WAIKOLOA, HAWAII – A new nine-item tool known as the Injured Trauma Survivor Screen demonstrated strong sensitivity and specificity for predicting posttraumatic stress disorder and depression in trauma patients.

At the annual meeting of the American Association for the Surgery of Trauma, Terri deRoon-Cassini, PhD, said that the rates of PTSD among trauma patients range from 10% to 42%, depending on the type of injury sustained. “There is significant life impairment, including an increased risk for suicide and an increased risk for morbidity and mortality,” said Dr. deRoon-Cassini, a clinical psychologist and associate professor with the division of trauma and critical care at the Medical College of Wisconsin, Milwaukee.

The ACS Committee on Trauma currently recommends PTSD screening by trauma centers, including the 20-item PTSD Checklist and the nine-item PHD-9 for depression. However, these symptom-based screens were not validated in hospitalized trauma patients. “This becomes important, because according to the symptom trajectory of PTSD after trauma, about 22% of people experience chronic disease and about 16%-18% of people who have symptoms at baseline do not translate to symptoms by 6 months, so screening with a symptom-based measure isn’t always the best route,” she said.

Doug Brunk/Frontline Medical News

• Did you think you were going to die? (risk factor being perceived life threat; odds ratio 6.32).

• Do you think this was done to you intentionally? (risk factor being intentionality; OR, 4.24).

• Have you felt more restless, tense, or jumpy than usual? (risk factor being assessment of arousal; OR, 5.31).

• Have you found yourself unable to stop worrying? (risk factor being worry/rumination; OR, 4.49).

• Do you find yourself thinking that the world is unsafe and that people are not to be trusted? (risk factor being negative alterations in cognition; OR, 5.52).

The five ITSS depression questions are:

• Have you ever taken medication for, or been given a mental health diagnosis? (risk factor being preexisting psychopathology; OR, 10.58).

• Has there ever been a time in your life you have been bothered by feeling down or hopeless or lost all interest in things you usually enjoyed for more than 2 weeks? (risk factor being premorbid depression; OR, 3.78).

• Did you think you were going to die? (risk factor being perceived life threat; OR, 9.69).

• Have you felt emotionally detached from your loved ones? (risk factor being negative alteration in mood; OR, 8.03).

• Do you find yourself crying and are unsure why? (risk factor being mood/depression; OR, 9.18).

The researchers administered the survey to 139 patients at two trauma centers. More than half (69%) were male, 48% were white, 40% were African American, and the remainder were from other ethnic backgrounds. The three most common mechanisms of injury were motor vehicle crashes (29%), motorcycle/all-terrain vehicle crashes (19%), and falls (13%). Dr. deRoon-Cassini reported that administration of the ITSS within 4 days of injury demonstrated a 75% sensitivity for identifying the risk for PTSD and depression, a 94% specificity for PTSD, and a 96% specificity for depression, with a cutoff score of 2 out of 5 for both subscales based on a receiver operating characteristic (ROC) curve analysis.

One month following administration of the ITSS, 20% of patients were diagnosed with depression and 29% were diagnosed with PTSD. Of those diagnosed with PTSD, 55% met criteria for concomitant depression “so we are seeing a high comorbidity between PTSD and depression, which is consistent with the medical literature,” she said.

“The ITSS represents a brief way that we can screen for PTSD and depression within a trauma system,” Dr. deRoon-Cassini said. “At our institution, social workers administer the tool. They have a flow sheet in our EMR system where they enter the responses. If someone screens positive, a best practice recommendation is put into the patient’s chart, which gets funneled to a trauma psychology consult. On the treatment side we try to intervene by triaging the severity of the current distress the person is experiencing, past comorbidities, and past trauma histories. From there we decide whether to do a brief intervention or more intensive evidence-based interventions for PTSD or depression together or separately.”

The study was funded by a grant from the Medical College of Wisconsin. Coauthors included Joshua Hunt, PhD, of the Medical College of Wisconsin, Milwaukee; Ann Marie Warren, PhD, of Baylor Medical Center, Dallas; and Karen Brasel, MD, FACS, of Oregon Health & Science University, Portland. Dr. deRoon-Cassini reported having no financial disclosures.

[email protected]

WAIKOLOA, HAWAII – A new nine-item tool known as the Injured Trauma Survivor Screen demonstrated strong sensitivity and specificity for predicting posttraumatic stress disorder and depression in trauma patients.

At the annual meeting of the American Association for the Surgery of Trauma, Terri deRoon-Cassini, PhD, said that the rates of PTSD among trauma patients range from 10% to 42%, depending on the type of injury sustained. “There is significant life impairment, including an increased risk for suicide and an increased risk for morbidity and mortality,” said Dr. deRoon-Cassini, a clinical psychologist and associate professor with the division of trauma and critical care at the Medical College of Wisconsin, Milwaukee.

The ACS Committee on Trauma currently recommends PTSD screening by trauma centers, including the 20-item PTSD Checklist and the nine-item PHD-9 for depression. However, these symptom-based screens were not validated in hospitalized trauma patients. “This becomes important, because according to the symptom trajectory of PTSD after trauma, about 22% of people experience chronic disease and about 16%-18% of people who have symptoms at baseline do not translate to symptoms by 6 months, so screening with a symptom-based measure isn’t always the best route,” she said.

Doug Brunk/Frontline Medical News

• Did you think you were going to die? (risk factor being perceived life threat; odds ratio 6.32).

• Do you think this was done to you intentionally? (risk factor being intentionality; OR, 4.24).

• Have you felt more restless, tense, or jumpy than usual? (risk factor being assessment of arousal; OR, 5.31).

• Have you found yourself unable to stop worrying? (risk factor being worry/rumination; OR, 4.49).

• Do you find yourself thinking that the world is unsafe and that people are not to be trusted? (risk factor being negative alterations in cognition; OR, 5.52).

The five ITSS depression questions are:

• Have you ever taken medication for, or been given a mental health diagnosis? (risk factor being preexisting psychopathology; OR, 10.58).

• Has there ever been a time in your life you have been bothered by feeling down or hopeless or lost all interest in things you usually enjoyed for more than 2 weeks? (risk factor being premorbid depression; OR, 3.78).

• Did you think you were going to die? (risk factor being perceived life threat; OR, 9.69).

• Have you felt emotionally detached from your loved ones? (risk factor being negative alteration in mood; OR, 8.03).

• Do you find yourself crying and are unsure why? (risk factor being mood/depression; OR, 9.18).

The researchers administered the survey to 139 patients at two trauma centers. More than half (69%) were male, 48% were white, 40% were African American, and the remainder were from other ethnic backgrounds. The three most common mechanisms of injury were motor vehicle crashes (29%), motorcycle/all-terrain vehicle crashes (19%), and falls (13%). Dr. deRoon-Cassini reported that administration of the ITSS within 4 days of injury demonstrated a 75% sensitivity for identifying the risk for PTSD and depression, a 94% specificity for PTSD, and a 96% specificity for depression, with a cutoff score of 2 out of 5 for both subscales based on a receiver operating characteristic (ROC) curve analysis.

One month following administration of the ITSS, 20% of patients were diagnosed with depression and 29% were diagnosed with PTSD. Of those diagnosed with PTSD, 55% met criteria for concomitant depression “so we are seeing a high comorbidity between PTSD and depression, which is consistent with the medical literature,” she said.

“The ITSS represents a brief way that we can screen for PTSD and depression within a trauma system,” Dr. deRoon-Cassini said. “At our institution, social workers administer the tool. They have a flow sheet in our EMR system where they enter the responses. If someone screens positive, a best practice recommendation is put into the patient’s chart, which gets funneled to a trauma psychology consult. On the treatment side we try to intervene by triaging the severity of the current distress the person is experiencing, past comorbidities, and past trauma histories. From there we decide whether to do a brief intervention or more intensive evidence-based interventions for PTSD or depression together or separately.”

The study was funded by a grant from the Medical College of Wisconsin. Coauthors included Joshua Hunt, PhD, of the Medical College of Wisconsin, Milwaukee; Ann Marie Warren, PhD, of Baylor Medical Center, Dallas; and Karen Brasel, MD, FACS, of Oregon Health & Science University, Portland. Dr. deRoon-Cassini reported having no financial disclosures.

[email protected]

WAIKOLOA, HAWAII – A new nine-item tool known as the Injured Trauma Survivor Screen demonstrated strong sensitivity and specificity for predicting posttraumatic stress disorder and depression in trauma patients.

At the annual meeting of the American Association for the Surgery of Trauma, Terri deRoon-Cassini, PhD, said that the rates of PTSD among trauma patients range from 10% to 42%, depending on the type of injury sustained. “There is significant life impairment, including an increased risk for suicide and an increased risk for morbidity and mortality,” said Dr. deRoon-Cassini, a clinical psychologist and associate professor with the division of trauma and critical care at the Medical College of Wisconsin, Milwaukee.

The ACS Committee on Trauma currently recommends PTSD screening by trauma centers, including the 20-item PTSD Checklist and the nine-item PHD-9 for depression. However, these symptom-based screens were not validated in hospitalized trauma patients. “This becomes important, because according to the symptom trajectory of PTSD after trauma, about 22% of people experience chronic disease and about 16%-18% of people who have symptoms at baseline do not translate to symptoms by 6 months, so screening with a symptom-based measure isn’t always the best route,” she said.

Doug Brunk/Frontline Medical News

• Did you think you were going to die? (risk factor being perceived life threat; odds ratio 6.32).

• Do you think this was done to you intentionally? (risk factor being intentionality; OR, 4.24).

• Have you felt more restless, tense, or jumpy than usual? (risk factor being assessment of arousal; OR, 5.31).

• Have you found yourself unable to stop worrying? (risk factor being worry/rumination; OR, 4.49).

• Do you find yourself thinking that the world is unsafe and that people are not to be trusted? (risk factor being negative alterations in cognition; OR, 5.52).

The five ITSS depression questions are:

• Have you ever taken medication for, or been given a mental health diagnosis? (risk factor being preexisting psychopathology; OR, 10.58).

• Has there ever been a time in your life you have been bothered by feeling down or hopeless or lost all interest in things you usually enjoyed for more than 2 weeks? (risk factor being premorbid depression; OR, 3.78).

• Did you think you were going to die? (risk factor being perceived life threat; OR, 9.69).

• Have you felt emotionally detached from your loved ones? (risk factor being negative alteration in mood; OR, 8.03).

• Do you find yourself crying and are unsure why? (risk factor being mood/depression; OR, 9.18).

The researchers administered the survey to 139 patients at two trauma centers. More than half (69%) were male, 48% were white, 40% were African American, and the remainder were from other ethnic backgrounds. The three most common mechanisms of injury were motor vehicle crashes (29%), motorcycle/all-terrain vehicle crashes (19%), and falls (13%). Dr. deRoon-Cassini reported that administration of the ITSS within 4 days of injury demonstrated a 75% sensitivity for identifying the risk for PTSD and depression, a 94% specificity for PTSD, and a 96% specificity for depression, with a cutoff score of 2 out of 5 for both subscales based on a receiver operating characteristic (ROC) curve analysis.

One month following administration of the ITSS, 20% of patients were diagnosed with depression and 29% were diagnosed with PTSD. Of those diagnosed with PTSD, 55% met criteria for concomitant depression “so we are seeing a high comorbidity between PTSD and depression, which is consistent with the medical literature,” she said.

“The ITSS represents a brief way that we can screen for PTSD and depression within a trauma system,” Dr. deRoon-Cassini said. “At our institution, social workers administer the tool. They have a flow sheet in our EMR system where they enter the responses. If someone screens positive, a best practice recommendation is put into the patient’s chart, which gets funneled to a trauma psychology consult. On the treatment side we try to intervene by triaging the severity of the current distress the person is experiencing, past comorbidities, and past trauma histories. From there we decide whether to do a brief intervention or more intensive evidence-based interventions for PTSD or depression together or separately.”

The study was funded by a grant from the Medical College of Wisconsin. Coauthors included Joshua Hunt, PhD, of the Medical College of Wisconsin, Milwaukee; Ann Marie Warren, PhD, of Baylor Medical Center, Dallas; and Karen Brasel, MD, FACS, of Oregon Health & Science University, Portland. Dr. deRoon-Cassini reported having no financial disclosures.

[email protected]

NEW YORK – “Most clinicians probably don’t have problems identifying patients who are depressed and giving them a trial of an antidepressant or a second antidepressant, but where do they run into stumbling blocks?” That’s a question Joshua A. Gordon, MD, PhD, the new director of the National Institute of Mental Health, said he is pondering as he steps into his new role.

Both a practicing clinical psychiatrist and a neuroscientist with a lab chiefly dedicated to optogenetics, Dr. Gordon shared his thoughts about what the priorities of the world’s largest mental health research institute should be, and how to balance immediate patient needs with the development of future interventions.

Conducted in New York City, where Dr. Gordon saw patients, maintained a lab, and was an associate professor of psychiatry at Columbia University for nearly 2 decades, this is the last installment in a series of interviews.

[email protected]

On Twitter @whitneymcknight

NEW YORK – “Most clinicians probably don’t have problems identifying patients who are depressed and giving them a trial of an antidepressant or a second antidepressant, but where do they run into stumbling blocks?” That’s a question Joshua A. Gordon, MD, PhD, the new director of the National Institute of Mental Health, said he is pondering as he steps into his new role.

Both a practicing clinical psychiatrist and a neuroscientist with a lab chiefly dedicated to optogenetics, Dr. Gordon shared his thoughts about what the priorities of the world’s largest mental health research institute should be, and how to balance immediate patient needs with the development of future interventions.

Conducted in New York City, where Dr. Gordon saw patients, maintained a lab, and was an associate professor of psychiatry at Columbia University for nearly 2 decades, this is the last installment in a series of interviews.

[email protected]

On Twitter @whitneymcknight

NEW YORK – “Most clinicians probably don’t have problems identifying patients who are depressed and giving them a trial of an antidepressant or a second antidepressant, but where do they run into stumbling blocks?” That’s a question Joshua A. Gordon, MD, PhD, the new director of the National Institute of Mental Health, said he is pondering as he steps into his new role.

Both a practicing clinical psychiatrist and a neuroscientist with a lab chiefly dedicated to optogenetics, Dr. Gordon shared his thoughts about what the priorities of the world’s largest mental health research institute should be, and how to balance immediate patient needs with the development of future interventions.

Conducted in New York City, where Dr. Gordon saw patients, maintained a lab, and was an associate professor of psychiatry at Columbia University for nearly 2 decades, this is the last installment in a series of interviews.

[email protected]

On Twitter @whitneymcknight

NEW YORK – Will it ever be possible to trace the neuronal pathways of specific mental states as they speed through our brains? Hear Joshua A. Gordon, MD, PhD, the National Institute of Mental Health’s new director, share his thoughts on just such a technology in an interview recorded just days before he assumed his new role at the world’s largest mental health research organization.

In the interview, Dr. Gordon also addresses whether the use of “optogenetics” – a novel therapy developed by neuroscientists that, if it works, promises to track mental disorders such as anxiety or depression – creates ethical dilemmas when deciding whether these disorders should be turned “on” or “off.”

“When I treat patients, I treat them because they are overwhelmed with depression, or because they’re hearing voices that are scary or ruining their lives, or because they have intractable anxiety,” Dr. Gordon said. “To relieve those symptoms, there is no ethical dilemma in my mind.”

[email protected]

On Twitter @whitneymcknight

NEW YORK – Will it ever be possible to trace the neuronal pathways of specific mental states as they speed through our brains? Hear Joshua A. Gordon, MD, PhD, the National Institute of Mental Health’s new director, share his thoughts on just such a technology in an interview recorded just days before he assumed his new role at the world’s largest mental health research organization.

In the interview, Dr. Gordon also addresses whether the use of “optogenetics” – a novel therapy developed by neuroscientists that, if it works, promises to track mental disorders such as anxiety or depression – creates ethical dilemmas when deciding whether these disorders should be turned “on” or “off.”

“When I treat patients, I treat them because they are overwhelmed with depression, or because they’re hearing voices that are scary or ruining their lives, or because they have intractable anxiety,” Dr. Gordon said. “To relieve those symptoms, there is no ethical dilemma in my mind.”

[email protected]

On Twitter @whitneymcknight

NEW YORK – Will it ever be possible to trace the neuronal pathways of specific mental states as they speed through our brains? Hear Joshua A. Gordon, MD, PhD, the National Institute of Mental Health’s new director, share his thoughts on just such a technology in an interview recorded just days before he assumed his new role at the world’s largest mental health research organization.

In the interview, Dr. Gordon also addresses whether the use of “optogenetics” – a novel therapy developed by neuroscientists that, if it works, promises to track mental disorders such as anxiety or depression – creates ethical dilemmas when deciding whether these disorders should be turned “on” or “off.”

“When I treat patients, I treat them because they are overwhelmed with depression, or because they’re hearing voices that are scary or ruining their lives, or because they have intractable anxiety,” Dr. Gordon said. “To relieve those symptoms, there is no ethical dilemma in my mind.”

[email protected]

On Twitter @whitneymcknight

• Used traditionally in Northwest Africa for its cosmetic, bactericidal, and fungicidal activity.

• Rich in vitamin E, oleic acid, and linoleic acid, which are believed to contribute to the perceived cutaneous benefits of this vegetable oil.

• Reputed to impart antiacne, antisebum, antiaging, moisturizing, and wound-healing activity, but clinical evidence is sparse.

• In a small study, the nightly topical application of argan oil resulted in a moisturizing effect, and in statistically significant decreases in transepidermal water loss and increases in the water content of the epidermis.

For more than 800 years, native Moroccans and explorers in the region have cited the health benefits of the topical use or consumption of argan oil.¹ The oil, derived from the fruit of Argania spinosa, is a slow-growing tree native to the arid climate of Southwestern Morocco^2-4 as well as the Algerian province of Tindouf in the Western Mediterranean area.⁵ For many years, it was primarily the populations of the Essaouira and Souss-Massa-Draa regions of Morocco that benefited from the production and use of argan oil.⁶ Largely through the efforts of the Moroccan government, as well as cooperating nongovernmental organizations and private entities, argan oil is now also a well-established ingredient on the edible oil as well as cosmetic oil markets throughout the world.⁶

Chemistry

Oleic acid, an omega-9 monounsaturated fatty acid, is abundant in argan oil (43%-49%) and has been found to act as a penetration enhancer by disturbing the skin barrier.^14,15 Linoleic acid, an omega-6 polyunsaturated fatty acid, found in concentrations of 29%-36% in the oil, is integral in the biosynthesis of inflammatory prostaglandins through the arachidonic acid pathway.^4,16 The presence of linoleic acid may help prevent or mitigate inflammation. Linoleic acid is also a component of ceramide 1 linoleate, which is diminished in dry skin. Topical application of linoleic acid can raise ceramide 1 linoleate levels in the skin, thus reducing xerosis.¹⁷ Argan oil also contains the saturated fatty acids palmitic acid (11%-15%) and stearic acid (4%-7%).²

Though argan oil is mainly composed of unsaturated fatty acids (80%),^1,18,19 the unsaponifiable fraction (1%) is replete with antioxidants, including sterols, saponins, and polyphenols.^4,19 The polyphenolic constituents, primarily gamma-tocopherol, which is considered the most efficient among the tocopherols at scavenging free radicals, are thought to account for the antioxidant effects of argan oil.^1,2,18,20,21

Topical uses

Unroasted kernels are used to produce cosmetic-grade argan oil, which is used in moisturizing creams, body lotions, and shampoos.² Although argan oil contains components that have antioxidant and anti-inflammatory features and there are many patents on the use of argan oil in skin care, there is a dearth of published research studies looking at the effect of argan oil–containing skin care products on aging, inflamed, or dry skin. A study by Dobrev evaluated the efficacy of a sebum control cream composed of saw palmetto extract, sesame seeds, and argan oil applied twice daily to the face over a period of 4 weeks in 20 healthy volunteers, 16 with oily skin and 4 with combination skin. All volunteers tolerated the product. A visible sebum-regulating or antisebum efficacy was observed in 95% of the subjects. Clinical evaluation scores and casual sebum levels decreased significantly after 1 month of treatment. Dobrev concluded that this argan oil-containing formulation was efficacious in lessening the greasiness and improving the appearance of oily facial skin.²²

Conclusion

Although clinical research data on argan oil are limited, its traditional uses and inclusion in novel cosmetic products suggest that further study is warranted. Randomized controlled trials are needed to elucidate cutaneous benefits, if any, from this rare botanical.

1. J Pharm Pharmacol. 2010 Dec;62(12):1669-75.

2. Altern Med Rev. 2011 Sep;16(3):275-9.

3. J Ethnopharmacol. 1999 Oct;67(1):7-14.

4. Pharmacol Res. 2006 Jul;54(1):1-5.

5. Nutr Rev. 2012 May;70(5):266-79.

6. Eur J Lipid Sci Technol. 2014 Oct;116(10):1316-21.

7. Ann Nutr Metab. 2005 May-Jun;49(3):196-201.

8. Nutr Metab Cardiovasc Dis. 2005 Oct;15(5):352-60.

9. Evid Based Complement Alternat Med. 2006 Sep;3(3):317-27.

10. Cancer Invest. 2006 Oct;24(6):588-92.

11. Cancer Detect Prev. 2007;31(1):64-9.

12. “Liquid Gold in Morocco,” by Amy Larocca, The New York Times, Nov. 18, 2007.

13. Phytomedicine. 2010 Feb;17(2):157-60.

14. J Control Release. 1995;37(3):299-306.

15. Thermochimica Acta. 1997 Jun;293:77-85.

16. Prostaglandins Leukot Essent Fatty Acids. 1995 Jun;52(6):387-91.

17. Int J Cosmet Sci. 1996 Feb;18(1):1-12.

18. Crit Rev Food Sci Nutr. 2010 May;50(5):473-7.

19. Eur J Cancer Prev. 2003 Feb;12(1):67-75.

20. Fitoterapia. 2008 Jul;79(5):337-44.

21. Am J Clin Nutr. 2001 Dec;74(6):714-22.

22. J Cosmet Dermatol. 2007;6(2):113-8.

23. Int J Nanomedicine. 2014 Aug 11;9:3855-64.

24. Clin Interv Aging. 2015 Jan 30;10:339-49.

25. Prz Menopauzalny. 2014 Oct;13(5):280-8.

26. Skin Res Technol. 2013;19:356-7.

27. Inflamm Allergy Drug Targets. 2014;13(3):168-76.

28. Nat Prod Commun. 2010 Nov;5(11):1799-802.

29. J Cosmet Sci. 2014 Mar-Apr;65(2):81-7.

Dr. Baumann is the CEO of Baumann Cosmetic & Research Institute in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. She is the author of “Cosmetic Dermatology: Principles and Practice” (New York: McGraw Hill, 2002), and a book for consumers, “The Skin Type Solution,” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients” (McGraw Hill) was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also develops and owns the Baumann Skin Type Solution skin typing solutions and related products.

• Used traditionally in Northwest Africa for its cosmetic, bactericidal, and fungicidal activity.

• Rich in vitamin E, oleic acid, and linoleic acid, which are believed to contribute to the perceived cutaneous benefits of this vegetable oil.

• Reputed to impart antiacne, antisebum, antiaging, moisturizing, and wound-healing activity, but clinical evidence is sparse.

• In a small study, the nightly topical application of argan oil resulted in a moisturizing effect, and in statistically significant decreases in transepidermal water loss and increases in the water content of the epidermis.

For more than 800 years, native Moroccans and explorers in the region have cited the health benefits of the topical use or consumption of argan oil.¹ The oil, derived from the fruit of Argania spinosa, is a slow-growing tree native to the arid climate of Southwestern Morocco^2-4 as well as the Algerian province of Tindouf in the Western Mediterranean area.⁵ For many years, it was primarily the populations of the Essaouira and Souss-Massa-Draa regions of Morocco that benefited from the production and use of argan oil.⁶ Largely through the efforts of the Moroccan government, as well as cooperating nongovernmental organizations and private entities, argan oil is now also a well-established ingredient on the edible oil as well as cosmetic oil markets throughout the world.⁶

Chemistry

Oleic acid, an omega-9 monounsaturated fatty acid, is abundant in argan oil (43%-49%) and has been found to act as a penetration enhancer by disturbing the skin barrier.^14,15 Linoleic acid, an omega-6 polyunsaturated fatty acid, found in concentrations of 29%-36% in the oil, is integral in the biosynthesis of inflammatory prostaglandins through the arachidonic acid pathway.^4,16 The presence of linoleic acid may help prevent or mitigate inflammation. Linoleic acid is also a component of ceramide 1 linoleate, which is diminished in dry skin. Topical application of linoleic acid can raise ceramide 1 linoleate levels in the skin, thus reducing xerosis.¹⁷ Argan oil also contains the saturated fatty acids palmitic acid (11%-15%) and stearic acid (4%-7%).²

Though argan oil is mainly composed of unsaturated fatty acids (80%),^1,18,19 the unsaponifiable fraction (1%) is replete with antioxidants, including sterols, saponins, and polyphenols.^4,19 The polyphenolic constituents, primarily gamma-tocopherol, which is considered the most efficient among the tocopherols at scavenging free radicals, are thought to account for the antioxidant effects of argan oil.^1,2,18,20,21

Topical uses

Unroasted kernels are used to produce cosmetic-grade argan oil, which is used in moisturizing creams, body lotions, and shampoos.² Although argan oil contains components that have antioxidant and anti-inflammatory features and there are many patents on the use of argan oil in skin care, there is a dearth of published research studies looking at the effect of argan oil–containing skin care products on aging, inflamed, or dry skin. A study by Dobrev evaluated the efficacy of a sebum control cream composed of saw palmetto extract, sesame seeds, and argan oil applied twice daily to the face over a period of 4 weeks in 20 healthy volunteers, 16 with oily skin and 4 with combination skin. All volunteers tolerated the product. A visible sebum-regulating or antisebum efficacy was observed in 95% of the subjects. Clinical evaluation scores and casual sebum levels decreased significantly after 1 month of treatment. Dobrev concluded that this argan oil-containing formulation was efficacious in lessening the greasiness and improving the appearance of oily facial skin.²²

Conclusion

Although clinical research data on argan oil are limited, its traditional uses and inclusion in novel cosmetic products suggest that further study is warranted. Randomized controlled trials are needed to elucidate cutaneous benefits, if any, from this rare botanical.

1. J Pharm Pharmacol. 2010 Dec;62(12):1669-75.

2. Altern Med Rev. 2011 Sep;16(3):275-9.

3. J Ethnopharmacol. 1999 Oct;67(1):7-14.

4. Pharmacol Res. 2006 Jul;54(1):1-5.

5. Nutr Rev. 2012 May;70(5):266-79.

6. Eur J Lipid Sci Technol. 2014 Oct;116(10):1316-21.

7. Ann Nutr Metab. 2005 May-Jun;49(3):196-201.

8. Nutr Metab Cardiovasc Dis. 2005 Oct;15(5):352-60.

9. Evid Based Complement Alternat Med. 2006 Sep;3(3):317-27.

10. Cancer Invest. 2006 Oct;24(6):588-92.

11. Cancer Detect Prev. 2007;31(1):64-9.

12. “Liquid Gold in Morocco,” by Amy Larocca, The New York Times, Nov. 18, 2007.

13. Phytomedicine. 2010 Feb;17(2):157-60.

14. J Control Release. 1995;37(3):299-306.

15. Thermochimica Acta. 1997 Jun;293:77-85.

16. Prostaglandins Leukot Essent Fatty Acids. 1995 Jun;52(6):387-91.

17. Int J Cosmet Sci. 1996 Feb;18(1):1-12.

18. Crit Rev Food Sci Nutr. 2010 May;50(5):473-7.

19. Eur J Cancer Prev. 2003 Feb;12(1):67-75.

20. Fitoterapia. 2008 Jul;79(5):337-44.

21. Am J Clin Nutr. 2001 Dec;74(6):714-22.

22. J Cosmet Dermatol. 2007;6(2):113-8.

23. Int J Nanomedicine. 2014 Aug 11;9:3855-64.

24. Clin Interv Aging. 2015 Jan 30;10:339-49.

25. Prz Menopauzalny. 2014 Oct;13(5):280-8.

26. Skin Res Technol. 2013;19:356-7.

27. Inflamm Allergy Drug Targets. 2014;13(3):168-76.

28. Nat Prod Commun. 2010 Nov;5(11):1799-802.

29. J Cosmet Sci. 2014 Mar-Apr;65(2):81-7.

Dr. Baumann is the CEO of Baumann Cosmetic & Research Institute in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. She is the author of “Cosmetic Dermatology: Principles and Practice” (New York: McGraw Hill, 2002), and a book for consumers, “The Skin Type Solution,” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients” (McGraw Hill) was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also develops and owns the Baumann Skin Type Solution skin typing solutions and related products.

• Used traditionally in Northwest Africa for its cosmetic, bactericidal, and fungicidal activity.

• Rich in vitamin E, oleic acid, and linoleic acid, which are believed to contribute to the perceived cutaneous benefits of this vegetable oil.

• Reputed to impart antiacne, antisebum, antiaging, moisturizing, and wound-healing activity, but clinical evidence is sparse.

• In a small study, the nightly topical application of argan oil resulted in a moisturizing effect, and in statistically significant decreases in transepidermal water loss and increases in the water content of the epidermis.

For more than 800 years, native Moroccans and explorers in the region have cited the health benefits of the topical use or consumption of argan oil.¹ The oil, derived from the fruit of Argania spinosa, is a slow-growing tree native to the arid climate of Southwestern Morocco^2-4 as well as the Algerian province of Tindouf in the Western Mediterranean area.⁵ For many years, it was primarily the populations of the Essaouira and Souss-Massa-Draa regions of Morocco that benefited from the production and use of argan oil.⁶ Largely through the efforts of the Moroccan government, as well as cooperating nongovernmental organizations and private entities, argan oil is now also a well-established ingredient on the edible oil as well as cosmetic oil markets throughout the world.⁶

Chemistry

Oleic acid, an omega-9 monounsaturated fatty acid, is abundant in argan oil (43%-49%) and has been found to act as a penetration enhancer by disturbing the skin barrier.^14,15 Linoleic acid, an omega-6 polyunsaturated fatty acid, found in concentrations of 29%-36% in the oil, is integral in the biosynthesis of inflammatory prostaglandins through the arachidonic acid pathway.^4,16 The presence of linoleic acid may help prevent or mitigate inflammation. Linoleic acid is also a component of ceramide 1 linoleate, which is diminished in dry skin. Topical application of linoleic acid can raise ceramide 1 linoleate levels in the skin, thus reducing xerosis.¹⁷ Argan oil also contains the saturated fatty acids palmitic acid (11%-15%) and stearic acid (4%-7%).²

Though argan oil is mainly composed of unsaturated fatty acids (80%),^1,18,19 the unsaponifiable fraction (1%) is replete with antioxidants, including sterols, saponins, and polyphenols.^4,19 The polyphenolic constituents, primarily gamma-tocopherol, which is considered the most efficient among the tocopherols at scavenging free radicals, are thought to account for the antioxidant effects of argan oil.^1,2,18,20,21

Topical uses

Unroasted kernels are used to produce cosmetic-grade argan oil, which is used in moisturizing creams, body lotions, and shampoos.² Although argan oil contains components that have antioxidant and anti-inflammatory features and there are many patents on the use of argan oil in skin care, there is a dearth of published research studies looking at the effect of argan oil–containing skin care products on aging, inflamed, or dry skin. A study by Dobrev evaluated the efficacy of a sebum control cream composed of saw palmetto extract, sesame seeds, and argan oil applied twice daily to the face over a period of 4 weeks in 20 healthy volunteers, 16 with oily skin and 4 with combination skin. All volunteers tolerated the product. A visible sebum-regulating or antisebum efficacy was observed in 95% of the subjects. Clinical evaluation scores and casual sebum levels decreased significantly after 1 month of treatment. Dobrev concluded that this argan oil-containing formulation was efficacious in lessening the greasiness and improving the appearance of oily facial skin.²²

Conclusion

Although clinical research data on argan oil are limited, its traditional uses and inclusion in novel cosmetic products suggest that further study is warranted. Randomized controlled trials are needed to elucidate cutaneous benefits, if any, from this rare botanical.

1. J Pharm Pharmacol. 2010 Dec;62(12):1669-75.

2. Altern Med Rev. 2011 Sep;16(3):275-9.

3. J Ethnopharmacol. 1999 Oct;67(1):7-14.

4. Pharmacol Res. 2006 Jul;54(1):1-5.

5. Nutr Rev. 2012 May;70(5):266-79.

6. Eur J Lipid Sci Technol. 2014 Oct;116(10):1316-21.

7. Ann Nutr Metab. 2005 May-Jun;49(3):196-201.

8. Nutr Metab Cardiovasc Dis. 2005 Oct;15(5):352-60.

9. Evid Based Complement Alternat Med. 2006 Sep;3(3):317-27.

10. Cancer Invest. 2006 Oct;24(6):588-92.

11. Cancer Detect Prev. 2007;31(1):64-9.

12. “Liquid Gold in Morocco,” by Amy Larocca, The New York Times, Nov. 18, 2007.

13. Phytomedicine. 2010 Feb;17(2):157-60.

14. J Control Release. 1995;37(3):299-306.

15. Thermochimica Acta. 1997 Jun;293:77-85.

16. Prostaglandins Leukot Essent Fatty Acids. 1995 Jun;52(6):387-91.

17. Int J Cosmet Sci. 1996 Feb;18(1):1-12.

18. Crit Rev Food Sci Nutr. 2010 May;50(5):473-7.

19. Eur J Cancer Prev. 2003 Feb;12(1):67-75.

20. Fitoterapia. 2008 Jul;79(5):337-44.

21. Am J Clin Nutr. 2001 Dec;74(6):714-22.

22. J Cosmet Dermatol. 2007;6(2):113-8.

23. Int J Nanomedicine. 2014 Aug 11;9:3855-64.

24. Clin Interv Aging. 2015 Jan 30;10:339-49.

25. Prz Menopauzalny. 2014 Oct;13(5):280-8.

26. Skin Res Technol. 2013;19:356-7.

27. Inflamm Allergy Drug Targets. 2014;13(3):168-76.

28. Nat Prod Commun. 2010 Nov;5(11):1799-802.

29. J Cosmet Sci. 2014 Mar-Apr;65(2):81-7.

Dr. Baumann is the CEO of Baumann Cosmetic & Research Institute in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. She is the author of “Cosmetic Dermatology: Principles and Practice” (New York: McGraw Hill, 2002), and a book for consumers, “The Skin Type Solution,” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients” (McGraw Hill) was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also develops and owns the Baumann Skin Type Solution skin typing solutions and related products.

Unchecked hypertension has “devastating” long-term implications for cognitive health, the American Heart Association concluded in a scientific statement.

“Hypertension disrupts the structure and function of cerebral blood vessels, leads to ischemic damage of white matter regions critical for cognitive function, and may promote Alzheimer pathology,” Costantino Iadecola, MD, of Weill Medical College of Cornell University, wrote online with his associates in Hypertension. There is especially strong evidence that hypertension in middle age leads to cognitive dysfunction later in life, although “the cognitive impact of late-life hypertension is less clear,” they said.

The AHA statement summarizes the current evidence on hypertension, cognitive impairment, and the cognitive effects of hypertension therapy. Observational studies linked hypertension to cumulative cerebrovascular damage over the course of life, but clinical trials did not clearly show that antihypertensive drugs can prevent or reverse cognitive decline, the authors reported. In lieu of making evidence-based recommendations, they emphasized “personalized treatment of hypertension, taking into account age, sex, APOE [apolipoprotein E] genotype, metabolic traits, [and] comorbidities” (Hypertension. 2016 Oct 10. doi: 10.1161/HYP.0000000000000053).

©American Heart Association

Unchecked hypertension has “devastating” long-term implications for cognitive health, the American Heart Association concluded in a scientific statement.

“Hypertension disrupts the structure and function of cerebral blood vessels, leads to ischemic damage of white matter regions critical for cognitive function, and may promote Alzheimer pathology,” Costantino Iadecola, MD, of Weill Medical College of Cornell University, wrote online with his associates in Hypertension. There is especially strong evidence that hypertension in middle age leads to cognitive dysfunction later in life, although “the cognitive impact of late-life hypertension is less clear,” they said.

The AHA statement summarizes the current evidence on hypertension, cognitive impairment, and the cognitive effects of hypertension therapy. Observational studies linked hypertension to cumulative cerebrovascular damage over the course of life, but clinical trials did not clearly show that antihypertensive drugs can prevent or reverse cognitive decline, the authors reported. In lieu of making evidence-based recommendations, they emphasized “personalized treatment of hypertension, taking into account age, sex, APOE [apolipoprotein E] genotype, metabolic traits, [and] comorbidities” (Hypertension. 2016 Oct 10. doi: 10.1161/HYP.0000000000000053).

©American Heart Association

Unchecked hypertension has “devastating” long-term implications for cognitive health, the American Heart Association concluded in a scientific statement.

“Hypertension disrupts the structure and function of cerebral blood vessels, leads to ischemic damage of white matter regions critical for cognitive function, and may promote Alzheimer pathology,” Costantino Iadecola, MD, of Weill Medical College of Cornell University, wrote online with his associates in Hypertension. There is especially strong evidence that hypertension in middle age leads to cognitive dysfunction later in life, although “the cognitive impact of late-life hypertension is less clear,” they said.

The AHA statement summarizes the current evidence on hypertension, cognitive impairment, and the cognitive effects of hypertension therapy. Observational studies linked hypertension to cumulative cerebrovascular damage over the course of life, but clinical trials did not clearly show that antihypertensive drugs can prevent or reverse cognitive decline, the authors reported. In lieu of making evidence-based recommendations, they emphasized “personalized treatment of hypertension, taking into account age, sex, APOE [apolipoprotein E] genotype, metabolic traits, [and] comorbidities” (Hypertension. 2016 Oct 10. doi: 10.1161/HYP.0000000000000053).

©American Heart Association

LONDON – Two large phase III trials with lebrikizumab, a monoclonal antibody that blocks the activity of interleukin-13 (IL-13), produced inconsistent evidence of benefit in patients with uncontrolled asthma, according to a presentation of both sets of data at the annual congress of the European Respiratory Society.

The two phase III studies compared lebrikizumab in doses of 37.5 mg and 125 mg to placebo, each administered subcutaneously every 4 weeks. The results were mixed not only for the primary endpoint, which was a reduction in the rate of exacerbations, but also for several secondary outcomes.

Ted Bosworth/Frontline Medical News

LONDON – Two large phase III trials with lebrikizumab, a monoclonal antibody that blocks the activity of interleukin-13 (IL-13), produced inconsistent evidence of benefit in patients with uncontrolled asthma, according to a presentation of both sets of data at the annual congress of the European Respiratory Society.

The two phase III studies compared lebrikizumab in doses of 37.5 mg and 125 mg to placebo, each administered subcutaneously every 4 weeks. The results were mixed not only for the primary endpoint, which was a reduction in the rate of exacerbations, but also for several secondary outcomes.

Ted Bosworth/Frontline Medical News

LONDON – Two large phase III trials with lebrikizumab, a monoclonal antibody that blocks the activity of interleukin-13 (IL-13), produced inconsistent evidence of benefit in patients with uncontrolled asthma, according to a presentation of both sets of data at the annual congress of the European Respiratory Society.

The two phase III studies compared lebrikizumab in doses of 37.5 mg and 125 mg to placebo, each administered subcutaneously every 4 weeks. The results were mixed not only for the primary endpoint, which was a reduction in the rate of exacerbations, but also for several secondary outcomes.

Ted Bosworth/Frontline Medical News

Patients with stage 1 non–small cell lung cancer who underwent resection with intent to cure were more likely, over the short term, to die of other causes, investigators reported.

“Non–cancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Takashi Eguchi, MD, and his associates at Memorial Sloan Kettering Cancer Center, New York wrote (J Clin Oncol. 2016 Oct 10. doi: 10.1200/JCO.2016.69.0834).

“These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status, and help determine patients’ optimal treatment options.”

The study included 2,186 patients who underwent curative-intent resection of stage 1 non-small cell lung cancer at Memorial Sloan Kettering between 2000 and 2011. The cumulative 5-year lung cancer death rate was 10.4%, but rose with age from 7.5% among patients younger than 65 years to 13.2% among patients who were at least 75 years old. Cumulative 5-year rates of mortality not due to cancer were lower, at 5.3% overall, 1.8% in the youngest cohort, and 9% in the oldest cohort. But a competing risk analysis of the entire cohort showed that non–cancer-specific cumulative mortality was higher than mortality from lung cancer for up to 1.5 years after resection, the investigators found. Furthermore, patients who were at least 75 years old were more likely to die of causes other than cancer for up to 2.5 years after surgery.

In the multivariable analysis, low predicted postoperative diffusing capacity of lung for carbon monoxide (DCLO) independently predicted severe morbidity (P less than .001), 1-year mortality (P less than .001), and non–cancer-specific mortality (P less than .001), the researchers said. These findings reflect prior work linking low DCLO with obstructive, restrictive, and pulmonary vascular disease, chronic heart failure, and poor postoperative outcomes, they noted.

Senior author Prasad S. Adusumilli, MD, provided funding. Dr. Eguchi and Dr. Adusumilli had no relevant financial disclosures.

Patients with stage 1 non–small cell lung cancer who underwent resection with intent to cure were more likely, over the short term, to die of other causes, investigators reported.

“Non–cancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Takashi Eguchi, MD, and his associates at Memorial Sloan Kettering Cancer Center, New York wrote (J Clin Oncol. 2016 Oct 10. doi: 10.1200/JCO.2016.69.0834).

“These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status, and help determine patients’ optimal treatment options.”

The study included 2,186 patients who underwent curative-intent resection of stage 1 non-small cell lung cancer at Memorial Sloan Kettering between 2000 and 2011. The cumulative 5-year lung cancer death rate was 10.4%, but rose with age from 7.5% among patients younger than 65 years to 13.2% among patients who were at least 75 years old. Cumulative 5-year rates of mortality not due to cancer were lower, at 5.3% overall, 1.8% in the youngest cohort, and 9% in the oldest cohort. But a competing risk analysis of the entire cohort showed that non–cancer-specific cumulative mortality was higher than mortality from lung cancer for up to 1.5 years after resection, the investigators found. Furthermore, patients who were at least 75 years old were more likely to die of causes other than cancer for up to 2.5 years after surgery.

In the multivariable analysis, low predicted postoperative diffusing capacity of lung for carbon monoxide (DCLO) independently predicted severe morbidity (P less than .001), 1-year mortality (P less than .001), and non–cancer-specific mortality (P less than .001), the researchers said. These findings reflect prior work linking low DCLO with obstructive, restrictive, and pulmonary vascular disease, chronic heart failure, and poor postoperative outcomes, they noted.

Senior author Prasad S. Adusumilli, MD, provided funding. Dr. Eguchi and Dr. Adusumilli had no relevant financial disclosures.

Patients with stage 1 non–small cell lung cancer who underwent resection with intent to cure were more likely, over the short term, to die of other causes, investigators reported.

“Non–cancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Takashi Eguchi, MD, and his associates at Memorial Sloan Kettering Cancer Center, New York wrote (J Clin Oncol. 2016 Oct 10. doi: 10.1200/JCO.2016.69.0834).

“These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status, and help determine patients’ optimal treatment options.”

The study included 2,186 patients who underwent curative-intent resection of stage 1 non-small cell lung cancer at Memorial Sloan Kettering between 2000 and 2011. The cumulative 5-year lung cancer death rate was 10.4%, but rose with age from 7.5% among patients younger than 65 years to 13.2% among patients who were at least 75 years old. Cumulative 5-year rates of mortality not due to cancer were lower, at 5.3% overall, 1.8% in the youngest cohort, and 9% in the oldest cohort. But a competing risk analysis of the entire cohort showed that non–cancer-specific cumulative mortality was higher than mortality from lung cancer for up to 1.5 years after resection, the investigators found. Furthermore, patients who were at least 75 years old were more likely to die of causes other than cancer for up to 2.5 years after surgery.

In the multivariable analysis, low predicted postoperative diffusing capacity of lung for carbon monoxide (DCLO) independently predicted severe morbidity (P less than .001), 1-year mortality (P less than .001), and non–cancer-specific mortality (P less than .001), the researchers said. These findings reflect prior work linking low DCLO with obstructive, restrictive, and pulmonary vascular disease, chronic heart failure, and poor postoperative outcomes, they noted.

Senior author Prasad S. Adusumilli, MD, provided funding. Dr. Eguchi and Dr. Adusumilli had no relevant financial disclosures.

WAIKOLOA, HAWAII – Preperitoneal pelvic packing reduces mortality in patients with life-threatening hemorrhage caused by unstable pelvic fractures, results from a long-term single-center study showed.

“Despite advances in care of the critically injured patient, mortality rates for patients with hemodynamic instability due to pelvic fractures remains greater than 30%,” Clay Cothren Burlew, MD, said at the annual meeting of the American Association for the Surgery of Trauma. “The majority of trauma centers in the United States use angioembolization for hemorrhage control. While angioembolization is effective in controlling arterial sources of hemorrhage, which constitutes about 15% of pelvic bleeding, it does not address the venous or bony sources of hemorrhage within the pelvis. Additionally, time to arterial hemorrhage control using angioembolization usually takes several hours to accomplish, even at the most advanced level I trauma centers.”

[email protected]

WAIKOLOA, HAWAII – Preperitoneal pelvic packing reduces mortality in patients with life-threatening hemorrhage caused by unstable pelvic fractures, results from a long-term single-center study showed.

“Despite advances in care of the critically injured patient, mortality rates for patients with hemodynamic instability due to pelvic fractures remains greater than 30%,” Clay Cothren Burlew, MD, said at the annual meeting of the American Association for the Surgery of Trauma. “The majority of trauma centers in the United States use angioembolization for hemorrhage control. While angioembolization is effective in controlling arterial sources of hemorrhage, which constitutes about 15% of pelvic bleeding, it does not address the venous or bony sources of hemorrhage within the pelvis. Additionally, time to arterial hemorrhage control using angioembolization usually takes several hours to accomplish, even at the most advanced level I trauma centers.”

[email protected]

WAIKOLOA, HAWAII – Preperitoneal pelvic packing reduces mortality in patients with life-threatening hemorrhage caused by unstable pelvic fractures, results from a long-term single-center study showed.

“Despite advances in care of the critically injured patient, mortality rates for patients with hemodynamic instability due to pelvic fractures remains greater than 30%,” Clay Cothren Burlew, MD, said at the annual meeting of the American Association for the Surgery of Trauma. “The majority of trauma centers in the United States use angioembolization for hemorrhage control. While angioembolization is effective in controlling arterial sources of hemorrhage, which constitutes about 15% of pelvic bleeding, it does not address the venous or bony sources of hemorrhage within the pelvis. Additionally, time to arterial hemorrhage control using angioembolization usually takes several hours to accomplish, even at the most advanced level I trauma centers.”

[email protected]

Investigators across the United States and Europe hope to answer questions surrounding the feasibility of preventing rheumatoid arthritis in a series of proof-of-concept clinical trials that are enrolling patients with various risk factors for the disease. At least five trials have begun – with one already completed – to prevent RA with disease-modifying antirheumatic drugs, including a U.S. trial with hydroxychloroquine and European trials involving methotrexate, rituximab, and abatacept. Another trial with atorvastatin is also underway.

All of the trials involve participants with different risk factors for RA and may thereby provide a range of answers about where the most promising areas for disease prevention lie.
 

Hydroxychloroquine

Perhaps the broadest in scope of all the studies investigating the prevention of RA is the StopRA (Strategy to Prevent the Onset of Clinically Apparent Rheumatoid Arthritis) trial, which is randomizing 200 subjects with an anticyclic citrullinated peptide 3 (anti-CCP3) that’s greater than twice the normal level, with or without arthralgia, to either hydroxychloroquine (HCQ) 200-400 mg/day or placebo for 1 year, followed by 2 years of follow-up. Pilot data indicated that a level of 40 U/mL or higher of anti-CCP3, which is twice the normal level for positivity, gave a 50% chance of developing RA in the next 3 years regardless of symptoms, family history, or other factors.

Courtesy Kevin Deane, MD

Methotrexate

The Dutch TREAT EARLIER (Treat Early Arthralgia to Reverse or Limit Impending Exacerbation to Rheumatoid Arthritis) trial is unique among the RA prevention trials for its inclusion of patients with clinically suspect arthralgia and subclinical inflammation on MRI in the hand or foot without any requirement for seropositivity. The trial’s 200 participants are randomized to methotrexate or placebo for 1 year. All subjects receive an initial 120-mg intramuscular injection of methylprednisolone. The primary outcome measured at 2 years is the frequency of clinically detectable arthritis fulfilling the 2010 European League Against Rheumatism/American College of Rheumatology criteria for RA or of unclassified arthritis with a swollen joint count of more than two joints, both persisting for at least 4 weeks. The trial, which is investigator initiated without industry sponsorship, has been enrolling patients for about 1.5 years and will need about that much more time to complete it.

Abatacept

The APIPPRA (Arthritis Prevention in the Preclinical Phase of Rheumatoid Arthritis with Abatacept) trial hopes to find out whether RA or clinical synovitis can be prevented with abatacept (Orencia) 125 mg weekly by comparing it against placebo over a 12-month period in 206 British and Dutch patients with arthralgia who are rheumatoid factor (RF) and ACPA-positive. Subjects who are RF negative, but who carry high levels of serum ACPA defined as three times the upper limit of normal may be included. There will be a 1-year follow-up after the intervention period to monitor patients for arthritis.

The ARIAA (Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia) trial is randomizing 98 German patients with ACPA-positive arthralgia to 6 months of abatacept 125 mg weekly for 6 months vs. placebo, followed by a 12-month follow-up period. The primary outcome of the double-blind trial is the proportion of patients with an improvement of acute inflammation characterized as improvement of synovitis or osteitis in the MRI of the dominant hand after 6 months of treatment. The proportion of patients who develop RA based on ACR/EULAR 2010 criteria at 6-month intervals is one of a multitude of secondary outcomes that will be measured. Individuals in the study must test positive for ACPA (with or without RF); have joint pain in the hand, feet, knee, shoulder, or elbow for at least 6 weeks prior to inclusion or in past history; and synovitis or osteitis present on MRI of the dominant hand at baseline.

The two abatacept trials, both of which are expected to be completed in 2018, are sponsored by abatacept’s manufacturer, Bristol-Myers Squibb.
 

Rituximab

Results from the randomized, placebo-controlled PRAIRI (Prevention of RA by Rituximab) trial that were reported at the annual European Congress of Rheumatology in June showed that a single, intravenous infusion of 1,000 mg of rituximab (Rituxan) given to people with arthralgia and a high risk for developing rheumatoid arthritis did not prevent RA, but the treatment did appear to delay the development of RA. During follow-up, 16 of the 40 people in the placebo group (40%) developed RA after a median of 12 months, and 14 of the 41 in the treated arm (34%) developed RA after a median of 17 months. A Kaplan-Meier survival analysis found that the development of RA in 25% of people occurred at about 12 months in the placebo arm, whereas in the intervention arm it did not occur until 24 months.

At three Dutch centers, the PRAIRI trial investigators enrolled people with arthralgia who had never been diagnosed with arthritis, had never used a disease-modifying antirheumatic drug, and had at least one of these two risk factors: a serum level of IgM rheumatoid factor of more than 12.5 IU/mL and a serum level of anticitrullinated peptide antibodies of more than 25 IU/mL. Enrolled participants also needed to have at least one of the following: a serum level of C-reactive protein greater than 3 mg/L, an erythrocyte sedimentation rate of greater than 28 mm/hr, and evidence of subclinical synovitis identified by either ultrasound or MRI.
 

Atorvastatin

The STAPRA (Statins to Prevent Rheumatoid Arthritis) trial is randomizing 220 people to double-blind treatment with either atorvastatin 40 mg or placebo for 3 years to determine whether the combined lipid-lowering and anti-inflammatory effects of statin therapy may be able to prevent the development of clinical arthritis in people at increased risk for RA. The participants must test positive for RF and ACPA or a high ACPA titer of three times the cut-off value. Arthralgia is not required, and participants must not have current clinically apparent synovitis. The main endpoint is the development of clinical arthritis as confirmed by a rheumatologist in the study. The trial is scheduled to be completed in 2020.

[email protected]

Investigators across the United States and Europe hope to answer questions surrounding the feasibility of preventing rheumatoid arthritis in a series of proof-of-concept clinical trials that are enrolling patients with various risk factors for the disease. At least five trials have begun – with one already completed – to prevent RA with disease-modifying antirheumatic drugs, including a U.S. trial with hydroxychloroquine and European trials involving methotrexate, rituximab, and abatacept. Another trial with atorvastatin is also underway.

All of the trials involve participants with different risk factors for RA and may thereby provide a range of answers about where the most promising areas for disease prevention lie.
 

Hydroxychloroquine

Perhaps the broadest in scope of all the studies investigating the prevention of RA is the StopRA (Strategy to Prevent the Onset of Clinically Apparent Rheumatoid Arthritis) trial, which is randomizing 200 subjects with an anticyclic citrullinated peptide 3 (anti-CCP3) that’s greater than twice the normal level, with or without arthralgia, to either hydroxychloroquine (HCQ) 200-400 mg/day or placebo for 1 year, followed by 2 years of follow-up. Pilot data indicated that a level of 40 U/mL or higher of anti-CCP3, which is twice the normal level for positivity, gave a 50% chance of developing RA in the next 3 years regardless of symptoms, family history, or other factors.

Courtesy Kevin Deane, MD

Methotrexate

The Dutch TREAT EARLIER (Treat Early Arthralgia to Reverse or Limit Impending Exacerbation to Rheumatoid Arthritis) trial is unique among the RA prevention trials for its inclusion of patients with clinically suspect arthralgia and subclinical inflammation on MRI in the hand or foot without any requirement for seropositivity. The trial’s 200 participants are randomized to methotrexate or placebo for 1 year. All subjects receive an initial 120-mg intramuscular injection of methylprednisolone. The primary outcome measured at 2 years is the frequency of clinically detectable arthritis fulfilling the 2010 European League Against Rheumatism/American College of Rheumatology criteria for RA or of unclassified arthritis with a swollen joint count of more than two joints, both persisting for at least 4 weeks. The trial, which is investigator initiated without industry sponsorship, has been enrolling patients for about 1.5 years and will need about that much more time to complete it.

Abatacept

The APIPPRA (Arthritis Prevention in the Preclinical Phase of Rheumatoid Arthritis with Abatacept) trial hopes to find out whether RA or clinical synovitis can be prevented with abatacept (Orencia) 125 mg weekly by comparing it against placebo over a 12-month period in 206 British and Dutch patients with arthralgia who are rheumatoid factor (RF) and ACPA-positive. Subjects who are RF negative, but who carry high levels of serum ACPA defined as three times the upper limit of normal may be included. There will be a 1-year follow-up after the intervention period to monitor patients for arthritis.

The ARIAA (Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia) trial is randomizing 98 German patients with ACPA-positive arthralgia to 6 months of abatacept 125 mg weekly for 6 months vs. placebo, followed by a 12-month follow-up period. The primary outcome of the double-blind trial is the proportion of patients with an improvement of acute inflammation characterized as improvement of synovitis or osteitis in the MRI of the dominant hand after 6 months of treatment. The proportion of patients who develop RA based on ACR/EULAR 2010 criteria at 6-month intervals is one of a multitude of secondary outcomes that will be measured. Individuals in the study must test positive for ACPA (with or without RF); have joint pain in the hand, feet, knee, shoulder, or elbow for at least 6 weeks prior to inclusion or in past history; and synovitis or osteitis present on MRI of the dominant hand at baseline.

The two abatacept trials, both of which are expected to be completed in 2018, are sponsored by abatacept’s manufacturer, Bristol-Myers Squibb.
 

Rituximab

Results from the randomized, placebo-controlled PRAIRI (Prevention of RA by Rituximab) trial that were reported at the annual European Congress of Rheumatology in June showed that a single, intravenous infusion of 1,000 mg of rituximab (Rituxan) given to people with arthralgia and a high risk for developing rheumatoid arthritis did not prevent RA, but the treatment did appear to delay the development of RA. During follow-up, 16 of the 40 people in the placebo group (40%) developed RA after a median of 12 months, and 14 of the 41 in the treated arm (34%) developed RA after a median of 17 months. A Kaplan-Meier survival analysis found that the development of RA in 25% of people occurred at about 12 months in the placebo arm, whereas in the intervention arm it did not occur until 24 months.

At three Dutch centers, the PRAIRI trial investigators enrolled people with arthralgia who had never been diagnosed with arthritis, had never used a disease-modifying antirheumatic drug, and had at least one of these two risk factors: a serum level of IgM rheumatoid factor of more than 12.5 IU/mL and a serum level of anticitrullinated peptide antibodies of more than 25 IU/mL. Enrolled participants also needed to have at least one of the following: a serum level of C-reactive protein greater than 3 mg/L, an erythrocyte sedimentation rate of greater than 28 mm/hr, and evidence of subclinical synovitis identified by either ultrasound or MRI.
 

Atorvastatin

The STAPRA (Statins to Prevent Rheumatoid Arthritis) trial is randomizing 220 people to double-blind treatment with either atorvastatin 40 mg or placebo for 3 years to determine whether the combined lipid-lowering and anti-inflammatory effects of statin therapy may be able to prevent the development of clinical arthritis in people at increased risk for RA. The participants must test positive for RF and ACPA or a high ACPA titer of three times the cut-off value. Arthralgia is not required, and participants must not have current clinically apparent synovitis. The main endpoint is the development of clinical arthritis as confirmed by a rheumatologist in the study. The trial is scheduled to be completed in 2020.

[email protected]

Investigators across the United States and Europe hope to answer questions surrounding the feasibility of preventing rheumatoid arthritis in a series of proof-of-concept clinical trials that are enrolling patients with various risk factors for the disease. At least five trials have begun – with one already completed – to prevent RA with disease-modifying antirheumatic drugs, including a U.S. trial with hydroxychloroquine and European trials involving methotrexate, rituximab, and abatacept. Another trial with atorvastatin is also underway.

All of the trials involve participants with different risk factors for RA and may thereby provide a range of answers about where the most promising areas for disease prevention lie.
 

Hydroxychloroquine

Perhaps the broadest in scope of all the studies investigating the prevention of RA is the StopRA (Strategy to Prevent the Onset of Clinically Apparent Rheumatoid Arthritis) trial, which is randomizing 200 subjects with an anticyclic citrullinated peptide 3 (anti-CCP3) that’s greater than twice the normal level, with or without arthralgia, to either hydroxychloroquine (HCQ) 200-400 mg/day or placebo for 1 year, followed by 2 years of follow-up. Pilot data indicated that a level of 40 U/mL or higher of anti-CCP3, which is twice the normal level for positivity, gave a 50% chance of developing RA in the next 3 years regardless of symptoms, family history, or other factors.

Courtesy Kevin Deane, MD

Methotrexate

The Dutch TREAT EARLIER (Treat Early Arthralgia to Reverse or Limit Impending Exacerbation to Rheumatoid Arthritis) trial is unique among the RA prevention trials for its inclusion of patients with clinically suspect arthralgia and subclinical inflammation on MRI in the hand or foot without any requirement for seropositivity. The trial’s 200 participants are randomized to methotrexate or placebo for 1 year. All subjects receive an initial 120-mg intramuscular injection of methylprednisolone. The primary outcome measured at 2 years is the frequency of clinically detectable arthritis fulfilling the 2010 European League Against Rheumatism/American College of Rheumatology criteria for RA or of unclassified arthritis with a swollen joint count of more than two joints, both persisting for at least 4 weeks. The trial, which is investigator initiated without industry sponsorship, has been enrolling patients for about 1.5 years and will need about that much more time to complete it.

Abatacept

The APIPPRA (Arthritis Prevention in the Preclinical Phase of Rheumatoid Arthritis with Abatacept) trial hopes to find out whether RA or clinical synovitis can be prevented with abatacept (Orencia) 125 mg weekly by comparing it against placebo over a 12-month period in 206 British and Dutch patients with arthralgia who are rheumatoid factor (RF) and ACPA-positive. Subjects who are RF negative, but who carry high levels of serum ACPA defined as three times the upper limit of normal may be included. There will be a 1-year follow-up after the intervention period to monitor patients for arthritis.

The ARIAA (Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia) trial is randomizing 98 German patients with ACPA-positive arthralgia to 6 months of abatacept 125 mg weekly for 6 months vs. placebo, followed by a 12-month follow-up period. The primary outcome of the double-blind trial is the proportion of patients with an improvement of acute inflammation characterized as improvement of synovitis or osteitis in the MRI of the dominant hand after 6 months of treatment. The proportion of patients who develop RA based on ACR/EULAR 2010 criteria at 6-month intervals is one of a multitude of secondary outcomes that will be measured. Individuals in the study must test positive for ACPA (with or without RF); have joint pain in the hand, feet, knee, shoulder, or elbow for at least 6 weeks prior to inclusion or in past history; and synovitis or osteitis present on MRI of the dominant hand at baseline.

The two abatacept trials, both of which are expected to be completed in 2018, are sponsored by abatacept’s manufacturer, Bristol-Myers Squibb.
 

Rituximab

Results from the randomized, placebo-controlled PRAIRI (Prevention of RA by Rituximab) trial that were reported at the annual European Congress of Rheumatology in June showed that a single, intravenous infusion of 1,000 mg of rituximab (Rituxan) given to people with arthralgia and a high risk for developing rheumatoid arthritis did not prevent RA, but the treatment did appear to delay the development of RA. During follow-up, 16 of the 40 people in the placebo group (40%) developed RA after a median of 12 months, and 14 of the 41 in the treated arm (34%) developed RA after a median of 17 months. A Kaplan-Meier survival analysis found that the development of RA in 25% of people occurred at about 12 months in the placebo arm, whereas in the intervention arm it did not occur until 24 months.

At three Dutch centers, the PRAIRI trial investigators enrolled people with arthralgia who had never been diagnosed with arthritis, had never used a disease-modifying antirheumatic drug, and had at least one of these two risk factors: a serum level of IgM rheumatoid factor of more than 12.5 IU/mL and a serum level of anticitrullinated peptide antibodies of more than 25 IU/mL. Enrolled participants also needed to have at least one of the following: a serum level of C-reactive protein greater than 3 mg/L, an erythrocyte sedimentation rate of greater than 28 mm/hr, and evidence of subclinical synovitis identified by either ultrasound or MRI.
 

Atorvastatin

The STAPRA (Statins to Prevent Rheumatoid Arthritis) trial is randomizing 220 people to double-blind treatment with either atorvastatin 40 mg or placebo for 3 years to determine whether the combined lipid-lowering and anti-inflammatory effects of statin therapy may be able to prevent the development of clinical arthritis in people at increased risk for RA. The participants must test positive for RF and ACPA or a high ACPA titer of three times the cut-off value. Arthralgia is not required, and participants must not have current clinically apparent synovitis. The main endpoint is the development of clinical arthritis as confirmed by a rheumatologist in the study. The trial is scheduled to be completed in 2020.

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LONDON – Recent evidence of ever smokers having measurable deficits in activity even when lung function is preserved has been further expanded by findings suggesting a different phenotype for patients in this group with radiologic evidence of emphysema, according to data from SPIROMICS (Subpopulations and Intermediate Outcome Measures In COPD Study).

The most recent data were presented at the annual congress of the European Respiratory Society.

Earlier this year, published data drawn from SPIROMICS demonstrated that current and former smokers with preserved lung function (forced expiratory volume in 1 second:forced vital capacity greater than or equal to 0.70) had activity limitations, respiratory symptoms, and exacerbations even though they did not meet the current definition of chronic obstructive pulmonary disease (COPD) (N Engl J Med. 2016;374:1811-21). In the new analysis, further distinctions could be made for patients in this subgroup who also had emphysema on computed tomography (CT).

“Among smokers with preserved lung function, emphysema on CT was associated with reduced activity levels and desaturation on the 6-minute walk test (6MWT),” reported Christian M. Lo Cascio, MD, Columbia University, New York. Compared with smokers with preserved lung function without CT evidence of emphysema, the patients with emphysema on CT did not have more symptoms or exacerbations.

“These and prior findings suggest two distinct but overlapping phenotypes in ever smokers with preserved lung function: an airway disease with respiratory symptoms and frequent exacerbations and emphysema characterized by activity limitation and increased mortality,” said Dr. Lo Cascio.

SPIROMICS, an observational study supported by the National Heart, Lung, and Blood Institute, has enrolled current and former smokers at six centers in the United States to prospectively analyze biomarker, genetic, and clinical data. In the previously published analysis, the focus was on the difference between 849 ever smokers with preserved lung function and 963 patients with mild to moderate COPD. In the data presented by Dr. Lo Cascio, 901 SPIROMICS patients with preserved lung function were analyzed with the focus on the difference between the 66 (7%) who had radiologic evidence of emphysema and the 835 (93%) who had undergone CT indicating that they did not have emphysema.

“Our hypothesis was that the subgroup of patients with emphysema on CT would have lower activity levels, greater desaturation of at least 4% on the 6MWT, more respiratory symptoms, and more exacerbations,” Dr. Lo Cascio reported.

The hypothesis was only half correct. As measured on the activity component of the St. Georges Respiratory Questionnaire, there was about a 10-point (P less than .001) greater reduction in reported activity levels among those with emphysema on CT relative to those without. In addition, the odds ratio (OR) for significant oxygen desaturation, defined as a 4% fall in oxygen saturation of hemoglobin during the 6MWD, was approximately two times greater (P less than .001) for the patients with CT evidence of emphysema.

There were no significant differences between the two groups in walking distance on the 6MWD. Both sets of patients had the same rate of exacerbations and scores on the symptom component of the St. Georges Respiratory Questionnaire, which captures cough, phlegm, wheezing, shortness of breath, and symptom-free days.

Overall, when ever smokers with preserved lung function were subdivided into those with and without CT evidence of emphysema, several similarities were found between the two groups. For those with CT evidence of emphysema and those with no CT evidence of emphysema, mean pack-years of smoking were 43 years and 40 years, respectively, and average body mass indexes were 28.1 and 29.1, respectively. The percentage of patients who had a COPD Assessment Test score of greater than or equal to 10 was 61% among those with CT evidence of emphysema, vs. 50% among those patients without CT evidence of emphysema.

When asked if looking for emphysema on CT in ever smokers with preserved lung function might have clinical utility, Dr. Lo Cascio suggested that it is not yet clear how this information might change management. These data strengthen other evidence from SPIROMICS that ever smokers who do not meet the definition of COPD already have a significant disease burden, he said.

Dr. Lo Cascio reports no relevant financial relationships.

LONDON – Recent evidence of ever smokers having measurable deficits in activity even when lung function is preserved has been further expanded by findings suggesting a different phenotype for patients in this group with radiologic evidence of emphysema, according to data from SPIROMICS (Subpopulations and Intermediate Outcome Measures In COPD Study).

The most recent data were presented at the annual congress of the European Respiratory Society.

Earlier this year, published data drawn from SPIROMICS demonstrated that current and former smokers with preserved lung function (forced expiratory volume in 1 second:forced vital capacity greater than or equal to 0.70) had activity limitations, respiratory symptoms, and exacerbations even though they did not meet the current definition of chronic obstructive pulmonary disease (COPD) (N Engl J Med. 2016;374:1811-21). In the new analysis, further distinctions could be made for patients in this subgroup who also had emphysema on computed tomography (CT).

“Among smokers with preserved lung function, emphysema on CT was associated with reduced activity levels and desaturation on the 6-minute walk test (6MWT),” reported Christian M. Lo Cascio, MD, Columbia University, New York. Compared with smokers with preserved lung function without CT evidence of emphysema, the patients with emphysema on CT did not have more symptoms or exacerbations.

“These and prior findings suggest two distinct but overlapping phenotypes in ever smokers with preserved lung function: an airway disease with respiratory symptoms and frequent exacerbations and emphysema characterized by activity limitation and increased mortality,” said Dr. Lo Cascio.

SPIROMICS, an observational study supported by the National Heart, Lung, and Blood Institute, has enrolled current and former smokers at six centers in the United States to prospectively analyze biomarker, genetic, and clinical data. In the previously published analysis, the focus was on the difference between 849 ever smokers with preserved lung function and 963 patients with mild to moderate COPD. In the data presented by Dr. Lo Cascio, 901 SPIROMICS patients with preserved lung function were analyzed with the focus on the difference between the 66 (7%) who had radiologic evidence of emphysema and the 835 (93%) who had undergone CT indicating that they did not have emphysema.

“Our hypothesis was that the subgroup of patients with emphysema on CT would have lower activity levels, greater desaturation of at least 4% on the 6MWT, more respiratory symptoms, and more exacerbations,” Dr. Lo Cascio reported.

The hypothesis was only half correct. As measured on the activity component of the St. Georges Respiratory Questionnaire, there was about a 10-point (P less than .001) greater reduction in reported activity levels among those with emphysema on CT relative to those without. In addition, the odds ratio (OR) for significant oxygen desaturation, defined as a 4% fall in oxygen saturation of hemoglobin during the 6MWD, was approximately two times greater (P less than .001) for the patients with CT evidence of emphysema.

There were no significant differences between the two groups in walking distance on the 6MWD. Both sets of patients had the same rate of exacerbations and scores on the symptom component of the St. Georges Respiratory Questionnaire, which captures cough, phlegm, wheezing, shortness of breath, and symptom-free days.

Overall, when ever smokers with preserved lung function were subdivided into those with and without CT evidence of emphysema, several similarities were found between the two groups. For those with CT evidence of emphysema and those with no CT evidence of emphysema, mean pack-years of smoking were 43 years and 40 years, respectively, and average body mass indexes were 28.1 and 29.1, respectively. The percentage of patients who had a COPD Assessment Test score of greater than or equal to 10 was 61% among those with CT evidence of emphysema, vs. 50% among those patients without CT evidence of emphysema.

When asked if looking for emphysema on CT in ever smokers with preserved lung function might have clinical utility, Dr. Lo Cascio suggested that it is not yet clear how this information might change management. These data strengthen other evidence from SPIROMICS that ever smokers who do not meet the definition of COPD already have a significant disease burden, he said.

Dr. Lo Cascio reports no relevant financial relationships.

LONDON – Recent evidence of ever smokers having measurable deficits in activity even when lung function is preserved has been further expanded by findings suggesting a different phenotype for patients in this group with radiologic evidence of emphysema, according to data from SPIROMICS (Subpopulations and Intermediate Outcome Measures In COPD Study).

The most recent data were presented at the annual congress of the European Respiratory Society.

Earlier this year, published data drawn from SPIROMICS demonstrated that current and former smokers with preserved lung function (forced expiratory volume in 1 second:forced vital capacity greater than or equal to 0.70) had activity limitations, respiratory symptoms, and exacerbations even though they did not meet the current definition of chronic obstructive pulmonary disease (COPD) (N Engl J Med. 2016;374:1811-21). In the new analysis, further distinctions could be made for patients in this subgroup who also had emphysema on computed tomography (CT).

“Among smokers with preserved lung function, emphysema on CT was associated with reduced activity levels and desaturation on the 6-minute walk test (6MWT),” reported Christian M. Lo Cascio, MD, Columbia University, New York. Compared with smokers with preserved lung function without CT evidence of emphysema, the patients with emphysema on CT did not have more symptoms or exacerbations.

“These and prior findings suggest two distinct but overlapping phenotypes in ever smokers with preserved lung function: an airway disease with respiratory symptoms and frequent exacerbations and emphysema characterized by activity limitation and increased mortality,” said Dr. Lo Cascio.

SPIROMICS, an observational study supported by the National Heart, Lung, and Blood Institute, has enrolled current and former smokers at six centers in the United States to prospectively analyze biomarker, genetic, and clinical data. In the previously published analysis, the focus was on the difference between 849 ever smokers with preserved lung function and 963 patients with mild to moderate COPD. In the data presented by Dr. Lo Cascio, 901 SPIROMICS patients with preserved lung function were analyzed with the focus on the difference between the 66 (7%) who had radiologic evidence of emphysema and the 835 (93%) who had undergone CT indicating that they did not have emphysema.

“Our hypothesis was that the subgroup of patients with emphysema on CT would have lower activity levels, greater desaturation of at least 4% on the 6MWT, more respiratory symptoms, and more exacerbations,” Dr. Lo Cascio reported.

The hypothesis was only half correct. As measured on the activity component of the St. Georges Respiratory Questionnaire, there was about a 10-point (P less than .001) greater reduction in reported activity levels among those with emphysema on CT relative to those without. In addition, the odds ratio (OR) for significant oxygen desaturation, defined as a 4% fall in oxygen saturation of hemoglobin during the 6MWD, was approximately two times greater (P less than .001) for the patients with CT evidence of emphysema.

There were no significant differences between the two groups in walking distance on the 6MWD. Both sets of patients had the same rate of exacerbations and scores on the symptom component of the St. Georges Respiratory Questionnaire, which captures cough, phlegm, wheezing, shortness of breath, and symptom-free days.

Overall, when ever smokers with preserved lung function were subdivided into those with and without CT evidence of emphysema, several similarities were found between the two groups. For those with CT evidence of emphysema and those with no CT evidence of emphysema, mean pack-years of smoking were 43 years and 40 years, respectively, and average body mass indexes were 28.1 and 29.1, respectively. The percentage of patients who had a COPD Assessment Test score of greater than or equal to 10 was 61% among those with CT evidence of emphysema, vs. 50% among those patients without CT evidence of emphysema.

When asked if looking for emphysema on CT in ever smokers with preserved lung function might have clinical utility, Dr. Lo Cascio suggested that it is not yet clear how this information might change management. These data strengthen other evidence from SPIROMICS that ever smokers who do not meet the definition of COPD already have a significant disease burden, he said.

Dr. Lo Cascio reports no relevant financial relationships.