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Getting serious about post-EVAR aortic neck dilation
CHICAGO – Clinically significant aortic neck dilation occurs in one-quarter of patients after endovascular abdominal aortic aneurysm repair and is associated with sharply increased risk for type Ia endoleak, stent migration at the proximal seal zone, continued aneurysmal sack enlargement, and even aneurysm rupture, Jason T. Lee, MD, said at a symposium on vascular surgery sponsored by Northwestern University.
He cited what he considers to be the best-quality systematic review of the literature regarding proximal neck dilation after endovascular aneurysm repair (EVAR), which was conducted by investigators at Paracelsus Medical University in Nuremberg, Germany. The data, he said, speak to the importance of trying to minimize the chances of aortic neck dilation (AND).
The review, which included 26 published studies through 2015 and nearly 10,000 EVAR patients, concluded that AND occurred in 24.6% of these patients. The investigators defined AND as more than 3 mm of dilation, which with an average neck diameter of about 30 mm in all comers, would represent a 10% aortic neck-diameter expansion. The incidence of the composite adverse outcome of type I endoleak, stent migration, and reintervention during a maximum of 9 years of follow-up was 29-fold greater in the AND group than in AND-free patients (J Endovasc Ther. 2017;24[1]:59-67).
Continuing controversy exists regarding the extent to which post-EVAR AND is a manifestation of the underlying aneurysmal process as opposed to an adverse effect caused by the outward radial force applied by the stent. That being said, there are several factors related to AND that are potentially within the vascular interventionalist’s control. Topping the list is aggressive oversizing of self-expanding stent grafts in an effort to obtain an excellent seal, according to Dr. Lee, a professor of surgery at Stanford (Calif.) University.
“The data from multiple series definitely suggests that more than 20% oversizing is correlated with a higher incidence of AND. So maybe the answer is oversizing by more like 10%-15%,” the vascular surgeon said.
Another factor contributing to AND is the overwhelming popularity of self-expanding aortic stent grafts, now utilized in 95% of all EVARS done in the United States. Balloon-expandable stent grafts require much less oversizing – less than 5% – to maintain their diameter post deployment, but they are rarely used. Indeed, the only commercially available balloon-expandable device in the United States is the TriVascular Ovation stent system, which seals the stent graft to the wall of the aorta via polyethylene glycol rather than by radial force.
Intriguingly, Italian investigators have reported that, in a multicenter series of 161 patients who underwent EVAR with the Ovation endograft, no AND occurred at CT scanning done after a minimum of 24 months of follow-up (J Vasc Surg. 2016;63[1]:8-15).
Previous studies of the implications of AND after EVAR have been limited to comparisons of early-generation devices, so Dr. Lee and his coinvestigators conducted a retrospective review of a prospective Stanford database that included 86 patients who underwent elective, uncomplicated infrarenal endovascular abdominal aortic aneurysm repairs using a variety of contemporary stent grafts. Eighty-six percent of patients experienced AND during a median radiologic follow-up of 21.9 months, with a mean 1.3-mm increase at 30 days and 3.3 mm at most recent follow-up. The degree of AND correlated with the amount of oversizing. However, AND didn’t vary significantly by device type, which included the Cook Zenith, Gore Excluder, Medtronic Endurant, and Endologix Powerlink self-expanding stent grafts (Ann Vasc Surg. 2017;43:115-20).
Aortic anatomy also plays a role in AND. Shorter necks with severe angulation have been found to pose a higher risk. Open repair, which entails much less AND than does EVAR, may make more sense in that challenging anatomic situation, according to Dr. Lee.
He reported current research funding from Cook, Gore, and Medtronic.
CHICAGO – Clinically significant aortic neck dilation occurs in one-quarter of patients after endovascular abdominal aortic aneurysm repair and is associated with sharply increased risk for type Ia endoleak, stent migration at the proximal seal zone, continued aneurysmal sack enlargement, and even aneurysm rupture, Jason T. Lee, MD, said at a symposium on vascular surgery sponsored by Northwestern University.
He cited what he considers to be the best-quality systematic review of the literature regarding proximal neck dilation after endovascular aneurysm repair (EVAR), which was conducted by investigators at Paracelsus Medical University in Nuremberg, Germany. The data, he said, speak to the importance of trying to minimize the chances of aortic neck dilation (AND).
The review, which included 26 published studies through 2015 and nearly 10,000 EVAR patients, concluded that AND occurred in 24.6% of these patients. The investigators defined AND as more than 3 mm of dilation, which with an average neck diameter of about 30 mm in all comers, would represent a 10% aortic neck-diameter expansion. The incidence of the composite adverse outcome of type I endoleak, stent migration, and reintervention during a maximum of 9 years of follow-up was 29-fold greater in the AND group than in AND-free patients (J Endovasc Ther. 2017;24[1]:59-67).
Continuing controversy exists regarding the extent to which post-EVAR AND is a manifestation of the underlying aneurysmal process as opposed to an adverse effect caused by the outward radial force applied by the stent. That being said, there are several factors related to AND that are potentially within the vascular interventionalist’s control. Topping the list is aggressive oversizing of self-expanding stent grafts in an effort to obtain an excellent seal, according to Dr. Lee, a professor of surgery at Stanford (Calif.) University.
“The data from multiple series definitely suggests that more than 20% oversizing is correlated with a higher incidence of AND. So maybe the answer is oversizing by more like 10%-15%,” the vascular surgeon said.
Another factor contributing to AND is the overwhelming popularity of self-expanding aortic stent grafts, now utilized in 95% of all EVARS done in the United States. Balloon-expandable stent grafts require much less oversizing – less than 5% – to maintain their diameter post deployment, but they are rarely used. Indeed, the only commercially available balloon-expandable device in the United States is the TriVascular Ovation stent system, which seals the stent graft to the wall of the aorta via polyethylene glycol rather than by radial force.
Intriguingly, Italian investigators have reported that, in a multicenter series of 161 patients who underwent EVAR with the Ovation endograft, no AND occurred at CT scanning done after a minimum of 24 months of follow-up (J Vasc Surg. 2016;63[1]:8-15).
Previous studies of the implications of AND after EVAR have been limited to comparisons of early-generation devices, so Dr. Lee and his coinvestigators conducted a retrospective review of a prospective Stanford database that included 86 patients who underwent elective, uncomplicated infrarenal endovascular abdominal aortic aneurysm repairs using a variety of contemporary stent grafts. Eighty-six percent of patients experienced AND during a median radiologic follow-up of 21.9 months, with a mean 1.3-mm increase at 30 days and 3.3 mm at most recent follow-up. The degree of AND correlated with the amount of oversizing. However, AND didn’t vary significantly by device type, which included the Cook Zenith, Gore Excluder, Medtronic Endurant, and Endologix Powerlink self-expanding stent grafts (Ann Vasc Surg. 2017;43:115-20).
Aortic anatomy also plays a role in AND. Shorter necks with severe angulation have been found to pose a higher risk. Open repair, which entails much less AND than does EVAR, may make more sense in that challenging anatomic situation, according to Dr. Lee.
He reported current research funding from Cook, Gore, and Medtronic.
CHICAGO – Clinically significant aortic neck dilation occurs in one-quarter of patients after endovascular abdominal aortic aneurysm repair and is associated with sharply increased risk for type Ia endoleak, stent migration at the proximal seal zone, continued aneurysmal sack enlargement, and even aneurysm rupture, Jason T. Lee, MD, said at a symposium on vascular surgery sponsored by Northwestern University.
He cited what he considers to be the best-quality systematic review of the literature regarding proximal neck dilation after endovascular aneurysm repair (EVAR), which was conducted by investigators at Paracelsus Medical University in Nuremberg, Germany. The data, he said, speak to the importance of trying to minimize the chances of aortic neck dilation (AND).
The review, which included 26 published studies through 2015 and nearly 10,000 EVAR patients, concluded that AND occurred in 24.6% of these patients. The investigators defined AND as more than 3 mm of dilation, which with an average neck diameter of about 30 mm in all comers, would represent a 10% aortic neck-diameter expansion. The incidence of the composite adverse outcome of type I endoleak, stent migration, and reintervention during a maximum of 9 years of follow-up was 29-fold greater in the AND group than in AND-free patients (J Endovasc Ther. 2017;24[1]:59-67).
Continuing controversy exists regarding the extent to which post-EVAR AND is a manifestation of the underlying aneurysmal process as opposed to an adverse effect caused by the outward radial force applied by the stent. That being said, there are several factors related to AND that are potentially within the vascular interventionalist’s control. Topping the list is aggressive oversizing of self-expanding stent grafts in an effort to obtain an excellent seal, according to Dr. Lee, a professor of surgery at Stanford (Calif.) University.
“The data from multiple series definitely suggests that more than 20% oversizing is correlated with a higher incidence of AND. So maybe the answer is oversizing by more like 10%-15%,” the vascular surgeon said.
Another factor contributing to AND is the overwhelming popularity of self-expanding aortic stent grafts, now utilized in 95% of all EVARS done in the United States. Balloon-expandable stent grafts require much less oversizing – less than 5% – to maintain their diameter post deployment, but they are rarely used. Indeed, the only commercially available balloon-expandable device in the United States is the TriVascular Ovation stent system, which seals the stent graft to the wall of the aorta via polyethylene glycol rather than by radial force.
Intriguingly, Italian investigators have reported that, in a multicenter series of 161 patients who underwent EVAR with the Ovation endograft, no AND occurred at CT scanning done after a minimum of 24 months of follow-up (J Vasc Surg. 2016;63[1]:8-15).
Previous studies of the implications of AND after EVAR have been limited to comparisons of early-generation devices, so Dr. Lee and his coinvestigators conducted a retrospective review of a prospective Stanford database that included 86 patients who underwent elective, uncomplicated infrarenal endovascular abdominal aortic aneurysm repairs using a variety of contemporary stent grafts. Eighty-six percent of patients experienced AND during a median radiologic follow-up of 21.9 months, with a mean 1.3-mm increase at 30 days and 3.3 mm at most recent follow-up. The degree of AND correlated with the amount of oversizing. However, AND didn’t vary significantly by device type, which included the Cook Zenith, Gore Excluder, Medtronic Endurant, and Endologix Powerlink self-expanding stent grafts (Ann Vasc Surg. 2017;43:115-20).
Aortic anatomy also plays a role in AND. Shorter necks with severe angulation have been found to pose a higher risk. Open repair, which entails much less AND than does EVAR, may make more sense in that challenging anatomic situation, according to Dr. Lee.
He reported current research funding from Cook, Gore, and Medtronic.
EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM
MMF proves viable as alternative option in moderate ANCA-associated vasculitis
Mycophenolate mofetil was noninferior to pulsed cyclophosphamide for remission induction in ANCA-associated vasculitis, but there were more relapses, in a randomized, unblinded trial of 140 patients with non–life-threatening disease.
“Our results demonstrate that MMF [mycophenolate mofetil] represents an alternative to CYC [cyclophosphamide] for remission induction in AAV [ANCA-associated vasculitis],” said investigators led by Rachel B. Jones, MD, of the department of renal medicine at Addenbrooke’s Hospital, Cambridge, England.
“While treatment with MMF may be associated with a higher risk of relapse compared with pulsed CYC, this increased risk may be acceptable to avoid the potential adverse effects of CYC” – infections, malignancies, and infertility – “particularly when the baseline risk of relapse is low,” as with the elderly or myeloperoxidase (MPO)-ANCA disease, “or if rituximab is unavailable,” Dr. Jones and her colleagues wrote in Annals of the Rheumatic Diseases.
Since enrollment began in 2007, they also noted that “it has become common to use rituximab as an alternative to CYC induction therapy ... However, rituximab is expensive, and its use is restricted in many countries ... Alternative effective low-cost induction therapies” – such as MMF – “may be required in some cases.”
The work, which was done on behalf of the European Vasculitis Study Group, was the largest randomized trial to date of MMF for AAV remission induction, and the first to include children; patients were enrolled at 21 sites in Europe, Australia, and New Zealand.
They were randomly assigned to MMF or pulsed CYC, with 66 adults and 4 children ranging in age from 10 to 16 years in each group. In addition to those with life-threatening disease, patients younger than 6 years old and those on dialysis or with an estimated glomerular filtration rate below 15 mL/min/m2 were excluded. Following remission, subjects were switched to oral azathioprine and a prednisone taper.
The primary outcome was remission by 6 months, defined as the absence of disease activity on two consecutive occasions at least 1 month apart, plus adherence to the taper. Baseline ANCA subtype, disease activity, and organ involvement were similar between the groups.
Overall, 47 patients in the in the MMF group (67%), including 1 child, reached the primary endpoint, versus 43 patients (61%), again including 1 child, in the CYC group (risk difference = 5.7%; 90% confidence interval, –7.5% to 19%), which established noninferiority. The median time to remission was about 90 days in both arms. “Compliance was a contributory factor to the lower remission rate[s] in children,” the authors noted.
More relapses occurred in the MMF group (33% vs. 19% with CYC). Among MPO-ANCA patients, the relapse rate was 15% versus 12% with CYC. In proteinase 3 (PR3)-ANCA patients, almost half in the MMF group relapsed (48% versus 24%).
There were no significant differences in serious infections (26% with MMF versus 17% with CYC; P = .3), malignancies, thromboembolisms, or death (four CYC patients and five MMF patients at 6 months).
Adult patients in the MMF group received MMF 2 g/day, with dose increases to 3 g/day permitted for uncontrolled disease at 4 weeks. Patients younger than 17 years old were dosed according to body surface area. The CYC group received intravenous pulsed CYC 15 mg/kg every 2-3 weeks with reductions for age and renal function. A total of 58 CYC patients (83%) received at least six pulses.
After remission, azathioprine was dosed at 2 mg/kg per day. Oral prednisolone started at 1 mg/kg per day and was reduced to 5 mg/day by 6 months.
Plasma exchange or additional methylprednisolone were allowed at entry; there were no differences in their use between the groups.
The trial was sponsored by Cambridge University Hospitals NHS Foundation Trust. Vifor Pharma provided a research grant to cover the trial and MMF costs. Dr. Jones and the other investigators reported ties to several companies, including GlaxoSmithKline, Genentech/Roche, ChemoCentryx, and Genzyme/Sanofi. Vifor holds an equity stake in ChemoCentryx.
SOURCE: Jones RB et al. Ann Rheum Dis. 2019 Jan 5. doi: 10.1136/annrheumdis-2018-214245.
We sometimes encounter patients for whom access to rituximab is a problem, for financial, logistical, or tolerability reasons. Also, some patients are really reluctant about an infusion, and there is still some skittishness about rituximab. I have had some patients who, despite my having strongly reiterated how rare progressive multifocal leukoencephalopathy is, have been unable to get past the fact that that’s in the package insert. It’s helpful to me as a clinician to know that mycophenolate is something we can turn to in these situations. As I discuss the ups and down of different potential strategies with patients, this is something that can be part of the discussion.
This was a really well done study, and they were honest about the limitations. They excluded patients with the most severe disease, so you are still not talking about your patients on dialysis getting mycophenolate. Also, there are questions in terms of it’s not being as effective at sustaining remission, but that’s a bridge you can cross once they are in remission, in terms of how vigilant you are about follow-up. You also can re-induce remission with mycophenolate if you have to.
Robert F. Spiera, MD, is director of the vasculitis and scleroderma program at the Hospital for Special Surgery in New York. He had no relevant disclosures, and is on the editorial advisory board of MDedge Rheumatology.
We sometimes encounter patients for whom access to rituximab is a problem, for financial, logistical, or tolerability reasons. Also, some patients are really reluctant about an infusion, and there is still some skittishness about rituximab. I have had some patients who, despite my having strongly reiterated how rare progressive multifocal leukoencephalopathy is, have been unable to get past the fact that that’s in the package insert. It’s helpful to me as a clinician to know that mycophenolate is something we can turn to in these situations. As I discuss the ups and down of different potential strategies with patients, this is something that can be part of the discussion.
This was a really well done study, and they were honest about the limitations. They excluded patients with the most severe disease, so you are still not talking about your patients on dialysis getting mycophenolate. Also, there are questions in terms of it’s not being as effective at sustaining remission, but that’s a bridge you can cross once they are in remission, in terms of how vigilant you are about follow-up. You also can re-induce remission with mycophenolate if you have to.
Robert F. Spiera, MD, is director of the vasculitis and scleroderma program at the Hospital for Special Surgery in New York. He had no relevant disclosures, and is on the editorial advisory board of MDedge Rheumatology.
We sometimes encounter patients for whom access to rituximab is a problem, for financial, logistical, or tolerability reasons. Also, some patients are really reluctant about an infusion, and there is still some skittishness about rituximab. I have had some patients who, despite my having strongly reiterated how rare progressive multifocal leukoencephalopathy is, have been unable to get past the fact that that’s in the package insert. It’s helpful to me as a clinician to know that mycophenolate is something we can turn to in these situations. As I discuss the ups and down of different potential strategies with patients, this is something that can be part of the discussion.
This was a really well done study, and they were honest about the limitations. They excluded patients with the most severe disease, so you are still not talking about your patients on dialysis getting mycophenolate. Also, there are questions in terms of it’s not being as effective at sustaining remission, but that’s a bridge you can cross once they are in remission, in terms of how vigilant you are about follow-up. You also can re-induce remission with mycophenolate if you have to.
Robert F. Spiera, MD, is director of the vasculitis and scleroderma program at the Hospital for Special Surgery in New York. He had no relevant disclosures, and is on the editorial advisory board of MDedge Rheumatology.
Mycophenolate mofetil was noninferior to pulsed cyclophosphamide for remission induction in ANCA-associated vasculitis, but there were more relapses, in a randomized, unblinded trial of 140 patients with non–life-threatening disease.
“Our results demonstrate that MMF [mycophenolate mofetil] represents an alternative to CYC [cyclophosphamide] for remission induction in AAV [ANCA-associated vasculitis],” said investigators led by Rachel B. Jones, MD, of the department of renal medicine at Addenbrooke’s Hospital, Cambridge, England.
“While treatment with MMF may be associated with a higher risk of relapse compared with pulsed CYC, this increased risk may be acceptable to avoid the potential adverse effects of CYC” – infections, malignancies, and infertility – “particularly when the baseline risk of relapse is low,” as with the elderly or myeloperoxidase (MPO)-ANCA disease, “or if rituximab is unavailable,” Dr. Jones and her colleagues wrote in Annals of the Rheumatic Diseases.
Since enrollment began in 2007, they also noted that “it has become common to use rituximab as an alternative to CYC induction therapy ... However, rituximab is expensive, and its use is restricted in many countries ... Alternative effective low-cost induction therapies” – such as MMF – “may be required in some cases.”
The work, which was done on behalf of the European Vasculitis Study Group, was the largest randomized trial to date of MMF for AAV remission induction, and the first to include children; patients were enrolled at 21 sites in Europe, Australia, and New Zealand.
They were randomly assigned to MMF or pulsed CYC, with 66 adults and 4 children ranging in age from 10 to 16 years in each group. In addition to those with life-threatening disease, patients younger than 6 years old and those on dialysis or with an estimated glomerular filtration rate below 15 mL/min/m2 were excluded. Following remission, subjects were switched to oral azathioprine and a prednisone taper.
The primary outcome was remission by 6 months, defined as the absence of disease activity on two consecutive occasions at least 1 month apart, plus adherence to the taper. Baseline ANCA subtype, disease activity, and organ involvement were similar between the groups.
Overall, 47 patients in the in the MMF group (67%), including 1 child, reached the primary endpoint, versus 43 patients (61%), again including 1 child, in the CYC group (risk difference = 5.7%; 90% confidence interval, –7.5% to 19%), which established noninferiority. The median time to remission was about 90 days in both arms. “Compliance was a contributory factor to the lower remission rate[s] in children,” the authors noted.
More relapses occurred in the MMF group (33% vs. 19% with CYC). Among MPO-ANCA patients, the relapse rate was 15% versus 12% with CYC. In proteinase 3 (PR3)-ANCA patients, almost half in the MMF group relapsed (48% versus 24%).
There were no significant differences in serious infections (26% with MMF versus 17% with CYC; P = .3), malignancies, thromboembolisms, or death (four CYC patients and five MMF patients at 6 months).
Adult patients in the MMF group received MMF 2 g/day, with dose increases to 3 g/day permitted for uncontrolled disease at 4 weeks. Patients younger than 17 years old were dosed according to body surface area. The CYC group received intravenous pulsed CYC 15 mg/kg every 2-3 weeks with reductions for age and renal function. A total of 58 CYC patients (83%) received at least six pulses.
After remission, azathioprine was dosed at 2 mg/kg per day. Oral prednisolone started at 1 mg/kg per day and was reduced to 5 mg/day by 6 months.
Plasma exchange or additional methylprednisolone were allowed at entry; there were no differences in their use between the groups.
The trial was sponsored by Cambridge University Hospitals NHS Foundation Trust. Vifor Pharma provided a research grant to cover the trial and MMF costs. Dr. Jones and the other investigators reported ties to several companies, including GlaxoSmithKline, Genentech/Roche, ChemoCentryx, and Genzyme/Sanofi. Vifor holds an equity stake in ChemoCentryx.
SOURCE: Jones RB et al. Ann Rheum Dis. 2019 Jan 5. doi: 10.1136/annrheumdis-2018-214245.
Mycophenolate mofetil was noninferior to pulsed cyclophosphamide for remission induction in ANCA-associated vasculitis, but there were more relapses, in a randomized, unblinded trial of 140 patients with non–life-threatening disease.
“Our results demonstrate that MMF [mycophenolate mofetil] represents an alternative to CYC [cyclophosphamide] for remission induction in AAV [ANCA-associated vasculitis],” said investigators led by Rachel B. Jones, MD, of the department of renal medicine at Addenbrooke’s Hospital, Cambridge, England.
“While treatment with MMF may be associated with a higher risk of relapse compared with pulsed CYC, this increased risk may be acceptable to avoid the potential adverse effects of CYC” – infections, malignancies, and infertility – “particularly when the baseline risk of relapse is low,” as with the elderly or myeloperoxidase (MPO)-ANCA disease, “or if rituximab is unavailable,” Dr. Jones and her colleagues wrote in Annals of the Rheumatic Diseases.
Since enrollment began in 2007, they also noted that “it has become common to use rituximab as an alternative to CYC induction therapy ... However, rituximab is expensive, and its use is restricted in many countries ... Alternative effective low-cost induction therapies” – such as MMF – “may be required in some cases.”
The work, which was done on behalf of the European Vasculitis Study Group, was the largest randomized trial to date of MMF for AAV remission induction, and the first to include children; patients were enrolled at 21 sites in Europe, Australia, and New Zealand.
They were randomly assigned to MMF or pulsed CYC, with 66 adults and 4 children ranging in age from 10 to 16 years in each group. In addition to those with life-threatening disease, patients younger than 6 years old and those on dialysis or with an estimated glomerular filtration rate below 15 mL/min/m2 were excluded. Following remission, subjects were switched to oral azathioprine and a prednisone taper.
The primary outcome was remission by 6 months, defined as the absence of disease activity on two consecutive occasions at least 1 month apart, plus adherence to the taper. Baseline ANCA subtype, disease activity, and organ involvement were similar between the groups.
Overall, 47 patients in the in the MMF group (67%), including 1 child, reached the primary endpoint, versus 43 patients (61%), again including 1 child, in the CYC group (risk difference = 5.7%; 90% confidence interval, –7.5% to 19%), which established noninferiority. The median time to remission was about 90 days in both arms. “Compliance was a contributory factor to the lower remission rate[s] in children,” the authors noted.
More relapses occurred in the MMF group (33% vs. 19% with CYC). Among MPO-ANCA patients, the relapse rate was 15% versus 12% with CYC. In proteinase 3 (PR3)-ANCA patients, almost half in the MMF group relapsed (48% versus 24%).
There were no significant differences in serious infections (26% with MMF versus 17% with CYC; P = .3), malignancies, thromboembolisms, or death (four CYC patients and five MMF patients at 6 months).
Adult patients in the MMF group received MMF 2 g/day, with dose increases to 3 g/day permitted for uncontrolled disease at 4 weeks. Patients younger than 17 years old were dosed according to body surface area. The CYC group received intravenous pulsed CYC 15 mg/kg every 2-3 weeks with reductions for age and renal function. A total of 58 CYC patients (83%) received at least six pulses.
After remission, azathioprine was dosed at 2 mg/kg per day. Oral prednisolone started at 1 mg/kg per day and was reduced to 5 mg/day by 6 months.
Plasma exchange or additional methylprednisolone were allowed at entry; there were no differences in their use between the groups.
The trial was sponsored by Cambridge University Hospitals NHS Foundation Trust. Vifor Pharma provided a research grant to cover the trial and MMF costs. Dr. Jones and the other investigators reported ties to several companies, including GlaxoSmithKline, Genentech/Roche, ChemoCentryx, and Genzyme/Sanofi. Vifor holds an equity stake in ChemoCentryx.
SOURCE: Jones RB et al. Ann Rheum Dis. 2019 Jan 5. doi: 10.1136/annrheumdis-2018-214245.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point:
Major finding: Overall, 47 patients in the in the MMF group (67%), including 1 child, reached remission by 6 months, versus 43 subjects (61%), again including 1 child, in the CYC group (risk difference = 5.7%; 90% CI, –7.5% to 19%), which established noninferiority.
Study details: Randomized, multisite trial with 140 patients.
Disclosures: The Cambridge University Hospitals NHS Foundation Trust sponsored the study. Vifor Pharma provided a research grant to cover the trial and MMF costs. Dr. Jones and the other investigators reported ties to several companies, including GlaxoSmithKline, Genentech/Roche, and ChemoCentryx, which is owned in part by Vifor.
Source: Jones RB et al. Ann Rheum Dis. 2019 Jan 5. doi: 10.1136/annrheumdis-2018-214245.
Carbs vs. fats for CVD
Also today, from MDedge Pediatrics, a consult on influenza and pneumonia, brodalumab beats ustekinumab to PASI 100, and a novel agent cuts LDL in patients who are intolerant to statins.
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Apple Podcasts
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Also today, from MDedge Pediatrics, a consult on influenza and pneumonia, brodalumab beats ustekinumab to PASI 100, and a novel agent cuts LDL in patients who are intolerant to statins.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
Also today, from MDedge Pediatrics, a consult on influenza and pneumonia, brodalumab beats ustekinumab to PASI 100, and a novel agent cuts LDL in patients who are intolerant to statins.
Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
Family estrangement: Would mutual respect make a difference?
Families are the bedrock of the lives of many, but some people opt to separate permanently from family members. A recent episode of the NPR program “1A” explored why families sever ties.
For journalist Harriet Brown, author of “Shadow Daughter: A Memoir of Estrangement,” (Da Capo Press, 2018), the decision to end her relationship with her mother came after she blamed Ms. Brown in “a blistering email” for the relapsed anorexia of Ms. Brown’s daughter.
“I was done with her,” Ms. Brown said on the program. “I told her I was done. That was it. And I never talked to her again. I think for both of us it felt final in some way.”
She said a lot of shame and stigma comes from having a bad relationship with a parent. “I really wanted to make it clear that ... sometimes walking away is really the best thing to do.”
Kristina M. Scharp, PhD, who has studied the estrangement phenomenon, said no national data exist on family estrangement. “About 12% of mothers and research would suggest even more fathers would report being estranged from one of their children,” said Dr. Scharp, who is with the University of Washington, Seattle. “It’s fairly common.”
Estrangement might be more common today because times have changed, said Joshua Coleman, PhD, author of “When Parents Hurt: Compassionate Strategies When you and Your Grown Child Don’t get Along” (HarperCollins, 2008). “Today’s adult children don’t view their relationships with their parents the way their folks did with their parents … the principles of obligation, duty, and respect that baby boomers and generations before them had for their elders aren’t necessarily there anymore,” Dr. Coleman said in a previous interview with the Chicago Tribune.
For her part, Ms. Brown said, the relationship with her mother – who is now deceased – might have been healed with respect. she said. “Honestly, it was that basic with my mother.”
Phelps gets mental health advocacy award
In the pool, Michael Phelps was golden, with 28 Olympics medals, 23 of them gold, hanging around his neck by the end of his swimming career. But the release from the water to real life after the 2016 Summer Olympics left no outlet for troubles that had dogged him for years. Drunk driving convictions and a ban from competition during his competitive years had failed to stop his downward spiral of depression. His thoughts turned to suicide.
But his story has a bright ending. With his realization that he had hit rock bottom, and with the help of his wife and therapists, he accepted his depression and learned to live with the reality that his life is, for the most part, pretty good.
His openness about his struggles with depression has been influential. The latest recognition came in early January, when he received the Morton E. Ruderman Award in Inclusion from the Ruderman Family Foundation. As reported in the Boston Globe, Mr. Phelps was recognized for his advocacy for people with disabilities and “his own journey with mental health.”
“I do like who I am and I’m comfortable with who I am. I couldn’t say that a few years ago. So I’m in a very good place and just living life one day at a time,” Mr. Phelps remarked in an interview with CNN last year.
Mr. Phelps is now a paid spokesperson for TalkSpace, an online therapy company.
“I’d like to make a difference. I’d like to be able to save a life if I can. You know, for me that’s more important than winning a gold medal. The stuff that I’m doing now is very exciting. It’s hard, it’s challenging but it’s fun for me. That’s what drives me to get out of bed every morning,” he said.
Offenders with mental illness get a break
A law included as part of budget legislation that was signed by then-Gov. Jerry Brown of California in June 2018 has offered people with mental health troubles who have been charged with a crime the opportunity for treatment instead of jail time.
As reported in the Los Angeles Times, the law provides judges with the discretion to order offenders into treatment rather than sentencing them. Success in treatment can lead to charges being dropped.
The law has been praised by some mental health advocates but panned by law enforcement officials and prosecutors with a harder view of criminal justice. The opposition stems largely from a December 2018 ruling by the 4th District Court of Appeal that the law could be applied to retroactively address the case of a man imprisoned for 29 years in 2017 for multiple felony charges that included domestic violence and assault.
The law does not extend to those charged with murder, manslaughter, rape, and child sexual abuse. To date, citing mental illness in seeking diversion of sentencing has not proven successful in most cases.
Schools get mental health allocation
The Orleans Parish School Board, which serves all of New Orleans, will allocate $1.3 million to the Center for Resilience, a local mental health day treatment program, beginning this year. The new program will expand mental health help to children in grades 9-12, according to a report in the Times-Picayune.
The funding will enable the center to expand an existing program that helps students with behavioral issues. Such help is not available in the traditional school system. By offsetting part of the price tag for the mental health care, the initiative “[helps to make] this critical service more available for our students most in need,” said Dominique Ellis, a spokesperson for the school board. “Mental health day treatment programs like the Center for Resilience typically cost between the ranges of $80,000-$100,000 per student to operate effectively.”
The development brings New Orleans level with money spent on similar programs in other school boards nationwide. It’s a service that is sorely needed. According to statistics supplied by the Center for Resilience, 60% of New Orleans children suffer from PTSD and are 4.5 times more likely to suffer from hyperactivity, aggression, and social withdrawal than similarly aged children elsewhere in the United States.
Bill addressing opioid crisis a “no-brainer”
Legislation put forward in the current session of the Texas Legislature would require pharmacists to identify all prescription opioids with a red cap and a hard-to-miss warning of the addictive risk of the medications. In addition, pharmacists would have to explain the risk in person to those receiving the medications and get signed acknowledgment of the conversation before dispensing the drugs.
As described in an article in the Austin American-Stateman, nearly 3,000 people in Texas died from drug overdoses in 2017. The deaths tied to opioid overdoses are not certain, but other data from 2015 suggest that one-third is a reasonable estimate.
“Losing a loved one to an opioid overdose is a tragedy that far too many Texas families experience,” said Rep. Shawn Thierry last month, when she introduced the three bills. “These distinctive red caps will serve as a clear notice to Texans that opioids are unlike milder forms of prescription pain relievers and have life-altering risks that must be considered before taking them.”
Warning labels on everything from food to tobacco products, and including them on prescription opioids is a “no-brainer,” Ms. Thierry said. “The more we can educate our residents the less likely they will be to misuse these medications.”
A report issued in November 2018 chronicled the drug crisis in Texas and offered recommendations. Many of the 100 recommendations involved the absence of treatment resources in the state.
Families are the bedrock of the lives of many, but some people opt to separate permanently from family members. A recent episode of the NPR program “1A” explored why families sever ties.
For journalist Harriet Brown, author of “Shadow Daughter: A Memoir of Estrangement,” (Da Capo Press, 2018), the decision to end her relationship with her mother came after she blamed Ms. Brown in “a blistering email” for the relapsed anorexia of Ms. Brown’s daughter.
“I was done with her,” Ms. Brown said on the program. “I told her I was done. That was it. And I never talked to her again. I think for both of us it felt final in some way.”
She said a lot of shame and stigma comes from having a bad relationship with a parent. “I really wanted to make it clear that ... sometimes walking away is really the best thing to do.”
Kristina M. Scharp, PhD, who has studied the estrangement phenomenon, said no national data exist on family estrangement. “About 12% of mothers and research would suggest even more fathers would report being estranged from one of their children,” said Dr. Scharp, who is with the University of Washington, Seattle. “It’s fairly common.”
Estrangement might be more common today because times have changed, said Joshua Coleman, PhD, author of “When Parents Hurt: Compassionate Strategies When you and Your Grown Child Don’t get Along” (HarperCollins, 2008). “Today’s adult children don’t view their relationships with their parents the way their folks did with their parents … the principles of obligation, duty, and respect that baby boomers and generations before them had for their elders aren’t necessarily there anymore,” Dr. Coleman said in a previous interview with the Chicago Tribune.
For her part, Ms. Brown said, the relationship with her mother – who is now deceased – might have been healed with respect. she said. “Honestly, it was that basic with my mother.”
Phelps gets mental health advocacy award
In the pool, Michael Phelps was golden, with 28 Olympics medals, 23 of them gold, hanging around his neck by the end of his swimming career. But the release from the water to real life after the 2016 Summer Olympics left no outlet for troubles that had dogged him for years. Drunk driving convictions and a ban from competition during his competitive years had failed to stop his downward spiral of depression. His thoughts turned to suicide.
But his story has a bright ending. With his realization that he had hit rock bottom, and with the help of his wife and therapists, he accepted his depression and learned to live with the reality that his life is, for the most part, pretty good.
His openness about his struggles with depression has been influential. The latest recognition came in early January, when he received the Morton E. Ruderman Award in Inclusion from the Ruderman Family Foundation. As reported in the Boston Globe, Mr. Phelps was recognized for his advocacy for people with disabilities and “his own journey with mental health.”
“I do like who I am and I’m comfortable with who I am. I couldn’t say that a few years ago. So I’m in a very good place and just living life one day at a time,” Mr. Phelps remarked in an interview with CNN last year.
Mr. Phelps is now a paid spokesperson for TalkSpace, an online therapy company.
“I’d like to make a difference. I’d like to be able to save a life if I can. You know, for me that’s more important than winning a gold medal. The stuff that I’m doing now is very exciting. It’s hard, it’s challenging but it’s fun for me. That’s what drives me to get out of bed every morning,” he said.
Offenders with mental illness get a break
A law included as part of budget legislation that was signed by then-Gov. Jerry Brown of California in June 2018 has offered people with mental health troubles who have been charged with a crime the opportunity for treatment instead of jail time.
As reported in the Los Angeles Times, the law provides judges with the discretion to order offenders into treatment rather than sentencing them. Success in treatment can lead to charges being dropped.
The law has been praised by some mental health advocates but panned by law enforcement officials and prosecutors with a harder view of criminal justice. The opposition stems largely from a December 2018 ruling by the 4th District Court of Appeal that the law could be applied to retroactively address the case of a man imprisoned for 29 years in 2017 for multiple felony charges that included domestic violence and assault.
The law does not extend to those charged with murder, manslaughter, rape, and child sexual abuse. To date, citing mental illness in seeking diversion of sentencing has not proven successful in most cases.
Schools get mental health allocation
The Orleans Parish School Board, which serves all of New Orleans, will allocate $1.3 million to the Center for Resilience, a local mental health day treatment program, beginning this year. The new program will expand mental health help to children in grades 9-12, according to a report in the Times-Picayune.
The funding will enable the center to expand an existing program that helps students with behavioral issues. Such help is not available in the traditional school system. By offsetting part of the price tag for the mental health care, the initiative “[helps to make] this critical service more available for our students most in need,” said Dominique Ellis, a spokesperson for the school board. “Mental health day treatment programs like the Center for Resilience typically cost between the ranges of $80,000-$100,000 per student to operate effectively.”
The development brings New Orleans level with money spent on similar programs in other school boards nationwide. It’s a service that is sorely needed. According to statistics supplied by the Center for Resilience, 60% of New Orleans children suffer from PTSD and are 4.5 times more likely to suffer from hyperactivity, aggression, and social withdrawal than similarly aged children elsewhere in the United States.
Bill addressing opioid crisis a “no-brainer”
Legislation put forward in the current session of the Texas Legislature would require pharmacists to identify all prescription opioids with a red cap and a hard-to-miss warning of the addictive risk of the medications. In addition, pharmacists would have to explain the risk in person to those receiving the medications and get signed acknowledgment of the conversation before dispensing the drugs.
As described in an article in the Austin American-Stateman, nearly 3,000 people in Texas died from drug overdoses in 2017. The deaths tied to opioid overdoses are not certain, but other data from 2015 suggest that one-third is a reasonable estimate.
“Losing a loved one to an opioid overdose is a tragedy that far too many Texas families experience,” said Rep. Shawn Thierry last month, when she introduced the three bills. “These distinctive red caps will serve as a clear notice to Texans that opioids are unlike milder forms of prescription pain relievers and have life-altering risks that must be considered before taking them.”
Warning labels on everything from food to tobacco products, and including them on prescription opioids is a “no-brainer,” Ms. Thierry said. “The more we can educate our residents the less likely they will be to misuse these medications.”
A report issued in November 2018 chronicled the drug crisis in Texas and offered recommendations. Many of the 100 recommendations involved the absence of treatment resources in the state.
Families are the bedrock of the lives of many, but some people opt to separate permanently from family members. A recent episode of the NPR program “1A” explored why families sever ties.
For journalist Harriet Brown, author of “Shadow Daughter: A Memoir of Estrangement,” (Da Capo Press, 2018), the decision to end her relationship with her mother came after she blamed Ms. Brown in “a blistering email” for the relapsed anorexia of Ms. Brown’s daughter.
“I was done with her,” Ms. Brown said on the program. “I told her I was done. That was it. And I never talked to her again. I think for both of us it felt final in some way.”
She said a lot of shame and stigma comes from having a bad relationship with a parent. “I really wanted to make it clear that ... sometimes walking away is really the best thing to do.”
Kristina M. Scharp, PhD, who has studied the estrangement phenomenon, said no national data exist on family estrangement. “About 12% of mothers and research would suggest even more fathers would report being estranged from one of their children,” said Dr. Scharp, who is with the University of Washington, Seattle. “It’s fairly common.”
Estrangement might be more common today because times have changed, said Joshua Coleman, PhD, author of “When Parents Hurt: Compassionate Strategies When you and Your Grown Child Don’t get Along” (HarperCollins, 2008). “Today’s adult children don’t view their relationships with their parents the way their folks did with their parents … the principles of obligation, duty, and respect that baby boomers and generations before them had for their elders aren’t necessarily there anymore,” Dr. Coleman said in a previous interview with the Chicago Tribune.
For her part, Ms. Brown said, the relationship with her mother – who is now deceased – might have been healed with respect. she said. “Honestly, it was that basic with my mother.”
Phelps gets mental health advocacy award
In the pool, Michael Phelps was golden, with 28 Olympics medals, 23 of them gold, hanging around his neck by the end of his swimming career. But the release from the water to real life after the 2016 Summer Olympics left no outlet for troubles that had dogged him for years. Drunk driving convictions and a ban from competition during his competitive years had failed to stop his downward spiral of depression. His thoughts turned to suicide.
But his story has a bright ending. With his realization that he had hit rock bottom, and with the help of his wife and therapists, he accepted his depression and learned to live with the reality that his life is, for the most part, pretty good.
His openness about his struggles with depression has been influential. The latest recognition came in early January, when he received the Morton E. Ruderman Award in Inclusion from the Ruderman Family Foundation. As reported in the Boston Globe, Mr. Phelps was recognized for his advocacy for people with disabilities and “his own journey with mental health.”
“I do like who I am and I’m comfortable with who I am. I couldn’t say that a few years ago. So I’m in a very good place and just living life one day at a time,” Mr. Phelps remarked in an interview with CNN last year.
Mr. Phelps is now a paid spokesperson for TalkSpace, an online therapy company.
“I’d like to make a difference. I’d like to be able to save a life if I can. You know, for me that’s more important than winning a gold medal. The stuff that I’m doing now is very exciting. It’s hard, it’s challenging but it’s fun for me. That’s what drives me to get out of bed every morning,” he said.
Offenders with mental illness get a break
A law included as part of budget legislation that was signed by then-Gov. Jerry Brown of California in June 2018 has offered people with mental health troubles who have been charged with a crime the opportunity for treatment instead of jail time.
As reported in the Los Angeles Times, the law provides judges with the discretion to order offenders into treatment rather than sentencing them. Success in treatment can lead to charges being dropped.
The law has been praised by some mental health advocates but panned by law enforcement officials and prosecutors with a harder view of criminal justice. The opposition stems largely from a December 2018 ruling by the 4th District Court of Appeal that the law could be applied to retroactively address the case of a man imprisoned for 29 years in 2017 for multiple felony charges that included domestic violence and assault.
The law does not extend to those charged with murder, manslaughter, rape, and child sexual abuse. To date, citing mental illness in seeking diversion of sentencing has not proven successful in most cases.
Schools get mental health allocation
The Orleans Parish School Board, which serves all of New Orleans, will allocate $1.3 million to the Center for Resilience, a local mental health day treatment program, beginning this year. The new program will expand mental health help to children in grades 9-12, according to a report in the Times-Picayune.
The funding will enable the center to expand an existing program that helps students with behavioral issues. Such help is not available in the traditional school system. By offsetting part of the price tag for the mental health care, the initiative “[helps to make] this critical service more available for our students most in need,” said Dominique Ellis, a spokesperson for the school board. “Mental health day treatment programs like the Center for Resilience typically cost between the ranges of $80,000-$100,000 per student to operate effectively.”
The development brings New Orleans level with money spent on similar programs in other school boards nationwide. It’s a service that is sorely needed. According to statistics supplied by the Center for Resilience, 60% of New Orleans children suffer from PTSD and are 4.5 times more likely to suffer from hyperactivity, aggression, and social withdrawal than similarly aged children elsewhere in the United States.
Bill addressing opioid crisis a “no-brainer”
Legislation put forward in the current session of the Texas Legislature would require pharmacists to identify all prescription opioids with a red cap and a hard-to-miss warning of the addictive risk of the medications. In addition, pharmacists would have to explain the risk in person to those receiving the medications and get signed acknowledgment of the conversation before dispensing the drugs.
As described in an article in the Austin American-Stateman, nearly 3,000 people in Texas died from drug overdoses in 2017. The deaths tied to opioid overdoses are not certain, but other data from 2015 suggest that one-third is a reasonable estimate.
“Losing a loved one to an opioid overdose is a tragedy that far too many Texas families experience,” said Rep. Shawn Thierry last month, when she introduced the three bills. “These distinctive red caps will serve as a clear notice to Texans that opioids are unlike milder forms of prescription pain relievers and have life-altering risks that must be considered before taking them.”
Warning labels on everything from food to tobacco products, and including them on prescription opioids is a “no-brainer,” Ms. Thierry said. “The more we can educate our residents the less likely they will be to misuse these medications.”
A report issued in November 2018 chronicled the drug crisis in Texas and offered recommendations. Many of the 100 recommendations involved the absence of treatment resources in the state.
RNA expression may hold key to hemophilia A severity
A decrease in the expression of two long noncoding RNAs in the factor VIII gene may explain the development of severe hemophilia, according to an analysis recently published in Hematology.
Researchers at the Iranian Comprehensive Hemophilia Care Center in Tehran identified two long noncoding RNAs for investigation – NONHSAT139219.2 and NONHSAT139215.2. They collected 5 mL of venous blood from 50 males with severe hemophilia A and 50 healthy male donors and analyzed the RNA expression.
The mean of the transcript levels of two long noncoding RNAs was significantly lower in the hemophilia A samples, compared with the normal samples – 5.52 for controls versus 1.25 for hemophilia A for NONHSAT139215 and 4.86 for controls versus 2.14 for hemophilia A samples for NONHSAT139219 (P less than .05).
Low expression levels of long noncoding RNAs in severe hemophilia A cases may be linked with the reduction of factor VIII levels, according to the investigators. “It is possible that the transcription of [long noncoding] RNAs leads to gene silencing or activation.”
This provides a potential biomarker with application in both prognosis and therapeutics; long noncoding RNA functional analysis should be performed in future studies, they wrote.
There was no outside funding for the study, and no potential conflict of interest was reported by the authors.
SOURCE: Niloofar N et al. Hematology. 2019;24(1):255-62.
A decrease in the expression of two long noncoding RNAs in the factor VIII gene may explain the development of severe hemophilia, according to an analysis recently published in Hematology.
Researchers at the Iranian Comprehensive Hemophilia Care Center in Tehran identified two long noncoding RNAs for investigation – NONHSAT139219.2 and NONHSAT139215.2. They collected 5 mL of venous blood from 50 males with severe hemophilia A and 50 healthy male donors and analyzed the RNA expression.
The mean of the transcript levels of two long noncoding RNAs was significantly lower in the hemophilia A samples, compared with the normal samples – 5.52 for controls versus 1.25 for hemophilia A for NONHSAT139215 and 4.86 for controls versus 2.14 for hemophilia A samples for NONHSAT139219 (P less than .05).
Low expression levels of long noncoding RNAs in severe hemophilia A cases may be linked with the reduction of factor VIII levels, according to the investigators. “It is possible that the transcription of [long noncoding] RNAs leads to gene silencing or activation.”
This provides a potential biomarker with application in both prognosis and therapeutics; long noncoding RNA functional analysis should be performed in future studies, they wrote.
There was no outside funding for the study, and no potential conflict of interest was reported by the authors.
SOURCE: Niloofar N et al. Hematology. 2019;24(1):255-62.
A decrease in the expression of two long noncoding RNAs in the factor VIII gene may explain the development of severe hemophilia, according to an analysis recently published in Hematology.
Researchers at the Iranian Comprehensive Hemophilia Care Center in Tehran identified two long noncoding RNAs for investigation – NONHSAT139219.2 and NONHSAT139215.2. They collected 5 mL of venous blood from 50 males with severe hemophilia A and 50 healthy male donors and analyzed the RNA expression.
The mean of the transcript levels of two long noncoding RNAs was significantly lower in the hemophilia A samples, compared with the normal samples – 5.52 for controls versus 1.25 for hemophilia A for NONHSAT139215 and 4.86 for controls versus 2.14 for hemophilia A samples for NONHSAT139219 (P less than .05).
Low expression levels of long noncoding RNAs in severe hemophilia A cases may be linked with the reduction of factor VIII levels, according to the investigators. “It is possible that the transcription of [long noncoding] RNAs leads to gene silencing or activation.”
This provides a potential biomarker with application in both prognosis and therapeutics; long noncoding RNA functional analysis should be performed in future studies, they wrote.
There was no outside funding for the study, and no potential conflict of interest was reported by the authors.
SOURCE: Niloofar N et al. Hematology. 2019;24(1):255-62.
FROM HEMATOLOGY
Key clinical point:
Major finding: Transcript levels of two long noncoding RNAs were significantly lower in severe hemophilia A patients, compared with healthy controls (P less than .05). Study details: An analysis of RNA expression levels in 50 patients with severe hemophilia A and 50 healthy controls at a single center in Iran.
Disclosures: There was no outside funding for the study, and no potential conflict of interest information was reported by the authors.
Source: Niloofar N et al. Hematology. 2019;24(1):255-62.
Intrapartum molecular GBS screening reduced newborn early-onset disease, antibiotic use
Point-of-care intrapartum molecular screening of group B Streptococcus reduced the incidence of early-onset disease cases and antibiotic use, according to research published in Obstetrics & Gynecology.
Najoua El Helali, PharmD, from the Service de Microbiologie Clinique at Groupe Hospitalier Paris Saint-Joseph, and her colleagues measured the rate of early-onset disease group B Streptococcus (GBS) in a single-center study analyzing antenatal culture screening for 4 years prior to implementation (2006-2009) of polymerase chain reaction (PCR) screening (2010-2015). There were 11,226 deliveries (11,818 live births) during the antenatal screening period and 18,835 deliveries (18,980 live births) during the PCR screening period. Overall, 4% of deliveries during the antenatal period and 0.1% of deliveries during the intrapartum period were not screened for GBS (P less than .001).
During 2006-2015, the rate of early-onset disease of GBS decreased to 0.21/1,000 cases from 1.01/1,000 cases (risk ratio, 0.25; 95% confidence interval, 0.14-0.43; P = .026), while the rate of probable early-onset disease GBS decreased to 0.73/1,000 cases from 2.8/1,000 cases (RR, 0.25; (95% CI, 0.14-0.43; P less than .001).
For patients with early-onset GBS, length of stay in hospital decreased by 64%, and antibiotic therapy decreased by 60%, but there was no significant difference in average length of stay or duration of antibiotic therapy during the study period. There was a reduction in annual delivery- and treatment-associated costs of early-onset disease GBS from $41,875 to $11,945, while the estimated extra cost of PCR screening to avoid one additional case of early-onset disease GBS was $5,819 and a cost increase of $49 per newborn.
“The additional PCR costs were offset in part by the reduction in early-onset GBS disease treatment costs,” the investigators said.
“A randomized, controlled multicenter study is probably needed to evaluate the cost-effectiveness of this prevention strategy and demonstrate a better efficacy in populations where poorly followed women are of unknown GBS status at presentation for delivery,” the researchers said. “In term newborns, however, using infection rate as an endpoint is problematic given the sample size needed.”
The researchers said their study was potentially limited by lack of a control group and population selection, and described mothers in their center as “mostly well-informed and well-monitored during their pregnancy.”
The authors reported no relevant conflicts of interest.
SOURCE: El Helali N et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003057.
Point-of-care intrapartum molecular screening of group B Streptococcus reduced the incidence of early-onset disease cases and antibiotic use, according to research published in Obstetrics & Gynecology.
Najoua El Helali, PharmD, from the Service de Microbiologie Clinique at Groupe Hospitalier Paris Saint-Joseph, and her colleagues measured the rate of early-onset disease group B Streptococcus (GBS) in a single-center study analyzing antenatal culture screening for 4 years prior to implementation (2006-2009) of polymerase chain reaction (PCR) screening (2010-2015). There were 11,226 deliveries (11,818 live births) during the antenatal screening period and 18,835 deliveries (18,980 live births) during the PCR screening period. Overall, 4% of deliveries during the antenatal period and 0.1% of deliveries during the intrapartum period were not screened for GBS (P less than .001).
During 2006-2015, the rate of early-onset disease of GBS decreased to 0.21/1,000 cases from 1.01/1,000 cases (risk ratio, 0.25; 95% confidence interval, 0.14-0.43; P = .026), while the rate of probable early-onset disease GBS decreased to 0.73/1,000 cases from 2.8/1,000 cases (RR, 0.25; (95% CI, 0.14-0.43; P less than .001).
For patients with early-onset GBS, length of stay in hospital decreased by 64%, and antibiotic therapy decreased by 60%, but there was no significant difference in average length of stay or duration of antibiotic therapy during the study period. There was a reduction in annual delivery- and treatment-associated costs of early-onset disease GBS from $41,875 to $11,945, while the estimated extra cost of PCR screening to avoid one additional case of early-onset disease GBS was $5,819 and a cost increase of $49 per newborn.
“The additional PCR costs were offset in part by the reduction in early-onset GBS disease treatment costs,” the investigators said.
“A randomized, controlled multicenter study is probably needed to evaluate the cost-effectiveness of this prevention strategy and demonstrate a better efficacy in populations where poorly followed women are of unknown GBS status at presentation for delivery,” the researchers said. “In term newborns, however, using infection rate as an endpoint is problematic given the sample size needed.”
The researchers said their study was potentially limited by lack of a control group and population selection, and described mothers in their center as “mostly well-informed and well-monitored during their pregnancy.”
The authors reported no relevant conflicts of interest.
SOURCE: El Helali N et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003057.
Point-of-care intrapartum molecular screening of group B Streptococcus reduced the incidence of early-onset disease cases and antibiotic use, according to research published in Obstetrics & Gynecology.
Najoua El Helali, PharmD, from the Service de Microbiologie Clinique at Groupe Hospitalier Paris Saint-Joseph, and her colleagues measured the rate of early-onset disease group B Streptococcus (GBS) in a single-center study analyzing antenatal culture screening for 4 years prior to implementation (2006-2009) of polymerase chain reaction (PCR) screening (2010-2015). There were 11,226 deliveries (11,818 live births) during the antenatal screening period and 18,835 deliveries (18,980 live births) during the PCR screening period. Overall, 4% of deliveries during the antenatal period and 0.1% of deliveries during the intrapartum period were not screened for GBS (P less than .001).
During 2006-2015, the rate of early-onset disease of GBS decreased to 0.21/1,000 cases from 1.01/1,000 cases (risk ratio, 0.25; 95% confidence interval, 0.14-0.43; P = .026), while the rate of probable early-onset disease GBS decreased to 0.73/1,000 cases from 2.8/1,000 cases (RR, 0.25; (95% CI, 0.14-0.43; P less than .001).
For patients with early-onset GBS, length of stay in hospital decreased by 64%, and antibiotic therapy decreased by 60%, but there was no significant difference in average length of stay or duration of antibiotic therapy during the study period. There was a reduction in annual delivery- and treatment-associated costs of early-onset disease GBS from $41,875 to $11,945, while the estimated extra cost of PCR screening to avoid one additional case of early-onset disease GBS was $5,819 and a cost increase of $49 per newborn.
“The additional PCR costs were offset in part by the reduction in early-onset GBS disease treatment costs,” the investigators said.
“A randomized, controlled multicenter study is probably needed to evaluate the cost-effectiveness of this prevention strategy and demonstrate a better efficacy in populations where poorly followed women are of unknown GBS status at presentation for delivery,” the researchers said. “In term newborns, however, using infection rate as an endpoint is problematic given the sample size needed.”
The researchers said their study was potentially limited by lack of a control group and population selection, and described mothers in their center as “mostly well-informed and well-monitored during their pregnancy.”
The authors reported no relevant conflicts of interest.
SOURCE: El Helali N et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003057.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point:
Major finding: The rate of early-onset disease group B Streptococcus decreased from 1.01/1,000 cases to 0.21/1,000 cases across the antenatal and intrapartum periods.
Study details: A single-center study of antenatal culture screening for 11,226 deliveries during 2006-2009 and intrapartum PCR screening for 18,835 deliveries during 2010-2015.
Disclosures: The authors reported no relevant conflicts of interest.
Source: El Helali N et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003057.
Digoxin-furosemide reduces viral load, diameter of cutaneous warts
Topical ionic contraviral therapy decreased the size of cutaneous warts caused by human papillomavirus virus (HPV) by a mean of 3 mm, a significant improvement compared with placebo, in a proof-of-concept study, Dr. Melanie Rijsbergen and her associates reported in the British Journal of Dermatology.
The Dr. Rijsbergen of the Center for Human Drug Research, Leiden, the Netherlands, and her coauthors wrote.
“It has been shown that DNA viruses, such as HPV, rely on potassium influx ... for replication. The cardiac glycoside digoxin and loop diuretic furosemide both inhibit potassium influx by interacting with the cell membrane ion cotransporters,” they said, noting that in 2006, an in vitro study found that “the inhibitory effect on DNA replication was most potent when digoxin and furosemide were combined.”
The placebo-controlled phase 2a trial randomized 80 patients with at least two plantar or common warts to one of four arms: digoxin 0.125% plus furosemide 0.125%; digoxin 0.125%; furosemide 0.125%; or placebo applied once a day for 42 consecutive days. A subset of 20 warts underwent histopathology and immunohistochemistry. In all, 139 warts were treated.
Patients were a mean of 26 years old and had developed warts a mean of 6 years before study onset. They had a mean of three warts each; about half were common and half were plantar.
In an analysis of all treated warts, each active treatment conferred a significant benefit, compared with placebo. The combination treatment was the most effective, with a mean diameter reduction of 3 mm. Warts exposed to digoxin alone or furosemide alone showed a mean reduction of about 2 mm.
At the study’s end, primary wart clearance rates were similar in all treatment groups – around 15%. None of the primary warts in the placebo group cleared. Common warts were more responsive to treatment than were plantar warts (24%-27% vs. 8%-15%). “The increased treatment resistance of plantar warts was previously described and seems to be mainly due to callus formation resulting in a decrease in cutaneous permeability of a drug,” the authors wrote.
The HPV viral load decreased by 94% in warts exposed to the combination therapy – a significant benefit, compared with placebo.
There were no discontinuations because of adverse events, and no serious adverse events related to treatment. There was no topical irritation associated with the treatment.
One author is an employee of Cutanea Life Sciences, which funded the study. Dr. Rijsbergen and the remaining authors declared no financial conflicts.
SOURCE: Rijsbergen M et al. Br J Dermatol. 2018 Dec 22. doi: 10.1111/bjd.17583.
Topical ionic contraviral therapy decreased the size of cutaneous warts caused by human papillomavirus virus (HPV) by a mean of 3 mm, a significant improvement compared with placebo, in a proof-of-concept study, Dr. Melanie Rijsbergen and her associates reported in the British Journal of Dermatology.
The Dr. Rijsbergen of the Center for Human Drug Research, Leiden, the Netherlands, and her coauthors wrote.
“It has been shown that DNA viruses, such as HPV, rely on potassium influx ... for replication. The cardiac glycoside digoxin and loop diuretic furosemide both inhibit potassium influx by interacting with the cell membrane ion cotransporters,” they said, noting that in 2006, an in vitro study found that “the inhibitory effect on DNA replication was most potent when digoxin and furosemide were combined.”
The placebo-controlled phase 2a trial randomized 80 patients with at least two plantar or common warts to one of four arms: digoxin 0.125% plus furosemide 0.125%; digoxin 0.125%; furosemide 0.125%; or placebo applied once a day for 42 consecutive days. A subset of 20 warts underwent histopathology and immunohistochemistry. In all, 139 warts were treated.
Patients were a mean of 26 years old and had developed warts a mean of 6 years before study onset. They had a mean of three warts each; about half were common and half were plantar.
In an analysis of all treated warts, each active treatment conferred a significant benefit, compared with placebo. The combination treatment was the most effective, with a mean diameter reduction of 3 mm. Warts exposed to digoxin alone or furosemide alone showed a mean reduction of about 2 mm.
At the study’s end, primary wart clearance rates were similar in all treatment groups – around 15%. None of the primary warts in the placebo group cleared. Common warts were more responsive to treatment than were plantar warts (24%-27% vs. 8%-15%). “The increased treatment resistance of plantar warts was previously described and seems to be mainly due to callus formation resulting in a decrease in cutaneous permeability of a drug,” the authors wrote.
The HPV viral load decreased by 94% in warts exposed to the combination therapy – a significant benefit, compared with placebo.
There were no discontinuations because of adverse events, and no serious adverse events related to treatment. There was no topical irritation associated with the treatment.
One author is an employee of Cutanea Life Sciences, which funded the study. Dr. Rijsbergen and the remaining authors declared no financial conflicts.
SOURCE: Rijsbergen M et al. Br J Dermatol. 2018 Dec 22. doi: 10.1111/bjd.17583.
Topical ionic contraviral therapy decreased the size of cutaneous warts caused by human papillomavirus virus (HPV) by a mean of 3 mm, a significant improvement compared with placebo, in a proof-of-concept study, Dr. Melanie Rijsbergen and her associates reported in the British Journal of Dermatology.
The Dr. Rijsbergen of the Center for Human Drug Research, Leiden, the Netherlands, and her coauthors wrote.
“It has been shown that DNA viruses, such as HPV, rely on potassium influx ... for replication. The cardiac glycoside digoxin and loop diuretic furosemide both inhibit potassium influx by interacting with the cell membrane ion cotransporters,” they said, noting that in 2006, an in vitro study found that “the inhibitory effect on DNA replication was most potent when digoxin and furosemide were combined.”
The placebo-controlled phase 2a trial randomized 80 patients with at least two plantar or common warts to one of four arms: digoxin 0.125% plus furosemide 0.125%; digoxin 0.125%; furosemide 0.125%; or placebo applied once a day for 42 consecutive days. A subset of 20 warts underwent histopathology and immunohistochemistry. In all, 139 warts were treated.
Patients were a mean of 26 years old and had developed warts a mean of 6 years before study onset. They had a mean of three warts each; about half were common and half were plantar.
In an analysis of all treated warts, each active treatment conferred a significant benefit, compared with placebo. The combination treatment was the most effective, with a mean diameter reduction of 3 mm. Warts exposed to digoxin alone or furosemide alone showed a mean reduction of about 2 mm.
At the study’s end, primary wart clearance rates were similar in all treatment groups – around 15%. None of the primary warts in the placebo group cleared. Common warts were more responsive to treatment than were plantar warts (24%-27% vs. 8%-15%). “The increased treatment resistance of plantar warts was previously described and seems to be mainly due to callus formation resulting in a decrease in cutaneous permeability of a drug,” the authors wrote.
The HPV viral load decreased by 94% in warts exposed to the combination therapy – a significant benefit, compared with placebo.
There were no discontinuations because of adverse events, and no serious adverse events related to treatment. There was no topical irritation associated with the treatment.
One author is an employee of Cutanea Life Sciences, which funded the study. Dr. Rijsbergen and the remaining authors declared no financial conflicts.
SOURCE: Rijsbergen M et al. Br J Dermatol. 2018 Dec 22. doi: 10.1111/bjd.17583.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Key clinical point: The combination of digoxin and furosemide in a topical gel reduced the diameter of cutaneous warts caused by HPV.
Major finding: Wart diameter was reduced by a mean of 3 mm among those treated with the combination.
Study details: The randomized, placebo-controlled phase 2a study compared the furosemide-digoxin combination with the two components separately, and placebo separately, in 80 adults.
Disclosures: One author is an employee of Cutanea Life Sciences, which funded the study. Dr. Rijsbergen and the remaining authors declared no financial conflicts.
Source: Rijsbergen M et al. J Dermatol. 2018 Dec 22. doi: 10.1111/bjd.17583.
Metformin associated with acidosis only in patients with eGFR 30 mL/min per 1.73 m 2
Clinical question: Does metformin increase the risk of lactic acidosis in chronic kidney disease (CKD)?
Background: Metformin is first-line therapy for type 2 diabetes mellitus (DM) because of its low cost, safety, and potential cardiovascular benefit, but fear of lactic acidosis has limited its use in CKD. The risk of acidosis in CKD patients with varying levels of renal function has not been clearly defined.
Study design: Retrospective community-based cohort study.
Setting: Geisinger Health System in Pennsylvania.
Synopsis: A total of 75,413 patients were identified with diagnostic codes or medication prescriptions indicating DM. Forty-five percent of patients were taking metformin at enrollment, increasing by 18% over the 5.7 years of median follow-up. The primary outcome was inpatient acidosis, defined by an ICD-9-CM code capturing multiple forms of acidosis but excluding diabetic ketoacidosis.
When metformin users and nonusers were compared, risk of acidosis was similar for the entire cohort and for subgroups of patients with an estimated glomerular filtration rate (eGFR) greater than 90, 60-89, 45-59, and 30-44. Conversely, metformin use was associated with a higher risk of acidosis in patients with eGFR less than 30 (adjusted hazard ratio, 2.07; 95% confidence interval, 1.33-3.22). Metformin not increasing the risk of acidosis at eGFR greater than 30 also was noted in an additional analysis using sulfonylurea medications as an active comparator and was replicated in a separate database with 82,000 patients from 350 private health systems. As with all observational studies, this study is limited by the potential for residual confounding.
Bottom line: Metformin appears to be safe in CKD patients with eGFR above 30 mL/min per 1.73 m2.
Citation: Lazarus B et al. Association of metformin use with risk of lactic acidosis across the range of kidney function: A community- based cohort study. JAMA Int Med. 2018;178(7):903-10.
Dr. Wanner is director, hospital medicine section, and associate chief, division of general internal medicine, University of Utah, Salt Lake City.
Clinical question: Does metformin increase the risk of lactic acidosis in chronic kidney disease (CKD)?
Background: Metformin is first-line therapy for type 2 diabetes mellitus (DM) because of its low cost, safety, and potential cardiovascular benefit, but fear of lactic acidosis has limited its use in CKD. The risk of acidosis in CKD patients with varying levels of renal function has not been clearly defined.
Study design: Retrospective community-based cohort study.
Setting: Geisinger Health System in Pennsylvania.
Synopsis: A total of 75,413 patients were identified with diagnostic codes or medication prescriptions indicating DM. Forty-five percent of patients were taking metformin at enrollment, increasing by 18% over the 5.7 years of median follow-up. The primary outcome was inpatient acidosis, defined by an ICD-9-CM code capturing multiple forms of acidosis but excluding diabetic ketoacidosis.
When metformin users and nonusers were compared, risk of acidosis was similar for the entire cohort and for subgroups of patients with an estimated glomerular filtration rate (eGFR) greater than 90, 60-89, 45-59, and 30-44. Conversely, metformin use was associated with a higher risk of acidosis in patients with eGFR less than 30 (adjusted hazard ratio, 2.07; 95% confidence interval, 1.33-3.22). Metformin not increasing the risk of acidosis at eGFR greater than 30 also was noted in an additional analysis using sulfonylurea medications as an active comparator and was replicated in a separate database with 82,000 patients from 350 private health systems. As with all observational studies, this study is limited by the potential for residual confounding.
Bottom line: Metformin appears to be safe in CKD patients with eGFR above 30 mL/min per 1.73 m2.
Citation: Lazarus B et al. Association of metformin use with risk of lactic acidosis across the range of kidney function: A community- based cohort study. JAMA Int Med. 2018;178(7):903-10.
Dr. Wanner is director, hospital medicine section, and associate chief, division of general internal medicine, University of Utah, Salt Lake City.
Clinical question: Does metformin increase the risk of lactic acidosis in chronic kidney disease (CKD)?
Background: Metformin is first-line therapy for type 2 diabetes mellitus (DM) because of its low cost, safety, and potential cardiovascular benefit, but fear of lactic acidosis has limited its use in CKD. The risk of acidosis in CKD patients with varying levels of renal function has not been clearly defined.
Study design: Retrospective community-based cohort study.
Setting: Geisinger Health System in Pennsylvania.
Synopsis: A total of 75,413 patients were identified with diagnostic codes or medication prescriptions indicating DM. Forty-five percent of patients were taking metformin at enrollment, increasing by 18% over the 5.7 years of median follow-up. The primary outcome was inpatient acidosis, defined by an ICD-9-CM code capturing multiple forms of acidosis but excluding diabetic ketoacidosis.
When metformin users and nonusers were compared, risk of acidosis was similar for the entire cohort and for subgroups of patients with an estimated glomerular filtration rate (eGFR) greater than 90, 60-89, 45-59, and 30-44. Conversely, metformin use was associated with a higher risk of acidosis in patients with eGFR less than 30 (adjusted hazard ratio, 2.07; 95% confidence interval, 1.33-3.22). Metformin not increasing the risk of acidosis at eGFR greater than 30 also was noted in an additional analysis using sulfonylurea medications as an active comparator and was replicated in a separate database with 82,000 patients from 350 private health systems. As with all observational studies, this study is limited by the potential for residual confounding.
Bottom line: Metformin appears to be safe in CKD patients with eGFR above 30 mL/min per 1.73 m2.
Citation: Lazarus B et al. Association of metformin use with risk of lactic acidosis across the range of kidney function: A community- based cohort study. JAMA Int Med. 2018;178(7):903-10.
Dr. Wanner is director, hospital medicine section, and associate chief, division of general internal medicine, University of Utah, Salt Lake City.
Biopsy? What Biopsy?
This 80-year-old man has been complaining to health care providers about the asymptomatic lesion on his right forearm for at least 5 years—“maybe more,” he says. During that time, he has been given a variety of diagnoses, mostly “infection” of some sort, along with prescriptions for oral antibiotics (cephalexin, trimethoprim/sulfa), topical antibiotics (mupirocin, triple-antibiotic cream), and germicidal washes (povidone and others). None of these treatment attempts has achieved results.
Prior to now, there has been no referral to dermatology, nor has any provider suggested biopsy of the lesion. The patient has a history of skin cancer (basal cell or squamous cell carcinomas) on his face, back, and arms. These followed a lifetime of sun exposure due to his work in construction and roofing.
EXAMINATION
The lesion in question is located on the dorsal aspect of his mid right forearm. Measuring almost 4 cm in aggregate, the lesion is composed of 2 adjacent bright red half-moon friable nodules in a circular configuration. There is almost no erythema or edema in or around the lesion, which is neither warm nor tender to touch.
There are no palpable nodes in the adjacent epitrochlear or axillary nodal locations.
The surrounding skin of this arm, as well as that of the opposite arm, is quite thin, discolored, and scaly and is covered with stellate scars. Examination of all other sun-exposed areas reveals similar changes but no other notable lesions.
What’s the diagnosis?
DISCUSSION
It would be obvious to most readers that a biopsy is in order, given the likelihood that this lesion is either a basal cell or squamous cell carcinoma—an impression bolstered by the contextual findings of advanced sun damage and the history of skin cancer. And yet, this patient finds himself with a nonhealing friable lesion that is at least 5 years old.
Repeated misdiagnosis as infection is actually a common occurrence. One suspects that at least some of the providers making this mistake followed the patient’s lead: Many affected patients assume such lesions represent infection and therefore demand treatment appropriate for that diagnosis.
As a rule, however, bacterial infections don’t last years, especially in the absence of pain and swelling. Yes, there are nonbacterial infections (eg, those caused by acid-fast bacilli) that can be just as, if not more, indolent, but they too are apt to be painful and swollen.
Biopsy, the obvious missing step in this entire saga, would rule out any of these odd things (including melanoma, which has been known to present in this atypical morphologic manner). Other items in the differential include pyogenic granuloma and metastatic cancer (eg, breast, colon, lung).
In this case, biopsy confirmed the lesion was (as expected) a basal cell carcinoma. The lesion was excised in 2 stages over a 2.5-month period. And the patient was reminded that he will remain at extremely high risk for additional sun-caused skin cancers for the rest of his life.
TAKE-HOME LEARNING POINTS
- Nonhealing lesions should be assumed to be skin cancer until proven otherwise, especially in sun-damaged individuals.
- Correct treatment is dictated by correct diagnosis; in this case, a biopsy was clearly indicated.
- Besides the more common cancers (eg, basal cell and squamous cell carcinoma), there were numerous other items in the differential, including melanoma and even metastatic cancer.
- Only rarely do skin infections smolder for years without pain or surrounding erythema.
This 80-year-old man has been complaining to health care providers about the asymptomatic lesion on his right forearm for at least 5 years—“maybe more,” he says. During that time, he has been given a variety of diagnoses, mostly “infection” of some sort, along with prescriptions for oral antibiotics (cephalexin, trimethoprim/sulfa), topical antibiotics (mupirocin, triple-antibiotic cream), and germicidal washes (povidone and others). None of these treatment attempts has achieved results.
Prior to now, there has been no referral to dermatology, nor has any provider suggested biopsy of the lesion. The patient has a history of skin cancer (basal cell or squamous cell carcinomas) on his face, back, and arms. These followed a lifetime of sun exposure due to his work in construction and roofing.
EXAMINATION
The lesion in question is located on the dorsal aspect of his mid right forearm. Measuring almost 4 cm in aggregate, the lesion is composed of 2 adjacent bright red half-moon friable nodules in a circular configuration. There is almost no erythema or edema in or around the lesion, which is neither warm nor tender to touch.
There are no palpable nodes in the adjacent epitrochlear or axillary nodal locations.
The surrounding skin of this arm, as well as that of the opposite arm, is quite thin, discolored, and scaly and is covered with stellate scars. Examination of all other sun-exposed areas reveals similar changes but no other notable lesions.
What’s the diagnosis?
DISCUSSION
It would be obvious to most readers that a biopsy is in order, given the likelihood that this lesion is either a basal cell or squamous cell carcinoma—an impression bolstered by the contextual findings of advanced sun damage and the history of skin cancer. And yet, this patient finds himself with a nonhealing friable lesion that is at least 5 years old.
Repeated misdiagnosis as infection is actually a common occurrence. One suspects that at least some of the providers making this mistake followed the patient’s lead: Many affected patients assume such lesions represent infection and therefore demand treatment appropriate for that diagnosis.
As a rule, however, bacterial infections don’t last years, especially in the absence of pain and swelling. Yes, there are nonbacterial infections (eg, those caused by acid-fast bacilli) that can be just as, if not more, indolent, but they too are apt to be painful and swollen.
Biopsy, the obvious missing step in this entire saga, would rule out any of these odd things (including melanoma, which has been known to present in this atypical morphologic manner). Other items in the differential include pyogenic granuloma and metastatic cancer (eg, breast, colon, lung).
In this case, biopsy confirmed the lesion was (as expected) a basal cell carcinoma. The lesion was excised in 2 stages over a 2.5-month period. And the patient was reminded that he will remain at extremely high risk for additional sun-caused skin cancers for the rest of his life.
TAKE-HOME LEARNING POINTS
- Nonhealing lesions should be assumed to be skin cancer until proven otherwise, especially in sun-damaged individuals.
- Correct treatment is dictated by correct diagnosis; in this case, a biopsy was clearly indicated.
- Besides the more common cancers (eg, basal cell and squamous cell carcinoma), there were numerous other items in the differential, including melanoma and even metastatic cancer.
- Only rarely do skin infections smolder for years without pain or surrounding erythema.
This 80-year-old man has been complaining to health care providers about the asymptomatic lesion on his right forearm for at least 5 years—“maybe more,” he says. During that time, he has been given a variety of diagnoses, mostly “infection” of some sort, along with prescriptions for oral antibiotics (cephalexin, trimethoprim/sulfa), topical antibiotics (mupirocin, triple-antibiotic cream), and germicidal washes (povidone and others). None of these treatment attempts has achieved results.
Prior to now, there has been no referral to dermatology, nor has any provider suggested biopsy of the lesion. The patient has a history of skin cancer (basal cell or squamous cell carcinomas) on his face, back, and arms. These followed a lifetime of sun exposure due to his work in construction and roofing.
EXAMINATION
The lesion in question is located on the dorsal aspect of his mid right forearm. Measuring almost 4 cm in aggregate, the lesion is composed of 2 adjacent bright red half-moon friable nodules in a circular configuration. There is almost no erythema or edema in or around the lesion, which is neither warm nor tender to touch.
There are no palpable nodes in the adjacent epitrochlear or axillary nodal locations.
The surrounding skin of this arm, as well as that of the opposite arm, is quite thin, discolored, and scaly and is covered with stellate scars. Examination of all other sun-exposed areas reveals similar changes but no other notable lesions.
What’s the diagnosis?
DISCUSSION
It would be obvious to most readers that a biopsy is in order, given the likelihood that this lesion is either a basal cell or squamous cell carcinoma—an impression bolstered by the contextual findings of advanced sun damage and the history of skin cancer. And yet, this patient finds himself with a nonhealing friable lesion that is at least 5 years old.
Repeated misdiagnosis as infection is actually a common occurrence. One suspects that at least some of the providers making this mistake followed the patient’s lead: Many affected patients assume such lesions represent infection and therefore demand treatment appropriate for that diagnosis.
As a rule, however, bacterial infections don’t last years, especially in the absence of pain and swelling. Yes, there are nonbacterial infections (eg, those caused by acid-fast bacilli) that can be just as, if not more, indolent, but they too are apt to be painful and swollen.
Biopsy, the obvious missing step in this entire saga, would rule out any of these odd things (including melanoma, which has been known to present in this atypical morphologic manner). Other items in the differential include pyogenic granuloma and metastatic cancer (eg, breast, colon, lung).
In this case, biopsy confirmed the lesion was (as expected) a basal cell carcinoma. The lesion was excised in 2 stages over a 2.5-month period. And the patient was reminded that he will remain at extremely high risk for additional sun-caused skin cancers for the rest of his life.
TAKE-HOME LEARNING POINTS
- Nonhealing lesions should be assumed to be skin cancer until proven otherwise, especially in sun-damaged individuals.
- Correct treatment is dictated by correct diagnosis; in this case, a biopsy was clearly indicated.
- Besides the more common cancers (eg, basal cell and squamous cell carcinoma), there were numerous other items in the differential, including melanoma and even metastatic cancer.
- Only rarely do skin infections smolder for years without pain or surrounding erythema.
Lesions around anus
The FP suspected invasive squamous cell carcinoma (SCC) related to human papillomavirus. He recognized that the patient was at a higher risk of this secondary to the HIV/AIDS diagnosis.
The FP recommended a shave biopsy (See the Watch & Learn video on “Shave biopsy.”) of the ulcerated lesion, and the patient consented to this procedure. The FP used a surgical marker to mark an area at the edge of the ulcer including some tissue outside of the ulcer. (This is recommended for biopsy of any ulcerated skin lesion.) He then injected 1% lidocaine with epinephrine into the edge of the ulcer for anesthesia and to minimize bleeding during the shave biopsy. The shave was performed and aluminum chloride, along with electrosurgery, was used to stop the bleeding.
The pathology showed an invasive SCC. Due to the size and location of the lesions, the patient was referred to Colorectal Surgery.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:999-1007.
To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/
You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com
The FP suspected invasive squamous cell carcinoma (SCC) related to human papillomavirus. He recognized that the patient was at a higher risk of this secondary to the HIV/AIDS diagnosis.
The FP recommended a shave biopsy (See the Watch & Learn video on “Shave biopsy.”) of the ulcerated lesion, and the patient consented to this procedure. The FP used a surgical marker to mark an area at the edge of the ulcer including some tissue outside of the ulcer. (This is recommended for biopsy of any ulcerated skin lesion.) He then injected 1% lidocaine with epinephrine into the edge of the ulcer for anesthesia and to minimize bleeding during the shave biopsy. The shave was performed and aluminum chloride, along with electrosurgery, was used to stop the bleeding.
The pathology showed an invasive SCC. Due to the size and location of the lesions, the patient was referred to Colorectal Surgery.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:999-1007.
To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/
You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com
The FP suspected invasive squamous cell carcinoma (SCC) related to human papillomavirus. He recognized that the patient was at a higher risk of this secondary to the HIV/AIDS diagnosis.
The FP recommended a shave biopsy (See the Watch & Learn video on “Shave biopsy.”) of the ulcerated lesion, and the patient consented to this procedure. The FP used a surgical marker to mark an area at the edge of the ulcer including some tissue outside of the ulcer. (This is recommended for biopsy of any ulcerated skin lesion.) He then injected 1% lidocaine with epinephrine into the edge of the ulcer for anesthesia and to minimize bleeding during the shave biopsy. The shave was performed and aluminum chloride, along with electrosurgery, was used to stop the bleeding.
The pathology showed an invasive SCC. Due to the size and location of the lesions, the patient was referred to Colorectal Surgery.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:999-1007.
To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/
You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com
