population, with a mean age of 18 years and most were female. They had already tried a number of acne treatments, including benzoyl peroxide, topical and oral antibiotics, and tretinoin.

They were assessed at baseline and at weeks 1, 2, 4, and 8. The outcome measures were acne severity; dryness, peeling, and erythema; and overall irritation.

Patients said that irritation increased significantly on the tretinoin-only (control) side by the end of week 1, while dryness did not change on the steroid combination side. By week 4 those scores were converging; by week 8 they were similar.

Physicians scored three categories of irritation: dryness, peeling, and erythema. They felt that dryness was significantly worse on the control side, peaked at week 2, and then slowly decreased, while dryness on the steroid side slowly increased and the scores converged by week 8. Peeling followed a similar pattern. Erythema was not significantly different at any time point.

Overall, acne severity decreased more quickly and dramatically on the steroid side, according to physicians. This finding, combined with the early decreases in symptoms of irritation, might improve compliance. “We have all noticed that the early irritation can be a significant inhibitor of compliance. Our results suggest that topical corticosteroids reduce peeling and dryness early in treatment. We think this could increase compliance and boost outcomes in patients starting topical retinoids,” Dr. Coman commented.

He had no disclosures. The Carilion Clinic funded the study.

WASHINGTON – Adding a topical steroid to tretinoin may be useful in reducing some of the retinoid-induced dermal irritation commonly seen with this treatment in patients with acne.

The reduction in dryness and peeling could, potentially, increase compliance with tretinoin treatment, especially in the first few weeks when retinoid reactions are most likely to occur, Dr. Garrett Coman said at the annual meeting of the American Academy of Dermatology.

“Patients definitely preferred adding the topical steroid to tretinoin-alone treatment,” said Dr. Coman, a clinical research fellow in the department of dermatology at the Virginia Tech Carilion School of Medicine and Research Institute, Roanoke. “At week 2, 64% already exhibited a strong preference, and that had increased to 86% by week 4.”

He and his colleagues conducted the 8-week, randomized, split-face trial of 20 patients who were treated with tretinoin for acne. In addition to 0.05% tretinoin, they applied 0.025% triamcinolone to one side of the face and a vehicle emollient to the other side.

Patients were a typical acne treatment population, with a mean age of 18 years and most were female. They had already tried a number of acne treatments, including benzoyl peroxide, topical and oral antibiotics, and tretinoin.

They were assessed at baseline and at weeks 1, 2, 4, and 8. The outcome measures were acne severity; dryness, peeling, and erythema; and overall irritation.

Patients said that irritation increased significantly on the tretinoin-only (control) side by the end of week 1, while dryness did not change on the steroid combination side. By week 4 those scores were converging; by week 8 they were similar.

Physicians scored three categories of irritation: dryness, peeling, and erythema. They felt that dryness was significantly worse on the control side, peaked at week 2, and then slowly decreased, while dryness on the steroid side slowly increased and the scores converged by week 8. Peeling followed a similar pattern. Erythema was not significantly different at any time point.

Overall, acne severity decreased more quickly and dramatically on the steroid side, according to physicians. This finding, combined with the early decreases in symptoms of irritation, might improve compliance. “We have all noticed that the early irritation can be a significant inhibitor of compliance. Our results suggest that topical corticosteroids reduce peeling and dryness early in treatment. We think this could increase compliance and boost outcomes in patients starting topical retinoids,” Dr. Coman commented.

He had no disclosures. The Carilion Clinic funded the study.

WASHINGTON – Adding a topical steroid to tretinoin may be useful in reducing some of the retinoid-induced dermal irritation commonly seen with this treatment in patients with acne.

The reduction in dryness and peeling could, potentially, increase compliance with tretinoin treatment, especially in the first few weeks when retinoid reactions are most likely to occur, Dr. Garrett Coman said at the annual meeting of the American Academy of Dermatology.

“Patients definitely preferred adding the topical steroid to tretinoin-alone treatment,” said Dr. Coman, a clinical research fellow in the department of dermatology at the Virginia Tech Carilion School of Medicine and Research Institute, Roanoke. “At week 2, 64% already exhibited a strong preference, and that had increased to 86% by week 4.”

He and his colleagues conducted the 8-week, randomized, split-face trial of 20 patients who were treated with tretinoin for acne. In addition to 0.05% tretinoin, they applied 0.025% triamcinolone to one side of the face and a vehicle emollient to the other side.

Patients were a typical acne treatment population, with a mean age of 18 years and most were female. They had already tried a number of acne treatments, including benzoyl peroxide, topical and oral antibiotics, and tretinoin.

They were assessed at baseline and at weeks 1, 2, 4, and 8. The outcome measures were acne severity; dryness, peeling, and erythema; and overall irritation.

Patients said that irritation increased significantly on the tretinoin-only (control) side by the end of week 1, while dryness did not change on the steroid combination side. By week 4 those scores were converging; by week 8 they were similar.

Physicians scored three categories of irritation: dryness, peeling, and erythema. They felt that dryness was significantly worse on the control side, peaked at week 2, and then slowly decreased, while dryness on the steroid side slowly increased and the scores converged by week 8. Peeling followed a similar pattern. Erythema was not significantly different at any time point.

Overall, acne severity decreased more quickly and dramatically on the steroid side, according to physicians. This finding, combined with the early decreases in symptoms of irritation, might improve compliance. “We have all noticed that the early irritation can be a significant inhibitor of compliance. Our results suggest that topical corticosteroids reduce peeling and dryness early in treatment. We think this could increase compliance and boost outcomes in patients starting topical retinoids,” Dr. Coman commented.

He had no disclosures. The Carilion Clinic funded the study.

[email protected]

On Twitter @Alz_Gal

WASHINGTON – Adding a topical steroid to tretinoin may be useful in reducing some of the retinoid-induced dermal irritation commonly seen with this treatment in patients with acne.

The reduction in dryness and peeling could, potentially, increase compliance with tretinoin treatment, especially in the first few weeks when retinoid reactions are most likely to occur, Dr. Garrett Coman said at the annual meeting of the American Academy of Dermatology.

“Patients definitely preferred adding the topical steroid to tretinoin-alone treatment,” said Dr. Coman, a clinical research fellow in the department of dermatology at the Virginia Tech Carilion School of Medicine and Research Institute, Roanoke. “At week 2, 64% already exhibited a strong preference, and that had increased to 86% by week 4.”

He and his colleagues conducted the 8-week, randomized, split-face trial of 20 patients who were treated with tretinoin for acne. In addition to 0.05% tretinoin, they applied 0.025% triamcinolone to one side of the face and a vehicle emollient to the other side.

Patients were a typical acne treatment population, with a mean age of 18 years and most were female. They had already tried a number of acne treatments, including benzoyl peroxide, topical and oral antibiotics, and tretinoin.

They were assessed at baseline and at weeks 1, 2, 4, and 8. The outcome measures were acne severity; dryness, peeling, and erythema; and overall irritation.

Patients said that irritation increased significantly on the tretinoin-only (control) side by the end of week 1, while dryness did not change on the steroid combination side. By week 4 those scores were converging; by week 8 they were similar.

Physicians scored three categories of irritation: dryness, peeling, and erythema. They felt that dryness was significantly worse on the control side, peaked at week 2, and then slowly decreased, while dryness on the steroid side slowly increased and the scores converged by week 8. Peeling followed a similar pattern. Erythema was not significantly different at any time point.

Overall, acne severity decreased more quickly and dramatically on the steroid side, according to physicians. This finding, combined with the early decreases in symptoms of irritation, might improve compliance. “We have all noticed that the early irritation can be a significant inhibitor of compliance. Our results suggest that topical corticosteroids reduce peeling and dryness early in treatment. We think this could increase compliance and boost outcomes in patients starting topical retinoids,” Dr. Coman commented.

He had no disclosures. The Carilion Clinic funded the study.

[email protected]

On Twitter @Alz_Gal

WASHINGTON – Adding a topical steroid to tretinoin may be useful in reducing some of the retinoid-induced dermal irritation commonly seen with this treatment in patients with acne.

The reduction in dryness and peeling could, potentially, increase compliance with tretinoin treatment, especially in the first few weeks when retinoid reactions are most likely to occur, Dr. Garrett Coman said at the annual meeting of the American Academy of Dermatology.

“Patients definitely preferred adding the topical steroid to tretinoin-alone treatment,” said Dr. Coman, a clinical research fellow in the department of dermatology at the Virginia Tech Carilion School of Medicine and Research Institute, Roanoke. “At week 2, 64% already exhibited a strong preference, and that had increased to 86% by week 4.”

He and his colleagues conducted the 8-week, randomized, split-face trial of 20 patients who were treated with tretinoin for acne. In addition to 0.05% tretinoin, they applied 0.025% triamcinolone to one side of the face and a vehicle emollient to the other side.

Patients were a typical acne treatment population, with a mean age of 18 years and most were female. They had already tried a number of acne treatments, including benzoyl peroxide, topical and oral antibiotics, and tretinoin.

They were assessed at baseline and at weeks 1, 2, 4, and 8. The outcome measures were acne severity; dryness, peeling, and erythema; and overall irritation.

Patients said that irritation increased significantly on the tretinoin-only (control) side by the end of week 1, while dryness did not change on the steroid combination side. By week 4 those scores were converging; by week 8 they were similar.

Physicians scored three categories of irritation: dryness, peeling, and erythema. They felt that dryness was significantly worse on the control side, peaked at week 2, and then slowly decreased, while dryness on the steroid side slowly increased and the scores converged by week 8. Peeling followed a similar pattern. Erythema was not significantly different at any time point.

Overall, acne severity decreased more quickly and dramatically on the steroid side, according to physicians. This finding, combined with the early decreases in symptoms of irritation, might improve compliance. “We have all noticed that the early irritation can be a significant inhibitor of compliance. Our results suggest that topical corticosteroids reduce peeling and dryness early in treatment. We think this could increase compliance and boost outcomes in patients starting topical retinoids,” Dr. Coman commented.

He had no disclosures. The Carilion Clinic funded the study.

[email protected]

On Twitter @Alz_Gal

Here are 4 articles in the April issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Later Menopause Lowers Risk for Later Depression
To take the posttest, go to: http://bit.ly/1U7I7f3
Expires January 6, 2017

VITALS
Key clinical point: Later menopause, with its longer estrogen exposure, appears tied to a lower risk of postmenopausal depression.
Major finding: The risk of depression decreased by 2% for each 2 premenopausal years after age 40.
Data source: The meta-analysis comprised 14 studies with more than 67,700 women.
Disclosures: Neither Dr. Georgakis nor any of the coauthors declared any financial conflicts.

2. Preschool ASD Prevalence Estimates Lower Than Grade School Estimates
To take the posttest, go to: http://bit.ly/24Mec0X
Expires January 5, 2017

VITALS
Key clinical point: The prevalence of autism spectrum disorders among 4-year-olds is about 30% lower than among 8-year-olds.
Major finding: Prevalence of ASD among 4-year-olds was 13/1,000 children across five U.S. states.
Data source: A comparison of health and medical records for nationally representative cohorts involving 58,467 4-year-olds and 56,727 8-year-olds in five U.S. states in 2010.
Disclosures: The Centers for Disease Control and Prevention funded the research. Dr. Christensen and her associates reported no disclosures.

3. Long-term PPI Use Linked to Increased Risk for Dementia
To take the posttest, go to: http://bit.ly/1nrCdsb
Expires February 24, 2017

VITALS
Key clinical point: Proton pump inhibitors may add to the risk of dementia in older adults. 
Major finding: The risk of incident dementia was 44% higher in adults who used PPIs long term, compared with those who did not. 
Data source: The prospective cohort study included 73,679 adults aged 75 years and older.
Disclosures: The researchers had no financial conflicts to disclose.

4. Elevated Cardiovascular Risks Linked to Hidradenitis Suppurativa
To take the posttest, go to: http://bit.ly/1nrEFz3
Expires February 17, 2017

VITALS
Key clinical point: Hidradenitis suppurativa is associated with a significantly increased risk of adverse cardiovascular events and all-cause mortality.
Major finding: Individuals with hidradenitis suppurativa had a 57% greater risk of myocardial infarction and 33% greater risk of ischemic stroke, compared with the general population. 
Data source: A population-based cohort study in 5,964 patients with hidradenitis suppurativa.
Disclosures: No conflicts of interest were declared.

Here are 4 articles in the April issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Later Menopause Lowers Risk for Later Depression
To take the posttest, go to: http://bit.ly/1U7I7f3
Expires January 6, 2017

VITALS
Key clinical point: Later menopause, with its longer estrogen exposure, appears tied to a lower risk of postmenopausal depression.
Major finding: The risk of depression decreased by 2% for each 2 premenopausal years after age 40.
Data source: The meta-analysis comprised 14 studies with more than 67,700 women.
Disclosures: Neither Dr. Georgakis nor any of the coauthors declared any financial conflicts.

2. Preschool ASD Prevalence Estimates Lower Than Grade School Estimates
To take the posttest, go to: http://bit.ly/24Mec0X
Expires January 5, 2017

VITALS
Key clinical point: The prevalence of autism spectrum disorders among 4-year-olds is about 30% lower than among 8-year-olds.
Major finding: Prevalence of ASD among 4-year-olds was 13/1,000 children across five U.S. states.
Data source: A comparison of health and medical records for nationally representative cohorts involving 58,467 4-year-olds and 56,727 8-year-olds in five U.S. states in 2010.
Disclosures: The Centers for Disease Control and Prevention funded the research. Dr. Christensen and her associates reported no disclosures.

3. Long-term PPI Use Linked to Increased Risk for Dementia
To take the posttest, go to: http://bit.ly/1nrCdsb
Expires February 24, 2017

VITALS
Key clinical point: Proton pump inhibitors may add to the risk of dementia in older adults. 
Major finding: The risk of incident dementia was 44% higher in adults who used PPIs long term, compared with those who did not. 
Data source: The prospective cohort study included 73,679 adults aged 75 years and older.
Disclosures: The researchers had no financial conflicts to disclose.

4. Elevated Cardiovascular Risks Linked to Hidradenitis Suppurativa
To take the posttest, go to: http://bit.ly/1nrEFz3
Expires February 17, 2017

VITALS
Key clinical point: Hidradenitis suppurativa is associated with a significantly increased risk of adverse cardiovascular events and all-cause mortality.
Major finding: Individuals with hidradenitis suppurativa had a 57% greater risk of myocardial infarction and 33% greater risk of ischemic stroke, compared with the general population. 
Data source: A population-based cohort study in 5,964 patients with hidradenitis suppurativa.
Disclosures: No conflicts of interest were declared.

Here are 4 articles in the April issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):

1. Later Menopause Lowers Risk for Later Depression
To take the posttest, go to: http://bit.ly/1U7I7f3
Expires January 6, 2017

VITALS
Key clinical point: Later menopause, with its longer estrogen exposure, appears tied to a lower risk of postmenopausal depression.
Major finding: The risk of depression decreased by 2% for each 2 premenopausal years after age 40.
Data source: The meta-analysis comprised 14 studies with more than 67,700 women.
Disclosures: Neither Dr. Georgakis nor any of the coauthors declared any financial conflicts.

2. Preschool ASD Prevalence Estimates Lower Than Grade School Estimates
To take the posttest, go to: http://bit.ly/24Mec0X
Expires January 5, 2017

VITALS
Key clinical point: The prevalence of autism spectrum disorders among 4-year-olds is about 30% lower than among 8-year-olds.
Major finding: Prevalence of ASD among 4-year-olds was 13/1,000 children across five U.S. states.
Data source: A comparison of health and medical records for nationally representative cohorts involving 58,467 4-year-olds and 56,727 8-year-olds in five U.S. states in 2010.
Disclosures: The Centers for Disease Control and Prevention funded the research. Dr. Christensen and her associates reported no disclosures.

3. Long-term PPI Use Linked to Increased Risk for Dementia
To take the posttest, go to: http://bit.ly/1nrCdsb
Expires February 24, 2017

VITALS
Key clinical point: Proton pump inhibitors may add to the risk of dementia in older adults. 
Major finding: The risk of incident dementia was 44% higher in adults who used PPIs long term, compared with those who did not. 
Data source: The prospective cohort study included 73,679 adults aged 75 years and older.
Disclosures: The researchers had no financial conflicts to disclose.

4. Elevated Cardiovascular Risks Linked to Hidradenitis Suppurativa
To take the posttest, go to: http://bit.ly/1nrEFz3
Expires February 17, 2017

VITALS
Key clinical point: Hidradenitis suppurativa is associated with a significantly increased risk of adverse cardiovascular events and all-cause mortality.
Major finding: Individuals with hidradenitis suppurativa had a 57% greater risk of myocardial infarction and 33% greater risk of ischemic stroke, compared with the general population. 
Data source: A population-based cohort study in 5,964 patients with hidradenitis suppurativa.
Disclosures: No conflicts of interest were declared.

Despite advances in the prevention and early detection of cardiovascular disease, heart attack patients are getting younger, fatter, and less health conscious.

A look at 10 years’ worth of patient data reveals these and other “alarming trends,” according to Dr. Samir R. Kapadia of the Cleveland Clinic.

“What we found was so very contradictory to what we expected,” he said at a press briefing held in advance of the annual meeting of the American College of Cardiology. “Amazingly, we saw that patients presenting with myocardial infarction were getting younger, and their body mass index was going up. There was more smoking, more hypertension, and more diabetes. And all of this despite our better understanding of cardiovascular risk factors.”

The findings seem to point to a serious gap between gathering scientific knowledge and putting that knowledge into practice.

“We have to extend our efforts and put a lot more into educating patients,” Dr. Kapadia said. “Maybe it’s not enough to just tell people to eat right and exercise – maybe we should also be providing them with a structured program. But this is not just the job of the cardiologist. Primary care physicians have to also have this insight, communicate it to the patients, and get them the resources they need to help prevent heart attacks.”

His retrospective study comprised 3,912 consecutive patients who were treated for ST-segment elevation MI (STEMI) from 1995 to 2014. Data were collected on age, gender, diabetes, hypertension, smoking, lipid levels, chronic renal impairment, and obesity. The group was divided into four epochs: 1995-1999, 2000-2004, 2005-2009, and 2010-2014. The researchers examined these factors both in the entire cohort and in a subset of 1,325 who had a diagnosis of coronary artery disease at the time of their MI.

Patients became significantly younger over the entire study period. In epoch 1, the mean age of the entire cohort was 63.6 years. By epoch 3, this had declined to 60.3 years – a significant drop. The change was also evident in the CAD subset; among these patients, mean age declined from 64.1 years in epoch 1 to 61.8 years in epoch 4.

Tobacco use increased significantly in both groups as well. In the overall cohort, the rate was 27.7% in epoch 1 and 45.4% in epoch 4. In the CAD subset, it rose from 24.6% to 42.7%.

Hypertension in the entire cohort increased from 56.7% to 77.3%. In the CAD subset, it increased from 60.9% to 89%.

Obesity increased in both cohorts in overlapping trends, from about 30% in epoch 1 to 40% in epoch 4.

Diabetes increased as well. In the entire cohort, it rose from 24.6% to 30.6%. In the CAD subset, it rose from 25.4% to 41.5%.

Dr. Kapadia noted that the proportion of patients with at least three major risk factors rose from 65% to 85%, and that the incidence of chronic obstructive pulmonary disease increased from 5% to 12%, although he didn’t break this trend down by group.

He had no financial disclosures.

Despite advances in the prevention and early detection of cardiovascular disease, heart attack patients are getting younger, fatter, and less health conscious.

A look at 10 years’ worth of patient data reveals these and other “alarming trends,” according to Dr. Samir R. Kapadia of the Cleveland Clinic.

“What we found was so very contradictory to what we expected,” he said at a press briefing held in advance of the annual meeting of the American College of Cardiology. “Amazingly, we saw that patients presenting with myocardial infarction were getting younger, and their body mass index was going up. There was more smoking, more hypertension, and more diabetes. And all of this despite our better understanding of cardiovascular risk factors.”

The findings seem to point to a serious gap between gathering scientific knowledge and putting that knowledge into practice.

“We have to extend our efforts and put a lot more into educating patients,” Dr. Kapadia said. “Maybe it’s not enough to just tell people to eat right and exercise – maybe we should also be providing them with a structured program. But this is not just the job of the cardiologist. Primary care physicians have to also have this insight, communicate it to the patients, and get them the resources they need to help prevent heart attacks.”

His retrospective study comprised 3,912 consecutive patients who were treated for ST-segment elevation MI (STEMI) from 1995 to 2014. Data were collected on age, gender, diabetes, hypertension, smoking, lipid levels, chronic renal impairment, and obesity. The group was divided into four epochs: 1995-1999, 2000-2004, 2005-2009, and 2010-2014. The researchers examined these factors both in the entire cohort and in a subset of 1,325 who had a diagnosis of coronary artery disease at the time of their MI.

Patients became significantly younger over the entire study period. In epoch 1, the mean age of the entire cohort was 63.6 years. By epoch 3, this had declined to 60.3 years – a significant drop. The change was also evident in the CAD subset; among these patients, mean age declined from 64.1 years in epoch 1 to 61.8 years in epoch 4.

Tobacco use increased significantly in both groups as well. In the overall cohort, the rate was 27.7% in epoch 1 and 45.4% in epoch 4. In the CAD subset, it rose from 24.6% to 42.7%.

Hypertension in the entire cohort increased from 56.7% to 77.3%. In the CAD subset, it increased from 60.9% to 89%.

Obesity increased in both cohorts in overlapping trends, from about 30% in epoch 1 to 40% in epoch 4.

Diabetes increased as well. In the entire cohort, it rose from 24.6% to 30.6%. In the CAD subset, it rose from 25.4% to 41.5%.

Dr. Kapadia noted that the proportion of patients with at least three major risk factors rose from 65% to 85%, and that the incidence of chronic obstructive pulmonary disease increased from 5% to 12%, although he didn’t break this trend down by group.

He had no financial disclosures.

Despite advances in the prevention and early detection of cardiovascular disease, heart attack patients are getting younger, fatter, and less health conscious.

A look at 10 years’ worth of patient data reveals these and other “alarming trends,” according to Dr. Samir R. Kapadia of the Cleveland Clinic.

“What we found was so very contradictory to what we expected,” he said at a press briefing held in advance of the annual meeting of the American College of Cardiology. “Amazingly, we saw that patients presenting with myocardial infarction were getting younger, and their body mass index was going up. There was more smoking, more hypertension, and more diabetes. And all of this despite our better understanding of cardiovascular risk factors.”

The findings seem to point to a serious gap between gathering scientific knowledge and putting that knowledge into practice.

“We have to extend our efforts and put a lot more into educating patients,” Dr. Kapadia said. “Maybe it’s not enough to just tell people to eat right and exercise – maybe we should also be providing them with a structured program. But this is not just the job of the cardiologist. Primary care physicians have to also have this insight, communicate it to the patients, and get them the resources they need to help prevent heart attacks.”

His retrospective study comprised 3,912 consecutive patients who were treated for ST-segment elevation MI (STEMI) from 1995 to 2014. Data were collected on age, gender, diabetes, hypertension, smoking, lipid levels, chronic renal impairment, and obesity. The group was divided into four epochs: 1995-1999, 2000-2004, 2005-2009, and 2010-2014. The researchers examined these factors both in the entire cohort and in a subset of 1,325 who had a diagnosis of coronary artery disease at the time of their MI.

Patients became significantly younger over the entire study period. In epoch 1, the mean age of the entire cohort was 63.6 years. By epoch 3, this had declined to 60.3 years – a significant drop. The change was also evident in the CAD subset; among these patients, mean age declined from 64.1 years in epoch 1 to 61.8 years in epoch 4.

Tobacco use increased significantly in both groups as well. In the overall cohort, the rate was 27.7% in epoch 1 and 45.4% in epoch 4. In the CAD subset, it rose from 24.6% to 42.7%.

Hypertension in the entire cohort increased from 56.7% to 77.3%. In the CAD subset, it increased from 60.9% to 89%.

Obesity increased in both cohorts in overlapping trends, from about 30% in epoch 1 to 40% in epoch 4.

Diabetes increased as well. In the entire cohort, it rose from 24.6% to 30.6%. In the CAD subset, it rose from 25.4% to 41.5%.

Dr. Kapadia noted that the proportion of patients with at least three major risk factors rose from 65% to 85%, and that the incidence of chronic obstructive pulmonary disease increased from 5% to 12%, although he didn’t break this trend down by group.

He had no financial disclosures.

Findings that are easily visible on mammograms – but never shared with patients – could be employed as a powerful new tool for cardiovascular risk assessment, a study showed.

In this prospective imaging study, breast arterial calcification in women without heart disease correlated with cardiovascular risk at least as well as the Framingham Risk Score, and a bit better than the 2013 Cholesterol Guidelines Pooled Cohort Equation.

It also increased the accuracy of both of these models for detecting women at high risk for heart disease, Dr. Laurie Margolies said at a press teleconference leading up to the annual meeting of the American College of Cardiology.

If validated in a larger cohort, the findings could well be “practice changing,” said Dr. Margolies, director of breast imaging at Mt. Sinai Hospital, New York.

She compared its potential impact to that of the now-critical breast density measurement for cancer detection. Until 2008, breast density was a visual, yet unreported and unemployed, mammographic finding.

“This is the same type of practice-changing, revolutionary way of reporting risk,” said Dr. Margolies. “We have a practical way of assessing coronary artery disease risk that adds no extra cost, no radiation, and very little time, and is superior to standard ways of [coronary artery disease] risk assessment. And since prevention is key to decreasing cardiovascular mortality, it would be very simple to report this score on all mammographies,” to give both patients and physicians a heads-up that cardiovascular health needs some quick attention.

The study was simultaneously published online (JACC Cardiovasc Imag. 2016 Mar 24. doi: 10.1016/j.jcmg.2015.10.022).

The cohort comprised 292 women who underwent digital screening mammography and a noncontrast chest CT scan during the same year. None had a history of coronary artery disease. Cardiovascular risk was assessed with three tools: the Framingham Risk Score (FRS), the 2013 Cholesterol Guidelines Pooled Cohort Equation (PCE), and the breast arterial calcification (BAC) score. The BAC score encompassed measurements of number of involved vessels, length of involved segments, and calcification density. Scores ranged from 1 to 12 and were classified by increasing severity: 0, 1-3, and 4-12.

Women were a mean of 61 years old; none had a history of coronary artery disease. Hypertension and hyperlipidemia were common (179 and 104 subjects, respectively). Diabetes was present in 79, smoking in 53, and chronic kidney disease in 57.

Any BAC was present in 42.5% of the group. Those with BAC were significantly older and more likely to have hypertension and kidney disease. Coronary artery calcification (CAC) was present in 47.6% of the overall group, but in 70% of those with BAC. These patients were also significantly older than those without CAC. Hypertension, chronic kidney disease, and diabetes were also more common.

The mean BAC score was 2.2. As women aged, the score was more likely to increase. A BAC score greater than 0 was present in 27% of those younger than 60 years, 47% of those aged 60-69 years, and 69% of those aged 70-92 years.

The mean CAC score was 1.6 ,and this also increased with age. The incidence of CAC for the three age groups was 28%, 55%, and 79%, respectively.

In a multivariate model, a severe BAC score of 4-12 conferred a threefold risk for CAC (odds ratio, 3.2), while older age and hypertension conferred a doubling of risk. “This shows us that BAC is a more powerful predictor than these standard risk factors,” Dr. Margolies said.

The mean 10-year Framingham Risk Score was 4.6. Most women in the cohort (85%) were low risk. Of these, 59% had a BAC of 0, and 63% had a CAC of 0. However, there was some disagreement in the models. Among the FRS low-risk group, 15% had an intermediate-risk BAC score of 1-3, and 22% had a high-risk BAC of 4-12. The CAC was intermediate risk in 29% and high risk in 13%.

Among those with an intermediate-risk FRS, the coronary artery calcification and breast arterial calcification scores were also intermediate risk in 45% and 12%, respectively; the CAC and BAC were high risk in 36% and 64%, respectively.

For the entire cohort, the FRS categories agreed with the BAC categories 55% of the time, and with the CAC categories 57% of the time.

Catherine Yeulet/©Thinkstock

The mean Cholesterol Guidelines Pooled Cohort Equation risk score was 11.8. This score tends to overestimate CAC presence, Dr. Margolies noted, an issue supported by the finding that only 42% of the cohort scored as low risk. In this low-risk group, 74% and 76% had CAC and BAC scores of 0, respectively. But in the PCE high-risk group, only 27% had high-risk CAC and 43% had high-risk BAC. In fact, the CAC and BAC scores were actually 0 in 33% and 40%, respectively.

For the entire cohort, the PCE risk agreed with the CAC 47% of the time and with the BAC 54% of the time.

By itself, a BAC score of more than 0 predicted a CAC score of more than 0 as well as both the Framingham Risk Score and the Pooled Cohort Equation score, with an area under the curve of 0.72 and 0.71, respectively.

BAC did, however, increase the accuracy of both these models for detecting high-risk CAC. In an analysis that included an additional 325 women with a history of coronary artery disease, the area under the curve increased to 0.77 when BAC was added to the FRS; it increased to 0.76 when added to the PCE model.

Adding BAC data to every mammogram would be an easy and very effective way to alert patients and their physicians to developing coronary artery disease, Dr. Margolies said.

“Even though heart disease kills 10 times more women than breast cancer does, there is no routine screening test for it. But digital mammography screening for breast cancer is a common procedure. I would advocate that we add the BAC data to mammogram reports so that we have a way to assess this risk. Women who were BAC positive could then undergo further risk assessment, preferably with a gated CT scan, with subsequent adjustment or initiation of statins,” she said.

Dr. Margolies had no relevant financial disclosures.

Findings that are easily visible on mammograms – but never shared with patients – could be employed as a powerful new tool for cardiovascular risk assessment, a study showed.

In this prospective imaging study, breast arterial calcification in women without heart disease correlated with cardiovascular risk at least as well as the Framingham Risk Score, and a bit better than the 2013 Cholesterol Guidelines Pooled Cohort Equation.

It also increased the accuracy of both of these models for detecting women at high risk for heart disease, Dr. Laurie Margolies said at a press teleconference leading up to the annual meeting of the American College of Cardiology.

If validated in a larger cohort, the findings could well be “practice changing,” said Dr. Margolies, director of breast imaging at Mt. Sinai Hospital, New York.

She compared its potential impact to that of the now-critical breast density measurement for cancer detection. Until 2008, breast density was a visual, yet unreported and unemployed, mammographic finding.

“This is the same type of practice-changing, revolutionary way of reporting risk,” said Dr. Margolies. “We have a practical way of assessing coronary artery disease risk that adds no extra cost, no radiation, and very little time, and is superior to standard ways of [coronary artery disease] risk assessment. And since prevention is key to decreasing cardiovascular mortality, it would be very simple to report this score on all mammographies,” to give both patients and physicians a heads-up that cardiovascular health needs some quick attention.

The study was simultaneously published online (JACC Cardiovasc Imag. 2016 Mar 24. doi: 10.1016/j.jcmg.2015.10.022).

The cohort comprised 292 women who underwent digital screening mammography and a noncontrast chest CT scan during the same year. None had a history of coronary artery disease. Cardiovascular risk was assessed with three tools: the Framingham Risk Score (FRS), the 2013 Cholesterol Guidelines Pooled Cohort Equation (PCE), and the breast arterial calcification (BAC) score. The BAC score encompassed measurements of number of involved vessels, length of involved segments, and calcification density. Scores ranged from 1 to 12 and were classified by increasing severity: 0, 1-3, and 4-12.

Women were a mean of 61 years old; none had a history of coronary artery disease. Hypertension and hyperlipidemia were common (179 and 104 subjects, respectively). Diabetes was present in 79, smoking in 53, and chronic kidney disease in 57.

Any BAC was present in 42.5% of the group. Those with BAC were significantly older and more likely to have hypertension and kidney disease. Coronary artery calcification (CAC) was present in 47.6% of the overall group, but in 70% of those with BAC. These patients were also significantly older than those without CAC. Hypertension, chronic kidney disease, and diabetes were also more common.

The mean BAC score was 2.2. As women aged, the score was more likely to increase. A BAC score greater than 0 was present in 27% of those younger than 60 years, 47% of those aged 60-69 years, and 69% of those aged 70-92 years.

The mean CAC score was 1.6 ,and this also increased with age. The incidence of CAC for the three age groups was 28%, 55%, and 79%, respectively.

In a multivariate model, a severe BAC score of 4-12 conferred a threefold risk for CAC (odds ratio, 3.2), while older age and hypertension conferred a doubling of risk. “This shows us that BAC is a more powerful predictor than these standard risk factors,” Dr. Margolies said.

The mean 10-year Framingham Risk Score was 4.6. Most women in the cohort (85%) were low risk. Of these, 59% had a BAC of 0, and 63% had a CAC of 0. However, there was some disagreement in the models. Among the FRS low-risk group, 15% had an intermediate-risk BAC score of 1-3, and 22% had a high-risk BAC of 4-12. The CAC was intermediate risk in 29% and high risk in 13%.

Among those with an intermediate-risk FRS, the coronary artery calcification and breast arterial calcification scores were also intermediate risk in 45% and 12%, respectively; the CAC and BAC were high risk in 36% and 64%, respectively.

For the entire cohort, the FRS categories agreed with the BAC categories 55% of the time, and with the CAC categories 57% of the time.

Catherine Yeulet/©Thinkstock

The mean Cholesterol Guidelines Pooled Cohort Equation risk score was 11.8. This score tends to overestimate CAC presence, Dr. Margolies noted, an issue supported by the finding that only 42% of the cohort scored as low risk. In this low-risk group, 74% and 76% had CAC and BAC scores of 0, respectively. But in the PCE high-risk group, only 27% had high-risk CAC and 43% had high-risk BAC. In fact, the CAC and BAC scores were actually 0 in 33% and 40%, respectively.

For the entire cohort, the PCE risk agreed with the CAC 47% of the time and with the BAC 54% of the time.

By itself, a BAC score of more than 0 predicted a CAC score of more than 0 as well as both the Framingham Risk Score and the Pooled Cohort Equation score, with an area under the curve of 0.72 and 0.71, respectively.

BAC did, however, increase the accuracy of both these models for detecting high-risk CAC. In an analysis that included an additional 325 women with a history of coronary artery disease, the area under the curve increased to 0.77 when BAC was added to the FRS; it increased to 0.76 when added to the PCE model.

Adding BAC data to every mammogram would be an easy and very effective way to alert patients and their physicians to developing coronary artery disease, Dr. Margolies said.

“Even though heart disease kills 10 times more women than breast cancer does, there is no routine screening test for it. But digital mammography screening for breast cancer is a common procedure. I would advocate that we add the BAC data to mammogram reports so that we have a way to assess this risk. Women who were BAC positive could then undergo further risk assessment, preferably with a gated CT scan, with subsequent adjustment or initiation of statins,” she said.

Dr. Margolies had no relevant financial disclosures.

Findings that are easily visible on mammograms – but never shared with patients – could be employed as a powerful new tool for cardiovascular risk assessment, a study showed.

In this prospective imaging study, breast arterial calcification in women without heart disease correlated with cardiovascular risk at least as well as the Framingham Risk Score, and a bit better than the 2013 Cholesterol Guidelines Pooled Cohort Equation.

It also increased the accuracy of both of these models for detecting women at high risk for heart disease, Dr. Laurie Margolies said at a press teleconference leading up to the annual meeting of the American College of Cardiology.

If validated in a larger cohort, the findings could well be “practice changing,” said Dr. Margolies, director of breast imaging at Mt. Sinai Hospital, New York.

She compared its potential impact to that of the now-critical breast density measurement for cancer detection. Until 2008, breast density was a visual, yet unreported and unemployed, mammographic finding.

“This is the same type of practice-changing, revolutionary way of reporting risk,” said Dr. Margolies. “We have a practical way of assessing coronary artery disease risk that adds no extra cost, no radiation, and very little time, and is superior to standard ways of [coronary artery disease] risk assessment. And since prevention is key to decreasing cardiovascular mortality, it would be very simple to report this score on all mammographies,” to give both patients and physicians a heads-up that cardiovascular health needs some quick attention.

The study was simultaneously published online (JACC Cardiovasc Imag. 2016 Mar 24. doi: 10.1016/j.jcmg.2015.10.022).

The cohort comprised 292 women who underwent digital screening mammography and a noncontrast chest CT scan during the same year. None had a history of coronary artery disease. Cardiovascular risk was assessed with three tools: the Framingham Risk Score (FRS), the 2013 Cholesterol Guidelines Pooled Cohort Equation (PCE), and the breast arterial calcification (BAC) score. The BAC score encompassed measurements of number of involved vessels, length of involved segments, and calcification density. Scores ranged from 1 to 12 and were classified by increasing severity: 0, 1-3, and 4-12.

Women were a mean of 61 years old; none had a history of coronary artery disease. Hypertension and hyperlipidemia were common (179 and 104 subjects, respectively). Diabetes was present in 79, smoking in 53, and chronic kidney disease in 57.

Any BAC was present in 42.5% of the group. Those with BAC were significantly older and more likely to have hypertension and kidney disease. Coronary artery calcification (CAC) was present in 47.6% of the overall group, but in 70% of those with BAC. These patients were also significantly older than those without CAC. Hypertension, chronic kidney disease, and diabetes were also more common.

The mean BAC score was 2.2. As women aged, the score was more likely to increase. A BAC score greater than 0 was present in 27% of those younger than 60 years, 47% of those aged 60-69 years, and 69% of those aged 70-92 years.

The mean CAC score was 1.6 ,and this also increased with age. The incidence of CAC for the three age groups was 28%, 55%, and 79%, respectively.

In a multivariate model, a severe BAC score of 4-12 conferred a threefold risk for CAC (odds ratio, 3.2), while older age and hypertension conferred a doubling of risk. “This shows us that BAC is a more powerful predictor than these standard risk factors,” Dr. Margolies said.

The mean 10-year Framingham Risk Score was 4.6. Most women in the cohort (85%) were low risk. Of these, 59% had a BAC of 0, and 63% had a CAC of 0. However, there was some disagreement in the models. Among the FRS low-risk group, 15% had an intermediate-risk BAC score of 1-3, and 22% had a high-risk BAC of 4-12. The CAC was intermediate risk in 29% and high risk in 13%.

Among those with an intermediate-risk FRS, the coronary artery calcification and breast arterial calcification scores were also intermediate risk in 45% and 12%, respectively; the CAC and BAC were high risk in 36% and 64%, respectively.

For the entire cohort, the FRS categories agreed with the BAC categories 55% of the time, and with the CAC categories 57% of the time.

Catherine Yeulet/©Thinkstock

The mean Cholesterol Guidelines Pooled Cohort Equation risk score was 11.8. This score tends to overestimate CAC presence, Dr. Margolies noted, an issue supported by the finding that only 42% of the cohort scored as low risk. In this low-risk group, 74% and 76% had CAC and BAC scores of 0, respectively. But in the PCE high-risk group, only 27% had high-risk CAC and 43% had high-risk BAC. In fact, the CAC and BAC scores were actually 0 in 33% and 40%, respectively.

For the entire cohort, the PCE risk agreed with the CAC 47% of the time and with the BAC 54% of the time.

By itself, a BAC score of more than 0 predicted a CAC score of more than 0 as well as both the Framingham Risk Score and the Pooled Cohort Equation score, with an area under the curve of 0.72 and 0.71, respectively.

BAC did, however, increase the accuracy of both these models for detecting high-risk CAC. In an analysis that included an additional 325 women with a history of coronary artery disease, the area under the curve increased to 0.77 when BAC was added to the FRS; it increased to 0.76 when added to the PCE model.

Adding BAC data to every mammogram would be an easy and very effective way to alert patients and their physicians to developing coronary artery disease, Dr. Margolies said.

“Even though heart disease kills 10 times more women than breast cancer does, there is no routine screening test for it. But digital mammography screening for breast cancer is a common procedure. I would advocate that we add the BAC data to mammogram reports so that we have a way to assess this risk. Women who were BAC positive could then undergo further risk assessment, preferably with a gated CT scan, with subsequent adjustment or initiation of statins,” she said.

Dr. Margolies had no relevant financial disclosures.