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New psoriasis therapies coming of age
The pathogenesis theories and treatment approaches to psoriasis have evolved over the past 3 decades, and the latest treatments continue to show safety and effectiveness, according to Alan Menter, MD, chairman of dermatology at Baylor University Medical Center, Dallas.
Before the 1980s, psoriasis was seen as a disease of keratinocyte dysfunction, with treatments that included methotrexate, UVB, and retinoids, Dr. Menter said in a presentation at the annual Coastal Dermatology Symposium. In the 1980s, it was considered an immunologic disease, and then an interleukin (IL)–12/Th1–mediated disease, with anti-CD2, anti-CD11a, and tumor necrosis factor–alpha blocker treatments from 1990 to 2004.
These include risankizumab, which targets the p19 subunit of IL-23 and is being studied for treatment of moderate to severe psoriasis. After one intravenous or subcutaneous dose of risankizumab in a phase 1 study, 16% of patients achieved a Psoriasis Area and Severity Index (PASI) 100, 58% achieved a PASI 90, and 87% achieved a PASI 75, and the publication of phase 2 results are pending, Dr. Menter said. The most common side effects included mild to moderate upper respiratory infections, mild nasopharyngitis, and mild to moderate headaches.
Psoriasis patients treated with guselkumab, which also targets the p19 subunit of IL-23 and was approved in July 2017 for patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, were significantly more likely to be clear or almost clear at 16 weeks, compared with those on placebo in a phase 2 randomized, controlled trial.
“Both IL-23 and IL-17 are promising targets in the treatment of moderate to severe plaque psoriasis,” said Dr. Menter. “It is important to be vigilant in following the safety profile of these drugs both in clinical trials and in postmarketing registries to ensure their long-term safety,” he added.
Additional research on how to curb side effects associated with these new and emerging therapies should target receptors downstream along the IL-23/Th17 pathway, Dr. Menter explained. Findings from a 2015 study suggest that deficiencies in cytokines and receptors further downstream in the IL-23/Th17 pathway “are associated with fewer disorders than deficiencies in upstream components of the pathway,” he said (J Invest Dermatol. 2015 Aug;135[8]:1946-53).
Although concerns about safety remain, avoiding biologics may have a negative impact as well, as moderate to severe psoriasis patients may experience deformed joints, decreased quality of life, heart attacks, strokes, and early death, Dr. Menter said.
Dr. Menter disclosed having received research support and/or serving as a consultant and/or lecturer for AbbVie, Allergan, Amgen, Anacor, Celgene, Dermira, Eli Lilly, Galderma, Janssen Biotech, LEO Pharma, Merck, Neothetics, Novartis, Pfizer, Regeneron, Stiefel, Symbio/Maruho, Vitae, and Xenoport.
The symposium was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical News.
The pathogenesis theories and treatment approaches to psoriasis have evolved over the past 3 decades, and the latest treatments continue to show safety and effectiveness, according to Alan Menter, MD, chairman of dermatology at Baylor University Medical Center, Dallas.
Before the 1980s, psoriasis was seen as a disease of keratinocyte dysfunction, with treatments that included methotrexate, UVB, and retinoids, Dr. Menter said in a presentation at the annual Coastal Dermatology Symposium. In the 1980s, it was considered an immunologic disease, and then an interleukin (IL)–12/Th1–mediated disease, with anti-CD2, anti-CD11a, and tumor necrosis factor–alpha blocker treatments from 1990 to 2004.
These include risankizumab, which targets the p19 subunit of IL-23 and is being studied for treatment of moderate to severe psoriasis. After one intravenous or subcutaneous dose of risankizumab in a phase 1 study, 16% of patients achieved a Psoriasis Area and Severity Index (PASI) 100, 58% achieved a PASI 90, and 87% achieved a PASI 75, and the publication of phase 2 results are pending, Dr. Menter said. The most common side effects included mild to moderate upper respiratory infections, mild nasopharyngitis, and mild to moderate headaches.
Psoriasis patients treated with guselkumab, which also targets the p19 subunit of IL-23 and was approved in July 2017 for patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, were significantly more likely to be clear or almost clear at 16 weeks, compared with those on placebo in a phase 2 randomized, controlled trial.
“Both IL-23 and IL-17 are promising targets in the treatment of moderate to severe plaque psoriasis,” said Dr. Menter. “It is important to be vigilant in following the safety profile of these drugs both in clinical trials and in postmarketing registries to ensure their long-term safety,” he added.
Additional research on how to curb side effects associated with these new and emerging therapies should target receptors downstream along the IL-23/Th17 pathway, Dr. Menter explained. Findings from a 2015 study suggest that deficiencies in cytokines and receptors further downstream in the IL-23/Th17 pathway “are associated with fewer disorders than deficiencies in upstream components of the pathway,” he said (J Invest Dermatol. 2015 Aug;135[8]:1946-53).
Although concerns about safety remain, avoiding biologics may have a negative impact as well, as moderate to severe psoriasis patients may experience deformed joints, decreased quality of life, heart attacks, strokes, and early death, Dr. Menter said.
Dr. Menter disclosed having received research support and/or serving as a consultant and/or lecturer for AbbVie, Allergan, Amgen, Anacor, Celgene, Dermira, Eli Lilly, Galderma, Janssen Biotech, LEO Pharma, Merck, Neothetics, Novartis, Pfizer, Regeneron, Stiefel, Symbio/Maruho, Vitae, and Xenoport.
The symposium was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical News.
The pathogenesis theories and treatment approaches to psoriasis have evolved over the past 3 decades, and the latest treatments continue to show safety and effectiveness, according to Alan Menter, MD, chairman of dermatology at Baylor University Medical Center, Dallas.
Before the 1980s, psoriasis was seen as a disease of keratinocyte dysfunction, with treatments that included methotrexate, UVB, and retinoids, Dr. Menter said in a presentation at the annual Coastal Dermatology Symposium. In the 1980s, it was considered an immunologic disease, and then an interleukin (IL)–12/Th1–mediated disease, with anti-CD2, anti-CD11a, and tumor necrosis factor–alpha blocker treatments from 1990 to 2004.
These include risankizumab, which targets the p19 subunit of IL-23 and is being studied for treatment of moderate to severe psoriasis. After one intravenous or subcutaneous dose of risankizumab in a phase 1 study, 16% of patients achieved a Psoriasis Area and Severity Index (PASI) 100, 58% achieved a PASI 90, and 87% achieved a PASI 75, and the publication of phase 2 results are pending, Dr. Menter said. The most common side effects included mild to moderate upper respiratory infections, mild nasopharyngitis, and mild to moderate headaches.
Psoriasis patients treated with guselkumab, which also targets the p19 subunit of IL-23 and was approved in July 2017 for patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, were significantly more likely to be clear or almost clear at 16 weeks, compared with those on placebo in a phase 2 randomized, controlled trial.
“Both IL-23 and IL-17 are promising targets in the treatment of moderate to severe plaque psoriasis,” said Dr. Menter. “It is important to be vigilant in following the safety profile of these drugs both in clinical trials and in postmarketing registries to ensure their long-term safety,” he added.
Additional research on how to curb side effects associated with these new and emerging therapies should target receptors downstream along the IL-23/Th17 pathway, Dr. Menter explained. Findings from a 2015 study suggest that deficiencies in cytokines and receptors further downstream in the IL-23/Th17 pathway “are associated with fewer disorders than deficiencies in upstream components of the pathway,” he said (J Invest Dermatol. 2015 Aug;135[8]:1946-53).
Although concerns about safety remain, avoiding biologics may have a negative impact as well, as moderate to severe psoriasis patients may experience deformed joints, decreased quality of life, heart attacks, strokes, and early death, Dr. Menter said.
Dr. Menter disclosed having received research support and/or serving as a consultant and/or lecturer for AbbVie, Allergan, Amgen, Anacor, Celgene, Dermira, Eli Lilly, Galderma, Janssen Biotech, LEO Pharma, Merck, Neothetics, Novartis, Pfizer, Regeneron, Stiefel, Symbio/Maruho, Vitae, and Xenoport.
The symposium was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical News.
FROM THE COASTAL DERMATOLOGY SYMPOSIUM
New treatments up the ante against acne
Acne remains “an equal opportunity annoyance,” according to Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical School, Newark, NJ.
However, acne medications also work equally well across age, gender, and skin type groups, and new systemic and topical options are emerging, said Dr. Baldwin, who serves as medical director of The Acne Treatment and Research Center in Morristown, NJ.
Several products that entered the market in 2016 have demonstrated success, she said in a presentation on acne at the annual Coastal Dermatology Symposium. She cited data on dapsone 7.5% gel (Aczone) applied daily, which showed significant improvements in moderate facial acne and lesion counts compared with vehicle.
A noteworthy new potential acne treatment combines 200 mg doxycycline with topical adapalene 0.3%/benzoyl peroxide 2.5%, Dr. Baldwin said. In a small but promising 12-week open-label study of patients aged 12 years and older with severe facial acne considered candidates for isotretinoin, inflammatory, noninflammatory, and overall total lesion counts reduced significantly from baseline, she said.
Other acne treatments in the pipeline include a nitric oxide gel, a topical sebum inhibitor, and minocycline gel and foam formulations.
Sarecycline, a tetracycline class antibiotic, has generated some excitement after a phase 2 dose ranging study presented at the 2017 American Academy of Dermatology’s annual meeting showed significant improvement in inflammatory lesion counts among acne patients who received 1.5 mg/kg or 3 mg/kg once a day compared with placebo patients, after 12 weeks. Noninflammatory lesion counts were not significantly improved compared with placebo. Potential advantages of sarecycline include improved efficacy with fewer side effects and possibly, a lower risk of antibiotic resistance, Dr. Baldwin said. Phase 3 study results of the 1.5 mg/kg dose are pending.
Data on the potential role of diet in acne continue to evolve, she noted. A recent study of 225 teens with acne suggested that skim and/or low-fat dairy products are associated with acne and that reducing consumption of these products might help (J Am Acad Dermatol. 2016 Aug;75[2]:318-22). Another small study of 64 adults involving a nutritional survey showed that those with moderate to severe acne consumed significantly more carbohydrates than did those without acne, an indication that clinicians could consider recommending that acne patients reduce their carbohydrate intake to see whether it makes a difference.
The symposium was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical News. Dr. Baldwin is a speaker and advisor for Allergan, Galderma, and Valeant; and is an investigator for Dermira, Galderma, Novan, and Valeant.
Acne remains “an equal opportunity annoyance,” according to Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical School, Newark, NJ.
However, acne medications also work equally well across age, gender, and skin type groups, and new systemic and topical options are emerging, said Dr. Baldwin, who serves as medical director of The Acne Treatment and Research Center in Morristown, NJ.
Several products that entered the market in 2016 have demonstrated success, she said in a presentation on acne at the annual Coastal Dermatology Symposium. She cited data on dapsone 7.5% gel (Aczone) applied daily, which showed significant improvements in moderate facial acne and lesion counts compared with vehicle.
A noteworthy new potential acne treatment combines 200 mg doxycycline with topical adapalene 0.3%/benzoyl peroxide 2.5%, Dr. Baldwin said. In a small but promising 12-week open-label study of patients aged 12 years and older with severe facial acne considered candidates for isotretinoin, inflammatory, noninflammatory, and overall total lesion counts reduced significantly from baseline, she said.
Other acne treatments in the pipeline include a nitric oxide gel, a topical sebum inhibitor, and minocycline gel and foam formulations.
Sarecycline, a tetracycline class antibiotic, has generated some excitement after a phase 2 dose ranging study presented at the 2017 American Academy of Dermatology’s annual meeting showed significant improvement in inflammatory lesion counts among acne patients who received 1.5 mg/kg or 3 mg/kg once a day compared with placebo patients, after 12 weeks. Noninflammatory lesion counts were not significantly improved compared with placebo. Potential advantages of sarecycline include improved efficacy with fewer side effects and possibly, a lower risk of antibiotic resistance, Dr. Baldwin said. Phase 3 study results of the 1.5 mg/kg dose are pending.
Data on the potential role of diet in acne continue to evolve, she noted. A recent study of 225 teens with acne suggested that skim and/or low-fat dairy products are associated with acne and that reducing consumption of these products might help (J Am Acad Dermatol. 2016 Aug;75[2]:318-22). Another small study of 64 adults involving a nutritional survey showed that those with moderate to severe acne consumed significantly more carbohydrates than did those without acne, an indication that clinicians could consider recommending that acne patients reduce their carbohydrate intake to see whether it makes a difference.
The symposium was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical News. Dr. Baldwin is a speaker and advisor for Allergan, Galderma, and Valeant; and is an investigator for Dermira, Galderma, Novan, and Valeant.
Acne remains “an equal opportunity annoyance,” according to Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical School, Newark, NJ.
However, acne medications also work equally well across age, gender, and skin type groups, and new systemic and topical options are emerging, said Dr. Baldwin, who serves as medical director of The Acne Treatment and Research Center in Morristown, NJ.
Several products that entered the market in 2016 have demonstrated success, she said in a presentation on acne at the annual Coastal Dermatology Symposium. She cited data on dapsone 7.5% gel (Aczone) applied daily, which showed significant improvements in moderate facial acne and lesion counts compared with vehicle.
A noteworthy new potential acne treatment combines 200 mg doxycycline with topical adapalene 0.3%/benzoyl peroxide 2.5%, Dr. Baldwin said. In a small but promising 12-week open-label study of patients aged 12 years and older with severe facial acne considered candidates for isotretinoin, inflammatory, noninflammatory, and overall total lesion counts reduced significantly from baseline, she said.
Other acne treatments in the pipeline include a nitric oxide gel, a topical sebum inhibitor, and minocycline gel and foam formulations.
Sarecycline, a tetracycline class antibiotic, has generated some excitement after a phase 2 dose ranging study presented at the 2017 American Academy of Dermatology’s annual meeting showed significant improvement in inflammatory lesion counts among acne patients who received 1.5 mg/kg or 3 mg/kg once a day compared with placebo patients, after 12 weeks. Noninflammatory lesion counts were not significantly improved compared with placebo. Potential advantages of sarecycline include improved efficacy with fewer side effects and possibly, a lower risk of antibiotic resistance, Dr. Baldwin said. Phase 3 study results of the 1.5 mg/kg dose are pending.
Data on the potential role of diet in acne continue to evolve, she noted. A recent study of 225 teens with acne suggested that skim and/or low-fat dairy products are associated with acne and that reducing consumption of these products might help (J Am Acad Dermatol. 2016 Aug;75[2]:318-22). Another small study of 64 adults involving a nutritional survey showed that those with moderate to severe acne consumed significantly more carbohydrates than did those without acne, an indication that clinicians could consider recommending that acne patients reduce their carbohydrate intake to see whether it makes a difference.
The symposium was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical News. Dr. Baldwin is a speaker and advisor for Allergan, Galderma, and Valeant; and is an investigator for Dermira, Galderma, Novan, and Valeant.
FROM THE COASTAL DERMATOLOGY SYMPOSIUM
Clinicians persist in prescribing antibiotics for acne
Prescribing systemic antibiotics for acne remains a common clinical practice, despite recommendations to reduce antibiotic use, according to an extensive database review. The results were published in the Journal of the American Academy of Dermatology.
“Despite ... recent recommendations regarding the importance of antibiotic stewardship and appropriate use of antibiotics in patients with acne, it is unclear whether there have been any significant changes in practice patterns,” wrote John S. Barbieri, MD, and his coauthors in the departments of dermatology, and biostatistics and epidemiology, at the University of Pennsylvania, Philadelphia (J Am Acad Dermatol. 2017;77[3]:456-63).
To assess prescribing practices, the researchers reviewed data from the OptumInsight Clinformatics Data Mart, which included medical and pharmacy claims for approximately 12-14 million annual covered lives. The study population included 572,630 individuals with at least two acne claims who were aged 12-40 years at the start of treatment.
The number of courses of spironolactone prescribed for acne per 100 female patients treated by dermatologists increased by 291% during the study period, from 2.08 to 8.13. Among nondermatologists, the number of spironolactone courses prescribed per 100 female patients increased from 1.43 to 4.09 over the same period, a 186% increase.
Overall, the number of oral antibiotic courses increased from 26.24 to 27.08 per 100 patients among dermatologists, and from 19.99 to 22.48 per 100 patients among nondermatologists. The median length of treatment on oral antibiotics was 126 days for patients being treated by dermatologists and 129 days among patients treated by nondermatologists.
The use of spironolactone “remains relatively uncommon” compared with oral antibiotics, the researchers pointed out, noting that the 2013 data show that for every course of spironolactone, there were 2.8 courses of oral antibiotics prescribed by dermatologists and 4.6 courses prescribed by nondermatologists.
Other prescribing trends during the time period among dermatologists included a drop in the number of combined oral contraceptive courses per 100 female patients, from 34.31 to 30.74 (and an increase from 31.70 to 32.13 among nondermatologists); and a drop in the number of isotretinoin courses prescribed per 100 patients, from 5.43 to 5.35 (and a drop from 2.24 to1.45 among nondermatologists).
“Given the importance of judicious use of oral antibiotics to prevent potential complications, increasing the use of concomitant topical retinoids and additional work to identify those patients who would benefit most from alternative agents such as spironolactone, combined oral contraceptive pills, or isotretinoin represent potential opportunities to improve the care of patients with acne,” they concluded.
The findings were limited by several factors including the retrospective nature of the study and lack of data on combination therapy, severity of illness, and treatment outcomes, they said.
The researchers had no financial conflicts to disclose. There was no funding source.
Prescribing systemic antibiotics for acne remains a common clinical practice, despite recommendations to reduce antibiotic use, according to an extensive database review. The results were published in the Journal of the American Academy of Dermatology.
“Despite ... recent recommendations regarding the importance of antibiotic stewardship and appropriate use of antibiotics in patients with acne, it is unclear whether there have been any significant changes in practice patterns,” wrote John S. Barbieri, MD, and his coauthors in the departments of dermatology, and biostatistics and epidemiology, at the University of Pennsylvania, Philadelphia (J Am Acad Dermatol. 2017;77[3]:456-63).
To assess prescribing practices, the researchers reviewed data from the OptumInsight Clinformatics Data Mart, which included medical and pharmacy claims for approximately 12-14 million annual covered lives. The study population included 572,630 individuals with at least two acne claims who were aged 12-40 years at the start of treatment.
The number of courses of spironolactone prescribed for acne per 100 female patients treated by dermatologists increased by 291% during the study period, from 2.08 to 8.13. Among nondermatologists, the number of spironolactone courses prescribed per 100 female patients increased from 1.43 to 4.09 over the same period, a 186% increase.
Overall, the number of oral antibiotic courses increased from 26.24 to 27.08 per 100 patients among dermatologists, and from 19.99 to 22.48 per 100 patients among nondermatologists. The median length of treatment on oral antibiotics was 126 days for patients being treated by dermatologists and 129 days among patients treated by nondermatologists.
The use of spironolactone “remains relatively uncommon” compared with oral antibiotics, the researchers pointed out, noting that the 2013 data show that for every course of spironolactone, there were 2.8 courses of oral antibiotics prescribed by dermatologists and 4.6 courses prescribed by nondermatologists.
Other prescribing trends during the time period among dermatologists included a drop in the number of combined oral contraceptive courses per 100 female patients, from 34.31 to 30.74 (and an increase from 31.70 to 32.13 among nondermatologists); and a drop in the number of isotretinoin courses prescribed per 100 patients, from 5.43 to 5.35 (and a drop from 2.24 to1.45 among nondermatologists).
“Given the importance of judicious use of oral antibiotics to prevent potential complications, increasing the use of concomitant topical retinoids and additional work to identify those patients who would benefit most from alternative agents such as spironolactone, combined oral contraceptive pills, or isotretinoin represent potential opportunities to improve the care of patients with acne,” they concluded.
The findings were limited by several factors including the retrospective nature of the study and lack of data on combination therapy, severity of illness, and treatment outcomes, they said.
The researchers had no financial conflicts to disclose. There was no funding source.
Prescribing systemic antibiotics for acne remains a common clinical practice, despite recommendations to reduce antibiotic use, according to an extensive database review. The results were published in the Journal of the American Academy of Dermatology.
“Despite ... recent recommendations regarding the importance of antibiotic stewardship and appropriate use of antibiotics in patients with acne, it is unclear whether there have been any significant changes in practice patterns,” wrote John S. Barbieri, MD, and his coauthors in the departments of dermatology, and biostatistics and epidemiology, at the University of Pennsylvania, Philadelphia (J Am Acad Dermatol. 2017;77[3]:456-63).
To assess prescribing practices, the researchers reviewed data from the OptumInsight Clinformatics Data Mart, which included medical and pharmacy claims for approximately 12-14 million annual covered lives. The study population included 572,630 individuals with at least two acne claims who were aged 12-40 years at the start of treatment.
The number of courses of spironolactone prescribed for acne per 100 female patients treated by dermatologists increased by 291% during the study period, from 2.08 to 8.13. Among nondermatologists, the number of spironolactone courses prescribed per 100 female patients increased from 1.43 to 4.09 over the same period, a 186% increase.
Overall, the number of oral antibiotic courses increased from 26.24 to 27.08 per 100 patients among dermatologists, and from 19.99 to 22.48 per 100 patients among nondermatologists. The median length of treatment on oral antibiotics was 126 days for patients being treated by dermatologists and 129 days among patients treated by nondermatologists.
The use of spironolactone “remains relatively uncommon” compared with oral antibiotics, the researchers pointed out, noting that the 2013 data show that for every course of spironolactone, there were 2.8 courses of oral antibiotics prescribed by dermatologists and 4.6 courses prescribed by nondermatologists.
Other prescribing trends during the time period among dermatologists included a drop in the number of combined oral contraceptive courses per 100 female patients, from 34.31 to 30.74 (and an increase from 31.70 to 32.13 among nondermatologists); and a drop in the number of isotretinoin courses prescribed per 100 patients, from 5.43 to 5.35 (and a drop from 2.24 to1.45 among nondermatologists).
“Given the importance of judicious use of oral antibiotics to prevent potential complications, increasing the use of concomitant topical retinoids and additional work to identify those patients who would benefit most from alternative agents such as spironolactone, combined oral contraceptive pills, or isotretinoin represent potential opportunities to improve the care of patients with acne,” they concluded.
The findings were limited by several factors including the retrospective nature of the study and lack of data on combination therapy, severity of illness, and treatment outcomes, they said.
The researchers had no financial conflicts to disclose. There was no funding source.
FROM JAAD
Key clinical point: Spironolactone use for acne is gaining in popularity, although antibiotic use persists.
Major finding: Spironolactone prescriptions for female acne increased by 291% between 2004 and 2013.
Data source: A retrospective analysis of a prescription information database from 2004-2013 for 572,630 patients with acne.
Disclosures: The researchers had no financial conflicts to disclose. There was no funding source.
New ADA hypertension and diabetes treatment guide features visual aid
Clinicians can consult a diagram to plan treatment of hypertension in diabetes patients as part of the new American Diabetes Association guidelines.
“Diabetes and Hypertension: A Position Statement by the American Diabetes Association” was published in the September 2017 issue of Diabetes Care, and online on Aug. 22. The statement updates the ADA’s previous statement on hypertension and diabetes published in 2003.
“Numerous studies have shown that antihypertensive therapy reduces ASCVD [atherosclerotic cardiovascular disease] events, heart failure, and microvascular complications in people with diabetes,” wrote Ian H. de Boer, MD, of the University of Washington, Seattle, and his colleagues.
The statement is a collaboration between nine diabetes experts from the United States, Europe, and Australia whose specialties include endocrinology, nephrology, cardiology, and internal medicine (Diabetes Care. 2017 Sep.;40:1273-84).
The statement recommends that diabetes patients have their blood pressure checked at every routine clinical visit and that those with an elevated blood pressure on a clinical visit (defined as office-based measurements of 140/90 mm Hg and higher) have multiple measurements, including on a separate day to confirm the diagnosis.
In addition, during the initial evaluation, and then periodically, diabetes patients should be assessed for orthostatic hypotension “to individualize blood pressure goals, select the most appropriate antihypertensive agents, and minimize adverse effects of antihypertensive therapy,” according to the recommendations.
For most patients with diabetes and hypertension, the goal should be a blood pressure below 140/90 mm Hg, and even lower targets may be appropriate for patients at high cardiovascular disease risk, the researchers said.
The guidelines include recommendations for managing hypertension and diabetes through lifestyle modifications such as increasing physical activity, achieving and maintaining a healthy weight, and following a healthy diet with minimal sodium intake and an emphasis on fruits, vegetables, and low-fat dairy products.
The guidelines also emphasize the need for caution when treating older adults who are taking multiple medications. “Systolic blood pressure should be the main target of treatment,” for adults aged 65 years and older with diabetes and hypertension, the authors said.
In addition, the guidelines provide direction for clinicians treating pregnant women. “During pregnancy, treatment with ACE inhibitors, ARBs [angiotensin receptor blockers], or spironolactone is contraindicated, as [these medications] may cause fetal damage,” the authors wrote. Pregnant women with preexisting hypertension or with mild gestational hypertension with systolic blood pressure below 160 mm Hg, a diastolic blood pressure below 105 mm Hg, and no sign of end-organ damage need not take antihypertensive medications, they said. For pregnant women who require antihypertensive treatment, the aim should be a systolic blood pressure between 120 mm Hg and 160 mm Hg and a diastolic blood pressure between 80 mm Hg and 105 mm Hg.
The authors concluded that there currently is insufficient evidence to support blood pressure medication for diabetes patients without hypertension.
The recommendations reference several key clinical trials that compared intensive and standard hypertension treatment strategies: the ACCORD BP (Action to Control Cardiovascular Risk in Diabetes – Blood Pressure) trial, the ADVANCE BP (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation – Blood Pressure) trial, the HOT (Hypertension Optimal Treatment) trial, and SPRINT (the Systolic Blood Pressure Intervention Trial).
Lead author Dr. de Boer reported serving as a consultant for Boehringer Ingelheim and Ironwood Pharmaceuticals, and his institution has received research equipment and supplies from Medtronic and Abbott. Study coauthors disclosed relationships with multiple companies including Merck, Abbott, Pfizer, and AstraZeneca.
Clinicians can consult a diagram to plan treatment of hypertension in diabetes patients as part of the new American Diabetes Association guidelines.
“Diabetes and Hypertension: A Position Statement by the American Diabetes Association” was published in the September 2017 issue of Diabetes Care, and online on Aug. 22. The statement updates the ADA’s previous statement on hypertension and diabetes published in 2003.
“Numerous studies have shown that antihypertensive therapy reduces ASCVD [atherosclerotic cardiovascular disease] events, heart failure, and microvascular complications in people with diabetes,” wrote Ian H. de Boer, MD, of the University of Washington, Seattle, and his colleagues.
The statement is a collaboration between nine diabetes experts from the United States, Europe, and Australia whose specialties include endocrinology, nephrology, cardiology, and internal medicine (Diabetes Care. 2017 Sep.;40:1273-84).
The statement recommends that diabetes patients have their blood pressure checked at every routine clinical visit and that those with an elevated blood pressure on a clinical visit (defined as office-based measurements of 140/90 mm Hg and higher) have multiple measurements, including on a separate day to confirm the diagnosis.
In addition, during the initial evaluation, and then periodically, diabetes patients should be assessed for orthostatic hypotension “to individualize blood pressure goals, select the most appropriate antihypertensive agents, and minimize adverse effects of antihypertensive therapy,” according to the recommendations.
For most patients with diabetes and hypertension, the goal should be a blood pressure below 140/90 mm Hg, and even lower targets may be appropriate for patients at high cardiovascular disease risk, the researchers said.
The guidelines include recommendations for managing hypertension and diabetes through lifestyle modifications such as increasing physical activity, achieving and maintaining a healthy weight, and following a healthy diet with minimal sodium intake and an emphasis on fruits, vegetables, and low-fat dairy products.
The guidelines also emphasize the need for caution when treating older adults who are taking multiple medications. “Systolic blood pressure should be the main target of treatment,” for adults aged 65 years and older with diabetes and hypertension, the authors said.
In addition, the guidelines provide direction for clinicians treating pregnant women. “During pregnancy, treatment with ACE inhibitors, ARBs [angiotensin receptor blockers], or spironolactone is contraindicated, as [these medications] may cause fetal damage,” the authors wrote. Pregnant women with preexisting hypertension or with mild gestational hypertension with systolic blood pressure below 160 mm Hg, a diastolic blood pressure below 105 mm Hg, and no sign of end-organ damage need not take antihypertensive medications, they said. For pregnant women who require antihypertensive treatment, the aim should be a systolic blood pressure between 120 mm Hg and 160 mm Hg and a diastolic blood pressure between 80 mm Hg and 105 mm Hg.
The authors concluded that there currently is insufficient evidence to support blood pressure medication for diabetes patients without hypertension.
The recommendations reference several key clinical trials that compared intensive and standard hypertension treatment strategies: the ACCORD BP (Action to Control Cardiovascular Risk in Diabetes – Blood Pressure) trial, the ADVANCE BP (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation – Blood Pressure) trial, the HOT (Hypertension Optimal Treatment) trial, and SPRINT (the Systolic Blood Pressure Intervention Trial).
Lead author Dr. de Boer reported serving as a consultant for Boehringer Ingelheim and Ironwood Pharmaceuticals, and his institution has received research equipment and supplies from Medtronic and Abbott. Study coauthors disclosed relationships with multiple companies including Merck, Abbott, Pfizer, and AstraZeneca.
Clinicians can consult a diagram to plan treatment of hypertension in diabetes patients as part of the new American Diabetes Association guidelines.
“Diabetes and Hypertension: A Position Statement by the American Diabetes Association” was published in the September 2017 issue of Diabetes Care, and online on Aug. 22. The statement updates the ADA’s previous statement on hypertension and diabetes published in 2003.
“Numerous studies have shown that antihypertensive therapy reduces ASCVD [atherosclerotic cardiovascular disease] events, heart failure, and microvascular complications in people with diabetes,” wrote Ian H. de Boer, MD, of the University of Washington, Seattle, and his colleagues.
The statement is a collaboration between nine diabetes experts from the United States, Europe, and Australia whose specialties include endocrinology, nephrology, cardiology, and internal medicine (Diabetes Care. 2017 Sep.;40:1273-84).
The statement recommends that diabetes patients have their blood pressure checked at every routine clinical visit and that those with an elevated blood pressure on a clinical visit (defined as office-based measurements of 140/90 mm Hg and higher) have multiple measurements, including on a separate day to confirm the diagnosis.
In addition, during the initial evaluation, and then periodically, diabetes patients should be assessed for orthostatic hypotension “to individualize blood pressure goals, select the most appropriate antihypertensive agents, and minimize adverse effects of antihypertensive therapy,” according to the recommendations.
For most patients with diabetes and hypertension, the goal should be a blood pressure below 140/90 mm Hg, and even lower targets may be appropriate for patients at high cardiovascular disease risk, the researchers said.
The guidelines include recommendations for managing hypertension and diabetes through lifestyle modifications such as increasing physical activity, achieving and maintaining a healthy weight, and following a healthy diet with minimal sodium intake and an emphasis on fruits, vegetables, and low-fat dairy products.
The guidelines also emphasize the need for caution when treating older adults who are taking multiple medications. “Systolic blood pressure should be the main target of treatment,” for adults aged 65 years and older with diabetes and hypertension, the authors said.
In addition, the guidelines provide direction for clinicians treating pregnant women. “During pregnancy, treatment with ACE inhibitors, ARBs [angiotensin receptor blockers], or spironolactone is contraindicated, as [these medications] may cause fetal damage,” the authors wrote. Pregnant women with preexisting hypertension or with mild gestational hypertension with systolic blood pressure below 160 mm Hg, a diastolic blood pressure below 105 mm Hg, and no sign of end-organ damage need not take antihypertensive medications, they said. For pregnant women who require antihypertensive treatment, the aim should be a systolic blood pressure between 120 mm Hg and 160 mm Hg and a diastolic blood pressure between 80 mm Hg and 105 mm Hg.
The authors concluded that there currently is insufficient evidence to support blood pressure medication for diabetes patients without hypertension.
The recommendations reference several key clinical trials that compared intensive and standard hypertension treatment strategies: the ACCORD BP (Action to Control Cardiovascular Risk in Diabetes – Blood Pressure) trial, the ADVANCE BP (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation – Blood Pressure) trial, the HOT (Hypertension Optimal Treatment) trial, and SPRINT (the Systolic Blood Pressure Intervention Trial).
Lead author Dr. de Boer reported serving as a consultant for Boehringer Ingelheim and Ironwood Pharmaceuticals, and his institution has received research equipment and supplies from Medtronic and Abbott. Study coauthors disclosed relationships with multiple companies including Merck, Abbott, Pfizer, and AstraZeneca.
FROM DIABETES CARE
Insist on flu vaccination for all, say experts
sponsored by the National Foundation for Infectious Diseases.
Some good news about the flu – vaccination rates increased slightly last year, compared with the previous year among all individuals aged 6 months and older without contraindications, according to data from the Centers for Disease Control and Prevention.
Experts continue to recommend annual influenza vaccination for all persons aged 6 months and older, but they emphasize the need to identify those at risk of not getting vaccinated and develop strategies to increase vaccination coverage.
“Vaccines are among the greatest public health achievements of modern times, but they are only as useful as we as a society take advantage of them,” Secretary of Health & Human Services Thomas E. Price, MD, said at the briefing.
Overall flu vaccination in the United States was 47% for the 2016-2017 season, compared with 46% during the 2015-2016 season, according to data from the Centers for Disease Control and Prevention.
Dr. Price emphasized that vaccination is only part of a successful flu prevention strategy. Stay home when you are sick to help avoid spreading germs to others and take antiviral drugs if a doctor prescribes them to help reduce and avoid complications from flu, he said.
Children aged 6-23 months were the only population subgroup to meet the 70% Healthy People 2020 goal last year, with a rate of 73%, said Patricia A. Stinchfield, RN, CPNP, senior director of infection prevention and control at Children’s Hospital Minnesota, Minneapolis.
“Our goal is to increase coverage for children of all ages,” she said. But it’s not just about the kids themselves, she emphasized.
“If your child gets the flu, they expose babies, grandparents, pregnant women. We need to vaccinate children to protect the public at large,” she said. In addition, health care professionals must be clear about recommending vaccination. The research shows that a specific recommendation often makes the difference for vaccinating families.
Pregnant women are among those who can and should safely be vaccinated, Ms. Stinchfield emphasized. Flu vaccination among pregnant women was 54% in 2016-2017, similar to the past three flu seasons, and approximately two-thirds (67%) of pregnant women in 2016-2017 reported that a health care provider recommended and offered flu vaccination, according to CDC data.
Older adults also are important targets for flu vaccination, noted Kathleen M. Neuzil, MD, director of the Center for Vaccine Development at the University of Maryland, Baltimore. Last year, approximately 65% of U.S. adults aged 65 years and older were vaccinated, which was the largest subgroup of adults aged 18 years and older, she said. Older adults may be caring for frail spouses or infant grandchildren, so protecting others should be a motivating factor in continuing to encourage vaccination in this age group, she noted.
The flu vaccine supply is plentiful going into the start of the 2016-2017 flu season, with an estimated 166 million doses available in several formulations, said Daniel B. Jernigan, MD, director of the CDC’s Influenza Division.
Options for vaccination include the standard vaccine, a cell-based vaccine, and a recombinant vaccine. In addition, an adjuvanted vaccine and a high-dose vaccine are available specifically for adults aged 65 years and older; these vaccines are designed to provoke a stronger immune response, Dr. Jernigan said.
However, the briefing participants agreed that the best strategy is to get vaccinated as soon as possible, rather than postponing vaccination in order to secure a particular vaccine type.
Clinicians should not underestimate the power of leading by example when it comes to flu vaccination, Dr. Schaffner noted. Support from the highest levels of administration is important to help overcome barriers to vaccination coverage for health care workers by making vaccination easy and accessible, he said.
The overall influenza vaccination coverage estimate among health care providers was 79% for the 2016-2017 season, similar to the 2014-2015 and 2015-2016 seasons, but representing a 15% increase since 2010-2011. Vaccination coverage was highest among health care personnel whose workplaces required it.
Complete data on 2016-2017 vaccination coverage in health care workers and in pregnant women were published in the CDC’s Morbidity and Mortality Weekly Report on Sept. 29.
The CDC’s complete flu vaccination recommendations are available online.
The briefing participants had no relevant financial conflicts to disclose.
sponsored by the National Foundation for Infectious Diseases.
Some good news about the flu – vaccination rates increased slightly last year, compared with the previous year among all individuals aged 6 months and older without contraindications, according to data from the Centers for Disease Control and Prevention.
Experts continue to recommend annual influenza vaccination for all persons aged 6 months and older, but they emphasize the need to identify those at risk of not getting vaccinated and develop strategies to increase vaccination coverage.
“Vaccines are among the greatest public health achievements of modern times, but they are only as useful as we as a society take advantage of them,” Secretary of Health & Human Services Thomas E. Price, MD, said at the briefing.
Overall flu vaccination in the United States was 47% for the 2016-2017 season, compared with 46% during the 2015-2016 season, according to data from the Centers for Disease Control and Prevention.
Dr. Price emphasized that vaccination is only part of a successful flu prevention strategy. Stay home when you are sick to help avoid spreading germs to others and take antiviral drugs if a doctor prescribes them to help reduce and avoid complications from flu, he said.
Children aged 6-23 months were the only population subgroup to meet the 70% Healthy People 2020 goal last year, with a rate of 73%, said Patricia A. Stinchfield, RN, CPNP, senior director of infection prevention and control at Children’s Hospital Minnesota, Minneapolis.
“Our goal is to increase coverage for children of all ages,” she said. But it’s not just about the kids themselves, she emphasized.
“If your child gets the flu, they expose babies, grandparents, pregnant women. We need to vaccinate children to protect the public at large,” she said. In addition, health care professionals must be clear about recommending vaccination. The research shows that a specific recommendation often makes the difference for vaccinating families.
Pregnant women are among those who can and should safely be vaccinated, Ms. Stinchfield emphasized. Flu vaccination among pregnant women was 54% in 2016-2017, similar to the past three flu seasons, and approximately two-thirds (67%) of pregnant women in 2016-2017 reported that a health care provider recommended and offered flu vaccination, according to CDC data.
Older adults also are important targets for flu vaccination, noted Kathleen M. Neuzil, MD, director of the Center for Vaccine Development at the University of Maryland, Baltimore. Last year, approximately 65% of U.S. adults aged 65 years and older were vaccinated, which was the largest subgroup of adults aged 18 years and older, she said. Older adults may be caring for frail spouses or infant grandchildren, so protecting others should be a motivating factor in continuing to encourage vaccination in this age group, she noted.
The flu vaccine supply is plentiful going into the start of the 2016-2017 flu season, with an estimated 166 million doses available in several formulations, said Daniel B. Jernigan, MD, director of the CDC’s Influenza Division.
Options for vaccination include the standard vaccine, a cell-based vaccine, and a recombinant vaccine. In addition, an adjuvanted vaccine and a high-dose vaccine are available specifically for adults aged 65 years and older; these vaccines are designed to provoke a stronger immune response, Dr. Jernigan said.
However, the briefing participants agreed that the best strategy is to get vaccinated as soon as possible, rather than postponing vaccination in order to secure a particular vaccine type.
Clinicians should not underestimate the power of leading by example when it comes to flu vaccination, Dr. Schaffner noted. Support from the highest levels of administration is important to help overcome barriers to vaccination coverage for health care workers by making vaccination easy and accessible, he said.
The overall influenza vaccination coverage estimate among health care providers was 79% for the 2016-2017 season, similar to the 2014-2015 and 2015-2016 seasons, but representing a 15% increase since 2010-2011. Vaccination coverage was highest among health care personnel whose workplaces required it.
Complete data on 2016-2017 vaccination coverage in health care workers and in pregnant women were published in the CDC’s Morbidity and Mortality Weekly Report on Sept. 29.
The CDC’s complete flu vaccination recommendations are available online.
The briefing participants had no relevant financial conflicts to disclose.
sponsored by the National Foundation for Infectious Diseases.
Some good news about the flu – vaccination rates increased slightly last year, compared with the previous year among all individuals aged 6 months and older without contraindications, according to data from the Centers for Disease Control and Prevention.
Experts continue to recommend annual influenza vaccination for all persons aged 6 months and older, but they emphasize the need to identify those at risk of not getting vaccinated and develop strategies to increase vaccination coverage.
“Vaccines are among the greatest public health achievements of modern times, but they are only as useful as we as a society take advantage of them,” Secretary of Health & Human Services Thomas E. Price, MD, said at the briefing.
Overall flu vaccination in the United States was 47% for the 2016-2017 season, compared with 46% during the 2015-2016 season, according to data from the Centers for Disease Control and Prevention.
Dr. Price emphasized that vaccination is only part of a successful flu prevention strategy. Stay home when you are sick to help avoid spreading germs to others and take antiviral drugs if a doctor prescribes them to help reduce and avoid complications from flu, he said.
Children aged 6-23 months were the only population subgroup to meet the 70% Healthy People 2020 goal last year, with a rate of 73%, said Patricia A. Stinchfield, RN, CPNP, senior director of infection prevention and control at Children’s Hospital Minnesota, Minneapolis.
“Our goal is to increase coverage for children of all ages,” she said. But it’s not just about the kids themselves, she emphasized.
“If your child gets the flu, they expose babies, grandparents, pregnant women. We need to vaccinate children to protect the public at large,” she said. In addition, health care professionals must be clear about recommending vaccination. The research shows that a specific recommendation often makes the difference for vaccinating families.
Pregnant women are among those who can and should safely be vaccinated, Ms. Stinchfield emphasized. Flu vaccination among pregnant women was 54% in 2016-2017, similar to the past three flu seasons, and approximately two-thirds (67%) of pregnant women in 2016-2017 reported that a health care provider recommended and offered flu vaccination, according to CDC data.
Older adults also are important targets for flu vaccination, noted Kathleen M. Neuzil, MD, director of the Center for Vaccine Development at the University of Maryland, Baltimore. Last year, approximately 65% of U.S. adults aged 65 years and older were vaccinated, which was the largest subgroup of adults aged 18 years and older, she said. Older adults may be caring for frail spouses or infant grandchildren, so protecting others should be a motivating factor in continuing to encourage vaccination in this age group, she noted.
The flu vaccine supply is plentiful going into the start of the 2016-2017 flu season, with an estimated 166 million doses available in several formulations, said Daniel B. Jernigan, MD, director of the CDC’s Influenza Division.
Options for vaccination include the standard vaccine, a cell-based vaccine, and a recombinant vaccine. In addition, an adjuvanted vaccine and a high-dose vaccine are available specifically for adults aged 65 years and older; these vaccines are designed to provoke a stronger immune response, Dr. Jernigan said.
However, the briefing participants agreed that the best strategy is to get vaccinated as soon as possible, rather than postponing vaccination in order to secure a particular vaccine type.
Clinicians should not underestimate the power of leading by example when it comes to flu vaccination, Dr. Schaffner noted. Support from the highest levels of administration is important to help overcome barriers to vaccination coverage for health care workers by making vaccination easy and accessible, he said.
The overall influenza vaccination coverage estimate among health care providers was 79% for the 2016-2017 season, similar to the 2014-2015 and 2015-2016 seasons, but representing a 15% increase since 2010-2011. Vaccination coverage was highest among health care personnel whose workplaces required it.
Complete data on 2016-2017 vaccination coverage in health care workers and in pregnant women were published in the CDC’s Morbidity and Mortality Weekly Report on Sept. 29.
The CDC’s complete flu vaccination recommendations are available online.
The briefing participants had no relevant financial conflicts to disclose.
Clinicians: Be clear about flu vaccine’s value
WASHINGTON – Flu vaccination rates remain below the 70% Healthy People 2020 goal for most of the U.S. population, but data show that a recommendation from a clinician can encourage individuals to get vaccinated and to vaccinate their children, according to a panel of experts who spoke at a press briefing sponsored by the National Foundation for Infectious Diseases.
“Annual vaccination is our first line of defense against the flu,” William Schaffner, MD, of Vanderbilt University, Nashville, Tenn., said at the briefing. The unpredictable nature of the flu makes annual vaccination even more important – and the earlier, the better, said Dr. Schaffner. “If you have seen one flu season, you have seen ... one flu season.”
In a video interview at the briefing, experts emphasized the safety and effectiveness of the flu vaccine for a range of populations, including children, pregnant women, and older adults. And they offered tips to convince patients of the importance of vaccination, as well as the need to make sure health care staff are protected.
Briefing participants included former Department of Health and Human Services Secretary Thomas A. Price, MD; Patricia A. Stinchfield, RN, MS, CPNP, CIC of Children’s Hospitals and Clinics of Minnesota, St. Paul; Kathleen M. Neuzil, MD, of the University of Maryland; and Daniel B. Jernigan, MD, of the Centers for Disease Control and Prevention.
The clinicians interviewed had no financial conflicts to disclose.
WASHINGTON – Flu vaccination rates remain below the 70% Healthy People 2020 goal for most of the U.S. population, but data show that a recommendation from a clinician can encourage individuals to get vaccinated and to vaccinate their children, according to a panel of experts who spoke at a press briefing sponsored by the National Foundation for Infectious Diseases.
“Annual vaccination is our first line of defense against the flu,” William Schaffner, MD, of Vanderbilt University, Nashville, Tenn., said at the briefing. The unpredictable nature of the flu makes annual vaccination even more important – and the earlier, the better, said Dr. Schaffner. “If you have seen one flu season, you have seen ... one flu season.”
In a video interview at the briefing, experts emphasized the safety and effectiveness of the flu vaccine for a range of populations, including children, pregnant women, and older adults. And they offered tips to convince patients of the importance of vaccination, as well as the need to make sure health care staff are protected.
Briefing participants included former Department of Health and Human Services Secretary Thomas A. Price, MD; Patricia A. Stinchfield, RN, MS, CPNP, CIC of Children’s Hospitals and Clinics of Minnesota, St. Paul; Kathleen M. Neuzil, MD, of the University of Maryland; and Daniel B. Jernigan, MD, of the Centers for Disease Control and Prevention.
The clinicians interviewed had no financial conflicts to disclose.
WASHINGTON – Flu vaccination rates remain below the 70% Healthy People 2020 goal for most of the U.S. population, but data show that a recommendation from a clinician can encourage individuals to get vaccinated and to vaccinate their children, according to a panel of experts who spoke at a press briefing sponsored by the National Foundation for Infectious Diseases.
“Annual vaccination is our first line of defense against the flu,” William Schaffner, MD, of Vanderbilt University, Nashville, Tenn., said at the briefing. The unpredictable nature of the flu makes annual vaccination even more important – and the earlier, the better, said Dr. Schaffner. “If you have seen one flu season, you have seen ... one flu season.”
In a video interview at the briefing, experts emphasized the safety and effectiveness of the flu vaccine for a range of populations, including children, pregnant women, and older adults. And they offered tips to convince patients of the importance of vaccination, as well as the need to make sure health care staff are protected.
Briefing participants included former Department of Health and Human Services Secretary Thomas A. Price, MD; Patricia A. Stinchfield, RN, MS, CPNP, CIC of Children’s Hospitals and Clinics of Minnesota, St. Paul; Kathleen M. Neuzil, MD, of the University of Maryland; and Daniel B. Jernigan, MD, of the Centers for Disease Control and Prevention.
The clinicians interviewed had no financial conflicts to disclose.
AT A PRESS BRIEFING BY THE NATIONAL FOUNDATION FOR INFECTIOUS DISEASES
Lithium may reduce melanoma risk
Adults with a history of lithium exposure had a 32% lower risk of melanoma than did those who were not exposed in an unadjusted analysis of data from more than 2 million patients.
Microarray gene profiling techniques suggest that Wnt genes, which “encode a family of secreted glycoproteins that activate cellular signaling pathways to control cell differentiation, proliferation, and motility,” may be involved in melanoma development, wrote Maryam M. Asgari, MD, of the department of dermatology at Massachusetts General Hospital and the department of population medicine at Harvard University, both in Boston, and her colleagues. In particular, “transcriptional profiling of melanoma cell lines has suggested that Wnt/beta-catenin signaling regulates a transcriptional signature predictive of less aggressive melanoma,” they wrote.
The psychiatric medication lithium activates the Wnt/beta-catenin signaling pathway and has shown an ability to inhibit the proliferation of melanoma cells in a mouse model, but “to our knowledge, no published epidemiologic studies have examined the association of melanoma risk with lithium exposure,” they wrote.
The researchers reviewed data from the Kaiser Permanente Northern California database of 2,213,848 adult white patients who were members during 1997-2012, which included 11,317 with lithium exposure. They evaluated the association between lithium exposure and both incident melanoma risk and melanoma-associated mortality (J Invest Dermatol. 2017 Oct;137[10]:2087-91.).
Individuals exposed to lithium had a 32% reduced risk of melanoma in an unadjusted analysis; in an adjusted analysis, the reduced risk was 23% and was not significant.
However, there was a significant difference in melanoma incidence per 100,000 person-years in lithium-exposed individuals, compared with unexposed individuals (67.4 vs. 92.5, respectively; P = .027).
Among patients with melanoma, those with exposure to lithium had a lower mortality rate than those not exposed (4.68 vs. 7.21 per 1,000 person-years, respectively), but the sample size for this subgroup was too small to determine statistical significance. In addition, lithium exposure was associated with reduced likelihood of developing skin tumors greater than 4 mm and of presenting with extensive disease. Among those exposed to lithium, none presented with a thick tumor (Breslow depth greater than 4 mm), and none had regional or distant disease when they were diagnosed, compared with 2.8% and 6.3%, respectively, of those not exposed to lithium.
The findings were limited by several factors, including reliance on prescription information to determine lithium exposure, a homogeneous study population, and confounding variables, such as sun exposure behaviors, the researchers noted. However, the large study population adds strength to the results, and “our conclusions provide evidence that lithium, a relatively inexpensive and readily available drug, warrants further study in melanoma,” they said.
Lead author Dr. Asgari and one of the other four authors disclosed serving as investigators for studies funded by Valeant Pharmaceuticals and Pfizer. This study was supported by the National Cancer Institute. Dr. Asgari is principal investigator in the Patient-Oriented Research in the Epidemiology of Skin Diseases lab at Massachusetts General Hospital, Boston.
Adults with a history of lithium exposure had a 32% lower risk of melanoma than did those who were not exposed in an unadjusted analysis of data from more than 2 million patients.
Microarray gene profiling techniques suggest that Wnt genes, which “encode a family of secreted glycoproteins that activate cellular signaling pathways to control cell differentiation, proliferation, and motility,” may be involved in melanoma development, wrote Maryam M. Asgari, MD, of the department of dermatology at Massachusetts General Hospital and the department of population medicine at Harvard University, both in Boston, and her colleagues. In particular, “transcriptional profiling of melanoma cell lines has suggested that Wnt/beta-catenin signaling regulates a transcriptional signature predictive of less aggressive melanoma,” they wrote.
The psychiatric medication lithium activates the Wnt/beta-catenin signaling pathway and has shown an ability to inhibit the proliferation of melanoma cells in a mouse model, but “to our knowledge, no published epidemiologic studies have examined the association of melanoma risk with lithium exposure,” they wrote.
The researchers reviewed data from the Kaiser Permanente Northern California database of 2,213,848 adult white patients who were members during 1997-2012, which included 11,317 with lithium exposure. They evaluated the association between lithium exposure and both incident melanoma risk and melanoma-associated mortality (J Invest Dermatol. 2017 Oct;137[10]:2087-91.).
Individuals exposed to lithium had a 32% reduced risk of melanoma in an unadjusted analysis; in an adjusted analysis, the reduced risk was 23% and was not significant.
However, there was a significant difference in melanoma incidence per 100,000 person-years in lithium-exposed individuals, compared with unexposed individuals (67.4 vs. 92.5, respectively; P = .027).
Among patients with melanoma, those with exposure to lithium had a lower mortality rate than those not exposed (4.68 vs. 7.21 per 1,000 person-years, respectively), but the sample size for this subgroup was too small to determine statistical significance. In addition, lithium exposure was associated with reduced likelihood of developing skin tumors greater than 4 mm and of presenting with extensive disease. Among those exposed to lithium, none presented with a thick tumor (Breslow depth greater than 4 mm), and none had regional or distant disease when they were diagnosed, compared with 2.8% and 6.3%, respectively, of those not exposed to lithium.
The findings were limited by several factors, including reliance on prescription information to determine lithium exposure, a homogeneous study population, and confounding variables, such as sun exposure behaviors, the researchers noted. However, the large study population adds strength to the results, and “our conclusions provide evidence that lithium, a relatively inexpensive and readily available drug, warrants further study in melanoma,” they said.
Lead author Dr. Asgari and one of the other four authors disclosed serving as investigators for studies funded by Valeant Pharmaceuticals and Pfizer. This study was supported by the National Cancer Institute. Dr. Asgari is principal investigator in the Patient-Oriented Research in the Epidemiology of Skin Diseases lab at Massachusetts General Hospital, Boston.
Adults with a history of lithium exposure had a 32% lower risk of melanoma than did those who were not exposed in an unadjusted analysis of data from more than 2 million patients.
Microarray gene profiling techniques suggest that Wnt genes, which “encode a family of secreted glycoproteins that activate cellular signaling pathways to control cell differentiation, proliferation, and motility,” may be involved in melanoma development, wrote Maryam M. Asgari, MD, of the department of dermatology at Massachusetts General Hospital and the department of population medicine at Harvard University, both in Boston, and her colleagues. In particular, “transcriptional profiling of melanoma cell lines has suggested that Wnt/beta-catenin signaling regulates a transcriptional signature predictive of less aggressive melanoma,” they wrote.
The psychiatric medication lithium activates the Wnt/beta-catenin signaling pathway and has shown an ability to inhibit the proliferation of melanoma cells in a mouse model, but “to our knowledge, no published epidemiologic studies have examined the association of melanoma risk with lithium exposure,” they wrote.
The researchers reviewed data from the Kaiser Permanente Northern California database of 2,213,848 adult white patients who were members during 1997-2012, which included 11,317 with lithium exposure. They evaluated the association between lithium exposure and both incident melanoma risk and melanoma-associated mortality (J Invest Dermatol. 2017 Oct;137[10]:2087-91.).
Individuals exposed to lithium had a 32% reduced risk of melanoma in an unadjusted analysis; in an adjusted analysis, the reduced risk was 23% and was not significant.
However, there was a significant difference in melanoma incidence per 100,000 person-years in lithium-exposed individuals, compared with unexposed individuals (67.4 vs. 92.5, respectively; P = .027).
Among patients with melanoma, those with exposure to lithium had a lower mortality rate than those not exposed (4.68 vs. 7.21 per 1,000 person-years, respectively), but the sample size for this subgroup was too small to determine statistical significance. In addition, lithium exposure was associated with reduced likelihood of developing skin tumors greater than 4 mm and of presenting with extensive disease. Among those exposed to lithium, none presented with a thick tumor (Breslow depth greater than 4 mm), and none had regional or distant disease when they were diagnosed, compared with 2.8% and 6.3%, respectively, of those not exposed to lithium.
The findings were limited by several factors, including reliance on prescription information to determine lithium exposure, a homogeneous study population, and confounding variables, such as sun exposure behaviors, the researchers noted. However, the large study population adds strength to the results, and “our conclusions provide evidence that lithium, a relatively inexpensive and readily available drug, warrants further study in melanoma,” they said.
Lead author Dr. Asgari and one of the other four authors disclosed serving as investigators for studies funded by Valeant Pharmaceuticals and Pfizer. This study was supported by the National Cancer Institute. Dr. Asgari is principal investigator in the Patient-Oriented Research in the Epidemiology of Skin Diseases lab at Massachusetts General Hospital, Boston.
FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY
Key clinical point: Lithium may reduce the risk of melanoma and melanoma mortality.
Major finding: The incidence of melanoma was significantly lower among adults exposed to lithium (67/100,000 person-years) than those not exposed (93/100,000 person-years).
Data source: The data come from a population-based, retrospective cohort study of 11,317 white adults in Northern California.
Disclosures: The lead author and one of the other four authors disclosed serving as investigators for studies funded by Valeant Pharmaceuticals and Pfizer. The study was supported by the National Cancer Institute.
Caffeine offers no perks for Parkinson’s patients
Caffeine consumption has no significant impact on motor skills in patients with Parkinson’s disease, based on data from a double-blind, randomized, placebo-controlled trial of 121 adults. The findings were published online Sept. 27 in Neurology.
Data from previous studies have suggested a link between caffeine consumption and reduced risk of Parkinson’s disease, wrote Ronald B. Postuma, MD, of McGill University in Montreal, and his colleagues (Neurology. 2017 Sep 27. doi: 10.1212/WNL.0000000000004568). In addition, Dr. Postuma and his coauthors found a small impact of caffeine on motor skills in patients with existing Parkinson’s as a secondary outcome in a 2012 study on the role of caffeine on daytime sleepiness. Based on these findings, they designed a multicenter, randomized, controlled trial of 121 adults with Parkinson’s to assess the impact of caffeine. The average age of the patients was 62 years and the average disease duration was 4 years.
Motor skills worsened in the caffeine group by an average of 0.16 points on the Movement Disorder Society–sponsored Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III during patients’ “on” state and by 0.64 points in the placebo group; the difference was not significant.
The researchers found no differences between groups in the clinical global impression of change based on both patient and examiner assessment. In addition, no differences appeared in depression or anxiety, or in quality of life.
The study findings included long-term follow up data from 88 patients assessed at 12 months and 66 patients assessed at 18 months. The results were similar to the 6-month results, and the study was stopped, although the original design included a 4-year extension.
A total of 29 patients in the caffeine group and 31 patients in the placebo group reported adverse events, and 7 patients in the caffeine group and 5 in the placebo group discontinued the study because of side effects. A serious adverse event was reported by one patient in each group, but neither was deemed related to the interventions.
The findings contrast with the effects of caffeine in the 6-week study in 2012 that showed a significant, 3.2-point improvement in motor skills on the MDS-UPDRS part III with caffeine use, as well as reduced daytime sleepiness, the researchers said (Neurology. 2012;79:651-8). Interpretations of the different findings between the trials may be constrained by factors including differences in the study populations, speed of dose escalation, and trial duration and the possible short-term nature of caffeine’s impact, they noted. “Regardless, our core finding is that caffeine cannot be recommended as symptomatic therapy for parkinsonism.” However, “since caffeine is safe and generally well tolerated, it seems reasonable to empirically try intermittent moderate doses of caffeine for somnolence, and repeat if improvement is seen,” they added.
Dr. Postuma disclosed grant funding from the Canadian Institute of Health Research, the Webster Foundation, and Fonds de Recherche du Québec-Santé for this study.
The appeal of an inexpensive, well-tolerated intervention such as caffeine to improve motor symptoms in Parkinson’s patients gave Dr. Postuma and his associates a good reason to try to replicate the positive results they found in an earlier study of caffeine.
The investigators found no benefit from caffeine, although their study was designed to have more than four times as many participants as the pilot study, was adequately powered to detect the same level of improvement as before, and was planned to have an extended follow-up period to look for persistent effects. The trial ended early and enrolled approximately half of its intended total, but was well run and did not suffer from differential compliance or loss to follow-up.
Although the small number of participants resulted in a wide confidence interval and cannot exclude a small effect, this trial suggests that caffeine does not significantly improve Parkinson’s disease symptoms and that it should not be a priority for future Parkinson’s disease intervention studies.
Charles B. Hall, PhD, is affiliated with the department of epidemiology and population health at Albert Einstein College of Medicine, New York. He disclosed salary support from the National Institute of Occupational Safety and Health, National Institute of Aging, National Cancer Institute, and National Center for Advancing Translational Sciences. His comments are derived from an editorial that accompanied Dr. Postuma and colleagues’ study (Neurology. 2017 Sep 27. doi: 10.1212/WNL.0000000000004584).
The appeal of an inexpensive, well-tolerated intervention such as caffeine to improve motor symptoms in Parkinson’s patients gave Dr. Postuma and his associates a good reason to try to replicate the positive results they found in an earlier study of caffeine.
The investigators found no benefit from caffeine, although their study was designed to have more than four times as many participants as the pilot study, was adequately powered to detect the same level of improvement as before, and was planned to have an extended follow-up period to look for persistent effects. The trial ended early and enrolled approximately half of its intended total, but was well run and did not suffer from differential compliance or loss to follow-up.
Although the small number of participants resulted in a wide confidence interval and cannot exclude a small effect, this trial suggests that caffeine does not significantly improve Parkinson’s disease symptoms and that it should not be a priority for future Parkinson’s disease intervention studies.
Charles B. Hall, PhD, is affiliated with the department of epidemiology and population health at Albert Einstein College of Medicine, New York. He disclosed salary support from the National Institute of Occupational Safety and Health, National Institute of Aging, National Cancer Institute, and National Center for Advancing Translational Sciences. His comments are derived from an editorial that accompanied Dr. Postuma and colleagues’ study (Neurology. 2017 Sep 27. doi: 10.1212/WNL.0000000000004584).
The appeal of an inexpensive, well-tolerated intervention such as caffeine to improve motor symptoms in Parkinson’s patients gave Dr. Postuma and his associates a good reason to try to replicate the positive results they found in an earlier study of caffeine.
The investigators found no benefit from caffeine, although their study was designed to have more than four times as many participants as the pilot study, was adequately powered to detect the same level of improvement as before, and was planned to have an extended follow-up period to look for persistent effects. The trial ended early and enrolled approximately half of its intended total, but was well run and did not suffer from differential compliance or loss to follow-up.
Although the small number of participants resulted in a wide confidence interval and cannot exclude a small effect, this trial suggests that caffeine does not significantly improve Parkinson’s disease symptoms and that it should not be a priority for future Parkinson’s disease intervention studies.
Charles B. Hall, PhD, is affiliated with the department of epidemiology and population health at Albert Einstein College of Medicine, New York. He disclosed salary support from the National Institute of Occupational Safety and Health, National Institute of Aging, National Cancer Institute, and National Center for Advancing Translational Sciences. His comments are derived from an editorial that accompanied Dr. Postuma and colleagues’ study (Neurology. 2017 Sep 27. doi: 10.1212/WNL.0000000000004584).
Caffeine consumption has no significant impact on motor skills in patients with Parkinson’s disease, based on data from a double-blind, randomized, placebo-controlled trial of 121 adults. The findings were published online Sept. 27 in Neurology.
Data from previous studies have suggested a link between caffeine consumption and reduced risk of Parkinson’s disease, wrote Ronald B. Postuma, MD, of McGill University in Montreal, and his colleagues (Neurology. 2017 Sep 27. doi: 10.1212/WNL.0000000000004568). In addition, Dr. Postuma and his coauthors found a small impact of caffeine on motor skills in patients with existing Parkinson’s as a secondary outcome in a 2012 study on the role of caffeine on daytime sleepiness. Based on these findings, they designed a multicenter, randomized, controlled trial of 121 adults with Parkinson’s to assess the impact of caffeine. The average age of the patients was 62 years and the average disease duration was 4 years.
Motor skills worsened in the caffeine group by an average of 0.16 points on the Movement Disorder Society–sponsored Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III during patients’ “on” state and by 0.64 points in the placebo group; the difference was not significant.
The researchers found no differences between groups in the clinical global impression of change based on both patient and examiner assessment. In addition, no differences appeared in depression or anxiety, or in quality of life.
The study findings included long-term follow up data from 88 patients assessed at 12 months and 66 patients assessed at 18 months. The results were similar to the 6-month results, and the study was stopped, although the original design included a 4-year extension.
A total of 29 patients in the caffeine group and 31 patients in the placebo group reported adverse events, and 7 patients in the caffeine group and 5 in the placebo group discontinued the study because of side effects. A serious adverse event was reported by one patient in each group, but neither was deemed related to the interventions.
The findings contrast with the effects of caffeine in the 6-week study in 2012 that showed a significant, 3.2-point improvement in motor skills on the MDS-UPDRS part III with caffeine use, as well as reduced daytime sleepiness, the researchers said (Neurology. 2012;79:651-8). Interpretations of the different findings between the trials may be constrained by factors including differences in the study populations, speed of dose escalation, and trial duration and the possible short-term nature of caffeine’s impact, they noted. “Regardless, our core finding is that caffeine cannot be recommended as symptomatic therapy for parkinsonism.” However, “since caffeine is safe and generally well tolerated, it seems reasonable to empirically try intermittent moderate doses of caffeine for somnolence, and repeat if improvement is seen,” they added.
Dr. Postuma disclosed grant funding from the Canadian Institute of Health Research, the Webster Foundation, and Fonds de Recherche du Québec-Santé for this study.
Caffeine consumption has no significant impact on motor skills in patients with Parkinson’s disease, based on data from a double-blind, randomized, placebo-controlled trial of 121 adults. The findings were published online Sept. 27 in Neurology.
Data from previous studies have suggested a link between caffeine consumption and reduced risk of Parkinson’s disease, wrote Ronald B. Postuma, MD, of McGill University in Montreal, and his colleagues (Neurology. 2017 Sep 27. doi: 10.1212/WNL.0000000000004568). In addition, Dr. Postuma and his coauthors found a small impact of caffeine on motor skills in patients with existing Parkinson’s as a secondary outcome in a 2012 study on the role of caffeine on daytime sleepiness. Based on these findings, they designed a multicenter, randomized, controlled trial of 121 adults with Parkinson’s to assess the impact of caffeine. The average age of the patients was 62 years and the average disease duration was 4 years.
Motor skills worsened in the caffeine group by an average of 0.16 points on the Movement Disorder Society–sponsored Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III during patients’ “on” state and by 0.64 points in the placebo group; the difference was not significant.
The researchers found no differences between groups in the clinical global impression of change based on both patient and examiner assessment. In addition, no differences appeared in depression or anxiety, or in quality of life.
The study findings included long-term follow up data from 88 patients assessed at 12 months and 66 patients assessed at 18 months. The results were similar to the 6-month results, and the study was stopped, although the original design included a 4-year extension.
A total of 29 patients in the caffeine group and 31 patients in the placebo group reported adverse events, and 7 patients in the caffeine group and 5 in the placebo group discontinued the study because of side effects. A serious adverse event was reported by one patient in each group, but neither was deemed related to the interventions.
The findings contrast with the effects of caffeine in the 6-week study in 2012 that showed a significant, 3.2-point improvement in motor skills on the MDS-UPDRS part III with caffeine use, as well as reduced daytime sleepiness, the researchers said (Neurology. 2012;79:651-8). Interpretations of the different findings between the trials may be constrained by factors including differences in the study populations, speed of dose escalation, and trial duration and the possible short-term nature of caffeine’s impact, they noted. “Regardless, our core finding is that caffeine cannot be recommended as symptomatic therapy for parkinsonism.” However, “since caffeine is safe and generally well tolerated, it seems reasonable to empirically try intermittent moderate doses of caffeine for somnolence, and repeat if improvement is seen,” they added.
Dr. Postuma disclosed grant funding from the Canadian Institute of Health Research, the Webster Foundation, and Fonds de Recherche du Québec-Santé for this study.
FROM NEUROLOGY
Key clinical point:
Major finding: Motor skills declined by an average of 0.16 points in the caffeine group and 0.64 points in the placebo group; the difference was not significant.
Data source: A double-blind, multicenter, placebo-controlled trial of 121 adults with Parkinson’s.
Disclosures: Dr. Postuma disclosed grant funding from the Canadian Institute of Health Research, the Webster Foundation, and Fonds de Recherche du Québec-Santé for this study.
Consider adding chemotherapy after GI surgery
Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.
Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).
The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.
The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.
The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.
However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.
The researchers had no financial conflicts to disclose.
The study findings “seem to indicate that additional systemic chemotherapy could be advantageous for patients treated with neoadjuvant chemoradiotherapy for resectable gastroesophageal cancer,” wrote David Cunningham, MD, FMedSci, and Elizabeth C. Smyth, MB, BCh., MSc., in an accompanying editorial.
“The small percentage of patients treated with adjuvant chemotherapy is reassuring; neoadjuvant chemoradiotherapy and surgery followed by adjuvant chemotherapy is not a treatment approach endorsed by current national or international guidelines,” they noted. The findings suggest that the 4% increase in overall survival at 3 years is promising because most gastroesophageal cancer recurrences arise within 3 years of surgery, they said. “However, these results require validation in the form of a randomized clinical trial,” they emphasized (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2792).
Dr. Cunningham and Ms. Smyth are affiliated with the department of gastrointestinal oncology and lymphoma at the Royal Marsden Hospital, London. Dr. Cunningham disclosed institutional research funding from Amgen, AstraZeneca, Bayer, Celgene, MedImmune, Merck Serono, Merrimack, and Sanofi. Ms. Smyth disclosed honoraria for advisory roles with Five Prime Therapeutics, Bristol-Myers Squibb, and Gritstone Oncology.
The study findings “seem to indicate that additional systemic chemotherapy could be advantageous for patients treated with neoadjuvant chemoradiotherapy for resectable gastroesophageal cancer,” wrote David Cunningham, MD, FMedSci, and Elizabeth C. Smyth, MB, BCh., MSc., in an accompanying editorial.
“The small percentage of patients treated with adjuvant chemotherapy is reassuring; neoadjuvant chemoradiotherapy and surgery followed by adjuvant chemotherapy is not a treatment approach endorsed by current national or international guidelines,” they noted. The findings suggest that the 4% increase in overall survival at 3 years is promising because most gastroesophageal cancer recurrences arise within 3 years of surgery, they said. “However, these results require validation in the form of a randomized clinical trial,” they emphasized (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2792).
Dr. Cunningham and Ms. Smyth are affiliated with the department of gastrointestinal oncology and lymphoma at the Royal Marsden Hospital, London. Dr. Cunningham disclosed institutional research funding from Amgen, AstraZeneca, Bayer, Celgene, MedImmune, Merck Serono, Merrimack, and Sanofi. Ms. Smyth disclosed honoraria for advisory roles with Five Prime Therapeutics, Bristol-Myers Squibb, and Gritstone Oncology.
The study findings “seem to indicate that additional systemic chemotherapy could be advantageous for patients treated with neoadjuvant chemoradiotherapy for resectable gastroesophageal cancer,” wrote David Cunningham, MD, FMedSci, and Elizabeth C. Smyth, MB, BCh., MSc., in an accompanying editorial.
“The small percentage of patients treated with adjuvant chemotherapy is reassuring; neoadjuvant chemoradiotherapy and surgery followed by adjuvant chemotherapy is not a treatment approach endorsed by current national or international guidelines,” they noted. The findings suggest that the 4% increase in overall survival at 3 years is promising because most gastroesophageal cancer recurrences arise within 3 years of surgery, they said. “However, these results require validation in the form of a randomized clinical trial,” they emphasized (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2792).
Dr. Cunningham and Ms. Smyth are affiliated with the department of gastrointestinal oncology and lymphoma at the Royal Marsden Hospital, London. Dr. Cunningham disclosed institutional research funding from Amgen, AstraZeneca, Bayer, Celgene, MedImmune, Merck Serono, Merrimack, and Sanofi. Ms. Smyth disclosed honoraria for advisory roles with Five Prime Therapeutics, Bristol-Myers Squibb, and Gritstone Oncology.
Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.
Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).
The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.
The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.
The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.
However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.
The researchers had no financial conflicts to disclose.
Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.
Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).
The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.
The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.
The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.
However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.
The researchers had no financial conflicts to disclose.
FROM JAMA ONCOLOGY
Key clinical point: Patients undergoing surgery for gastroesophageal cancer may benefit from additional chemotherapy.
Major finding: Overall survival rates improved in patients who received adjuvant chemotherapy, compared with those who did not (40 months vs. 34 months, respectively).
Data source: A review of 10,086 adults in the National Cancer Database who underwent gastroesophageal cancer surgery during 2006-2013.
Disclosures: The researchers had no financial conflicts to disclose.
Battling physician burnout delivers monetary benefits for health care organizations
The financial impact of physician burnout can provide a guide to help organizations address the problem, according to a special communication published online in JAMA Internal Medicine.
Approximately half of U.S. physicians experience some degree of professional burnout, but health care organizations have done little to respond, wrote Tait Shanafelt, MD, of Stanford (Calif.) University, and colleagues (JAMA Intern Med. 2017 Sep 25. doi: 10.1001/jamainternmed.2017.4340).
The researchers cited “a lack of awareness regarding the economic costs of physician burnout” and a lack of confidence that anything can be done as key factors in why the organizational response to burnout has been so limited.
The business end of physician burnout includes the costs associated with physician turnover and decreased productivity, as well as “financial risks to the organization’s long-term viability due to the relationship between burnout and lower quality of care, decreased patient satisfaction, and problems with patient safety,” the researchers said.
Organizations can combat physician burnout, the authors noted, and the effort is financially worthwhile, as well as morally and ethically important. “Burnout is primarily a system-level problem driven by excess job demands and inadequate resources and support, not an individual problem triggered by personal limitations,” they wrote.
The researchers developed a model outlining “Typical Steps in an Organization’s Journey Toward Expertise in Physician Well-being.” The steps begin with strategies that have a minor impact, including awareness of the problem of physician burnout and a focus on individual interventions such as mindfulness training, exercise, and nutrition.
However, the “transformative” changes in an organization include developing a “culture of wellness,” strategic investment in physician well-being, the presence of a “chief well-being officer” at the executive level, and accountability for physician wellness shared among organizational leaders.
The cost of such strategies varies among institutions, and the researchers provided worksheets to calculate the organizational cost of burnout and the return on investment if intervention steps are taken.
For example, an organization employing 450 physicians could potentially spend $1 million per year on an intervention to reduce physician burnout from 50% to 40%. The intervention investment could yield organizational cost savings of $1.125 million per year, with a 12.5% return on investment, as well as the potential financial benefits of improved patient satisfaction and quality of care.
“Understanding the business case to reduce burnout and promote engagement, as well as overcoming the misperception that nothing meaningful can be done, are key steps for organizations to begin to take action,” the researchers concluded.
“Improvement is possible, investment is justified, and return on investment measurable,” they said.
Dr. Shanafelt is a coinventor of the Physician Well-Being Index, Medical Student Well-Being Index, and Well-Being Index; copyright and licensing rights for these tools belong to the Mayo Clinic, and Dr. Shanafelt receives part of the royalties. The researchers had no other financial conflicts to disclose.
The financial impact of physician burnout can provide a guide to help organizations address the problem, according to a special communication published online in JAMA Internal Medicine.
Approximately half of U.S. physicians experience some degree of professional burnout, but health care organizations have done little to respond, wrote Tait Shanafelt, MD, of Stanford (Calif.) University, and colleagues (JAMA Intern Med. 2017 Sep 25. doi: 10.1001/jamainternmed.2017.4340).
The researchers cited “a lack of awareness regarding the economic costs of physician burnout” and a lack of confidence that anything can be done as key factors in why the organizational response to burnout has been so limited.
The business end of physician burnout includes the costs associated with physician turnover and decreased productivity, as well as “financial risks to the organization’s long-term viability due to the relationship between burnout and lower quality of care, decreased patient satisfaction, and problems with patient safety,” the researchers said.
Organizations can combat physician burnout, the authors noted, and the effort is financially worthwhile, as well as morally and ethically important. “Burnout is primarily a system-level problem driven by excess job demands and inadequate resources and support, not an individual problem triggered by personal limitations,” they wrote.
The researchers developed a model outlining “Typical Steps in an Organization’s Journey Toward Expertise in Physician Well-being.” The steps begin with strategies that have a minor impact, including awareness of the problem of physician burnout and a focus on individual interventions such as mindfulness training, exercise, and nutrition.
However, the “transformative” changes in an organization include developing a “culture of wellness,” strategic investment in physician well-being, the presence of a “chief well-being officer” at the executive level, and accountability for physician wellness shared among organizational leaders.
The cost of such strategies varies among institutions, and the researchers provided worksheets to calculate the organizational cost of burnout and the return on investment if intervention steps are taken.
For example, an organization employing 450 physicians could potentially spend $1 million per year on an intervention to reduce physician burnout from 50% to 40%. The intervention investment could yield organizational cost savings of $1.125 million per year, with a 12.5% return on investment, as well as the potential financial benefits of improved patient satisfaction and quality of care.
“Understanding the business case to reduce burnout and promote engagement, as well as overcoming the misperception that nothing meaningful can be done, are key steps for organizations to begin to take action,” the researchers concluded.
“Improvement is possible, investment is justified, and return on investment measurable,” they said.
Dr. Shanafelt is a coinventor of the Physician Well-Being Index, Medical Student Well-Being Index, and Well-Being Index; copyright and licensing rights for these tools belong to the Mayo Clinic, and Dr. Shanafelt receives part of the royalties. The researchers had no other financial conflicts to disclose.
The financial impact of physician burnout can provide a guide to help organizations address the problem, according to a special communication published online in JAMA Internal Medicine.
Approximately half of U.S. physicians experience some degree of professional burnout, but health care organizations have done little to respond, wrote Tait Shanafelt, MD, of Stanford (Calif.) University, and colleagues (JAMA Intern Med. 2017 Sep 25. doi: 10.1001/jamainternmed.2017.4340).
The researchers cited “a lack of awareness regarding the economic costs of physician burnout” and a lack of confidence that anything can be done as key factors in why the organizational response to burnout has been so limited.
The business end of physician burnout includes the costs associated with physician turnover and decreased productivity, as well as “financial risks to the organization’s long-term viability due to the relationship between burnout and lower quality of care, decreased patient satisfaction, and problems with patient safety,” the researchers said.
Organizations can combat physician burnout, the authors noted, and the effort is financially worthwhile, as well as morally and ethically important. “Burnout is primarily a system-level problem driven by excess job demands and inadequate resources and support, not an individual problem triggered by personal limitations,” they wrote.
The researchers developed a model outlining “Typical Steps in an Organization’s Journey Toward Expertise in Physician Well-being.” The steps begin with strategies that have a minor impact, including awareness of the problem of physician burnout and a focus on individual interventions such as mindfulness training, exercise, and nutrition.
However, the “transformative” changes in an organization include developing a “culture of wellness,” strategic investment in physician well-being, the presence of a “chief well-being officer” at the executive level, and accountability for physician wellness shared among organizational leaders.
The cost of such strategies varies among institutions, and the researchers provided worksheets to calculate the organizational cost of burnout and the return on investment if intervention steps are taken.
For example, an organization employing 450 physicians could potentially spend $1 million per year on an intervention to reduce physician burnout from 50% to 40%. The intervention investment could yield organizational cost savings of $1.125 million per year, with a 12.5% return on investment, as well as the potential financial benefits of improved patient satisfaction and quality of care.
“Understanding the business case to reduce burnout and promote engagement, as well as overcoming the misperception that nothing meaningful can be done, are key steps for organizations to begin to take action,” the researchers concluded.
“Improvement is possible, investment is justified, and return on investment measurable,” they said.
Dr. Shanafelt is a coinventor of the Physician Well-Being Index, Medical Student Well-Being Index, and Well-Being Index; copyright and licensing rights for these tools belong to the Mayo Clinic, and Dr. Shanafelt receives part of the royalties. The researchers had no other financial conflicts to disclose.
FROM JAMA INTERNAL MEDICINE